[December 13, 2004 (Volume 69, Number 238)]
[Unified Agenda]
From the Federal Register Online via GPO Access [frwais.access.gpo.gov]
[DOCID:ua041202-1]
[Page 72645-72890]
REGULATORY INFORMATION SERVICE CENTER
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Part II
Regulatory Information Service Center
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Introduction to the Unified Agenda of Federal Regulatory and
Deregulatory Actions
Federal Register / Vol. 69, No. 238 / Monday, December 13, 2004 / The
Regulatory Plan
Federal Register / Vol. 69, No. 238 / Monday, December 13, 2004 / The
Regulatory Plan
[[Page 72645]]
Introduction to The Regulatory Plan and the Unified Agenda of Federal
Regulatory and Deregulatory Actions
AGENCY: Regulatory Information Service Center.
ACTION: Introduction to The Regulatory Plan and the Unified Agenda of
Federal Regulatory and Deregulatory Actions.
_______________________________________________________________________
SUMMARY: The Regulatory Flexibility Act requires that agencies publish
semiannual regulatory agendas describing regulatory actions they are
developing (5 U.S.C. 602). Executive Order 12866 ``Regulatory Planning
and Review,'' signed September 30, 1993 (58 FR 51735) and Office of
Management and Budget memoranda implementing section 4 of that Order
establish minimum standards for agencies' agendas, including specific
types of information for each entry. Section 4 of Executive Order 12866
also directs that each agency prepare, as part of its submission to the
fall edition of the Unified Agenda, a regulatory plan of the most
important significant regulatory actions that the agency reasonably
expects to issue in proposed or final form during the upcoming fiscal
year.
The Regulatory Plan (Plan) and the Unified Agenda of Federal
Regulatory and Deregulatory Actions (Unified Agenda) help agencies
fulfill these requirements. This publication contains the plans of 28
Federal agencies and the regulatory agendas for these and 32 other
Federal agencies.
ADDRESSES: Regulatory Information Service Center (MI), General Services
Administration, 1800 F Street NW., Suite 3033, Washington, DC 20405.
FOR FURTHER INFORMATION CONTACT: For further information about specific
regulatory actions, please refer to the Agency Contact listed for each
entry.
To provide comment on or to obtain further information about this
publication, contact: Ronald C. Kelly, Executive Director, Regulatory
Information Service Center (MI), General Services Administration, 1800
F Street NW., Suite 3033, Washington, DC 20405, (202) 482-7340. You may
also send comments to us by e-mail at:
RISC@gsa.gov
SUPPLEMENTARY INFORMATION:
TABLE OF CONTENTS
Page
Introduction to The Regulatory Plan and the Unified Agenda of Federal
Regulatory and Deregulatory Actions
I. What Are The Regulatory Plan and the Unified Agenda?......... 72646
II. Why Are The Regulatory Plan and the Unified Agenda 72646
Published?.....................................................
III. How Are The Regulatory Plan and the Unified Agenda 72647
Organized?.....................................................
IV. What Information Appears for Each Entry?.................... 72648
V. Abbreviations................................................ 72649
VI. How Can Users Get Copies of the Plan and the Agenda......... 72649
Introduction to the Fall 2004 Regulatory Plan 72651
AGENCY REGULATORY PLANS
Cabinet Departments
Department of Agriculture....................................... 72663
Department of Commerce.......................................... 72694
Department of Defense........................................... 72704
Department of Education......................................... 72709
Department of Energy............................................ 72712
Department of Health and Human Services......................... 72717
Department of Homeland Security................................. 72745
Department of Housing and Urban Development..................... 72759
Department of the Interior...................................... 72767
Department of Justice........................................... 72776
Department of Labor............................................. 72781
Department of Transportation.................................... 72796
Department of the Treasury...................................... 72807
Department of Veterans Affairs.................................. 72817
Other Executive Agencies
Environmental Protection Agency................................. 72819
Equal Employment Opportunity Commission......................... 72850
General Services Administration................................. 72852
National Aeronautics and Space Administration................... 72853
National Archives and Records Administration.................... 72854
Office of Personnel Management.................................. 72856
Pension Benefit Guaranty Corporation............................ 72858
Small Business Administration................................... 72861
Social Security Administration.................................. 72865
Independent Regulatory Agencies
Consumer Product Safety Commission.............................. 72880
Federal Housing Finance Board................................... 72883
Federal Maritime Commission..................................... 72884
Federal Trade Commission........................................ 72885
National Indian Gaming Commission............................... 72890
AGENCY AGENDAS
Cabinet Departments
Department of Agriculture....................................... 72891
Department of Commerce.......................................... 72973
Department of Defense........................................... 73055
Department of Education......................................... 73097
Department of Energy............................................ 73105
Department of Health and Human Services......................... 73119
Department of Homeland Security................................. 73185
Department of Housing and Urban Development..................... 73299
Department of the Interior...................................... 73331
Department of Justice........................................... 73403
Department of Labor............................................. 73449
Department of State............................................. 73483
Department of Transportation.................................... 73491
Department of the Treasury...................................... 73599
Department of Veterans Affairs.................................. 73739
Other Executive Agencies
Advisory Council on Historic Preservation....................... 73763
Agency for International Development............................ 73765
Architectural and Transportation Barriers Compliance Board...... 73769
Commission on Civil Rights...................................... 73773
Committee for Purchase From People Who Are Blind or Severely 73775
Disabled.......................................................
Corporation for National and Community Service.................. 73779
Court Services and Offender Supervision Agency for the District 73783
of Columbia....................................................
Environmental Protection Agency................................. 73785
Equal Employment Opportunity Commission......................... 73943
Federal Mediation and Conciliation Service...................... 73947
General Services Administration................................. 73951
National Aeronautics and Space Administration................... 73961
National Archives and Records Administration.................... 73969
National Foundation on the Arts and the Humanities
Institute of Museum and Library Services...................... 73977
National Endowment for the Arts............................... 73981
National Endowment for the Humanities......................... 73983
National Science Foundation..................................... 73985
Office of Federal Housing Enterprise Oversight.................. 73989
[[Page 72646]]
Office of Government Ethics..................................... 73993
Office of Management and Budget................................. 74001
Office of Personnel Management.................................. 74005
Peace Corps..................................................... 74031
Pension Benefit Guaranty Corporation............................ 74035
Presidio Trust.................................................. 74039
Railroad Retirement Board....................................... 74043
Selective Service System........................................ 74047
Small Business Administration................................... 74049
Social Security Administration.................................. 74059
Joint Authority
Department of Defense/General Services Administration/National 74077
Aeronautics and Space Administration (Federal Acquisition
Regulation)....................................................
Independent Regulatory Agencies
Commodity Futures Trading Commission............................ 74091
Consumer Product Safety Commission.............................. 74099
Farm Credit Administration...................................... 74109
Farm Credit System Insurance Corporation........................ 74117
Federal Communications Commission............................... 74119
Federal Deposit Insurance Corporation........................... 74179
Federal Energy Regulatory Commission............................ 74187
Federal Housing Finance Board................................... 74195
Federal Maritime Commission..................................... 74199
Federal Reserve System.......................................... 74205
Federal Trade Commission........................................ 74215
National Credit Union Administration............................ 74227
National Indian Gaming Commission............................... 74237
Nuclear Regulatory Commission................................... 74243
Securities and Exchange Commission.............................. 74259
Surface Transportation Board.................................... 74287
INDEXES TO UNIFIED AGENDA ENTRIES
A. Regulatory Flexibility Act Section 610 Review Index.......... 74291
B. Regulatory Flexibility Analysis Index........................ 74293
C. Small Entities Index (Regulatory Flexibility Analysis Not 74303
Required)......................................................
D. Government Levels Index...................................... 74315
E. Federalism Index............................................. 74349
F. Subject Index................................................ 74351
INTRODUCTION TO THE REGULATORY PLAN AND THE UNIFIED AGENDA OF
FEDERAL REGULATORY AND DEREGULATORY ACTIONS
I. What Are The Regulatory Plan and the Unified Agenda?
The Regulatory Plan serves as a defining statement of the
Administration's regulatory and deregulatory policies and priorities.
The Plan is part of the fall edition of the Unified Agenda. Each
participating agency's regulatory plan contains: (1) A narrative
statement of the agency's regulatory priorities and, for most agencies,
(2) a description of the most important significant regulatory and
deregulatory actions that the agency reasonably expects to issue in
proposed or final form during the upcoming fiscal year. This edition
includes the regulatory plans of 28 agencies.
The Unified Agenda provides information, in a uniform format,
about regulations that the Government is considering or reviewing. The
Unified Agenda has appeared in the Federal Register twice each year
since 1983. This edition includes regulatory agendas from 60 Federal
agencies. Agencies of the United States Congress are not included.
The Regulatory Information Service Center (the Center) compiles
the Plan and the Unified Agenda for the Office of Information and
Regulatory Affairs (OIRA), part of the Office of Management and Budget.
OIRA is responsible for overseeing the Federal Government's regulatory,
paperwork, and information resource management activities, including
implementation of Executive Order 12866. The Center also provides
information about Federal regulatory activity to the President and his
Executive Office, the Congress, agency managers, and the public.
The activities included in the Agenda are, in general, those that
will have a regulatory action within the next 12 months. Agencies may
include activities that will have a longer timeframe than 12 months.
Agency agendas also show actions or reviews completed or withdrawn
since the last Unified Agenda. The agendas do not contain regulations
that were excluded under Executive Order 12866, such as those
concerning military or foreign affairs functions or regulations related
to agency organization, management, or personnel matters.
Agencies prepared entries for this publication to give the public
notice of their plans to review, propose, and issue regulations. They
have tried to predict their activities over the next 12 months as
accurately as possible, but dates and schedules are subject to change.
Agencies may withdraw some of the regulations now under development,
and they may issue or propose other regulations not included in their
agendas. Agency actions in the rulemaking process may occur before or
after the dates they have listed. The Regulatory Plan and the Unified
Agenda do not create a legal obligation on agencies to adhere to
schedules in this publication or to confine their regulatory activities
to those regulations that appear within it.
II. Why Are The Regulatory Plan and the Unified Agenda Published?
The Regulatory Plan and the Unified Agenda help agencies comply
with their obligations under the Regulatory Flexibility Act and various
Executive orders and other statutes.
Regulatory Flexibility Act
The Regulatory Flexibility Act requires agencies to identify those
rules that may have a significant economic impact on a substantial
number of small entities (5 U.S.C. 602). Agencies meet that requirement
by including the information in their submissions for the Unified
Agenda. Agencies may also indicate those regulations that they are
reviewing as part of their periodic review of existing rules under the
Regulatory Flexibility Act (5 U.S.C. 610). Executive Order 13272
entitled ``Proper Consideration of Small Entities in Agency
Rulemaking,'' signed August 13, 2002 (67 FR 53461) provides additional
guidance on compliance with the Act.
Executive Order 12866
Executive Order 12866 entitled ``Regulatory Planning and Review,''
signed September 30, 1993 (58 FR 51735) requires covered agencies to
prepare an agenda of all regulations under development or review. The
Order also requires that certain agencies prepare annually a regulatory
plan of their ``most important significant regulatory actions,'' which
appears as part of the fall Unified Agenda.
Executive Order 13132
Executive Order 13132 entitled ``Federalism,'' signed August 4,
1999 (64 FR 43255) directs agencies to have an accountable process to
ensure meaningful and timely input by State and local officials in the
development of regulatory policies that have ``federalism
implications'' as defined in the Order. Under the Order, an agency that
is proposing regulations with federalism implications, which either
preempt State law or impose nonstatutory unfunded substantial direct
compliance costs on State and local governments, must consult with
State and local officials early in the process of developing the
regulation. In
[[Page 72647]]
addition, the agency must provide to the Director of the Office of
Management and Budget a federalism summary impact statement for such
regulations, which consists of a description of the extent of the
agency's prior consultation with State and local officials, a summary
of their concerns and the agency's position supporting the need to
issue the regulation, and a statement of the extent to which those
concerns have been met. As part of this effort, agencies include in
their submissions for the Unified Agenda information on whether their
regulatory actions may have an effect on the various levels of
government and whether those actions have federalism implications.
Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, title II)
requires agencies to prepare written assessments of the costs and
benefits of significant regulatory actions ``that may result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more . . . in any 1 year .
. . .'' The requirement does not apply to independent regulatory
agencies, nor does it apply to certain subject areas excluded by
section 4 of the Act. Affected agencies identify in the Unified Agenda
those regulatory actions they believe are subject to title II of the
Act.
Executive Order 13211
Executive Order 13211 entitled ``Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use,'' signed
May 18, 2001 (66 FR 28355) directs agencies to provide, to the extent
possible, information regarding the adverse effects that agency actions
may have on the supply, distribution, and use of energy. Under the
Order, the agency must prepare and submit a Statement of Energy Effects
to the Administrator of the Office of Information and Regulatory
Affairs, Office of Management and Budget, for ``those matters
identified as significant energy actions.'' As part of this effort,
agencies may optionally include in their submissions for the Unified
Agenda information on whether they have prepared or plan to prepare a
Statement of Energy Effects for their regulatory actions.
Small Business Regulatory Enforcement Fairness Act
The Small Business Regulatory Enforcement Fairness Act (Pub. L.
104-121, title II) established a procedure for congressional review of
rules (5 U.S.C. 801 et seq.), which defers, unless exempted, the
effective date of a ``major'' rule for at least 60 days from the
publication of the final rule in the Federal Register. The Act
specifies that a rule is ``major'' if it has resulted or is likely to
result in an annual effect on the economy of $100 million or more or
meets other criteria specified in that Act. The Act provides that the
Administrator of OIRA will make the final determination as to whether a
rule is major.
III. How Are The Regulatory Plan and the Unified Agenda
Organized?
The Regulatory Plan appears in part II of this edition of the
Federal Register. The Plan is a single document beginning with an
introduction, followed by a table of contents, followed by each
agency's section of the Plan. Following the Plan, each agency's agenda
appears as a separate part. The sections of the Plan and the parts of
the Unified Agenda are organized alphabetically in four groups: Cabinet
departments; other executive agencies; the Federal Acquisition
Regulation, a joint authority (Agenda only); and independent regulatory
agencies. Agencies may in turn be divided into subagencies.
Each agency's section of the Plan contains a narrative statement
of regulatory priorities and, for most agencies, a description of the
agency's most important significant regulatory and deregulatory
actions. Each agency's part of the Agenda begins with a preamble
providing information specific to that part followed by a table of
contents. Following the table of contents is a description of the
agency's regulatory and deregulatory actions.
In the Agenda, each agency presents its entries under one of five
headings according to the rulemaking stage of the entry. In the Plan,
only the first three stages are applicable. The stages are:
1. Prerule Stage -- actions agencies will undertake to determine
whether or how to initiate rulemaking. Such actions occur prior to
a Notice of Proposed Rulemaking (NPRM) and may include Advance
Notices of Proposed Rulemaking (ANPRMs) and reviews of existing
regulations.
2. Proposed Rule Stage -- actions for which agencies plan to publish a
Notice of Proposed Rulemaking as the next step in their rulemaking
process or for which the closing date of the NPRM Comment Period is
the next step.
3. Final Rule Stage -- actions for which agencies plan to publish a
final rule or an interim final rule or to take other final action
as the next step.
4. Long-Term Actions -- items under development but for which the
agency does not expect to have a regulatory action within the 12
months after publication of this edition of the Unified Agenda.
Some of the entries in this section may contain abbreviated
information.
5. Completed Actions -- actions or reviews the agency has completed or
withdrawn since publishing its last agenda. This section also
includes items the agency began and completed between issues of the
Agenda.
In the Agenda, an agency may use subheadings to identify
regulations that it has grouped according to particular topics. When
these subheadings are used, they appear above the title of the first
regulation in each group.
A bullet () preceding the title of an entry indicates that
the entry is appearing in the Unified Agenda for the first time.
All entries are numbered sequentially from the beginning to the
end of the publication. The sequence number preceding the title of each
entry identifies the location of the entry in this edition. This
sequence number is used as the reference in the table of contents and
in all indexes to enable readers to find entries. Entries in the Plan
are also in the Unified Agenda with the same Regulation Identifier
Number (RIN) but with different sequence numbers. For these entries,
the Plan sequence number is used as the reference in all indexes.
This publication contains six indexes.
Index A lists regulatory actions for which agencies have
indicated that they are conducting a periodic review under section
610(c) of the Regulatory Flexibility Act.
Index B lists the regulatory actions for which agencies
believe that the Regulatory Flexibility Act may require a
Regulatory Flexibility Analysis.
Index C lists additional regulatory actions for which agencies
have chosen to indicate that some impact on small entities is
likely even though a Regulatory Flexibility Analysis may not be
required.
Index D lists regulatory actions that agencies believe may
have effects on levels of government.
Index E lists regulatory actions that agencies believe may
have federalism implications as defined in Executive Order 13132.
[[Page 72648]]
Index F is a subject index based on the Federal Register
Thesaurus of Indexing Terms.
IV. What Information Appears for Each Entry?
All entries in the Unified Agenda contain uniform data elements
including, at a minimum, the following information:
Title of the Regulation -- a brief description of the subject of
the regulation, possibly including section 610 review designation. The
notation ``Section 610 Review'' following the title indicates that the
agency has selected the rule for its periodic review of existing rules
under the Regulatory Flexibility Act (5 U.S.C. 610(c)). Some agencies
have indicated completions of section 610 reviews or rulemaking actions
resulting from completed section 610 reviews.
Priority -- an indication of the significance of the regulation.
Agencies assign each entry to one of the following five categories of
significance.
(1) Economically Significant
As defined in Executive Order 12866, a rulemaking action that will
have an annual effect on the economy of $100 million or more or will
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities. The definition of an ``economically significant'' rule is
similar but not identical to the definition of a ``major'' rule under 5
U.S.C. 801 (Pub. L. 104-121). (See below.)
(2) Other Significant
A rulemaking that is not Economically Significant but is considered
Significant by the agency. This category includes rules that the agency
anticipates will be reviewed under Executive Order 12866 or rules that
are a priority of the agency head. These rules may or may not be
included in the agency's regulatory plan.
(3) Substantive, Nonsignificant
A rulemaking that has substantive impacts but is neither
Significant, nor Routine and Frequent, nor Informational/
Administrative/Other.
(4) Routine and Frequent
A rulemaking that is a specific case of a multiple recurring
application of a regulatory program in the Code of Federal Regulations
and that does not alter the body of the regulation.
(5) Informational/Administrative/Other
A rulemaking that is primarily informational or pertains to agency
matters not central to accomplishing the agency's regulatory mandate
but that the agency places in the Unified Agenda to inform the public
of the activity.
In addition, if a rule is ``major'' under 5 U.S.C. 801 (Pub. L.
104-121) because it has resulted or is likely to result in an annual
effect on the economy of $100 million or more or meets other criteria
specified in that Act, this is indicated under the ``Priority''
heading. The Act provides that the Administrator of the Office of
Information and Regulatory Affairs will make the final determination as
to whether a rule is major.
Unfunded Mandates -- whether the rule is covered by section 202 of
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). The Act
requires that, before issuing an NPRM likely to result in a mandate
that may result in expenditures by State, local, and tribal
governments, in the aggregate, or by the private sector of more than
$100 million in 1 year, agencies, other than independent regulatory
agencies, shall prepare a written statement containing an assessment of
the anticipated costs and benefits of the Federal mandate. If the
agency believes the entry is not subject to the Act, this data element
will not be printed.
Legal Authority -- the section(s) of the United States Code
(U.S.C.) or Public Law (Pub. L.) or the Executive order (E.O.) that
authorize(s) the regulatory action. Agencies may provide popular name
references to laws in addition to these citations.
CFR Citation -- the section(s) of the Code of Federal Regulations
that will be affected by the action.
Legal Deadline -- whether the action is subject to a statutory or
judicial deadline, the date of that deadline, and whether the deadline
pertains to an NPRM, a Final Action, or some other action.
Abstract -- a brief description of the problem the regulation will
address; the need for a Federal solution; to the extent available,
alternatives that the agency is considering to address the problem; and
potential costs and benefits of the action.
Timetable -- the dates and citations (if available) for all past
steps and a projected date for at least the next step for the
regulatory action. A date printed in the form 02/00/05 means the agency
is predicting the month and year the action will take place but not the
day it will occur. In some instances, agencies may indicate what the
next action will be, but the date of that action is ``To Be
Determined.'' ``Next Action Undetermined'' indicates the agency does
not know what action it will take next.
Regulatory Flexibility Analysis Required -- whether an analysis is
required by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
because the rulemaking action is likely to have a significant economic
impact on a substantial number of small entities as defined by the Act.
Small Entities Affected -- the types of small entities (businesses,
governmental jurisdictions, or organizations) on which the rulemaking
action is likely to have an impact as defined by the Regulatory
Flexibility Act. Some agencies have chosen to indicate likely effects
on small entities even though they believe that a Regulatory
Flexibility Analysis will not be required.
Government Levels Affected -- whether the action is expected to
affect levels of government and, if so, whether the governments are
State, local, tribal, or Federal.
Federalism -- whether the action has ``federalism implications'' as
defined in Executive Order 13132. This term refers to actions ``that
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.''
If the action does not have federalism implications, this data element
will not be printed. Independent regulatory agencies are not required
to supply this information.
Agency Contact -- the name and phone number of at least one person
in the agency who is knowledgeable about the rulemaking action. The
agency may also provide the title, address, fax number, e-mail address,
and TDD for each agency contact.
Some agencies have provided the following optional information:
URL for More Information -- the Internet address of a site that
provides more information about the entry.
[[Page 72649]]
URL for Public Comments -- the Internet address of a site that
will accept public comments on the entry. Alternatively, timely public
comments may be submitted at the governmentwide e-rulemaking site,
http://www.regulations.gov.
Additional Information -- any information an agency wishes to
include that does not have a specific data element.
Compliance Cost to the Public -- the estimated gross compliance
cost of the action.
Affected Sectors -- the industrial sectors that the action may most
affect, either directly or indirectly. Affected Sectors are identified
by North American Industry Classification System (NAICS) codes.
Energy Effects -- an indication of whether the agency has prepared
or plans to prepare a Statement of Energy Effects for the action, as
required by Executive Order 13211 ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use,'' signed May
18, 2001 (66 FR 28355).
Related RINs-- one or more past or current RINs associated with
activity related to this action, such as merged RINs, split RINs, new
activity for previously completed RINs, or duplicate RINs.
Entries appearing in The Regulatory Plan include one or more of
the following additional data elements, but will, at a minimum, include
information in Statement of Need:
Statement of Need -- a description of the need for the regulatory
action.
Summary of the Legal Basis -- a description of the legal basis for
the action, including whether any aspect of the action is required by
statute or court order.
Alternatives -- a description of the alternatives the agency has
considered or will consider as required by section 4(c)(1)(B) of
Executive Order 12866.
Anticipated Costs and Benefits -- a description of preliminary
estimates of the anticipated costs and benefits of the action.
Risks -- a description of the magnitude of the risk the action
addresses, the amount by which the agency expects the action to reduce
this risk, and the relation of the risk and this risk reduction effort
to other risks and risk reduction efforts within the agency's
jurisdiction.
V. Abbreviations
The following abbreviations appear throughout this publication:
ANPRM -- An Advance Notice of Proposed Rulemaking is a preliminary
notice, published in the Federal Register, announcing that an agency is
considering a regulatory action. An agency may issue an ANPRM before it
develops a detailed proposed rule. An ANPRM describes the general area
that may be subject to regulation and usually asks for public comment
on the issues and options being discussed. An ANPRM is issued only when
an agency believes it needs to gather more information before
proceeding to a notice of proposed rulemaking.
CFR -- The Code of Federal Regulations is an annual codification of
the general and permanent regulations published in the Federal Register
by the agencies of the Federal Government. The Code is divided into 50
titles, each title covering a broad area subject to Federal regulation.
The CFR is keyed to and kept up to date by the daily issues of the
Federal Register.
EO -- An Executive order is a directive from the President to
Executive agencies, issued under constitutional or statutory authority.
Executive orders are published in the Federal Register and in title 3
of the Code of Federal Regulations.
FR -- The Federal Register is a daily Federal Government
publication that provides a uniform system for publishing Presidential
documents, all proposed and final regulations, notices of meetings, and
other official documents issued by Federal agencies.
FY -- The Federal fiscal year runs from October 1 to September 30.
NPRM -- A Notice of Proposed Rulemaking is the document an agency
issues and publishes in the Federal Register that describes and
solicits public comments on a proposed regulatory action. Under the
Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a
minimum:
a statement of the time, place, and nature of the public
rulemaking proceeding;
a reference to the legal authority under which the ruleis
proposed; and
either the terms or substance of the proposed rule or a
description of the subjects and issues involved.
PL (or Pub. L.) -- A Public Law is a law passed by Congress and
signed by the President or enacted over his veto. It has general
applicability, unlike a private law that applies only to those persons
or entities specifically designated. Public laws are numbered in
sequence throughout the 2-year life of each Congress; for example, PL
108-4 is the fourth public law of the 108th Congress.
RFA -- A Regulatory Flexibility Analysis is a description and
analysis of the impact of a rule on small entities, including small
businesses, small governmental jurisdictions, and certain small not-
for-profit organizations. The Regulatory Flexibility Act (5 U.S.C. 601
et seq.) requires each agency to prepare an initial RFA for public
comment when it is required to publish an NPRM and to make available a
final RFA when the final rule is published, unless the agency head
certifies that the rule would not have a significant economic impact on
a substantial number of small entities.
RIN -- The Regulation Identifier Number is assigned by the
Regulatory Information Service Center to identify each regulatory
action listed in The Regulatory Plan and the Unified Agenda, as
directed by Executive Order 12866 (section 4(b)). Additionally, OMB has
asked agencies to include RINs in the headings of their Rule and
Proposed Rule documents when publishing them in the Federal Register,
to make it easier for the public and agency officials to track the
publication history of regulatory actions throughout their development.
Seq. No. -- The Sequence Number identifies the location of an entry
in this publication. Note that a specific regulatory action will have
the same RIN throughout its development but will generally have
different sequence numbers in different editions of The Regulatory Plan
and the Unified Agenda.
USC -- The United States Code is a consolidation and codification
of all general and permanent laws of the United States. The USC is
divided into 50 titles, each title covering a broad area of Federal
law.
VI. How Can Users Get Copies of the Plan and the Agenda?
Printed copies of this edition of the Federal Register are
available from the Superintendent of Documents, U.S.
[[Page 72650]]
Government Printing Office, P.O. BOX 371954, Pittsburgh, PA 15250-7954.
Telephone: (202) 512-1800 or 1-866-512-1800 (toll-free).
Copies of individual agency materials may be available directly
from the agency or may be found on the agency's website. Please contact
the particular agency for further information.
All editions of The Regulatory Plan and the Unified Agenda of
Federal Regulatory and Deregulatory Actions since Fall 1995 are also
available in electronic form. You can search the Agenda and the Plan
at:
http://reginfo.gov
You may also search the Agenda and the Plan on the Government
Printing Office's GPO Access website at:
http://www.gpoaccess.gov/ua/index.html
Dated: November 22, 2004.
Ronald C. Kelly,
Executive Director.
[FR Doc. 04-26308 Filed 12-10-04; 8:45 am]
BILLING CODE 6820-27-S
[December 13, 2004 (Volume 69, Number 238)]
[Unified Agenda]
From the Federal Register Online via GPO Access [frwais.access.gpo.gov]
[DOCID:ua041202-2]
[Page 72650-72890]
The Regulatory Plan
____________________________________________________________________
INTRODUCTION TO THE FALL 2004 REGULATORY PLAN
Federal regulation is a fundamental instrument of
national policy. It is one of the three major tools --
in addition to spending and taxing -- used to implement
policy. It is used to advance numerous public
objectives, including homeland security, environmental
protection, educational quality, food safety,
transportation safety, health care quality, equal
employment opportunity, energy security, immigration
control, and consumer protection. The Office of
Management and Budget's (OMB) Office of Information and
Regulatory Affairs (OIRA) is responsible for overseeing
and coordinating the Federal Government's regulatory
policies.
The Regulatory Plan is published as part of the fall
edition of the Unified Agenda of Federal Regulatory and
Deregulatory Actions, and serves as a statement of the
Administration's regulatory and deregulatory policies
and priorities. The purpose of the Plan is to make the
regulatory process more accessible to the public and to
ensure that the planning and coordination necessary for
a well-functioning regulatory process occurs. The Plan
identifies regulatory priorities and contains
information about the most significant regulatory
actions that agencies expect to undertake in the coming
year. An accessible regulatory process enables citizen
centered service, which is a vital part of the
President's Management Agenda.
Federal Regulatory Policy
The Bush Administration supports Federal regulations
that are sensible and based on sound science,
economics, and the law. Accordingly, the Administration
is striving for a regulatory process that adopts new
rules when markets fail to serve the public interest,
simplifies and modifies existing rules to make them
more effective or less costly or less intrusive, and
rescinds outmoded rules whose benefits do not justify
their costs. In pursuing this agenda, OIRA has adopted
an approach based on the principles of regulatory
analysis and policy espoused in Executive Order 12866,
signed by President Clinton in 1993.
Effective regulatory policy is not uniformly pro-
regulation or anti-regulation. It begins with the
authority granted under the law. Within the discretion
available to the regulating agency by its statutory
authority, agencies apply a number of principles
articulated in Executive Order 12866 (as well as other
orders, such as Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use,'' signed May 18, 2001, 66
FR 28355), in order to design regulations that achieve
their ends in the most efficient way. This means
bringing to bear on the policy problem sound economic
principles, the highest quality information, and the
best possible science. This is not always an easy task,
as sometimes economic and scientific information may
point in very different directions, and therefore
designing regulations does not mean just the rote
application of quantified data to reach policy
decisions. In making regulatory decisions, we expect
agencies to consider not only benefit and cost items
that can be quantified and expressed in monetary units,
but also other attributes and factors that cannot be
integrated readily in a benefit-cost framework, such as
fairness and privacy. However, effective regulation is
the result
[[Page 72652]]
of the careful use of all available high-
quality data, and the application of broad principles
established by the President.
In pursuing this goal of establishing an effective,
results-oriented regulatory system, the Bush
Administration has increased the level of public
involvement and transparency in its review and
clearance of new and existing regulations.
For new rulemakings and programs, OIRA has enhanced the
transparency of OMB's regulatory review process. OIRA's
website now enables the public to find information on
rules that are formally under review at OMB, have
recently been cleared, or have been returned to
agencies for reconsideration. OIRA has also increased
the amount of information available on its website. In
addition to information on meetings and correspondence,
OIRA makes available communications from the OIRA
Administrator to agencies, including ``prompt
letters,'' ``return letters,'' and ``post clearance
letters,'' as well as the Administrator's memorandum to
the President's Management Council (September 20, 2001)
on presidential review of agency rulemaking by OIRA.
For existing rulemakings, OIRA has initiated a modest
series of calls for reform nominations in 2001, 2002,
and 2004. In the draft 2001 annual Report to Congress
on the Costs and Benefits of Federal Regulation, OMB
asked for suggestions from the public about specific
regulations that should be modified in order to
increase net benefits to the public. We received
suggestions regarding 71 regulations, 23 of which OMB
designated as high priorities. After a similar call for
reforms in the 2002 draft Report, OMB received
recommendations on 316 distinct rules, guidance
documents, and paperwork requirements from over 1,700
commenters. Of the 156 reform nominations that OMB
determined were ripe for consideration by Cabinet-level
agencies and the Environmental Protection Agency,
agencies have decided to pursue 34 rules and 11
guidance documents for reform, are undecided about 26
rules and 4 guidance documents, and have decided not to
pursue reform of 62 rules and 19 guidance documents at
this time. Finally, in the 2004 draft Report, OMB
requested public nominations of promising regulatory
reforms relevant to the manufacturing sector. In
particular, commenters were asked to suggest specific
reforms to rules, guidance documents, or paperwork
requirements that would improve manufacturing
regulation by reducing unnecessary costs, increasing
effectiveness, enhancing competitiveness, reducing
uncertainty, and increasing flexibility. With the
publication of the final 2004 Report, OMB will discuss
the next steps in these regulatory reform initiatives
and will work closely with the agencies to ensure a
robust reform process. For further information, all of
these Reports are available on OIRA's website at http:/
/www.whitehouse.gov/omb/inforeg/regpol.html.
The Bush Administration has also moved aggressively to
establish basic quality performance goals for all
information disseminated by Federal agencies, including
information disseminated in support of proposed and
final regulations. The Federal agencies issued
guidelines on October 1, 2002 under the Information
Quality Act to ensure the ``quality, objectivity,
utility, and integrity'' of all information
disseminated by Federal agencies. Under these
guidelines, Federal agencies are taking appropriate
steps to incorporate the information quality
performance standards into agency information
dissemination practices, and developing pre-
dissemination review procedures to substantiate the
quality of information before it is disseminated. Under
the agency information quality guidelines, ``affected
persons'' can request that the agencies correct
information if they believe that scientific, technical,
economic, statistical or other information disseminated
does not meet the agency and OMB standards. If the
requestor is dissatisfied with the initial agency
response to a correction request, an appeal opportunity
is provided
[[Page 72653]]
by the agencies. To date, agencies have
received and responded to approximately 30 complaints
that appear to be stimulated by the Information Quality
Law. Although we are still in the early phases of
implementation, agencies are aware that ensuring the
high quality of government information disseminations
is a high priority of the Administration. Further
information on OIRA's activities implementing the
Information Quality Act is available on OIRA's website
at http://www.whitehouse.gov/omb/inforeg/
infopoltech.html.
As part of its efforts to improve the quality,
objectivity, utility, and integrity of information
disseminated by the Federal agencies, OMB has proposed
guidance to realize the benefits of meaningful peer
review of the most important science disseminated by
the Federal government. The Bulletin on Peer Review
establishes minimum standards for when peer review is
required and how intensive the peer review should be
for different information. The Bulletin requires the
most rigorous form of peer review for highly
influential scientific assessments. Further information
on peer review is available on OIRA's website at http:/
/www.whitehouse.gov/omb/inforeg/infopoltech.html.
In addition, the Administration is currently increasing
the impact of OMB's analytical perspective. The OIRA
Administrator is using the ``prompt letter'' to
agencies as a new way to suggest promising regulatory
priorities, and highlight issues that may warrant
regulatory attention. Though not meant to have legal
authority, these prompt letters are designed to bring
issues to the attention of agencies in a transparent
manner that permits public scrutiny and debate. Prompt
letters may highlight regulations that should be
pursued, rescinded, revised, or further investigated.
For example, OIRA's first set of prompts has suggested
lifesaving opportunities at FDA, NHTSA, OSHA and EPA.
In a letter to FDA, OIRA suggested that priority be
given to completing a promising rulemaking (started in
the previous Administration), to require that food
labels report the trans-fatty acid content of foods.
(Trans-fats are now recognized as a significant
contributor to coronary heart disease.) FDA has now
issued a final rule that will require the disclosure of
trans-fat content in food labels. Similarly, OSHA has
responded to an OIRA prompt letter by notifying each
employer in the country of the lifesaving effects and
cost-effectiveness of automatic defibrillators, a
lifesaving technology designed to save lives during
sudden cardiac arrest. A list of all of the prompt
letters is available at OIRA's website at http://
www.whitehouse.gov/omb/inforeg/prompt--letter.html.
In addition to increasing the level of public
involvement and transparency in its review of
regulations, the Bush Administration has sought to
enhance the role of analysis in the development of
effective regulations. On September 17, 2003, OMB
issued revised guidance to agencies on regulatory
analysis.\1\ Key features of the revised guidance
include more emphasis on cost-effectiveness, more
careful evaluation of qualitative and intangible
values, and a greater emphasis on considering the
uncertainty inherent in estimates of impact. OIRA was
very interested in updating the guidance in light of
these and other innovations now commonplace in the
research community. The 2004 Regulatory Plan continues
OIRA's effort to ensure coordination across Federal
agencies in pursuing analytically sound regulatory
policies.
The Administration's 2004 Regulatory Priorities
With regard to Federal regulation, the Bush
Administration's objective is quality, not quantity.
Those rules that are adopted promise to be more
effective, less intrusive, and more cost-effective in
achieving national objectives while demonstrating
greater durability in the face of political and legal
attack. The Regulatory Plan is integral to enhancing
the quality of
[[Page 72654]]
Federal regulations, and OMB seeks to
ensure that the public is provided with the information
needed to understand and comment on the Federal
regulatory agenda. Accordingly, the 2004 Regulatory
Plan highlights the following themes:
Regulations that are particularly good
examples of the Administration's ``smart''
regulation agenda to streamline regulations
and reporting requirements, which is a key
part of the President's economic plan.
Regulations that are of particular
concern to small businesses.
Regulations that respond to public
nominations submitted to OMB in 2001 or
2002.
Conclusion
Smarter regulatory policies, created through public
participation, transparency, and cooperation across
Federal agencies, are a key Administration objective.
The following department and agency plans provide
further information on regulatory priorities. All
agencies' plans are a reflection of the
Administration's Federal Regulatory Policy objectives,
which aim at implementing an effective and results-
oriented regulatory system.
------------
\1\ See Circular A-4, ``Regulatory Analysis,''
published as part of OMB's 2003 Report to Congress on
the Costs and Benefits of Federal Regulations. The
report is available on OMB's website at: http://
www.whitehouse.gov/omb/inforeg/2003--cost-ben--final--
rpt.pdf
[[Page 72655]]
DEPARTMENT OF AGRICULTURE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 National Organic Program: Add Standards for the Organic Certification of Wild Captured Aquatic 0581-AB97 Prerule Stage
Animals (TM-01-08)
2 Mandatory Country of Origin Labeling of Beef, Pork, Lamb, Fish, Perishable Agricultural 0581-AC26 Final Rule Stage
Commodities, and Peanuts (LS-03-04)
3 Revision of the Nursery Stock Regulations (Q.37) 0579-AB85 Prerule Stage
4 Foot-and-Mouth Disease; Payment of Indemnity 0579-AB34 Final Rule Stage
5 Chronic Wasting Disease in Elk and Deer; Interstate Movement Restrictions and Payment of Indemnity 0579-AB35 Final Rule Stage
6 Senior Farmers' Market Nutrition Program (SFMNP) 0584-AD35 Proposed Rule
Stage
7 FSP: Discretionary Quality Control Provisions of Title IV of Public Law 107-171 0584-AD37 Proposed Rule
Stage
8 Special Nutrition Programs: Fluid Milk Substitutions 0584-AD58 Proposed Rule
Stage
9 Child and Adult Care Food Program: Improving Management and Program Integrity 0584-AC24 Final Rule Stage
10 Commodity Supplemental Food Program (CSFP): Plain Language, Program Accountability, and Program 0584-AC84 Final Rule Stage
Flexibility
11 FSP: High Performance Bonuses 0584-AD29 Final Rule Stage
12 FSP: Eligibility and Certification Provisions of the Farm Security and Rural Investment Act of 2002 0584-AD30 Final Rule Stage
13 FSP: Non-Discretionary Quality Control Provisions of Title IV of Public Law 107-171 0584-AD31 Final Rule Stage
14 FSP: Employment and Training Program Provisions of the Farm Security and Rural Investment Act of 0584-AD32 Final Rule Stage
2002
15 Direct and Discretionary Certification in the School Meals Programs 0584-AD60 Final Rule Stage
16 Performance Standards for Pumped or Massaged Bacon 0583-AC49 Proposed Rule
Stage
17 Egg Products Inspection Regulations 0583-AC58 Proposed Rule
Stage
18 Food Standards; General Principles and Food Standards Modernization 0583-AC72 Proposed Rule
Stage
19 Performance Standard for Chilling of Ready-To-Cook Poultry 0583-AC87 Proposed Rule
Stage
20 Performance Standards for the Production of Processed Meat and Poultry Products 0583-AC46 Final Rule Stage
21 Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products 0583-AC60 Final Rule Stage
22 Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the 0583-AC88 Final Rule Stage
Disposition of Non-Ambulatory Disabled Cattle
23 State Petitions for Inventoried Roadless Area Management 0596-AC10 Proposed Rule
Stage
24 National Forest System Land Management Planning 0596-AB86 Final Rule Stage
25 Emergency Watershed Protection Program 0578-AA30 Final Rule Stage
26 Technical Service Provider Assistance 0578-AA35 Final Rule Stage
27 Conservation Security Program 0578-AA36 Final Rule Stage
28 Grassland Reserve 0578-AA38 Final Rule Stage
29 Confidentiality of Conservation Program Information 0578-AA40 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF COMMERCE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
30 Designate Critical Habitat for 7 Evolutionarily Significant Units (ESUs) of Pacific Salmon and 0648-AO04 Proposed Rule
Steelhead in California Stage
31 Designate Critical Habitat for 13 Evolutionarily Significant Units (ESUs) of Pacific Salmon and 0648-AQ77 Proposed Rule
Steelhead in Washington, Oregon and Idaho Stage
32 Amendments 18 and 19 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner 0648-AS47 Proposed Rule
Crabs--Crab Rationalization Program Stage
[[Page 72656]]
33 Northwest Hawaiian Islands National Marine Sanctuary; Designation and Implementation of Regulations 0648-AS83 Proposed Rule
Stage
34 Listing Determinations for 27 Evolutionarily Significant Units (ESUs) of West Coast Salmon and 0648-AR93 Final Rule Stage
Oncorhynchus Mykiss
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF EDUCATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
35 Reauthorization of the Individuals With Disabilities Education Act 1820-AB54 Prerule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF ENERGY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
36 Energy Efficiency Standards for Residential Furnaces and Boilers 1904-AA78 Proposed Rule
Stage
37 Energy Efficiency Standards for Electric Distribution Transformers 1904-AB08 Proposed Rule
Stage
38 Energy Efficiency Standards for Commercial Unitary Air Conditioners and Heat Pumps 1904-AB09 Proposed Rule
Stage
39 Worker Safety and Health 1901-AA99 Proposed Rule
Stage
40 Radiation Protection of the Public and the Environment 1901-AA38 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
41 Food Labeling; Prominence of Calories 0910-AF22 Prerule Stage
42 Food Labeling; Serving Sizes of Products That Can Reasonably Be Consumed at One Eating Occasion; 0910-AF23 Prerule Stage
Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion
Sizes
43 Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Certain 0910-AA49 Proposed Rule
Biological Drugs, and Animal Drugs Stage
44 Substances Prohibited From Use in Animal Food or Feed 0910-AF46 Proposed Rule
Stage
45 Use of Materials Derived From Cattle In Human and Animal Medical Products 0910-AF54 Proposed Rule
Stage
46 Requirements for Human and Animal Medical Products Manufactured From, Processed With, or Otherwise 0910-AF55 Proposed Rule
Containing Material From Cattle Stage
47 Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products 0910-AA94 Final Rule Stage
48 Safety Reporting Requirements for Human Drug and Biological Products 0910-AA97 Final Rule Stage
49 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product 0910-AB28 Final Rule Stage
Establishments; Inspection and Enforcement
50 CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients 0910-AB76 Final Rule Stage
Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback)
51 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and 0910-AB88 Final Rule Stage
Dietary Supplements
52 Prevention of Salmonella Enteritidis in Shell Eggs 0910-AC14 Final Rule Stage
53 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs 0910-AC35 Final Rule Stage
[[Page 72657]]
54 Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism 0910-AC39 Final Rule Stage
Preparedness and Response Act of 2002
55 Registration of Food and Animal Feed Facilities 0910-AC40 Final Rule Stage
56 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and 0910-AC41 Final Rule Stage
Response Act of 2002
57 Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol 0910-AF18 Final Rule Stage
58 Use of Materials Derived From Cattle in Human Food and Cosmetics 0910-AF47 Final Rule Stage
59 Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or 0910-AF48 Final Rule Stage
Otherwise Containing Material From Cattle
60 End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) 0938-AG82 Proposed Rule
Stage
61 Hospital Conditions of Participation: Requirements for Approval and Reapproval of Transplant 0938-AH17 Proposed Rule
Centers To Perform Organ Transplants (CMS-3835-P) Stage
62 Hospice Care--Conditions of Participation (CMS-3844-P) 0938-AH27 Proposed Rule
Stage
63 Organ Procurement Organization Conditions for Coverage (CMS-3064-P) 0938-AK81 Proposed Rule
Stage
64 Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities That Provide 0938-AL26 Proposed Rule
Inpatient or Residential Care (CMS-2130-P) Stage
65 Revisions to the Oversight and Validation Program for Accrediting Organizations Approved for 0938-AN62 Proposed Rule
Deeming Authority (CMS-2255-P) Stage
66 Medicare Advantage Program--Title II (CMS-4069-F) 0938-AN06 Final Rule Stage
67 Medicare Drug Benefit Effective Calendar Year 2006--Title I (CMS-4068-F) 0938-AN08 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
68 Homeland Security Information Sharing 1601-AA25 Proposed Rule
Stage
69 Procedures for Handling Critical Infrastructure Information 1601-AA14 Final Rule Stage
70 Regulations Implementing the Support Antiterrorism by Fostering Effective Technologies Act of 2002 1601-AA15 Final Rule Stage
(the SAFETY Act)
71 Department of Homeland Security (DHS) Human Resources Management System 1601-AA21 Final Rule Stage
72 Commercial Fishing Industry Vessels (USCG-2003-16158) 1625-AA77 Proposed Rule
Stage
73 Post Casualty Drug and Alcohol Testing (USCG-2001-8773) 1625-AA27 Final Rule Stage
74 United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT); Auth. To 1650-AA00 Final Rule Stage
Collect Biometric Data From Addit'l Travelers and Expansion to 50 Most Highly Trafficked Land
Border Ports
75 Establishing Procedures for Recertification of Schools Approved by the Student and Exchange Visitor 1653-AA42 Prerule Stage
Program (SEVP) to Enroll F or M Nonimmigrant Students
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
76 Consolidated Plan Amendments (FR-4923) 2501-AD07 Proposed Rule
Stage
77 Treble Damages for Failure To Engage in Loss Mitigation (FR-4553) 2501-AC66 Final Rule Stage
78 Housing Counseling Program (FR-4798) 2502-AH99 Proposed Rule
Stage
79 Empowerment Zones: Resident Benefit and Economic Development Standards for Grants (FR-4853) 2506-AC16 Proposed Rule
Stage
[[Page 72658]]
80 Capital Fund Program (FR-4880) 2577-AC50 Proposed Rule
Stage
81 Operating Fund Allocation Formula (FR-4874) 2577-AC51 Proposed Rule
Stage
82 Native American Housing Assistance and Self-Determination Act (NAHASDA): Revisions to the Indian 2577-AC57 Proposed Rule
Housing Block Grant Program Formula (FR-4938) Stage
83 Project-Based Voucher Program (FR-4636) 2577-AC25 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
84 Valuation of Oil From Indian Leases 1010-AD00 Proposed Rule
Stage
85 Grazing Administration--Exclusive of Alaska 1004-AD42 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF JUSTICE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
86 Nondiscrimination on the Basis of Disability in Public Accommodations and Commercial Facilities 1190-AA44 Prerule Stage
87 Nondiscrimination on the Basis of Disability in State and Local Government Services 1190-AA46 Prerule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF LABOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
88 Family and Medical Leave Act of 1993; Conform to the Supreme Court's Ragsdale Decision 1215-AB35 Proposed Rule
Stage
89 Child Labor Regulations, Orders, and Statements of Interpretation (ESA/W-H) 1215-AA09 Final Rule Stage
90 Revision to the Department of Labor Benefit Regulations for Trade Adjustment Assistance for Workers 1205-AB32 Proposed Rule
Under the Trade Act of 1974, as Amended Stage
91 Revision to the Department of Labor Regulations for Petitions and Determinations of Eligibility To 1205-AB40 Proposed Rule
Apply for Trade Adjustment Assistance for Workers and Issuance of Regulations for the Alternative Stage
TAA
92 Labor Certification Process for the Permanent Employment of Aliens in the United States 1205-AA66 Final Rule Stage
93 Rulemaking Relating to Termination of Abandoned Individual Account Plans 1210-AA97 Proposed Rule
Stage
94 Amendment of Regulation Relating to Definition of Plan Assets--Participant Contributions 1210-AB02 Proposed Rule
Stage
95 Regulations Implementing the Health Care Access, Portability, and Renewability Provisions of the 1210-AA54 Final Rule Stage
Health Insurance Portability and Accountability Act of 1996
96 Prohibiting Discrimination Against Participants and Beneficiaries Based on Health Status 1210-AA77 Final Rule Stage
97 Asbestos Exposure Limit 1219-AB24 Proposed Rule
Stage
98 Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners 1219-AB29 Final Rule Stage
99 Occupational Exposure to Crystalline Silica 1218-AB70 Prerule Stage
100 Occupational Exposure to Hexavalent Chromium (Preventing Occupational Illness: Chromium) 1218-AB45 Proposed Rule
Stage
[[Page 72659]]
101 Assigned Protection Factors: Amendments to the Final Rule on Respiratory Protection 1218-AA05 Final Rule Stage
102 Standards Improvement (Miscellaneous Changes) for General Industry, Marine Terminals, and 1218-AB81 Final Rule Stage
Construction Standards (Phase II)
103 Uniformed Services Employment and Reemployment Rights Act Regulations 1293-AA09 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
104 Aging Aircraft Program (Widespread Fatigue Damage) 2120-AI05 Proposed Rule
Stage
105 Enhanced Airworthiness Program for Airplane Systems (EAPAS) and SFAR 88 2120-AI31 Proposed Rule
Stage
106 Aging Aircraft Safety--Development of TC and STC Holder Data 2120-AI32 Proposed Rule
Stage
107 Flight Simulation Device Qualification 2120-AH07 Final Rule Stage
108 Transport Airplane Fuel Tank Flammability Reduction 2120-AI23 Final Rule Stage
109 Unified Registration System 2126-AA22 Proposed Rule
Stage
110 Hours of Service of Drivers; Supporting Documents 2126-AA76 Proposed Rule
Stage
111 Tire Pressure Monitoring Systems 2127-AJ23 Proposed Rule
Stage
112 Whistle Bans at Highway-Rail Grade Crossings 2130-AA71 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
113 Implementation of a Revised Basel Capital Accord (Basel II) 1557-AC91 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
114 Enrollment--Provision of Hospital and Outpatient Care to Veterans--Subpriorities of Priority 2900-AL51 Final Rule Stage
Categories 7 and 8 and Enrollment Level Decision
--------------------------------------------------------------------------------------------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
115 Endocrine Disruptor Screening Program (EDSP); Chemical Selection Approach for Initial Round of 2070-AD59 Prerule Stage
Screening
116 Notification of Chemical Exports Under TSCA Section 12(b) 2070-AJ01 Prerule Stage
117 Lead-Based Paint Activities; Voluntary Program for Renovation and Remodeling 2070-AJ03 Prerule Stage
118 Clean Air Fine Particle Implementation Rule 2060-AK74 Proposed Rule
Stage
119 Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Allowables 2060-AL75 Proposed Rule
Plantwide Applicability Limit (PAL), Aggregation, and Debottlenecking Stage
[[Page 72660]]
120 Pesticides; Data Requirements for Conventional Chemicals 2070-AC12 Proposed Rule
Stage
121 Pesticides; Emergency Exemption Process Revisions 2070-AD36 Proposed Rule
Stage
122 Acceptability of Research Using Human Subjects 2070-AD57 Proposed Rule
Stage
123 Increase Metals Reclamation From F006 Waste Streams 2050-AE97 Proposed Rule
Stage
124 Regulatory Amendments to the F019 Hazardous Waste Listing To Exclude Wastewater Treatment Sludges 2050-AG15 Proposed Rule
From Chemical Conversion Coating Process (Zinc Phosphating) of Automobile Bodies of Aluminum Stage
125 Toxics Release Inventory Reporting Burden Reduction Rule 2025-AA14 Proposed Rule
Stage
126 Clean Air Visibility Rule 2060-AJ31 Final Rule Stage
127 Clean Air Mercury Rule--Electric Utility Steam Generating Units 2060-AJ65 Final Rule Stage
128 Clean Air Ozone Implementation Rule (Part 1 and Part 2) 2060-AJ99 Final Rule Stage
129 Nonattainment Major New Source Review (NSR) 2060-AM59 Final Rule Stage
130 Test Rule; Testing of Certain High Production Volume (HPV) Chemicals 2070-AD16 Final Rule Stage
131 NESHAPS: Standards for Hazardous Air Pollutants for Hazardous Waste Combustors (Phase I Final 2050-AE01 Final Rule Stage
Replacement Standards and Phase II)
132 Hazardous Waste Manifest Regulation 2050-AE21 Final Rule Stage
133 Standardized Permit for RCRA Hazardous Waste Management Facilities 2050-AE44 Final Rule Stage
134 RCRA Burden Reduction Initiative 2050-AE50 Final Rule Stage
135 Recycling of Cathode Ray Tubes (CRTs): Changes to Hazardous Waste Regulations 2050-AE52 Final Rule Stage
136 Hazardous Waste Management System; Modification of the Hazardous Waste Program: Mercury-Containing 2050-AG21 Final Rule Stage
Equipment
137 National Primary Drinking Water Regulations: Groundwater Rule 2040-AA97 Final Rule Stage
138 National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface Water Treatment Rule 2040-AD37 Final Rule Stage
139 National Primary Drinking Water Regulations: Stage 2 Disinfection Byproducts Rule 2040-AD38 Final Rule Stage
140 Minimizing Adverse Environmental Impact From Cooling Water Intake Structures at Existing Facilities 2040-AD70 Final Rule Stage
Under Section 316(b) of the Clean Water Act, Phase 3
141 Cross-Media Electronic Reporting (ER) and Recordkeeping Rule (CROMERRR) 2025-AA07 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
142 Coordination of Retiree Health Benefits With Medicare and State Health Benefits 3046-AA72 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
NATIONAL ARCHIVES AND RECORDS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
143 Federal Records Management 3095-AB16 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
PENSION BENEFIT GUARANTY CORPORATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
144 Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets 1212-AA55 Proposed Rule
Stage
145 Transparency of Information Related to Plan Liabilities 1212-AB01 Proposed Rule
Stage
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[[Page 72661]]
SMALL BUSINESS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
146 Small Business Lending Companies Regulations 3245-AE14 Proposed Rule
Stage
147 Proposed Small Business Innovation Research (SBIR) Policy Directive 3245-AF21 Proposed Rule
Stage
148 Small Business Technology Transfer Program Policy Directive 3245-AE96 Final Rule Stage
149 Small Business Government Contracting Programs 3245-AF12 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
150 Privacy and Disclosure of Official Records and Information (711P) 0960-AE88 Proposed Rule
Stage
151 Federal Salary Offset (Withholding a Portion of a Federal Employee's Salary To Collect a Delinquent 0960-AE89 Proposed Rule
Debt Owed to the Social Security Administration) (721P) Stage
152 Exemption of Work Activity as a Basis for a Continuing Disability Review (Ticket to Work and Work 0960-AE93 Proposed Rule
Incentives Improvement Act of 1999) (725P) Stage
153 Revised Medical Criteria for Evaluating Immune System Disorders (804P) 0960-AF33 Proposed Rule
Stage
154 Amendments to the Ticket to Work and Self-Sufficiency Program (967P) 0960-AF89 Proposed Rule
Stage
155 Elimination of Parent-to-Child Deeming for Individuals Who No Longer Meet the Definition of Spouse 0960-AF96 Proposed Rule
of the Natural or Adoptive Parent (793P) Stage
156 Rules for Helping Blind and Disabled Individuals Achieve Self-Support (506P) 0960-AG00 Proposed Rule
Stage
157 Medicare Prescription Drug Premium and Cost-Sharing (1024P) 0960-AG03 Proposed Rule
Stage
158 Civil Monetary Penalties, Assessments, and Recommended Exclusions (2362P) 0960-AG08 Proposed Rule
Stage
159 Representative Payment; Additional Protections for Persons With Representative Payees (2422P) 0960-AG09 Proposed Rule
Stage
160 Issuance of Work Report Receipts, Payment of Trial Work Period Months After a Fraud Conviction and 0960-AG10 Proposed Rule
Changes to the Student Earned Income Exclusion (2502P) Stage
161 Income Related Medicare Part B Premium Subsidy Reduction (2101P) 0960-AG11 Proposed Rule
Stage
162 Denial of Title II Benefits to Persons Fleeing Prosecution, Custody, or Confinement, and to Persons 0960-AG12 Proposed Rule
Violating Probation or Parole (2222P) Stage
163 Privacy and Disclosure of Official Records and Information; Availability of Information and Records 0960-AG14 Proposed Rule
to the Public (2562P) Stage
164 Revised Medical Criteria for Evaluating Malignant Neoplastic Diseases (399F) 0960-AD67 Final Rule Stage
165 Elimination of Clothing From the Definitions of Income and In-Kind Support and Maintenance, 0960-AF84 Final Rule Stage
Exclusions of One Automobile, and Household Goods and Personal Effects Under SSI From Resources
(950F)
166 Continuation of Benefit Payments to Certain Individuals Who Are Participating in a Program of 0960-AF86 Final Rule Stage
Vocational Rehabilitation Services, Employment Services, or Other Support Services (925F)
167 Administrative Review Process; Incorporation by Reference of Oral Findings of Fact and Rationale in 0960-AF92 Final Rule Stage
Wholly Favorable Written Decisions (964I)
168 Expanded Authority for Cross-Program Recovery of Benefit Overpayments (2221F) 0960-AG06 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 72662]]
CONSUMER PRODUCT SAFETY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
169 Flammability Standard for Upholstered Furniture 3041-AB35 Proposed Rule
Stage
170 Proposed Standard To Address Open-Flame Ignition of Mattresses/Bedding 3041-AC02 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
[FR Doc. 04-26308 Filed 12-10-04; 8:45 am]
BILLING CODE 6820-27-S
[[Page 72663]]
DEPARTMENT OF AGRICULTURE (USDA)
Statement of Regulatory Priorities
USDA is a primary issuer of regulations within the Federal Government
covering a broad range of issues. Within the rulemaking process is the
department-wide effort to reduce burden on participants and program
administrators alike by focusing on improving program outcomes, and
particularly on achieving the performance measures specified in the
USDA and agency Strategic Plans. Significant focus is being placed on
efficiencies that can be achieved through eGov activities, the
migration to efficient electronic services and capabilities, and the
implementation of focused, efficient information collections necessary
to support effective program management. Important areas of activity
include the following:
USDA will develop new regulations and review existing
regulations to prevent the introduction or spread of pests
and diseases into the United States. In addition, it will
continue to work to minimize impediments to trade while
protecting U.S. animal and plant resources.
In the area of food safety, USDA will continue to develop
science-based regulations that improve the safety of meat,
poultry, and egg products in the least burdensome and most
cost-effective manner. Regulations will be revised to
address emerging food safety challenges, streamlined to
remove excessively prescriptive regulations, and updated to
be made consistent with hazard analysis and critical
control point principles.
As changes are made for the nutrition assistance programs,
USDA will work to foster actions that will help improve
diets and particularly to prevent and reduce overweight and
obesity. In 2005, this will include implementing
refinements to the nutrition assistance programs included
in reauthorization statutes as well as additional changes
that will promote healthful eating and physical activity,
while also improving the efficiency and integrity of
program operations.
USDA will continue to finalize rulemaking related to
implementing the Farm Security and Rural Investment Act of
2002 (Farm Bill). Some of the Farm Bill rules have already
been issued in final including those for the Conservation
Reserve Program and the Environmental Quality Incentives
Program. Other programs, such as the Conservation Security
Program and the Grasslands Reserve Program, were
implemented with interim final rules on which the public
has submitted comments. Our focus in 2005 will be to make
clarifications and modifications in response to these
comments and to promulgate these rules in final.
Reducing Paperwork Burden on Customers
USDA has made substantial progress in implementing the goal of the
Paperwork Reduction Act of 1995 to reduce the burden of information
collection on the public. To meet the requirements of the Government
Paperwork Elimination Act (GPEA), agencies across USDA are providing
electronic alternatives to their traditionally paper-based customer
transactions. As a result, producers increasingly have the option to
electronically file forms and all other documentation online. To
facilitate the expansion of electronic government and promote
compliance with GPEA, USDA implemented an electronic authentication
capability that allows customers to ``sign-on'' once and conduct
business with all USDA agencies. Underlying these efforts are ongoing
analyses to identify and eliminate redundant data collections and
streamline collection instructions. The end result of implementing
these initiatives is better service to our customers enabling them to
choose when and where to conduct business with USDA.
The Role of Regulations
The programs of USDA are diverse and far reaching, as are the
regulations that attend their delivery. Regulations codify how USDA
will conduct its business, including the specifics of access to, and
eligibility for, USDA programs. Regulations also specify the
responsibilities of State and local governments, private industry,
businesses, and individuals that are necessary to comply with their
provisions.
The diversity in purpose and outreach of our programs contributes
significantly to USDA being near the top of the list of departments
that produce the largest number of regulations annually. These
regulations range from nutrition standards for the school lunch
program, to natural resource and environmental measures governing
national forest usage and soil conservation, to regulations protecting
American agribusiness (the largest dollar value contributor to exports)
from the ravages of domestic or foreign plant or animal pestilence, and
they extend from farm to supermarket to ensure the safety, quality, and
availability of the Nation's food supply.
Many regulations function in a dynamic environment, which requires
their periodic modification. The factors determining various
entitlement, eligibility, and administrative criteria often change from
year to year. Therefore, many significant regulations must be revised
annually to reflect changes in economic and market benchmarks.
Almost all legislation that affects USDA programs has accompanying
regulatory needs, often with a significant impact. The Farm Security
and Rural Investment Act of 2002, Public Law 107-171; the Child
Nutrition and WIC Reauthorization Act of 2004, Public Law 108-265; and
the Agricultural Risk Protection Act of 2000, Public Law 106-224,
affect most agencies of USDA resulting in the modification, addition,
or deletion of many programs. These statutes set in motion rulemakings
that provide for improvements in market loss and conservation
assistance, crop and livestock disease and pest protection, marketing
enhancements, pollution control, research and development for biomass,
and refinements to the nutrition assistance programs to help ensure the
best practical outcomes for beneficiaries and the taxpayer.
Major Regulatory Priorities
This document represents summary information on prospective
significant regulations as called for in Executive Order 12866. The
following agencies are represented in this regulatory plan, along with
a summary of their mission and key regulatory priorities for 2005:
Food and Nutrition Service
Mission: FNS increases food security and reduces hunger in partnership
with cooperating organizations by providing children and low-income
people access to food, a healthful diet, and nutrition education in a
manner that supports American agriculture and inspires public
confidence.
Priorities: In addition to responding to provisions of legislation
authorizing and modifying Federal nutrition assistance programs, FNS'
2004 regulatory plan supports the broad goals and objectives in the
Agency's strategic plan that include:
[[Page 72664]]
Improved
Nutrition of Children and Low-Income People. This goal represents FNS'
efforts to improve nutrition by providing access to program benefits
(Food Stamps, WIC food vouchers and nutrition services, school meals,
commodities, and State administrative funds), nutrition education, and
quality meals and other benefits. It includes three major objectives:
1) Improved food security, which reflects nutrition assistance benefits
issued to program participants; 2) FNS program participants make
healthy food choices, which represents our efforts to improve nutrition
knowledge and behavior through nutrition education and breastfeeding
promotion; and 3) improved nutritional quality of meals, food packages,
commodities, and other program benefits, which represents our efforts
to ensure that program benefits meet the appropriate nutrition
standards to effectively improve nutrition for program participants.
In support of this goal, FNS plans to finalize rules implementing
provisions of the Farm Security and Rural Investment Act of 2002 (Pub.
L. 107-171), as well as under other authorities, that will give States
additional new flexibility to streamline complex rules, simplify
program administration, support work, and improve access to benefits in
the Food Stamp Program. FNS will also publish rules implementing
provisions of the Child Nutrition and WIC Reauthorization Act of 2004
(Pub. L. 108-265) to improve access to the WIC and Child Nutrition
Programs and to support and strengthen school and community-based
efforts to promote healthful eating and physical activity.
Improved
Stewardship of Federal Funds. This goal represents FNS' ongoing
commitment to maximize the accuracy of benefits issued, maximize the
efficiency and effectiveness of program operations, and minimize
participant and vendor fraud. It includes two major objectives: 1)
Improved benefit accuracy and reduced fraud, which represents the
Agency's effort to reduce participant and Agency errors and to control
Food Stamp and WIC trafficking and participant, vendor, and
administrative agency fraud; and 2) improved efficiency of program
administration, which represents our efforts to streamline program
operations and improve program structures as necessary to maximize
their effectiveness.
In support of this goal, FNS plans to finalize rules implementing
provisions of Public Law 107-171 that give States substantial new
flexibility to streamline some of the Food Stamp Program's complex
rules, making it easier to administer and less error-prone. In
addition, FNS will finalize rules that will simplify funding for the
Food Stamp Employment and Training Program, and propose rules to
enhance retailer sanctions and to streamline the sanction process. FNS
will also publish rules implementing provisions of the Child Nutrition
and WIC Reauthorization Act of 2004 (Pub. L. 108-265) to promote the
accuracy of the certification process in the school meals programs, to
improve WIC vendor management, and to ensure the effectiveness of WIC
infant formula rebates in reducing program costs.
Food Safety and Inspection Service
Mission: The Food Safety and Inspection Service (FSIS) is responsible
for ensuring that meat, poultry, and egg products in commerce are
wholesome, not adulterated, and properly marked, labeled, and packaged.
Priorities: FSIS is committed to developing and issuing science-based
regulations intended to ensure that meat, poultry, and egg products are
wholesome and not adulterated or misbranded. FSIS continues to review
its existing authorities and regulations to ensure that emerging food
safety challenges are adequately addressed, to streamline excessively
prescriptive regulations, and to revise or remove regulations that are
inconsistent with the Agency's hazard analysis and critical control
point regulations.
In addition to undertaking regulatory amendments based on the results
of its review activities, FSIS has been developing regulations for
emergency use. Such regulations are an outcome of the Agency's
proactive, risk-based policy toward emerging and exotic threats to the
safety of the Nation's meat, poultry, and egg product supply.
Following are some of the Agency's recent and planned initiatives:
In February 2001, FSIS proposed a rule to establish food safety
performance standards for all processed ready-to-eat (RTE) meat and
poultry products and for partially heat-treated meat and poultry
products that are not ready-to-eat. The proposal contained provisions
addressing post-lethality contamination of RTE products with Listeria
monocytogenes. In June 2003, FSIS published an interim final rule
requiring establishments that produce RTE products to apply verified
control measures to prevent such product contamination. The Agency is
planning further action with respect to other elements of the 2001
proposal.
In January 2004, FSIS issued a series of interim final rules to
prevent the bovine spongiform encephalopathy (BSE) agent from entering
the human food supply. FSIS issued the interim final rules in response
to the confirmation of BSE in an imported cow in Washington State. The
cow was imported from Alberta, Canada. The interim final rules: 1)
Prohibit material that scientific studies demonstrate contain the BSE
agent in cattle infected with BSE for use as human food; 2) prohibit
the slaughter of non-ambulatory disabled cattle for human food; 3)
prohibit the use of air-injection stunning devices on cattle; and 4)
establish additional requirements for beef meat produced using advanced
meat recovery (AMR) systems to ensure that high risk tissues are not
incorporated into beef AMR product. In addition, in January 2004, FSIS
issued a Federal Register Notice announcing that it would no longer
pass and apply the mark of inspection to carcasses selected for BSE
testing by USDA's Animal and Plant Health Inspection Service (APHIS)
until the sample is determined to be negative. In July 2004, FSIS,
APHIS, and the Food and Drug Administration issued an Advance Notice of
Proposed Rulemaking (ANPRM) to solicit comments on additional actions
that could be implemented by the U.S. government to prevent animal and
human exposure to the BSE agent. The comment period for the ANPRM
closed on September 14, 2004.
FSIS will propose removing from the poultry products inspection
regulations the requirement for ready-to-cook poultry products to be
chilled to 40 [deg]F or below within certain time periods according to
the weight of the dressed carcasses.
FSIS has proposed a rule clarifying requirements for meat produced
using advanced recovery systems by replacing the compliance program
parameters in the current regulations with non-compliance criteria for
bone solids, bone marrow, and neural tissue. Establishments would have
to have process control procedures in place before labeling or using
the product derived by use of such systems.
In addition, FSIS is planning to propose requirements for federally
inspected egg product plants to develop and implement HACCP systems and
[[Page 72665]]
sanitation standard operating procedures. The Agency will be proposing
pathogen reduction performance standards for egg products. Further, the
Agency will be proposing to remove requirements for approval by FSIS of
egg-product plant drawings, specifications, and equipment prior to use,
and to end the system for pre-marketing approval of labels for egg
products.
FSIS will also propose to remove provisions that prescribe the
substances and amounts of such substances that must be used to produce
pumped or massaged bacon. FSIS will propose to replace these
prescriptive provisions with an upper limit for nitrite and a
performance standard that establishments producing pumped or massaged
bacon would be required to meet.
FSIS has proposed requirements for the nutrition labeling of ground or
chopped meat and poultry products and single-ingredient products. This
proposed rule would require nutrition labeling, on the label or at the
point-of-purchase, for the major cuts of single-ingredient, raw
products and would require nutrition information on the label of ground
or chopped products.
In addition, FSIS is developing a proposed rule with the Food and Drug
Administration (FDA). FSIS and FDA are proposing to establish a set of
general principles for food standards. The proposed general principles
will establish the criteria that the agencies will use in considering
whether a petition to establish, revise, or eliminate a food standard
will be the basis for a proposed rule. These proposed general
principles are the agencies' first step in instituting a process to
modernize their standards of identity (and any accompanying standards
of quality and fill of container) and standards of composition.
Small business concerns: Nearly all FSIS regulations affect small
businesses in some way because the majority of FSIS-inspected
establishments and other FSIS-regulated entities are small businesses.
FSIS makes available to small and very small establishments technical
materials and guidance on how to comply with FSIS regulations. The
Agency's post-September 11, 2001, security guidance materials were
prepared especially for the benefit of small firms involved in the
production, transportation, and distribution of meat, poultry, and egg
products.
Animal and Plant Health Inspection Service
Mission: The mission of the Animal and Plant Health Inspection Service
(APHIS) is to protect the health and value of American agricultural and
natural resources. APHIS conducts programs to prevent the introduction
of exotic pests and diseases into the United States and conducts
surveillance, monitoring, control, and eradication programs for pests
and diseases in this country. These activities enhance agricultural
productivity and competitiveness and contribute to the national economy
and the public health.
Priorities: APHIS continues to work on regulatory initiatives to
ensure that a comprehensive framework is in place to address the
threats posed to animal and plant resources. One important animal
health initiative is a herd certification program for chronic wasting
disease, a neurological disease of deer and elk. APHIS is also
proceeding with rulemaking to improve its provisions for providing
indemnity for animals and materials should an outbreak of foot-and-
mouth disease occur in the United States. On the plant side, APHIS is
planning to revise the regulations for the introduction of organisms
and products altered or produced through genetic engineering to reflect
new consolidated authorities under the Plant Protection Act. The Agency
is also considering revisions to its nursery stock regulations to
reduce the risk posed by imported plants, roots, seeds, bulbs, and
other propagative materials. APHIS is also continuing to work with the
Centers for Disease Control and Prevention to implement and amend, as
necessary, regulations for the possession, use, and transfer of
biological agents and toxins that could pose a severe disease or pest
risk to animals and plants or their products.
In addition, recognizing the need to minimize impediments to trade
while providing necessary protection to animal and plant resources,
APHIS is developing a proposal to streamline the process for approving
new fruits and vegetables for importation. The Agency is also
continuing to work on amending its regulations concerning bovine
spongiform encephalopathy (BSE) to provide for the importation of
certain animals and products that present low risk, particularly from
countries such as Canada, where effective measures have been in place
to prevent the spread of the disease.
APHIS documents published in the Federal Register and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
Agricultural Marketing Service
Mission: The Agricultural Marketing Service (AMS) facilitates the
marketing of agricultural products in domestic and international
markets, while ensuring fair trading practices and promoting a
competitive and efficient marketplace to the benefit of producers,
traders, and consumers of U.S. food and fiber products.
Priorities: (1) As mandated by the 2002 Farm Bill, AMS is establishing
a mandatory country of origin program for beef, lamb, pork, fish,
perishable agricultural commodities, and peanuts. Under current Federal
laws and regulations, country of origin labeling is not universally
required for these commodities. In particular, labeling of U.S. origin
is not mandatory, and labeling of imported products at the consumer
level is not required in all cases. Thus, consumers desiring to
purchase products based on country of origin are not fully able to do
so. A proposed rule was published October 30, 2003, based on interim
voluntary guidelines also required by the 2002 Farm Bill (that were
issued on October 8, 2002), and related input from listening sessions
held throughout the country during 2003. On October 5, 2004, the
Agricultural Marketing Service published an interim final rule with
request for comments for the labeling of fish and shellfish covered
commodities that will become effective on April 4, 2005. A final
regulatory action for all covered commodities will be issued by June
30, 2006.
(2) On April 12, 2003, Congress amended the Organic Foods Production
Act (OFPA) to authorize certification of wild seafood. In response to
this, AMS plans to propose regulations to amend the National Organic
Program (NOP) regulations to add practice standards for organic
certification of wild-caught and aquatic farm raised species. Under the
OFPA, an organic certification program must be established for
producers and handlers of agricultural products that have been produced
using organic methods. The NOP has been reviewing organic certification
of fish including wild-caught and aquaculture operations in response to
a FY 2000 congressional mandate to develop regulations for the
certification of seafood. The NOP has engaged in public meetings and
workshops and conducted public comment proceedings on this subject.
[[Page 72666]]
AMS Program Rulemaking Pages: All of AMS' rules, as published in the
Federal Register, are available on the Internet at http://
www.ams.usda.gov/rulemaking. This site also includes commenting
instructions and addresses, links to news releases and background
material, and comments received on various rules.
Farm Service Agency
Mission: The mission of the Farm Service Agency is to stabilize farm
income, help farmers conserve land and water resources, provide credit
to new or disadvantaged farmers and ranchers, and help farm operations
recover from the effects of disaster.
Priorities: The Farm Service's immediate priorities are to: (1)
Implement the disaster assistance programs required by the Emergency
Supplemental Appropriations for Hurricane Disaster Assistance Act, 2005
(H.R. 4837) and (2) implement the tobacco buyout program required by
the Fair and Equitable Tobacco Reform Act of 2004 (Pub. L. 108-357).
The disaster programs will provide assistance to agricultural producers
in areas that were affected by the unusual number and severity of
hurricanes in 2003 and 2004 for losses of crops, livestock, trees,
dairy production, and sugarcane. The tobacco buyout program will end
the 70-year-old tobacco quota and price support program. Quota holders
and producers will be compensated for the value of their lost quota
through a program financed by assessments on manufacturers and
importers of tobacco products.
Forest Service
Mission: The mission of the Forest Service is to sustain the health,
productivity, and diversity of the Nation's forests and rangelands to
meet the needs of present and future generations. This includes
protecting and managing National Forest System lands; providing
technical and financial assistance to States, communities, and private
forest landowners; and developing and providing scientific and
technical assistance and scientific exchanges in support of
international forest and range conservation.
Priorities: The Forest Service's priorities for fall 2004 are to
publish final regulations at 36 CFR part 219, subpart A, to establish a
framework for National Forest System land management planning and to
seek comments on a proposed rule to replace the existing regulations at
36 CFR part 294, subpart B, with a petitioning process that would
provide Governors an opportunity to seek establishment of management
requirements for National Forest System inventoried roadless areas
within their State.
The final planning rule reaffirms an emphasis on sustainability to
provide for multiple uses over time and reaffirms an adaptive cycle of
land management planning, including detailed project planning, plan
implementation, monitoring, evaluation, and plan amendment or revision.
This final rule is based on the principle that plans provide a
framework for subsequent detailed project analysis and that analysis
and disclosure are continuous throughout the adaptive planning cycle. A
proposed rule was published in the Federal Register on December 6, 2002
(67 FR 72770).
The proposed State petitions for inventoried roadless area management
rule emphasizes a commitment to collaborate and cooperate with States
on the long-term strategy for the management of inventoried roadless
areas on National Forest System lands. The petition process allows for
the recognition of local situations and resolution of unique resource
management challenges within a specific State. A proposed rule was
published in the Federal Register on July 16, 2004 (69 FR 42636). The
comment period originally ended on September 14, 2004, but was extended
to November 15, 2004 (69 FR 54600).
Natural Resources Conservation Service
Mission: The Natural Resources Conservation Service (NRCS) mission is
to provide leadership in a partnership effort to help people conserve,
maintain, and improve our natural resources and environment.
Priorities: NRCS' priority for FY 2005 will be to finalize the rules
related to the conservation provisions of the Farm Security and Rural
Investment Act of 2002 (the 2002 Farm Bill), in response to public
comments received pursuant to the promulgation of interim final rules
for those programs. NRCS believes that these clarifications and
modifications will ensure efficient and responsive delivery of
conservation programs to landowners and land users and help further the
agency mission to help people conserve, maintain, and improve our
natural resources and the environment.
A non-Farm Bill priority for NRCS remains updating the 1981 Emergency
Watershed Protection Program rule. New rulemaking will implement
necessary efficiencies and make the EWP policies and rule more
consistent. It will also ensure the Agency quickly meets the needs of
landowners and sponsors adversely impacted by natural disasters and
assists these communities in their recovery efforts.
NRCS remains committed to compliance with the Government Paperwork
Elimination Act and the Freedom to E-File Act, which require Government
agencies in general and NRCS in particular to provide the public the
option of submitting information or transacting business electronically
to the maximum extent possible. NRCS is designing its program forms to
allow the public to conduct business with NRCS electronically.
The NRCS plans to publish the following proposed or final rules during
FY 2005:
1. Final Rule for the Technical Service Provider Assistance (TSP)
2. Final Rule for the Conservation Security Program (CSP)
3. Final Rule for Grassland Reserve Program (GRP)
4. Interim Final Rule for Confidentiality to provide the regulatory
framework for existing statutory mandate and NRCS policy
guidance.
5. Final Rule for the Emergency Watersheds Program (EWP)
The rulemaking for CSP, TSP, GRP, EWP, CIG, and Appeals are minor
changes to existing interim final rules, and efforts will focus on
making these rules final.
_______________________________________________________________________
USDA--Agricultural Marketing Service (AMS)
-----------
PRERULE STAGE
-----------
1. NATIONAL ORGANIC PROGRAM: ADD STANDARDS FOR THE ORGANIC
CERTIFICATION OF WILD CAPTURED AQUATIC ANIMALS (TM-01-08)
Priority:
Other Significant
Legal Authority:
7 USC 6501 through 6522
CFR Citation:
7 CFR 205
Legal Deadline:
None
[[Page 72667]]
Abstract:
The Agricultural Marketing Service (AMS) is revising regulations
pertaining to labeling of agricultural products as organically produced
and handled (7 CFR part 205). The term ``aquatic animal'' will be
incorporated in the definition of livestock to establish production and
handling standards for operations that capture aquatic animals from the
wild. AMS has defined ``aquatic animal'' as any finfish or shellfish
used for human consumption, whether taken from regulated but free
roaming marine and fresh water populations (wild captured) or
propagated and raised in a controlled or selected environment
(aquaculture). Production standards for operations producing aquatic
animals will incorporate requirements for livestock origin, feed
ration, health care, living conditions, and recordkeeping. Handling
standards for such operations will address prevention of commingling of
organically produced commodities and prevention of contact between
organically produced and prohibited substances.
Statement of Need:
This amendment to the National Organic Program is intended to
facilitate interstate commerce and marketing of fresh and processed
aquatic animals that are organically produced and to assure consumers
that such products meet consistent, uniform standards. Also, this
amendment will establish national standards for the production and
handling of organically-produced aquatic animals and products,
including a national list of substances approved and prohibited for use
in organic production and handling.
Summary of Legal Basis:
This amendment is proposed under the Organic Foods Production Act of
1990 (OFPA). OFPA includes fish for food in its definition of
livestock. Additionally, on April 12, 2003, Congress amended OFPA
section 2107 (7 U.S.C. 6506) to authorize certification of wild
seafood.
Alternatives:
AMS is fulfilling a congressional mandate to proceed with rulemaking
for the establishment of national standards for the organic production
and handling of aquatic animals.
Other options are to do nothing or to propose regulations prohibiting
the labeling of aquatic animals as organically produced. Neither
alternative is viable inasmuch as Congress has amended OFPA to
authorize certification of wild seafood and is expecting the USDA to
engage in rulemaking to establish standards for the production,
handling, and labeling of organic aquatic animals.
Anticipated Cost and Benefits:
Potential benefits to consumers include more information on organic
aquatic animals and protection from false and misleading organic
claims. This proposal will address the problem of existing certifying
agents using different standards. This proposal will also resolve the
issue of whether aquatic animals can be labeled as organically
produced.
The costs of this proposed regulation are the direct costs to comply
with the specific standards. USDA-accredited certifying agents
potentially will incur additional costs of accreditation should they
opt to certify producers and handlers of aquatic animals. New
applicants for accreditation to certify producers and handlers of
aquatic animals under the National Organic Program will incur fees for
accreditation. Producers and handlers of organically produced and
handled aquatic animals will incur costs for certification levied by
USDA-accredited certifying agents. USDA would not levy any fees on the
certified operations. Producers and handlers will face numerous
provisions that will regulate their production and handling methods.
Retailers would not be directly regulated but would be subject to the
same requirements for organic animals and products as they are
currently for other foods under the NOP. AMS believes this action will
have a minimal impact on retailers. Certified handlers will have to
comply with requirements regarding the approved use of labels. The
USDA, States operating State programs, and certifying agents will incur
costs for enforcement of these new organic standards. Certifying
agents, producers, and handlers would incur costs for reporting and
recordkeeping. Certifying agents will be required to file reports and
documents with the USDA and to maintain records regarding their
accreditation and the certification of their clients. Certified
operations will be required to develop and annually update an organic
system plan and to maintain records regarding their certification and
the administration of their operation.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 12/00/04
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Governmental Jurisdictions
Government Levels Affected:
Federal, Local, State, Tribal
Agency Contact:
Richard H. Mathews
Associate Deputy Administrator
Department of Agriculture
Agricultural Marketing Service
Rm. 2510-South
14th & Independence Avenue SW
Washington, DC 20250
Phone: 202 720-3252
Fax: 202 205-7808
Email: richard.mathews@usda.gov
RIN: 0581-AB97
_______________________________________________________________________
USDA--AMS
-----------
FINAL RULE STAGE
-----------
2. MANDATORY COUNTRY OF ORIGIN LABELING OF BEEF, PORK, LAMB, FISH,
PERISHABLE AGRICULTURAL COMMODITIES, AND PEANUTS (LS-03-04)
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
7 USC 1621 through 1627, Agricultural Marketing Act of 1946
CFR Citation:
7 CFR 60
Legal Deadline:
Final, Statutory, September 30, 2004.
Abstract:
The Farm Security and Rural Investment Act of 2002 (Farm Bill) (Pub. L.
107-171) and the 2002 Supplemental Appropriations Act (2002
Appropriations) (Pub. L. 107-206) amended the Agricultural Marketing
Act of 1946 (Act) (7 U.S.C. 1621 et seq.) to require retailers to
notify their customers of the country of origin of covered commodities
beginning September 30, 2004. Covered commodities include muscle cuts
of
[[Page 72668]]
beef (including veal), lamb, and pork; ground beef, ground lamb, and
ground pork; farm-raised fish and shellfish; wild fish and shellfish;
perishable agricultural commodities; and peanuts. The FY 2004
Consolidated Appropriations bill (2004 Appropriations) (Pub. L. 108-
199) delayed the implementation of mandatory COOL for all covered
commodities except wild and farm-raised fish and shellfish until
September 30, 2006. This final rule contains definitions, the
requirements for consumer notification and product marking, and the
recordkeeping responsibilities of both retailers and suppliers.
Statement of Need:
Under current Federal laws and regulations, country of origin labeling
is not universally required for the covered commodities. In particular,
labeling of U.S. origin is not mandatory, and labeling of imported
products at the consumer level is required only in certain
circumstances. This intent of the law is to provide consumers with
additional information on which to base their purchasing decisions.
Summary of Legal Basis:
Section 10816 of Public Law 107-171 amended the Agricultural Marketing
Act of 1946 to require retailers to inform consumers of the country of
origin for covered commodities beginning September 30, 2004, and
requires USDA to promulgate requirements for the mandatory labeling
program no later than September 30, 2004.
Alternatives:
Various methods are being considered by which the objectives of this
law could be accomplished. The proposed rule specifically invites
comment on several alternatives including alternative definitions for
``processed food item,'' alternative labeling of mixed origin, and
alternatives to using ``slaughtered'' on the label. The proposed rule
published October 30, 2003, provided for a 60-day comment period which
closed on December 29, 2003. A notice extending the comment period was
published December 22, 2003. The notice extended the comment period to
February 27, 2004.
Anticipated Cost and Benefits:
USDA has examined the economic impact of the proposed rule as required
by Executive Order 12866. The estimated benefits associated with this
rule are likely to be negligible. The estimated first-year incremental
cost for growers, producers, processors, wholesalers, and retailers
ranges from $582 million to $3.9 billion. The estimated cost to the
U.S. economy in higher food prices and reduced food production in the
tenth year after implementation of the rule ranges from $138 million to
$596 million. AMS has invited further comment on start up costs and
maintenance costs for the first year and beyond for firms directly
affected by the proposed rule.
Risks:
AMS has not identified any risks at this time.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 61944 10/30/03
NPRM Comment Period End 12/29/03
Interim Final Ru69 FR 59708 10/05/04
Interim Final Rule Comment Period End 01/03/05
Interim Final Rule Effective 04/04/05
Final Action 06/00/06
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
State
Federalism:
This action may have federalism implications as defined in EO 13132.
Additional Information:
The U.S. Department of Agriculture issued an interim final rule with
request for comments for the labeling of fish and shellfish covered
commodities that will become effective on April 4, 2005. A final
regulatory action for all covered commodities will be issued by June
30, 2006.
Agency Contact:
William Sessions
Associate Deputy Administrator
Department of Agriculture
Agricultural Marketing Service
Room 2092-South, Stop 0249
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5705
Email: william.sessions@usda.gov
RIN: 0581-AC26
_______________________________________________________________________
USDA--Animal and Plant Health Inspection Service (APHIS)
-----------
PRERULE STAGE
-----------
3. REVISION OF THE NURSERY STOCK REGULATIONS (Q.37)
Priority:
Other Significant
Legal Authority:
7 USC 450; 7 USC 7701 to 7772; 21 USC 136 to 136a
CFR Citation:
7 CFR 319
Legal Deadline:
None
Abstract:
This action will solicit public comment on whether and how we should
amend the regulations that govern the importation of nursery stock,
also known as plants for planting. Under the current regulations, all
plants for planting are allowed to enter the United States if they are
accompanied by a phytosanitary certificate and if they are inspected
and found to be free of plant pests, unless their importation is
specifically prohibited or further restricted by the regulations. We
are considering several possible changes to this approach, including
establishing a category in the regulations for plants for planting that
would be excluded from importation pending risk evaluation and
approval; developing ongoing programs to reduce the risk of entry and
establishment of quarantine pests via imported plants for planting;
combining existing regulations governing the importation of plants for
planting into one subpart; and reevaluating the risks posed by
importation of plants for planting whose importation is currently
prohibited. We are also considering how to best collect data on current
imports of plants for planting so we can accurately ascertain the
volume, type, and origin of such plants entering the United States. We
are soliciting public comment on these issues to help us determine what
changes we should propose to improve our regulations and which of these
changes should be assigned the highest priority for implementation.
Statement of Need:
APHIS typically relies on inspection at a Federal plant inspection
station or
[[Page 72669]]
port of entry to mitigate the risks of pest introduction associated
with the importation of plants for planting. Importation of plants for
planting is further restricted or prohibited only if there is specific
evidence that such importation could introduce a quarantine pest into
the United States. Most of the taxa of plants for planting currently
being imported have not been thoroughly studied to determine whether
their importation presents a risk of introducing a quarantined pest
into the United States. The volume and the number of types of plants
for planting have increased dramatically in recent years, and there are
several problems associated with gathering data on what plants for
planting are being imported and on the risks such importation presents.
In addition, quarantined pests that enter the United States via the
importation of plants for planting pose a particularly high risk of
becoming established within the United States. Given these
circumstances, APHIS needs to consider various ways in which the
regulations governing plants for planting might be revised in order to
address the risk of pest introduction via the importation of plants for
planting. This ANPRM solicits public comment on several measures we are
considering.
Summary of Legal Basis:
The Secretary of Agriculture may prohibit or restrict the importation
or entry of any plant if the Secretary determines that the prohibition
or restriction is necessary to prevent the introduction into the United
States of a plant pest or noxious weed (7 U.S.C. 7712).
Alternatives:
APHIS has identified two alternatives to the approach we are
considering in this advance notice of proposed rulemaking. The first is
to maintain the status quo; this alternative was rejected because,
given our limited resources and the risks of pest introduction posed by
the rapid increase in the importation of plants for planting, we do not
believe that this approach would allow us to address the potential
risks posed by quarantine pests in a timely manner. The second is to
prohibit the importation of all nursery stock pending risk evaluation,
approval, and notice-and-comment rulemaking, similar to APHIS's
approach to regulating imported fruits and vegetables; this approach
was rejected because, in the absence of additional resources for
conducting risk evaluation and rulemaking, this approach would lead to
a major interruption in international trade and would have significant
economic effects on both U.S. importers and U.S. consumers of plants
for planting.
Anticipated Cost and Benefits:
This action is currently in the advance notice of proposed rulemaking
stage; we are gathering information to guide us in deciding what
actions to take. In the absence of specific proposed measures, we
cannot determine specific costs and benefits. However, the costs
associated with plant pests that are introduced to the United States
via imported nursery stock are expected to increase in the absence of
some action to revise the nursery stock regulations to allow us to
better address pest risks.
Risks:
In the absence of some action to revise the nursery stock regulations
to allow us to better address pest risks, increased introductions of
plant pests via imported nursery stock are likely, causing extensive
damage to both agricultural and natural plant resources.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 12/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Additional Information:
APHIS documents published in the Federal Register and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
Agency Contact:
Dr. Arnold T. Tschanz
Senior Staff Officer, Regulatory Coordination Staff, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 141
4700 River Road
Riverdale, MD 20737-1236
Phone: 301 734-5306
RIN: 0579-AB85
_______________________________________________________________________
USDA--APHIS
-----------
FINAL RULE STAGE
-----------
4. FOOT-AND-MOUTH DISEASE; PAYMENT OF INDEMNITY
Priority:
Other Significant
Legal Authority:
7 USC 8301 to 8317
CFR Citation:
9 CFR 53
Legal Deadline:
None
Abstract:
This rule would amend the regulations for the cooperative control and
eradication of foot-and-mouth disease (FMD) and other serious diseases,
including both cooperative programs and extraordinary emergencies. The
purpose of this rule is to remove possible sources of delay in
eradicating foot-and-mouth disease, should an occurrence of that
disease occur in this country, so that eligible claimants will be fully
compensated while at the same time protecting the U.S. livestock
population from the further spread of this highly contagious disease.
Statement of Need:
APHIS has reviewed these regulations to determine their sufficiency,
should an occurrence of foot-and-mouth disease occur in the United
States. This review was prompted, in part, by a series of outbreaks of
foot-and-mouth disease that occurred in the United Kingdom and
elsewhere around the world. Based on this review, APHIS has determined
that changes to the regulations are needed with regard to the valuation
of animals and materials, as well as the payment of an indemnity to
those persons who suffer loss of property as a result of foot-and-mouth
disease.
Summary of Legal Basis:
The Secretary of Agriculture, either independently or in cooperation
with other Federal agencies, States or political subdivisions of
States, national governments of foreign countries, local governments of
foreign countries, domestic or international organizations, domestic or
international associations, Indian tribes, and other persons, may carry
out operations and measures to detect, control, or eradicate any pest
or
[[Page 72670]]
disease of livestock that threatens the livestock of the United States,
including the payment of claims arising out of the destruction of any
animal, article, or means of conveyance, if necessary to prevent the
dissemination of the pest or disease of livestock (7 U.S.C. 8306, 8308,
8310, and 8315).
Alternatives:
The rule comprises several regulatory changes, each of which is
intended to facilitate the control and eradication of foot-and-mouth
disease, should an outbreak of this disease occur in the United States.
Reasonable alternatives to the rule would be to not make any changes at
all and rely on the current regulations as applied to cooperative
programs and extraordinary emergencies.
Anticipated Cost and Benefits:
The rule is expected to affect livestock operations and Federal and
State government agencies. The vast majority of livestock operations
are small entities. The potential costs and benefits would depend upon
the characteristics of the outbreak and mitigation strategy. The
proposed changes would strengthen programs for the control and
eradication of FMD by broadening USDA's options. The changes would also
lessen the chances that FMD's eradication would be delayed.
Risks:
The changes contained in the rule would be particularly important in
removing sources of delay in achieving FMD eradication, should an
outbreak of foot-and-mouth disease occur in the United States. An
effective response in the early stages of such an outbreak greatly
reduces the risk of the disease's wider dissemination.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 67 FR 21934 05/01/02
NPRM Comment Per67 FR 43566d 06/28/02
NPRM Comment Period End 07/01/02
NPRM Comment Period End 07/31/02
Final Action 06/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, State
Additional Information:
APHIS documents published in the Federal Register and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
Agency Contact:
Dr. Mark Teachman
Senior Staff Veterinarian, Emergency Programs, VS
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 41
4700 River Road
Riverdale, MD 20737-1231
Phone: 301 734-8073
RIN: 0579-AB34
_______________________________________________________________________
USDA--APHIS
5. CHRONIC WASTING DISEASE IN ELK AND DEER; INTERSTATE MOVEMENT
RESTRICTIONS AND PAYMENT OF INDEMNITY
Priority:
Other Significant
Legal Authority:
7 USC 8301 to 8316
CFR Citation:
9 CFR 55; 9 CFR 81
Legal Deadline:
None
Abstract:
This rulemaking would establish requirements for the interstate
movement of farmed elk and deer and provide indemnity for the
depopulation of farmed elk and deer that have been infected with, or
exposed to, chronic wasting disease (CWD).
Statement of Need:
CWD has been confirmed in free-ranging deer and elk in a limited number
of counties in northeastern Colorado and southeastern Wyoming and has
also been diagnosed in farmed elk herds in South Dakota, Nebraska,
Oklahoma, Montana, and Colorado. This project includes an interim rule
to establish indemnity for voluntary depopulation of CWD-affected
herds, followed by rulemaking to establish a voluntary certification
program and interstate movement restrictions on captive elk and deer.
APHIS believes that establishing restrictions on the interstate
movement of infected and exposed farmed elk and deer, coupled with the
payment of some level of indemnity for infected and exposed animals,
will encourage producers who are not yet engaging in surveillance
activities to begin doing so. To date, the level of support from States
and the farmed cervid industry for such a program has been high.
Without a Federal program in place to depopulate infected and exposed
animals, the movement of infected animals into new herds and States
with no known infection will continue or may even accelerate. APHIS
needs to take action to document the prevalence of the disease and to
prevent its further spread.
Summary of Legal Basis:
The Secretary of Agriculture, either independently or in cooperation
with other Federal agencies, States or political subdivisions of
States, national governments of foreign countries, local governments of
foreign countries, domestic or international organizations, domestic or
international associations, Indian tribes, and other persons, may carry
out operations and measures to detect, control, or eradicate any pest
or disease of livestock of the United States, including the payment of
claims arising out of the destruction of any animal, article, or means
of conveyance, if necessary to prevent the dissemination of the pest or
disease of livestock (7 U.S.C. 8305 to 8306, 8308, 8310, and 8315).
Alternatives:
APHIS has identified two additional alternatives to our selected
action. The first--to maintain the status quo--was rejected because it
would not address the animal disease risks associated with CWD. The
second option would have been to provide financial and technical
assistance to the cervid industry for continuation and expansion of a
variety of herd management practices to reduce or eliminate CWD.
Although this option may be less costly than the option chosen by
APHIS, this option was not selected because it would not advance CWD
eradication as quickly or effectively as the chosen option. However,
APHIS will continue to work with industry to develop voluntary herd
management practices to preserve and increase the reduction in CWD
levels that the proposed program is expected to achieve.
Anticipated Cost and Benefits:
The presence of CWD in elk and deer causes significant economic and
market
[[Page 72671]]
losses to U.S. producers. Recently, Canada has begun to require, as a
condition for importing U.S. elk into Canada, that the animals be
accompanied by a certificate stating that the herd of origin is not
located in Colorado or Wyoming, and CWD has never been diagnosed in the
herd of origin. The Republic of Korea recently suspended the
importation of deer and elk and their products from the United States
and Canada. Fear of CWD can severely affect the domestic prices for
deer and elk, as it is more difficult for producers to sell cervid that
are associated with any hint of exposure to the disease.
Risks:
Aggressive action in controlling this disease now will decrease the
chance of having to deal with a much larger, widespread, and costly
problem later, such as the situation with bovine spongiform
encephalopathy (``mad cow disease'') in Europe. Although there is
currently no evidence that CWD is linked to disease in humans, or in
domestic animals other than deer and elk, a theoretical risk of such a
link exists.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru67 FR 5925 02/08/02
Interim Final Rule Comment Period End 04/09/02
NPRM 68 FR 74513 12/24/03
NPRM Comment Period End 02/23/04
Final Action 03/00/05
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal, State
Additional Information:
APHIS documents published in the Federal Register and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
Agency Contact:
Dr. Dean Goeldner
Staff Veterinarian, National Center for Animal Health Programs
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road
Unit 43
Riverdale, MD 20737-1231
Phone: 301 736-4916
RIN: 0579-AB35
_______________________________________________________________________
USDA--Food and Nutrition Service (FNS)
-----------
PROPOSED RULE STAGE
-----------
6. SENIOR FARMERS' MARKET NUTRITION PROGRAM (SFMNP)
Priority:
Other Significant
Legal Authority:
PL 107-171, sec 4306
CFR Citation:
7 CFR 249
Legal Deadline:
None
Abstract:
This proposed rule will implement the provision of the Farm Security
and Rural Investment Act of 2002 (Pub. L. 107-171) that gives the
Department the authority to promulgate regulations for the operation
and administration of the SFMNP. The purposes of the SFMNP are to
provide fresh, nutritious, unprepared locally grown fruits, vegetables,
and herbs from farmers' markets, roadside stands, and community
supported agriculture programs to low-income seniors and to increase
the consumption of agricultural commodities by expanding, developing,
and/or aiding in the development of domestic farmers' markets, roadside
stands, and community supported agriculture programs. (02-012)
Statement of Need:
The SFMNP has been administered since fiscal year 2001 as a competitive
grant program in which State agencies, interested in receiving a grant
to operate the program, submitted an application for SFMNP grant funds
to USDA's Food and Nutrition Service. Such grants were reviewed and
ranked against a set of explicit criteria, and SFMNP grants were then
awarded to those State agencies whose applications received the highest
scores. Public Law 107-171 authorized funding for the SFMNP through FY
2007 and also gave the Department the authority to promulgate
regulations for the future operation and administration of the SFMNP.
This legislative action establishes the SFMNP as a permanent nutrition
assistance program and eliminates the need for State agencies to
participate in an annual competition for program funds. Therefore, this
proposed rulemaking converts the SFMNP from a competitive grant program
to a permanent FNS-administered nutrition assistance program.
Summary of Legal Basis:
Public Law 107-171 (section 4306) authorized funding for the SFMNP
through FY 2007 and also gave the Department the authority to
promulgate regulations for the future operation and administration of
the SFMNP.
Alternatives:
USDA considered a variety of alternatives when constructing the
regulation for the SFMNP. Primarily, the proposed regulation is modeled
after the WIC Farmers' Market Nutrition Program and the Senior Farmers'
Market Nutrition Pilot Programs. Consistency lends to administrative
ease among the State agencies, localities, and USDA, as well as
provides continuity to beneficiaries and farmers who have been
operating the pilot programs since 2001. Nevertheless, USDA addressed
seven specific alternatives: Type of grant structure, eligible grantees
and recipients, the use of community-supported agriculture programs,
provision of administrative funding, eligibility requirements,
verification procedures, and benefit levels. Each of these alternatives
is explored in detail in the preamble to the proposed rulemaking.
Anticipated Cost and Benefits:
The funding level for the SFMNP is expected to remain stable through FY
2007. Therefore, the Department does not anticipate significant changes
to the costs/benefits of the SFMNP as a result of the publication of
this proposed rule.
Risks:
The proposed rule carries a 90-day comment period, during which
interested parties may submit comments on any and all provisions
contained in the rulemaking. Once the
[[Page 72672]]
comment period has expired, all comments received will be carefully
considered in the development of the final rule. Opportunities for
training on and discussion of the SFMNP regulations (in both their
proposed and final forms) will be offered to State agencies and other
entities with a vested interest in the operation and administration of
the SFMNP.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 02/00/05
NPRM Comment Period End 05/00/05
Final Action 09/00/05
Final Action Effective 10/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses, Organizations
Government Levels Affected:
Federal, Local, State, Tribal
Federalism:
Undetermined
URL For More Information:
www.fns.usda.gov
URL For Public Comments:
www.fns.usda.gov/wic
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN: 0584-AD35
_______________________________________________________________________
USDA--FNS
7. FSP: DISCRETIONARY QUALITY CONTROL PROVISIONS OF TITLE IV OF PUBLIC
LAW 107-171
Priority:
Other Significant
Legal Authority:
7 USC 2011 to 2032; PL 107-171
CFR Citation:
7 CFR 271; 7 CFR 273; 7 CFR 275; 7 CFR 277
Legal Deadline:
None
Abstract:
This proposed rule will implement several quality control changes to
the Food Stamp Act required by sections 4118 and 4119 of title IV of
the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171).
The provisions in this rule affect the following areas: 1) The
elimination of enhanced funding; 2) revisions to the time frames for
completing individual case reviews; 3) extending the time frames in the
procedures for households that refuse to cooperate with QC reviews; 4)
procedures for adjusting liability determinations following appeal
decisions; and 5) conforming and technical changes. (02-015)
Statement of Need:
The rule is needed to implement several food stamp quality control
provisions of Public Law 107-171 the Farm Security and Rural Investment
Act of 2002. Elimination of enhanced funding is required by the Act.
The Act also requires the Department to propose rules for adjusting
liability determinations following appeals decisions. The remaining
changes are either conforming changes resulting from the required
changes or policy changes already in effect but not updated in the
regulations.
Summary of Legal Basis:
The legal basis for this rule is Public Law 107-171 the Farm Security
and Rural Investment Act of 2002.
Alternatives:
This rule deals in part with changes required by title IV of Public Law
107-171 the Farm Security and Rural Investment Act of 2002. The
Department has no discretion in eliminating enhanced funding for fiscal
years 2003 and beyond. The provision addressing results of appeals is
required to be regulated by Public Law 107-171. The remaining changes
amend existing regulations and are required to make technical changes
resulting from these changes or to update policy consistent with
current requirements.
Anticipated Cost and Benefits:
The provisions of this rule are not anticipated to have any impact on
benefit levels. The provisions of this rule are anticipated to reduce
administrative costs.
Risks:
The FSP provides nutrition assistance to millions of Americans
nationwide. The quality control system measures the accuracy of States
providing food stamp benefits to the program recipients. This rule is
intended to implement some of the quality control provisions of title
IV of Public Law 107-171 the Farm Security and Rural Investment Act of
2002. The provisions of this rule will eliminate enhanced funding for
low payment error rates. It will revise the system for determining
State agency liabilities and sanctions for high payment error rates
following appeal decisions.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 02/00/05
NPRM Comment Period Ends 05/00/05
Final Action 05/00/06
Final Action Effective 06/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
Related RIN: Split from 0584-AD31
RIN: 0584-AD37
_______________________________________________________________________
USDA--FNS
8. SPECIAL NUTRITION PROGRAMS: FLUID MILK SUBSTITUTIONS
Priority:
Other Significant
Legal Authority:
PL 108-265, sec 102
CFR Citation:
7 CFR 210; 7 CFR 220
Legal Deadline:
None
Abstract:
Currently, by regulation, schools must make substitutions for fluid
milk for students with a disability when the
[[Page 72673]]
request is authorized by a licensed physician and may make
substitutions for students with medical or other dietary needs if
requested by recognized medical authority. These regulatory provisions
were included in Public Law 108-265 which amended the Richard B.
Russell National School Lunch Act. Public Law 108-265 also amended the
current law to allow schools to substitute non-dairy beverages
nutritionally equivalent (as established by the Secretary) to fluid
milk for medical or other special dietary needs at the request of a
parent/guardian. In response to Public Law 108-265, the National School
Lunch Program and School Breakfast Program regulations will be revised
to add these requirements.
(04-016)
Statement of Need:
The changes made to the Richard B. Russell National School Lunch Act
concerning substitutions for fluid milk are intended to assist children
with an intolerance to or a cultural or other restriction concerning
the consumption of milk. This regulation allows schools to make
substitutions at the request of a parent or guardian which assists
families that are unable to obtain a doctor's statement. However, the
Secretary must develop criteria to limit the substitutions for milk to
nutritionally equivalent beverages. The determination of nutritionally
equivalent beverages will require careful research and consultation.
Summary of Legal Basis:
These changes are being made in response to provisions in Public Law
108-265.
Alternatives:
USDA will be working with other Federal agencies to develop criteria
for nutritionally equivalent substitutes for fluid milk as well as
conducting research. USDA is issuing a proposed rule on this provision
in order to solicit public comments prior to any final decisionmaking.
Anticipated Cost and Benefits:
Schools may incur additional costs in obtaining and offering substitute
beverages. However, a significant benefit is to children who cannot
consume milk and who will now have a nutritionally equivalent beverage
to milk.
Risks:
USDA must be diligent in making any determinations of nutritional
equivalency to milk.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 10/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
Local, State
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN: 0584-AD58
_______________________________________________________________________
USDA--FNS
-----------
FINAL RULE STAGE
-----------
9. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM
INTEGRITY
Priority:
Other Significant
Legal Authority:
42 USC 1766; PL 103-448; PL 104-193; PL 105-336
CFR Citation:
7 CFR 226
Legal Deadline:
None
Abstract:
This rule amends the Child and Adult Care Food Program (CACFP)
regulations. The changes in this rule result from the findings of State
and Federal program reviews and from audits and investigations
conducted by the Office of Inspector General. This rule revises: State
agency criteria for approving and renewing institution applications;
program training and other operating requirements for child care
institutions and facilities; and State- and institution-level
monitoring requirements. This rule also includes changes that are
required by the Healthy Meals for Healthy Americans Act of 1994 (Pub.
L. 103-448), the Personal Responsibility and Work Opportunities
Reconciliation Act of 1996 (Pub. L. 104-193), and the William F.
Goodling Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336).
The changes are designed to improve program operations and monitoring
at the State and institution levels and, where possible, to streamline
and simplify program requirements for State agencies and institutions.
(95-024)
Statement of Need:
In recent years, State and Federal program reviews have found numerous
cases of mismanagement, abuse, and in some instances, fraud by child
care institutions and facilities in the CACFP. These reviews revealed
weaknesses in management controls over program operations and examples
of regulatory noncompliance by institutions, including failure to pay
facilities or failure to pay them in a timely manner; improper use of
program funds for non-program expenditures; and improper meal
reimbursements due to incorrect meal counts or to miscategorized or
incomplete income eligibility statements. In addition, audits and
investigations conducted by the Office of Inspector General (OIG) have
raised serious concerns regarding the adequacy of financial and
administrative controls in CACFP. Based on its findings, OIG
recommended changes to CACFP review requirements and management
controls.
Summary of Legal Basis:
Some of the changes proposed in the rule are discretionary changes
being made in response to deficiencies found in program reviews and OIG
audits. Other changes codify statutory changes made by the Healthy
Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal
Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub.
L. 104-193), and the William F. Goodling Child Nutrition
Reauthorization Act of 1998 (Pub. L. 105-336).
Alternatives:
In developing the proposal, the Agency considered various alternatives
to minimize burden on State agencies and
[[Page 72674]]
institutions while ensuring effective program operation. Key areas in
which alternatives were considered include State agency reviews of
institutions and sponsoring organization oversight of day care homes.
Anticipated Cost and Benefits:
This rule contains changes designed to improve management and financial
integrity in the CACFP. When implemented, these changes would affect
all entities in CACFP, from USDA to participating children and
children's households. These changes will primarily affect the
procedures used by State agencies in reviewing applications submitted
by, and monitoring the performance of, institutions which are
participating or wish to participate in the CACFP. Those changes which
would affect institutions and facilities will not, in the aggregate,
have a significant economic impact.
Data on CACFP integrity is limited, despite numerous OIG reports on
individual institutions and facilities that have been deficient in
CACFP management. While program reviews and OIG reports clearly
illustrate that there are weaknesses in parts of the program
regulations and that there have been weaknesses in oversight, neither
program reviews, OIG reports, nor any other data sources illustrate the
prevalence and magnitude of CACFP fraud and abuse. This lack of
information precludes USDA from estimating the amount of money lost due
to fraud and abuse or the reduction in fraud and abuse the changes in
this rule will realize.
Risks:
Continuing to operate the CACFP under existing provisions of the
regulations that do not sufficiently protect against fraud and abuse in
CACFP puts the program at significant risk. This rule includes changes
designed to strengthen current program regulations to reduce the risk
associated with the program.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 55103 09/12/00
NPRM Comment Period End 12/11/00
Interim Final Ru69 FR 53502 09/01/04
Interim Final Rule Effective 10/01/04
Interim Final Rule Comment Period End 09/01/05
Final Action 12/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Local, State
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN: 0584-AC24
_______________________________________________________________________
USDA--FNS
10. COMMODITY SUPPLEMENTAL FOOD PROGRAM (CSFP): PLAIN LANGUAGE, PROGRAM
ACCOUNTABILITY, AND PROGRAM FLEXIBILITY
Priority:
Other Significant
Legal Authority:
PL 101-624; PL 104-127
CFR Citation:
7 CFR 247
Legal Deadline:
None
Abstract:
This rule will rewrite regulations pertaining to the Commodity
Supplemental Food Program (7 CFR part 247) in ``plain language.'' It
will also amend regulatory provisions in this part to increase program
accountability, impose more rigorous performance measures on State and
local agencies, increase flexibility for program operators, and
incorporate legislative provisions that have been implemented through
program policy. (99-005)
Statement of Need:
This rule is necessary to amend regulatory provisions in 7 CFR part 247
to increase program accountability, impose more rigorous performance
measures on State and local agencies, increase flexibility for program
operators and incorporate legislative provisions that have been
implemented through program policy.
Summary of Legal Basis:
Executive Order 12866 requires each agency to write regulations that
are simple and easy to understand. The rule meets these requirements.
This rule also incorporates legislative amendments found in sections
1771(d) and 1771(e) of the Food, Agriculture, Conservation, and Trade
Act of 1990; section 402(b) of the Federal Agriculture Improvement and
Reform Act of 1996; section 4201(b) of the Farm Security and Rural
Investment Act of 2002; and the Single Audit Act Amendments of 1996.
Alternatives:
No alternatives available.
Anticipated Cost and Benefits:
Changes in the rule reduce the burden imposed on State and local
agencies while ensuring program accountability and are generally
insignificant to the costs or overall operations of the program.
Risks:
There are no risks involved with this proposed rule.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 62164 10/31/03
NPRM Comment Period End 12/30/03
Final Action 03/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Local, State, Tribal
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN: 0584-AC84
[[Page 72675]]
_______________________________________________________________________
USDA--FNS
11. FSP: HIGH PERFORMANCE BONUSES
Priority:
Other Significant
Legal Authority:
PL 107-171
CFR Citation:
7 CFR 272; 7 CFR 275
Legal Deadline:
None
Abstract:
This action will finalize amendments to the FSP regulations originally
proposed on December 17, 2003, titled FSP High Performance Bonuses.
These amendments were provided for in the Farm Security and Rural
Investment Act of 2002 for States that demonstrate high or improved
performance in administration of the Food Stamp Program. This action
will finalize the measurement criteria for fiscal year 2005 and beyond.
(02-006)
Statement of Need:
This rule is mandated by Public Law 107-171 to implement the
performance measures used to award high performance bonuses for fiscal
years 2005 and beyond.
Summary of Legal Basis:
The legal basis for this rule is Public Law 107-171.
Alternatives:
This rule is mandated by law. Therefore, there are no alternatives.
Anticipated Cost and Benefits:
Undetermined
Risks:
The law mandates that we publish the performance measures for the high
performance bonuses for FY 2005 and beyond.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 70193 12/17/03
NPRM Comment Period End 02/17/04
Final Action 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State, Tribal
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN: 0584-AD29
_______________________________________________________________________
USDA--FNS
12. FSP: ELIGIBILITY AND CERTIFICATION PROVISIONS OF THE FARM SECURITY
AND RURAL INVESTMENT ACT OF 2002
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 107-171, secs 4101 to 4109, 4114, 4115, and 4401
CFR Citation:
7 CFR 273
Legal Deadline:
None
Abstract:
This rulemaking proposes to amend Food Stamp Program regulations to
implement 11 provisions of the Farm Security and Rural Investment Act
of 2002 that establish new eligibility and certification requirements
for the receipt of food stamps.
Statement of Need:
The rule is needed to implement the food stamp certification and
eligibility provisions of Public Law 107-171, the Farm Security and
Rural Investment Act of 2002.
Summary of Legal Basis:
The legal basis for this rule is Public Law 107-171, the Farm Security
and Rural Investment Act of 2002.
Alternatives:
This proposed rule deals with changes required by Public Law 107-171,
the Farm Security and Rural Investment Act of 2002. The Department has
limited discretion in implementing provisions of that law. Most of the
provisions in this rule are effective October 1, 2002, and must be
implemented by State agencies prior to publication of this rule.
Anticipated Cost and Benefits:
The provisions of this rule will simplify State administration of the
Food Stamp Program, increase eligibility for the program among certain
groups, increase access to the program among low-income families and
individuals, and increase benefit levels. The provisions of Public Law
107-171 implemented by this rule will have a 5-year cost of
approximately $1.9 billion.
Risks:
The FSP provides nutrition assistance to millions of Americans
nationwide--working families, eligible non-citizens, and elderly and
disabled individuals. Many low-income families don't earn enough money
and many elderly and disabled individuals don't receive enough in
retirement or disability benefits to meet all of their expenses and
purchase healthy and nutritious meals. The FSP serves a vital role in
helping these families and individuals achieve and maintain self-
sufficiency and purchase a nutritious diet. This rule is intended to
implement the certification and eligibility provisions of Public Law
107-171, the Farm Security and Rural Investment Act of 2002. It will
simplify State administration of the Food Stamp Program, increase
eligibility for the program among certain groups, increase access to
the program among low-income families and individuals, and increase
benefit levels. The provisions of this rule will increase benefits by
approximately $1.95 billion over 5 years. When fully effective in FY
2006, the provisions of this rule will add approximately 415,000 new
participants.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 20724 04/16/04
NPRM Comment Period End 06/15/04
Final Action 10/00/05
Final Action Effective 12/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State, Tribal
[[Page 72676]]
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN: 0584-AD30
_______________________________________________________________________
USDA--FNS
13. FSP: NON-DISCRETIONARY QUALITY CONTROL PROVISIONS OF TITLE IV OF
PUBLIC LAW 107-171
Priority:
Other Significant
Legal Authority:
7 USC 2011 to 2032; PL 107-171
CFR Citation:
7 CFR 273; 7 CFR 275
Legal Deadline:
None
Abstract:
This final rule implements several quality control changes to the Food
Stamp Act required by sections 4118 and 4119 of title IV of the Farm
Security and Rural Investment Act of 2002 (Pub. L. 107-171). The
provisions in this rule affect the following areas: 1) Timeframes for
completing quality control reviews; 2) timeframes for completing the
arbitration process; 3) timeframes for determining final error rates;
4) the threshold for potential sanctions and time period for sanctions;
5) the calculation of State error rates; 6) the formula for determining
States' liability amounts; 7) sanction notification and method of
payment; and 8) corrective action plans. (02-014)
Statement of Need:
The rule is needed to implement the food stamp quality control
provisions of Public Law 107-171, the Farm Security and Rural
Investment Act of 2002.
Summary of Legal Basis:
The legal basis for this rule is Public Law 107-171, the Farm Security
and Rural Investment Act of 2002.
Alternatives:
This interim rule deals with changes required by Public Law 107-171,
the Farm Security and Rural Investment Act of 2002. The Department has
no discretion in implementing these provisions of that law. The
provisions in this rule are effective for the fiscal year 2003 quality
control review period and must be implemented by FNS and State agencies
during fiscal year 2003.
Anticipated Cost and Benefits:
The provisions of this rule are not anticipated to have any impact on
benefit levels or administrative costs.
Risks:
The FSP provides nutrition assistance to millions of Americans
nationwide. The quality control system measures the accuracy of States
providing food stamp benefits to the program recipients. This rule is
intended to implement the quality control provisions of Public Law 107-
701, the Farm Security and Rural Investment Act of 2002. It will
significantly revise the system for determining State agency
liabilities and sanctions for high payment error rates.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru68 FR 59519 10/16/03
Interim Final Rule Effective 12/15/03
Interim Final Rule Comment Period End 01/14/04
Final Action 10/00/05
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal, Local, State
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN: 0584-AD31
_______________________________________________________________________
USDA--FNS
14. FSP: EMPLOYMENT AND TRAINING PROGRAM PROVISIONS OF THE FARM
SECURITY AND RURAL INVESTMENT ACT OF 2002
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 107-171
CFR Citation:
7 CFR 273.7
Legal Deadline:
None
Abstract:
This final rule implements revisions to the Food Stamp Employment and
Training (E&T) Program funding requirements. (02-009)
Statement of Need:
This rule is necessary to implement statutory revisions to E&T Program
funding provisions.
Summary of Legal Basis:
All provisions of this proposed rule are mandated by Public Law 107-
171.
Alternatives:
The alternative is not to revise current funding rules. This is not
practical. The current rules have been superseded by changes brought
about by Public Law 107-171. These changes were effective on May 13,
2002, the date of enactment of Public Law 107-171.
Anticipated Cost and Benefits:
None.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 12981 03/19/04
NPRM Comment Period End 05/18/04
Final Action 12/00/04
Final Action Effective 02/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN: 0584-AD32
[[Page 72677]]
_______________________________________________________________________
USDA--FNS
15. DIRECT AND DISCRETIONARY CERTIFICATION IN THE SCHOOL MEALS
PROGRAMS
Priority:
Other Significant
Legal Authority:
PL 108-265, sec 104
CFR Citation:
7 CFR 245
Legal Deadline:
None
Abstract:
Currently a school food authority may ``directly certify'' any child as
eligible for free or reduced-price school meals, without further
application, by directly communicating with the appropriate State or
local agency to obtain documentation of the child's status as a member
of a food stamp household or a family receiving TANF.
In response to Public Law 108-265, which amended the Richard B. Russell
National School Lunch Act, 7 CFR 245, Determining Eligibility for Free
and Reduced Price Meals and Free Milk in Schools, will be revised to
require that school food authorities ``directly certify'' as eligible
for free school meals, without further application, any child who is a
member of a food stamp household. In order to carry out this
requirement, the law also requires that each State agency enter into an
agreement with the State food stamp agency to establish procedures
under which children who are members of food stamp households will be
directly certified and amends the Food Stamp Act to require State food
stamp agencies to enter into the required agreements and cooperate in
carrying out direct certification. The direct certification
requirements are phased-in. For School Year 2006-2007, school districts
with an enrollment of 25,000 students or more in the preceding year
must comply. For School Year 2007-2008, school districts with an
enrollment of 10,000 students or more in the preceding year must
comply. For subsequent school years, all districts must comply. Until
mandatory ``direct certification'' for children in food stamp
households is fully implemented, the existing permissive authority is
retained. In addition, this rule adds (to existing authority with
regard to children in TANF families) permissive authority for school
food authorities to directly certify homeless children, children served
by programs under the Runaway and Homeless Youth Act, and migrant
children. (04-018)
Statement of Need:
The changes made to the Richard B. Russell National School Lunch Act
concerning direct verification are intended to improve program access,
reduce paperwork, and improve the accuracy of the delivery of free meal
benefits. This regulation will implement the statutory changes and
provide State agencies and local educational agencies with the policies
and procedures to conduct mandatory and discretionary direct
certification.
Summary of Legal Basis:
These changes are being made in response to provisions in Public Law
108-265.
Alternatives:
FNS will be working closely with State agencies to implement the
changes made by this regulation and will be developing extensive
guidance materials in conjunction with our cooperators.
Anticipated Cost and Benefits:
This regulation will reduce paperwork, target benefits more precisely,
and will improve program access of eligible school children.
Risks:
This regulation may require adjustments to existing computer systems to
more readily share information between schools, food stamp offices, and
other agencies.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Rule 06/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Governmental Jurisdictions
Government Levels Affected:
Local, State
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN: 0584-AD60
_______________________________________________________________________
USDA--Food Safety and Inspection Service (FSIS)
-----------
PROPOSED RULE STAGE
-----------
16. PERFORMANCE STANDARDS FOR PUMPED OR MASSAGED BACON
Priority:
Other Significant
Legal Authority:
21 USC 601 et seq
CFR Citation:
9 CFR 424.22(b)
Legal Deadline:
None
Abstract:
FSIS is proposing to revise the regulatory provisions concerning the
production and testing of pumped or massaged bacon (9 CFR 424.22(b)).
FSIS is proposing to remove provisions that prescribe the substances
and amounts of such substances that must be used to produce pumped or
massaged bacon. FSIS is proposing to replace these provisions with an
upper limit for nitrite and a performance standard that establishments
producing pumped or massaged bacon must meet. To meet the proposed
performance standard, the process used to produce pumped or massaged
bacon would be required to limit the presence of nitrosamines when the
product is cooked.
Statement of Need:
FSIS is proposing to replace restrictive provisions concerning the
processing of pumped or massaged bacon with an upper limit for nitrite
and a performance standard. The proposed performance standard concerns
limiting the presence of volatile nitrosamines in pumped or massaged
bacon. These proposed changes are necessary to make the regulations
concerning pumped or massaged bacon consistent
[[Page 72678]]
with those governing Hazard Analysis and Critical Control Point (HACCP)
systems.
Summary of Legal Basis:
Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695), a meat or
meat food product is adulterated ``if it bears or contains any
poisonous or deleterious substance that may render it injurious to
health; but in case the substance is not an added substance, such
article shall not be considered adulterated under this clause if the
quantity of such substance in or on such article does not ordinarily
render it injurious to health'' (21 U.S.C. 601(m)(1)). Volatile
nitrosamines are deleterious because they are carcinogenic, and though
not added directly to pumped or massaged bacon, they may be produced
when the pumped or massaged bacon is fried. Processors can control the
levels of nitrosamines that may be present when the product is fried by
controlling the levels of ingoing nitrite and ingoing curing
accelerators that are used in the production of pumped or massaged
bacon. In 1978, USDA stated that nitrosamines present at confirmable
levels in pumped bacon after preparation for eating were deemed to
adulterate the product. FSIS still maintains that pumped bacon with
confirmable levels of nitrosamines after preparation for eating is
adulterated. Under this proposed rule, processors meeting the
performance standard would control the levels of nitrosamines in the
finished product by complying with a performance standard.
Alternatives:
No action; performance standards for all types of bacon (not just
pumped or massaged bacon, as proposed).
Anticipated Cost and Benefits:
Because FSIS is proposing to convert existing regulations to a
performance standard and is not proposing any new requirements for
establishments producing pumped or massaged bacon, FSIS does not
anticipate that this proposed rule would result in any significant
costs or benefits. Pumped or massaged bacon processing establishments
whose HACCP plans do not currently address nitrosamines as hazards
reasonably likely to occur may incur some costs. Also, establishments
that choose to test their products for nitrosamines after this rule
becomes effective may incur some costs. Because this rule provides
establishments the flexibility to develop new procedures for producing
bacon, this rule may result in profits to processors who develop
cheaper means of producing product or who develop a pumped or massaged
bacon product with wide consumer appeal.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program and Employee
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: daniel.engeljohn@fsis.usda.gov
RIN: 0583-AC49
_______________________________________________________________________
USDA--FSIS
17. EGG PRODUCTS INSPECTION REGULATIONS
Priority:
Economically Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
21 USC 1031 to 1056
CFR Citation:
9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR
590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 591; . . .
Legal Deadline:
None
Abstract:
The Food Safety and Inspection Service (FSIS) is proposing to require
egg products plants and plants pasteurizing shell eggs to develop and
implement Hazard Analysis and Critical Control Points (HACCP) systems
and Sanitation Standard Operating Procedures (SOPs). FSIS also is
proposing pathogen reduction performance standards that would be
applicable to egg products and pasteurized shell eggs. Plants would be
expected to develop HACCP systems that ensure products meet the
pathogen reduction performance standards. Finally, FSIS is proposing to
amend the Federal egg products inspection regulations by removing
current requirements for prior approval by FSIS of egg products plant
drawings, specifications, and equipment prior to their use in official
plants. The Agency also plans to eliminate the prior label approval
system for egg products. This proposal will not encompass shell egg
packers. In the near future, FSIS will initiate non-regulatory outreach
efforts for shell egg packers that will provide information intended to
help them to safely process shell eggs intended for human consumption
or further processing.
The actions being proposed are part of FSIS' regulatory reform effort
to improve FSIS' egg products food safety regulations, better define
the roles of Government and the regulated industry, encourage
innovations that will improve food safety, remove unnecessary
regulatory burdens on inspected egg products plants, and make the egg
products regulations as consistent as possible with the Agency's meat
and poultry products regulations. FSIS is also taking these actions in
light of changing inspection priorities and recent findings of
Salmonella in pasteurized egg products.
Statement of Need:
FSIS is proposing to require egg products plants and plants
pasteurizing shell eggs to develop and implement HACCP systems and
sanitation SOPs. FSIS also is proposing pathogen reduction performance
standards that would be applicable to pasteurized shell eggs and egg
products. Plants would be expected to develop HACCP systems that ensure
that these products meet the lethality required by the pathogen
reduction performance standards. In addition, FSIS is proposing to
amend the Federal egg products inspection regulations by removing
current requirements for approval by FSIS of egg product plant
drawings, specifications, and equipment prior to their use in official
plants. Finally, the Agency plans to eliminate the pre-marketing label
approval system for egg products but
[[Page 72679]]
to require safe-handling labels on all shell eggs.
The actions being proposed are part of FSIS' regulatory reform effort
to improve FSIS' shell egg and egg products food safety regulations,
better define the roles of Government and the regulated industry,
encourage innovations that will improve food safety, remove unnecessary
regulatory burdens on inspected egg products plants, and make the egg
products regulations as consistent as possible with the Agency's meat
and poultry products regulations. FSIS also is taking these actions in
light of changing inspection priorities and recent findings of
Salmonella in pasteurized egg products.
This proposal is directly related to FSIS' PR/HACCP initiative.
Summary of Legal Basis:
This proposed rule is authorized under the Egg Products Inspection Act
(21 U.S.C. 1031 to 1056). It is not the result of any specific mandate
by the Congress or a Federal court.
Alternatives:
A team of FSIS economists and food technologists is conducting a cost-
benefit analysis to evaluate the potential economic impacts of several
alternatives on the public, egg products industry, and FSIS. These
alternatives include: (1) Taking no regulatory action; (2) requiring
all inspected egg products plants to develop, adopt, and implement
written sanitation SOPs and HACCP plans; and (3) converting to a
lethality-based pathogen reduction performance standard many of the
current highly prescriptive egg products processing requirements. The
team will consider the effects of a uniform, across-the-board standard
for all egg products; a performance standard based on the relative risk
of different classes of egg products; and a performance standard based
on the relative risks to public health of different production
processes.
Anticipated Cost and Benefits:
FSIS is analyzing the potential costs of this proposed rulemaking to
industry, FSIS and other Federal agencies, State and local governments,
small entities, and foreign countries. The expected costs to industry
will depend on a number of factors. These costs include the required
lethality, or level of pathogen reduction, and the cost of HACCP plan
and sanitation SOP development, implementation, and associated employee
training. The pathogen reduction costs will depend on the amount of
reduction sought and in what classes of product, product formulations,
or processes.
Relative enforcement costs to FSIS and Food and Drug Administration may
change because the two agencies share responsibility for inspection and
oversight of the egg industry and a common farm-to-table approach for
shell egg and egg products food safety. Other Federal agencies and
local governments are not likely to be affected.
FSIS has cooperative agreements with four States and the Commonwealth
of Puerto Rico under which they provide inspection services to egg
processing plants under Federal jurisdiction. FSIS reimburses the
States for staffing costs and expenses for full-time State inspectors.
HACCP implementation may result in a reduction of staffing resource
requirements in the States and a corresponding reduction of the Federal
reimbursement. As a result, some States may decide to stop providing
inspection services and convert to Federal inspection of egg products
plants.
Egg and egg product inspection systems of foreign countries wishing to
export eggs and egg products to the U.S. must be equivalent to the U.S.
system. FSIS will consult with these countries, as needed, if and when
this proposal becomes effective.
This proposal is not likely to have a significant impact on small
entities. The entities that would be directly affected by this proposal
would be the approximately 75 federally inspected egg products plants,
most of which are small businesses, according to Small Business
Administration criteria. If necessary, FSIS will develop compliance
guides to assist these small firms in implementing the proposed
requirements.
Potential benefits associated with this rulemaking include:
Improvements in human health due to pathogen reduction; improved
utilization of FSIS inspection program resources; and cost savings
resulting from the flexibility of egg products plants in achieving a
lethality-based pathogen reduction performance standard. Once specific
alternatives are identified, economic analysis will identify the
quantitative and qualitative benefits associated with each.
Human health benefits from this rulemaking are likely to be small
because of the low level of (chiefly post-processing) contamination of
pasteurized egg products. In light of recent scientific studies that
raise questions about the efficacy of current regulations, however, it
is likely that measurable reductions will be achieved in the risk of
foodborne illness.
Risks:
FSIS believes that this regulatory action may result in a further
reduction in the risks associated with egg products. The development of
a lethality-based pathogen reduction performance standard for egg
products, replacing command-and-control regulations, will remove
unnecessary regulatory obstacles to, and provide incentives for,
innovation to improve the safety of egg products.
To assess the potential risk-reduction impacts of this rulemaking on
the public, an intra-Agency group of scientific and technical experts
is conducting a risk management analysis. The group has been charged
with identifying the lethality requirement sufficient to ensure the
safety of egg products and the alternative methods for implementing the
requirement. The egg products processing and distribution module of the
Salmonella enteritidis Risk Assessment, made public June 12, 1998, will
be appropriately modified to evaluate the risk associated with the
regulatory alternatives.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 06/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
Federal, State
Federalism:
Undetermined
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program and Employee
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: daniel.engeljohn@fsis.usda.gov
RIN: 0583-AC58
[[Page 72680]]
_______________________________________________________________________
USDA--FSIS
18. FOOD STANDARDS; GENERAL PRINCIPLES AND FOOD STANDARDS MODERNIZATION
Priority:
Other Significant
Legal Authority:
21 USC 601 et seq; 21 USC 451 et seq; 21 USC 321 et seq
CFR Citation:
9 CFR 410; 21 CFR 130
Legal Deadline:
None
Abstract:
The Food Safety and Inspection Service (FSIS) and the Food and Drug
Administration (FDA) are proposing to modernize their food standards.
The agencies are proposing a set of general principles for food
standards. The adherence to these principles will result in standards
that will better promote honesty and fair dealing in the interest of
consumers, protect the public, allow for technological advances in food
production, are consistent with international food standards, and are
clear, simple, and easy to use for both manufacturers and the agencies
that enforce compliance with the standards. The proposed general
principles will establish the criteria that the agencies will use in
considering whether a petition to establish, revise, or eliminate a
food standard will be the basis for a proposed rule.
Statement of Need:
This rule is necessary to modernize FDA and FSIS food standards, so
that they are consistent with the agencies' authorizing statutes, allow
for technological advances in food production, are consistent with
international food standards to the extent feasible, and are clear,
simple, and easy to use for both manufacturers and the agencies that
enforce compliance with the standards.
Summary of Legal Basis:
Under 21 U.S.C. 341, FDA has authority to fix and establish standards
of identity, standards of quality, or standards of fill of container
for food products regulated by FDA, when such regulations will promote
honesty and fair dealing in the interest of consumers. Similarly, under
21 U.S.C. 607(c) and 457(b), FSIS has authority to establish meat and
poultry product standards of identity or composition whenever such
regulations are necessary for the protection of the public. The
proposed rule will ensure that FDA and FSIS food standards are
consistent with the authorizing statutes.
Alternatives:
In addition to the option chosen, the Agencies considered the following
options: 1) No action; 2) removing all food standards from the
regulations and treating all foods as nonstandardized foods; 3) using
Agency resources to review and revise food standards rather than
relying on external petitions; and 4) requesting external industry
groups to review, revise, and administer the food standards (private
certification).
Anticipated Cost and Benefits:
Establishing general principles for food standards ensures that FSIS
and FDA use a consistent and systematic approach when assessing
standards. These principles would also apprise external parties of the
framework FDA and FSIS intend to use when assessing standards, thereby
reducing the costs for external parties to petition the agencies to
change standards. An additional benefit is that establishing the set of
principles specified in this proposed rule ensures that FDA and FSIS
assess standards with respect to their ability to reduce consumers'
search costs, while also reducing the likelihood that standards will
impose unnecessary costs, or reduce competition and thereby increase
prices.
FSIS and FDA expect the costs associated with this rule to be small and
the benefits to be relatively substantial. Therefore, the Agencies
believe that the benefits of establishing the proposed principles
outweigh the costs.
Risks:
None
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 02/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Robert Post Ph.D.
Director, Labeling and Consumer Protection Staff
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0279
Email: robert.post@fsis.usda.gov
RIN: 0583-AC72
_______________________________________________________________________
USDA--FSIS
19. PERFORMANCE STANDARD FOR CHILLING OF READY-TO-COOK POULTRY
Priority:
Other Significant
Legal Authority:
21 USC 451 to 470
CFR Citation:
9 CFR 381.66
Legal Deadline:
None
Abstract:
FSIS is proposing a performance standard for the chilling of ready-to-
cook poultry products that is intended to ensure the control of
microorganisms on the products from a point after evisceration until
the products are frozen, further processed, or packaged for shipment
from the processing plant. The current specific time and temperature
requirements for chilling poultry carcasses of various weights would be
retained as alternative requirements that poultry processors could
choose to meet. FSIS is taking this action to provide poultry
processors with greater flexibility in achieving the purposes of the
poultry chilling requirements whilst complying with the Agency's Hazard
Analysis and Critical Control Point (HACCP) and other regulations. This
proposal responds to petitions from industry trade associations.
Statement of Need:
This proposed rule addresses Federal regulations that are inconsistent
with the PR/HACCP regulations because they restrict the ability of
poultry processors to choose appropriate and effective measures to
eliminate, reduce, or control biological hazards identified in their
hazard analyses. The regulations also complicate efforts by
establishments to comply with the terms of the January 9, 2001, final
rule
[[Page 72681]]
further restricting the amount of water that may be retained in raw
meat or poultry products after post-evisceration processing; some
establishments may have to use chilling procedures that result in
higher levels of retained water in carcasses than may be necessary to
achieve the same food safety objective. For example, establishments
that operate automated chillers may have to subject poultry carcasses
to higher agitation rates or longer dwell times in the chillers. Also,
as discussed above, the time/temperature chilling regulations for
poultry are inconsistent with the PR/HACCP regulations, the retained
water regulations, and the meat inspection regulations.
Summary of Legal Basis:
This regulatory action is authorized under the Poultry Products
Inspection Act (21 U.S.C. 451 to 470).
Alternatives:
FSIS evaluated five regulatory alternatives: (1) Taking no regulatory
action; (2) replacing the command-and-control requirements with a
performance standard; (3) requiring meatpackers, as well as poultry
processors, to comply with such a performance standard; (4) requiring
all establishments that prepare raw meat or poultry products or handle,
transport, or receive the products in transportation to comply with a
performance standard; or (5) removing the command-and-control
requirements from the poultry products inspection regulations. The
Agency chose the second alternative but would make the existing
requirements a ``safe harbor.''
Anticipated Cost and Benefits:
Poultry processors would gain the flexibility to choose the best
processing techniques and procedures for achieving production
efficiencies, meeting HACCP food safety objectives, and preventing
economic adulteration of raw product with retained water in amounts
greater than those which are unavoidable for food-safety purposes. They
would be able to operate with a wider range of chilling temperatures
consistent with the requirements of the PR/HACCP regulations. The
poultry products industry could achieve energy efficiencies resulting
in annual savings of as much as $2.8 million. The industry could also
reduce carcass ``dwell times'' in immersion chillers and thereby reduce
the amount of water absorbed and retained by the carcasses. The
reduction in dwell time might enable some establishments, particularly
those currently operating at the throughput capacity of their chillers,
to increase production by installing additional evisceration lines.
Poultry establishments would therefore be able to operate more
efficiently to provide consumers with product that is not adulterated.
FSIS also would gain some flexibility by being able to reallocate some
inspection resources from measuring the temperature of chilled birds to
such activities as HACCP system verification.
This proposed rule would directly impose no new costs on the regulated
industry. It would relieve burdens arising from the disparate impacts
of the current regulations on the meat and poultry industries.
Risks:
None
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 05/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program and Employee
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: daniel.engeljohn@fsis.usda.gov
RIN: 0583-AC87
_______________________________________________________________________
USDA--FSIS
-----------
FINAL RULE STAGE
-----------
20. PERFORMANCE STANDARDS FOR THE PRODUCTION OF PROCESSED MEAT AND
POULTRY PRODUCTS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
21 USC 451 et seq; 21 USC 601 et seq
CFR Citation:
9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR 319; 9 CFR 320; 9 CFR
325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430; CFR 431
Legal Deadline:
None
Abstract:
FSIS has proposed to establish pathogen reduction performance standards
for all ready-to-eat (RTE) and partially heat-treated meat and poultry
products. The performance standards spell out the objective level of
pathogen reduction that establishments must meet during their
operations in order to produce safe products but allow the use of
customized, plant-specific processing procedures other than those
prescribed in the earlier regulations. Along with HACCP, food safety
performance standards will give establishments the incentive and
flexibility to adopt innovative, science-based food safety processing
procedures and controls, while providing objective, measurable
standards that can be verified by Agency inspectional oversight. This
set of performance standards will include and be consistent with
standards already in place for certain ready-to-eat meat and poultry
products.
Statement of Need:
The Food Safety and Inspection Service (FSIS) has proposed to amend the
Federal meat and poultry inspection regulations by establishing food
safety performance standards for all ready-to-eat and all partially
heat-treated meat and poultry products. The proposed performance
standards set forth both levels of pathogen reduction and limits on
pathogen growth that official meat and poultry establishments must
achieve during their operations in order to produce unadulterated
products but allow the use of customized, plant-specific processing
procedures. The proposed performance standards apply to ready-to-eat
meat and poultry products, categorized as follows: Dried products
(e.g., beef or poultry jerky); salt-cured products (e.g., country ham);
fermented products (e.g., salami and Lebanon bologna); cooked and
otherwise processed products (e.g., beef and chicken burritos, corned
beef, pastrami, poultry rolls, and turkey franks); and thermally
processed, commercially sterile products (e.g.,
[[Page 72682]]
canned spaghetti with meat balls and canned corned beef hash).
Although FSIS routinely samples and tests some ready-to-eat products
for the presence of pathogens prior to distribution, there are no
specific regulatory pathogen reduction requirements for most of these
products. The proposed performance standards will help ensure the
safety of these products; give establishments the incentive and
flexibility to adopt innovative, science-based food safety processing
procedures and controls; and provide objective, measurable standards
that can be verified by Agency oversight.
The proposal also contained provisions addressing Listeria
monocytogenes in RTE products. An Interim Final Rule on this subject
was published June 6, 2003 (68 FR 34208).
FSIS also has proposed to eliminate its regulations that require that
both ready-to-eat and not-ready-to-eat pork and products containing
pork be treated to destroy trichinae (Trichinella spiralis). These
requirements are inconsistent with HACCP, and some will be unnecessary
if FSIS makes final the proposed performance standards for ready-to-eat
meat and poultry products.
Summary of Legal Basis:
Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the
Poultry Product Inspection Act (21 U.S.C. 451 to 470), FSIS issues
regulations governing the production of meat and poultry products
prepared for distribution in commerce. The regulations, along with FSIS
inspection programs, are designed to ensure that meat and poultry
products are safe, not adulterated, and properly marked, labeled, and
packaged.
Alternatives:
As an alternative to all of the proposed requirements, FSIS considered
taking no action. As alternatives to the proposed performance standard
requirements, FSIS considered end-product testing and requiring ``use-
by'' date labeling on ready-to-eat products.
Anticipated Cost and Benefits:
Benefits are expected to result from less contaminated products
entering commercial food distribution channels as a result of improved
sanitation and process controls and in-plant verification. FSIS
believes that the benefits of the rule would exceed the total costs of
implementing its provisions.
The main provisions of the proposed rule are: Lethality performance
standards for Salmonella and E. coli 0157:H7 and stabilization
performance standards for C. perfringens that firms must meet when
producing RTE meat and poultry products. Most of the costs of these
requirements would be associated with one-time process performance
validation in the first year of implementation of the rule and with
revision of HACCP plans. Total industry-wide costs are estimated to be
$7.1 million. Benefits are expected to result from the entry into
commercial food distribution channels of product with lower levels of
contamination resulting from improved in-plant process verification and
sanitation.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 66 FR 12590 02/27/01
NPRM Comment Period End 05/29/01
NPRM Comment Per66 FR 35112d 07/03/01
NPRM Comment Period End 09/10/01
Interim Final Ru68 FR 34208 06/06/03
Interim Final Rule Effective 10/06/03
Interim Final Rule Comment Period End 12/08/04
Final Action 06/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program and Employee
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: daniel.engeljohn@fsis.usda.gov
RIN: 0583-AC46
_______________________________________________________________________
USDA--FSIS
21. NUTRITION LABELING OF SINGLE-INGREDIENT PRODUCTS AND GROUND OR
CHOPPED MEAT AND POULTRY PRODUCTS
Priority:
Other Significant
Legal Authority:
21 USC 601 et seq; 21 USC 451 et seq
CFR Citation:
9 CFR 317; 9 CFR 381
Legal Deadline:
None
Abstract:
FSIS has proposed to amend the Federal meat and poultry products
inspection regulations to require nutrition labeling for the major cuts
of single-ingredient, raw meat and poultry products, either on their
label or at their point-of-purchase, unless an exemption applies. FSIS
also proposed to require nutrition information on the label of ground
or chopped meat and poultry products, unless an exemption applies. The
requirements for ground or chopped products will be consistent with
those for multi-ingredient products.
FSIS also proposed to amend the nutrition labeling regulations to
provide that when a ground or chopped product does not meet the
regulatory criteria to be labeled ``low fat,'' a lean percentage claim
may be included on the label or in labeling, as long as a statement of
the fat percentage also is displayed on the label or in labeling.
Statement of Need:
The Agency will require that nutrition information be provided for the
major cuts of single-ingredient, raw meat and poultry products, either
on their label or at their point-of-purchase, because during the most
recent surveys of retailers, the Agency did not find significant
participation in the voluntary nutrition labeling program for single-
ingredient, raw meat and poultry products. Without the nutrition
information for the major cuts of single-ingredient, raw meat and
poultry products that would be provided if significant participation in
the voluntary nutrition labeling program existed, FSIS has concluded
that these products would be misbranded.
Because consumers cannot easily estimate the level of fat in ground or
chopped meat and poultry products and because producers are able to
[[Page 72683]]
formulate precisely the fat content of ground or chopped products, FSIS
has concluded that ground or chopped meat and poultry products that do
not bear nutrition information on their labels would also be
misbranded.
Finally, FSIS will amend the nutrition labeling regulations to provide
that when a ground or chopped product does not meet the criteria to be
labeled ``low fat,'' a lean percentage claim may be included on the
product, as long as a statement of the fat percentage is also displayed
on the label or in labeling. FSIS will include these provisions in the
final nutrition labeling regulations because many consumers have become
accustomed to this labeling on ground beef products and because this
labeling provides a quick, simple, accurate means of comparing all
ground or chopped meat and poultry products.
Summary of Legal Basis:
This action is authorized under the Federal Meat Inspection Act (21
U.S.C. 601 to 695) and the Poultry Products Inspection Act (21 U.S.C.
451 to 470).
Alternatives:
No action; nutrition labels required on all single-ingredient, raw
products (major cuts and non-major cuts) and all ground or chopped
products; nutrition labels required on all major cuts of single-
ingredient, raw products (but not non-major cuts) and all ground or
chopped products; nutrition information at the point-of-purchase
required for all single-ingredient, raw products (major and non-major
cuts) and for all ground or chopped products.
Anticipated Cost and Benefits:
Costs will include the equipment for making labels, labor, and
materials used for labels for ground or chopped products. The cost of
providing nutrition labeling for the major cuts of single-ingredient,
raw meat and poultry products should not be significant, because retail
establishments would have the option of providing nutrition information
through point-of-purchase materials.
Benefits of the nutrition labeling rule would result from consumers
modifying their diets in response to new nutrition information
concerning ground or chopped products and the major cuts of single-
ingredient, raw products. Reductions in consumption of fat and
cholesterol are associated with reduced incidence of cancer and
coronary heart disease.
FSIS has concluded that the quantitative benefits will exceed the
quantitative costs of the rule.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 66 FR 4970 01/18/01
NPRM Comment Period End 04/18/01
Extension of Com66 FR 20213 04/20/01
NPRM Comment Period End 07/17/01
Final Action 02/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Robert Post Ph.D.
Director, Labeling and Consumer Protection Staff
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0279
Email: robert.post@fsis.usda.gov
RIN: 0583-AC60
_______________________________________________________________________
USDA--FSIS
22. PROHIBITION OF THE USE OF SPECIFIED RISK MATERIALS FOR HUMAN FOOD
AND REQUIREMENTS FOR THE DISPOSITION OF NON-AMBULATORY DISABLED CATTLE
Priority:
Economically Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
21 USC 601 et seq
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
On January 12, 2004, the Food Safety and Inspection Service (FSIS)
issued an interim final rule to amend the Federal meat inspection
regulations to designate the brain, skull, eyes, trigeminal ganglia,
spinal cord, vertebral column (excluding the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the
wings of the sacrum), and dorsal root ganglia (DRG) of cattle 30 months
of age and older, and the tonsils and distal ileum of the small
intestine of all cattle, as ``specified risk materials'' (SRMs). The
Agency declared that SRMs are inedible and prohibited their use for
human food. In addition, as a result of the interim final rule, FSIS
now requires that all non-ambulatory disabled cattle presented for
slaughter be condemned. The Agency also requires that federally
inspected establishments that slaughter cattle and federally inspected
establishments that process the carcasses or parts of cattle develop,
implement, and maintain written procedures for the removal,
segregation, and disposition of SRMs. Establishments must incorporate
these procedures into their HACCP plans or in their Sanitation SOPs or
other prerequisite program. FSIS took this action in response to the
diagnosis on December 23, 2003, by the U.S. Department of Agriculture
of a positive case of bovine spongiform encephalopathy (BSE) in an
adult Holstein cow in the State of Washington. This action is intended
to minimize human exposure to materials that scientific studies have
demonstrated as containing the BSE agent in cattle infected with the
disease. Infectivity has never been demonstrated in the muscle tissue
of cattle experimentally or naturally infected with BSE at any stage of
the disease.
Statement of Need:
FSIS issued an interim final rule to amend the meat inspection
regulations to add provisions to prevent meat and meat products that
may contain the BSE agent from entering commerce.
BSE is a chronic, degenerative, neurological disorder of cattle.
Worldwide, there have been more than 185,000 cases since the disease
was first diagnosed in 1986 in Great Britain. Recent laboratory and
epidemiological research indicate that there is a causal association
between BSE and variant Creutzfeldt-Jakob Disease (vCJD), a slow
degenerative disease that affects the central nervous system of humans.
Both BSE and vCJD are always fatal.
USDA policy in regard to BSE has been to be proactive and preventive.
The regulations: (1) Prohibit certain materials that have been shown to
[[Page 72684]]
contain the BSE agent in BSE-infected cattle to be used for human food
or in the production of human food; (2) prescribe handling, storage,
and transportation requirements for such materials; (3) prohibit
slaughter procedures that may cause potentially infective tissues to
migrate to edible tissues; (4) prescribe requirements for the
slaughtering and processing of cattle whose materials are most likely
to contain the BSE agent if the animal is infected with BSE; and (5)
prescribe requirements for the sanitation or disposal of plant
equipment that may be contaminated with the BSE agent.
Summary of Legal Basis:
Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695), FSIS
issues regulations governing the production of meat and meat food
products. The regulations, along with FSIS inspection programs, are
designed to ensure that meat food products are safe, not adulterated,
and properly marked, labeled, and packaged.
Alternatives:
As an alternative to the interim final rule, FSIS considered taking no
action. FSIS rejected this option because, as previously mentioned,
USDA policy in regard to BSE has been to be proactive and preventive.
Anticipated Cost and Benefits:
This interim final rule could result in costs to the regulated
industry. FSIS expects to minimize the costs by targeting the
regulations to apply to those cattle whose materials are most likely to
contain the BSE agent if the animal is infected with BSE. Banning
certain materials, such as brain and spinal cord, for use as human food
may require additional staff and time to remove such materials.
Materials prohibited for use as human food could not be sold
domestically or exported. Companies may be required to find new ways to
handle and dispose of these materials, which would impose additional
costs. Prohibiting the use of bovine vertebral column as a source
material in AMRS could result in a decrease in product yield and may
require companies that use these systems to produce boneless beef and
beef products to find other uses for bovine vertebral column.
Establishments whose equipment may have been contaminated with the BSE
agent may have costs associated with sanitation or disposal of plant
equipment.
FSIS may incur costs to increase inspection and compliance activities
to ensure that the measures taken to prevent meat and meat food
products that may contain the BSE agent from entering commerce are
effective. Producers may receive lower prices from processors, and some
of their stock may be condemned outright. The price consumers pay for
meat may rise or fall depending on how the discovery of BSE in the U.S.
affects consumer demand for beef.
The main benefit of this proposed rule is the prevention of vCJD in the
United States. There have been over 100 definite and probable cases of
vCJD detected worldwide since the disease was first identified in 1986
in the United Kingdom. While vCJD is still considered a rare condition,
the extent or occurrence of a vCJD epidemic in the United Kingdom
cannot be determined because of the long incubation period (up to 25
years). Thus, the interim final rule could have widespread public
health benefits if it serves to prevent a vCJD epidemic from developing
in the U.S. Even if vCJD remains a rare condition, this proposed rule
will still have public health benefits because of the severity of the
symptoms associated with vCJD and the fact that vCJD is always fatal.
This interim final rule may benefit the meat industry by helping to
restore confidence in the domestic meat supply. This may limit losses
to meat slaughter and processing operations in the long run.
Risks:
Although vCJD is a rare condition, the symptoms are severe, and it is
always fatal. This interim final rule is intended to reduce the risk of
humans developing vCJD in the U.S. in the event BSE is detected in
native cattle. The measures implemented by FSIS are intended to
minimize human exposure to materials from cattle that could potentially
contain the BSE agent. In April 1998, USDA entered into a cooperative
agreement with Harvard University's School of Public Health to conduct
a risk analysis to assess the potential pathways for entry into U.S.
cattle and the U.S. food supply, to evaluate existing regulations and
policies, and to identify any additional measures that could be taken
to protect human and animal health. FSIS used the findings of the risk
assessment to inform its decision to prohibit certain bovine materials
for human food.
Unlike bacterial and viral pathogens that may be found in or on meat
food products, the BSE agent cannot be destroyed by conventional
methods, such as cooking or irradiation. Also, although it is rare,
vCJD, the human disease associated with exposure to the BSE agent, is
generally more severe than the human illnesses associated with exposure
to bacterial and viral pathogens. Thus, additional measures to reduce
the risk of human exposure to the BSE agent are necessary to protect
public health.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru69 FR 1862 01/12/04
Interim Final Rule Comment Period End 04/12/04
Final Action 12/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program and Employee
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: daniel.engeljohn@fsis.usda.gov
RIN: 0583-AC88
_______________________________________________________________________
USDA--Forest Service (FS)
-----------
PROPOSED RULE STAGE
-----------
23. STATE PETITIONS FOR INVENTORIED ROADLESS AREA MANAGEMENT
Priority:
Other Significant
Legal Authority:
16 USC 472; 16 USC 529; 16 USC 551; 16 USC 1608; 16 USC 1613; 23 USC
201; 23 USC 205
CFR Citation:
36 CFR 294 subpart B
[[Page 72685]]
Legal Deadline:
None
Abstract:
On January 12, 2001, the Forest Service published the Roadless Area
Conservation final rule (the ``roadless rule'') in the Federal Register
establishing prohibitions on road construction, road reconstruction,
and timber harvesting in inventoried roadless areas at 36 CFR part 294,
subpart B (66 FR 3244). Since publication, the roadless rule has been
challenged by nine lawsuits filed in six judicial districts and in four
Federal circuits. On July 14, 2003, the U.S. District Court for the
District of Wyoming issued a permanent injunction order enjoining the
Department from implementing the roadless rule. That ruling has been
appealed.
Due to the continued legal uncertainty of providing protection for
roadless areas through the application of the roadless rule, the Agency
is proposing to amend the roadless rule by replacing the prohibitions
of the January 2001 rule with a procedural rule that would set out an
administrative process for State Governors to petition the Secretary of
Agriculture to establish or adjust management direction for roadless
areas within their State. Such petitions would be evaluated and, if
agreed to, addressed by the Secretary in subsequent rulemaking on a
State-by-State basis.
Statement of Need:
The Department of Agriculture is committed to conserving and managing
roadless values and considers inventoried roadless areas an important
component of the National Forest System. The 2001 roadless rule has
been the subject of nine lawsuits in Federal district courts in Idaho,
Utah, North Dakota, Wyoming, Alaska, and the District of Columbia. On
July 14, 2003, the U.S. District Court for the District of Wyoming
found the 2001 roadless rule to be unlawful and ordered that the rule
be permanently enjoined. That ruling has been appealed to the Tenth
Circuit by intervenors. Due to the continued legal uncertainty
surrounding the 2001 roadless rule, the Forest Service published a
proposed rule on July 16, 2004, that would replace it with a
petitioning process that would provide Governors an opportunity to seek
establishment of management requirements for inventoried roadless areas
within their State. This opportunity for State petitions would be
available for 18 months following the effective date of the final rule.
It is anticipated that this timeframe will be sufficient for States to
collaborate effectively with local governments, Indian Tribes,
stakeholders, and other interested parties to develop proposals that
consider a full range of public input. A State petition would be
evaluated and, if accepted by the Secretary of Agriculture, the Forest
Service would initiate subsequent State-specific rulemaking for the
management of inventoried roadless areas in cooperation with the State
involved in the petitioning process and in consultation with
stakeholders and experts. The Department believes that revising 36 CFR
part 294 to replace the existing rule with a State petitioning process
that would allow State-specific consideration of the needs of these
areas is an appropriate solution to address the challenges of
inventoried roadless area management. On September 9, 2004, in response
to several written requests, the Forest Service extended the public
comment period on the proposed rule until November 15, 2004. The
Department will issue a final rule after thorough evaluation and
consideration of public comments.
Summary of Legal Basis:
There is no aspect of this action that is required by statute or court
order. On January 12, 2001, the Department of Agriculture promulgated a
regulation to provide for the conservation and management of
inventoried roadless areas within the National Forest System under the
principles of the Multiple-Use Sustained-Yield Act of 1960. The
existing Roadless Area Conservation Rule has been the subject of nine
lawsuits and on July 14, 2003, was permanently enjoined and set aside
by the U.S. District Court for the District of Wyoming. That ruling has
been appealed to the Tenth Circuit by intervenors. This proposal is to
replace the 2001 enjoined rule.
Alternatives:
Until promulgation of the 2001 roadless rule, the Forest Service
managed inventoried roadless areas based on management requirements in
individual land management plans. These plans have been developed for
each unit of the National Forest System through a public notice and
comment process, building on years of scientific findings and extensive
public involvement. These plans typically identify and recommend
inventoried roadless areas that would be appropriate to be designated
as wilderness by the Congress and provide guidance on activities and
uses in these areas. This is the current management situation with the
2001 roadless rule permanently enjoined. An alternative to the proposed
rule would be for the management of these areas to revert to the
management requirements in individual land management plans and not to
allow Governors to petition the Secretary to adjust the management for
these areas within their States (no action alternative).
Anticipated Cost and Benefits:
Preliminary estimates of the anticipated costs and benefits of this
proposed rule have been developed by comparing selected effects if 58.5
million acres of inventoried roadless areas are managed following the
prohibitions for road construction and timber management activities in
the 2001 roadless rule or if these same areas are managed in accordance
with the existing management requirements contained in individual land
management plans. Approximately 25 percent of the total acres of
inventoried roadless areas are in the State of Alaska. About 72 percent
of the total is in the 11 Western States of Montana, Idaho, Wyoming,
Washington, Utah, Oregon, New Mexico, Nevada, Colorado, California, and
Arizona. The remaining 3 percent is scattered among 27 other States.
While it is currently unknown which States may choose to submit a
petition for State-specific rulemaking, the Forest Service assumes that
all 38 States and the Commonwealth of Puerto Rico will do so in the
first year after the rule is final. The costs to the Forest Service and
the Department to evaluate and make a decision on a single petition are
estimated to range from $75,000 to $150,000. Costs could range from
$25,000 to $100,000 for an individual State submitting a petition.
Total costs to the 38 States and the Commonwealth of Puerto Rico for 39
petitions would range from $975,000 to $3,900,000, therefore; and total
costs to the Government would range from $2,925,000 to $5,850,000.
Total costs of the rule are therefore estimated to range from
$3,900,000 to $9,750,000. This proposed rule is expected to provide a
variety of potential beneficial effects, which include the conservation
of inventoried roadless areas; the protection of human health and
safety; the reduction of hazardous fuels and restoration of essential
wildlife habitats; the assurance of reasonable access to public and
private property or facilities;
[[Page 72686]]
and the improvement of collaboration and partnerships with States.
Risks:
There are no risks addressed by this proposed rule. The conservation
and management requirements of inventoried roadless areas on National
Forest System lands have been developed through the land management
planning process directed by the National Forest Management Act of
1976, and these management requirements are and have been consistent
with all applicable Federal statutes, regulations, and policies. The
controversy surrounding the management of these lands concerns the
level of development activities that should be allowed on them. These
areas were originally identified because they met the criteria for
potential wilderness, and they are evaluated for their wilderness
potential in the land management planning process. Certain
developmental activities such as road construction, road
reconstruction, or timber management, if allowed, may affect the future
evaluation and consideration of these areas as potential wilderness.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 42636 07/16/04
NPRM Comment Period End 09/14/04
NPRM Comment Per69 FR 54600d 09/09/04
NPRM Comment Period End 11/15/04
Final Action 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
State
Agency Contact:
Andria D. Weeks
Regulatory Analyst
Department of Agriculture
Forest Service
MS 1134
ATTN: ORMS, D&R Branch Mail Stop 1134
1400 Independence Avenue SW
Washington, DC 20250-0003
Phone: 703 605-4610
Fax: 703 605-5111
Email: aweeks@fs.fed.us
RIN: 0596-AC10
_______________________________________________________________________
USDA--FS
-----------
FINAL RULE STAGE
-----------
24. NATIONAL FOREST SYSTEM LAND MANAGEMENT PLANNING
Priority:
Other Significant
Legal Authority:
16 USC et seq; 5 USC 301
CFR Citation:
36 CFR 219 subpart A
Legal Deadline:
None
Abstract:
The Forest Service is adopting a final rule that revises the National
Forest System Land and Resource Management Planning Rule adopted
November 9, 2000. The proposed rule was published December 6, 2002 (67
FR 72770). The proposed changes are a result of a review conducted by
Forest Service personnel at the direction of the Office of the
Secretary.
The final rule also responds to internal review and comments received
after the proposed rule was published on December 6, 2002. This rule is
intended to improve upon the 2000 rule by providing a planning process
that is more readily understood, is within the Agency's capability to
implement, is within anticipated budgets and staffing levels, and
recognizes the programmatic nature of planning.
Statement of Need:
The President's environmental program includes natural resource
planning for all units of the National Forest System. In support of
that effort, the Forest Service is adopting a final rule at 36 CFR part
219, subpart A, to revise the land management planning rule, published
on November 9, 2000, governing how future changes in land management
planning direction will be made and how those changes will be
documented. The proposed rule was published in the Federal Register on
December 6, 2002, for a 90-day public comment period. The comment
period was extended 30 days to April 7, 2003. The proposed rule
continued to support the major principles of the 2000 rule, which are
the underlying concepts of sustainability, monitoring and evaluation,
collaboration, and use of science. The proposed rule, however, improved
the clarity of the 2000 rule, characterized planning as a continuous
process, offered two options to provide for diversity of plant and
animal communities, and provided for plan analysis to be categorically
excluded from National Environmental Policy Act (NEPA) documentation.
The Agency received over 195,000 comments on the proposed rule.
Consideration of these comments will lead to a final rule that better
enables the Forest Service to be good land stewards by providing the
clean air and water and wildlife protection the public expects. This
goal would be accomplished by shifting from a complex, cumbersome, and
expensive up front planning process, to a streamlined process that
better involves the public, and shifts resources to land management and
continual monitoring and evaluation.
Summary of Legal Basis:
The Forest and Rangeland Renewable Resources Planning Act of 1974 (88
Stat. 476 et seq.), as amended by the National Forest Management Act of
1976 (NFMA) (90 Stat. 2949 et seq.), requires the Secretary to
promulgate regulations under the principles of the Multiple-Use
Sustained-Yield Act of 1960 that set out the process for the
development and revision of land management plans (16 U.S.C. 1604(g)).
Alternatives:
The Forest Service considered and compared the final planning rule to
both the 1982 and the 2000 planning regulations. Land management plans
prepared under the 1982 rule were difficult to prepare, took 5 to 7
years to complete, and required detailed analytical requirements that
were of limited use due to the high degree of uncertainty of the
projections. The 2000 planning rule requires a number of detailed
analytical requirements, lacks clarity regarding many of these
requirements, is not flexible enough, and lacks recognition of the
limits of agency budgets and personnel needed to implement it.
Anticipated Cost and Benefits:
Estimates of the anticipated costs and benefits focused on key
activities in land and resource management planning for which costs
could be estimated under the 1982, 2000, and final planning rules.
Based on costs that can be quantified, this final rule is estimated to
result in a savings, compared to the expected costs under the 1982 rule
and compared to the 2000 rule.
[[Page 72687]]
In addition to the anticipated cost savings, numerous intangible
benefits are expected to result from the final rule. The overall goal
of the final rule is to develop a planning framework that fosters
stewardship of the National Forest System lands and improves the
likelihood of contributing toward the ecological, social, and economic
components of sustainability. Better decisions provide sustained goods,
services, and values without impairment of the health of the land.
These improvements will be based on better collaboration with the
public, improved monitoring and evaluation, integration of science, and
a more flexible process that reduces the burden on both the public and
the Agency. A planning process that addresses public concerns and leads
to improved health of the public lands has value beyond the cost
savings estimated in the analysis.
Risks:
The final planning rule will help to reduce the risks of natural
resource management on National Forest System lands by strengthening
the Forest Service's ability to respond quickly and effectively to a
variety of continually changing issues, such as the development of new
scientific information, new listing of species, the effects of
wildfire, changes in demographics or the economy, and unforeseen
effects of plan implementation activities. The final planning rule
allows for a more flexible approach to planning and reducing risks by
providing for a continual and adaptive planning cycle involving on-the-
ground project proposal, analysis, and implementation; monitoring and
evaluation; and plan adjustment. The final planning rule would allow
flexible implementation of projects to avoid and reduce risks; for
example, projects to implement the Agency's hazardous fuels reduction
program.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 67 FR 72770 12/06/02
NPRM Comment Period End 03/24/03
Final Action 02/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Andria D. Weeks
Regulatory Analyst
Department of Agriculture
Forest Service
MS 1134
ATTN: ORMS, D&R Branch Mail Stop 1134
1400 Independence Avenue SW
Washington, DC 20250-0003
Phone: 703 605-4610
Fax: 703 605-5111
Email: aweeks@fs.fed.us
RIN: 0596-AB86
_______________________________________________________________________
USDA--Natural Resources Conservation Service (NRCS)
-----------
FINAL RULE STAGE
-----------
25. EMERGENCY WATERSHED PROTECTION PROGRAM
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 81-516; 33 USC 701; PL 95-334; PL 104-127; 16 USC 2203
CFR Citation:
7 CFR 624
Legal Deadline:
None
Abstract:
A revision is necessary to incorporate changes in the program, which
have resulted from the passage of the 1996 Farm Bill; to fulfill a
desire to make the program more responsive and efficient; and to
respond to concerns of the public and the Agency. The rule is being
reorganized and several items added.
Statement of Need:
The Emergency Watershed Protection (EWP) Program alleviates threats to
life and property that remain in the Nation's watersheds in the
aftermath of natural disasters such as floods, hurricanes, tornadoes,
and wildfires. The EWP Program is administered by the USDA NRCS, which
provides technical and financial assistance to local sponsoring
authorities to preserve life and property threatened by disaster-caused
erosion and flooding. Funding is provided through congressional
emergency appropriations. Threats that the EWP Program addresses are
termed ``watershed impairments.'' These include debris-clogged stream
channels, undermined and unstable stream banks, jeopardized water
control structures and public infrastructure, and damaged upland sites
stripped of protective vegetation by fire or drought. If these
watershed impairments are not addressed, they would pose a serious
threat of injury, loss of life, or devastating property damage should a
subsequent event occur.
NRCS' final rule action is to codify existing EWP Program
implementation and institute programmatic changes that allow:
1.The repair of enduring conservation practices;
2.Limits repeated site repairs;
3.Allows additional easement purchases;
4.Addresses environmental justice issues; and
5.Limits treatments on federal lands.
To implement the final rule action, NRCS would incorporate changes in
Program administration and in project execution dealing with
traditional watershed impairments. It would expand the Program by
providing to the list of watershed impairments EWP currently addresses:
1.Floodplain sediment deposition removal;
2.Upland wind-borne debris removal; and
3.Repair damaged structural conservation practices.
The purpose and need for the NRCS final rule action are to provide
administrative transparency that ensures that the public is fully
informed of program operations. Program delivery improvements are
designed to enable NRCS field and State office personnel to pro EW
assistance more effectively and efficiently. The improvements would
more fully, equitably, and consistently meet the needs of people
requiring emergency assistance. Program improvements are designed to
address environmental, economic, and social concerns and values.
Summary of Legal Basis:
The regulation for EWP, 7 CFR 624, was first promulgated in 1973. The
EWP Program was authorized by section 216 of the Flood Control Act of
1950 (Pub. L. 81-516) by amending the Flood Control Act of 1944 (Pub.
L. 78-534).
[[Page 72688]]
The EWP Manual documents NRCS policy governing EWP; the National EWP
Handbook provides field procedures. NRCS staff administers EWP in the
field when sponsors request assistance with disaster damage. NRCS staff
completes Disaster Survey Reports (DSRs) describing the watershed
impairments at a particular site, their eligibility for repairs, the
cost and benefits of appropriate conservation measures, the social
impacts, and the environmental and technical soundness of the measures.
The NRCS EWP implementing documents, manual, and handbook (including
the DSR) will be revised to reflect any program changes in the EWP
regulation. This means of assessing that net social benefits exceed net
social costs on each individual DSR site assures that NRCS complies
with the expectations of public process.
Section 382 of the Federal Agricultural Improvement and Reform Act of
1996, the 1996 Farm Bill, authorizes the acquisition of floodplain
easements on flood prone lands as an alternative to traditional
eligible EWP recovery practices. The floodplain easement acquisition
component is fully voluntary and complements the traditional recovery
practices to provide a more permanent solution to repetitive disaster
assistance payments. This achieves greater environmental and societal
benefits where the situation warrants and the affected landowner is
willing to participate in the easement approach.
Alternatives:
Prioritized Watershed Planning and Management.
Anticipated Cost and Benefits:
Same under each option since Congress and Administration establish the
appropriation. EWP is funded through emergency supplemental
appropriations.
Risks:
Program delivery improvements through the promulgation of regulation
are designed to enable NRCS field and State office personnel with EWP
Program responsibility to provide EWP assistance more effectively and
efficiently when and where it is needed. The improvements would more
fully, equitably, and consistently meet the needs of people requiring
emergency assistance. Program defensibility improvements are designed
to address environmental, economic, and social concerns and values.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 65202 11/19/03
NPRM Comment Period End 01/20/04
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Victor Cole
National EWP Leader
Department of Agriculture
Natural Resources Conservation Service
Room 6019-S
PO Box 2890
Washington, DC 20013
Phone: 202 690-4575
Fax: 202 720-2143
Email: vcole@usda.gov
RIN: 0578-AA30
_______________________________________________________________________
USDA--NRCS
26. TECHNICAL SERVICE PROVIDER ASSISTANCE
Priority:
Other Significant
Legal Authority:
16 USC 3842
CFR Citation:
7 CFR 652
Legal Deadline:
None
Abstract:
Third Party Vendor assistance will allow producers to obtain technical
services from the department or entities by a certification process.
This process will distinguish between certification of an individual
working under his or her own auspices and that of an organization such
as a corporation or a public agency which has individuals working on
its behalf. Certification of an individual means the individual has the
requisite education and technical expertise to perform the technical
services. Certification of an entity or public agency means that the
organization may receive payment for the services provided by
individuals working under its auspices, but the work must be performed
or warranted by certified individuals and the organization must assume
the liability for the quality of work performed.
Statement of Need:
In 1994, the Department of Agriculture reorganized and transferred
increased responsibilities for administration of conservation programs
to the Natural Resources Conservation Service (NRCS) to provide
technical and financial assistance to producers to improve the natural
resource conditions on their land. The Federal Agricultural Improvement
and Reform Act of 1996 (the 1996 Farm Bill), Public Law 104--127,
created several new conservation programs for which the Secretary of
Agriculture delegated administrative responsibility to NRCS.
Through the implementation of its conservation programs, NRCS utilizes
its technical expertise to provide producers with information to help
them make land management decisions. When a producer applies to
participate in a conservation program, NRCS helps the producer evaluate
the resource conditions on their land to determine the most appropriate
way to meet the producer's conservation objectives. Through its
conservation planning process, NRCS helps the producer develop a
conservation plan and, depending upon the availability of funds, the
Department provides financial assistance to the producer to implement
identified conservation practices or systems. The Farm Security and
Rural Investment Act of 2002 (the 2002 Farm Bill), Public Law 107--171,
expanded the availability of financial and technical assistance funds
for the implementation of conservation programs. At the time of
enactment, the Congressional Budget Office estimated that the 2002 Farm
Bill represented a $17 billion increase in the level of funding for
conservation programs.
The current staffing levels of NRCS are insufficient to adequately meet
the increased need for technical assistance under the conservation
programs authorized or reauthorized by the 2002 Farm Bill. Section 2701
of the 2002 Farm Bill amended section 1242 of the Food Security Act of
1985 (Food Security Act), as amended, to require the Secretary of
Agriculture to provide technical assistance er the Food Security Act
conservation programs to a producer eligible for that assistance
``directly ... or at the option of the producer, through a payment ...
to the producer for an approved third party, if available.'' The
Secretary of Agriculture delegated authority to implement section 1242
to NRCS.
Section 1242 of the Food Security Act greatly expanded the availability
of technical assistance to producers by
[[Page 72689]]
encouraging other potential providers of technical assistance to assist
in the delivery of technical services. To ensure that high quality
technical services are available to all producers, section 1242
requires the Secretary of Agriculture to establish, by regulation, a
system for ``approving individuals and entities to provide technical
assistance to carry out programs under the [Farm Bill] ... and
establishing the amounts and methods for payments for that
assistance.''
NRCS published an interim final rule on November 21, 2002, that
established a certification process under which NRCS evaluated and
approved individuals, entities, and public agencies as eligible to
provide conservation technical services for certain conservation
programs. The interim final rule also established the criteria by which
NRCS will evaluate all potential providers of technical assistance.
On March 24, 2003, NRCS published an amendment to the interim final
rule, establishing the process for determining payment levels for
technical service provider assistance. In addition the amendment set
forth the policy regarding subcontracting by technical service
providers in the course of their delivery of technical services. The
amendment also clarified the process for certification and amended the
definition of technical service provider. The March 24, 2003, amendment
had a 90-day comment period. NRCS received 15 comments from seven
entities to this amendment.
On July 9, 2003, NRCS published a second amendment to the interim final
rule, establishing a limited exception to tification and payment
requirements when the Department is partnering with State, local, or
tribal governments to carry out its duties to provide technical
services. The July 9, 2003, amendment had a 30-day comment period. NRCS
received 25 comments from 11 entities to this second amendment.
The final rule will establish the regulatory framework for technical
service provider assistance for FY 2005 and thereafter, and will
provide response to public comment.
Summary of Legal Basis:
Section 2701 of the 2002 Farm Bill amended section 1242 of the Food
Security Act of 1985 (Food Security Act), as amended, to require the
Secretary of Agriculture to provide technical assistance under the Food
Security Act conservation programs to a producer eligible for that
assistance ``directly ... or at the option of the producer, through a
payment ... to the producer for an approved third party, if
available.'' The Secretary of Agriculture delegated authority to
implement section 1242 to NRCS.Section 1242 of the Food Security Act
greatly expanded the availability of technical assistance to producers
by encouraging other potential providers of technical assistance to
assist in the delivery of technical services. To ensure that high
quality technical services are available to all producers, section 1242
requires the Secretary of Agriculture to establish, by regulation, a
system for ``approving individuals and entities to provide technical
assistance to carry out programs under the [Farm Bill] ... and
establishing the amounts and methods for payments for that
assistance.``
Alternatives:
Secretary of Agriculture is required by statute to provide conservation
program participants the ability to acquire qualified third-party
technical assistance. Alternative is to not implement statute as
required.
Anticipated Cost and Benefits:
$153 million benefits and annual costs of $77 million, of which only an
estimated $28 million annually is cost associated with this rule.
Risks:
USDA conservation program participants will not be able to obtain the
technical assistance needed to implement conservation practices and the
associated benefits to the Nation's natural resource base.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru67 FR 70119 11/21/02
Interim Final Rule Comment Period End 02/19/03
Interim Final Rule Effective 03/01/03
Interim Final Ru68 FR 14131 03/24/03
Interim Final Rule Comment Period End 06/23/03
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Sylvia Gillen
Coordinator, Technical Service Providers
Department of Agriculture
Natural Resources Conservation Service
Room 5205-S
PO Box 2890
Washington, DC 20013-2890
Phone: 202 720-6775
Fax: 202 720-3052
Email: sylvia.gillen@usda.gov
RIN: 0578-AA35
_______________________________________________________________________
USDA--NRCS
27. CONSERVATION SECURITY PROGRAM
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
16 USC 3838
CFR Citation:
7 CFR 1470
Legal Deadline:
None
Abstract:
Under the Conservation Security Program (CSP) NRCS is authorized to
provide financial and technical assistance to owners and operators of
agricultural operations to promote conservation and improvement of the
quality of soil, water, air, energy, plant and animal life, and other
conservation purposes.
Statement of Need:
USDA intends that CSP will recognize those farmers and ranchers, the
land stewards, who meet the highest standards of conservation and
environmental management. By managing all of the natural resources on
their farms and ranches in a sustainable fashion to these high
standards, stewards of the land benefit themselves, their communities,
and society as a whole. CSP can be an important tool for those stewards
and others who strive towards the highest standards of conservation and
environmental management. CSP helps sustain the economic well-being of
those farmers and ranchers who reach this pinnacle of good land
stewardship and enhance the ongoing production of clean water and clean
air on their farms
[[Page 72690]]
and ranches, which are valuable commodities to all Americans.
The fundamental philosophy and intent of CSP is to support ongoing
conservation stewardship of working agricultural lands by providing
payments and assistance to producers to maintain and enhance the
condition of the resources. To implement the Secretary's vision, the
program will reward owners and operators of agricultural lands for
their conservation stewardship efforts and assist them with the
implementation and maintenance of additional conservation measures that
can improve the natural resource conditions of their agricultural
operations. CSP particularly targets producers and activities that can
provide the greatest additional benefits for the resource concerns
identified in this rule and in CSP signup announcements. NRCS is
additionally encouraging those who do not meet the sign-up requirements
for CSP to initiate a review of the natural resource conditions on
their land and begin or continue moving toward achieving the minimum
conservation requirements to enter CSP at a later signup. Other USDA
programs may be available for technical or financial assistance to help
them achieve their resource management goals.
Summary of Legal Basis:
The Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171,
May 13, 2002) (the Act) amended the Food Security Act of 1985 (16
U.S.C. 3801 et seq.) to authorize the Conservation Security Program
(CSP). The program is administered by USDA's Natural Resources
Conservation Service (NRCS). The CSP is a voluntary program that
provides financial and technical assistance to producers who advance
the conservation and improvement of soil, water, air, energy, plant,
and animal life and other conservation purposes on tribal and private
working lands. Such lands include cropland, grassland, prairie land,
improved pasture, and range land, as well as forested land and other
non-cropped areas that are an incidental part of the agriculture
operation.
As originally enacted, the Conservation Security Program was an
entitlement program where many producers would have received payments
if they were eligible. Subsequent to the enactment of the 2002 Act, the
Omnibus Bill of 2003 amended the Act to limit CSP's total expenditures
to a total of $3.77 billion over 11 years (fiscal year 2003 through
fiscal year 2013). When developing the regulations to implement CSP,
USDA confronted several challenges. The greatest challenge, however,
was to design a new conservation entitlement program with a cap on its
total expenditures over multiple years. Statute did not provide
direction as to how the Secretary should implement a broad entitlement
program with the statutory fiscal constraints.The limits imposed by the
budget cap greatly reduce the potential scope of the program. For
example, USDA's Economic Research Service (ERS) estimates that over 1.8
million farms and ranches may be eligible for CSP, using the land
eligibility criteria found in the authorizing legislation. If all of
these agricultural operations were enrolled, the cost of the program
would exceed the $3.77 billion cap potentially in the first sign-up. In
contract, NRCS estimates that the budget cap would allow less than
50,000 total agricultural operations to participate over the life of
the program. Estimates derived from a variety of analyses indicate that
the average Tier III contract, based on nationally averaged data, could
be near $15,000 per year. If contracts were an average of 7 years in
duration, the statutory funding could support an estimated 30,000 Tier
III contracts. The average Tier I and Tier II contracts could be near
$7,000 annually. If contracts were to average 5 years in duration, the
statutory funding could support an estimated 90,000 Tier I and II
contracts.
Furthermore, NRCS expects that a large number of producers will seek
participation in CSP and ask for assistance to determine their
potential eligibility for the program. Thus, the statutory cap on
technical assistance of 15 percent becomes another limiting factor for
implementing CSP. By law, NRCS cannot incur technical assistance costs
for NRCS employees or approved technical assistance providers in excess
of 15 percent of the available funds.
Alternatives:
NRCS Preferred Approach:
1. Limit sign-ups: Conduct periodic CSP sign-ups.
2. Eligibility: Criteria should be sufficiently rigorous to ensure that
participants are committed to conservation stewardship. Additionally,
eligibility criteria should ensure that the most pressing resource
concerns are addressed.
3. Contracts requirements should be sufficiently rigorous to ensure
that participants undertake and maintain high levels of stewardship.
4. Prioritize funding to ensure that those producers with the highest
commitment to conservation are funded first.
5. Structure payments to ensure that environmental benefits will be
achieved.
Alternative Approaches:
1. Prioritize funding based on environmental considerations (e.g., high
priority watersheds) with consideration given to past historical
conservation.
2. Apportion the limited budget according to a formula of some kind,
for example by discounting each participant's contract payments equally
(i.e., prorate payments).
3. Close signup once available funds are exhausted (i.e., first come,
first served).
4. Limit the number of tiers of participation offered.
5. Only allow historic stewards to participate--only those who have
already completed the highest conservation achievement would be funded.
Anticipated Cost and Benefits:
NRCS developed a simulation model to analyze CSP benefits and costs.
The model assesses producer participation and the overall benefits and
costs to society associated with that participation. The model is based
on a series of composite farms, replicating the process of calculating
the CSP participation decision. Given farm-level estimates of
participation, enrolled acreage, payments, and costs, the model
estimates on-site and environmental (off-site) benefits, net economic
costs, Government costs, Government-to-producer transfer payments, net
benefit to society, and the benefit-cost ratio.
The model calculates the overall CSP payment by calculating several
payment components individually, and then by summing the results of:
The base payment, cost-sharing for installation of new structural
practices and adoption of new land management practices, cost-sharing
for maintenance of existing structural and land management practices,
and enhancement payments. The Net Present Value (NPV) of each payment
is determined by a payment rate per acre, the number of acres to which
the payment applies, contract years in which the payment is made (i.e.,
whether the payment is made on a one-time or annual basis), discounted
to the
[[Page 72691]]
present using a 7 percent annual discount rate. Payments for structural
and land management practices were calculated using a methodology
similar to that used for the Environmental Quality Incentives Program
(EQIP) Benefit/Cost Analysis, Final Report, May 29, 2003.
Although the analysis provides estimates of the social net benefits of
each alternative examined, its primary value is to illustrate the
relative order of the identified alternatives, rather than provide
accurate estimates of the costs and benefits. NRCS based its estimates
on a number of assumptions because of substantial data gaps. There is,
for example, no available information on the benefits associated with
major program elements, such as enhancement activities above and beyond
the non-degradation level. Instead, the RIA used estimates generated
from experience with EQIP, CRP, and other USDA conservation programs.
NRCS also assumes that producers would enroll in CSP if the program
provided any positive net benefit to them (i.e., even as small as $1).
This assumption does not take into consideration producers' cash flow
constraints, which along with other factors could affect participation.
Since the analysis does not have information on the behavioral response
of producers to the incentives provided by CSP, the benefits analysis
provided in the RIA is largely a hypothetical construct and does not
reflect the benefits of the proposed program and the identified
alternatives. NRCS intends to refine the analysis for the final rule.
Risks:
By issuing the proposed rule, NRCS builds upon the public input it
received during the comment period associated with its ANPRM and is
obtaining additional public comment on the implementation of a new,
innovative conservation program. The proposed rule provides the public
an opportunity to participate in the NRCS formation of program policies
and procedures prior to NRCS publishing a final rule for the program.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 193 01/02/04
NPRM Comment Period End 03/02/04
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Martha Joseph
Resource Conservationist
Department of Agriculture
Natural Resources Conservation Service
Room 6027-S
P.O. Box 2890
Washington, DC 20013
Phone: 202 720-7157
Fax: 202 720-2143
Email: martha.joseph@usda.gov
RIN: 0578-AA36
_______________________________________________________________________
USDA--NRCS
28. GRASSLAND RESERVE
Priority:
Other Significant
Legal Authority:
PL 107-171; 16 USC 3838
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
Under Grassland Reserve Program (GRP) the Department enters into
easement or rental agreements with owners of grazing land to protect
and restore such lands. The Department will designate payment for cost
share to restore the functions and values of grasslands.
Statement of Need:
Historically, grassland and shrublands occupied approximately one
billion acres, about half the landmass of the 48 contiguous United
States (Richard Conner, Texas A&M, June 2001). Roughly 50 percent of
these lands have been converted to cropland, urban land, and other land
uses. Privately owned grasslands (pastureland and rangeland) cover
approximately 526 million acres in this country (1997 National Resource
Inventory (NRI)). Grasslands provide both ecological and economic
benefits to local residents and society in general. Grassland
importance lies not only in the immense area covered but also in the
diversity of benefits they produce. These lands provide water for urban
and rural uses, livestock products, flood protection, wildlife habitat,
and carbon sequestration. These lands also provide aesthetic value in
the form of open space and are vital links in the enhancement of rural
social stability and economic vigor, as well as being part of the
Nation's history.
Grassland loss through conversion to other land uses such as cropland,
parcels for home sites, invasion of woody or non-native species, and
urban development threatens grassland resources. About 24 million acres
of grasslands and shrublands were converted to cropland or non-
agriculture uses between 1992 through 1997 (1997 National Resource
Inventory).
In the 2002 Farm Bill amendments to the Food Security Act of 1985 (the
1985 Act), Congress authorized the establishment of GRP. GRP is a
voluntary program to assist landowners and agriculture operators in
restoring and protecting grassland and land that contains forbs and
shrublands. The 2002 Farm Bill provided that $254 million would be made
available through FY 2007 to enroll no more than 2 million restored or
improved grasslands. The statute requires that 40 percent of the
program funds be used for 10-year, 15-year, and 20-year rental
agreements, and 60 percent of the funds be used for 30-year rental
agreements and easements.
The Secretry of Agriculture delegated the authority to administer GRP
on behalf of the Commodity Credit Corporation, to the Chief, Natural
Resources Conservation Service (NRCS) and the Administrator, Farm
Service Agency (FSA). These agency leaders are Vice Presidents of the
CCC. NRCS has the lead responsibility on technical issues and easement
administration, and FSA has the lead responsibility for rental
agreement administration and financial activities. The Secretary also
delegated authority to the Forest Service to hold easements at the
option of the landowner on properties adjacent to USDA Forest Service
properties. At the State level, the NRCS State Conservationist and the
FSA State Executive Director will determine how best to utilize the
human resources of both agencies to deliver the program and implement
National policies in an efficient manner.
Summary of Legal Basis:
The Farm Security and Rural Investment Act of 2002 (2002 Farm Bill)
amended chapter 2, subtitle D of title XII of the Food Security Act of
1985, to add subchapter C authorizing the Grassland Reserve Program
(GRP), 16 U.S.C. 3838n to 3838q. The purpose of this program is to
assist landowners and others in restoring and protecting
[[Page 72692]]
eligible grassland and certain other lands through rental agreements
and easements. CCC published an interim final rule on May 21, 2004 (60
FR 29173), and requested public comment. This final rule responds to
comments received from the public comment period and sets forth how the
Secretary of Agriculture (the Secretary), using the funds, facilities,
and authorities of the Commodity Credit Corporation (CCC), will
implement GRP to meet the statutory objectives of the program.
Alternatives:
Continue implementation under current interim final rule.
Anticipated Cost and Benefits:
$254 million through FY 2007.
Risks:
Grasslands are being lost through urban expansion, cropland conversion,
or encroachment of invasive species. The Grassland Reserve Program
assists farmers and ranchers in the restoration and conservation of the
Nation's grasslands.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru69 FR 29173 05/21/04
Interim Final Rule Comment Period End 07/20/04
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Leslie Deavers
Watersheds and Wetlands Division
Department of Agriculture
Natural Resources Conservation Service
Washington, DC 20013
Phone: 202 720-1067
Fax: 202 720-2143
Email: leslie.deavers@usda.gov
RIN: 0578-AA38
_______________________________________________________________________
USDA--NRCS
29. CONFIDENTIALITY OF CONSERVATION PROGRAM INFORMATION
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
5 USC 552(b)(3)
CFR Citation:
7 CFR 609
Legal Deadline:
None
Abstract:
Section 1244 of the Food Security Act of 1985, as amended by the Farm
Security and Rural Investment Act of 2002, prohibits the release and
disclosure of proprietary information unless certain exceptions apply.
Once implemented, the regulations will ensure program participant
confidence that proprietary information will not be released and
disclosed and will ensure that the public benefits provided by the
conservation programs will not be undermined.
Statement of Need:
The Natural Resources Conservation Service (NRCS) implements several
conservation programs, including its conservation technical assistance
activities under the Soil Conservation and Domestic Allotment Act and
many of the technical and financial assistance activities under
subtitle D of the Food Security Act of 1985. Through the implementation
of these conservation programs, NRCS utilizes its technical expertise
to provide owners, operators, and producers with information to help
them make land management decisions. When an owner, operator, or
producer applies for financial assistance under a conservation program,
NRCS evaluates the resource conditions on their land in relation to
natural resource program priorities.
Program participants provide NRCS with detailed information about the
condition of their land and their agricultural operations to help
ensure that they obtain the best technical assistance available and
that their investment, augmented with NRCS financial assistance, is
well-targeted. Program participants consider much of the information
provided to NRCS as proprietary and might be reluctant to work with
NRCS if such information could be disclosed as public information under
the Freedom of Information Act (FOIA).
The voluntary adoption of conservation practices on agricultural land
reaps great public benefits in soil loss reduction, water quality
improvement, water conservation, wildlife habitat development, and
wetland restoration. The Farm Security and Rural Investment Act of 2002
(the 2002 Act) greatly expanded the funding available to implement NRCS
conservation programs. The 2002 Act also included a provision to
protect information about program participants and their agricultural
operations to help ensure that agricultural producers would continue to
participate voluntarily in the expanded availability of conservation
programs. Otherwise, the public availability of program participant
information could undermine the successful voluntary adoption of
conservation practices that provide so many public benefits.
Summary of Legal Basis:
Section 1244 of the Food Security Act of 1985, as amended by the Farm
Security and Rural Investment Act of 2002, prohibits the release and
disclosure of such information unless certain exceptions apply.
Section 1244 of the Food Security Act of 1985, as amended, balances the
public right to information to ensure an open Government and an
informed citizenry while protecting the privacy rights of program
participants from opening up their proprietary information to
competitors or to the wider public. First, section 1244 provides that
the provision is pursuant to section 552a ... . Of title 5 of the
United States Code. Section 552a... is part of FOIA and provides for
additional protection from disclosure of documentation. Thus, section
1244 provides protection from disclosure or release of information that
otherwise would be subject to release under FOIA.
In particular, information provided by program participants may not be
subject to release to the public based upon either the Privacy Act or
an exemption from release under FOIA. Under Exemption 4 of FOIA,
program participants may receive protection from disclosure of
commercial or financial information voluntarily provided to the
government. However, disclosure under exemption 4 is discretionary, and
current executive orders provide that, whenever possible, Federal
agencies should exercise their discretion to release the information.
Section 1244 removes this discretion of the Federal agency. Even if
information could be released under Exemption 4 of FOIA or under the
Privacy Act, section 1244 requires that NRCS not disclose or release
the information.
While protecting program participants from having their proprietary
information considered public information, section 1244 ensures that
the public maintains its ability to
[[Page 72693]]
obtain payment information regarding conservation program participants.
Alternatives:
The Secretary of Agriculture is required to maintain the
confidentiality of proprietary information provided by conservation
program participants. Alternative is to not implement statute as
required or not to obtain proprietary information from program
participants. Either alternative is unacceptable.
Anticipated Cost and Benefits:
Undetermined at this time.
Risks:
Without regulatory framework, USDA employees are at risk for
prosecution for releasing information that is required to be withheld
from disclosure. Such disclosure has financial penalties.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
State
Agency Contact:
Dwight Halman
Deputy Chief for Management
Department of Agriculture
Natural Resources Conservation Service
P.O. Box 2890
Washington, DC 20013
Phone: 202 720-2588
Email: dwight.halman@usda.gov
RIN: 0578-AA40
BILLING CODE 3410-90-S
[[Page 72694]]
DEPARTMENT OF COMMERCE (DOC)
Statement of Regulatory and Deregulatory Priorities
Enhancing long-term economic growth is a central focus of the
President's policies and priorities. The mission of the Department of
Commerce is to promote job creation, economic growth, technological
competitiveness, sustainable development, and improved living standards
for all Americans by working in partnership with businesses,
universities, communities, and workers to:
Build for the future and promote U.S. economic
competitivenessin the global marketplace by strengthening
and safeguarding the Nation's economic infrastructure;
Keep America competitive with cutting-edge science and
technology and an unrivaled information base; and
Provide effective management and stewardship of our Nation's
resources and assets to ensure sustainable economic
opportunities.
The DOC mission statement, containing our three strategic themes,
provides the vehicle for understanding the Department's aims, how they
interlock, and how they are to be implemented through our programs.
This statement was developed with the intent that it serve as both a
statement of departmental philosophy and as the guiding force behind
the Department's programs.
The importance that this mission statement and these strategic themes
have for the Nation is amplified by the vision they pursue for
America's communities, businesses, and families. Commerce is the
smallest Cabinet agency, yet our presence is felt, and our
contributions are found, in every State.
The DOC touches Americans, daily, in many ways--we make possible the
weather reports that all of us hear every morning; we facilitate the
technology that all of us use in the workplace and in the home each
day; we support the development, gathering, and transmitting of
information essential to competitive business; we make possible the
diversity of companies and goods found in America's (and the world's)
marketplace; and we support environmental and economic health for the
communities in which Americans live.
The DOC has a clear and powerful vision for itself, for its role in the
Federal Government, and for its roles supporting the American people,
now and in the future. We confront the intersection of trade promotion,
civilian technology, economic development, sustainable development, and
economic analysis, and we want to provide leadership in these areas for
the Nation.
We work to provide programs and services that serve our country's
businesses, communities, and families, as initiated and supported by
the President and the Congress. We are dedicated to making these
programs and services as effective as possible, while ensuring that
they are being delivered in the most cost-effective ways. We seek to
function in close concert with other agencies having complementary
responsibilities so that our collective impact can be most powerful. We
seek to meet the needs of our customers quickly and efficiently, with
programs, information, and services they require and deserve.
As a permanent part of the Federal Government, but serving an
Administration and Congress that can vary with election results, we
seek to serve the unchanging needs of the Nation, according to the
priorities of the President and the Congress. The President's
priorities for the Department range from issues concerning the economy
to the environment. For example, the President directs the Department
to promote electronic commerce activities; encourage open and free
trade; represent American business interests abroad; and assist small
businesses to expand and create jobs. We are able to address these
priorities effectively by functioning in accordance with the
legislation that undergirds our programs and by working closely with
the President and the committees in Congress, which have programmatic
and financial oversight for our programs.
The DOC also promotes and expedites American exports, helps nurture
business contacts abroad, protects U.S. firms from unfair foreign
competition, and makes how-to-export information accessible to small
and mid-sized companies throughout the Nation, thereby ensuring that
U.S. market opportunities span the globe.
The DOC encourages development in every community, clearing the way for
private-sector growth by building and rebuilding economically deprived
and distressed communities. We promote minority entrepreneurship to
establish businesses that frequently anchor neighborhoods and create
new job opportunities. We work with the private sector to enhance
competitive assets.
As the Nation looks to revitalize its industries and communities, the
DOC works as a partner with private entities to build America with an
eye on the future. Through technology, research and development, and
innovation, we are making sure America continues to prosper in the
short-term, while also helping industries prepare for long-term
success.
The DOC's considerable information capacities help businesses
understand clearly where our national and world economies are going and
take advantage of that knowledge by planning the road ahead. Armed with
the Department's economic and demographic statistics, businesses can
undertake the new ventures, investments, and expansions that make our
economy grow.
The DOC has instituted programs and policies that lead to cutting-edge,
competitive, and better paying jobs. We work every day to boost
exports, to deregulate business, to help smaller manufacturers battle
foreign competition, to advance the technologies critical to our future
prosperity, to invest in our communities, and to fuse economic and
environmental goals.
The DOC is American business' surest ally in job creation, serving as a
vital resource base, a tireless advocate, and its Cabinet-level voice.
The Regulatory Plan directly tracks these policy and program
priorities, only a few of which involve regulation of the private
sector by the Department.
Responding to the Administration's Regulatory Philosophy and Principles
The vast majority of the Department's programs and activities do not
involve regulation. Of the Department's 12 primary operating units,
only two--the Bureau of Industry and Security (BIS) and the National
Oceanic and Atmospheric Administration (NOAA)--plan significant
preregulatory or regulatory actions for this Regulatory Plan year. Of
all the significant actions planned by the Department, NOAA plans to
complete five actions that rise to the level of ``most important'' of
the Department's ``significant regulatory actions''. They are (1)
Amendments 18 and 19 to the Fishery Management Plan for Bering Sea/
Aleutian Islands King and Tanner Crabs - Crab Rationalization Program;
(2) Designate Critical Habitat for 7 Evolutionarily Significant Units
(ESUs) of Pacific Salmon and Steelhead in California; (3) Designate
Critical Habitat for 13 Evolutionarily Significant Units (ESUs) of
Pacific Salmon and Steelhead in Washington and Oregon;
[[Page 72695]]
(4) Listing Determinations for 27 Evolutionarily Significant Units
(ESUs) of West Coast Salmon and Oncorhynchus Mykiss; and (5) Northwest
Hawaiian Islands National Marine Sanctuary; Designation and
Implementing Regulations. Further information on these actions are
provided below.
Though not principally a regulatory agency, the DOC has long been a
leader in advocating and using market-oriented regulatory approaches in
lieu of traditional command-and-control regulations when such
approaches offer a better alternative. All regulations are designed and
implemented to maximize societal benefits while placing the smallest
possible burden on those being regulated.
The DOC is also refocusing on its regulatory mission by taking into
account, among other things, the President's regulatory principles. To
the extent permitted by law, all preregulatory and regulatory
activities and decisions adhere to the Administration's statement of
regulatory philosophy and principles, as set forth in section 1 of
Executive Order 12866. Moreover, we have made bold and dramatic
changes, never being satisfied with the status quo. We have emphasized,
initiated, and expanded programs that work in partnership with the
American people to secure the Nation's economic future. At the same
time we have downsized, cut regulations, closed offices, and eliminated
programs and jobs that are not part of our core mission. The bottom
line is that, after much thought and debate, we have made many hard
choices needed to make this Department ``state of the art.''
The Secretary has prohibited the issuance of any regulation that
discriminates on the basis of race, religion, gender, or any other
suspect category and requires that all regulations be written so as to
be understandable to those affected by them. The Secretary also
requires that the Department afford the public the maximum possible
opportunity to participate in departmental rulemakings, even where
public participation is not required by law.
National Oceanic and Atmospheric Administration
The National Oceanic and Atmospheric Administration (NOAA) establishes
and administers Federal policy for the conservation and management of
the Nation's oceanic, coastal, and atmospheric resources. It provides a
variety of essential environmental services vital to public safety and
to the Nation's economy, such as weather forecasts and storm warnings.
It is a source of objective information on the state of the
environment. NOAA plays the lead role in achieving the departmental
goal of promoting stewardship by providing assessments of the global
environment.
Recognizing that economic growth must go hand-in-hand with
environmental stewardship, the Department, through NOAA, conducts
programs designed to provide a better understanding of the connections
between environmental health, economics, and national security.
Commerce's emphasis on ``sustainable fisheries'' is saving fisheries
and confronting short-term economic dislocation, while boosting long-
term economic growth. The Department is where business and
environmental interests intersect, and the classic debate on the use of
natural resources is transformed into a ``win-win'' situation for the
environment and the economy.
Three of NOAA's major components, the National Marine Fisheries
Services (NMFS), the National Ocean Service (NOS), and the National
Environmental Satellite, Data, and Information Service (NESDIS),
exercise regulatory authority.
NMFS oversees the management and conservation of the Nation's marine
fisheries, protects marine mammals, and promotes economic development
of the U.S. fishing industry. NOS assists the coastal states in their
management of land and ocean resources in their coastal zones,
including estuarine research reserves; manages the Nation's national
marine sanctuaries; monitors marine pollution; and directs the national
program for deep-seabed minerals and ocean thermal energy. NESDIS
administers the civilian weather satellite program and licenses private
organizations to operate commercial land-remote sensing satellite
systems.
The Administration is committed to an environmental strategy that
promotes sustainable economic development and rejects the false choice
between environmental goals and economic growth. The intent is to have
the Government's economic decisions guided by a comprehensive
understanding of the environment. The Department, through NOAA, has a
unique role in promoting stewardship of the global environment through
effective management of the Nation's marine and coastal resources and
in monitoring and predicting changes in the Earth's environment, thus
linking trade, development, and technology with environmental issues.
NOAA has the primary Federal responsibility for providing sound
scientific observations, assessments, and forecasts of environmental
phenomena on which resource management and other societal decisions can
be made.
In the environmental stewardship area, NOAA's goals include: rebuilding
U.S. fisheries by refocusing policies and fishery management planning
on increased scientific information; increasing the populations of
depleted, threatened, or endangered species of marine mammals by
implementing recovery plans that provide for their recovery while still
allowing for economic and recreational opportunities; promoting healthy
coastal ecosystems by ensuring that economic development is managed in
ways that maintain biodiversity and long-term productivity for
sustained use; and modernizing navigation and positioning services. In
the environmental assessment and prediction area, goals include:
modernizing the National Weather Service; implementing reliable
seasonal and interannual climate forecasts to guide economic planning;
providing science-based policy advice on options to deal with very
long-term (decadal to centennial) changes in the environment; and
advancing and improving short-term warning and forecast services for
the entire environment.
Magnuson-Stevens Act Rulemakings
Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-
Stevens Act) rulemakings concern the conservation and management of
fishery resources in the U.S. 3-to-200-mile Exclusive Economic Zone
(EEZ). Among the several hundred rulemakings that NOAA plans to issue
in the Regulatory Plan year, a number of the preregulatory and
regulatory actions will be significant. The exact number of such
rulemakings is unknown, since they are usually initiated by the actions
of eight regional Fishery Management Councils (FMCs) that are
responsible for preparing fishery management plans (FMPs) and FMP
amendments, and for drafting implementing regulations for each managed
fishery. Once a rulemaking is triggered by an FMC, the Magnuson-Stevens
Act places stringent deadlines upon NMFS by which it must exercise its
rulemaking responsibilities.
While most of these rulemakings will be minor, involving only the
opening or closing of a fishery under an existing
[[Page 72696]]
FMP, five actions are of particular significance. In the first action
entitled ``Amendments 18 and 19 to the to the Fishery Management Plan
for Bering Sea/Aleutian Islands King and Tanner Crabs in the Bering Sea
and the Aleutian Islands - Crab Rationalization Program,'' NMFS
proposes to rationalize the Bering Sea and Aleutian Islands crab
fisheries in the United States Exclusive Economic Zone off Alaska by
amending the Fishery Management Plan for Bering Sea and Aleutian
Islands King and Tanner Crabs. The goal of rationalization is to end
the race for fish and solve the problems of overcapacity while
providing for a balanced distribution of benefits and improving
fisheries management and resource conservation. In the second and third
actions entitled ``Designate Critical Habitat for 7 Evolutionarily
Significant Units (ESUs) of Pacific Salmon and Steelhead in
California`'' and ``Designate Critical Habitat for 13 Evolutionarily
Significant Units (ESUs) of Pacific Salmon and Steelhead in Washington
and Oregon,'' NMFS would designate critical habitat for 20 Pacific
salmon and O. mykiss Evolutionarily Significant Units (ECUS) listed
under the Endangered Species Act of 1973. The geographic areas proposed
for designation include lakes, riverine, and estuarian habitat in
Washington, Oregon, Idaho, and California. In addition, in the action
entitled Listing Determinations for 27 ESUs of West Coast Salmon and
Oncorhynchus Mykiss, NMFS proposes to list ESUs as endangered or
threatened, and also to delist ESUs as necessary. Finally, in the
action entitled Northwest Hawaiian Islands National Marine Sanctuary;
Designation and Implementation of Regulations, NOAA would designate the
Northwest Hawaiian Islands as a national marine sanctuary and propose
implementing regulations that best reflect the goals and objectives of
the proposed sanctuary.
The Magnuson-Stevens Act, which is the primary legal authority for
Federal regulation to conserve and manage fishery resources,
establishes eight regional FMCs, responsible for preparing FMPs and FMP
amendments. NMFS issues regulations to implement FMPs and FMP
amendments. FMPs address a variety of fishery matters, including
depressed stocks, overfished stocks, gear conflicts, and foreign
fishing. One of the problems that FMPs may address is preventing
overcapitalization (preventing excess fishing capacity) of fisheries.
This may be resolved by limiting access to those dependent on the
fishery in the past and/or by allocating the resource through
individual transferable quotas, which can be sold on the open market to
other participants or those wishing access. Quotas set on sound
scientific information, whether as a total fishing limit for a species
in a fishery or as a share assigned to each vessel participant, enable
stressed stocks to rebuild. Other measures include staggering fishing
seasons or limiting gear types to avoid gear conflicts on the fishing
grounds, and establishing seasonal and area closures to protect fishery
stocks.
The FMCs provide a forum for public debate and, using the best
scientific information available, make the judgments needed to
determine optimum yield on a fishery-by-fishery basis. Optional
management measures are examined and selected in accordance with the
national standards set forth in the Magnuson-Stevens Act. This process,
including the selection of the preferred management measures,
constitutes the development, in simplified form, of an FMP. The FMP,
together with draft implementing regulations and supporting
documentation, is submitted to NMFS for review against the national
standards set forth in the Magnuson-Stevens Act, in other provisions of
the Act, and other applicable laws. The same process applies to
amending an existing approved FMP.
TheMagnuson-Stevens Act contains ten national standards against which
fishery management measures are judged. NMFS has supplemented the
standards with guidelines interpreting each standard, and has updated
and added to those guidelines. One of the national standards requires
that management measures, where practicable, minimize costs and avoid
unnecessary duplication. Under the guidelines, NMFS will not approve
management measures submitted by an FMC unless the fishery is in need
of management. Together, the standards and the guidelines correspond to
many of the Administration's principles of regulation as set forth in
section 1(b) of Executive Order 12866. One of the national standards
establishes a qualitative equivalent to the Executive Order's ``net
benefits'' requirement--one of the focuses of the Administration's
statement of regulatory philosophy as stated in section 1(a) of the
Executive order.
Bureau of Industry and Security
The Bureau of Industry and Security (BIS) promotes U.S. national and
economic security and foreign policy interests by managing and
enforcing the Department's security-related trade and competitiveness
programs. BIS plays a key role in challenging issues involving national
security and nonproliferation, export growth, and high technology. The
Bureau's continuing major challenge is combating the proliferation of
weapons of mass destruction while furthering the growth of U.S.
exports, which are critical to maintaining our leadership in an
increasingly competitive global economy. BIS strives to be the leading
innovator in transforming U.S. strategic trade policy and programs to
adapt to the changing world.
Major Programs and Activities
The Export Administration Regulations (EAR) provide for export controls
on dual use goods and technology (primarily commercial goods that have
potential military applications) not only to fight proliferation, but
also to pursue other national security, short supply, and foreign
policy goals (such as combating terrorism). Simplifying and updating
these controls in light of the end of the Cold War has been a major
accomplishment of BIS.
BIS is also responsible for:
Enforcing the export control and antiboycott provisionsof the
Export Administration Act (EAA), as well as other statutes
such as the Fastener Quality Act. The EAA is enforced
through a variety of administrative, civil, and criminal
sanctions.
Analyzing and protecting the defense industrial and
technologybase, pursuant to the Defense Production Act and
other laws. As the Defense Department increases its
reliance on dual-use high technology goods as part of its
cost-cutting efforts, ensuring that we remain competitive
in those sectors and subsectors is critical to our national
security.
Helping Ukraine, Kazakstan, Belarus, Russia, and othernewly
emerging countries develop effective export control
systems. The effectiveness of U.S. export controls can be
severely undercut if ``rogue states'' or terrorists gain
access to sensitive goods and technology from other
supplier countries.
Working with former defense plants in the Newly
IndependentStates to help make a successful transition to
profitable and peaceful civilian endeavors. This involves
helping remove unnecessary obstacles to trade and
investment and identifying
[[Page 72697]]
opportunities for joint ventures with U.S. companies.
Assisting U.S. defense enterprises to meet the challenge of
the reduction in defense spending by converting to civilian
production and by developing export markets. This work
assists in maintaining our defense industrial base as well
as preserving jobs for U.S. workers.
_______________________________________________________________________
DOC--National Oceanic and Atmospheric Administration (NOAA)
-----------
PROPOSED RULE STAGE
-----------
30. DESIGNATE CRITICAL HABITAT FOR 7 EVOLUTIONARILY SIGNIFICANT UNITS
(ESUS) OF PACIFIC SALMON AND STEELHEAD IN CALIFORNIA
Priority:
Other Significant
Legal Authority:
16 USC 1533
CFR Citation:
50 CFR 226
Legal Deadline:
NPRM, Judicial, November 30, 2004.
Final, Judicial, June 15, 2005.
Abstract:
This action would designate critical habitat for 7 Pacific salmon and
O. mykiss Evolutionarily Significant Units (ESUs) listed under the
Endangered Species Act of 1973. The geographic area proposed for
designation include riverine and estuarine habitat in California.
Statement of Need:
On February 16, 2000, NMFS published final critical habitat
designations for 19 ESUs, thereby completing designations for all 25
ESUs listed at the time. In considering the economic impact of the
February 16, 2000, action, NMFS determined that the critical habitat
designations would impose very little or no additional requirements on
Federal agencies beyond those already associated with the listing of
the species themselves. The National Association of Homebuilders (NAHB)
challenged the designations in District Court in Washington, D.C. as
having inadequately considered the economic impacts of the critical
habitat designations (National Association of Homebuilders v. Evans,
2002 WL 1205743 No. 00-CV-2799 (D.D.C.)). As a result of a district
court's approval of a consent decree, the 19 critical habitat
designations were vacated. A subsequent complaint from a group of
fishing and environmental organizations regarding our failure to
designate critical habitat led to a court approved agreement (July 13,
2004) to designate critical habitat for any listed ESUs under the
Northwest Region's responsibility by September 30, 2004, and for any
listed ESUs under the Southwest Region's responsibility by November 30,
2004. Final critical habitat designations for all of these ESUs are due
on June 15, 2005.
Summary of Legal Basis:
Sections 4(a)(3)(A) and 4(b)(6)(C)(ii) of the Endangered Species Act
(ESA) require the Secretary to designate critical habitat concurrently
with making a determination that a species is threatened or endangered.
Section 4(b)(6)(C)(ii) requires that a final regulation designating
critical habitat be published concurrently with the final regulation
listing the species as threatened or endangered unless such habitat is
not then determinable, in which case, the Secretary may extend the one-
year period for finalizing critical habitat by one additional year. The
court approved agreement mentioned in the first paragraph requires
final critical habitat designations by June 15, 2005, concurrently with
the deadline for final listing determinations on the 26 ESUs that were
proposed for revised listing determinations and the one additional ESU
that was proposed for listing.
Section 4(b)(2) requires that critical habitat designation be based on
the best scientific data available after taking economic impacts,
impacts on national security, and any other relevant impact of
specifying any particular area as critical habitat into account. The
Secretary may exclude any area from critical habitat if he determines
that the benefits of such exclusion outweigh the benefits of specifying
such area as part of the critical habitat, unless failure to designate
such area as critical habitat will result in the extinction of the
species concerned.
Alternatives:
Critical habitat designation is a requirement under the ESA.
Alternatives can be considered during the section 4(b)(2) analysis when
NMFS weighs the benefits of excluding some critical habitat with the
benefits of specifying it as critical habitat. NMFS ranked different
critical habitat areas as high, medium, or low value in terms of the
benefits that can be expected to accrue to the salmon ESUs. One
alternative is to include all habitat that has been identified as
critical in the critical habitat designation. Another alternative is to
exclude all the low value areas from the designation. A third
alternative is to exclude a combination of all low value areas and some
medium value areas.
Anticipated Cost and Benefits:
NMFS has conducted an economic analysis on the proposal to designate
critical habitat for the ESUs in the Region. The net economic impacts
of ESA section 7 associated with the areas proposed for designation are
estimated to be approximately $88,980,000. The benefits to Pacific
salmon cannot be monetized easily, but critical habitat designation
should contribute to the health of the species.
Risks:
The principal benefit of designating critical habitat is that Federal
activities that may affect such habitat are subject to consultation
pursuant to section 7 of the ESA. Such consultation requires every
Federal agency to insure that any action it authorizes, funds or
carries out is not likely to result in the destruction or adverse
modification of critical habitat. This complements the section 7
provision that Federal agencies insure that their action is not likely
to jeopardize the continued existence of a listed species. Another
benefit is that the designation of critical habitat can serve to
educate the public regarding the potential conservation value of an
area. This may focus and contribute to conservation efforts by clearly
delineating areas of high conservation value for certain species.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 79328 12/19/00
NPRM Comment Period End 02/20/01
NPRM 11/00/04
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
None
[[Page 72698]]
Agency Contact:
James H. Lecky
Assistant Regional Administrator, Southwest Region
Department of Commerce
National Oceanic and Atmospheric Administration
501 W. Ocean Blvd. No. 4200
Long Beach, CA 90802
Phone: 502 980-4015
Fax: 502 980-4027
Related RIN: Related to 0648-AQ77
RIN: 0648-AO04
_______________________________________________________________________
DOC--NOAA
31. DESIGNATE CRITICAL HABITAT FOR 13 EVOLUTIONARILY SIGNIFICANT UNITS
(ESUS) OF PACIFIC SALMON AND STEELHEAD IN WASHINGTON, OREGON AND IDAHO
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
16 USC 1533
CFR Citation:
50 CFR 226; 50 CFR 424
Legal Deadline:
NPRM, Judicial, September 30, 2004.
Final, Judicial, June 15, 2005.
Abstract:
This action would designate critical habitat for 13 Pacific salmon and
O. mykiss Evolutionarily Significant Units (ESUs) listed under the
Endangered Species Act of 1973. The geographic areas proposed for
designation include lakes, riverine, and estuarine habitat in
Washington, Oregon, and Idaho, and marine nearshore habitat in
Washington.
Statement of Need:
On February 16, 2000, NMFS published final critical habitat
designations for 19 ESUs, thereby completing designations for all 25
ESUs listed at the time. In considering the economic impact of the
February 16, 2000, action, NMFS determined that the critical habitat
designations would impose very little or no additional requirements on
Federal agencies beyond those already associated with the listing of
the species themselves. The National Association of Homebuilders (NAHB)
challenged the designations in District Court in Washington, D.C. as
having inadequately considered the economic impacts of the critical
habitat designations (National Association of Homebuilders v. Evans,
2002 WL 1205743 No. 00-CV-2799 (D.D.C.)). As a result of a district
court's approval of a consent decree, the 19 critical habitat
designations were vacated. A subsequent complaint from a group of
fishing and environmental organizations regarding our failure to
designate critical habitat led to a court approved agreement (July 13,
2004) to designate critical habitat for any listed ESUs under the
Northwest Region's responsibility by September 30, 2004, and for any
listed ESUs under the Southwest Region's responsibility by November 30,
2004. Final critical habitat designations for all of these ESUs are due
on June 15, 2005.
Summary of Legal Basis:
Sections 4(a)(3)(A) and 4(b)(6)(C)(ii) of the Endangered Species Act
(ESA) require the Secretary to designate critical habitat concurrently
with making a determination that a species is threatened or endangered.
Section 4(b)(6)(C)(ii) requires that a final regulation designating
critical habitat be published concurrently with the final regulation
listing the species as threatened or endangered unless such habitat is
not then determinable, in which case, the Secretary may extend the one-
year period for finalizing critical habitat by one additional year. The
court approved agreement mentioned in the first paragraph requires
final critical habitat designations by June 15, 2005, concurrently with
the deadline for final listing determinations on the 26 ESUs that were
proposed for revised listing determinations and the one additional ESU
that was proposed for listing.
Section 4(b)(2) requires that critical habitat designation be based on
the best scientific data available after taking economic impacts,
impacts on national security, and any other relevant impact of
specifying any particular area as critical habitat into account. The
Secretary may exclude any area from critical habitat if he determines
that the benefits of such exclusion outweigh the benefits of specifying
such area as part of the critical habitat, unless failure to designate
such area as critical habitat will result in the extinction of the
species concerned.
Alternatives:
Critical habitat designation is a requirement under the ESA.
Alternatives can be considered during the section 4(b)(2) analysis when
NMFS weighs the benefits of excluding some critical habitat with the
benefits of specifying it as critical habitat. NMFS has ranked
different critical habitat areas as high, medium, or low value in terms
of the benefits that can be expected to accrue to the salmon ESUs. One
alternative is to include all habitat that has been identified as
critical in the critical habitat designation. Another alternative is to
exclude all the low value areas from the designation. A third
alternative is to exclude a combination of all low value areas and some
medium value areas.
Anticipated Cost and Benefits:
NMFS has conducted an economic analysis on the proposal to designate
critical habitat for the ESUs in the Northwest Region. The net economic
impacts of ESA section 7 associated with the areas proposed for
designation are estimated to be approximately $223,950,127. The
benefits to Pacific salmon cannot be monetized easily, but critical
habitat designation should contribute to the health of the species.
Risks:
The principal benefit of designating critical habitat is that Federal
activities that may affect such habitat are subject to consultation
pursuant to section 7 of the ESA. Such consultation requires every
Federal agency to insure that any action it authorizes, funds or
carries out is not likely to result in the destruction or adverse
modification of critical habitat. This complements the section 7
provision that Federal agencies insure that their action is not likely
to jeopardize the continued existence of a listed species. Another
benefit is that the designation of critical habitat can serve to
educate the public regarding the potential conservation value of an
area. This may focus and contribute to conservation efforts by clearly
delineating areas of high conservation value for certain species.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 68 FR 55926 09/29/03
ANPRM Comment Period End 11/13/03
NPRM 11/00/04
NPRM Comment Period End 02/00/05
Final Action 06/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions
[[Page 72699]]
Government Levels Affected:
Local, State, Tribal
Agency Contact:
D. Robert Lohn
Regional Administrator, Northwest Region, NMFS
Department of Commerce
National Oceanic and Atmospheric Administration
7600 Sand Point Way NE, Building 1
Seattle, WA 48115-0070
Phone: 206 526-6150
Fax: 206 526-6426
RIN: 0648-AQ77
_______________________________________________________________________
DOC--NOAA
32. AMENDMENTS 18 AND 19 TO THE FISHERY MANAGEMENT PLAN FOR
BERING SEA/ALEUTIAN ISLANDS KING AND TANNER CRABS--CRAB RATIONALIZATION
PROGRAM
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
16 USC 1801
CFR Citation:
50 CFR 679; 50 CFR 680
Legal Deadline:
Other, Statutory, January 1, 2005, Secretary approval of statutorily
mandated FMP Amendment.
Abstract:
This action would rationalize the Bering Sea and Aleutian Islands crab
fisheries in the United States Exclusive Economic Zone off Alaska by
amending the Fishery Management Plan for Bering Sea and Aleutian
Islands King and Tanner Crabs. The goal of rationalization is to end
the race for fish and solve the problems of overcapacity while
providing for a balanced distribution of benefits and improving
fisheries management and resource conservation.
Statement of Need:
This action would amend the regulations to implement Amendments 18 and
19 of the Fishery Management Plan for Bering Sea/Aleutian Islands King
and Tanner Crabs in Waters off Alaska. The U.S. Congress amended the
Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-
Stevens) to require the Secretary of Commerce to approve the Crab
Rationalization Program (Program) by January 1, 2005. Amendments 18 and
19 to the Fishery Management Plan for Bering Sea/Aleutian Islands King
and Tanner Crabs (FMP) constitute this program. The regulations in this
action are needed to implement this program. This rule is necessary to
increase resource conservation, improve economic efficiency, and to
address social concerns. This action is intended to promote the goals
and objectives of the Magnuson-Stevens Act, the FMP, and other
applicable laws.
Summary of Legal Basis:
In January 2004, the U.S. Congress amended section 313 of the Magnuson-
Stevens Act through the Consolidated Appropriations Act of 2004 (Pub.
L. No. 108-199, section 801), by adding paragraph (j). As amended,
section 313(j)(1) requires the Secretary to approve and implement, by
January 1, 2005, the Voluntary Three-pie Cooperative Program (Program)
as it was approved by the North Pacific Fishery Management Council
(Council) between June 2002 and April 2003, and all trailing amendments
including those reported to Congress on May 6, 2003.
At this time, NMFS has not determined that the FMP amendments that this
rule would implement are consistent with the national standards of the
Magnuson-Stevens Act and other applicable laws. NMFS, in making that
determination, will take into account the data, views, and comments
received during the comment period.
Alternatives:
The Environmental Impact Statement (EIS) presents four alternative
programs for management of the BSAI crab fisheries, namely, Status Quo/
No Action (Alternative 1); a Voluntary Three-pie Cooperative Program
(Alternative 2); an Individual Fisherman's Quota (IFQ) Program
(Alternative 3); and a Cooperative Program (alternative 4). These
alternatives constitute the suite of ``significant alternatives,''
under this action, for Regulatory Flexibility Act purposes. Please
refer to EIS and Regulatory Impact Review (RIR) for more details.
Anticipated Cost and Benefits:
It is probable that producers will experience a net benefit as a result
of implementing quota and cooperative features of the Program. The
fishing industry operating in the BSAI crab fishery may see an economic
increase from the implementation of the Program by lengthening the
interval of time that crab are supplied to the market. Other
rationalized fisheries have been observed to generate higher market
prices by allowing for a longer interval of time during a year to
supply product to the marketplace. In addition, it is likely that the
costs to crab fishing and processing operations will be substantially
reduced as a result of the quota and cooperative features of the
Program. The BSAI crab fisheries are among the most highly
overcapitalized fisheries in the Alaska region. Participation in the
current short and inefficient open access fishing season has resulted
in a greater number of fishing vessels, higher vessel operating costs,
a greater number of crew, and costly redundancies in processing
capacity compared with what will be required as a result of the quota
and cooperative elements of the Program.
It is unknown how this regulation would affect consumers. There is the
potential that consumers will benefit from less seasonal crab supplies.
It is probable that a less rapidly paced fishery may result in improved
product quality at harvest. Handling damage from the compressed
seasons, symptomatic of the present managed open access crab fisheries
may be significantly reduced by longer seasons under the quota
fisheries, where vessels have expanded choices of how often and what
times of year to fish.
Due to the lack of data on fixed and variable costs for both the BSAI
crab fishery and processing operations, and inadequate data on market
prices by crab product quality and product form, it is not possible to
estimate the magnitude of the qualitative changes to the industry or
nation from the Program. After the Program is implemented, the official
record of quota market transactions and a mandatory economic data
collection program will allow for detailed quantitative estimates of
benefits and costs.
Risks:
The Program is a limited access system that balances the interests of
several groups who depend on these fisheries. The Program addresses
conservation and management issues associated with the current derby
fishery and would reduce bycatch and associated discard mortality. The
Program also would increase the safety of crab fishermen by ending the
race for fish. Share allocations to harvesters and processors, together
with incentives to participate in fishery cooperatives, would increase
efficiencies, provide economic stability, and facilitate
[[Page 72700]]
compensated reduction of excess capacities in the harvesting and
processing sectors. Community interests would be protected by Community
Development Quota (CDQ) allocations and regional landing and processing
requirements, as well as by several community protection measures.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Notice 69 FR 53359 09/01/04
NPRM 69 FR 63200 10/29/04
NPRM Comment Period End 12/13/04
Final Action 02/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions, Organizations
Government Levels Affected:
Federal, Local, State
Agency Contact:
James W. Balsiger
Administrator, Alaska Region
Department of Commerce
National Oceanic and Atmospheric Administration
NMFS
P.O. 21668
Juneau, AK 99802
Phone: 907 586-7221
Fax: 907 586-7249
RIN: 0648-AS47
_______________________________________________________________________
DOC--NOAA
33. NORTHWEST HAWAIIAN ISLANDS NATIONAL MARINE SANCTUARY;
DESIGNATION AND IMPLEMENTATION OF REGULATIONS
Priority:
Other Significant
Legal Authority:
PL 106-513; 16 USC 1431 et seq
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
The National Marine Sanctuaries Program, together with state and
federal partners and other stakeholders, designate the Northwest
Hawaiian Islands as a national marine sanctuary and implement
regulations that best reflects the goals and objectives of the proposed
sanctuary.
Statement of Need:
By designating the Northwest Hawaiian Islands (NWHI) as a national
marine sanctuary, the National Marine Sanctuary Program (NMSP),
together with state and federal partners and other stakeholders, hope
to catalyze the collaborative development of an ecosystem approach to
address management issues. The NWHI are among the few, large-scale,
intact, predator-dominated coral reef ecosystems left in the world.
Significant Native Hawaiian cultural and maritime historical resources
are found throughout the region. These vast and remote coral reef
ecosystems support a distinctive assemblage of marine mammals, fish,
sea turtles, birds, and invertebrates, including species that are
endemic, rare, threatened, or endangered. Unfortunately, coral reef
systems like the NWHI are in a state of decline as direct or indirect
result of human activities.
Fishing is one of many human activities that may have direct and
indirect effects on the health and integrity of coral reef ecosystems.
Some of the direct impacts of fishing on coral reef ecosystems include
depletion of fish stocks and habitat degradation. Examples of indirect
effects include shifts in community structure and predatory-prey
relationships. Historically, fisheries management approaches have been
conducted through a single species approach. While this fishery
management approach can provide valuable information, it does not
consider the broader impacts of the activity on an ecosystem. The NMSP
and the National Oceanic and Atmospheric Administration (NOAA) as a
whole are working toward an ecosystem approach to resource management.
This form of management is adaptive, is geographically specified, takes
account of ecosystem knowledge and uncertainties, considers multiple
external influences, and strives to balance diverse social objectives.
Fishing in the NWHI must be carefully considered and evaluated in the
context of an ecosystem approach to management in order to achieve a
healthy, functional, and resilient ecosystem.
Summary of Legal Basis:
The NMSP of NOAA is in the process of designating the Northwest
Hawaiian Islands Coral Reef Ecosystem Reserve (Reserve) as a national
marine sanctuary as directed by the National Marine Sanctuaries
Amendments Act (NMSAA) of 2000 and Executive Orders 13178 and 13196,
and in accordance with the National Marine Sanctuaries Act (NMSA). The
Reserve was established in 2000 by EO 13178 with the principal purpose
of long-term conservation and protection of the coral reef ecosystem
and related marine resources and species of the Northwest Hawaiian
Islands (NWHI) in their natural character. The sanctuary designation
process is described in Section 304 of the NMSA and requires the
preparation of an environmental impact statement.
Alternatives:
The NMSP is considering seven alternatives. The first alternative
(Status Quo/No Action Alternative) maintains the NWHI Research and EO
provisions as is. It assumes a sanctuary will not be designated. This
places caps on all fishing activities that were active at the time the
EO was issued, and prohibits the development of new or inactive
fisheries. This alternative makes provisions for several types of
commercial and recreational fishing including bottomfishing/pelagic
trolling, commercial trolling, sustenance fishing, and Native Hawaiian
cultural and subsistence use. The second alternative mirrors the
provisions of EO 13178 and 13196 but assumes those provisions will
become regulations promulgated under the NMSA. In addition, this
alternative provides straight-line boundaries, as opposed to fathom
boundaries, to define Reserve/Sanctuary Preservation Areas to aid in
user compliance and enforcement. Fishing regulations would be
promulgated that would prohibit precious coral and crustacean harvest,
but provide for bottomfish/pelagic trolling, commercial pelagic
trolling, various forms of recreational fishing, and Native Hawaiian
cultural and subsistence uses. The third alternative was developed by
the Western Pacific Fishery Management Council and assumes that the
Reserve would be designated as a national marine sanctuary, with
fishing regulations promulgated under the NMSA. However, fishing
activities would be managed in accordance with existing fishery
management plans for those fishing activities currently practiced. This
alternative also suggests that future harvest of precious corals and
crustaceans would be managed under previously developed FMPs. However,
in a Federal Register notice, NOAA issues a zero-harvest guideline and
[[Page 72701]]
cited the EO as a reason to continue closure of the crustacean fishery.
The fourth alternative establishes a sanctuary with fishing regulations
that would protect the highest ecosystem values while allowing
compatible fishing activities in areas where they are likely to have
less impact on the ecosystem. It prohibits precious coral and
crustacean harvest, and pelagic longlining, but provides for commercial
bottomfish/pelagic trolling, commercial pelagic trolling, various forms
of recreational fishing, and Native Hawaiian cultural and subsistence
uses through a permitting process. The fifth alternative is an
iteration of the fourth alternative and prohibits the same fishing
activities. It also provides for bottomfish/pelagic trolling,
commercial pelagic trolling, various forms of recreational fishing and
Native Hawaiian cultural subsistence uses. The sixth alternative was
developed by the Reserve Advisory Council and is similar to alternative
2 but would close bottomfish/pelagic trolling within 1 year of
sanctuary designation. It also calls for a zoning system to limit
commercial and recreational pelagic fishing to minimize interactions
with protected wildlife. The seventh alternative closes immediately the
entire area to all extractive use, except for research or education.
Anticipated Cost and Benefits:
There are currently nine active commercial bottomfishermen in the NWHI,
five in the Mau zone and four in the Ho'omalu zone. Total reported 2003
gross revenue for the nine NWHI fishermen was just under $1.3 million
with $611 thousand for the Mau zone and $674 thousand for the Ho'omalu
zone. Total costs for 2003 were estimated at $974 thousand for the nine
NWHI fishermen. The first alternative (Status Quo/No Action
Alternative) would result in a 28 percent reduction in pounds landed
for bottomfish/pelagic trolling catch, and 13 percent reduction for
pelagic species compared to pre-EO levels based on full implementation
of the EO. The second alternative would result in a 28 percent
reduction in pounds landed for bottomfish/ pelagic trolling catch, and
13 percent reduction in the pelagic catch associated with
bottomfishing, as compared to pre-EO levels. The third alternative
would result in a 0 percent reduction in pounds landed. The fourth
alternative would reduce commercial bottomfish catch by 24 percent and
pelagic landings by 13 percent. The fifth alternative would reduce
bottomfish catch by 62 percent and pelagic catch by 10 percent due to
the phase-out of bottomfishing for the Ho'omalu zone. The sixth
alternative contemplates the complete phase-out of this industry within
one year and would impact the industry by 100 percent. The seventh
alternative would close the entire region to extractive use and would
impact the industry by 100 percent.
Risks:
The establishment of the NWHI as a national marine sanctuary would
protect one of the world's most productive and biologically rich
ecosystems on Earth. The NWHI are among the few, large-scale, intact,
predator-dominated coral reef ecosystems left in the world. Significant
Native Hawaiian cultural and maritime historical resources are found
throughout the region. These vast and remote coral reef ecosystems
support a distinctive assemblage of marine mammals, fish, sea turtles,
birds, and invertebrate, including species that are endemic, rare,
threatened, or endangered. Federally protected species include the
endangered Hawaiian monk seal. Roughly one-quarter of the 7,000 species
found in the NWHI are believed to be endemic to the Hawaiian Island
chain, found nowhere else on Earth.
Almost all of the alternatives would continue to allow some level of
human activity in the area, including fishing. Research, monitoring and
education activities would also be allowed pursuant to a permit system.
There would, therefore, be risks to human safety associated with
fishing and other vessels operating in remote areas of the Hawaiian
Islands. At times, vessels could be exposed to potentially serious
weather and sea conditions that could result in loss of life or injury
as well as loss of property. In addition, risks to the environment
could result from vessel groundings, lost fishing gear and other
equipment, fuel spills, unauthorized discharges including sewage, etc.
Depending on location, any of these incidents could harm or destroy
fragile coral reefs or marine life.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, Local, State
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Ted Beuttler
Department of Commerce
National Oceanic and Atmospheric Administration
SSMC4
Room 6111
East-West Highway
Silver Spring, MD 20910
Phone: 301 713-2967
Email: ted.beuttler@noaa.gov
RIN: 0648-AS83
_______________________________________________________________________
DOC--NOAA
-----------
FINAL RULE STAGE
-----------
34. LISTING DETERMINATIONS FOR 27 EVOLUTIONARILY SIGNIFICANT UNITS
(ESUS) OF WEST COAST SALMON AND ONCORHYNCHUS MYKISS
Priority:
Other Significant
Legal Authority:
16 USC 1533
CFR Citation:
50 CFR 223; 50 CFR 224
Legal Deadline:
NPRM, Judicial, March 31, 2004.
NMFS has requested an extension to the court-ordered deadline, but no
decision has been made as of 4/23/2004.
Abstract:
NMFS has completed status reviews for 26 West Coast salmon and O.
mykiss (inclusive of anadromous steelhead and co-occurring resident
rainbow trout) Evolutionarily Significant Units (ESUs) previously
listed as threatened and endangered species under the ESA, as well as
one ESU that was designated as a candidate species. Following a
September 2001 U.S. District Court ruling that rejected how NMFS treats
hatchery populations in its listing determinations, the agency received
several petitions seeking to delist, or to redefine and list several
ESUs on the basis of the Court's ruling. In response to these petitions
NMFS initiated status
[[Page 72702]]
reviews for 16 ESUs, and elected to conduct status reviews for an
additional 11 ESUs. Based on these reviews, NMFS is taking this action
to list ESUs as endangered or threatened, and also to delist ESUs as
necessary.
Statement of Need:
In September 2001, the U.S. District Court in Eugene, Oregon, in Alsea
Valley Alliance v. Evans (161 F. Supp. 2d 1154, D. Oreg. 2001; Alsea
decision), set aside NMFS' 1998 ESA listing of Oregon Coast coho salmon
(63 FR 42587; 08/10/1998). The Court ruled that the ESA does not allow
NMFS to list a subset of an ESU, and that NMFS had improperly excluded
stocks from the listing once it had decided that certain hatchery
stocks were part of the ESU. Although the Court's ruling affected only
one ESU, the interpretive issue raised by the ruling called into
question nearly all of NMFS' Pacific salmonid listing determinations.
The Court struck down the 1998 final rule listing Oregon coast coho as
a threatened species, thus removing the ESU from the protections of the
ESA. The Court remanded the case to NMFS for reconsideration consistent
with the Alsea decision. NMFS did not contest the Court's ruling and
informed the Court it would comply. In November 2001, intervenors
appealed the Court's ruling to the U.S. Ninth Circuit Court of Appeals.
Pending resolution of the appeal, the Ninth Circuit stayed the District
Court's remand order and invalidation of the 1998 listing. While the
stay was in place, the Oregon Coast coho ESU was again afforded the
protections of the ESA (Alsea Valley Alliance v. Evans, 9th Circuit
appeal, No. 01-36071, December 14, 2001). On February 24, 2004, the
Appeals Court dismissed the appeal, and dissolved its stay of the
District Courts' ruling in Alsea.
Following the District Court's ruling in the Alsea case, NMFS received
several petitions (summarized below) addressing 17 listed salmonid
ESUs, including five steelhead ESUs. These petitions cited the Alsea
ruling and focused on NMFS' past practice of excluding certain ESU
hatchery stocks from listing protection. Various litigants have also
challenged the failure to list resident populations included in
threatened and endangered steelhead ESUs. The anadromous form of O.
mykiss is presently under NMFS' jurisdiction, while the resident
freshwater forms, usually called ``rainbow'' or ``redband'' trout, are
under FWS jurisdiction. In Environmental Defense Center et al. v. Evans
et al. (EDC v. Evans, SACV-00-1212-AHS (EEA)), the plaintiffs argue
that NMFS failed to include resident populations in the endangered
listing of the Southern California steelhead ESU (62 FR 43937; August
18, 1997). In Modesto Irrigation District et al. v. Evans et al. (MID
v. Evans, CIV-F-02-6553 OWW DLB (E.D.Cal)), the plaintiffs seek to
invalidate NMFS' 1997 threatened listing of the Central Valley
California steelhead ESU (63 FR 13347; March 19, 1998) for failing to
list hatchery and resident populations identified as part of the ESU.
This same factual situation is found in all listed steelhead ESUs; the
listings do not include hatchery and/or resident populations considered
to be part of the ESUs. For the proposed listing determinations
detailed in this rule to be compliant with the Court's ruling in the
Alsea case, all populations or stocks (natural, hatchery, resident,
etc.) included in an ESU must be listed if it is determined that the
ESU is threatened or endangered under the ESA.
Although the ESA section 4(d) regulations for threatened salmonids have
proven effective at appropriately protecting threatened salmonid ESUs
and permitting certain activities, several of the limits described
therein are redundant, outdated, or are located disjunctly in the Code
of Federal Regulations (CFR). The resulting complexity of the existing
4(d) regulations unnecessarily increases the administrative and
regulatory burden of managing protective regulations for threatened
ESUs, and does not effectively convey to the public the specific ESUs
for which certain activities may be exempted from the take prohibitions
under 4(d). As part of this proposed rulemaking, NMFS proposes to
clarify the existing section 4(d) regulations for threatened salmonids
so that they can be more efficiently and effectively accessed and
interpreted by all affected parties.
Summary of Legal Basis:
Following the ruling in the Alsea case, NMFS received several petitions
seeking to delist, or to redefine and list, ESUs of Pacific salmon and
steelhead. The petitioners made reference to the Alsea decision in
arguing for NMFS to reconsider the listing status for certain ESUs.
Between September 2001 and April 2002, NMFS received eight separate
petitions addressing a total of 17 listed salmon and steelhead ESUs.
The ESA requires that, as a consequence of accepting the above
petitions, NMFS promptly commence a review of the species' status and
make a finding within 12 months after receiving the petition, whether
the petitioned action is warranted (ESA section 4(b)(3)). There are 16
ESUs for which NMFS has statutory deadlines for the completion of ESA
status reviews and listing determinations: seven chinook ESUs (the
Upper Willamette River, Lower Columbia River, Upper Columbia River
spring-run, Puget Sound, Snake River fall-run, and Snake River spring/
summer-run chinook ESUs); three coho ESUs (the Central California
Coast, Southern Oregon/Northern California Coast, and Oregon Coast coho
ESUs); two chum ESUs (the Columbia River and Hood Canal summer-run chum
salmon ESUs); and five steelhead ESUs (the Upper Willamette River,
Lower Columbia River, Middle Columbia River, Upper Columbia River, and
Snake River Basin steelhead ESUs).
Alternatives:
NMFS is required to use the best available scientific and commercial
information in making its listing determinations under the ESA. Listing
determinations are not subject to National Environmental Policy Act
analysis, and they are exempt from economic considerations. This rule
would clarify the existing section 4(d) regulations, and thus, NMFS is
not evaluating new alternatives.
Anticipated Cost and Benefits:
This action would largely preserve the existing regulatory regime.
Currently, hatchery fish are not listed, so their take is not
prohibited. The provisions in this action would allow hatchery fish to
continue to be available for harvest by not prohibiting their take.
Currently, for the two species listed as endangered, all take is
prohibited by section 9(a) of the ESA. The provisions in this action
would maintain take prohibitions but with the greater flexibility
allowed by a section 4(d) rule. Currently, the species listed as
threatened are covered under a mix of 4(d) rules with varying degrees
of flexibility. This rule would consolidate all of the species under
one rule and apply the set of prohibitions and exceptions NMFS has
found most flexible. For one species, Columbia River Coho, this rule
would impose take prohibitions where none previously existed. NMFS has
concluded that this revision will not have significant impacts on small
entities. Since take of hatchery fish will not be prohibited, fisheries
will be largely unaffected. Landowners will not
[[Page 72703]]
be affected because the range of the newly listed coho ESU overlaps
that of already-listed species whose take is already prohibited.
Risks:
NMFS' Pacific Salmonid Biological Review Team (BRT) (an expert panel of
scientists from several federal agencies including NMFS, FWS, and the
U.S. Geological Survey) reviewed the viability and extinction risk of
naturally spawning populations in the 27 ESUs that are the subject of
this proposed rule (NMFS, 2003b). The BRT evaluated the risk of
extinction based on the performance of the naturally spawning
populations in each of the ESUs under the assumption that present
conditions will continue into the future. The BRT did not explicitly
consider artificial propagation in its evaluations. The BRT assessed
ESU-level extinction risk (as indicated by the viability of the
naturally spawning populations) at two levels: first, at the simpler
population level; then, at the overall ESU level. The BRT used criteria
for `Viable Salmonid Populations' (VSP; McElhany et al., 2000) to guide
its risk assessments. The VSP criteria were developed to provide a
consistent and logical reference for making viability determinations
and are based on are view and synthesis of the conservation biology and
salmon literature. Individual populations were evaluated according to
the four VSP criteria: Abundance, growth rate/productivity, spatial
structure, and diversity. These four parameters are universal
indicators of species viability, and individually and collectively
function as reasonable predictors of extinction risk. After reviewing
all relevant biological information for the populations in a particular
ESU, the BRT ascribed an ESU-level risk score for each of the four VSP
criteria.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 33102 06/14/04
NPRM Comment Period End 09/13/04
NPRM 69 FR 53031 08/31/04
NPRM Comment Period Extended to 10/20/04
Final Action 06/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State, Tribal
Agency Contact:
Laurie K. Allen
Acting Director
Department of Commerce
National Oceanic and Atmospheric Administration
Office of Protected Resources
1315 East-West Highway
Silver Spring, MD 20912
Phone: 301 713-2332
RIN: 0648-AR93
BILLING CODE 3510-BW-S
[[Page 72704]]
DEPARTMENT OF DEFENSE (DOD)
Statement of Regulatory Priorities
Background
The Department of Defense (DoD) is the largest Federal department
consisting of 3 military departments (Army, Navy, and Air Force), 9
unified combatant commands, 16 Defense agencies, and 11 DoD field
activities. It has over 1,400,000 military personnel and 675,000
civilians assigned as of July 31, 2004, and over 200 large and medium
installations in the continental United States, U. S. territories, and
foreign countries. The overall size, composition, and dispersion of the
Department of Defense, coupled with an innovative regulatory program,
presents a challenge to the management of the Defense regulatory
efforts under Executive Order 12866 ``Regulatory Planning and Review''
of September 30, 1993.
Because of its diversified nature, DoD is affected by the regulations
issued by regulatory agencies such as the Departments of Energy, Health
and Human Services, Housing and Urban Development, Labor,
Transportation, and the Environmental Protection Agency. In order to
develop the best possible regulations that embody the principles and
objectives embedded in Executive Order 12866, there must be
coordination of proposed regulations among the regulating agencies and
the affected Defense components. Coordinating the proposed regulations
in advance throughout an organization as large as DoD is
straightforward, yet a formidable undertaking.
DoD is not a regulatory agency but occasionally issues regulations
that have an impact on the public. These regulations, while small in
number compared to the regulating agencies, can be significant as
defined in Executive Order 12866. In addition, some of DoD's
regulations may affect the regulatory agencies. DoD, as an integral
part of its program, not only receives coordinating actions from the
regulating agencies, but coordinates with the agencies that are
impacted by its regulations as well.
The regulatory program within DoD fully incorporates the provisions of
the President's priorities and objectives under Executive Order 12866.
Promulgating and implementing the regulatory program throughout DoD
presents a unique challenge to the management of our regulatory
efforts.
Coordination
Interagency
DoD annually receives regulatory plans from those agencies that impact
the operation of the Department through the issuance of regulations. A
system for coordinating the review process is in place, regulations are
reviewed, and comments are forwarded to the Office of Management and
Budget. The system is working in the Department, and the feedback from
the Defense components is most encouraging, since they are able to see
and comment on regulations from the other agencies before they are
required to comply with them. The coordination process in DoD continues
to work as outlined in Executive Order 12866.
Internal
Through regulatory program points of contact in the Department, we
have established a system that provides information from the
Administrator of the Office of Information and Regulatory Affairs
(OIRA) to the personnel responsible for the development and
implementation of DoD regulations. Conversely, the system can provide
feedback from DoD regulatory personnel to the Administrator, OIRA. DoD
continues to refine its internal procedures, and this ongoing effort to
improve coordination and communication practices is well received and
supported within the Department.
Overall Priorities
The Department of Defense needs to function at a reasonable cost,
while ensuring that it does not impose ineffective and unnecessarily
burdensome regulations on the public. The rulemaking process should be
responsive, efficient, cost-effective, and both fair and perceived as
fair. This is being done in the Department while it must react to the
contradictory pressures of providing more services with fewer
resources. The Department of Defense, as a matter of overall priority
for its regulatory program, adheres to the general principles set forth
in Executive Order 12866 as amplified below.
Problem Identification
Congress typically passes legislation to authorize or require an
agency to issue regulations and often is quite specific about the
problem identified for correction. Therefore, DoD does not generally
initiate regulations as a part of its mission.
Conflicting Regulations
Since DoD seldom issues significant regulations, the probability of
developing conflicting regulations is low. Conversely, DoD is affected
to a great degree by the regulating agencies. From that perspective,
DoD is in a position to advise the regulatory agencies of conflicts
that appear to exist using the coordination processes that exist in the
DoD and other Federal agency regulatory programs. It is a priority in
the Department to communicate with other agencies and the affected
public to identify and proactively pursue regulatory problems that
occur as a result of conflicting regulations both within and outside
the Department.
Alternatives
DoD will identify feasible alternatives that will obtain the desired
regulatory objectives. Where possible, the Department encourages the
use of incentives to include financial, quality of life, and others to
achieve the desired regulatory results.
Risk Assessment
Assessing and managing risk is a high priority in the DoD regulatory
program. The Department is committed to risk prioritization and an
``anticipatory'' approach to regulatory planning, which focuses
attention on the identification of future risk. Predicting future
regulatory risk is exceedingly difficult due to rapid introduction of
new technologies, side effects of Government intervention, and changing
societal concerns. These difficulties can be mitigated to a manageable
degree through the incorporation of risk prioritization and
anticipatory regulatory planning into DoD's decisionmaking process,
which results in an improved regulatory process and increases the
customer's understanding of risk.
Cost-Effectiveness
One of the highest priority objectives of DoD is to obtain the desired
regulatory objective by the most cost-effective method available. This
may or may not be through the regulatory process. When a regulation is
required, DoD considers incentives for innovation to achieve desired
results, consistency in the application of the regulation,
predictability of the activity outcome (achieving the expected
results), and the costs for regulation development, enforcement, and
compliance. These will include costs to the public, Government, and
regulated entities, using the best available data or parametric
analysis methods, in the cost-benefit analysis and the decisionmaking
process.
[[Page 72705]]
Cost-Benefit
Conducting cost-benefit analyses on regulation alternatives is a
priority in the Department of Defense so as to ensure that the
potential benefits to society outweigh the costs. Evaluations of these
alternatives are done quantitatively or qualitatively or both,
depending on the nature of the problem being solved and the type of
information and data available on the subject. DoD is committed to
considering the most important alternative approaches to the problem
being solved and providing the reasoning for selecting the proposed
regulatory change over the other alternatives.
Information-Based Decisions
The Defense Department uses the latest technology to provide access to
the most current technical, scientific, and demographic information in
a timely manner through the worldwide communications capabilities that
are available on the Internet. Realizing that increased public
participation in the rulemaking process improves the quality and
acceptability of regulations, DoD is committed to exploring the use of
information technology (IT) in rule development and implementation. IT
provides the public with easier and more meaningful access to the
processing of regulations. Furthermore, the Department endeavors to
increase the use of automation in the Notice and Comment rulemaking
process in an effort to reduce time pressures and increase public
access in the regulatory process. Notable progress has been made in the
Defense acquisition regulations area toward achieving the
Administration's E-government initiative of making it simpler for
citizens to receive high-quality service from the Federal Government,
inform citizens, and allow access to the development of rules.
Performance-Based Regulations
Where appropriate, DoD is incorporating performance-based standards
that allow the regulated parties to achieve the regulatory objective in
the most cost-effective manner.
Outreach Initiatives
DoD endeavors to obtain the views of appropriate State, local, and
tribal officials and the public in implementing measures to enhance
public awareness and participation both in developing and implementing
regulatory efforts. Historically, this has included such activities as
receiving comments from the public, holding hearings, and conducting
focus groups. This reaching out to organizations and individuals that
are affected by or involved in a particular regulatory action remains a
significant regulatory priority of the Department and, we feel, results
in much better regulations.
The Department is actively engaged in addressing the requirements of
the Government Paperwork Elimination Act (GPEA) in implementing
electronic government and in achieving IT accessibility for individuals
with disabilities. This is consistent with the Administration's
strategy of advancing E-government as expressed in ``The President's
Management Agenda.'' The Department is actively participating in the
eRulemaking Initiative to develop a Governmentwide docket management
system that will provide the framework for wider citizen input and
improve regulatory policies and outcomes by cultivating public
participation in Federal decisionmaking.
Coordination
DoD has enthusiastically embraced the coordination process between and
among other Federal agencies in the development of new and revised
regulations. Annually, DoD receives regulatory plans from key
regulatory agencies and has established a systematic approach to
providing the plans to the appropriate policy officials within the
Department. Feedback from the DoD components indicates that this
communication among the Federal agencies is a major step forward in
improving regulations and the regulatory process, as well as in
improving Government operations.
Minimize Burden
In the regulatory process, there are more complaints concerning burden
than anything else. In DoD, much of the burden is in the acquisition
area. Over the years, acquisition regulations have grown and become
burdensome principally because of legislative action. But, in
coordination with Congress, the Office of Federal Procurement Policy,
and the public, DoD is initiating significant reforms in acquisition so
as to effect major reductions in the regulatory burden on personnel in
Government and the private sector. DoD has implemented a multi-year
strategy for reducing the paperwork burden imposed on the public. This
plan shows that DoD has met and will exceed the goals set forth in the
Paperwork Reduction Act. It is the goal of the Department of Defense to
impose upon the public the smallest burden viable, as infrequently as
possible, and for no longer than absolutely necessary.
Plain Language
Ensuring that regulations are simple and easy to understand is a high
regulatory priority in the Department of Defense. All too often, the
regulations are complicated, difficult to understand, and subject to
misinterpretation, all of which can result in the costly process of
litigation. The objective in the development of regulations is to write
them in clear, concise language that is simple and easy to understand.
DoD recognizes that it has a responsibility for drafting clearly
written rules that are reader-oriented and easily understood. Rules
will be written for the customer using natural expressions and simple
words. Stilted jargon and complex construction will be avoided. Clearly
written rules will tell our customers what to do and how to do it. DoD
is committed to a more customer-oriented approach and uses plain
language rules thereby improving compliance and reducing litigation.
In summary, the rulemaking process in DoD should produce a rule that:
Addresses an identifiable problem, implements the law, incorporates the
President's policies defined in Executive Order 12866, is in the public
interest, is consistent with other rules and policies, is based on the
best information available, is rationally justified, is cost-effective,
can actually be implemented, is acceptable and enforceable, is easily
understood, and stays in effect only as long as is necessary. Moreover,
the proposed rule or the elimination of a rule should simply make
sense.
Regulations Related to the Events of September 11, 2001
Defense Federal Acquisition Regulation Supplement (DFARS) Case 2003-
D107, Firefighting Service Contracts, implements section 331 of the
National Defense Authorization Act for Fiscal Year 2004. Section 331
provides authority for contractor performance of firefighting functions
at military installations or facilities for periods of one year or
less, if the functions would otherwise have to be performed by members
of the Armed Forces who are not readily available by reason of a
deployment. The interim rule was published in the Federal Register on
June 25, 2004 (69 FR 35532).
Federal Acquisition Regulation (FAR) Case 2003-022, Special Emergency
Procurement Authority, implements section 1443 of the Fiscal Year 2004
[[Page 72706]]
Consolidated Appropriations Act. Section 1443 provides continuing
authorities for acquisitions of property and services by or for an
executive agency that are to be used in support of a contingency
operation or to facilitate defense against or recovery from terrorism
or nuclear, biological, chemical, or radiological attack. The interim
rule was published in the Federal Registeron February 23, 2004 (69 FR
8312).
Suggestions From the Public for Reform--Status of DoD Items
The Army Corps of Engineers has not undertaken any rulemaking actions
in response to the public nominations submitted to the Office of
Management and Budget in 2001 or 2002. Those nominations were discussed
in ``Making Sense of Regulation: 2001 Report to Congress on the Costs
and Benefits of Regulations and Unfunded Mandates on State, Local, and
Tribal Entities'' and ``Stimulating Smarter Regulation: 2002 Report to
Congress on the Costs and Benefits of Regulations and Unfunded Mandates
on State, Local, and Tribal Entities.''
When the Army Corps of Engineers reissued the nationwide permits on
January 15, 2002 (67 FR 2020), several changes were made to clarify and
simplify the nationwide permit program. These changes increased
flexibility in decisionmaking, while enhancing protection of the
aquatic environment.
The changes to the regulatory definitions of ``fill material'' and
``discharge of fill material'' that were published in the May 9, 2002,
Federal Register resulted from the public notice and comment process
required by the Administrative Procedures Act. The revised definitions
provide consistency between Army Corps of Engineers and U.S.
Environmental Protection Agency (EPA) regulations governing discharges
of fill material into waters of the United States and do not warrant
the preparation of an Environmental Impact Statement.
In the January 15, 2003, issue of the Federal Register (68 FR 1991),
the Army Corps of Engineers and EPA issued an Advance Notice of
Proposed Rulemaking (ANPRM) to obtain early comment on issues related
to the scope of waters subject to Clean Water Act jurisdiction in light
of the Solid Waste Agency of Northern Cook County v. Army Corps of
Engineers decision by the U.S. Supreme Court (531 U.S. 159 (2001)). In
Appendix A of this ANPRM, there is a joint memorandum issued by the
Corps and EPA that provides clarifying guidance regarding the U.S.
Supreme Court's decision in this case. This joint memorandum supercedes
the January 19, 2001, guidance document and addresses several legal
issues concerning Clean Water Act jurisdiction that have arisen since
this decision. In response to the ANPRM, approximately 150,000 comments
were received. On December 16, 2003, the Corps and EPA announced that a
new rule on Clean Water Act regulatory jurisdiction over isolated
waters would not be issued.
The Army Corps of Engineers is continuing its efforts to update and
clarify the 1987 ``Corps of Engineers Wetlands Delineation Manual''
(1987 Manual). This effort may also include the development of regional
wetland delineation manuals. Any proposed changes to the 1987 Manual,
or the issuance of regional wetland delineation manuals, will be
subject to the public notice and comment procedures required by the
Administrative Procedures Act.
Specific Priorities
For this regulatory plan, there are four specific DoD priorities, all
of which reflect the established regulatory principles. In those areas
where rulemaking or participation in the regulatory process is
required, DoD has studied and developed policy and regulations that
incorporate the provisions of the President's priorities and objectives
under the Executive order.
DoD has focused its regulatory resources on the most serious
environmental, health, and safety risks. Perhaps most significant is
that each of the priorities described below promulgates regulations to
offset the resource impacts of Federal decisions on the public or to
improve the quality of public life, such as those regulations
concerning civil functions of the U.S. Army Corps of Engineers,
acquisition, installations and the environment, and the Defense
personnel system.
U.S. Army Corps of Engineers, Directorate of Civil Works
Compensatory Mitigation in the Army Regulatory Program
Section 314 of the National Defense Authorization Act for Fiscal Year
2004 (Pub. L. 108-136) requires the Secretary of the Army, acting
through the Chief of Engineers, to issue regulations that establish
performance standards and criteria for the use of compensatory
mitigation for wetland functions lost as a result of activities
authorized by Department of the Army (DA) permits. The statute also
requires the regulation to contain provisions for the application of
equivalent standards and criteria to each type of compensatory
mitigation. The statutory deadline for publishing the final regulation
is November 24, 2005.
The proposed regulation will be developed by considering concepts in
current Federal compensatory mitigation guidance documents and updating
and modifying those concepts to improve compensatory mitigation
decisionmaking and processes. We believe that the proposed regulation
should take a watershed approach to compensatory mitigation for
permitted impacts to wetlands, streams, and other aquatic resources.
Although the statute refers only to wetlands, we believe that the
regulation should be broader in scope and address compensatory
mitigation requirements for impacts to other aquatic resources, such as
streams, in addition to wetlands.
Army Regulatory Program's Compliance With the National Historic
Preservation Act
In 1990, the Army Corps of Engineers published as appendix Cof 33 CFR
part 325, a rule that governs compliance with the National Historic
Preservation Act (NHPA) for the Army's Regulatory Program. Over the
years, there have been substantial changes in policy, and the NHPA was
amended in 1992, leading to the publication in December 2000 of new
implementing regulations at 36 CFR part 800, issued by the Advisory
Council on Historic Preservation. Those regulations were amended on
July 6, 2004. The Advisory Council on Historic Preservation's
regulations allow Federal agencies to utilize alternate procedures in
lieu of the regulations at 36 CFR part 800. To solicit public comment
on the appropriate mechanism for revising the Army Regulatory Program's
process for considering effects to historic properties resulting from
activities authorized by DA permits, the Army Corps of Engineers
published an Advance Notice of Proposed Rulemaking to obtain the views
of interested parties. After reviewing the comments received in
response to the ANPRM, the Army Corps of Engineers may develop and
propose, in fiscal year 2005, agency alternate procedures to comply
with the requirements of section 106 of the National Historic
Preservation Act.
Defense Procurement and Acquisition
The Department continues its efforts to reengineer its acquisition
system to
[[Page 72707]]
achieve its vision of an acquisition system that is recognized as being
the smartest, most efficient, most responsive buyer of best value goods
and services, which meet the warfighter's needs from a globally
competitive base. To achieve this vision, the Department will focus in
the acquisition regulations during this next year on implementing and
institutionalizing initiatives that may include additional changes to
existing and recently modified regulations to ensure that we are
achieving the outcomes we desire (continuous process improvement).
The Department of Defense continuously reviews its supplement to the
Federal Acquisition Regulation (FAR) and continues to lead Government
efforts to simplify the following acquisition processes:
Transform the Defense Federal Acquisition Regulation
Supplement(DFARS) to improve the efficiency and
effectiveness of the acquisition process, while allowing
the acquisition workforce flexibility to innovate. The
transformed DFARS will contain only requirements of law,
DoD-wide policies, delegations of FAR authorities,
deviations from FAR requirements, and policies/procedures
that have a significant effect beyond the internal
operating procedures of DoD or a significant cost or
administrative impact on contractors or offerors.
Provide uniform treatment of contractor personnel whoprovide
support in theater to a force deployed outside the United
States in contingency operations, humanitarian or
peacekeeping operations, and other major military
operations or training exercises designated by the
Combatant Commander.
Implement new Free Trade Agreements and revise the FARand
DFARS subparts on trade agreements, to make terminology
consistent with our international agreements.
Finalize the rewrite of FAR part 27, Patents, Data
andCopyrights, to clarify, streamline, and update guidance
and clauses on patents, data, and copyrights.
Provide guidance on acceptability of photocopies of powersof
attorney for bid bonds and allow treatment of questions
regarding the authenticity and enforceability of the power
of attorney at the time of bid opening as a matter of
responsibility.
Review various FAR cost principles to determine whethercertain
FAR cost principles are still relevant in today's business
environment, whether they place an unnecessary
administrative burden on contractors and the Government,
and whether they can be streamlined or simplified.
Revise policy on the applicability of cost
accountingstandards. The goal of this initiative is to
modify and streamline the applicability of Federal cost
accounting standards.
Phase in requirements for contractors to affix radio
frequencyidentification (RFID) tags to items delivered
under DoD contracts. This practice will improve visibility
of DoD assets in the supply chain, increase the accuracy of
shipment and receipt data, and reduce the amount of time it
takes to deliver material to the warfighter.
Consider FAR and DFARS changes to facilitate timely
contractcloseout.
Implement Earned Value Management in the FAR.
Revise the FAR part 45, Government Property, to organizeand
streamline the management of Government property.
Defense Installations and the Environment
The Department is committed to reducing the total ownership costs of
the military infrastructure while providing the Nation with military
installations that efficiently support the warfighter in: Achieving
military dominance, ensuring superior living and working conditions,
and enhancing the safety of the force and the quality of the
environment. DoD has focused its regulatory priorities on explosives
safety, human health, and the environment. These regulations provide
means for the Department to provide information about restoration
activities at Federal facilities and to take public advice on the
restoration activities.
Restoration Advisory Boards
The requirement for the establishment of Restoration Advisory Boards
(RABs) is grounded in section 324(a) of Public Law 104-106, which
requires the Secretary of Defense to ``prescribe regulations regarding
the establishment, characteristics, composition, and funding of
restoration advisory boards.'' Section 324(a) also stated that DoD's
issuance of regulations shall not be a precondition to the
establishment of RABs (amended section 2705(d)(2)(B)). In August 1996,
the Department proposed and requested public comments on regulations
regarding the characteristics, composition, funding, and establishment
of RABs. These regulations were not finalized.
As a consequence of litigation in 2001, the Department substantially
revised the regulations and shared a draft of the RAB Rule with RAB
community members as part of the Department's outreach to affected
members of the public. On March 26, 2003, OMB reviewed the Draft
Proposed RAB Rule and agreed that it is not a ``significant regulatory
action'' under Executive Order 12866. DoD has incorporated all
appropriate community members' comments and provided a revised Draft
Proposed RAB Rule to OMB for interagency review prior to publication in
the Federal Register.
Because the applicability of the Federal Advisory Committee Act (FACA)
to RABs was unclear, DoD sought a statutory clarification. Section 317
of the fiscal year 2004 National Defense Authorization Act provides
that FACA does not apply to RABs. The revised Draft Proposed RAB Rule
reflects this clarification.
Munitions Response Site Prioritization Protocol
Section 2710(b)(1) of title 10, United States Code, directs the
Secretary of Defense to develop, in consultation with representatives
of the States and Indian tribes, a proposed protocol for assigning to
each defense site a relative priority for munitions response
activities. Section 2710 provides for public notice and comment on the
proposed protocol and requires that the proposed protocol be available
for public comment on or before November 30, 2002. DoD is directed to
issue a final protocol to be applied to defense sites listed in the
Department's munitions response site inventory.
The Department met with State and tribal representatives and also
representatives of other Federal agencies during preparation of the
proposed rule published on August 22, 2003. The Department reviewed and
incorporated comments from the 16 sets of comments received during the
public comment period, which ended on November 19, 2003. The draft
final rule is under review within the Department, which plans to
publish the final rule in fiscal year 2005.
Most of the changes pertain to clarification of terms and definitions
based on comments received or new statutory definitions promulgated in
the National Defense Authorization Act for Fiscal Year 2004 and
codified at 10 U.S.C. section 101. The most significant change to the
proposed rule pertains to
[[Page 72708]]
the module that evaluates health hazards associated with munitions
constituents and other chemical constituents. The Department also
revised the rule to clarify that current landowners may participate in
the application of the rule at Formerly Used Defense Sites and that the
quality assurance panel that reviews each priority score will consist
only of Department personnel.
National Security Personnel System
The National Defense Authorization Act for Fiscal Year 2004 (Pub. L.
108-136, November 24, 2003) provided the Department of Defense (DoD)
the authority to establish a more flexible civilian personnel
management system. The National Security Personnel System (NSPS) will
allow the Department to be a more competitive and progressive employer
at a time when the country's national security demands a highly
responsive system of civilian personnel management.
NSPS will establish new rules for how DoD civilians are hired,
assigned, compensated, promoted, and disciplined. NSPS will also
address the Department's labor relations and appeals processes. This
will all be within the framework of merit principles, veterans'
preference, and employees' rights to organize and bargain collectively.
The goal of NSPS is to strengthen DoD's ability to accomplish its
mission in an ever-changing defense environment.
In April 2004, the Department established a DoD Program Executive
Office, National Security Personnel System (PEO-NSPS) to manage,
oversee, and coordinate the development, design, and implementation of
NSPS throughout the Department. This includes drafting (with OPM)
regulations establishing NSPS.
Human Resources Management System
Section 9902(a) of Public Law 108-136 authorizes the Secretary of
Defense and the Director of the Office of Personnel Management (OPM) to
issue jointly prescribed regulations to establish a human resources
management system for the Department of Defense. These regulations will
provide for new rules and flexibilities in the areas of:
Position classification and pay
Performance management (including a pay for performancesystem,
as required in section 9902(b)(6)(I) of Public Law 108-136)
Hiring, assignment, and reduction in force
Labor Management Relations System
Section 9902(m) of Public Law 108-136 authorizes the Secretary of
Defense and the Director, OPM, to establish a new labor management
relations system for the Department and to allow for a collaborative,
issue-based approach to labor management relations. Regulations
developed jointly with OPM will provide a new framework for labor
relations in DoD, with the goal of streamlined processes to allow for
quicker and more efficient resolution of labor relations issues, while
preserving collective bargaining rights for DoD employees.
Employee Appeals
Section 9902(h) of Public Law 108-136 provide the Secretary of Defense
with authority to establish an appeals process in conjunction with NSPS
to provide employees fair treatment in decisions relating to their
employment. The new appeals will be designed to streamline appeals
procedures while ensuring that employees are afforded the protections
of due process, as required by law.
NSPS Design Process and Timeline
The design of NSPS (which will result in regulations to be issued in
the Federal Register) includes an extensive outreach effort to gather
input and feedback from a variety of stakeholder groups, including DoD
labor unions, employees, supervisors, managers, military commanders,
and external groups such as veteran service organizations, (non-union)
employee interest groups, and ``good-government'' groups. DoD working
groups, comprised of DoD and OPM human resources experts, line
managers, and system practitioners (e.g., legal, EEO) met in the late
summer 2004 to identify and craft NSPS design options. In addition, DoD
and OPM have met several times with DoD labor union representatives to
gather input and discuss potential system designs.
Once NSPS design options are decided upon by DoD and OPM senior
leadership, proposed regulations establishing and governing NSPS will
be published via the Federal Register for public comment. The
Department plans to issue proposed NSPS regulations in December 2004,
Statutory procedures for collaborating with employee representatives on
the content of the regulations are provided in sections 9902(f) and
9902(m)(3).
BILLING CODE 5001-06-S
[[Page 72709]]
DEPARTMENT OF EDUCATION (ED)
Statement of Regulatory and Deregulatory Priorities
General
We support States, local communities, institutions of higher
education, and others to improve education nationwide. Our roles
include providing leadership and financial assistance for education to
agencies, institutions, and individuals in situations in which there is
a national interest; monitoring and enforcing Federal civil rights laws
in programs and activities that receive Federal financial assistance;
and supporting research, evaluation, and dissemination of findings to
improve the quality of education.
The 4,300 employees of our Department help to realize the educational
promise of America. We administer programs, grants, and loans that
touch nearly every American at one point in their lives--approximately
14,000 public school districts, nearly 54 million students attending
93,000 elementary and secondary schools, and almost 22 million
postsecondary students.
To connect our customers to a ``one-stop-shopping'' center for
information about our programs and initiatives, we instituted 1-800-
USA-LEARN (1-800-872-5327). We also set up 1-800-4FED-AID (1-800-433-
3243) for information on student aid, and we provide an online library
of information on education legislation, research, statistics, and
promising programs at the following Internet address: http://www.ed.gov
More than 763,225 people take advantage of these resources every week.
In addition, our Office of Internal Communications established for the
summer a Visitors Center at our headquarters. From Memorial Day to
Labor Day, the center was staffed by employee volunteers who were
trained to engage the public and respond to their inquiries. Some 1,000
visitors stopped by to give their views on education, learn about the
No Child Left Behind Act and other Federal education legislation, and
find out about resources and materials that we offer. We gave young
children a special ``Visitors Center Activity Book,'' and talked with
adults about our online resources.
We have forged effective partnerships with customers and others to
develop policies, regulations, guidance, technical assistance, and
approaches to compliance. We have a record of successful communication
and shared policy development with affected persons and groups,
including parents, students, educators, representatives of State,
local, and tribal governments, neighborhood groups, schools, colleges,
special education and rehabilitation service providers, professional
associations, advocacy organizations, businesses, and labor
organizations.
In particular, we continue to seek greater and more useful customer
participation in our rulemaking activities through the use of
consensual rulemaking and new technology. If we determine that the
development of regulations is absolutely necessary, we seek customer
participation at all stages--in advance of formal rulemaking, during
rulemaking, and after rulemaking is completed in anticipation of
further improvements through statutory or regulatory changes. We have
expanded our outreach efforts through the use of satellite broadcasts,
electronic bulletin boards, and teleconferencing. For example, we
invite comments on all proposed regulations through the Internet.
We are continuing our efforts to streamline information collections,
reduce burden on information providers involved in our programs, and
make information maintained by us easily available to the public. To
the extent permitted by statute, we will revise regulations to
eliminate barriers that inhibit coordination across programs (such as
by creating common definitions). This should help reduce the frequency
of reports and eliminate unnecessary data requirements.
We currently have in place four Internet-based software applications:
e-Application, e-Reports, e-Reader, and e-Administration. These enable
applicants, grantees, and grant teams to file, review, and process
applications and performance reports and to make administrative changes
online. These applications were implemented in pilot phases between FY
2000 and 2003, and the program participation in these initiatives
continues to grow each year. In addition, we are participating in the
Governmentwide Grants.gov Find and Apply portal, which is a one-stop
shopping site allowing grant applicants to find and apply for funding
opportunities from agencies across the Federal government.
New Initiatives
We have recently implemented an Enterprise-Wide Risk Management
initiative. The goal of this initiative is to mitigate concentrations
of risk (including the risk of improper or erroneous payments) within
our portfolio of grants, loans, and other operations by focusing human,
financial, and technical resources to achieve targeted results. We have
begun to identify a number of entities that have concentrations of risk
(e.g., incomplete audits, qualified audit reports, and more that $1
million of funds at risk of reverting to Treasury), and we will be
taking positive steps to partner with these entities to mitigate the
risks.
We are also focusing on strategic management of human capital. Efforts
are being taken to reduce the number of vacancies and the time it takes
to fill those vacancies, clarify expectations of results, and enhance
the performance appraisal process to promote differentiating among
performance levels and to provide clear and effective feedback. We are
also focused on strengthening and developing leadership talent by
analyzing the critical skill needs of the organization, providing
training based on identified leadership competencies, and implementing
an executive leadership development program that will contribute to the
depth and breadth of leaders at the Department.
Among our other new undertakings, the Secretary announced the Teacher-
to-Teacher Initiative through which some of the Nation's best teachers
and educational experts will have the opportunity to share with their
colleagues classroom practices that have been successful in raising
student performance and closing the achievement gap. The initiative
includes ongoing workshops for teachers, teacher and principal
roundtables, a national teacher summit, a ``Toolkit for Teachers''
containing resource materials, a weekly e-mail update entitled
``Teacher E-Bytes,'' and ``American Stars of Teaching,'' which focuses
attention on effective teachers who are making a real difference in
their students' lives.
No Child Left Behind
The No Child Left Behind Act of 2001, which reauthorized the
Elementary and Secondary Education Act of 1965, increases
accountability for States, school districts, and schools; provides
greater choice for parents and students, particularly those attending
low-performing schools; provides more flexibility for States and local
educational agencies in the use of Federal education dollars; and
places a stronger emphasis on reading, especially for our youngest
children.
[[Page 72710]]
Each State, Puerto Rico, and the District of Columbia has submitted an
accountability plan, which the Department approved. Each submitting
jurisdiction has used its respective plan to hold schools and school
districts accountable in school years 2002-03 and 2003-04 for all their
students, including students in specific subgroups such as students
with disabilities and limited English proficient (LEP) students.
With respect to students with disabilities and LEP students, in
particular, the Department recently initiated regulatory actions to
address unique issues. We issued final regulations that permit a State
to (1) develop alternate achievement standards for students with the
most significant cognitive disabilities and (2) include those students'
proficient and advanced scores in adequate yearly progress (AYP)
determinations, subject to a cap of one percent. We also published
proposed regulations to permit a State to (1) exempt LEP students new
to schools in the United States from one administration of the State's
reading assessment and (2) include, for up to 2 years, former LEP
students in the LEP subgroup for making AYP determinations.
We shall continue to focus on helping States place a highly qualified
teacher in every classroom; identifying schools and districts in need
of improvement and making sure they are getting the assistance they
need to get back on track; expanding the opportunities for eligible
students to receive tutoring and other supplemental services; and
helping districts create capacity in order to make public school choice
available to all eligible students who wish to transfer schools.
We shall also begin to peer review the new State content and student
achievement standards and aligned assessment systems required by the No
Child Left Behind Act. These must be in place by the 2005-06 school
year.
Principles for Regulating
Our Principles for Regulating determine when and how we will regulate.
Through consistent application of the following principles, we have
eliminated unnecessary regulations and identified situations in which
major programs could be implemented without any regulations or with
only limited regulations.
We will regulate only if regulating improves the quality and equality
of services to our customers, learners of all ages. We will regulate
only if absolutely necessary and then in the most flexible, most
equitable, and least burdensome way possible.
Whether to regulate:
When essential to promote quality and equality of opportunity
in education.
When a demonstrated problem cannot be resolved without
regulation.
When necessary to provide legally binding interpretation to
resolve ambiguity.
Not if entities or situations to be regulated are so diverse
that a uniform approach does more harm than good.
How to regulate:
Regulate no more than necessary.
Minimize burden and promote multiple approaches to meeting
statutory requirements.
Encourage federally funded activities to be integrated with
State and local reform activities.
Ensure that benefits justify costs of regulation.
Establish performance objectives rather than specify
compliance behavior.
Encourage flexibility so institutional forces and incentives
achieve desired results.
Regulatory and Deregulatory Priorities for the Next Year
Reauthorization of the Individuals With Disabilities Education Act
(IDEA), parts C and D, and anticipated amendments to parts A and B,
will make changes considered to be necessary to improve the
implementation of the education of children with disabilities program
(including pre-school services) and the early intervention program for
infants and toddlers with disabilities under parts B and C and the
effectiveness of national discretionary grants, contracts, and
cooperative agreements in improving the education of children with
disabilities under part D. The Secretary solicited public comment on
the reauthorization of IDEA using the underlying framework of the
President's principles of education reform to ensure that no child is
left behind.
Reauthorization of the Higher Education Act of 1965 (HEA) will make
changes considered necessary to the grant, loan, and work assistance
programs authorized under title IV of the HEA in order to improve
educational quality, expand access, and ensure affordability in
postsecondary education. This reauthorization will seek to balance the
reduction of burdensome requirements, especially on students, with the
need to adequately safeguard taxpayers' funds. It would also make
changes considered necessary to improve the implementation of the
teacher quality enhancement programs under title II of the HEA, the
institutional assistance programs under titles III and V of the HEA,
the international and foreign language studies programs under title VI
of the HEA, and the graduate education and postsecondary education
improvement programs under title VII of the HEA.
_______________________________________________________________________
ED--Office of Special Education and Rehabilitative Services (OSERS)
-----------
PRERULE STAGE
-----------
35. REAUTHORIZATION OF THE INDIVIDUALS WITH DISABILITIES EDUCATION ACT
(SECTION 610 REVIEW)
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
20 USC 1400 to 1487
CFR Citation:
34 CFR ch III
Legal Deadline:
None
Abstract:
These regulations would implement changes made by the anticipated
reauthorization of the Individuals With Disabilities Education Act.
This action is a notice that, if regulations are necessary, ED would
review the regulations in 34 CFR chapter III under section 610 of the
Regulatory Flexibility Act (5 U.S.C. 610). The purpose of this review
would be to determine if these regulations should be continued without
change, or should be amended or rescinded, to minimize any significant
economic impact upon a substantial number of small entities. We would
request comments on the continued need for the regulations; the
complexity of the regulations; the extent to which they overlap,
duplicate, or conflict with other Federal, State, or local government
regulations; and the degree to which technology, economic
[[Page 72711]]
conditions, or other relevant factors have changed since the
regulations were promulgated.
Statement of Need:
These regulations may be necessary to implement new legislation. ED
would also complete its review of these regulations under section
610(c) of the Regulatory Flexibility Act. In developing any
regulations, the Department would seek to reduce regulatory burden and
increase flexibility to the maximum extent possible.
Summary of Legal Basis:
New legislation.
Alternatives:
In addition to implementing the anticipated reauthorization of the
Individuals With Disabilities Education Act, the purpose of this review
would be to determine whether there are appropriate alternatives.
Anticipated Cost and Benefits:
Existing regulatory provisions may be eliminated or improved as a
result of this review.
Risks:
These regulations would not address a risk to public health, safety, or
the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Notice 67 FR 1411 01/10/02
ANPRM 02/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Federalism:
Undetermined
URL For Public Comments:
www.regulations.gov
Agency Contact:
JoLeta Reynolds
Department of Education
Office of Special Education and Rehabilitative Services
Room 3082
Room 4150, PCP
400 Maryland Avenue SW
Washington, DC 20202-2570
Phone: 202 245-7494
RIN: 1820-AB54
BILLING CODE 4000-01-S
[[Page 72712]]
DEPARTMENT OF ENERGY (DOE)
Statement of Regulatory and Deregulatory Priorities
The Department makes vital contributions to the Nation's welfare
through its extraordinary scientific and technical capabilities in
energy research, environmental remediation, and national security. The
Department's mission is to:
Foster a secure and reliable energy system that is
environmentallyand economically sustainable;
Provide responsible stewardship of the Nation'snuclear
weapons;
Clean up the Department'sfacilities;
Lead in the physical sciences and advance the
biological,environmental and computational sciences; and,
Provide premiere instruments of science for the
Nation'sresearch enterprise.
The Department of Energy's regulatory plan reflects the Department's
continuing commitment to enhance safety, cut costs, reduce regulatory
burden, and increase responsiveness to the public. While not primarily
a major Federal regulatory agency, the Department's regulatory
activities are essential to achieving its critical mission and to
implementing major initiatives in the President's National Energy Plan.
Energy Efficiency Program for Consumer Products and Commercial
Equipment
The Department's priorities for its rulemaking activities related to
energy efficiency standards and determinations, which have been
established with significant input from the public, are reflected in
the rulemaking schedules set forth in The Regulatory Plan and the
Unified Agenda of Federal Regulatory and Deregulatory Actions.
During the coming year, the Department expects to revise the energy
efficiency standards for residential furnaces and boilers; electric
distribution transformers; and for commercial unitary air conditioners
and heat pumps. Additional information and timetables for these actions
can be found below. In addition, the Department will continue working
on the analyses required to revise the standards for packaged terminal
air conditioners and heat pumps, oil- and gas-fired commercial packaged
boilers, tankless gas-fired instantaneous water heaters, 3-phased air
conditioners and heat pumps, and single package vertical air
conditioners and heat pumps.
The Department plans to publish final rules concerning test procedures
for residential central air conditioners and heat pumps and electric
distribution transformers. Information and timetables concerning these
actions can be found in the Department's regulatory agenda, which
appears elsewhere in this issue of the Federal Register.
Nuclear Safety Regulations
The Department is committed to openness and public participation as it
addresses one of its greatest challenges--managing the environment,
health, and safety risks posed by its nuclear activities. A key element
in the management of these risks is to establish the Department's
expectations and requirements relative to nuclear safety and to hold
its contractors accountable for safety performance. The 1988 Price-
Anderson Amendments Act revisions to the Atomic Energy Act of 1954
(AEA) provide for the imposition of civil and criminal penalties for
violations of DOE nuclear safety requirements. As a result, new nuclear
safety requirements were initiated with the publication of four notices
of proposed rulemaking for review and comment in 1991. The Department's
nuclear safety procedural regulations (10 CFR part 820) were published
as a final rule in 1993. The Department's substantive nuclear safety
requirements (10 CFR parts 830 and 835) were finalized in 2001 and
1998, respectively. The remaining action, 10 CFR part 834, Radiation
Protection and the Environment, is scheduled for publication by the end
of 2006. In addition, the Department will be proposing in November 2004
to add a new part, 10 CFR 851, Worker Safety and Health, that would
establish basic requirements to ensure workers are protected from
safety and health hazards at DOE facilities.
_______________________________________________________________________
DOE--Energy Efficiency and Renewable Energy (EE)
-----------
PROPOSED RULE STAGE
-----------
36. ENERGY EFFICIENCY STANDARDS FOR RESIDENTIAL FURNACES AND BOILERS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
42 USC 6295
CFR Citation:
10 CFR 430
Legal Deadline:
Final, Statutory, January 1, 1994.
Abstract:
The Energy Policy and Conservation Act (EPCA), as amended, establishes
initial energy efficiency standard levels for most types of major
residential appliances and generally requires DOE to undertake two
subsequent rulemakings, at specified times, to determine whether the
extant standard for a covered product should be amended.
This is the initial review of the statutory standards for residential
furnaces and boilers.
Statement of Need:
Experience has shown that the choice of residential appliances and
commercial equipment being purchased by both builders and building
owners is generally based on the initial cost rather than on life-cycle
costs. Thus, the law requires minimum energy efficiency standards for
appliances to eliminate inefficient appliances and equipment from the
market.
Summary of Legal Basis:
EPCA establishes initial energy efficiency standard levels for most
types of major residential appliances and certain commercial equipment.
EPCA generally requires DOE to undertake rulemakings, at specified
times, to determine whether the standard for a covered product should
be made more stringent.
Alternatives:
The statute requires the Department to conduct rulemakings to review
standards and to revise standards to achieve the maximum improvement in
energy efficiency that the Secretary determines is technologically
feasible and economically justified. In making this determination, the
Department conducts a thorough analysis of the alternative standard
levels, including the existing standard, based on criteria specified by
statute. The process improvements that were announced (61 FR 36974,
July 15, 1996) further enhance the analysis of alternatives in
[[Page 72713]]
the appliance standards development process. For example, under this
process, the Department will ask stakeholders and private sector
technical experts to review its analyses of the likely impacts, costs,
and benefits of alternative standard levels. In addition, the
Department will solicit and consider information on nonregulatory
approaches for encouraging the purchase of energy efficient products.
Anticipated Cost and Benefits:
The specific costs and benefits of this rulemaking have not been
established because the final standard levels have not been determined.
Nevertheless, existing appliance standards are projected to save 23
quadrillion Btus of energy from 1993 to 2015, resulting in estimated
consumer savings of $1.7 billion per year in 2000 and estimated annual
emission reductions of 107 million tons of carbon dioxide and 280
thousand tons of nitrogen oxides in that year. Under the existing
standards, the discounted energy savings for consumers are 2.5 times
greater than the upfront price premium paid for the appliance.
Risks:
Without appliance standards, energy use will continue to increase with
resulting damage to the environment caused by atmospheric emissions.
Enhancing appliance energy efficiency reduces atmospheric emissions
such as CO2 and NOx. Establishing standards that are too stringent
could result in excessive increases in the cost of the product and
possible reductions in product utility. It might also place an undue
burden on manufacturers that could result in loss of jobs or other
adverse economic impacts.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 58 FR 47326 09/08/93
Framework Workshop 07/17/01
Venting Workshop 05/08/02
ANPRM 69 FR 45419 07/29/04
DOE Review of Technical Support Documents 09/00/05
NPRM 09/00/06
Final Action 09/00/07
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Local, State
Additional Information:
The timetable for this action reflects program priorities, which were
established with significant input from the public.
Agency Contact:
Mohammed Kahn, EE-2J
Department of Energy
Energy Efficiency and Renewable Energy
Office of Building Technologies Program
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-7892
Email: mohammed.kahn@ee.doe.gov
RIN: 1904-AA78
_______________________________________________________________________
DOE--EE
37. ENERGY EFFICIENCY STANDARDS FOR ELECTRIC DISTRIBUTION TRANSFORMERS
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
42 USC 6317
CFR Citation:
10 CFR 430
Legal Deadline:
None
Abstract:
The Energy Policy and Conservation Act, as amended, (EPCA) establishes
initial energy efficiency standard levels for certain types of major
residential appliances and certain types of commercial equipment. EPCA
contains no energy efficiency standards for distribution transformers.
This rulemaking will determine whether it is appropriate to establish
such standards.
Statement of Need:
Experience has shown that the choice of residential appliances and
commercial equipment being purchased by both builders and building
owners is generally based on the initial cost rather than on life-cycle
cost. Thus, the law requires minimum energy efficiency standards for
appliances to eliminate inefficient appliances and equipment from the
market.
Summary of Legal Basis:
EPCA establishes initial energy efficiency standard levels for certain
types of major residential appliances and certain types of commercial
equipment and generally requires DOE to undertake rulemakings, at
specified times, to establish the standards for those covered products
without statutory standards.
Alternatives:
The statute requires DOE to conduct rulemakings to review standards and
to revise standards to achieve the maximum improvement in energy
efficiency that the Secretary determines is technologically feasible
and economically justified. In making this determination, the
Department conducts a thorough analysis of alternative standard levels,
including the existing standard, based on criteria specified by
statute. The process improvements that were announced (61 FR 36974,
July 15, 1996) further enhance the analysis of alternative standards.
For example, DOE will ask stakeholders and private sector technical
experts to review its analyses of the likely impacts, costs, and
benefits of alternative standard levels. In addition, the Department
will solicit and consider information on nonregulatory approaches for
encouraging the purchase of energy efficient products.
Anticipated Cost and Benefits:
The specific costs and benefits for this rulemaking have not been
established because the final standard levels have not been determined.
Nevertheless, existing appliance standards are projected to save 23
quadrillion Btus of energy from 1993 to 2015, resulting in estimated
consumer savings of $1.7 billion per year in the year 2000 and
estimated annual emission reductions of 107 million tons of carbon
dioxide and 280 thousand tons of nitrogen oxides in the year 2000.
Under the existing standards, the discounted energy savings for
consumers are 2.5 times greater than the up-front price premium paid
for the appliance.
Risks:
Without appliance efficiency standards, energy use will continue to
increase with resulting damage to the environment caused by atmospheric
emissions. Enhancing appliance energy efficiency reduces atmospheric
emissions of carbon dioxide and nitrogen oxides. Establishing standards
that are too stringent could result in excessive increases in the cost
of the product, possible reductions in product utility and may place an
undue burden on manufacturers that could result in a loss of jobs or
other adverse economic impacts.
[[Page 72714]]
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Determination No62 FR 54809 10/22/97
ANPRM 69 FR 45375 07/29/04
DOE Review of Technical Support Documents 09/00/05
NPRM 09/00/06
Final Action 09/00/07
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
None
Additional Information:
The timetable for this action reflects program priorities, which were
established with significant input from the public.
Agency Contact:
Sam Johnson, EE-2J
Department of Energy
Energy Efficiency and Renewable Energy
Office of Building Technologies Program
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-0854
Fax: 202 586-4617
Email: sam.johnson@ee.doe.gov
RIN: 1904-AB08
_______________________________________________________________________
DOE--EE
38. ENERGY EFFICIENCY STANDARDS FOR COMMERCIAL UNITARY AIR CONDITIONERS
AND HEAT PUMPS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
42 USC 6293
CFR Citation:
10 CFR 431
Legal Deadline:
None
Abstract:
The Energy Policy and Conservation Act (EPCA), as amended, establishes
initial energy efficiency standard levels for certain types of major
residential appliances and certain types of commercial equipment. EPCA
requires DOE to amend the standards for products whenever ASHRAE amends
its standards.
Statement of Need:
Experience has shown that the choice of residential appliances and
commercial equipment being purchased by both builders and building
owners is generally based on the initial cost rather than on life-cycle
cost. Thus, the law requires minimum energy efficiency standards for
appliances to eliminate inefficient appliances and equipment from the
market.
Summary of Legal Basis:
EPCA establishes initial energy efficiency standard levels for certain
types of major residential appliances and certain types of commercial
equipment and requires DOE to amend the standard for this product when
ASHRAE amends its standards, as recently occurred. DOE can establish a
more stringent standard than the ASHRAE standard, if DOE determines by
clear and convincing evidence that such higher standard is
technologically feasible and economically justified and would result in
additional energy conservation.
Alternatives:
The statute requires DOE to conduct rulemakings to review standards and
to revise standards to achieve the maximum improvement in energy
efficiency that the Secretary determines is technologically feasible
and economically justified. In making this determination, the
Department conducts a thorough analysis of alternative standard levels,
including the existing standard, based on criteria specified by
statute. The process improvements that were announced (61 FR 36974,
July 15, 1996) further enhance the analysis of alternative standards.
For example, DOE will ask stakeholders and private sector technical
experts to review its analyses of the likely impacts, costs, and
benefits of alternative standard levels. In addition, the Department
will solicit and consider information on nonregulatory approaches for
encouraging the purchase of energy efficient products.
Anticipated Cost and Benefits:
The specific costs and benefits for this rulemaking have not been
established because the final standard levels have not been determined.
Risks:
Without energy efficiency standards, energy use will continue to
increase with resulting damage to the environment caused by atmospheric
emissions. Enhancing energy efficiency reduces atmospheric emissions of
carbon dioxide and nitrogen oxides. Establishing standards that are too
stringent could result in excessive increases in the cost of the
product, possible reductions in product utility and may place an undue
burden on manufacturers that could result in a loss of jobs or other
adverse economic impacts.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Screening Worksh66 FR 43123 10/01/01
ANPRM 69 FR 45459 07/29/04
DOE Review of Technical Support Documents 09/00/05
NPRM 09/00/06
Final Action 09/00/07
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
None
Additional Information:
The timetable for this action reflects program priorities, which were
established with significant input from the public.
Agency Contact:
James Raba, EE-2J
Department of Energy
Energy Efficiency and Renewable Energy
Office of Building Technologies Program
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-8654
Email: jim.raba@ee.doe.gov
RIN: 1904-AB09
_______________________________________________________________________
DOE--Departmental and Others (ENDEP)
-----------
PROPOSED RULE STAGE
-----------
39. WORKER SAFETY AND HEALTH
Priority:
Other Significant
Legal Authority:
42 USC 2011; 42 USC 5801 to 5911; 42 USC 7101 to 7352
CFR Citation:
10 CFR 851
[[Page 72715]]
Legal Deadline:
Final, Statutory, December 2, 2003.
Abstract:
This action would add a new 10 CFR 851 regulation to DOE's regulations
establishing a body of rules setting forth basic requirements to ensure
workers are protected from safety and health hazards at DOE facilities.
Statement of Need:
The purpose of this rule is to ensure that the Department's obligation
to protect the safety and health of its workers is fulfilled and to
provide, if needed, a basis for the imposition of civil penalties
consistent with section 3173 of the Bob Stump National Defense
Authorization Act of 2003. This action is consistent with the
Department's commitment to the issuance of safety and health
requirements using notice and comment rulemaking.
Summary of Legal Basis:
Under the Atomic Energy Act of 1954 (AEA), as amended, the Department
of Energy has the authority to regulate activities at facilities under
its jurisdiction. On December 2, 2002, section 3173 of the National
Defense Authorization Act amended the AEA to add section 234C (codified
as 42 U.S.C. 2282c). Section 234C requires the Department to promulgate
regulations for industrial and construction safety and health at DOE
contractor facilities for contractors covered by an agreement of
indemnification. The regulation must provide a level of protection to
workers at such facilities that is substantially equivalent to the
level of protection currently being provided to workers. Section 234C
also makes DOE contractors that violate the safety and health
regulations subject to civil penalties or a reduction of fees and other
payments under its contract with DOE.
Alternatives:
None
Anticipated Cost and Benefits:
The incremental costs of the proposed rules should be minimal because
contractors are currently bound by comparable contractual obligations.
Risks:
The proposed rule would allow DOE to assess penalties as directed by
Congress for noncompliance. Therefore, contractors will be put at risk
if they violate the safety and health requirements of the rule. The
proposed rule may also reduce the injuries and illnesses of workers due
to increased emphasis on complaint programs.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 68276 12/08/03
NPRM Comment Period End 02/06/04
NPRM Suspension 69 FR 9277 02/27/04
Supplemental NPRM 12/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Additional Information:
A Notice of Suspension was issued on 02/27/2004 to allow time for the
Department to consult with the Defense Nuclear Facilities Safety Board
(DNFSB) in order to resolve its concerns.
Agency Contact:
Bill McArthur
Department of Energy
1000 Independence Avenue, SW.
Washington, DC 20585
Phone: 301 930-9674
RIN: 1901-AA99
_______________________________________________________________________
DOE--ENDEP
-----------
FINAL RULE STAGE
-----------
40. RADIATION PROTECTION OF THE PUBLIC AND THE ENVIRONMENT
Priority:
Other Significant
Legal Authority:
42 USC 2201; 42 USC 7191
CFR Citation:
10 CFR 834
Legal Deadline:
None
Abstract:
This action would add a new 10 CFR 834 to DOE's regulations
establishing a body of rules setting forth the basic requirements for
ensuring radiation protection of the public and environment in
connection with DOE nuclear activities. These requirements stem from
the Department's ongoing effort to strengthen the protection of health,
safety, and the environment from the nuclear and chemical hazards posed
by these DOE activities. Major elements of the proposal include a dose
limitation system for protection of the public; requirements for liquid
discharges; reporting and monitoring requirements; and residual
radioactive material requirements.
Statement of Need:
The purpose of this rule is to ensure that the Department's obligation
to protect health and safety is fulfilled and to provide, if needed, a
basis for the imposition of civil and criminal penalties consistent
with the Price-Anderson Amendments Act of 1988. This action is
consistent with the Department's commitment to the issuance of nuclear
safety requirements using notice and comment rulemaking.
Summary of Legal Basis:
Under the Atomic Energy Act of 1954, as amended, the Department of
Energy has the authority to regulate activities at facilities under its
jurisdiction. The Department is committed to honoring its obligation to
ensure the health and safety of the public and workers affected by its
operations and the protection of the environs around its facilities.
Alternatives:
The Department could continue to impose nuclear safety requirements
through directives made applicable to DOE contractors through the terms
of their contracts.
Anticipated Cost and Benefits:
The incremental costs of the proposed rules should be minimal because
contractors are currently bound by comparable contractual obligations.
Full compliance by contractors with nuclear safety standards will
result in substantial societal benefits.
Risks:
This rulemaking should reduce the risk of nuclear safety problems by
clarifying safety requirements applicable to DOE contractors and
improving compliance.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 58 FR 16268 03/25/93
Second NPRM 60 FR 45381 08/31/95
Conform to Related EPA Regulation 09/00/05
Final Action 06/00/06
[[Page 72716]]
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal
Additional Information:
The Environmental Protection Agency (EPA) is considering revising the
Federal Guidance for Radiation Protection of the Public. This
Presidential-level guidance would refine the radiation protection and
dose limitation framework for the public, and may include numerical
Radiation Protection Goals (i.e., dose limits). Because it is DOE's
policy to be consistent with Federal radiation protection policy, the
Department is adjusting the schedule for part 834 in anticipation of
revised Federal Guidance and will issue the rule following EPA action
on the guidance. This will allow DOE to be consistent with the most
current Presidential-level guidance upon its release.
Agency Contact:
Andrew Wallo III
Director, Office of Air, Water and Radiation Protection, Policy and
Guidance
Department of Energy
Office of Environmental Guidance
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-4996
RIN: 1901-AA38
BILLING CODE 6450-01-S
[[Page 72717]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Statement of Regulatory Priorities
The Department of Health and Human Services (HHS) is responsible for a
broad range of programs designed to protect and promote the health and
the social and economic well being of the American public. These
programs especially affect some of the Nation's most vulnerable
populations, including children, the elderly, and persons with
disabilities. And, in one way or another, HHS' activities touch the
lives of virtually every person in our country, citizens and non-
citizens alike.
HHS' programs and activities include: Medicare, Medicaid, support for
public health preparedness, biomedical research, substance abuse and
mental health treatment, assurance of safe and effective drugs and
other medical products, food safety, financial assistance to low income
families, Head Start, services to older Americans, and direct health
services delivery. These programs and services are essential to the
well being of tens of millions of Americans across our country--people
of every age, in every location, and in every walk of life.
To improve the administration and conduct of these programs and
activities, Secretary Thompson has made it clear that the Department
must develop and issue regulations in a culture of responsiveness,
where listening and responding to those we serve and those we regulate
is the cornerstone. From health promotion and disease prevention to
public health preparedness to food safety, the Secretary is committed
to widening communication with consumers, beneficiaries, and all
regulated entities. Furthermore, the Secretary wishes to ensure that
all HHS regulations are readily understandable, are clear and concise,
and grounded both in pertinent law and common sense.
FY 2005 Regulatory Themes
The Secretary has adopted four overarching regulatory themes for FY
2005:
modernizing Medicare;
improving the Nation's ability to prepare for and/or respond
to public health emergencies and disasters;
reducing medical errors and enhancing patient safety; and
protecting America's consumers.
Most of the Department's regulatory priorities for this fiscal year
will fall under these themes (see the listing below). It should be
noted, however, that the Secretary's overall priorities go beyond these
categories and include, for example, increasing the percentage of the
Nation's children and adults with access to regular health care;
motivating American adults to gain the benefits of physical activity;
enhancing the capacity and productivity of the Nation's health-science
research enterprise; and supporting efforts to increase the
independence of low-income families, the disabled, and older Americans.
Modernizing Medicare
On December 8, 2003, President Bush signed into law the Medicare
Prescription Drug, improvement and Modernization Act of 2003 (MMA).
This landmark legislation provides seniors and people living with
disabilities with a prescription drug benefit, more choices, and better
benefits under Medicare, and many other administrative and programmatic
changes, the result of which is the most significant improvement to
senior health care in nearly 40 years. Secretary Thompson announced in
July 2003 proposed regulations to implement the prescription drug
benefit, as well as new health plan choices, improved health care for
rural America, and improved preventive care benefits. Bringing these
proposals to completion is among the Secretary's highest priorities.
The prescription drug benefit will allow all Medicare beneficiaries to
enroll in drug coverage through a prescription drug plan or Medicare
health plan, with Medicare paying for 75 percent of the premium.
Additional benefits for Medicare beneficiaries with limited means will
cover, on average, 95 percent of their drug costs. The new benefits
also will provide new protections for retirees who currently receive
drug coverage through their employers or unions. All the new Medicare
benefits are voluntary, as seniors can choose to keep their existing
traditional coverage.
Also, the following regulatory actions, supported by older statutory
authority, will also effect important improvements in Medicare:
a final rule to establish national and local coverage-
determination appeals processes; standardized appeals
processes will allow beneficiaries to challenge coverage
policies that could otherwise prevent legitimate claim
payments;
two regulatory proposals to establish clearer performance
standards under Medicare for Organ Procurement
Organizations, and a new mechanism for reapproval of Organ
Transplant centers; and
a proposed rule under which current requirements for Medicare
reimbursement for services to persons with End Stage Renal
Disease would be completely overhauled and simplified.
Improving the Department's Ability to Respond to Emergencies and
Disasters
HHS is responsible for directing and coordinating the medical and
public health response to terrorism, natural disasters, major
accidents, and other events that can result in mass casualties. Timely
and well-focused responses to such events are key to limiting death and
injury. The Department and its partners must be able to react quickly,
and tailor responses to the specific emergency without being encumbered
by counter-productive activities.
Regulations in the Plan designed to help ensure that HHS has
appropriate authority and flexibility to address emergencies and
disasters include:
three final rules to improve readiness to respond to threats
of food-related bioterrorism, by:
requiring prior notification to the Food and Drug
Administration (FDA) of all food importation to the United
States,
requiring owners or operators of domestic or foreign
facilities that manufacture/process, pack, or hold food for
human or animal consumption in the United States to
register the facility with the FDA; and
requiring the maintenance of food-handling records identifying
the immediate source from which a wholesale food facility
received a food shipment as well as the shipment's
immediate subsequent recipient, assisting FDA in addressing
credible threats of serious adverse health consequences;
a proposed rule reorganizing current FDA regulations requiring
registration of drug establishments, enabling the agency to
quickly identify firms that manufacture a specific product
or ingredient that may be needed during a national
emergency; and
a proposed rule providing for an exception from the general
requirement for informed consent in the use of
investigational devices to identify chemical, biological,
radiological, or nuclear agents in a potential terrorist
threat or other public health emergency.
[[Page 72718]]
Reducing Medical Errors and Enhancing Patient Safety
Medical errors and other patient safety risks have been the subject of
many recent studies and reports. The Secretary has directed that
actions be taken to reduce these risks. Regulatory actions included in
the Plan under this theme include:
a final rule requiring that drug product labels contain a
toll-free number for use in reporting adverse events
associated with the use of that product;
a final rule requiring improvements in the format and content
requirements of the ``professional'' labeling of drug
products, enabling health care practitioners to prescribe
drugs more safely;
a final rule requiring that blood establishments follow
written procedures (often called ``lookback'') for
appropriate action when it is determined that blood or
blood components are at increased risk for transmitting
hepatitis C virus infection.
Protecting America's Consumers
Consumer health and safety is a major concern for the public and the
Secretary. Consumers are inundated each year with an availability of
new products and ingredients. Every year, tens of thousands of
Americans become sick and some die from foodborne pathogens, and the
size of vulnerable populations (e.g., the elderly and those with
compromised immune systems) is growing. The Secretary is especially
interested in actions that enhance safety associated with the
production of food, or provide better nutrition information to American
consumers.
Regulations under this theme include:
a final rule to standardize the manufacturing and packaging of
dietary supplements;
a final rule to strengthen safety requirements for the storage
and distribution of eggs;
a group of actions to further strengthen existing safeguards
that protect consumers against the agent that causes bovine
spongiform encephalopathy (``mad cow disease`), and
two advance notices of proposed rulemaking that request
information from the public regarding better labeling of
the caloric content of food products.
Public Comments and Reactions
The Secretary welcomes comments not only on specific regulations as
they are published in the Federal Register, but also on the overarching
themes he has established. Such comments, as well as suggestions for
regulatory improvements and initiatives, should be sent to Secretary
Tommy G. Thompson, c/o Ann C. Agnew, Executive Secretary to the
Department, Room 603, Hubert H. Humphrey Building, 200 Independence
Avenue SW., Washington, DC 20201.
REGULATIONS BY THEME
(parentheses contain RIN numbers)
Modernizing Medicare
Medicare Prescription Drug Benefit--MMA Title I (0938-AN08)
Medicare Advantage Program--MMA Title II (0938-AN06)
Revisions to the Review and Approval of National Accreditation
Organizations for Deeming Authority (0939-AN62)
Organ Procurement Organizations: Conditions for Coverage (0938-AK81)
End Stage Renal Disease: Conditions for Coverage (0938-AG82)
Requirements for Approval of Transplant Centers To Perform Transplants
(0938-AHI7)
Improving the Nations Ability to Respond to Emergencies and Disasters
Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act (0910-AC41)
Registration of Food and Animal Facilities (0910-AC40)
Establishment and Maintenance of Records To Identify Immediate Previous
Source and Immediate Subsequent Recipient of Foods (0910-AC39)
Exception From General Requirements for Informed Consent; Request for
Comments and Information (0910-AC25)
Foreign and Domestic Establishment Registration and Listing
Requirements for Drugs and Biologics (0910- AA49)
Reducing Medical Errors and Enhancing Patient Safety
Toll-Free Number for Reporting Adverse Events on Labeling For Human
Drugs (0910-AC35)
Revised Requirements on Content and Format of Labeling for Human
Prescription Drugs and Biological Products (0910-AA94)
CGMPs for Blood and Blood Components: Notification of Cosignees and
Transfusion Recipients Receiving Blood Components at Increase Risk of
Transmitting Hepatitis C Virus (Lookback)
Current Good Tissue Practice for Manufacturers of Human Cells, Tissues
and Cellular and Tissue-Based Products (0910-AB28)
Protecting America's Consumers
Use of Materials Derived From Cattle In Human and Animal Medical
Products (0910-AF54)
Requirements for Human and Animal Medical Products Manufactured From,
Processed With, or Otherwise Containing, Material From Cattle (0910-
AF55)
Use of Materials Derived From Cattle in Human Food and Cosmetics (0910-
AF47)
Recordkeeping Requirements for Human Food and Cosmetics Manufactured
From, Processed With, or Otherwise Containing Material From Cattle
(0910- AF48)
Substances Prohibited From Use in Animal Food or Feed (0910- AF-46)
Food Labeling; Prominence of Calories (0910- AF22)
Food Labeling; Serving Sizes (0910-AF23)
Use of Ozone-Depleting Substances: Removal of Essential-Use
Designation; Albuterol (0910-AF18)
Control of Salmonella Enteritidis in Shell Eggs During Production And
Retail (0910-AC14)
Current Good Manufacturing Practices for Manufacturing, Packing, or
Holding Dietary Ingredients and Dietary Supplements (0910-AB88)
_______________________________________________________________________
HHS--Food and Drug Administration (FDA)
-----------
PRERULE STAGE
-----------
41. FOOD LABELING; PROMINENCE OF CALORIES
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
21 USC 321; 21 USC 343; 21 USC 371
CFR Citation:
21 CFR 101.9
[[Page 72719]]
Legal Deadline:
None
Abstract:
In response to the Report of the Working Group on Obesity (OWG) that
FDA issued on March 12, 2004, the agency will issue an advance notice
of proposed rulemaking (ANPRM) in its efforts to combat the Nation's
obesity problem. The ANPRM will request comments on ways to give more
prominence to ``calories'' on the food label.
Statement of Need:
The Nation is currently facing a major long-term public health crisis.
This trend toward overweight and obesity has accelerated during the
past decade and is well documented by numerous scientific analyses. In
1999-2000, 64 percent of U.S. adults were overweight, increased from 56
percent when surveyed in 1988-1994; 30 percent of adults were obese,
increased from 23 percent in the earlier survey. Among children age 6
through 19 years, 15 percent were overweight, compared with 10 percent
to 11 percent in the earlier survey. Overweight and obesity are
associated with increased morbidity and mortality. It is estimated that
about 400,000 deaths per year may be attributed to obesity, and
overweight and obesity increase the risk for coronary heart disease,
type 2 diabetes, and certain cancers. The total economic cost of
obesity in the United States is up to $117 billion per year, including
more than $50 billion in avoidable medical costs, more than 5 percent
of total annual health care expenditures. Fundamentally, overweight and
obesity represents an imbalance between energy intake (e.g., calorie
intake) and energy output (expended both as physical activity and
metabolic activity).
Summary of Legal Basis:
Section 403(q)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21
USC 343) provides that certain foods under FDA's jurisdiction bear
nutrition information that provides for, among other things, the total
calories served from any source and the total number of calories
derived from total fat in each serving size or other unit of measure.
This ANPRM is soliciting recommendations on ways to give more
prominence to caloric information on the food label.
Alternatives:
Possible alternatives to this advance notice of proposed rulemaking
are: 1) do not amend certain provisions of the nutrition labeling
regulations to give more prominence to calories on the food label; or
2) rely on industry to voluntarily give more prominence to ``calories''
on the food label.
Anticipated Cost and Benefits:
If rulemaking results from this ANPRM, the rule would generate costs
because it would require firms to reformulate food labels. Benefits of
any rulemaking resulting from this ANPRM, depends on how consumers and
producers respond to any changes in calorie labeling.
Risks:
Attention to caloric intake is a key element of weight control since
weight loss and weight management are dependent on caloric balance.
Increasing the prominence of caloric information on food labels is one
way to provide consumers with information about their caloric intake.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 12/00/04
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Jill Kevala
Chemist
Department of Health and Human Services
Food and Drug Administration
HFS-830, Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1450
Fax: 301 436-2636
Email: jkevala@cfsan.fda.gov
RIN: 0910-AF22
_______________________________________________________________________
HHS--FDA
42. FOOD LABELING; SERVING SIZES OF PRODUCTS THAT CAN REASONABLY BE
CONSUMED AT ONE EATING OCCASION; UPDATING OF REFERENCE AMOUNTS
CUSTOMARILY CONSUMED; APPROACHES FOR RECOMMENDING SMALLER PORTION SIZES
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
21 USC 321; 21 USC 343; 21 USC 371
CFR Citation:
21 CFR 101.9(b); 21 CFR 101.12
Legal Deadline:
None
Abstract:
In response to the Report of the Working Group on Obesity (OWG) that
FDA issued on March 12, 2004, the agency will issue an advance notice
of proposed rulemaking (ANPRM) in its efforts to combat the Nation's
obesity problem. The ANPRM will request comments on changes to the
agency's nutrition labeling regulations on serving size and comments on
allowance of truthful, nonmisleading, and useful approaches for
promoting consumption of smaller portion sizes.
Statement of Need:
The Nation is currently facing a major long-term public health crisis.
This trend toward overweight and obesity has accelerated during the
past decade and is well documented by numerous scientific analyses. In
1999-2000, 64 percent of U.S. adults were overweight, increased from 56
percent when surveyed in 1988-1994; 30 percent of adults were obese,
increased from 23 percent in the earlier survey. Among children age 6
through 19 years, 15 percent were overweight, compared with 10 percent
to 11 percent in the earlier survey. Overweight and obesity are
associated with increased morbidity and mortality. It is estimated that
about 400,000 deaths per year may be attributed to obesity, and
overweight and obesity increase the risk for coronary heart disease,
type 2 diabetes, and certain cancers. The total economic cost of
obesity in the United States is up to $117 billion per year, including
more than $50 billion in avoidable medical costs, more than 5 percent
of total annual health care expenditures. Fundamentally, overweight and
obesity represents an imbalance between
[[Page 72720]]
energy intake (e.g., calorie intake) and energy output (expended both
as physical activity and metabolic activity).
Summary of Legal Basis:
Section 403(q)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21
USC 343 (q)(1)(A)(i)) provides that certain foods under FDA's
jurisdiction bear nutrition information based on a serving size that
reflects the amount of food customarily consumed and is expressed in a
common household measure appropriate to the food. This ANPRM is
soliciting recommendations on ways to amend certain provisions of its
nutrition labeling regulations concerning serving size
Alternatives:
Possible alternatives to this advance notice of proposed rulemaking
are: (1) do not amend certain serving size provisions of the nutrition
labeling regulations, particularly on packaged products that can be
readily consumed at one eating occasion, but that indicate they
represent more than one serving; or (2) rely on industry to voluntarily
revise their labels to clarify that, particularly for packaged products
that can be readily consumed at one eating occasion, that there is more
than one serving in the package.
Anticipated Cost and Benefits:
If rulemaking results from this ANPRM, the rule would generate costs
because it would require firms to relabel some food products, in
addition to potential reformulation and testing costs. Benefits of any
rulemaking resulting from this ANPRM, depends on how consumers and
producers respond to any changes in labeling serving sizes or portion
sizes.
Risks:
Attention to serving size is a key element of weight control since
weight loss and weight management are dependent on the amount of food
consumed at one eating occasion. Clarifying how serving size is
presented on food labels is one way to provide consumers with
information about their caloric intake.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 12/00/04
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Lori LeGault
Nutritionist
Department of Health and Human Services
Food and Drug Administration
HFS-840
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1797
Fax: 301 436-2635
Email: llegault@cfsan.fda.gov
RIN: 0910-AF23
_______________________________________________________________________
HHS--FDA
-----------
PROPOSED RULE STAGE
-----------
43. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING
REQUIREMENTS FOR HUMAN DRUGS, CERTAIN BIOLOGICAL DRUGS, AND ANIMAL
DRUGS
Priority:
Other Significant
Legal Authority:
21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360;
21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 USC 264; 42 USC 271
CFR Citation:
21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR 330; 21 CFR 514;
21 CFR 515; 21 CFR 601; 21 CFR 607; 21 CFR 610; 21 CFR 1271
Legal Deadline:
None
Abstract:
The proposed rule would reorganize, consolidate, clarify, and modify
current regulations at 21 CFR part 207 concerning who must register
establishments and list human drugs, certain biological drugs, and
animal drugs. These regulations contain information on when, how, and
where to register drug establishments and list drugs, and what
information must be submitted for initial registration and listing and
for changes to registration and listing. The proposed rule would
require that this information be submitted via the Internet into the
FDA registration and listing database, instead of the current
requirement to submit the information to FDA on paper forms. The
proposed rule would also require that the NDC number appear on drug
labels. In addition, FDA would assign the NDC number to newly listed
drugs and take other steps to minimize the use of inaccurate NDC
numbers on drug labels.
Statement of Need:
FDA relies on establishment registration and drug listing for
administering its postmarketing surveillance programs, such as
identifying firms that manufacture a specific product or ingredient
when that product or ingredient is in short supply or needed for a
national emergency, for example, during a bioterrorism threat. FDA also
uses registration and listing information for administering other
programs such as assessing user fees. FDA is taking this action to
improve its establishment registration and drug listing system and to
utilize the latest technology in the collection of this information. In
addition, improving the accuracy of and requiring NDC numbers on drug
labels would help promote the Department's bar code, medication errors,
and electronic prescribing initiatives.
Summary of Legal Basis:
The agency has broad authority under sections 301(p), 502(o), 510, and
701(a) of the act and sections 351 and 361 of the Public Health Service
Act (PHS Act) to regulate certain establishments with respect to their
submission of registration and listing information. Failure to register
in accordance with section 510 of the act is a prohibited act under
section 301(p) of the act. Failure to comply with section 510 of the
act renders drugs misbranded under section 502(o) of the act.
Alternatives:
The alternatives to this rulemaking include not updating the
registration and listing regulations and not requiring the electronic
submission of registration and listing information. FDA originally
published the registration regulations in 1963 and the listing
regulations in 1973. The registration and listing paper forms that are
currently mailed to FDA have been in use since that time. For the
reasons stated above, and as a result of the advances in data
collection and transmission technology, FDA believes this rulemaking is
the preferable alternative.
[[Page 72721]]
Anticipated Cost and Benefits:
FDA estimates that the costs to industry resulting from the proposed
rule would include annually recurring and one-time costs. The recurring
costs would include, among other things, measures taken by registrants
to protect the integrity of FDA's registration and listing database
(such as the use of a unique electronic identifier). The one-time costs
would include, among other things, additional time required to enter
registration and listing data into FDA's database. In addition, certain
registrants would need to convert their labeling to an electronically
searchable format the first time they electronically list these
products. The specific cost to FDA of developing, administering, and
maintaining the Electronic Drug Registration and Listing System (EDRLS)
is being calculated. EDRLS will not be ready for use until the rule is
finalized.
FDA believes that electronic registration and listing will be less
costly to industry in the long run than the current requirements. The
proposed rule would require less establishment and product information
from many registrants and savings would result from not having to
process paper copies of the registration and listing forms. The
electronic registration and listing process would also enable
registrants to receive on-screen feedback if the information submitted
is not complete, reducing errors and the time and cost of communicating
back and forth with FDA. Information search and retrieval time will
also be reduced for FDA, allowing for quicker agency response time.
The proposal would make the regulations more user-friendly and would
make the registration and listing process easier by incorporating the
use of the Internet to submit all information. The proposal would
improve the ability to identify and catalogue marketed drugs by helping
to eliminate inaccurate NDC numbers on drug labels.
Risks:
None
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Howard P. Muller
Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: mullerh@cder.fda.gov
RIN: 0910-AA49
_______________________________________________________________________
HHS--FDA
44. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
21 USC 321; 21 USC 342; 21 USC 343; 21 USC 349; 21 USC 371
CFR Citation:
21 CFR 589.2001
Legal Deadline:
None
Abstract:
The Food and Drug Administration (FDA) is proposing to amend its
regulations to prohibit the use of certain cattle origin materials in
the food or feed of all animals to help strengthen existing safeguards
to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S.
cattle. The discovery of a BSE-positive dairy cow in December 2003 has
caused FDA to review its policies for prevention of BSE which resulted
in this rulemaking.
Statement of Need:
In December 2003, the U.S. Department of Agriculture (USDA) announced a
positive case of BSE in a dairy cow in Washington State. Subsequent
epidemiological investigations confirmed that the infected cow was born
and most likely became infected in Alberta, Canada, prior to Canada's
1997 implementation of a ban on feeding mammalian protein to ruminants.
This case followed the identification of BSE in a single cow in
Alberta, Canada, in May 2003.
In response to the identification of these BSE cases in North America,
FDA is proposing to amend its regulations to prohibit the use of
certain cattle origin materials in the food or feed of all animals.
This measure will further strengthen existing safeguards designed to
help prevent the spread of BSE in U.S. cattle.
BSE belongs to a family of diseases known as transmissible spongiform
encephalopathies (TSEs). TSE's are fatal, progressively degenerative
central nervous system diseases of man and other animals. TSE's
include, among other diseases, BSE in cattle, scrapie in sheep and
goats, chronic wasting disease (CWD) in deer and elk, and Creutzfeldt-
Jakob disease (CJD) in humans. There is no known treatment for these
diseases, and there is no vaccine to prevent them. In addition,
although validated postmortem diagnostic tests are available, there are
no validated diagnostic tests for BSE that can be used to test for the
disease in live animals.
In the Federal Register of July 14, 2004 (69 FR 42288), FDA and USDA
jointly published an advance notice of proposed rulemaking (ANPRM) to
inform the public about the recommendations made by a team of
international BSE experts (IRT) convened by the Secretary of
Agriculture in January 2004 and to request comments on a number of
issues related to possible regulatory measures. Among other
recommendations, the IRT recommended that: 1) all specified risk
materials (SRMs) be excluded from all animal feed including pet food;
2) cross contamination be prevented throughout thfeed chain; and 3) the
use of all mammalian and poultry protein in ruminant feed be
prohibited. FDA intends to consider all information received in
response to the ANPRM prior to making a determination as to what
measures are needed to further strengthen animal feed safeguards.
Summary of Legal Basis:
The agency is proposing these regulations under sections 402 and 701 of
the Federal Food, Drug, and Cosmetics Act.
Alternatives:
FDA has considered four other measures that are not included in the
proposed rule. These measures include: 1) a requirement that those
facilities handling both prohibited materials and ruminant feeds use
dedicated facilities or equipment for each; 2) a ban on the
[[Page 72722]]
use of poultry litter in ruminant feeds; 3) a ban on the use of blood
and blood products in ruminant feeds; and 4) a ban on the use of what
is commonly referred to as plate waste in ruminant feeds.
Anticipated Cost and Benefits:
The proposed regulation may be expected to require the expenditure of
over $100 million in any one year by the private sector and may have a
significant impact on a substantial number of small entities. The
estimated total annualized costs of the rule are the sum of the costs
of prohibiting the list of cattle origin materials identified in the
proposed rule.
The benefit of the proposed rule includes the elimination of much of
the remaining risk of spreading BSE in U.S. cattle. Assuming the
hypothetical import of five infected cattle, FDA believes that the
proposed rule would effectively remove about 95 percent of the
remaining risk of human exposure to BSE infected material. The U.S.
economy may also benefit from increased exports to the extent that the
rule persuades foreign governments to import U.S. beef products. While
we are unable to quantify these benefits, they are potentially large,
given the significant loss of exports resulting from the discovery of
an infected cow in Washington State.
Risks:
BSE is an incurable disease that can affect cattle and certain other
mammals that ingest infective material from BSE infected cattle. In
1996, a newly recognized form of the human disease, Creutzfeldt-Jakob
disease (CJD), referred to as variant CJD (vCJD), was reported in the
United Kingdom. Scientific and epidemiological studies have linked vCJD
to exposure to the BSE agent, most likely through human consumption of
beef products contaminated with the agent that causes BSE. The
discovery of a BSE positive dairy cow in Washington State in December
2003, caused the Agency to review its policies for the prevention of
the spread of BSE within the United States. The need for regulatory
action in this case is related to the inability of the market and
existing regulations to ensure that the risk of BSE exposure through
animal feed is minimized to the extent possible, given that BSE could
potentially have an enormous adverse impact on both animal and human
health.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 69 FR 42288 07/14/04
ANPRM Comment Period End 08/13/04
NPRM 02/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Burt Pritchett
Biologist
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
HFV-222
7519 Standish Place, MPN-4
Rockville, MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email: burt.pritchett@fda.hhs.gov
RIN: 0910-AF46
_______________________________________________________________________
HHS--FDA
45. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN AND ANIMAL
MEDICAL PRODUCTS
Priority:
Other Significant
Legal Authority:
Not Yet Determined
CFR Citation:
21 CFR 116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500; 21 CFR 600.16;
21 CFR 895; 21 CFR 1271.465; 21 CFR 1271.470
Legal Deadline:
None
Abstract:
The regulation would prohibit the use of certain cattle material in the
manufacture of human medical products and animal drugs. The rule would
prohibit the same cattle material that is prohibited in the previous
FDA IFR that applies to foods and cosmetics. These include certain high
risk tissues (e.g., brain, skull, eyes, spinal cord, trigeminal
ganglia, parts of the vertebral column, and dorsal root ganglia) from
cattle 30 months and older, tonsils and the distal ileum as well as the
rest of the small intestine of cattle of any age, mechanically
separated beef, material from nonambulatory disabled cattle, and
material from cattle not inspected and passed for human consumption.
The prohibitions would apply only to materials derived from animals
slaughtered after the effective dates of the rules.
Statement of Need:
FDA is taking this action in response to the finding of an adult cow,
imported from Canada, that tested positive for BSE in the State of
Washington. This action will minimize human exposure to materials that
scientific studies have demonstrated are highly likely to contain the
BSE agent in cattle infected with the disease. Scientists believe that
the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely
caused by the consumption of products contaminated with the agent that
causes BSE.
Summary of Legal Basis:
Undetermined.
Alternatives:
There were several alternatives considered to the rule. These same
alternatives, plus any new ones presented in comments, will be
considered for the final.
No new regulation.
Prohibit the use of prohibited cattle materials in human
medical products and animal drugs and require access to existing
records relevant to determine compliance.
Prohibit the use of prohibited cattle materials in human
medical products and animal drugs and require establishment,
maintenance, and access to records demonstrating that prohibited cattle
materials are not used in human food and cosmetics.
Anticipated Cost and Benefits:
FDA expects minimal costs of compliance as this rule reflects current
practices of most affected manufacturers. The costs of this rule are
the costs to industry of assuring that prohibited materials are not
used in the manufacture of medical products. By reducing exposure to
potentially infective materials, this rule will provide an additional
safeguard against a case of vCJD occurring in humans if cattle infected
with BSE are used in the manufacture or processing of medical products.
Risks:
The benefits of the rule will be the value of the public and health
benefits.
[[Page 72723]]
The public and animal health benefit is the reduction in the risk of
the human and ruminant illness associated with exposure to the agent
that causes BSE.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 02/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Eric Flamm
Senior Policy Advisor, Office of Policy
Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner
5600 Fishers Lane
Room 15-61, HF-23
Rockville, MD 20857
Phone: 301 827-0891
Fax: 301 827-4774
Email: eric.flamm@fda.hhs.gov
RIN: 0910-AF54
_______________________________________________________________________
HHS--FDA
46. REQUIREMENTS FOR HUMAN AND ANIMAL MEDICAL PRODUCTS
MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL
FROM CATTLE
Priority:
Other Significant
Legal Authority:
Not Yet Determined
CFR Citation:
21 CFR 116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500; 21 CFR 600.16;
21 CFR 895; 21 CFR 1271.465; 21 CFR 1271.470
Legal Deadline:
None
Abstract:
This is a companion rulemaking to FDA's rule entitled ``Use of
Materials Derived From Cattle in Human and Animal Medical Products,''
to be published in the same issue of the Federal Register. The rule
would propose recordkeeping requirements for human and animal medical
products that contain cattle material. Manufacturers and sponsors of
such products would have to establish and maintain records to
demonstrate that prohibited materials were not used in their
manufacture.
Statement of Need:
FDA is proposing recordkeeping requirements because records documenting
the absence of prohibited cattle materials are needed by manufacturers
and processors of human medical products and animal drugs that contain
or are manufactured with cattle material to ensure that these products
do not contain prohibited cattle materials. Prohibited cattle materials
are materials that scientific studies have demonstrated are highly
likely to contain the BSE agent in cattle infected with the disease.
Scientists believe that the human disease variant Creutzfeldt-Jakob
disease (vCJD) is likely caused by the consumption of products
contaminated with the agent that causes BSE.
FDA is proposing additional restrictions for higher risk human medical
products and for ruminant drugs to address the greater disease risk
posed by these products should they contain any infectious material
from a BSE-positive animal.
Summary of Legal Basis:
Undetermined.
Alternatives:
Alternatives were not specifically considered in the proposed rule with
regard to recordkeeping requirements because it was a companion
rulemaking to the interim final rule prohibiting the use of certain
cattle material in human medical products and animal drugs.
Recordkeeping alternatives were considered in the interim final rule.
Those same alternatives, plus any new ones presented in comments, will
be considered for the final rule.
There were several alternatives considered to the proposed additional
restrictions. These same alternatives, plus any new ones presented in
comments, will be considered for the final.
No additional restrictions.
Prohibit the use in higher risk human medical products of
listed neural tissues from cattle 12 months and older and all cattle
material from countries listed by APHIS as having unacceptable risk or
incidence of BSE, and prohibit the use in ruminant drugs of those
materials that are prohibited in ruminant feed.
Anticipated Cost and Benefits:
FDA believes this rule reflects current practices of most affected
manufacturers. The costs of this rule are the costs to industry of
assuring that prohibited materials are not used in the manufacture of
medical products and of conforming with additional restrictions on the
use of cattle material in certain medical products (implantable, etc.).
In addition, affected manufacturers will incur costs associated with
establishing and maintaining records to demonstrate compliance. By
reducing exposure to potentially infective materials, this rule will
provide an additional safeguard against a case of vCJD occurring in
humans if cattle infected with BSE are used in the manufacture or
processing of medical products.
Risks:
The benefits of finalizing the proposed rule with respect to its
recordkeeping requirements are derived from the benefits of the interim
final rule, which are the value of the public and animal health
benefits. The benefits of finalizing the proposed rule with respect to
its additional requirements are also the value of the public and animal
health benefits. The public and animal health benefit is the reduction
in the risk of the human or animal illness associated with exposure to
the agent that causes BSE.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 02/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Federalism:
Undetermined
[[Page 72724]]
Agency Contact:
Eric Flamm
Senior Policy Advisor, Office of Policy
Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner
5600 Fishers Lane
Room 15-61, HF-23
Rockville, MD 20857
Phone: 301 827-0891
Fax: 301 827-4774
Email: eric.flamm@fda.hhs.gov
RIN: 0910-AF55
_______________________________________________________________________
HHS--FDA
-----------
FINAL RULE STAGE
-----------
47. REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN
PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371; 42
USC 262
CFR Citation:
21 CFR 201
Legal Deadline:
None
Abstract:
This regulation is one component of the Secretary's initiative to
reduce medical errors. The regulation would amend the regulations
governing the format and content of professional labeling for human
prescription drugs (including biological products that are regulated as
drugs), 21 CFR 201.56 and 201.57. The regulation would require that
such labeling include a section containing highlights of prescribing
information, and a section containing a table of contents of
prescribing information; reorder currently required information and
make minor changes to its content, and establish minimum graphical
requirements.
Statement of Need:
The current format and content requirements in sections 201.56 and
201.57 were established in 1979 to help ensure that labeling includes
adequate information to enable health care practitioners to prescribe
drugs safely and effectively. However, various developments in recent
years, such as increasing product liability and technological advances
in drug product development, have contributed to an increase in the
amount, detail, and complexity of labeling information. This has made
it harder for practitioners to find specific information and to discern
the most critical information in labeling.
FDA took numerous steps to evaluate the usefulness of labeling for
practitioners and to determine whether, and how, its format and content
can be improved. The agency conducted focus groups and a national
survey of office-based physicians to ascertain how labeling is used by
health care practitioners, what labeling information is most important
to practitioners, and how labeling should be revised to improve its
usefulness to practitioners.
Based on the concerns cited by practitioners in the focus groups and
physician survey, FDA developed and tested two prototypes of revised
labeling formats designed to facilitate access to important labeling
information. Based on this testing, FDA developed a third revised
prototype that it made available to the public for comment. Ten written
comments were received on the prototype. FDA also presented the revised
prototype at an informal public meeting held on October 30, 1995. At
the public meeting, the agency also presented the background research
and provided a forum for oral feedback from invited panelists and
members of the audience. The panelists generally supported the
prototype.
The proposed rule, published in 2000, described format and content
requirements for prescription drug labeling that incorporate
information and ideas gathered during this process. The agency has
received several comments on the proposal and the comment period was
extended until June 22, 2001.
Summary of Legal Basis:
The agency has broad authority under sections 201, 301, 501, 502, 503,
505, and 701 of the Federal Food, Drug, and Cosmetic Act (the Act) (21
U.S.C. 321, 331, 351, 352, 353, 355, and 371) and section 351 of the
Public Health Service Act (42 U.S.C. 262) to help ensure that
prescription drugs (including biological products that are regulated as
drugs) are safe and effective for their intended uses. A major part of
FDA's efforts regarding the safe and effective use of drug products
involves FDA's review, approval, and monitoring of drug labeling. Under
section 502(f)(1) of the Act, a drug is misbranded unless its labeling
bears ``adequate directions for use'' or it is exempted from this
requirement by regulation. Under section 201.100 (21 CFR 201.100), a
prescription drug is exempted from the requirement in section 502(f)(1)
of the Act only if, among other things, it contains the information
required, in the format specified, by sections 201.56 and 201.57.
Under section 502(a) of the Act, a drug product is misbranded if its
labeling is false or misleading in any particular. Under section 505(d)
and 505(e) of the Act, FDA must refuse to approve an application and
may withdraw the approval of an application if the labeling for the
drug is false or misleading in any particular. Section 201(n) of the
Act provides that in determining whether the labeling of a drug is
misleading, there shall be taken into account not only representations
or suggestions made in the labeling, but also the extent to which the
labeling fails to reveal facts that are material in light of such
representations or material with respect to the consequences which may
result from use of the drug product under the conditions of use
prescribed in the labeling or under customary usual conditions of use.
These statutory provisions, combined with section 701(a) of the Act and
section 351 of the Public Health Service Act, clearly authorize FDA to
promulgate a final regulation designed to help ensure that
practitioners prescribing drugs (including biological products) will
receive information essential to their safe and effective use in a
format that makes the information easier to access, read, and use.
Alternatives:
The alternatives to the final rule include not amending the content and
format requirements in sections 201.56 and 201.57 at all, or amending
them to a lesser extent. The agency has determined that although drug
product labeling, as currently designed, is useful to physicians, many
find it difficult to locate specific information in labeling, and some
of the most frequently consulted and most important information is
obscured by other information. In addition, the agency's research
showed that physicians strongly support the concept of including a
highlights section of the most important prescribing information, a
table of contents and numbering system that permits specific
[[Page 72725]]
information to be easily located, and other requirements, such as the
requirement for a minimum type size. Thus, the agency believes that the
requirements in the final rule will greatly facilitate health care
practitioners' access and use of prescription drug and biological
product labeling information.
Anticipated Cost and Benefits:
The purpose of this rule is to make it easier for health care
practitioners to access, read and use information in prescription drug
labeling, thereby increasing the extent to which they rely on labeling
to obtain information. FDA believes the revisions to the content and
format of labeling will enhance the safe and effective use of
prescription drug products, and in turn, reduce the number of adverse
reactions resulting from medication errors due to misunderstood or
wrongly applied drug information. The new requirements are important to
the success of other initiatives aimed at improving patient care and
decreasing the likelihood of medication errors. For example, revised
labeling will facilitate initiatives to process, review and archive
labeling electronically and provide a mechanism to facilitate the
development of electronic prescribing systems.
The potential costs associated with the final rule include the cost of
redesigning labeling for previously approved products to which the
proposed rule would apply and submitting the new labeling to FDA for
approval. In addition, one-time and ongoing incremental costs would be
associated with printing the longer labeling that would result from
additional required sections. These costs would be minimized by
applying the amended requirements only to newer products and by
staggering the implementation date for previously approved products.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 81082 12/22/00
NPRM Comment Period End 03/22/01
NPRM Comment Period Reopened 03/30/01
NPRM Comment Period Reopening End 06/22/01
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Elizabeth J. Sadove
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research Administration
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA94
_______________________________________________________________________
HHS--FDA
48. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL
PRODUCTS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 USC 263; 42 USC
263a to 263-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC
351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21 USC 361a;
21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381
CFR Citation:
21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR 600; 21 CFR 601;
21 CFR 606
Legal Deadline:
None
Abstract:
This regulation is one component of the Secretary's initiative to
reduce medical errors. The final rule would amend the expedited and
periodic safety reporting regulations for human drugs and biological
products to revise certain definitions and reporting formats as
recommended by the International Conference on Harmonisation and to
define new terms; to add to or revise current reporting requirements;
to revise certain reporting time frames; and propose other revisions to
these regulations to enhance the quality of safety reports received by
FDA.
Statement of Need:
FDA currently has safety reporting requirements in section 21 CFR
312.32 for sponsors of investigational drugs for human use. FDA also
has safety reporting requirements in sections 21 CFR 310.305, 314.80,
314.98 and 600.80 and 600.81 for applicants, manufacturers, packers,
and distributors of approved human drug and biological products. FDA
has undertaken a major effort to clarify and revise these regulations
to improve the management of risks associated with the use of these
products. For this purpose, the agency is proposing to implement
certain definitions and reporting formats and standards recommended by
the International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH) to provide more
effective and efficient safety reporting to regulatory authorities
worldwide. Currently, the United States, European Union, and Japan
require submission of safety information for marketed drug and
biological products using different reporting formats and different
reporting intervals.
Summary of Legal Basis:
The agency has broad authority under sections 505 and 701 of the
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355 and 371)
and section 351 of the Public Health Service Act (42 U.S.C. 262) to
monitor the safety of drug and biological products for human use.
Alternatives:
The alternatives to the proposal include not amending our existing
safety reporting requirements. This alternative would be inconsistent
with FDA's efforts to harmonize its safety reporting requirements with
international initiatives and with its mission to protect public
health.
Anticipated Cost and Benefits:
Manufacturers of human drug and biological products currently have
limited incentives to invest capital and resources in standardized
global safety reporting systems because individual firms acting alone
cannot attain the economic gains of harmonization. This final rule
would harmonize FDA's
[[Page 72726]]
safety reporting requirements with certain international initiatives,
thereby providing the incentive for manufacturers to modify their
safety reporting systems. Initial investments made by manufacturers to
comply with the rule are likely to ultimately result in substantial
savings to them over time.
The impact on industry includes costs associated with revised safety
reporting and recordkeeping requirements. The benefits of the proposed
rule are public health benefits and savings to the affected industries.
The expected public health benefits would result from the improved
timeliness and quality of the safety reports and analyses, making it
possible for health care practitioners and consumers to expedite
corrective actions and make more informed decisions about treatments.
Savings to the affected industry would accrue from more efficient
allocation of resources resulting from international harmonization of
the safety reporting requirements.
Risks:
None
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 12406 03/14/03
NPRM Comment Period Extended 06/18/03
NPRM Comment Period End 07/14/03
NPRM Comment Period Extension End 10/14/03
Comment Review End 04/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Agency Contact:
Elizabeth J. Sadove
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research Administration
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA97
_______________________________________________________________________
HHS--FDA
49. CURRENT GOOD TISSUE PRACTICE FOR HUMAN CELL, TISSUE, AND CELLULAR
AND TISSUE-BASED PRODUCT ESTABLISHMENTS; INSPECTION AND ENFORCEMENT
Priority:
Other Significant
Legal Authority:
42 USC 216; 42 USC 243; 42 USC 263a; 42 USC 264; 42 USC 271
CFR Citation:
21 CFR 16; 21 CFR 1270; 21 CFR 1271
Legal Deadline:
None
Abstract:
The Food and Drug Administration (FDA) is requiring human cell, tissue,
and cellular and tissue-based product (HCT/P) establishments to follow
current good tissue practice (CGTP), which governs the methods used in,
and the facilities and controls used for, the manufacture of HCT/Ps,
recordkeeping, and the establishment of a quality program. FDA is also
issuing regulations pertaining to labeling, reporting, inspections, and
enforcement.
Statement of Need:
Donor screening and testing, although crucial, are not sufficient to
prevent the transmission of disease through HCT/Ps. Each step in the
manufacturing process needs to be controlled. Errors in labeling and
testing records, failure to adequately clean work areas, and faulty
packaging are examples of improper practices that could lead to a
product capable of transmitting disease to a recipient. The agency is
concerned about the spread of communicable disease through the use of
such products. CGTP requirements are a fundamental component of FDA's
risk-based approach to regulating HCT/Ps.
Summary of Legal Basis:
The Public Health Service Act (42 U.S.C. 264) authorizes FDA to
promulgate regulations to prevent the spread of communicable diseases.
HCT/Ps may transmit communicable diseases. The CGTP regulations are
essential to the prevention of communicable disease transmission.
Alternatives:
An alternative to the proposed approach would be to continue with the
use of voluntary industry standards. Reliance on industry's voluntary
standards for good tissue practice, rather than establishing regulatory
requirements, would not ensure uniform or consistent compliance and
would preclude the agency's ability to effectively monitor HCT/Ps to
ensure public health and safety.
Anticipated Cost and Benefits:
FDA has estimated that this rule would impose a total annualized cost
of about $8 million for the entire industry. The primary beneficiaries
of the proposed CGTP would be the patients who receive HCT/Ps. Benefits
to patients would result from the reduced risk of communicable disease
by avoiding product contamination through CGTP.
Risks:
FDA believes that the risks posed by requiring CGTP are minimal. In
contrast, failure to reduce the risk of transmission of communicable
disease through the use of HCT/Ps would jeopardize the public health.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 66 FR 1508 01/08/01
NPRM Comment Period End 05/08/01
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
State
[[Page 72727]]
Agency Contact:
Paula S. McKeever
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17)
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434
RIN: 0910-AB28
_______________________________________________________________________
HHS--FDA
50. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT
INCREASED RISK OF TRANSMITTING HCV INFECTION (LOOKBACK)
Priority:
Other Significant. Major under 5 USC 801.
Legal Authority:
21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21
USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264;
21 USC 372; 21 USC 372; 21 USC 381; 42 USC 263
CFR Citation:
21 CFR 606; 21 CFR 610
Legal Deadline:
None
Abstract:
This rulemaking is one of a number of actions being taken to amend the
biologics regulations to remove, revise, or update the regulations
applicable to blood, blood components, and blood derivatives. These
actions are based on FDA's comprehensive review of the biologics
regulations and on reports by the U.S. House of Representatives
Committee on Government Reform and Oversight's, Subcommittee on House
Resources and Intergovernmental Relations, the General Accounting
Office, and the Institute of Medicine, as well as on public comments.
In this rulemaking, FDA will amend the biologics regulations to require
that blood establishments prepare and follow written procedures for
appropriate action when it is determined that blood and blood
components pose an increased risk for transmitting hepatitis C virus
(HCV) infection because they have been collected from a donor who, at a
later date, tested reactive for evidence of HCV. The HIV lookback
regulations will be amended for consistency.
Statement of Need:
In the Federal Register of June 22, 1999 (64 FR 33309), FDA announced
the availability of guidance, which updated previous guidance,
providing recommendations for donor screening and further testing for
antibodies to HCV, notification of consignees, transfusion recipient
tracing and notification, and counseling by physicians regarding
transfusion with blood components at increased risk for transmitting
HCV (these activities are often called ``lookback''). FDA believes that
regulations should be established consistent with the recommendations,
to assure that there is clear enforcement authority in case
deficiencies in an establishment's lookback program are found and to
provide clear instructions for continuing lookback activities.
Summary of Legal Basis:
The Public Health Service Act (42 U.S.C. 201 et seq.) and the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) authorize FDA to
regulate biological products and to ensure that the products are safe,
pure, potent, and effective. The Public Health Service Act also
contains authority under which FDA can promulgate regulations to
prevent the spread of communicable diseases. This rulemaking would
assure that appropriate action is taken when blood has been collected
which may potentially be capable of transmitting HCV; that persons who
have been transfused with such blood components are notified so that
they receive proper counseling and treatment; and that infected donors
are notified. These regulations will therefore help prevent the further
transmission of HCV.
Alternatives:
FDA has considered permitting continued voluntary compliance with the
recommendations that have already been issued. However, lookback will
remain appropriate for the foreseeable future, and FDA believes that
the procedures should be clearly established in the regulations.
Anticipated Cost and Benefits:
FDA is in the process of analyzing the costs related to the rulemaking.
Monetary burdens will be associated with the tracing of previous
donations of donors, quarantining in-date products, identifying the
recipients of previous blood donations, and notifying these recipients,
as appropriate. FDA believes that these costs will be more than
balanced by the public health benefits, including benefits related to
the notification of past transfusion recipients who may be unaware that
they may be infected with HCV.
Risks:
FDA believes that there are minimum risks posed by requiring that
appropriate lookback procedures for HCV be prepared and followed.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 69377 11/16/00
NPRM Comment Period End 02/14/01
Final Action 03/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Paula S. McKeever
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17)
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434
Related RIN: Related to 0910-AB26
RIN: 0910-AB76
_______________________________________________________________________
HHS--FDA
51. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
[[Page 72728]]
Legal Authority:
21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371; 21 USC 374;
21 USC 381; 21 USC 393; 42 USC 264
CFR Citation:
21 CFR 111
Legal Deadline:
None
Abstract:
The Food and Drug Administration proposed in the Federal Register of
March 13, 2003 (68 FR 12158), current good manufacturing practice
(CGMP) regulations for dietary ingredients and dietary supplements. The
proposed rule was published to establish the minimum CGMPs necessary to
ensure that, if firms engage in activities related to manufacturing,
packaging, or holding dietary ingredients of dietary supplements, they
do so in a manner that will not adulterate and misbrand such dietary
ingredients or dietary supplements. FDA also proposed to require
manufacturers to evaluate the identity, purity, quality, strength, and
composition of their dietary ingredients and dietary supplements. The
proposed rule also responds to concerns that such regulations are
necessary to ensure that consumers are provided with dietary supplement
products which have not been adulterated as a result of manufacturing,
packing, or holding, e.g., which have the identity and provide the
quantity of dietary ingredients declared in labeling.
Statement of Need:
FDA intends to publish a final rule to establish CGMP for dietary
supplements and dietary ingredients for several reasons. First, FDA is
concerned that some firms may not be taking appropriate steps during
the manufacture of dietary supplements and dietary ingredients to
ensure that products are not adulterated as a result of manufacturing,
packing, or holding. There have been cases of misidentified ingredients
harming consumers using dietary supplements. FDA is also aware of
products that contain potentially harmful contaminants because of
apparently inadequate manufacturing controls and quality control
procedures. The agency believes that a system of CGMPs is the most
effective and efficient way to ensure that these products will not be
adulterated during manufacturing, packing, or holding.
Summary of Legal Basis:
If CGMP regulations were adopted by FDA, failure to manufacture, pack,
or hold dietary supplements or dietary ingredients under CGMP
regulations would render the dietary supplement or dietary ingredients
adulterated under section 402(g) of the Act.
Alternatives:
The two principal alternatives to comprehensive CGMPs are end product
testing and Hazard Analysis Critical Control Points (HACCP). The agency
asked whether different approaches may be better able to address the
needs of the broad spectrum of firms that conduct one or more distinct
operations, such as the manufacture of finished products, or solely the
distribution and sale of finished products at the wholesale or retail
level.
Anticipated Cost and Benefits:
The costs of the regulation will include the value of resources devoted
to increased sanitation, process monitoring and controls, testing, and
written records. The benefits of the proposed regulation are to improve
both product safety and quality. We estimate that the proposed
regulation will reduce the number of sporadic human illnesses and rare
catastrophic illnesses from contaminated products. The current quality
of these products is highly variable, and consumers lack information
about the potential hazards and variable quality of these products. The
product quality benefits occur because there will be fewer product
recalls and more uniform products will reduce consumer search for
preferred quality products. The proposed rule will have a significant
impact on a substantial number of small businesses, so it will be
significant under the Regulatory Flexibility Act. We anticipate that
small businesses will bear a proportionately larger cost than large
businesses.
Risks:
Any potential for consumers to be provided adulterated (e.g.,
contaminated with industrial chemicals, pesticides, microbial
pathogens, or dangerous misidentified ingredients or toxic components
of ingredients) products must be considered a very serious risk because
of the possibility that such contamination could be widespread,
affecting whole segments of the population, causing some severe long-
term effects and even loss of life. Dietary supplements are used by a
large segment of the American public. Moreover, they are often used by
segments of the population that are particularly vulnerable to
adulterated products, such as the elderly, young children, pregnant and
nursing women, and persons who may have serious illnesses or are taking
medications that may adversely interact with dietary supplements. FDA
has adopted or proposed manufacturing controls for a number of foods
and commodities that present potential health hazards to consumers if
not processed properly, including seafood, juice products, and fruits
and vegetables, and it is appropriate that FDA consider whether
manufacturing controls are necessary to assure consumers that dietary
supplements are not adulterated during the manufacturing, packing, or
holding process.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 62 FR 5700 02/06/97
ANPRM Comment Period End 06/06/97
NPRM 68 FR 12157 03/13/03
NPRM Comment Period End 08/11/03
Final Action 03/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Linda Kahl
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-206
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 202 418-3101
Fax: 202 418-3131
Email: linda.kahl@hhs.fda.gov
RIN: 0910-AB88
_______________________________________________________________________
HHS--FDA
52. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS
Priority:
Economically Significant. Major under 5 USC 801.
[[Page 72729]]
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 393; 42 USC 243;
42 USC 264; 42 USC 271; . . .
CFR Citation:
21 CFR 16; 21 CFR 116; 21 CFR 118
Legal Deadline:
None
Abstract:
In July 1999, the Food and Drug Administration (FDA) and the Food
Safety Inspection Service (FSIS) committed to developing an action plan
to address the presence of salmonella enteritidis (SE) in shell eggs
and egg products using a farm-to-table approach. FDA and FSIS held a
public meeting on August 26, 1999, to obtain stakeholder input on the
draft goals, as well as to further develop the objectives and action
items for the action plan. The Egg Safety Action Plan was announced on
December 11, 1999. The goal of the Action Plan is to reduce egg-related
SE illnesses by 50 percent by 2005 and eliminate egg-related SE
illnesses by 2010.
The Egg Safety Action Plan consists of eight objectives covering all
stages of the farm-to-table continuum as well as support functions. On
March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July
31, 2000 (Washington, DC), joint public meetings were held by FDA and
FSIS to solicit and discuss information related to the implementation
of the objectives in the Egg Safety Action Plan.
In accordance with discussions at the public meetings, FDA intends to
publish a proposed rule to require that shell eggs be produced under a
plan that is designed to prevent transovarian SE from contaminating
eggs at the farm during production.
FDA intends to discuss in its proposal certain provisions of the 1999
Food Code that are relevant to how eggs are handled, prepared, and
served at certain retail establishments. In addition, the agency plans
to consider whether it should require provisions for certain retail
establishments that serve populations most at risk of egg-related
illness (i.e., the elderly, children, and the immunocompromised).
Statement of Need:
FDA is proposing regulations as part of the farm-to-table safety system
for eggs outlined by the President's Council on Food Safety in its Egg
Safety Action Plan. FDA intends to propose these regulations because of
the continued reports of outbreaks of foodborne illness and death
caused by SE that are associated with the consumption of shell eggs.
The agency believes these regulations can have significant effect in
reducing the risk of illness from SE-contaminated eggs and will
contribute significantly to the interim public health goal of the Egg
Safety Action Plan of a 50 percent reduction in egg-related SE illness
by 2005.
Summary of Legal Basis:
FDA's legal basis for the proposed rule derives in part from sections
402(a)(4), and 701(a) of the Federal Food, Drug and Cosmetic Act (the
Act) ((21 U.S.C. 342(a)(4) and 371(a)). Under section 402(a)(4) of the
Act, a food is adulterated if it is prepared, packed, or held in
insanitary conditions whereby it may have been contaminated with filth
or may have been rendered injurious to health. Under section 701(a) of
the Act, FDA is authorized to issue regulations for the efficient
enforcement of the Act. FDA also intends to rely on section 361 of the
Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA
authority to promulgate regulations to control the spread of
communicable disease.
Scientific reports in published literature and data gathered from
existing voluntary egg quality assurance programs indicate that
measures designed to prevent SE from entering a poultry house (e.g.,
rodent/pest control, use of chicks from SE-monitored breeders, and
biosecurity programs) can be very effective in reducing SE-
contamination of eggs and related foodborne illness.
Alternatives:
There are several alternatives that the agency intends to consider in
the proposed rule. The principal alternatives include: (1) no new
regulatory action; (2) alternative testing requirements; (3)
alternative on-farm prevention measures; (4) alternative retail
requirements; and (5) HACCP.
Anticipated Cost and Benefits:
The benefits from the proposed regulation to control Salmonella
Enteritidis in shell eggs on the farm derive from better farming
practices. Improved practices reduce contamination and generate
benefits measured as the value of the human illnesses prevented. FDA
has produced preliminary estimates of costs and benefits for a number
of options. The mitigations considered include on-farm rodent control,
changes in retail food preparation practices, diversion of eggs from
infected flocks to pasteurization, record keeping, refrigeration, and
feed testing. The actual costs and benefits of the proposed rule will
depend upon the set of mitigations chosen and the set of entities
covered by the proposed rule.
Risks:
Any potential for contamination of eggs with SE and its subsequent
survival or growth must be considered a very serious risk because of
the possibility that such contamination, survival, and growth could
cause widespread foodborne illness, including some severe long-term
effects and even loss of life. FDA made a decision to publish a
proposed rule that would include SE prevention measures, based on a
considerable body of evidence, literature, and expertise in this area.
In addition, this decision was also based on the USDA risk assessment
on SE in shell eggs and egg products and the identified public health
benefits associated with controlling SE in eggs at the farm and retail
levels.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 56824 09/22/04
Final Action 09/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Agency Contact:
Rebecca Buckner
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
HFS-366
College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: rebecca.buckner@cfsan.fda.gov
RIN: 0910-AC14
[[Page 72730]]
_______________________________________________________________________
HHS--FDA
53. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN
DRUGS
Priority:
Other Significant
Legal Authority:
21 USC 355b
CFR Citation:
21 CFR 201; 21 CFR 208; 21 CFR 209
Legal Deadline:
Final, Statutory, January 4, 2003.
Abstract:
To require the labeling of human drugs approved under section 505 of
the Federal Food, Drug, and Cosmetic Act to include a toll-free number
for reports of adverse events, and a statement that the number is to be
used for reporting purposes only and not to receive medical advice.
Statement of Need:
Consumers may not be aware of FDA's adverse event reporting program
under Medwatch. This requirement will promote FDA's mission to protect
the public health by informing consumers of FDA's Medwatch system.
Summary of Legal Basis:
Section 17 of the Best Pharmaceuticals for Children Act (BPCA) requires
a final rule to issue within one year of the date of its enactment on
January 4, 2002.
Alternatives:
This rule is required by section 17 of the BPCA. FDA has considered
alternatives within the scope of the statutory requirements, in
particular, ways to reach the broadest consumer audience and to
minimize costs to the pharmacy profession.
Anticipated Cost and Benefits:
Anticipated costs are to drug manufacturers and authorized dispensers
of drug products, including pharmacies. The BPCA contains a provision
requiring the Secretary to seek to minimize the cost to the pharmacy
profession. Anticipated benefits are to obtain information about
adverse events from consumers, which may inform FDA of trends in
reported adverse events and result in a review of the safety and/or
effectiveness of particular drug products on the market.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 21778 04/22/04
NPRM Comment Period End 07/21/04
Final Action 05/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Carol Drew
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC35
_______________________________________________________________________
HHS--FDA
54. ESTABLISHMENT AND MAINTENANCE OF RECORDS PURSUANT TO THE PUBLIC
HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
PL 107-188, sec 306
CFR Citation:
21 CFR 1
Legal Deadline:
None
Abstract:
This rulemaking is one of a number of actions being taken to improve
FDA's ability to respond to threats of bioterrorism. Section 414(b) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by
section 306 of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (the Act), authorizes the Secretary, through
FDA, to promulgate final regulations by December 12, 2003. The Act
authorizes regulations that require the establishment and maintenance
of records, for not longer than two years, that would allow the
Secretary to identify the immediate previous sources and the immediate
subsequent recipients of food, including its packaging. The required
records would be those that are needed by FDA in order to address
credible threats of serious adverse health consequences or death to
humans or animals. Specific covered entities are those that
manufacture, process, pack, transport, distribute, receive, hold, or
import food. Farms and restaurants are excluded. The Secretary is
directed to take into account the size of a business in promulgating
these regulations. Section 306 of the Act also added section 414(a) and
amended section 704(a) of FFDCA to permit FDA to inspect these records
and other information if the Secretary has a reasonable belief that an
article of food is adulterated and presents a threat of serious adverse
health consequences or death to humans or animals.
Statement of Need:
The events of September 11, 2001, highlighted the need to enhance the
security of the U.S. food supply. Congress responded by passing the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (the Bioterrorism Act), which was signed into law on June 12,
2002. The regulations will implement section 306 of the Bioterrorism
Act.
Summary of Legal Basis:
Section 306 of the Bioterrorism Act amended the FFDCA by adding section
414(b), which authorizes the Secretary to establish by regulation
requirements for the creation and maintenance of records. That section
of the Bioterrorism Act also added section 414(a) and amended section
704(a) of the FFDCA to permit FDA to inspect records and other
information under certain circumstances. In addition, section 306 of
the Bioterrorism Act also amends section 301 of the Federal Food, Drug,
and Cosmetic Act by making the failure to establish or maintain any
record required by the new regulations, or refusal to permit access to
those records or other information as required by the new regulations,
a prohibited act.
[[Page 72731]]
Alternatives:
None.
Anticipated Cost and Benefits:
The records provisions will be classified as significant under
Executive Order 12866 (having an annual effect on the economy of over
$100 million). The recordkeeping provisions would impose a substantial
cost on industry. A first estimate is that the proposed provisions will
cost the food industry approximately $235 million in the first year,
approximately $510 million in the second year, and approximately $220
million every year there after.
The provisions will improve substantially FDA's ability to respond to
outbreaks from deliberate and accidental contamination of food. FDA
will use data collected by the Center for Disease Control and
Prevention (CDC) and FDA on past outbreaks to estimate the benefit of
improved documentation in standard tracing investigations. Of the 1,344
food-borne illness outbreaks CDC identified in 1999, only 368 (27
percent) had a confirmed etiology. A host of factors contribute to the
inability to identify the cause of an outbreak, but many investigations
are hampered by the lack of adequate records identifying the chain of
custody of foods. While it is not possible to directly estimate the
benefits of averting a terrorist attack, as we do not know what form an
attack might take or the probability of an attack occurring, FDA uses
data collected by the agency on past outbreaks to estimate the benefit
of the recordkeeping provisions on standard traceback investigations.
Specifically, we estimate the number of illnesses averted from faster
tracebacks and higher traceback completion rates that will result from
improved recordkeeping practices.
Risks:
Regulations implementing legislation to protect the health of citizens
against bioterrorism would advance the development, organization, and
enhancement of public health prevention systems and tools. The
magnitude of the risks addressed by such systems and tools is at least
as great as the other risk reduction efforts within HHS' jurisdiction.
These regulations will improve the ability to address credible threats
of serious adverse health consequences or death to humans or animals.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 25188 05/09/03
NPRM Comment Period End 07/08/03
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
URL For More Information:
www.fda.gov/oc/bioterrorism/bioact.html
URL For Public Comments:
www.fda.gov/ohrms/dockets/02n0277/02n0277.htm
Agency Contact:
Nega Beru
Supervisory Chemist, Office of Plant, Dairy Foods and Beverages
Department of Health and Human Services
Food and Drug Administration
HFS-305
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1400
Fax: 301 436-2651
Email: nberu@cfsan.fda.gov
RIN: 0910-AC39
_______________________________________________________________________
HHS--FDA
55. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
PL 107-188, sec 305
CFR Citation:
21 CFR 1
Legal Deadline:
Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, section 305, directs the Secretary, through FDA, to issue
a final regulation establishing registration requirements by December
12, 2003. The statute is self-implementing on this date if FDA does not
issue a final regulation that is effective by December 12, 2003.
Abstract:
This rulemaking is one of a number of actions being taken to improve
FDA's ability to respond to threats of bioterrorism and other foodborne
illness emergencies. Section 415 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), which was added by section 305 of the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(the Bioterrorism Act), directs the Secretary to require facilities
engaged in manufacturing, processing, packing, or holding of food for
consumption in the United States to be registered with the Secretary.
Section 415 directs the Secretary to promulgate final regulations
implementing the requirements by December 12, 2003. The owner,
operator, or agent in charge of the facility must submit the
registration. Foreign facilities must include the name of the United
States agent for the facility. The registration must include the name
and address of each facility at which, and all trade names under which,
the registrant conducts business. If the Secretary determines it is
necessary through guidance, the registration must include the general
food category (as identified under 21 CFR 170.3) of foods manufactured,
processed, packed, or held at the facility. The registrant is required
to notify the Secretary of changes to the information contained in the
registration in a timely manner. Under the interim final rule (IFR)
published on October 10, 2003 (68 FR 58894), upon receipt of the
completed registration form, FDA will notify the registrant of receipt
of the registration and assign a unique registration number to the
facility. Section 415 requires the Secretary to compile and maintain an
up-to-date list of registered facilities. This list and any
registration documents submitted to the Secretary are not subject to
disclosure under the Freedom of Information Act. For purposes of
section 415, ``facility'' includes any factory, warehouse, or
establishment engaged in the manufacturing, processing, packing, or
holding of food. Exempt from the registration requirement are farms,
restaurants, other retail food establishments, nonprofit food
establishments in which food is prepared for or served directly to the
[[Page 72732]]
consumer, and fishing vessels (except those engaged in processing as
defined in 21 CFR 123.3(k)). Foreign facilities required to register
include only those from which food is exported to the United States
without further processing or packaging outside the United States. The
Bioterrorism Act provides that if food from an unregistered foreign
facility is offered for import into the United States, the food will be
held at the port of entry or at a secure facility, until the foreign
facility has registered. On April 14, 2004, FDA issued a notice
reopening for 30 days, on a limited range of issues, the comment period
on the IFR. FDA took this action consistent with its statement in the
IFR that it would reopen the comment period for 30 days in order to
ensure that those commenting on the IFR had the benefit of FDA's
outreach and educational efforts and had experience with the systems,
timeframes, and data elements of the registration system.
Statement of Need:
The events of September 11, 2001, highlighted the need to enhance the
security of the U.S. food supply. Congress responded by passing the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002, which was signed into law on June 12, 2002. This regulation is
required by the Bioterrorism Act and is needed to implement the new
statutory provision.
Summary of Legal Basis:
Section 305 of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (the Bioterrorism Act) amends the FFDCA by
adding section 415, which directs the Secretary to establish by
regulation requirements for the registration of food and animal feed
facilities. Section 305 amends section 301 of the FFDCA by making the
failure to register in accordance with section 415 a prohibited act.
Section 305 also amends section 801 of the FFDCA by requiring that food
from an unregistered foreign facility that is offered for import into
the United States be held at the port of entry or at a secure facility
until the foreign facility has registered.
Alternatives:
None, based on clear statutory directive to establish the regulation.
Anticipated Cost and Benefits:
Costs: Requiring registration for domestic and foreign facilities that
manufacture, process, pack, or hold food will create costs for
facilities to register and for FDA to set up and administer a database
of firms. Industry costs are primarily a function of the number of
firms affected and the amount of labor needed to register those
facilities. Foreign facilities are required to hire U.S. agents. FDA
estimates that 216,721 domestic establishments and 205,405 foreign
establishments covered by the statute and IFR will bear a cost of
approximately $23 million and $306 million, respectively, in the first
year. Annual costs will include new registration updates and fees for
United States agents. For domestic facilities annual costs will be $6.9
million. For foreign facilities annual costs will be $228.8 million.
FDA's costs will include labor hours, hardware, software, and mailing
costs for creating and administering a database. The costs to the
agency for setting up the database and registering the first year
registrants are estimated to be $13.2 million. This includes four FDA
FTEs, contractor development of the database, hardware, software,
industry outreach, and a firewall. The costs for maintaining the
database and adding new establishments are estimated to be $8 million
in the second year. Total first year costs will be $342.2 million and
second year costs will be $243.7 million. In the IFR, FDA requested
comment on certain issues relating to the costs of the U.S. Agent
requirement.
Benefits: These provisions will improve FDA's ability to respond to
outbreaks from accidental and deliberate contamination of food and
deter deliberate contamination. It is not possible to directly estimate
the benefits of averting a terrorist attack, as FDA does not know the
probability of an attack occurring or the reduction in risk resulting
from registration. Instead, in order to estimate the benefits of
averting foodborne emergencies, the IFR evaluates the costs of some
severe foodborne illness outbreaks.
Risks:
Regulations implementing legislation to protect the health of citizens
against bioterrorism will advance the development, organization, and
enhancement of public health prevention systems and tools. The
magnitude of the risks addressed by such systems and tools is at least
as great as the other risk reduction efforts within HHS' jurisdiction.
This will improve the ability to address credible bioterrorist threats
to food for humans or animals, and other food-related public health
emergencies.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 5377 02/03/03
Interim Final Ru68 FR 58894 10/10/03
Interim Final Ru69 FR 19766Period Reopened 04/14/04
Interim Final Rule Comment Period Reopened End 05/14/04
Final Rule 06/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Catherine Copp
Special Assistance to the Associate Director, Office of Regulations and
Policy
Department of Health and Human Services
Food and Drug Administration
Center for Food and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1589
Fax: 301 436-2637
Email: catherine.copp@cfsan.fda.gov
RIN: 0910-AC40
_______________________________________________________________________
HHS--FDA
56. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND
BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 107-188, sec 307
CFR Citation:
21 CFR 1.276 et seq
Legal Deadline:
Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, section 307, directs the Secretary, through FDA, to issue
final regulations establishing prior notice requirements for all
imported food by December 12, 2003. If FDA fails
[[Page 72733]]
to issue final regulations by this date, the statute is self-executing
on this date, and requires FDA to receive prior notice of not less than
eight hours, nor more than five days until final regulations are
issued.
Abstract:
This rulemaking is one of a number of actions being taken to improve
FDA's ability to respond to threats of bioterrorism. Section 801(m) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by
section 307 of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002, authorizes the Secretary, through FDA, to
promulgate final regulations by December 12, 2003. Section 801(m)
requires notification to FDA prior to the entry of imported food. The
required prior notice would provide the identity of the article of
food; the manufacturer; the shipper; the grower, if known at the time
of notification; the originating country; the shipping country; and the
anticipated port of entry. The regulation identifies the parties
responsible for providing the notice and explains the information that
the prior notice is required to contain, the method of submission of
the notice, and the minimum and maximum period of advance notice
required. Section 307 also states that if FDA does not receive prior
notice or receives inadequate prior notice, the imported food shall be
refused admission and held at the port of entry until proper notice is
provided.
Statement of Need:
The events of September 11, 2001, highlighted the need to enhance the
security of the U.S. food supply. Congress responded by passing the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (the Bioterrorism Act), which was signed into law on June 12,
2002. The regulations implement section 307 of the Bioterrorism Act.
Summary of Legal Basis:
Section 307 of the Bioterrorism Act amended the FFDCA by adding section
801(m), which authorizes the Secretary through FDA to establish by
regulation requirements for the notification to FDA prior to the entry
of imported food. In addition, section 307 of the Bioterrorism Act also
amends section 301 of the FFDCA by making the offering of a food for
import or the importing of a food without prior notification, as
required by the new regulations, a prohibited act.
Alternatives:
None, based on clear statutory directive to establish regulations.
Anticipated Cost and Benefits:
The prior notification provision is an economically significant
regulatory action. For the calendar year 2002, there were approximately
5.2 million human and animal food line items imported into U.S.
commerce by airplane, train, vessel, and truck.
This final rule will require that FDA be notified prior to the arrival
of the food. This rule may cause changes in current business practices
for some importers, most likely those persons importing fresh produce
and seafood. Costs will include the costs of preparing the prior
notice, and the costs associated with delayed entry of fresh produce
and seafood.
FDA costs will include the labor hours, hardware, and software costs to
develop a stand-alone technology system to handle prior notice entries.
Having prior notice of imported food will help deter deliberate and
accidental contamination of food shipments. Knowledge of when, where,
and how imported food will enter the United States will help mitigate
the effects of any potential food contamination issues.
It is not possible to directly estimate the benefits of averting a
terrorist attack, as we do not know what form an attack might take or
the probability of an attack occurring. However, we can look at some
outbreaks attributed to imported foods to estimate the benefits of
having prior notice.
Risks:
Regulations implementing legislation to protect the health of citizens
against bioterrorism and other public health threats would advance the
development, organization and enhancement of public health prevention
systems and tools. The magnitude of the risks addressed by such systems
and tools is at least as great as the other risk reduction efforts
within HHS' jurisdiction. These regulations will improve the FDA's
ability to address bioterrorism events and public-health threats
associated with imported food.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 5428 02/03/03
Interim Final Ru68 FR 58974 10/10/03
Interim Final Ru69 FR 19763Period Reopened 04/14/04
Interim Final Rule Comment Period Reopened End 07/13/04
Final Rule 06/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Agency Contact:
Mary Ayling
Lead, Inspection and Compliance Team, Food Safety Staff
Department of Health and Human Services
Food and Drug Administration
HFS-32
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-2131
Fax: 301 436-2605
Email: mary.ayling@cfsan.fda.gov
RIN: 0910-AC41
_______________________________________________________________________
HHS--FDA
57. USE OF OZONE-DEPLETING SUBSTANCES: REMOVAL OF ESSENTIAL USE
DESIGNATION; ALBUTEROL
Priority:
Economically Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
15 USC 402; 15 USC 409; 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342;
21 USC 343; 21 USC 346a; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC
355; 21 USC 360b; 21 USC 361; 21 USC 362; 21 USC 371; 21 USC 372; 21
USC 374; 42 USC 7671 et seq
CFR Citation:
21 CFR 2.125
Legal Deadline:
None
Abstract:
Under the Clean Air Act, the Food and Drug Administration (FDA) within
the U.S. Department of Health and Human Services, in consultation with
the
[[Page 72734]]
Environmental Protection Agency, is required to determine whether an
FDA-regulated product that releases an ozone-depleting substance (ODS)
is essential. The two agencies have tentatively determined that the two
currently marketed non-ODS metered-dose inhalers (MDIs) will be
satisfactory alternatives to albuterol MDIs that contain ODS, and have
proposed to remove the essential use designations for albuterol MDIs.
If the essential use designation is removed, albuterol MDIs that
contain an ODS could not be marketed after a suitable transition
period. The proposed rule specifically asked for comments on which
phase-out period length will best ensure a smooth transition and
minimize any adverse affects on the public health.
Statement of Need:
Chlorofluorocarbons (CFCs) are organic compounds that contain carbon,
chlorine, and fluorine atoms. CFCs were first used commercially in the
early 1930's and were later found to be useful as propellants in self-
pressurized aerosol products, such as MDIs. CFCs are very stable in the
troposphere--the lowest part of the atmosphere. They move to the
stratosphere, a region that begins about 10-16 kilometers (km) (6-10
miles) above Earth's surface and extends up to about 50 km (31 miles)
altitude. Within the stratosphere there is a zone about 15-40 km (10-25
miles) above the Earth's surfaces in which ozone is relatively highly
concentrated. The zone in the stratosphere is generally called the
ozone layer. Once in the stratosphere, CFCs are broken down by strong
ultraviolet light, where they release chlorine atoms that then deplete
stratospheric ozone. Depletion of stratospheric ozone by CFCs and other
ODS will lead to higher UVB levels, which in turn will cause increased
skin cancers and cataracts and potential damage to some marine
organisms, plants, and plastics.
The link between CFCs and the depletion of stratospheric ozone was
discovered in the mid-1970's. Since 1978, the U.S. government has
pursued a consistent policy of limiting the production and use of ODS,
including CFCs.
Summary of Legal Basis:
The Clean Air Act and EPA's implementing regulations contain general
prohibitions on the use and manufacture of ODS, such as CFCs.
Exceptions to these bans are provided for specific medical products
that FDA, in consultation with EPA, has found to be essential. FDA's
essential use determinations have been contained in 21 CFR section
2.125.
FDA published a new 21 CFR section 2.125 in the Federal Register on
July 24, 2002 (67 FR 48370), (corrected in the Federal Registers of
July 30, 2002 (67 FR 49396), and September 17, 2002 (67 FR 58678)).
Section 2.125 provides criteria for determining when a use is essential
and when a use is no longer essential. The procedures to determine when
a use is no longer essential were implemented to better carry out
responsibilities under both the Clean Air Act and the Montreal Protocol
on Substances that Deplete the Ozone Layer, (September 16, 1987, S.
Treaty Doc. No. 10, 100th Cong., 1st sess., 26 I.L.M. 1541 (1987)).
Fran Du Melle, Executive Vice President of the American Lung
Association, submitted a citizen petition on behalf of the U.S.
Stakeholders Group on MDI Transition on January 29, 2003 (Docket No.
03P-0029/CP1). The petition requested that FDA initiate rulemaking to
remove the essential use designation of albuterol MDIs. After
evaluating the petition, comments submitted in response to the
petition, and other information, FDA has tentatively determined that
albuterol MDIs meet the criteria in section 2.125, and proposed a rule
to remove other essential-use designations.
Alternatives:
In the proposed rule, FDA specifically requested comments on the best
effective date for any final rule to remove the essential use status of
albuterol MDIs. FDA is considering which dates will allow manufacturers
to obtain the capacity to produce adequate numbers of non-ODS albuterol
MDIs. FDA is also considering which dates might minimize any financial
burden on patients who would have to switch to non-ODS albuterol MDIs.
Anticipated Cost and Benefits:
The expected benefit from this rulemaking, as part of an overall policy
to eliminate production and use of ODSs, is the preservation of the
Earth's stratospheric ozone.
Currently there are generic versions of ODS albuterol MDIs, while there
are no generic non-ODS albuterol MDIs. This rulemaking could force
patients to switch from lower-priced generic versions of ODS albuterol
MDIs to higher-priced non-ODS albuterol MDIs.
Risks:
FDA is concerned about the possibility that some patients might stop
using needed drugs because the prices of non-ODS albuterol MDIs might
be higher than those of ODS albuterol MDIs.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 33602 06/16/04
NPRM Comment Period End 08/16/04
Final Action 03/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Wayne H. Mitchell
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: mitchellw@cder.fda.gov
RIN: 0910-AF18
_______________________________________________________________________
HHS--FDA
58. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND
COSMETICS
Priority:
Other Significant
Legal Authority:
21 USC 342; 21 USC 361; 21 USC 371
CFR Citation:
21 CFR 189.5; 21 CFR 700.27
Legal Deadline:
None
Abstract:
On July 14, 2004, FDA issued an interim final rule, effective
immediately, to prohibit the use of certain cattle material, to address
the potential risk of bovine spongiform encephalopathy (BSE), in human
food,
[[Page 72735]]
including dietary supplements, and cosmetics. Prohibited cattle
materials include specified risk materials, small intestine of all
cattle, material from nonambulatory disabled cattle, material from
cattle not inspected and passed for human consumption, and mechanically
separated (MS) (Beef). Specified risk materials are the brain, skull,
eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the
vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia
of cattle 30 months and older; and the tonsils and distal ileum of the
small intestine of all cattle. Prohibited cattle materials do not
include tallow that contains no more than 0.15 percent hexane-insoluble
impurities and tallow derivatives. This action minimizes human exposure
to materials that scientific studies have demonstrated are highly
likely to contain the BSE agent in cattle infected with the disease.
Scientists believe that the human disease variant Creutzfeldt-Jakob
disease (vCJD) is likely caused by the consumption of products
contaminated with the agent that causes BSE. After reviewing comments
received to the interim final rule, FDA will finalize the prohibitions
on certain cattle material.
Statement of Need:
FDA is taking this action in response to the finding of an adult cow,
imported from Canada, that tested positive for BSE in the State of
Washington. This action will minimize human exposure to materials that
scientific studies have demonstrated are highly likely to contain the
BSE agent in cattle infected with the disease. Scientists believe that
the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely
caused by the consumption of products contaminated with the agent that
causes BSE.
Summary of Legal Basis:
FDA's legal basis for the IFR derived from the adulteration provisions
in sections 402(a)(2)(C), 402(a)(3), 402(a)(4), 402(a)(5), 601(c), and
under section 701(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. sections 342(a)(2)(C), 342(a)(3), 342(a)(4), 342(a)(5), 361(c),
and 371(a)). Under section 402(a)(3) of the Act, a food is deemed
adulterated ``if it consists in whole or in part of any filthy, putrid,
or decomposed substance, or if it is otherwise unfit for food.''
Because of the discovery of a BSE positive cow in the United States and
the possibility of disease transmission to humans from exposure to
material from infected cattle, BSE risk materials are unfit for food.
Furthermore, some cattle are not inspected and passed because they have
died before slaughter. Material from these cattle is adulterated under
section 402(a)(5). The failure to ensure that food or cosmetics are
prepared, packed, or held under conditions in which BSE risk materials
do not contaminate the food or cosmetics constitutes an insanitary
condition whereby the food or cosmetics may have been rendered
injurious to health and thus renders the food or cosmetics adulterated
under section 402(a)(4) or 601(c).
We are also relying on the food additive provision in section
402(a)(2)(C). Because neither a food additive regulation nor an
exemption is an effect for BSE risk materials intended for use in human
food, such materials, with the exception of dietary ingredients in
dietary supplements, are adulterated under section 402(a)(2)(C) of the
act and their presence in food renders the food adulterated. Finally,
requiring measures to prevent food and cosmetics from being adulterated
allows for efficient enforcement of the act under section 701(a). Once
material is removed from cattle, we may not be able to obtain the
information necessary to determine whether it is BSE risk material.
Therefore, the records access requirement is also necessary for the
efficient enforcement of this rule.
Alternatives:
There were several alternatives considered to the interim final rule.
These same alternatives, plus any new ones presented in comments, will
be considered for the final.
No new regulation.
Prohibit the use of prohibited cattle materials in human food
and cosmetics and require access to existing records relevant to
determine compliance.
Prohibit the use of prohibited cattle materials in human food
and cosmetics and require establishment, maintenance, and access to
records demonstrating that prohibited cattle materials are not used in
human food and cosmetics.
Anticipated Cost and Benefits:
We expect the social cost of the final rule, which we approximate by
multiplying the difference in ingredient prices by the preregulation
quantity of ingredients, will be borne by producers and consumers of
affected products. If demand is inelastic compared with supply,
consumers will bear most of the social cost. If supply is inelastic
compared with demand, producers will bear most of the social cost. The
ready availability of alternatives for the prohibited ingredients, and
the small number of products currently using them, implies that the
social costs of this rule will likely be small for foods. The social
costs for cosmetics will be greater. We estimate that the cost of
ingredient switching for cosmetics will range from a lower bound of $0
to an upper bound of $18 million. The benefit of the final rule is that
its requirements will-by reducing exposure to potentially infective
materials-provide a safeguard against a case of vCJD occurring in
humans if cattle infected with BSE enter the human food or cosmetic
supply.
Risks:
The benefits of the final rule will be the value of the public health
benefits. The public health benefit is the reduction in the risk of the
human illness associated with consumption of the agent that causes BSE.
The Harvard-Tuskegee risk assessment has stated that a ban on specified
risk materials, including cattle brains, spinal cord and vertebral
column, from inclusion in human and animal food would reduce the very
few potential BSE cases in cattle by a further 88 percent and potential
human exposure to infectivity in meat and meat products by a further 95
percent.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru69 FR 42256 07/14/04
Interim Final Rule Comment Period End 10/12/04
Final Action 03/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
[[Page 72736]]
Agency Contact:
Rebecca Buckner
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
HFS-366
College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: rebecca.buckner@cfsan.fda.gov
RIN: 0910-AF47
_______________________________________________________________________
HHS--FDA
59. RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS
MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL
FROM CATTLE
Priority:
Other Significant
Legal Authority:
21 USC 342; 21 USC 361; 21 USC 371; 21 USC 381
CFR Citation:
21 CFR 189.5; 21 CFR 700.27
Legal Deadline:
None
Abstract:
On July 14, 2004, FDA proposed to require that manufacturers and
processors of human food and cosmetics that are manufactured from,
processed with, or otherwise contain, material from cattle must
establish and maintain records sufficient to demonstrate the food or
cosmetic is not manufactured from, processed with, or does not
otherwise contain, prohibited cattle materials. This is a companion
rulemaking to FDA's interim final rule entitled ``Use of Materials
Derived From Cattle in Human Food and Cosmetics.`` FDA intends to
finalize this proposal after reviewing any comments received.
Statement of Need:
FDA proposed recordkeeping requirements because records documenting the
absence of prohibited cattle materials are needed by manufacturers and
processors of human food and cosmetics that contain cattle material to
ensure that these products do not contain prohibited cattle materials.
Prohibited cattle materials are materials that scientific studies have
demonstrated are highly likely to contain the BSE agent in cattle
infected with the disease. Scientists believe that the human disease
variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the
consumption of products contaminated with the agent that causes BSE.
Summary of Legal Basis:
Because the rule is a companion rulemaking to the interim final rule
prohibiting the use of certain cattle material in human food and
cosmetics, we issued the proposed rule under the authorities cited in
the interim final rule (21 U.S.C. sections 342(a)(2)(C), 342(a)(3),
342(a)(4), 342(a)(5), 361(c), and 371(a)) as well as sections 801(a)
and 701(b) of the Federal Food, Drug, and Cosmetic Act (the Act).
Without records documenting the absence of BSE risk materials in source
materials, manufacturers and processors of human food and cosmetics
cannot know whether they are adulterating their products by including
BSE risk materials in their products. Therefore, a failure of
manufacturers and processors to establish and maintain such records
results in human food and cosmetics being prepared under unsanitary
conditions whereby they may have been rendered injurious to health.
Furthermore, without adequate records, FDA cannot know whether
manufacturers and processors of human food and cosmetics have complied
with the prohibitions against use of BSE risk materials. Therefore, the
recordkeeping requirements are necessary for the efficient enforcement
of the interim final rule.
We are also issuing the provisions of this proposed rule related to
records regarding imported human food and cosmetics under sections
801(a) and 701(b) of the Act. Section 801(a) (21 U.S.C. 381(a))
provides for refusal of admission into the United States of human food
and cosmetics that appear to be adulterated. Section 701(b) (21 U.S.C.
371(b)) authorizes the Secretaries of Treasury and Health and Human
Services to jointly prescribe regulations for the efficient enforcement
of section 801. This proposed rule sets out requirements for imported
human food and cosmetics to ensure that only products that fully comply
with the requirements of the interim final rule are admitted into the
United States.
Alternatives:
Alternatives were not specifically considered in the proposed rule
because it was a companion rulemaking to the interim final rule
prohibiting the use of certain cattle material in human food and
cosmetics. Recordkeeping alternatives were considered in the interim
final rule. Those same alternatives, plus any new ones presented in
comments, will be considered for the final rule.
Anticipated Cost and Benefits:
If the proposal is finalized, we expect that the costs will be to setup
and then to maintain a recordkeeping system to document all cattle-
derived ingredients, except tallow derivatives, used in FDA-regulated
food and cosmetics. The setup costs are about $1 million, and the
annual costs of maintaining the recordkeeping system are about
$200,000. The benefit of the rule is that its requirements will--by
requiring records that the provisions of the interim final rule have
been followed--provide an additional safeguard against a case of vCJD
occurring in humans.
Risks:
The benefits of finalizing the proposed rule are derived from the
benefits of the interim final rule, which are the value of the public
health benefits. The public health benefit is the reduction in the risk
of the human illness associated with consumption of the agent that
causes BSE. The Harvard-Tuskegee risk assessment has stated that a ban
on specified risk materials, including cattle brains, spinal cord and
vertebral column, from inclusion in human and animal food would reduce
the very few potential BSE cases in cattle by a further 88 percent and
potential human exposure to infectivity in meat and meat products by a
further 95 percent.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 42275 07/14/04
NPRM Comment Period End 08/13/04
Final Action 03/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
[[Page 72737]]
Agency Contact:
Rebecca Buckner
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
HFS-366
College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: rebecca.buckner@cfsan.fda.gov
RIN: 0910-AF48
_______________________________________________________________________
HHS--Centers for Medicare & Medicaid Services (CMS)
-----------
PROPOSED RULE STAGE
-----------
60. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-P)
(SECTION 610 REVIEW)
Priority:
Other Significant
Legal Authority:
42 USC 1395rr
CFR Citation:
42 CFR 400; 42 CFR 405; 42 CFR 406; 42 CFR 409; 42 CFR 410; 42 CFR 412;
42 CFR 488; 42 CFR 489; 42 CFR 494; 42 CFR 413; 42 CFR 414
Legal Deadline:
None
Abstract:
This proposed rule would revise the requirements that end stage renal
disease (ESRD) facilities must meet to be certified under the Medicare
program.
Statement of Need:
This proposed rule is a complete overhaul of the current ESRD
conditions for coverage to reduce unnecessary process and procedural
requirements and focus on the patient and the results and quality of
the care furnished to the patient. The proposed conditions for ESRD
facilities would include, among other things, new infection control
guidelines; updated water quality standards; new fire safety standards;
as well as patient assessment, care planning, quality improvement, and
electronic data reporting provisions that reflect the current advances
in dialysis technology and standard care practices. The ESRD conditions
were last published in their entirety in 1976.
Summary of Legal Basis:
Section 1881 (42 U.S.C. 1395rr) of the Social Security Act (the Act)
authorizes benefits for individuals who have been determined to have
end stage renal disease as provided in section 226 (A). Section 1881(b)
of the Act authorizes payments on behalf of such individuals to
providers of services and renal dialysis facilities ``which meet
requirements as the Secretary shall by regulation prescribe.'' ESRD
conditions for coverage may be revised as needed under the Secretary's
rulemaking authority in section 1881.
Alternatives:
Retain the current conditions. CMS has undertaken various quality
improvement initiatives, e.g., the Dialysis Facility Compare Web site
and the CMS Clinical Performance Measures Project that have improved
beneficiaries' quality of care. These initiatives, however, lack the
potential impact of an overall regulatory change.
Anticipated Cost and Benefits:
We anticipate a minimal cost for each dialysis facility in the initial
year of implementation and in subsequent years. These costs are thought
to be a small percent of dialysis facilities' expenses.
Risks:
Failure to update would result in outdated ESRD conditions for coverage
that are over 26 years old and do not reflect current medical practices
or scientific advances in the field.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/04
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Robert Miller
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-02-01
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6797
Teresa Casey
Health Insurance Specalist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-05-04
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-7215
RIN: 0938-AG82
_______________________________________________________________________
HHS--CMS
61. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL AND
REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS-
3835-P)
Priority:
Other Significant
Legal Authority:
42 USC 1302; 42 USC 1395hh
CFR Citation:
42 CFR 482
Legal Deadline:
None
Abstract:
This proposed rule would establish conditions of participation for
Medicare-covered transplants.
Statement of Need:
CMS is proposing new requirements for transplant centers to address
several issues. First, although currently there are initial
requirements hospitals must meet to become Medicare-approved to perform
transplants, there are no requirements for reapproval. Thus, once a
transplant center has received initial approval, CMS has no mechanism
to remove the center's approval if its performance declines. Second,
current outcome measures for initial approval are not risk adjusted and
do not reflect the significant improvements in patient survival that
have occurred in the years since the Medicare requirements were
[[Page 72738]]
put into place. Finally, current requirements for Medicare approval are
difficult for transplant centers to locate and use, as they have been
published in a variety of different documents, including the Federal
Register, the Coverage Issues Manual, and Medicare Coverage Policy
Decision Memoranda. Therefore, it is intended that the transplant
requirements: (1) ensure that transplants are performed safely and
effectively by establishing requirements for approval and re-approval
and a process for oversight and enforcement activities; (2) establish
risk-adjusted outcome measures that reflect improvements in patient and
graft survival and ongoing changes in transplantation technology; and,
(3) codify requirements for all transplant center types in one
regulation.
Summary of Legal Basis:
The Medicare statute contains specific authority for prescribing the
health and safety requirements for facilities to furnish ESRD care to
beneficiaries, including renal transplant centers, under section
1181(b)(1) of the Social Security Act. Section 1102 of the Act
authorizes the Secretary to publish rules and regulations ``necessary
for the efficient administration of the functions with which the
Secretary is charged under the Act.'' Section 1871 (a) of the Act
authorizes the Secretary to ``prescribe such regulations as may be
necessary to carry out the administration of the insurance programs
under this title.``
Alternatives:
CMS has considered various alternatives in developing outcome and
process performance measures for transplant centers. CMS will propose
requirements for initial and reapproval and will solicit public
comments to identify additional alternatives.
Anticipated Cost and Benefits:
CMS estimates the economic impact of this rule to be $300,148 annually.
While 867 transplant centers may be affected by the requirements in
this proposed rule to a greater or lesser degree, the majority of the
centers most likely have already put into practice the majority of the
proposed process requirements. For the most part, the proposed
requirements merely reflect advances in transplantation technology, as
well as standard care practices. Furthermore, although the proposed
rule would require a large amount of data to be submitted to the Organ
Procurement and Transplantation Network (OPTN), transplant centers
already submit these data to the OPTN.
In 2002, 12,795 donors (deceased and living) were recovered in the U.S.
and 24,851 transplants (deceased and living donors) were performed; yet
80,792 patients were waiting for a transplant at the end of 2002. Given
the scarcity of donated organs compared to the number of patients on
waiting lists and the critical need to use limited resources
efficiently, the proposed requirements for transplant centers would
establish quality and procedural standards that ensure transplants are
performed in a safe and effective manner both to protect transplant
recipients and living donors and to improve graft survival, thus
reducing the need for costly retransplantation following a failed
original transplant.
Organ donation and transplantation is a priority for the Secretary as
evidenced by the Secretary's Donation Initiative (Initiative); launch
of the Initiative was one of the Secretary's first actions. The
proposed rule will include requirements to guard against medical errors
that endanger living donors and transplant recipients, including the
transplantation of organs of the wrong blood type.
Risks:
Failure to publish the proposed requirements would result in the
continued Medicare approval of transplant centers that may not perform
organ transplants safely and effectively with the best possible
outcomes for Medicare beneficiaries and other patients.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses, Organizations
Government Levels Affected:
None
Agency Contact:
Eva Fung
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-06-6
Office of Clinical Standards and Quality
S3-06-06
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-7539
Aucha Prachanronarong
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
S3-02-01
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-9614
RIN: 0938-AH17
_______________________________________________________________________
HHS--CMS
62. HOSPICE CARE--CONDITIONS OF PARTICIPATION (CMS-3844-P)
Priority:
Other Significant
Legal Authority:
42 USC 1302; 42 USC 1395hh
CFR Citation:
42 CFR 418
Legal Deadline:
None
Abstract:
This proposed rule is a regulatory reform initiative that would revise
existing conditions of participation that hospices must meet to
participate in the Medicare and Medicaid programs. The proposed
requirements focus on the actual care delivered to patients and
patients' families by hospices and the results of that care, reflect an
interdisciplinary view of patient care, allow hospices greater
flexibility in meeting quality standards, and eliminate unnecessary
procedural requirements.
Statement of Need:
This rule proposes to completely revise and reorganize the existing
Conditions of Participation (CoPs) for Medicare participating hospice
providers published in 1983. The proposed rule is a regulatory reform
initiative that would revise the existing CoPs that hospices must meet
to participate in
[[Page 72739]]
the Medicare and Medicaid programs. The proposed requirements focus on
the care delivered to patients and patients' families by hospices and
the outcomes of that care. The proposed requirements continue to
reflect an interdisciplinary view of patient care and allow hospices
flexibility in meeting quality standards. These changes are an integral
part of the Administration's efforts to achieve broad-based
improvements in the quality of health care furnished through the
Medicare and Medicaid programs. This proposed rule codifies hospice
requirements in the Balanced Budget Act of 1997 and the Medicare
Modernization Act of 2003, sections 408 and 946.
Summary of Legal Basis:
Section 1861(dd) of the Social Security Act (the Act) provides the
statutory qualifications and requirements that a hospice must meet to
receive payment for hospice care given to Medicare beneficiaries who
elect the hospice benefit under the Medicare and Medicaid programs.
This section gives the Secretary broad authority to establish standards
for hospices. Under this authority, the Secretary established CoPs for
hospices at 42 CFR 418, et seq.
In addition, section 1102 of the Act gives the Secretary the authority
to make and publish such rules and regulations as may be necessary to
the efficient administration of the functions with which he is charged
under the Act. This section of the Act gives the Secretary broad
authority to establish requirements for hospices that are necessary for
the efficient administration of the Medicare program.
Alternatives:
Rely on the current CoPs: This is not a reasonable option because the
current CoPs are not patient-focused but rather problem-focused, an
approach that has inherent limits. Trying to ensure quality through the
enforcement of prescriptive health and safety standards, rather than
trying to improve quality of care for all patients, adversely affects
agency improvement efforts and does not stimulate broad-based quality
of care initiatives. On the other hand, revising the current CoPs would
take advantage of continuing advances in health care delivery.
Increase prescriptive requirements relative to patient rights, drugs
and durable medical equipment, and personnel qualifications. CMS
decided not to pursue this approach because the additional burden that
would be placed on hospices would outweigh any potential benefits.
Exclude the revisions to the comprehensive assessment and
interdisciplinary group requirements: Since these areas represent two
of the most frequently cited deficiencies noted during hospice surveys
and have a great impact on patient care, CMS decided that these
sections did, in fact, need to be strengthened.
Anticipated Cost and Benefits:
While we anticipate a minimal annual cost per hospice to comply with
the requirements in this rule, we expect a positive reaction from all
affected entities including beneficiaries, associations, and providers.
This rule is highly anticipated by the hospice industry since the
standards have not been updated since 1990.
Risks:
Overall, this rule is a ``good news rule'' for which we expect a
positive reaction from all affected entities including beneficiaries,
associations, providers, and Congress. Beneficiaries--we expect that
beneficiaries will be pleased with the strong focus on patient's
rights, patient education, and patient safety throughout the proposed
rule. Associations--the National Hospice and Palliative Care
Organization and the National Association for Home Care have been
requesting the promulgation of new regulations for several years and
has actively worked with us in sharing information. Hospice providers--
hospices may have mixed feelings about the proposed regulations. We are
proposing to bring the regulations in line with current standards of
practice and are proposing to substantially decrease provider burden in
many areas of the proposed rule such as in nurse staffing and dietary
counseling. However, we are also proposing to increase the focus on
patient assessment, quality assessment, and performance improvement
that may require an additional level of effort. We believe that the
patient safety and quality care benefits should outweigh these
concerns. In response to requests from hospice and nursing facility
associations, we have clarified the relationship between hospices and
nursing facilities through a proposed new condition. Nurse
practitioners (NPs)--we are proposing to allow NPs to see, treat, and
write orders for patients, as defined by the plan of care. Congress--we
do not expect that these proposed regulations would be opposed in their
overall approach to patient care.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/04
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses, Organizations
Government Levels Affected:
None
Federalism:
Undetermined
Agency Contact:
Mary Rossi Coajou
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6051
Danielle Shearer
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6617
RIN: 0938-AH27
_______________________________________________________________________
HHS--CMS
63. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-P)
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
Not Yet Determined
CFR Citation:
Not Yet Determined
Legal Deadline:
Final, Statutory, January 1, 2002, Requires promulgation of new
conditions.
Abstract:
This rule would establish conditions for coverage for organ procurement
organizations (OPOs) to be certified by the Secretary to receive
payment from
[[Page 72740]]
Medicare and Medicaid for organ procurement costs, and to be designated
by the Secretary for a specific geographic service area. The Organ
Procurement Organization Certification Act of 2000 requires CMS to
increase the certification cycle for OPOs from 2 years to 4 years and
to promulgate new performance standards for OPOs.
Statement of Need:
As required by the Organ Procurement Organization Certification Act of
2000 and Section 219 of the Consolidated Appropriations Act, 2001, this
proposed rule sets forth multiple new outcome and process performance
measures for OPOs, as well as a new appeals process for OPOs to appeal
a decertification based on substantive and procedural grounds.
Summary of Legal Basis:
Section 1138(b) of the Social Security Act (the Act) provides the
statutory qualifications and requirements that an OPO must meet to
receive payment for organ procurement costs associated with procuring
organs for hospitals under the Medicare and Medicaid programs. This
section gives the Secretary broad authority to establish performance-
related standards for OPOs. Under this authority, the Secretary
established conditions for coverage for OPOs at 42 CFR 486.301, et seq.
Section 1138(b) of the Act specifies that an OPO must be certified or
re-certified by the Secretary as meeting the standards to be a
qualified OPO as described in section 371(b) of the Public Health
Service (PHS) Act. The PHS Act requirements were established by the
National Organ Transplant Act of 1984 and include provisions for OPO
board membership, staffing, agreements with hospitals, and membership
in the OPTN. The Organ Procurement Organization Certification Act of
2000 (42 U.S.C. section 273(b)(1)(D)) amended section 371(b) of the PHS
Act to require CMS to promulgate multiple new outcome and process
performance measures for OPOs and develop a new process for OPOs to
appeal a decertification based on substantive and procedural grounds.
In addition, section 1102 of the Act gives the Secretary the authority
to make and publish such rules and regulations as may be necessary to
the efficient administration of the functions with which the Secretary
is charged under the Act. This section of the Act gives the Secretary
broad authority to establish requirements for OPOs that are necessary
for the efficient administration of the Medicare program.
Alternatives:
CMS has considered various alternatives in developing outcome and
process performance measures. CMS will propose measures based on donor
potential and other related factors in OPO service areas and CMS will
solicit public comments to identify additional alternatives.
Anticipated Cost and Benefits:
CMS believes the provisions contained in this proposed rule would have
little or no economic impact on hospitals and would not have a
substantial economic impact on a significant number of OPOs.
It is expected that improved OPO performance would result from the rule
and would increase organ donation and transplantation, thereby
decreasing deaths of patients waiting for organs. Increasing organ
donation and transplantation is a priority for the Secretary as
evidenced by the Secretary's Donation Initiative (Initiative); launch
of the Initiative was one of the Secretary's first actions.
In addition, the proposed rule would include requirements to guard
against medical errors that can lead to transplantation of organs of
the wrong blood type or transmission of infectious disease to
transplant recipients.
Risks:
Failure to publish the rule may decrease organ donation and
transplantation, thereby increasing deaths of patients waiting for
organs.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru66 FR 67109 12/28/01
NPRM 11/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Marcia Newton
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-02-01
Office of Clinical Standards and Quality
7500 Security Boulevard
S3-05-18
Baltimore, MD 21244-1850
Phone: 410 786-5265
RIN: 0938-AK81
_______________________________________________________________________
HHS--CMS
64. USE OF RESTRAINT AND SECLUSION IN MEDICARE AND MEDICAID
PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE
(CMS-2130-P)
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
PL 106-554, (BIPA 2000 of the Children's Health Act)
CFR Citation:
42 CFR 101; 42 CFR 418; 42 CFR 482; 42 CFR 483; 42 CFR 485
Legal Deadline:
None
Abstract:
This proposed rule would implement provisions of the Children's Health
Act of 2000 (CHA) related to the use of restraints or seclusion for
individuals receiving services in health care facilities that receive
Federal funding. The rule would establish common terminology and basic
expectations for the use of restraints and seclusion for health care
facilities that furnish inpatient or residential care and receive
Medicare or Medicaid funding.
Statement of Need:
In recent years, media, Government, and consumer reports of deaths and
injuries occurring due to the use of restraint or seclusion have
heightened concern about these mechanisms as interventions. Concern
about use is nothing new; however, the appropriate use of restraint and
seclusion has been debated and regulated in various health care
settings for many years. Researchers have examined the use of restraint
and seclusion, related injuries and deaths, and potential alternatives
to address safety and care concerns while posing less inherent risk to
the
[[Page 72741]]
individual. Patient advocates have lobbied for reduced and more highly
regulated use. Health care facilities and professionals have examined
mechanisms for reduction, and some have implemented training programs
to promote safe application and use. Reports of injuries and deaths,
however, have brought concerns about care and safety to the forefront.
The issue has gained national attention, with a call for regulation
across health care settings.
Several highly publicized newspaper articles and Federal reports are
the impetus for this regulation. The CHA established a significant
collaboration of several important children's health bills. CMS has
responsibility for part H, which established certain requirements
related to the rights of residents of certain facilities receiving
Federal funds. SAMHSA intends to publish a notice of proposed
rulemaking to implement part I, which sets forth requirements related
to the rights of residents of certain nonmedical, community-based
facilities for children and youth. The CHA establishes for certain
facilities common definitions, staff training standards, reporting
requirements, and strict enforcement criteria.
Summary of Legal Basis:
The Children's Health Act of 2000 (Pub. L. 106-310), section 3207, part
H.
Alternatives:
No other regulatory alternatives were considered. Nevertheless, current
regulations exist, in some form, for hospitals and residential
treatment facilities, while nursing homes and ICFs/MR use survey
guidelines. The CHA's intent is to develop consistency in requirements
across all Federally-funded patient or residential care facilities. The
statutory language required that regulations be promulgated within one
year of its enactment. This proposed rule is currently two years behind
its mandated time of publication.
Anticipated Cost and Benefits:
The anticipated benefits include enhanced patient safety and better
consumer protections. Increases in staff education and training are
expected to lead to treatment alternatives and decreases in the use of
restraint and seclusion as a means of intervention, which then leads to
less traumatic experiences for both beneficiaries and staff. The
regulation creates a change in facility practices and policies on the
use of restraint or seclusion as a treatment mechanism. The regulation
will create standard criteria for patient or residential care
facilities that receive Federal funds, which will establish an
industrywide effect on beneficiaries who are receiving services within
these Federal facilities. The regulation creates consistent criteria
for staff training, and defining and reporting on restraint or
seclusion.
The anticipated cost is based on regulations that will affect more than
32,350 Medicare and Medicaid funded facilities. At this time, however,
the extent of potential facilities affected is unattainable until
comments are received from other HHS agencies. It is estimated that the
cost will be roughly $500 million per a year for Federal Medicaid, and
$2.5 billion to $3 billion for all payers. The proposed rule will
specifically solicit comments on actual staff training and reporting
costs, and it is assumed this cost will decrease since the majority of
facilities currently have training and reporting requirements.
Risks:
The risk in implementing the regulation -
1. Increase in cost for facilities in staff training; however,
facilities that currently use restraint or seclusion as a form of
intervention have some general staff training requirements. The CHA
will only expand the content of this training.
2. Increase possibility of facilities having their Federal funding
status placed in jeopardy due to noncompliance with regulations.
Industry may raise concern that the CHA's enforcement aspect is too
harsh. For nursing homes, argument may occur that the CHA's enforcement
goes against the intent of the Congress and its OBRA '87 language to
devise other alternative sanctions besides termination from the
Medicare or Medicaid programs.
3. Concern from facilities that currently do not have any regulations
governing the use of restraints or seclusion (for example, nursing
homes, hospice inpatient facilities, critical access hospitals; however
nursing homes have requirements in their survey guidance materials).
The risk in not implementing the regulation -
1. Continued unregulated use of restraint and seclusion in certain
Federally funded facilities.
2. Continued under reporting of deaths as a result of restraint or
seclusion, or deaths that occur within 24 hours after an individual has
been restrained or in seclusion, or where it is reasonable to assume
that the individual's death was caused by being placed in restraints or
in seclusion.
3. Barrage of continued concerns from advocacy groups and Congress to
publish this regulation, as well as requests from facilities for
guidance.
4. Lack of protection for special needs populations, such as children,
adolescents, persons with mental illness, developmental disabilities,
or co-occurring mental retardation who are disproportionately affected
by the usage of restraint or seclusion as a common form of
intervention.
5. Lack of direction to organizations, advocacy groups, and more than
32,350 facilities for developing common definition.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Carla McGregor
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicaid and State Operations
7500 Security Boulevard
S2-09-23
Baltimore, MD 21244
Phone: 410 786-7089
RIN: 0938-AL26
_______________________________________________________________________
HHS--CMS
65. REVISIONS TO THE OVERSIGHT AND VALIDATION PROGRAM FOR
ACCREDITING ORGANIZATIONS APPROVED FOR DEEMING AUTHORITY (CMS-2255-P)
Priority:
Other Significant. Major under 5 USC 801.
[[Page 72742]]
Legal Authority:
Social Security Act, sec 1864; Social Security Act, sec 1865; Social
Security Act, sec 1875
CFR Citation:
42 CFR 488.1 to 488.9
Legal Deadline:
None
Abstract:
This rule is in response to the recommendations in the GAO Report,
``CMS Needs Additional Aurthority to Adequately Oversee Patient Safety
in Hospitals'' (GAO-04-850). With resepct to the oversight and
validation of hospital accreditation programs, a rate if disparity
calculation is specified in Federal regulations at 42 CFR, section
488.8. This rule proposes to consider additional alternative measures
to assess the performance of the accreditation organizations.
Statement of Need:
In the Department's official response to the recommendations in the GAO
Report dealing with accredited hospitals, (GAO-04-850, ``CMS Needs
Additional Authority to Adequately Oversee Patient Safety in
Hospitals''), the Administrator committed to proposing that this
regulatory initiative be added to the Department's regulatory plan for
fiscal year 2005. With respect to the oversight and validation of
hospital accreditation programs, a rate of disparity calculation is
specified in Federal regulations at 42 CFR section 488.8. The agency
agreed that it is quite appropriate to reexamine the rule and to
consider additional or alternative measures to assess the performance
of the accreditation organizations. CMS has already begun to examine
this issue as part of the agency's hospital quality improvement
activities. CMS is working to refine existing measures and develop new
ones. It will be necessary to undertake rulemaking to revise the
formula for calculating the rate of disparity measure, as well as to
validate the threshold for acceptable performance or reasonable
assurance. The notice and comment procedures inherent in the rulemaking
process will provide an appropriate forum for this discussion of this
significant public policy and will allow all of the stakeholders to
participate. It will also provide for exposure to new perspectives and
may yield innovative approaches to these problems. In addition, CMS
will explore regulatory strategies to address the long-standing JCAHO
performance issues with respect to the Life Safety Code.
Summary of Legal Basis:
Sections 1864, 1865, and 1875 of the Social Security Act.
Alternatives:
None. There are no alternative authorities that would permit this
regulation to be issued as an interim final rule or final rule.
Anticipated Cost and Benefits:
None. There are no alternative authorities that would permit this
regulation to be issued as an interim final rule or final rule.
Risks:
Risks include higher expenditures for the survey and certification
program in conducting validation surveys of accredited providers and in
other improvements to the measures and analyses used to evaluate the
performance of accrediting organizations for inclusion in the annual
report to Congress. Unless these additional costs are addressed through
the appropriation and budget processes, reallocation of existing
resources could reduce the oversight of other categories of providers
and endanger the health and safety of program beneficiaries.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 08/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Undetermined
Agency Contact:
Amber L. Wolfe
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicaid and State Operations
7500 Security Boulevard
S2-12-25
Baltimore, MD 21244
Phone: 410 786-6773
Email: awolfe@cms.hhs.gov
RIN: 0938-AN62
_______________________________________________________________________
HHS--CMS
-----------
FINAL RULE STAGE
-----------
66. MEDICARE ADVANTAGE PROGRAM--TITLE II (CMS-4069-F)
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL108-173, MMA
CFR Citation:
42 CFR 417; 42 CFR 422
Legal Deadline:
None
Abstract:
This final rule implements title II of the Medicare Modernization Act
establishing the Medicare Advantage program that will replace the
existing Medicare+Choice program. Medicare Advantage offers improved
managed care plans with coordinated care and competitive bidding, to
promote greater efficiency and responsiveness to Medicare
beneficiaries.
Statement of Need:
Implementation of the Medicare Advantage (MA) Program is required by
section 201 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003. The MA program replaces the Medicare+Choice
(M+C) program established under part C of title XVIII of the Social
Security Act. The primary goal of the MA program is to expand health
plan choices available to Medicare beneficiaries in areas that
previously had no private plans and in areas with few competing plans.
Beneficiary choice should be enhanced by the introduction of new types
of plans, including specialized MA plans, and regional plans that are
structured as preferred provider organizations. The MA program becomes
effective January 1, 2006.
Summary of Legal Basis:
Section 201 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108-173).
Alternatives:
None.
Anticipated Cost and Benefits:
In general, the MA program will have a positive impact on
beneficiaries.
[[Page 72743]]
Transfer payments from the Federal Government will go towards the
provision of additional benefits to enrollees of health plans and
reduced out-of-pocket costs, including reduced part B and part D
premiums for these enrollees. The law will result in increased revenue
for participating private plans for the provision of the basic Medicare
benefit and the provision of additional benefits. This is expected to
help improve the availability of health plan choices for beneficiaries.
Risks:
Risks include not publishing the final regulation in time to allow
prospective local and regional MA plans to participate in the MA
program. Prospective MA plans need to apply to become an MA plan and
prepare bids in the spring of 2005. This is a particular concern for MA
organizations considering offering new types of plans, such as MA
regional PPOs and specialized MA plans. If plans choose not to
participate due to a delay in publishing the final regulation, there
may be the risk of low participation in the MA program for 2006 and
beneficiaries will continue to have little choice or only the choice of
fee-for-service in many parts of the country. Because expanded choice
of plans for beneficiaries is the cornerstone of the MMA legislation,
this is a big risk.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 46866 08/03/04
NPRM Comment Period End 10/04/04
Final Action 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Jane Andrews
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Beneficiary Services
7500 Security Boulevard
C4-13-01
Baltimore, MD 21244-1850
Phone: 410 786-3133
Email: jandrews@cms.hhs.gov
RIN: 0938-AN06
_______________________________________________________________________
HHS--CMS
67. MEDICARE DRUG BENEFIT EFFECTIVE CALENDAR YEAR 2006--TITLE I (CMS-
4068-F)
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 108-173, MMA
CFR Citation:
42 CFR 417; 42 CFR 423
Legal Deadline:
None
Abstract:
This final rule implements title I of the Medicare Modernization Act,
which establishes a new voluntary outpatient prescription drug benefit
under a new Medicare part D, beginning January 1, 2006. Coverage for
the drug benefit will be provided by private prescription drug plans
(PDPs) that offer drug only coverage, or through Medicare Advantage
plans or preferred provider plans (PPOs) that will offer prescription
drug and non-drug coverage. Plans will offer a standard drug benefit
but have the flexibility to vary the drug benefit within actuarial
equivalency parameters. Assistance with premiums and cost sharing will
be provided to eligible low-income beneficiaries.
Statement of Need:
Implementation of the Medicare Prescription Drug Benefit is required by
section 101 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA). The addition of a prescription drug
benefit to Medicare represents a landmark change to the Medicare
program that will significantly improve the health care coverage
available to millions of Medicare beneficiaries. The MMA specifies that
the prescription drug benefit program will become available to
beneficiaries beginning on January 1, 2006.
Summary of Legal Basis:
Section 101 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108-173).
Alternatives:
None.
Anticipated Cost and Benefits:
The Prescription Drug benefit will have a positive impact on
beneficiaries. All Medicare beneficiaries will have access to a
voluntary drug benefit. A typical beneficiary--not eligible for
additional low-income benefits--with no coverage today will see their
total spending on drugs drop by 53 percent. In addition, it is
estimated that nearly 11 million beneficiaries with limited means will
participate in the low-income subsidy, receiving substantial additional
help from Medicare. Beneficiaries will see lower drug costs as a result
of price negotiation and coordination of health services by the
prescription drug plans and Medicare Advantage plans.
Risks:
Risks include not publishing the final regulation in time to allow
prospective prescription drug plans (PDPs) to participate. Prospective
PDPs need to apply to become a Medicare PDP and prepare bids in the
spring of 2005. This is a particular concern since this is a brand new
program and benefit. If plans choose not to participate due to a delay
in publishing the final regulation, there is the risk of low
participation in the part D program for 2006 and beneficiaries will be
without the drug benefit. Because the drug benefit is the cornerstone
of the MMA legislation, this is a big risk.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 46632 08/03/04
NPRM Comment Period End 10/04/04
Notice 69 FR 45822 07/30/04
Final Action 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
Federal, State, Tribal
Federalism:
This action may have federalism implications as defined in EO 13132.
[[Page 72744]]
Agency Contact:
Tracey McCutcheon
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Beneficiary Services
7500 Security Boulevard
C4-25-02
Baltimore, MD 21244
Phone: 410 786-6715
Email: tmccutcheon@cms.hhs.gov
Related RIN: Related to 0938-AN07
RIN: 0938-AN08
BILLING CODE 4150-24-S
[[Page 72745]]
DEPARTMENT OF HOMELAND SECURITY (DHS)
Statement of Regulatory Priorities
The attack on our homeland of September 11, 2001, was an assault on
the ideas that make our Nation great. We were reminded that the values
we hold dear must not be taken for granted. From these tragic events, a
stronger union has emerged. Our citizens, and those of countries around
the world, renewed their commitment to this Nation and the values for
which it stands. In January 2003, the United States Government
established the Department of Homeland Security (the Department or
DHS), the Nation's 15th and newest Cabinet department, consolidating 22
previously disparate agencies and 180,000 employees under one unified
organization. By rapidly and efficiently setting up the needed
infrastructure, the Department was able to remain focused on its
overriding and urgent mission: securing the American homeland and
protecting the American people. Our Department quickly developed the
high-level strategic thinking embodied in our strategic management
initiatives and plans. Our Mission Statement is our guiding principle:
We are charged to lead the unified national effort to secure America.
We will prevent and deter terrorist attacks and protect against and
respond to threats and hazards to the Nation. We will ensure safe and
secure borders, welcome lawful immigrants and visitors, and promote the
free flow of commerce.
DHS' Strategic Plan supports the President's National Strategy for
Protecting Homeland Security. Our Strategic Plan governs the
development of DHS' strategies, programs and projects, and ultimately
is reflected in the Department's budget and regulatory agenda. DHS'
Strategic Plan is posted on the Department's Web site: http://
www.dhs.gov/dhspublic/interapp/editorial/editorial--0413.xml.
The Strategic Plan reflects the determination of our Nation to prevail
against terror, to protect our homeland and to create a better world in
the process. The Department strives for organizational excellence and
uses a centralized and unified approach in managing its regulatory
resources. Each regulatory project is linked to the Department's
Strategic Plan and departmental goals and objectives. Senior Department
leadership reviews each regulatory project, including the Unified
Agenda, to ensure that the project fosters and supports the
Department's Strategic Goals outlined in DHS' Strategic Plan. DHS'
Strategic Goals are:
AWARENESS--Identify and understand threats, assess vulnerabilities,
determine potential impacts, and disseminate timely information to our
homeland security partners and the American public.
PREVENTION--Detect, deter, and mitigate threats to our homeland.
PROTECTION--Safeguard our people and their freedoms, critical
infrastructure, property, and the economy of our Nation from acts of
terrorism, natural disasters, or other emergencies.
RESPONSE--Lead, manage, and coordinate the national response to acts of
terrorism, natural disasters, or other emergencies.
RECOVERY--Lead national, State, local, and private sector efforts to
restore services and rebuild communities after acts of terrorism,
natural disasters, or other emergencies.
SERVICE--Serve the public effectively by facilitating lawful trade,
travel, and immigration.
ORGANIZATIONAL EXCELLENCE--Value our most important resource, our
people. Create a culture that promotes a common identity, innovation,
mutual respect, accountability, and teamwork to achieve efficiency,
effectiveness, and operational synergies.
The Department ensures that all of its regulatory initiatives are
aligned with its guiding principles to: protect civil rights and civil
liberties, integrate our actions, build coalitions and partnerships,
develop human resources, innovate, and be accountable to the American
public. The Department values public involvement in the development of
its regulatory plan, Unified Agenda, and regulations.
Last year, the Department partnered with two agencies leading the
Federal electronic docket management initiative: the Environmental
Protection Agency (EPA) and the Department of Transportation (DOT).
Both agencies agreed to host selected DHS regulations on their docket
management Web sites. The Department chose four significant regulations
to pilot these docketing systems: Human Resources Management System
Regulations and ``US-VISIT'' are on the EPA's EDocket; DHS Supplement
to the Federal Acquisition Regulations and the regulations to Support
Antiterrorism by Fostering Effective Technologies Act (SAFETY ACT) are
hosted on the DOT Docket Management System (DMS). By using these two
docketing systems, DHS provided optimal access to the public to review
and comment on these regulatory proposals. In fact, the Human Resources
Management System Regulations received nearly 4,000 public comments.
Our ability to use existing electronic docketing systems has maximized
departmental resources and significantly enhanced the regulatory
process. The Department has decided that, since the U.S. Coast Guard
and the Transportation Security Administration are legacy DOT agencies
and that members of the public that ordinarily participate in their
rulemaking process are accustomed to using DOT's DMS, those two
agencies will remain on DOT's DMS until full migration to the Federal
docketing management system. The remaining Department Headquarters and
organizational elements have joined EPA's Federal EDocket system and
members of the public can expect to see these elements using EPA's
Federal EDocket system for those regulations listed in the Unified
Agenda. The EPA Federal EDocket Web site is http://www.epa.gov/
feddocket. The DOT DMS Web site for the U.S. Coast Guard and the
Transportation Security Administration regulations is dms.dot.gov. The
public may also provide public comments to DHS' regulations through
www.regulations.gov. We strongly encourage public participation in DHS'
upcoming regulatory initiatives.
Office of the Secretary
DHS is managed by Tom Ridge, the Secretary of the Department of
Homeland Security; Admiral James Loy, the Deputy Secretary; five Under
Secretaries (Asa Hutchinson, Under Secretary for the Directorate of
Border and Transportation Security; Michael Brown, Under Secretary for
Emergency Preparedness and Response; Janet Hale, Under Secretary for
Management; General Frank Libutti, Under Secretary for Information
Analysis and Infrastructure Protection; and Charles McQueary, Under
Secretary for Science and Technology) and by those persons leading the
independent organizational elements who report directly to the
Secretary and the Deputy Secretary (Admiral Thomas Collins, Commandant
of the U.S. Coast Guard; Eduardo Aguirre, Jr., Director of the U.S.
Citizenship and Immigration Services agency are two independent
elements with rulemaking authority). Joe Whitley, the General Counsel
to the Department, manages the Department's regulatory plan and Unified
Agenda.
[[Page 72746]]
The Office of the Secretary's regulatory plan includes regulations
sponsored by the Department's Under Secretaries with the exception of
the Under Secretary for Emergency Preparedness and Response (EP&R). The
Under Secretary for EP&R is also the head of the Federal Emergency
Management Agency (FEMA) and so the EP&R regulatory plan is the same as
FEMA's. The U.S. Coast Guard and the U.S. Citizenship and Immigration
Services are two independent organizational elements that exercise
their statutory authorities, in part, through regulation. Their
regulatory plans are discussed separately below. The Bureau of Customs
and Border Protection, the Bureau of Immigration and Customs
Enforcement, and the Transportation Security Administration's
regulatory plans will also be discussed separately.
During fiscal year 2005, the Office of the Secretary expects to
complete work on a regulatory program to implement the United States
Visitor and Immigrant Status Indicator Technology (US-VISIT) program.
US-VISIT is an integrated, automated entry-exit system that records the
arrival and departure of aliens; verifies aliens' identities, and
authenticates aliens' travel documents through comparison of
biometrics. US-VISIT will enhance national security while facilitating
legitimate travel and trade through our borders. This regulatory
program supports the Department's Strategic Goals of awareness,
prevention, and protection by securing our borders against terrorists
who intend to harm the United States.
The Department expects to finalize the interim rule on Procedures for
Handling Critical Infrastructure Information (CII). This rulemaking
establishes uniform procedures for the receipt, care, and storage of
CII voluntarily submitted to the Federal Government. The procedures
apply to all Federal agencies that receive, care for, or store CII
voluntarily submitted to the Federal Government. It supports the
Department's Strategic Goals of awareness, prevention, protection, and
response by identifying and assessing the vulnerability of critical
infrastructure and key assets.
The Department and the Office of Personnel Management expect to
finalize their proposed regulations to establish a new human resources
management system within DHS, as authorized by the Homeland Security
Act of 2002. The affected subsystems include the systems governing
basic pay, classification, performance management, labor relations,
adverse actions, and employee appeals. This regulatory initiative
supports DHS' Strategic Goal of organizational excellence by valuing
our most important resource, our people. It is expected that the
regulation will assist the Department by providing a coherent human
resources management mechanism that maximizes efficiencies,
effectiveness, and operational synergies promoting the Department's
Strategic Goal of organizational excellence.
The Department also intends to finalize its interim rule on the SAFETY
ACT. The SAFETY ACT regulation implements the Support Anti-Terrorism by
Fostering Effective Technology Act found at subtitle G of the Homeland
Security Act of 2002 (Homeland Security Act). DHS published an interim
final rule with request for comments implementing the SAFETY ACT
provision. This rule provides critical incentives for the development
and deployment of antiterrorism technologies by providing liability
protections for sellers of ``qualified antiterrorism technologies'' and
others.
The Department intends to publish implementing regulations under
section 892 of the Homeland Security Act addressing sharing sensitive
homeland security information (SHSI). The regulations will propose
procedures for the identification, sharing, and safeguarding of
homeland security information that is sensitive but unclassified. These
procedures will apply to all agencies of the Federal Government and may
apply to State and local governments and first responders. This
regulatory initiative supports DHS' Strategic Goals of awareness,
prevention, protection, response and recovery by providing a
comprehensive and unified mechanism of sharing sensitive homeland
security information at Federal, State, and local levels.
U.S. Coast Guard
The U.S. Coast Guard (USCG) is a military, multi-mission, and maritime
agency. Its statutory responsibilities include ensuring marine safety
and security, preserving maritime mobility, protecting the marine
environment, enforcing U.S. laws and international treaties, and
performing search and rescue. The Coast Guard's Strategic Goals are
aligned with the Department's Strategic Goals. In performing its
duties, the Coast Guard has established certain priorities for its
regulatory program and has identified which of its five strategic
goals--maritime safety, protection of natural resources, maritime
security, maritime mobility, and national defense--the project
supports.
The Coast Guard continues to use plain language in its notices and
rulemaking documents to promote better understanding of regulations and
increased public participation in its rulemakings. The Coast Guard
encourages early public involvement in this process and has particular
concern for the impacts its rules have on small businesses. It has
supported the e-rulemaking initiative, and, on the first day of Federal
Register publication of each rulemaking project, the public can submit
comments electronically and view agency documents and public comments
on the Department of Transportation's Document Management System, which
is available online at The Coast Guard endeavors to reduce the
paperwork burden it places on the public and strives to issue only
necessary regulations that are tailored to impose the least burden on
society. The 60 rulemaking projects described in the Unified Agenda,
and both of the rules appearing on The Regulatory Plan support our
strategic goals and reflect the Department's and the Coast Guard's
regulatory policies.
As part of its response to the terrorist attacks of September 11,
2001, after conducting public workshops and meetings, the Coast Guard,
on July 1, 2003, issued six separate, but complementary, maritime
security temporary interim rules designed to implement Maritime
Transportation Security Act of 2002 (MTSA) mandates regarding maritime
facilities, vessels, and ports and to require automatic identification
equipment on certain vessels. Under authority of MTSA, the Coast Guard
superceded these temporary interim rules with final rules that were
published on October 22, 2003 (68 FR 60448). Also in response to 9/11,
Coast Guard Captains of the Port have issued rules establishing
security zones around nuclear power plants, airports, cruise ships,
liquefied natural gas vessels, and maritime facilities.
Its post-September 11, 2001 emphasis on maritime security and national
defense has not prevented the Coast Guard from carrying out its other
regulatory responsibilities. Coast Guard Headquarters has issued many
rules or proposed rules that are not security-related, as indicated by
the wide range of topics covered in its 60 rulemaking projects in the
final-rule, long-term actions, or proposed-rule stages in the Unified
Agenda. Of particular interest to the Coast Guard are the two rules
appearing in The Regulatory Plan: Post
[[Page 72747]]
Casualty Drug and Alcohol Testing and Commercial Fishing Industry
Vessels. These rules promote the Department's Strategic Goals of
protection by providing regulatory measures aimed at protecting the
marine environment, living marine resources, and maritime safety.
The Coast Guard, through the rulemaking projects identified in The
Regulatory Plan and the Unified Agenda, plans to continue to meet its
multi-mission, regulatory obligations as reflected in its strategic and
policy goals and the goals of the President's Six Point Plan for
Economic Growth by streamlining its regulations.
U.S. Citizenship and Immigration Services
The U.S. Citizenship and Immigration Services' (USCIS) mission is to
restore public confidence in the integrity of America's immigration
services by making certain that those immigrant applicants meeting our
statutory and regulatory requirements, such as those provided by the
Immigration and Nationalization Act and its implementing regulations,
duly receive all rights and benefits granted by law. USCIS will ensure
that it issues benefits only to eligible individuals.
Strengthening Immigration Services
USCIS' key regulatory initiatives that govern nonimmigrant classes and
admission requirements focus on eliminating the backlog of processing
pending applications and petitions. Promulgation of these rules will
help in streamlining processing procedures and the paperwork burden
thereby improving customer service. These regulations are the Removal
of the Standardized Request for Evidence Processing Timeframe;
Petitions for Employment Based Immigrants; Removal of Limitations on
the Validity Period for Certain Employment Authorization Documents; and
Affidavits of Support on Behalf of Immigrants. Together, these rules
will amend various USCIS regulatory provisions to: (1) remove fixed
regulatory timeframes for responses to requests for evidence or notices
of intent to deny; (2) remove fixed validity periods for employment
authorization documents; (3) modify the evidentiary requirements for
employment-based petitions to focus on evidence establishing the bona
fides of the U.S employer and the validity of the job offered; and (4)
clarify the standards for adjudication of Affidavits of Support that
petitioning relatives must file to establish that the beneficiary will
not become a public charge. These regulatory projects foster the
President's SixPoint Plan for economic growth by streamlining
regulatory requirements and are aligned with the Department's Strategic
Goal of service and organizational excellence. These proposed rules
will give USCIS the flexibility to set more appropriate timeframes for
evidence requests and document validity periods as well as to clarify
the standards for adjudication of various benefit applications and
petitions, thereby enabling USCIS to reduce its backlog and benefit
processing times.
An additional key regulatory initiative is the streamlining of the
nonimmigrant regulations codified in 8 CFR part 214, which have grown
in size and complexity during the past 15 years as Congress has added
at least 10 new nonimmigrant classes and expanded the requirements and
restrictions on many of the existing classes. This regulatory
initiative provides for a comprehensive reorganization, streamlining,
and rewriting of 8 CFR part 214 in plain language. This regulation is
titled Restructuring the Nonimmigrant Regulations and furthers the
President's Six Point Plan for economic growth.
There are a number of other planned regulatory actions focused on
improving benefit processing and adjudication services, preventing
fraudulent claims, and ensuring that USCIS issues ben efits only to
eligible individuals. These and other planned rulemakings are
delineated in USCIS' agenda. These proposed rules will amend various
UCSIS regulatory provisions to: (1) clarify the procedures for
individuals to seek review of adverse decisions issued by USCIS and the
standards for adjudication of such requests; (2) allow USCIS to
precertify certain U.S. employers' ability to pay an alien or that the
job offered by the U.S. employer is a specialty occupation; (3) extend
the time period within which an employer may file a petition for an
alien with extraordinary ability or who is an athlete or entertainer;
(4) modify USCIS' procedures to ensure that all background checks are
completed on individual aliens before USCIS issues evidence of alien
registration; and (5) standardize adjudication of all requests for
waiver of fees.
By clarifying the standards for adjudication of various benefit
applications and petitions, extending the timeframes for filing of
petitions, and eliminating the need for certain employers to
reestablish that they have met certain requirements for filing a
petition every time a new petition is filed, USCIS is able to
streamline its adjudication process, thus reducing its backlog through
faster adjudication, and ultimately decreasing benefit processing
times. USCIS believes that these regulatory initiatives will improve
the processing of applications and petitions by streamlining the
processes and thereby helping to alleviate the backlog. USCIS further
believes that these initiatives have appropriate safeguards to prevent
fraud and abuse. These regulatory activities foster many of the
Department's Strategic Goals: awareness, prevention, protection, and
organizational excellence by placing USCIS in a better position to
safeguard against any risk that may be posed by unlawful applicants to
national security or public safety by ensuring that documents are
issued after the completion of required background and security checks.
This initiative also fosters the President's Six Point Plan for
Economic Growth.
Emergency Preparedness and Response / Federal Emergency Management
Administration
The mission of the Federal Emergency Management Agency (FEMA) is: ``To
lead the Nation to prepare for, mitigate the effects of, respond to,
and recover from major disasters and emergencies, both natural and man-
made, including acts of terrorism.'' FEMA is charged with developing
and maintaining an integrated, nationwide operational capability to
respond to and recover from disasters and emergencies, regardless of
their cause, in partnership with other Federal agencies, State and
local governments, volunteer organizations, and the private sector.
FEMA coordinates and implements the Federal response to disasters
declared by the President. FEMA also has the responsibility to ensure
effective emergency preparedness. The agency is led by the Under
Secretary for Emergency Preparedness and Response, Under Secretary
Michael Brown.
The 9/11 Heroes Stamp Act of 2001 directed the U.S. Postal Service to
issue a postal stamp and distribute the proceeds through FEMA to the
families of emergency relief personnel killed or permanently disabled
while serving in the line of duty in connection with the terrorist
attacks of September 11, 2001. RIN 1660-AA34, Assistance Program Under
the 9/11 Heroes Stamp Act of 2001, establishes the mechanism through
which FEMA will distribute these funds. This regulation fosters the
Department's Strategic Goal of recovery by assisting the families of
emergency
[[Page 72748]]
relief personnel who served in the line of duty on 9/11 to rebuild
their lives. RIN 1660-AA07, National Urban Search and Rescue Response
System, would standardize the financing, administration, and operation
of the National Urban Search and Rescue Response System; a cooperative
effort of FEMA, participating State emergency management agencies, and
local public safety agencies across the country.
Directorate of Border and Transportation Security
The Directorate of Border and Transportation Security (BTS) is
comprised of the law enforcement agencies (with the exception of the
U.S. Coast Guard and the U.S. Secret Service), three of which are
contributors to The Regulatory Plan; the Bureau of Customs and Border
Protection, led by Robert Bonner; the Bureau of Immigration and Customs
Enforcement, headed by Michael Garcia; and the Transportation Security
Administration, headed by Admiral David Stone.
Bureau of Customs and Border Protection
On November 25, 2002, the President signed the Homeland Security Act
of 2002 (Homeland Security Act) establishing the Department of Homeland
Security. Under section 403(1) of the Homeland Security Act, the United
States Customs Service, including functions of the Secretary of the
Treasury relating thereto, transferred to the Secretary of Homeland
Security. As part of the DHS reorganization, the Customs Service
inspection and trade functions were combined with the immigration and
agricultural inspection functions and the Border Patrol and transferred
into the Bureau of Customs and Border Protection (CBP). It is noted
that certain regulatory authority of the United States Customs Service
relating to customs revenue functions was retained by the Department of
the Treasury (see the Department of the Treasury regulatory plan).
CBP is the Federal agency principally responsible for the security of
our Nation's borders, both at and between the ports of entry and at
official crossings into the United States. CBP must accomplish its
border security and enforcement mission without stifling the flow of
legitimate trade and travel. The primary mission of CBP is its homeland
security mission, that is, to prevent terrorists and terrorist weapons
from entering the United States. An important aspect of this priority
mission involves improving security at our borders and ports of entry,
but it also means extending our zone of security beyond our physical
borders.
CBP is also responsible for administering laws concerning the
importation into the United States of goods and enforcing the laws
concerning the entry of persons into the United States. This
responsibility includes regulating and facilitating international
trade; collecting import duties; enforcing U.S. trade, immigration and
other laws of the United States at our borders; inspecting imports,
overseeing the activities of persons and businesses engaged in
importing; enforcing the laws concerning smuggling and trafficking in
contraband; apprehending individuals attempting to enter the United
States illegally; protecting our agriculture and economic interests
from harmful pests and diseases; servicing all people, vehicles, and
cargo entering the United States; maintaining export controls; and
protecting American businesses from theft of their intellectual
property.
In carrying out its priority mission, CBP's goal is to facilitate the
processing of legitimate trade and people efficiently without
compromising security. During the past fiscal year, consistent with its
primary mission of homeland security, CBP issued a final rule that
increases advance data regarding incoming conveyances and goods. In
accordance with the Trade Act of 2002, this final rule requires
operators of sea vessels, aircraft, trucks, and trains to transmit
advance information electronically to CBP pertaining to cargo before
the cargo is either brought into or sent from the United States on
those conveyances.
During fiscal year 2005, CBP plans to enhance homeland security
further by issuing several other regulatory documents that will require
advance information. CBP plans to finalize the following interim final
rules: Passenger and Crew Manifests Required for Passenger Flights in
Foreign Air Transportation to the United States (Passenger and Crew
Manifests rule) and Passenger Name Record Information Required for
Passengers on Flights in Foreign Air Transportation To or From the
United States (Passenger Name Record Information rule). The Passenger
and Crew Manifests rule requires that each air carrier, foreign and
domestic, operating a passenger flight in foreign air transportation to
the United States electronically transmit to CBP in advance of arrival
a passenger and crew manifest that contains certain specified
information. The Passenger Name Record Information rule requires that
each air carrier must provide CBP with electronic access to Passenger
Name Record information contained in the carrier's automated
reservation system and/or departure control system that sets forth the
identity and travel plans of any passengers on flights in foreign air
transportation either to or from the United States. Both of these rules
foster DHS' Strategic Goals of awareness and prevention.
In addition to its plans to continue issuing regulations to enhance
border security, CBP, during fiscal year 2005, expects to continue to
issue regulatory documents that will facilitate legitimate trade and
implement trade benefit programs. Discussion of CBP regulations
regarding the customs revenue function is contained in the regulatory
plan of the Department of the Treasury. Also, CBP expects to issue
regulatory projects reflecting CBP's responsibility for the immigration
inspection function.
Bureau of Immigration and Customs Enforcement
The Bureau of Immigration and Customs Enforcement (ICE), the largest
investigative arm of the Department, is responsible for identifying and
preventing security vulnerabilities to the Nation's border, economic,
transportation, and infrastructure. Its mission is to prevent acts of
terrorism by targeting the people, money, and materials that support
terrorist and criminal activities. Established to combat the criminal
and national security threats emergent in a post 9/11 environment, ICE
combines a new investigative approach with new resources to provide
unparalleled investigation, interdiction and security services to the
public and our law enforcement partners in the Federal and local
sectors.
ICE will be pursuing rulemaking to implement major components of the
President's and the Department's Strategic Goals. ICE will continue to
promulgate regulations focused on addressing control issues for over
500,000 international students attending colleges and universities in
the United States and a similar number of exchange visitors entering
the United States through the Department of State's (DOS) ``J'' visa
program. This regulatory action will foster the Department's Strategic
Goals of awareness and prevention.
In an effort to streamline the removal process of persons who no
longer have immigration status, ICE will promulgate a rule that
requires aliens who become subject to a final order of removal to
surrender themselves to the ICE within 30 days thereafter. This rule
provides
[[Page 72749]]
that aliens who are given notice of the mandatory duty to surrender and
later fail to comply with the surrender obligation will be denied all
discretionary immigration benefits for the remainder of their presence
in the United States and for 10 years after their departure. This
action enhances the integrity of the removal process by shifting the
burden upon termination of removal proceedings--eliminating the
requirement that ICE seek out those subject to final removal orders--
and instead requiring that such persons present themselves for removal.
The surrender requirement will apply to aliens who receive notice of
the obligation in the course of their immigration proceedings or
concurrently with the final order of removal. This regulatory
initiative promotes the Department's Strategic Goals of awareness and
prevention.
Concurrently, ICE has launched an initiative to address the fact that
large numbers of aliens who already have final removal orders have not
departed the United States. Such aliens, termed absconders, are the
subject of the ICE subregulatory Absconder Apprehension Initiative
(AAI), which is designed to enhance the ability of ICE to apprehend
absconders. In AAI, the agency has begun reviewing the files of
absconders to enter appropriate records into the National Crime
Information Center (NCIC) database so that they may be apprehended when
encountered by Federal, State, or local law enforcement officials. This
effort supplements efforts being undertaken by ICE to use recent
resource enhancements to apprehend those absconders whom ICE can
locate.
Transportation Security Administration
In response to the September 11, 2001, terrorist attacks in the United
States, and with the potential for future attacks in this country,
Congress enacted the Aviation and Transportation Security Act (ATSA),
Public Law 107-71, 115 Stat. 597 on November 19, 2001. ATSA established
the Transportation Security Administration (TSA) to protect the
transportation system----a complex ``system of systems'' comprised of
aircraft, ships, and rail and motor vehicles; airports, seaports, and
transshipment facilities; roads, railways, bridges, and pipelines; and
supporting infrastructures----and ensure the freedom of movement for
people and commerce. Initially, TSA was created as an agency within the
Department of Transportation (DOT). As of March 1, 2003, the Homeland
Security Act transferred TSA from DOT to the Department.
Much of TSA's initial efforts focused on meeting congressionally
mandated aviation-security objectives. We have made significant
progress and will continue to fulfill our obligations in the aviation
sector. However, we have expanded our efforts to address threats across
all modes of transportation and to provide world-class security and
customer service to travelers and shippers. As we work to meet the
immediate needs of the transportation sector, we continue to develop
and implement the strategies, through its people, processes, and
technology that enable us to perform our daily activities while
ultimately preparing us for the future.
TSA's Strategic Goals are aligned with the Department's Strategic
Goals. In fiscal year 2005, TSA will emphasize regulatory efforts to
implement transportation security enhancements responsive to
Presidential leadership, DHS priorities, Congressional mandates, and
public input, particularly the recommendations of the ``National
Commission on Terrorist Attacks Upon the United States'' (the 9/11
Commission Report). In defining appropriate security enhancements, TSA
will continue testing concepts, such as Registered Traveler, Secure
Flight, and the Transportation Worker Identification Credential, to
demonstrate feasibility and obtain public input prior to national
implementation and rulemaking. These regulatory initiatives promote
DHS' Strategic Goals of awareness, prevention, and protection by
providing important information on certain persons using or are
employed on our transportation systems. TSA is partnering with other
DHS organizational elements, such as the Bureau of Immigration and
Customs Enforcement, and the U.S. Coast Guard, and with other Federal,
State, and local agencies, to achieve common objectives and assure a
uniform and appropriate standard of transportation security for the
benefit of the American public.
TSA is broadening targeted security screening of persons to include
land transportation elements, foster development of methods to enhance
screening of cargo in surface transport, and will publish a notice of
proposed rulemaking to enhance air cargo security. These regulatory
projects will increase our ability to identify and deter threats to our
homeland, furthering DHS' Strategic Goals of awareness, prevention, and
protection. In appropriate instances, TSA will seek authority to levy
fees to offset all or a portion of the cost of certain security
enhancements, such as certain background checks, and will propose a
revised formula for computing the Aviation Security Infrastructure Fee
(ASIF).
TSA will act to assure that sensitive security information (SSI)
concerning all modes of transportation is collected when necessary,
handled appropriately, shared among appropriate persons, and protected
from improper disclosure or use. TSA will also take steps to assure
that requirements directly affecting the security of the U.S. air
transportation industry will be applied wherever the security of U.S.
personnel or assets is at stake, and that industry personnel in
identified critical transportation activities receive appropriate
security training. Also, TSA will codify security requirements
applicable to designated airports in the National Capitol Area. These
regulatory initiatives promote DHS' Strategic Goals of awareness,
prevention, protection, response, and organizational excellence by
applying the appropriate measures to collect and disseminate SSI, and
providing appropriate security training to industry personnel.
_______________________________________________________________________
DHS--Office of the Secretary (OS)
-----------
PROPOSED RULE STAGE
-----------
68. HOMELAND SECURITY INFORMATION SHARING
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
PL 107-296; 116 Stat 2135; 6 USC 301
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
This proposed regulation will establish procedures for sharing,
identifying and safeguarding, processing and handling, Homeland
Security Information between agencies and appropriate State and local
personnel.
[[Page 72750]]
Statement of Need:
This proposed rule will implement section 892 of the Homeland Security
Act (HSA) addressing sharing sensitive homeland security information.
The regulations will propose procedures for the identification,
sharing, and safeguarding of homeland security information. These
proposed procedures will apply to all agencies of the Federal
Government, State and local governments, and first responders. The
Department will seek comment on proposed procedures to facilitate more
robust, effective, and timely sharing of homeland security information
among agencies of the Federal Government and between the Federal
Government and State and local personnel engaged in homeland security
activities. Section 892 of the HSA provides explicit statutory
authority to realize the objectives of the President's National
Homeland Security Strategy and the recommendations of the 9/11
Commission Report by mandating clear procedures to establish the extent
of sharing for homeland security information and govern how the actual
sharing of the information will be accomplished. These regulations will
assist the Federal Government, State and local governments, and first
responders to effectively defend against and respond to potential
terrorist attacks.
Summary of Legal Basis:
This regulation is needed to assist the Department of Homeland Security
in meeting its statutory obligation under the Homeland Security Act to
share sensitive homeland security information.
Alternatives:
The Department of Homeland Security believes that there is no
alternative to sharing sensitive homeland security information. The
statute mandates the sharing and the 9/11 Commission recommends its
sharing.
Anticipated Cost and Benefits:
The Department of Homeland Security is still considering the costs
associated with the identification, protection, storing, and sharing of
homeland security information. We do not have a determination at this
point. The benefits of sharing homeland security information is to
provide Federal agencies, State and local governments, and first
responders better information so that they may detect and prevent
terrorists attacks.
Risks:
This regulatory project will complement other DHS initiatives designed
to detect, deter and prevent terrorist attacks.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/04
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Federal, Local, State
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Eric Werner
Department of Homeland Security
Office of the General Counsel
Washington, DC 20528
Phone: 202 401-0775
Email: eric.werner@dhs.gov
RIN: 1601-AA25
_______________________________________________________________________
DHS--OS
-----------
FINAL RULE STAGE
-----------
69. PROCEDURES FOR HANDLING CRITICAL INFRASTRUCTURE INFORMATION
Priority:
Other Significant
Legal Authority:
PL 107-296, 116 Stat 2135; 5 USC ch 1, sec 301; Section 214 of The
Homeland Security Act of 2002
CFR Citation:
6 CFR 29
Legal Deadline:
None
Abstract:
This notice of proposed rulemaking establishes the procedures necessary
to fulfill the provisions of section 214(e) of the Critical
Infrastructure Information (CII) Act of 2002. This regulation
establishes uniform procedures for the receipt, care, and storage of
CII voluntarily submitted to the Federal Government. These procedures
apply to all Federal agencies that receive, care for, or store CII
voluntarily submitted to the Federal Government pursuant to the CII Act
of 2002 (6 U.S.C. 214). In addition, these procedures apply to United
States Government contractors, to foreign, State, and local
governments, and Government authorities, pursuant to their express
agreements.
Statement of Need:
This final rule will establish procedures to implement section 214 of
the Homeland Security Act of 2002 regarding the receipt, care, and
storage of critical infrastructure information voluntarily submitted to
the Department of Homeland Security. The protection of critical
infrastructure reduces the vulnerability of the United States to acts
of terrorism. The purpose of the regulation is to encourage private
sector entities to share information pertaining their particular and
unique vulnerabilities, as well as those that may be systemic and
sector wide. As part of its responsibilities under the Homeland
Security Act of 2002, this information will be analyzed by the
Department of Homeland Security to develop a more thorough
understanding of the critical infrastructure vulnerabilities of the
Nation. By offering an opportunity for protection from disclosure under
the Freedom of Information Act that qualifies under section 214, the
Department will assure private sector entities that their information
will be safeguarded from abuse by competitors or the open market.
Summary of Legal Basis:
This regulation is needed to finalize the interim final rule that
implements section 214 of the Homeland Security Act by establishing
uniform procedures for the receipt, care, and storage of critical
infrastructure Information.
Alternatives:
The Department of Homeland Security believes that there is no
alternative to protecting critical infrastructure information. Section
214 of the Homeland Security Act instructs DHS to establish uniform
procedures for the receipt, care, and storage of critical
infrastructure information that is voluntarily submitted to the
Government.
Anticipated Cost and Benefits:
The Department of Homeland Security had considered the costs and
benefits in the interim final rule. The interim rule affects entities
in the private sector that have critical infrastructure information
that they wish to share
[[Page 72751]]
with DHS. The interim rule requires that when DHS receives, validates,
and shares CII, DHS and the receiving parties, whether they be other
Federal agencies or State or local governments with whom DHS has signed
agreements detailing the procedures on how protected CII must be
safeguarded, must take appropriate action to safeguard its contents and
to destroy it when it is no longer needed. The interim rule does not
require the use of safes or enhanced security equipment or the use of a
crosscut shredder. Rather, the interim rule requires only that an
affected entity or person restrict disclosure of, and access to, the
protected information to those with a need to know, and destroy such
information when it is no longer needed. Under the rule, a locked
drawer or cabinet is an acceptable means of complying with the
requirement to secure Protected Critical Infrastructure Information,
and a normal paper shredder or manual destruction are acceptable means
of destroying protected CII.
Risks:
This regulatory project will complement other DHS initiatives designed
to detect, deter, and prevent terrorist attacks.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 18524 04/15/03
Interim Final Ru69 FR 8073 02/20/04
Interim Final Rule Comment Period End 05/20/04
Final Action 06/00/05
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Raghav Kotval
Department of Homeland Security
Washington, DC 20528
Phone: 202 772-5025
RIN: 1601-AA14
_______________________________________________________________________
DHS--OS
70. REGULATIONS IMPLEMENTING THE SUPPORT ANTITERRORISM BY FOSTERING
EFFECTIVE TECHNOLOGIES ACT OF 2002 (THE SAFETY ACT)
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
Not Yet Determined
CFR Citation:
6 CFR 25
Legal Deadline:
None
Abstract:
This interim rule implements subtitle G of title VIII of the Homeland
Security Act of 2002--the Support of Antiterrorism by Fostering
Effective Technologies Act of 2002 (the SAFETY Act). As discussed in
the SAFETY Act, through regulations promulgated by the Department of
Homeland Security (the Department), it provides critical incentives for
the development and deployment of antiterrorism technologies by
providing liability protections for sellers of ``qualified
antiterrorism technologies'' and others.
Statement of Need:
This regulation implements the SAFETY Act. The Department believes the
current development of antiterrorism technologies has been slowed due
to the potential liability risks associated with their development and
eventual deployment. In a fully functioning insurance market,
technology developers would be able to insure themselves against
excessive liability risk; however, the terrorism risk insurance market
appears to be in disequilibrium. The attacks of September 11
fundamentally changed the landscape of terrorism insurance. Congress,
in the findings of the Terrorism Risk Insurance Act of 2003 (TRIA),
concluded that temporary financial assistance in the insurance market
is needed to ``allow for a transitional period for the private markets
to stabilize, resume pricing of such insurance, and build capacity to
absorb any future losses.'' TRIA section 101(b)(2). This interim
rulemaking addresses a similar concern, to the extent that potential
technology developers are unable to efficiently insure against large
losses due to an ongoing reassessment of terrorism issues in insurance
markets.
Even after a temporary insurance market adjustment, purely private
terrorism risk insurance markets may exhibit negative externalities.
Because the risk pool of any single insurer may not be large enough to
efficiently spread and therefore insure against the risk of damages
from a terrorist attack, and because the potential for excessive
liability may render any terrorism insurance prohibitively expensive,
society may suffer from less than optimal technological protection
against terrorist attacks. The measures set forth in the interim rule
are designed to meet this goal; they provide certain liability
protection from lawsuits and consequently will increase the likelihood
that businesses will pursue important technologies that may not be
pursued without this protection.
Summary of Legal Basis:
On July 11, 2003, a notice of proposed rulemaking was published
entitled ``Regulations Implementing the Support Antiterrorism by
Fostering Effective Technologies Act of 2002 (the SAFETY Act)'' in the
Federal Register (68 FR 41420). No public hearing was requested and
none was held. The interim rule was published in October 2003. The
Department finds that the need to foster antiterrorism technology by
instituting liability protection measures, as soon as found
practicable, furnishes good cause for this interim rule to take effect
immediately under both the Administrative Procedure Act, 5 U.S.C.
552(d)(3), and section 808 of the Congressional Review Act. The
Department believes the current development of antiterrorism
technologies has been slowed due to the potential liability risks
associated with their development and eventual deployment. In a fully
functioning insurance market, technology developers would be able to
insure themselves against excessive liability risk; however, the
terrorism risk insurance market appears to be in disequilibrium. The
attacks of September 11 fundamentally changed the landscape of
terrorism insurance. Congress, in its statement of findings and purpose
in TRIA, concluded that temporary financial assistance in the insurance
market is needed to ``allow for a transitional period for the private
markets to stabilize, resume pricing of such insurance, and build
capacity to absorb any future losses.'' TRIA section 101(b)(2).
Alternatives:
The Department considered public comments received on the interim rule
[[Page 72752]]
and will determine whether possible supplemental regulations are needed
as we gain experience with implementing the Act.
Anticipated Cost and Benefits:
Costs and Benefits to Technology Development Firms
Since the interim rulemaking puts in place an additional voluntary
option for technology developers, the expected direct net benefits to
firms of the interim rulemaking will be positive; companies presumably
will not choose to pursue the designation of ``antiterrorism
technology'' unless they believe it to be a profitable endeavor. The
Department cannot predict with certainty the number of applicants for
this program. An additional source of uncertainty is the reaction of
the insurance market to this designation. As mentioned above, insurance
markets appear currently to be adjusting their strategy for terrorism
risk, so little market information exists that would inform this
estimate. The Department invited comments on these issues.
If a firm chooses to invest effort in pursuing SAFETY Act liability
protection, the direct costs to that firm will be the time and money
required to submit the required paperwork and other information to the
Department. Only companies that choose to request this protection will
incur costs. Please see the accompanying PRA analysis for an estimate
of these costs.
The direct benefits to firms include lower potential losses from
liability for terrorist attacks, and as a consequence a lower burden
from liability insurance for this type of technology. In this
assessment, we were careful to only consider benefits and costs
specifically due to the implementation of the interim rule and not
costs that would have been incurred by companies absent any interim
rulemaking. The SAFETY Act requires the sellers of the technology to
obtain liability insurance ``of such types and in such amounts''
certified by the Secretary. The entire cost of insurance is not a cost
specifically imposed by the interim rulemaking, as companies in the
course of good business practice routinely purchase insurance absent
Federal requirements to do so. Any difference in the amount or price of
insurance purchased as a result of the SAFETY Act would be a cost or
benefit of this interim rule for firms.
The wording of the SAFETY Act clearly states that sellers are not
required to obtain liability insurance beyond the maximum amount of
liability insurance reasonably available from private liability sources
on the world market at prices and terms that will not unreasonably
distort the sales price of the seller's antiterrorism technologies. We
tentatively concluded, however, that this interim rulemaking will
impact both the prices and terms of liability insurance relative to the
amount of insurance coverage absent the SAFETY Act. The probable effect
of the interim rule is to lower the quantity of liability coverage
needed in order for a firm to protect itself from terrorism liability
risks, which would be considered a benefit of this interim rule to
firms. The change will most likely be a shift back in demand that leads
to a movement along the supply curve for technology firms already in
this market; they probably will buy less liability coverage. This will
have the effect of lowering the price per unit of coverage in this
market.
The Department also expects, however, that the interim rulemaking will
lead to greater market entry, which will generate surplus for both
technology firms and insurers. Again, this market is still in
development, and the Department solicits comments on exactly how to
predict the effect of this interim rulemaking on technology
development.
Costs and Benefits to Insurers
The Department has little information on the future structure of the
terrorism risk insurance market, and how this interim rulemaking
affects that structure we continue to consider this matter. As stated
above, this type of intervention could serve to lower the demand for
insurance in the current market, thus the static effect on the
profitability of insurers is negative. The benefits of the lower
insurance burden to technology firms would be considered a cost to
insurers; the static changes to insurance coverage would cause a
transfer from insurers to technology firms. On the other hand, this
type of intervention should serve to increase the surplus of insurers
by making some types of insurance products possible that would have
been prohibitive to customers or impossible for insurers to design in
the absence of this interim rulemaking.
Costs and Benefits to the Public
The benefits to the public of the interim rulemaking were very
difficult to put in dollar value terms since its ultimate objective is
the development of new technologies that will help prevent or limit the
damage from terrorist attacks. It is not possible to even determine
whether these technologies could help prevent large or small scale
attacks, as the SAFETY Act applies to a vast range of technologies,
including products, services, software, and other forms of intellectual
property that could have a widespread impact. In qualitative terms, the
SAFETY Act removes a great deal of the risk and uncertainty associated
with product liability and in the process creates a powerful incentive
that will help fuel the development of critically needed antiterrorism
technologies. Additionally, we expect the SAFETY Act to reduce the
research and development costs of these technologies.
The tradeoff, however, may be that a greater number of technologies may
be developed and qualify for this program that have a lower average
effectiveness against terrorist attacks than technologies currently on
the market, or technologies that would be developed in the absence of
the interim rulemaking. In the absence of this rulemaking, strong
liability discouragement implies that the fewer products that are
deployed in support of antiterrorist efforts may be especially
effective, since profit maximizing firms will always choose to develop
the technologies with the highest demand first. It is the tentative
conclusion of the Department that liability discouragement in this
market is too strong or prohibitive, for the reasons mentioned above.
The Department tentatively concludes that this interim rule will have
positive net benefits to the public, since it serves to strike a better
balance between consumer protection and technological development. The
Department welcomes comments informing this tradeoff argument, and
public input on whether this interim rulemaking does strike the correct
balance.
Risks:
The United States remains at risk to terrorist attacks. It is in the
public's interest to have this interim rule effective immediately
because its aim is to foster the development and deployment of
antiterrorism technologies. Additionally, this interim rule will
clarify to the greatest extent possible the application of the
liability protections created by the SAFETY Act, thus providing an
instant incentive for prospective applicants to apply for its
protections and for others to begin exploring new measures that will
prevent or reduce acts of terrorism. The interim rule will also provide
the Department with sufficient program
[[Page 72753]]
flexibility to address the specific circumstances of each particular
request for SAFETY Act coverage. The application process is
interactive. Those persons availing themselves of the protections
afforded in this interim rule will also be interacting with the
Department in the application process. Furthermore, the Department will
continue to consider comments on this interim rule. Since the use of
the liability protections afforded in this interim rulemaking is
voluntary, there are no mandatory costs or burdens associated with the
immediate implementation of this rule.
By having these provisions in place, the Department may begin
processing applications for the liability protections and thus provide
qualified sellers of antiterrorism technologies valuable incentives to
develop and sell such technologies, as well as incentives for others to
deploy such technologies. The purpose of those technologies is to
detect, deter, mitigate, or assist in the recovery from a catastrophic
act of terrorism. Thus, the Department finds that it is not only
impracticable to delay an effective date of implementation, but it is
also in the public's interest to make the interim rule effective upon
publication in the Federal Register.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 41419 07/11/03
NPRM Comment Period End 08/11/03
Interim Final Ru68 FR 59683 10/16/03
Interim Final Rule Comment Period End 12/15/03
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
Agency Contact:
Wendy Howe
Directorate of Science and Technology
Department of Homeland Security
Office of the Secretary
Washington, DC 20528
Phone: 703 575-4511
RIN: 1601-AA15
_______________________________________________________________________
DHS--OS
71. DEPARTMENT OF HOMELAND SECURITY (DHS) HUMAN RESOURCES MANAGEMENT
SYSTEM
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
PL 107-296, Homeland Security Act
CFR Citation:
5 CFR 970
Legal Deadline:
None
Abstract:
The Department of Homeland Security and the Office of Personnel
Management are issuing final regulations to establish a new human
resources management system within DHS, as authorized by the Homeland
Security Act of 2002. The affected subsystems include those governing
basic pay, classification, performance management, labor relations,
adverse actions, and employee appeals. These changes are designed to
ensure the Department's human resources management system aligns with
its critical mission requirements without compromising the statutorily
protected civil service rights of its employees.
Statement of Need:
DHS and OPM have determined that the Department needs to establish a
new human resources management system, one that is flexible and
contemporary. The system is being designed to assure that the
Department will be able to attract, retain, and reward a workforce that
is able to meet the critical mission entrusted to the Department.
Summary of Legal Basis:
This rule is authorized by the Homeland Security Act of 2002, Public
Law 107-296--specifically, 5 U.S.C. 9701(a).
Alternatives:
DHS and OPM could have elected not to change the current human
resources management system. However, the current system does not
satisfy the needs of the Department. For example, the current system
rewards longevity of service, requires time-consuming bargaining
procedures that could detract from the Department's ability to act
expeditiously to enhance security, and results in lengthy delays for
resolving issues relating to individual employees.
Within the framework of the new regulations, OM and DHS have considered
many alternatives to specific regulatory requirements that were
suggested by employee representatives and individuals who commented on
the proposed rule and participated in the rulemaking process. An
analysis of each alternative considered appears in the preamble to the
regulation.
Anticipated Cost and Benefits:
DHS estimates that the overall costs associated with implementing the
new DHS HR system will be approximately $130 million through fiscal
year 2007. Costs will not equal or exceed $100 million in any one year.
Risks:
This description should include, if applicable, ``how the magnitude of
the risk addressed by the action relates to other risks within the
jurisdiction of the agency'' (section 4(c)(1)(D) of E.O. 12866). The
risk addressed is that the Department will be hampered in its efforts
to implement needed security measures because, for example, it will not
be able to attract and retain high-performing individuals or will not
be able to take actions expeditiously. DHS is unable to quantify this
risk or the extent to which the regulation will reduce it; however, it
appears likely that the rule will contribute significantly to enhancing
homeland security.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 8030 02/20/04
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
Agency Contact:
Kay Frances Dolan
Department of Homeland Security
1201 New York Avenue NW.
Washington, DC 20528
Phone: 202 357-8202
Fax: 202 357-8295
Email: kayfrances.dolan@dhs.gov
Related RIN: Related to 3206-AK31
RIN: 1601-AA21
[[Page 72754]]
_______________________________________________________________________
DHS--U.S. Coast Guard (USCG)
-----------
PROPOSED RULE STAGE
-----------
72. COMMERCIAL FISHING INDUSTRY VESSELS (USCG-2003-16158)
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
46 USC 4502(a) to 4502(d)
CFR Citation:
46 CFR 28
Legal Deadline:
None
Abstract:
This rulemaking would add new and clarify existing rules for commercial
fishing vessels in 46 CFR part 28. It would also establish rules on
stability and watertight integrity for fishing vessels under 79 feet in
length and institute regulations for the carriage of immersion suits in
seasonally cold waters. To improve crew preparedness in case of an
emergency, this project would also add requirements such as mandatory
logging of already required drills, providing evidence of training, and
ensuring that personnel required to be trained are current in their
training. The project would amend 46 CFR part 28 to clarify and improve
the consistency of the regulatory language so to aid in vessels
compliance with the existing rules. This rulemaking supports the Coast
Guard's strategic goals of maritime safety and protection of natural
resources.
Statement of Need:
Commercial fishing remains one of the most dangerous industries in
America. The Commercial Fishing Industry Vessel Safety Act of 1988 (the
Act, codified in 46 U.S.C., chapter 45) mandated regulations intended
to improve the safety of vessels operating in that industry. The Coast
Guard first issued rules under the Act in 1991. This rulemaking would
complete our earlier, incomplete efforts to require fishing vessels to
carry immersion suits for their workers and to incorporate stability
features in their design. We would also require vessels to document
certain training and drill measures, require the use of high water
alarms in some spaces, and revise or clarify some existing
requirements, all to reflect industry and Coast Guard experience since
passage of the Act.
Summary of Legal Basis:
46 U.S.C. 4502, as delegated by the Secretary of DHS to the Coast
Guard.
Alternatives:
Regulatory alternatives considered and rejected: (a) maintain
regulatory status quo; (b) full Coast Guard licensing of commercial
fishermen and full Coast Guard inspection of commercial fishing; (c)
adopt training-based certificate program for operators and crew.
Nonregulatory alternatives considered: continue voluntary compliance
with Coast Guard 1986 guidelines.
Anticipated Cost and Benefits:
The bulk of the costs are expected to come from the stability and
watertight integrity requirements as well as the requirement for
carrying immersion suits in seasonally cold waters. Exempting existing
vessels from the stability and watertight regulations would reduce the
costs considerably. The benefits of this rule would be calculated by
isolating the specific marine-casualty cases over a suitable time that
could have been prevented or mitigated by the rule. Cases will be
retrieved from a Coast Guard database. After each casualty has been
looked at individually to establish a causal link between the
regulation in question and the correlating benefit, damages to vessels,
lives lost, and injuries will be quantified and given dollar values.
Risks:
Commercial fishing continues to rank at or near the top of the most
hazardous occupations in the United States. Coast Guard data indicate
that regulations adopted under the 1988 Act have had a significant
impact in reducing industry casualties, but that impact has leveled
off. Studies suggest that this rulemaking, by targeting significant
remaining problem areas, could have an additional significant impact on
casualty reduction.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 07/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Federal, Tribal
Agency Contact:
Lt. Kenneth Vazquez
Project Manager, G-MOC-3
Department of Homeland Security
U.S. Coast Guard
2100 Second Street SW.
Washington, DC 20593
Phone: 202 267-0478
RIN: 1625-AA77
_______________________________________________________________________
DHS--USCG
-----------
FINAL RULE STAGE
-----------
73. POST CASUALTY DRUG AND ALCOHOL TESTING (USCG-2001-8773)
Priority:
Other Significant
Legal Authority:
PL 105-383, sec 304
CFR Citation:
46 CFR 4
Legal Deadline:
None
Abstract:
This project will revise the requirements for chemical testing
following a serious marine incident. The revision will establish
procedures to ensure that alcohol testing be conducted within two hours
of a serious marine incident, as required by the Coast Guard
Authorization Act of 1998. The rule will also make additional minor
procedural changes to the part. This rule supports the Coast Guard
strategic goal of maritime safety.
Statement of Need:
The Coast Guard proposes changing the alcohol testing requirements for
commercial vessels following a serious marine incident. The 1998 Coast
Guard Authorization Act requires the Coast Guard to establish
procedures ensuring alcohol testing is conducted within two hours of a
serious marine casualty. The Coast Guard proposes to establish
requirements for testing within the statutory time limits, to expand
the existing requirements for commercial vessels to have alcohol-
testing devices on board, and to authorize use of a wider variety of
testing devices. This rulemaking would also make additional minor
procedural changes to part 4, including a time limit for conducting
drug testing following a serious marine incident. This action is
required to
[[Page 72755]]
comply with the 1998 Coast Guard Authorization Act.
Summary of Legal Basis:
In 1998, Congress passed Public Law 105-383, which revised title 46,
U.S. Code, by adding a new section 2303a, Post Serious Marine Casualty
Alcohol Testing (hereafter section 2303a). Section 2303a requires the
Coast Guard to establish procedures ensuring that after a serious
marine casualty occurs, required alcohol testing is conducted no later
than two hours after the casualty occurred. If the alcohol testing
cannot be conducted within that timeframe because of safety concerns
directly related to the casualty, section 2303a requires the alcohol
testing to be conducted as soon thereafter as the safety concerns have
been adequately addressed to permit such testing. However, section
2303a prohibits us from requiring alcohol testing to be conducted more
than eight hours after the casualty occurs.
Alternatives:
We would use the standard rulemaking process to develop regulations for
serious marine incident alcohol testing. Nonregulatory alternatives
such as Navigation and Vessel Inspection Circulars and Marine Safety
Manual have been considered and may be used for the development of
policy and directives to provide the maritime industry and our field
offices guidelines for implementation of the regulation. Nonregulatory
alternatives cannot be substituted for the standards being proposed
with this rule.
Anticipated Cost and Benefits:
A cost analysis was prepared and published with the notice of proposed
rulemaking on February 28, 2003 (67 FR 9622). The benefits of this
action will be to ensure that alcohol tests are conducted after serious
marine incidents so that the public will be informed whether or not
alcohol use contributed to the incident. This action will also deter
improper alcohol use by commercial vessel personnel.
Risks:
Under current regulations, the risk of not obtaining a valid alcohol
test after a serious marine incident is high because specific time
frames are not given. This action will significantly reduce the risk of
not obtaining a valid test.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 9622 02/28/03
NPRM Comment Period End 06/30/03
Notice of Public68 FR 50992eopening of Comment Period 08/25/03
NPRM; Reopening 68 FR 60073Period 10/21/03
Comment Period End 11/20/03
Final Rule 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
Local, State
Additional Information:
Transferred from RIN 2115-AG07
URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Robert C. Schoening
Project Manager, G-MOA-1
Department of Homeland Security
U.S. Coast Guard
2100 Second Street SW.
Room 2406
2100 Second Street SW.
Washington, DC 20593-0001
Phone: 202 267-0684
Email: rschoening@comdt.uscg.mil
RIN: 1625-AA27
_______________________________________________________________________
DHS--Directorate of Border and Transportation Security (BTS)
-----------
FINAL RULE STAGE
-----------
74. UNITED STATES VISITOR AND IMMIGRANT STATUS INDICATOR
TECHNOLOGY PROGRAM (US-VISIT); AUTH. TO COLLECT BIOMETRIC DATA FROM
ADDIT'L TRAVELERS AND EXPANSION TO 50 MOST HIGHLY TRAFFICKED LAND
BORDER PORTS
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
8 USC 1365a; . . .
CFR Citation:
8 CFR 215; 8 CFR 235; 8 CFR 252
Legal Deadline:
Other, Statutory, September 30, 2004, Publication deadline to meet
representations made to Congress.
Abstract:
This interim rule was signed by the Secretary on August 26, 2004, and
published in the Federal Register on August 31, 2004. This interim rule
expands US-VISIT to the 50 most highly trafficked land border ports of
entry in the United States. This interim rule also will require persons
entering the United States without visas under the Visa Waiver Program
(VWP) to provide biometric, biographic, and other information required
under US-VISIT.
Statement of Need:
On January 5, 2004, the Department established the United States
Visitor and Immigrant Status Technology Program (US-VISIT), an
integrated, automated entry-exit system that records the arrival and
departure of aliens; verifies aliens' identities; and authenticates
aliens' travel documents through comparison of biometric identifiers.
The US-VISIT Program is integral to strengthening the security of the
United States. US-VISIT requires aliens seeking to be admitted to the
United States pursuant to nonimmigrant visas to provide fingerprints,
photographs, or other biometric identifiers upon arrival in, or
departure from, the United States at designated ports of entry and
departure.
This interim rule is necessary to safeguard the public safety by
expanding the US-VISIT program to the 50 most highly trafficked land
border ports of entry in the United States. Further, this interim rule
authorizes the Department to obtain biometric information from persons
traveling without visas under the VWP. Enrolling VWP travelers in US-
VISIT will allow the Department to conduct biometric-based checks at
time of a VWP traveler's application for admission into the United
States and thus greatly reduces the risk that the VWP traveler's
identity could subsequently be used by another traveler seeking to
enter the United States.
Summary of Legal Basis:
The Department established US-VISIT in accordance with several
statutory mandates that collectively require the Department to create
an integrated, automated entry and exit system (entry-exit system) that
records the arrival and departure of aliens; verifies the
[[Page 72756]]
identities of aliens; and authenticates travel documents presented by
such aliens through the comparison of biometric identifiers. Aliens
subject to US-VISIT requirements may be required to provide
fingerprints, photographs, or other biometric identifiers upon arrival
in, or departure from, the United States. The statutory mandates which
authorize the Department to establish US-VISIT include, but are not
limited to, section 2(a) of the Immigration and Naturalization Service
Data Management Improvement Act of 2000 (DMIA), Public Law 106-215;
section 205 of the Visa Waiver Permanent Program Act of 2000 (VWPPA),
Public Law 106-396; section 414 of the Uniting and Strengthening
America by Providing Appropriate Tools Required to Intercept and
Obstruct Terrorism Act of 2001 (USA PATRIOT Act), Public Law 107-56;
and section 302 of the Enhanced Border Security and Visa Entry Reform
Act of 2002 (Border Security Act) Public Law 107-173.
Under DMIA (8 U.S.C. section 1365a(d)), the Department is required to
implement US-VISIT at the 50 most highly trafficked land border ports
of entry no later than December 31, 2004. This interim rule allows the
Department to meet that statutory deadline.
Alternatives:
The Department will continue to consider public comments and determine
whether possible supplemental regulations are needed as we gain
experience with implementing this program.
Anticipated Cost and Benefits:
The anticipated benefits of this rule include: (1) improving
identification of travelers who may present threats to public safety
and the national security of the United States through use of biometric
identifiers; (2) enhancing the government's ability to match an alien's
fingerprints and photographs to other law enforcement or intelligence
data associated with identical biometrics; (3) improving the ability of
the United States to identify individuals who may be inadmissible to
the United States; (4) improving cooperation across international,
Federal, State, and local agencies through better access to data on
foreign nationals who may pose a threat to the United States; (5)
improving facilitation of legitimate travel and commerce by improving
the timeliness and accuracy of the determination of a traveler's
immigration status and admissibility; (6) enhancing enforcement of
immigration laws, contributing to the increased integrity of the system
of immigration in the United States, including the collection of more
complete arrival and departure information on VWP travelers and aliens
who seek to enter the United States through a land border port of
entry; (7) reducing fraud, undetected impostors, and identity theft;
and, (8) increasing integrity within the VWP program, through better
data collection, tracking, and identification, allowing better
compliance monitoring through increased and more accurate data.
The costs associated with implementation of this interim rule for
travelers not otherwise exempt from US-VISIT requirements include an
increase of approximately 15 seconds in inspection processing time per
applicant over the current average inspection time of one minute,
whether at a land, air, or sea port-of-entry. No significant difference
is anticipated in the processing of an alien traveling with a visa as
compared to a traveler without a visa under VWP.
The Department anticipates that, by December 31, 2005, when US-VISIT is
required to be implemed at all land border ports of entry in the United
States, approximately 3.2 million nonimmigrant applicants for Form I-94
issuance could be affected at the designated land ports-of-entry. The
Department, when conducting a cost-benefit analysis for the January 5,
2004, interim rule, estimated that the time required to obtain the
biometric information required under US-VISIT was approximately 15
seconds per person. Since the implementation of US-VISIT at air and sea
ports on January 5, 2004, the Department has not received reports of
average processing times greater than 15 seconds nor any significant
delays for travelers resulting from the collection of biometric
information under US-VISIT. The limited 15 second processing time was
not expected to cause significant delays for travelers at air or sea
ports because persons not required to provide biometrics (e.g. U.S.
citizens, lawful permanent residents, and visa-exempt non-immigrants)
generally are routed through different inspection lines, thereby easing
any impact of the biometric collection process. Because the same
biometric information will be obtained at land border ports of entry,
through a similar secondary inspection process, DHS does not anticipate
any increase in the 15 second processing time or any significant delay
for travelers at land border ports of entry in the United Stated.
In addition, over time, the efficiency with which the process is
employed will increase, and the process can be expected to improve
further.
The additional costs to the Government and the public to implement the
requirements of this rule are approximately $155 million for all 50
ports during fiscal year 2004, or approximately $3.1 million at each of
the ports. These expenditures are required to upgrade the information
technology hardware (i.e. desktop hardware and peripherals, upgrading
local and wide area networks) at the affected ports.
Risks:
The United States remains at risk to terrorist attacks. Since its
implementation in January 2004, US-VISIT has proven that the use of
biometrics to check identity and background is a highly effective law
enforcement tool. US-VISIT has already prevented 196 criminal aliens
from entering the United States, even though the program is currently
operating on a limited basis. Expanding the classes of aliens subject
to US-VISIT to VWP aliens immediately should result in additional
aliens being identified on ``lookout'' lists being prevented admission
or arrested as fugitives or wanted criminals. Further, expanding the
program to include the major land border ports-of-entry should result
in even more ``hits.'' Accordingly, expanding both the classes of
aliens subject to US-VISIT, as well as the location of ports where US-
VISIT will be implemented, will have a considerable and positive effect
on national security. Any delay in the implementation of this interim
rule to allow for public comment may increase the opportunity for
aliens who may otherwise not be admissible to the United States, due to
suspected terrorist affiliations or criminal records, to enter the
United States using false identifies, and false, fraudulent, or stolen
passports or other travel documents.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru69 FR 53318 08/31/04
Interim Final Rule Effective 09/30/04
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
[[Page 72757]]
Small Entities Affected:
No
Government Levels Affected:
Federal
Public Compliance Cost:
; Yearly Recurring Cost: $155000000; Base Year for Dollar Estimates:
2004
Agency Contact:
Michael Hardin
Department of Homeland Security
Directorate of Border and Transportation Security
US-VISIT
18th floor
1616 N. Fort Myer Drive
Arlington, VA 22209
Phone: 202 298-5200
Email: michael.hardin@dhs.gov
Related RIN: Related to 1651-AA54
RIN: 1650-AA00
_______________________________________________________________________
DHS--Bureau of Immigration and Customs Enforcement (BICE)
-----------
PRERULE STAGE
-----------
75. ESTABLISHING PROCEDURES FOR RECERTIFICATION OF SCHOOLS
APPROVED BY THE STUDENT AND EXCHANGE VISITOR PROGRAM (SEVP) TO ENROLL F
OR M NONIMMIGRANT STUDENTS
Priority:
Other Significant
Legal Authority:
PL 107-173, sec 502; 8 USC 1356(m); PL 107-56
CFR Citation:
8 CFR 103; 8 CFR 214
Legal Deadline:
Final, Statutory, October 2004, Schools become eligible for
recertification as early as October 1, 2004.
The Uniting and Strengthening America by Providing Appropriate Controls
Required to Intercept and Obstruct Terrorism Act (USA PARTRIOT Act),
Public Law 107-56, mandated that SEVIS be completely implemented before
January 1, 2003. Both Directive No. 2 and the Border Security Act
require DHS to conduct periodic reviews of all schools within two years
of the initial approval of their SEVP certification, and every two
years thereafter. In order to meet this mandate.
Abstract:
This interim rule amends DHS regulations governing recertification of
schools approved by the Student and Exchange Visitor Program (SEVP) for
attendance by F or M nonimmigrant students. It sets the fee amount for
recertification at a flat nonrefundable rate of $580 dollars, adds a
provision to allow a school to voluntarily withdraw from its
certification, and clarifies procedures for school operation with
regard to nonimmigrant students during the review process and following
withdrawal of certification.
On October 30, 2001, the President issued Homeland Security Directive
No. 2, requiring periodic reviews of all institutions certified to
receive nonimmigrant students. The Enhanced Border Security and Visa
Entry Reform Act of 2002 (Border Security Act), Public Law 107-173,
enacted May 14, 2002, also requires a periodic review of approved
schools every two years. This rule is being promulgated consistent with
these mandates.
Statement of Need:
The Uniting and Strengthening America by Providing Appropriate Tools
Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act),
Public Law 107-56, mandated that SEVIS be fully implemented prior to
January 1, 2003. Both Directive 2, and the Border Security Act require
DHS to conduct periodic reviews of all schools within two years of
their initial SEVP certification and every two years thereafter. In
order to meet this mandate and because the periodic review of all
approved schools is important to safeguarding against abuse of American
openness to foreign students by foreign terrorists, this rule must be
effective immediately. Vital national security concerns that underpin
Directive No. 2, the USA PATRIOT Act, and the Border Security Act might
be placed at risk by observing the requirements of 5 U.S.C. 533(b) and
(d). Additionally, the provision for the recertification fee has been
in 8 CFR 124.3(h)(3) since September 25, 2002.
Summary of Legal Basis:
On October 30, 2001, the President issued Homeland Security Directive
No. 2 (Directive 2) requiring DHS to conduct periodic reviews of all
institutions approved to accept nonimmigrant students. More recently,
section 502 of the Enhanced Border Security and Visa Entry Reform Act
of 2002 (Border Security Act), Public Law 107-173, enacted May 14,
2002, required DHS to review all schools approved for attendance by F
or M nonimmigrant students within two years of the passage of the
Border Security Act. Further, it mandates that DHS recertify the
approval of all schools every two years thereafter. 8 U.S.C. 1356(m)
requires the recovery of the full cost of providing adjudication
services for immigration-related benefits. Because certification allows
schools to have their foreign students admitted to the United States as
nonimmigrants under certain visa categories, certification constitutes
a benefit under title 8 and is subject to the 1356(m) requirement. The
requirement for recertification and the intent to charge a fee was
established in 67 FR 60107 (September 25, 2002). At that time, it was
anticipated that the cost of recertification would be comparable to the
cost of initial certification.
Alternatives:
None
Anticipated Cost and Benefits:
8 U.S.C. 1356(m) requires the recovery of the full cost of providing
adjudication services for immigration-related benefits. Because
certification allows schools to have their foreign students admitted to
the United States as nonimmigrants under certain visa categories,
certification constitutes a benefit under title 8 and is subject to the
1356(m) requirement.
The requirement for recertification and the intent to charge a fee was
established in 67 FR 60107 (September 25, 2002). At that time, it was
anticipated that the cost of recertification would be comparable to the
cost of initial certification.
Combined with a fee collected from nonimmigrant F and M students and J
exchange visitors, the fees in this rule are intended to meet costs of
SEVP.
Risks:
Timely implementation of this rule is critical to continued fulfillment
of the SEVP mission.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 01/00/05
NPRM 06/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Organizations
[[Page 72758]]
Government Levels Affected:
None
Additional Information:
ICE No. 2329-04
Agency Contact:
Susan Geary
Acting Director, Student and Visitor Exchange Program
Department of Homeland Security
Bureau of Immigration and Customs Enforcement
800 K Street NW.
Washington, DC 20536
Phone: 202 305-2346
Fax: 202 353 3723
Email: susan.geary@dhs.gov
RIN: 1653-AA42
BILLING CODE 4410-10-S
[[Page 72759]]
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD)
Statement of Regulatory Priorities
The regulatory plan for the Department of Housing and Urban
Development for fiscal year (FY) 2005 highlights the priority
regulations and policy initiatives directed toward the achievement of
HUD's traditional goals of increasing the supply of affordable housing
(rental and homeownership), ensuring equal opportunity for housing, and
promoting jobs and economic development, as well as its more recent
goal of restoring the public's trust in HUD. These goals are embodied
in HUD's mission and its strategic goals for FY 2005.
Under the leadership of Secretary Alphonso Jackson, HUD approaches the
new fiscal year with a renewed sense of commitment to its mission and
goals and greater accountability for its performance. Reflecting HUD's
role as the primary Federal agency responsible for addressing America's
housing needs and improving and developing the nation's communities,
the Secretary's regulatory plan is designed to implement HUD's broad,
but focused, strategic goals and objectives. HUD's strategic goals and
objectives are to:
1. Increase homeownership opportunities;
2. Promote decent, affordable housing;
3. Strengthen communities;
4. Ensure equal opportunity in housing;
5. Embrace high standards of ethics, management, and accountability;
and
6. Promote participation of faith-based and community organizations.
Under the leadership of Secretary Jackson, HUD's regulatory plan for
FY 2005 builds upon the successes of the previous fiscal year through
regulations that are designed to expand homeownership opportunities,
promote decent, affordable housing, particularly for the most
vulnerable Americans, and strengthen America's communities.
Priority: Expanding Homeownership through Educating Potential First-
time Homebuyers
Helping more low- and moderate-income Americans become homeowners is a
national priority. Under the leadership of Secretary Jackson, the
Department is committed to helping everyone, especially first-time
homebuyers and minority families, take advantage of new opportunities
to own their own homes. The reasons for this priority are clear.
Homeownership benefits individual families by helping them build
economic security, and it fosters healthy, vibrant communities. Owning
a home is good for families and provides a sense of security that
allows families to build wealth. Homeownership is also good for
communities. Homeowners work to maintain the value of their investment,
which translates into a greater concern for neighborhoods and
surrounding communities. A family that owns its home is more likely to
upgrade the property, to take pride in its neighborhood, and to feel
invested in the community. When citizens become homeowners, they become
stakeholders as well. By increasing the ranks of stakeholders,
communities not only enjoy increased stability, but also benefit from a
new spirit of revitalization.
Regulatory Action: Housing Counseling
In order to expand homeownership, the Department is working to ensure
that those who purchase a home are better able to avoid circumstances
that might result in foreclosure. An educated homebuyer is the best
defense against abusive lending practices, known as predatory lending,
that have too often been used by unscrupulous lenders. One of the best
ways to avoid future problems and promote homeownership is to educate
families about the process and responsibilities of homeownership.
Housing counseling services can also help low- and moderate-income
renters improve their access to affordable housing by increasing their
abilities to budget for needed home expenses and regular rent payments,
enhancing their housing conditions, and helping them to avoid rental
delinquency. These counseling services have proven to be extremely
important in helping families purchase a home and keep it in times of
financial stress. With appropriate advice, families coping with
financial difficulties are more likely to survive tough times with
their homes intact. As a result, HUD is pursuing rulemaking to codify
the key provisions of its housing counseling program. Housing
counseling services include assisting eligible homebuyers to seek out
and purchase homes; helping renters locate and qualify for assisted
rental units; helping eligible homebuyers obtain affordable housing;
assisting homeowners to avoid foreclosures; assisting renters to avoid
evictions; helping the homeless find temporary or permanent shelter;
reporting fair housing or discrimination complaints or both; and
addressing other housing problems.
Priority: Expanding Homeownership by Helping Existing Homeowners Keep
Their Homes
HUD is continuing its efforts to assist first-time homeowners maintain
their homeownership status. Among the ways HUD is advancing this goal
is through foreclosure prevention activities and better monitoring of
appraisals. In particular, the requirement imposed on Federal Housing
Administration (FHA) lenders to engage in loss mitigation has proven a
successful strategy for assisting homeowners keep their homes and will
be strengthened.
Regulatory Action: Treble Damages For Failure to Engage in Loss
Mitigation
The HUD appropriations act for fiscal year 1999 amended the National
Housing Act (NHA) to add a triple penalty for failure to engage in
appropriate loss mitigation to the existing civil money penalty system.
Section 230(a) of title II of the NHA, as amended, makes it mandatory
for the mortgagee, upon the default of a single-family mortgage, to
engage in loss mitigation actions, including, but not limited to,
special forbearance, loan modification, and deeds in lieu of
foreclosure, for the purpose of providing alternatives to foreclosure.
On April 14, 2004, HUD published a proposed rule that would amend HUD's
civil money penalty regulations to reflect HUD's authorization to
impose treble damages on a mortgagee for any mortgage for which the
mortgagee had a duty but failed to engage in appropriate loss
mitigation actions. The proposed rule followed publication of an
advanced notice of proposed rulemaking (ANPRM) and took into
consideration public comments on the ANPRM. HUD intends to give
priority to making this rule final.
Priority: Promote Decent Affordable Housing
While seeking to expand homeownership opportunities, HUD recognizes
that homeownership may not be practical for all families. To help these
families obtain safe, decent, and affordable housing, HUD's regulatory
plan will strengthen its current rental assistance programs. HUD will
focus on improving the physical quality of public and assisted housing
and on improving housing agencies' utilization of assistance.
Regulatory Action: Public Housing Operating Fund Program
[[Page 72760]]
On October 21, 1998, the Congress enacted the Quality Housing and Work
Responsibility Act of 1998 (QHWRA), which made sweeping changes to
HUD's public and assisted housing programs. Section 519 of QHWRA
amended section 9 of the United States Housing Act of 1937 to establish
an operating fund for the purpose of making assistance available to
public housing agencies (PHAs) for the operation and management of
public housing. On March 29, 2001, HUD published an interim rule,
developed through negotiated rulemaking, implementing the operating
fund.
Since that time, HUD, as directed by Congress, contracted with the
Harvard University Graduate School of Design to conduct a study of the
cost incurred in operating a well run public housing agency (the
Harvard Cost Study). The Harvard University Graduate School of Design
performed extensive research on the issue of calculating the expense
level of well managed public housing and conducted a number of public
meetings to allow for an exchange of thoughts and expectations with
PHAs. The Harvard University Graduate School of Design issued its final
report on June 6, 2003.
On March 10, 2004, HUD announced the establishment of its Negotiated
Rulemaking Committee on the Operating Fund. The goal of the committee
was to provide advice and recommendations for a rule for effectuating
changes to the Operating Fund Program in response to the Harvard Cost
Study. The committee held four meetings to complete its work. Operating
by consensus decisionmaking and under its approved charter and
protocols, the committee developed a rule, the goal of which is to
improve and clarify the current regulations governing the Operating
Fund Program. The rule also takes into consideration the
recommendations contained in the Harvard Cost Study.
Regulatory Action: Project-Based Voucher Program
The Project-Based Voucher Program replaces the former Project-Based
Certificate Program and provides PHAs with flexibility in administering
the program that will assist PHAs in increasing housing opportunities.
The Project-Based Program was authorized by law in 1998, as part of the
statutory merger of the certificate and voucher tenant-based programs.
In 2000, the Congress substantially revised the project-based voucher
law. The statutory revisions of 2000 made a number of changes to the
program including permitting a PHA to pay project-based assistance for
a term of up to 10 years, permitting a PHA to provide project-based
assistance for existing housing that does not need rehabilitation, as
well as for newly constructed or rehabilitated housing, and allowing a
family to move from a project-based voucher unit after one year and
transfer to the PHA's tenant-based voucher program. Initial guidance on
the new law was provided to PHAs and residents in January 2001. On
March 18, 2004, HUD published a proposed rule that would begin the
process of providing the more permanent regulatory framework for this
new program. HUD intends to give priority to making this rule final.
Regulatory Action: Public Housing Capital Fund Program
QHWRA also amended section 9 of the United States Housing Act of 1937
to establish a capital fund for the purpose of making assistance
available to PHAs for the development, financing, and modernization of
public housing. This proposed rule would establish the full regulatory
framework for the capital fund program. This proposed rule would
combine several legacy programs. Many of the requirements of these
programs are redundant, overlapping, and in need of updating. In
addition, new components, such as capital fund financing, capital-fund-
only assistance, and homeownership, need program guidance. HUD is
embarking on a comprehensive review of the legacy programs to
streamline, shorten, and combine the requirements into a single
regulation.
Regulatory Action: Revisions to Indian Housing Block Grant Program
HUD's policy to promote the general welfare by meeting the national
goal of providing decent, safe, and affordable housing extends to the
nation's over 562 federally recognized Indian tribes. HUD's tribal
partners are diverse. They are located on Indian reservations, in
Alaska Native villages, and in other traditional Indian areas. In
addressing tribal housing issues, HUD is committed to the principle of
government-to-government relations with federally recognized Indian
tribes. In this regard, HUD established a negotiated rulemaking
committee to develop several revisions to the Indian Housing Block
Grant Program allocation formula authorized under section 302 of the
Native American Housing Assistance and Self-Determination Act of 1996.
The first meeting of the committee took place in April 2003. Overall,
the committee met a total of seven times, with the final meeting held
in January 2004. Based on the committee's agreement to operate by
consensus rulemaking and under its approved charter and protocols, the
committee undertook a comprehensive review of the Indian Housing Block
Grant (IHBG) formula. The committee identified certain areas of the
IHBG formula that required clarification, were outdated, or were not
operating as intended by the original negotiated rulemaking committee.
This proposed rule reflects the consensus decisions as reached by the
committee during the negotiated rulemaking process on the best way to
address these issues.
Priority: Strengthen Communities
HUD is committed to preserving America's cities as vibrant hubs of
commerce and making communities better places to live, work, and raise
a family. Toward this end, many State and local governments depend upon
HUD and its system of grants to support community development projects,
revive troubled neighborhoods, and spark urban renewal. HUD is
committed to helping communities address development priorities through
local decisionmaking. HUD will also move to ensure that its community
development partners have greater flexibility to address locally
determined priorities and maintain long-term prosperity.
Regulatory Action: Streamlining the Consolidated Plan
In fiscal year 2002, the President's Management Agenda directed HUD to
work with local stakeholders to streamline the consolidated plan,
making it more results-oriented and useful to communities in assessing
their own progress toward addressing the problems of low-income areas.
To launch this activity, HUD held several focus group sessions with
grantees and other stakeholders in 2002 to discuss ways to streamline
the consolidated plan and improve performance measurement. HUD also
convened a national planning meeting to introduce the concept of the
Consolidated Plan Improvement Initiative to a national audience that
included public interest groups, grantees, and other stakeholders. At
this meeting, six working groups were established to assess alternative
planning requirements, review performance measures, and identify
communities that would be willing to test pilots of alternative
planning procedures.
This proposed rule resulted from an extensive consultation process
that involved stakeholders representing the
[[Page 72761]]
interests of State and local governments and low-income persons. The
proposed rule builds on the existing framework that established the
consolidated plan as a collaborative process whereby a community
establishes a unified plan of community development actions. That
framework gives States and local governments the flexibility to use
existing plans and strategies to help citizens understand the
jurisdiction's priority needs and assess the jurisdiction's progress
toward meeting identified goals and objectives through measurable
indicators.
Regulatory Action: Empowerment Zone Resident Benefit and Economic
Development
In December 1998, HUD designated 15 new urban Empowerment Zones (EZs).
The 1998 designation is referred to as Round II. These designees are
able to use tax-incentive packages to open new businesses, provide
thousands of new jobs, rehabilitate and build new housing, and change
lives for the better in urban and rural areas throughout the Nation.
This EZ initiative offers communities opportunities and resources to
overcome seemingly insurmountable problems by providing incentives for
new business, affordable housing, and jobs. HUD believes that the
opportunity to prosper through tax incentives is a major shift in the
paradigm of how government creates the atmosphere to stimulate economic
revitalization.
This regulation would ensure that Round II EZs assure that a certain
level of the benefits resulting from the use of and the expenditure of
associated grant funds will accrue to persons who reside within the EZ.
Accordingly, this regulation would require an implementation plan
submitted for HUD approval by EZs to describe their planned use of HUD
EZ grants funds to meet one of three standards of resident benefit: a
principal benefit standard, a proportional benefit standard, or an
exception criterion for determining the amount of HUD EZ grant funds
that may be used to fund a particular project or activity described in
an implementation plan. This rule would also provide more specific
direction on the restriction contained in the statutory language
appropriating the funds that the HUD EZ grant funds be used ``in
conjunction with economic development activities'' and sets standards
for applying the restriction to individual activities that may be
assisted through the use of the funds.
The Priority Regulations that Comprise HUD's FY 2005 Regulatory Plan
A more detailed description of the priority regulations that comprise
HUD's FY 2005 regulatory plan follows.
_______________________________________________________________________
HUD--Office of the Secretary (HUDSEC)
-----------
PROPOSED RULE STAGE
-----------
76. CONSOLIDATED PLAN AMENDMENTS (FR-4923)
Priority:
Other Significant
Legal Authority:
42 USC 3535(d); 42 USC 3601 to 3619; 42 USC 5301 to 5315; 42 USC 12701
to 12711; 42 USC 12741 to 12756; 42 USC 12901 to 12912; . . .
CFR Citation:
24 CFR 91
Legal Deadline:
None
Abstract:
This rule would amend the consolidated plan regulations to make
clarifying and streamlining changes that are expected to make the
consolidated plan more results-oriented and useful to communities in
assessing their own progress toward addressing the problems of low-
income areas. The proposed rule would eliminate some obsolete and
redundant provisions and make other changes that would conform the
consolidated plan regulations with HUD's public housing regulations
that govern the Public Housing Agency Plan.
Statement of Need:
This rule resulted from an extensive consultation process that involved
stakeholders representing the interests of State and local governments
and low-income persons. The general view of the involved stakeholders
was that the consolidated plan should be a concise, action-oriented
management tool that would be more understandable to the public and
more useful to decisionmakers in the community.
Summary of Legal Basis:
The Consolidated Plan incorporates the planning activities of the
Comprehensive Housing Affordability Strategy (CHAS), enacted by the
Cranston-Gonzalez National Affordable Housing Act of 1990 and the
document submission requirements for four formula grant programs:
Community Development Block Grant, HOME, Emergency Shelter Grant, and
Housing Opportunities for Persons with AIDS (HOPWA).
Alternatives:
This action is a rule of general applicability and future effect that
does not fall into any of the rulemaking exceptions.
Anticipated Cost and Benefits:
This rule is based on an extensive consultation process that involved
numerous stakeholders representing the interests of State and local
governments and low-income persons. Anticipated changes benefit State
and local governments by providing a streamlined reporting process that
is more internally consistent and conforms to recent statutory changes.
At the same time, this rule should have minimal impact on State and
local governments.
Risks:
This rule poses no threat to public safety, health, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Salvatore Sclafani
Office of Policy Development and Coordination, Office of Community
Planning and Development
Department of Housing and Urban Development
Phone: 202 708-1817
RIN: 2501-AD07
[[Page 72762]]
_______________________________________________________________________
HUD--HUDSEC
-----------
FINAL RULE STAGE
-----------
77. TREBLE DAMAGES FOR FAILURE TO ENGAGE IN LOSS MITIGATION (FR-4553)
Priority:
Other Significant
Legal Authority:
12 USC 1715u; 12 USC 1735f-14; 12 USC 1701q-1; 12 USC 1703; 1735f-15;
15 USC 1717a; 28 USC 2641 note; 12 USC 1709; 12 USC 1710; 12 USC 1715b;
42 USC 3535(d)
CFR Citation:
24 CFR 30; 24 CFR 203
Legal Deadline:
None
Abstract:
This rule will implement a statutory triple penalty for failure to
engage in loss mitigation to the existing penalty system, and will also
describe the process for assessing treble damages when a mortgagee
fails to engage in loss mitigation activities with cooperative and
qualified mortgagors. The rule will amend 24 CFR parts 30 and 203 to
set out the maximum penalty amounts for those servicing mortgagees that
fail to engage in loss mitigation. Mortgagees that fail to engage in
loss mitigation may be subject to penalties of three times the amount
of any mortgage insurance benefits claimed by the mortgagee. In
assessing loss mitigation performance, this rule will rank mortgagees
into four tiers, with tier 1 representing the highest loss mitigation
performance, and tier 4 the lowest (i.e., a systematic failure to
engage in loss mitigation). This rule will focus primarily on the tier
4 performers.
Statement of Need:
This rule implements a law authorizing HUD to assess civil money
penalties for specific types of mortgage lender violations, including
failure to engage in loss mitigation. The law also directs HUD to
implement regulations as it determines necessary to implement the civil
money penalty provisions. This rule is necessary to encourage certain
lenders that rarely engage in loss mitigation activities to do so.
Failure to engage in loss mitigation leads to additional claims on
FHA's insurance funds. Greater emphasis by certain lenders on loss
mitigation will act to reduce those claims and enhance the health of
the funds.
Summary of Legal Basis:
Section 230 of the National Housing Act (NHA), (12 U.S.C. 1715u),
requires mortgage lenders utilizing FHA-insured financing to engage in
loss mitigation actions upon the default of any insured mortgage.
Section 536(b)(1)(I) of the NHA (12 U.S.C. 1735f-14(b)(1)(I)) includes
failure to engage in loss mitigation among the activities for which HUD
may assess civil penalties. Section 536(a) of the NHA (12 U.S.C. 1735f-
14(a)) provides that in the case of failure to engage in loss
mitigation, the penalty may be tripled. Section 536(h) of the NHA (12
U.S.C. 1735f-14(h)) provides that HUD shall issue regulations to
implement these provisions as it determines is appropriate.
Alternatives:
This action is a rule of general applicability and future effect that
does not fall into any of the rulemaking exceptions. Therefore,
rulemaking is the only available procedure to implement these
provisions.
Anticipated Cost and Benefits:
This rule authorizes the imposition of a penalty on those lenders that
have poor records in the area of loss mitigation. The announcement of
the availability of treble damages as an enforcement tool should
encourage lenders to engage in loss mitigation activities upon default
by mortgagors, with adherence to statutorily required loss mitigation
activities the rule is expected to help safeguard the insurance fund in
the form of reduced claims on the insurance fund and hence reduced
payouts.
Risks:
This rule imposes no risks to public health, safety, or the
environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 65 FR 76520 12/06/00
ANPRM Comment Period End 02/05/01
NPRM 69 FR 19906 04/14/04
NPRM Comment Period End 06/14/04
Final Action 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Michael Reyes
Office of the Deputy Assistant Secretary for Single Family Housing
Department of Housing and Urban Development
Office of the Secretary
Phone: 405 553-7576
RIN: 2501-AC66
_______________________________________________________________________
HUD--Office of Housing (OH)
-----------
PROPOSED RULE STAGE
-----------
78. HOUSING COUNSELING PROGRAM (FR-4798)
Priority:
Other Significant
Legal Authority:
12 USC 1701; 42 USC 3535(d)
CFR Citation:
24 CFR 214
Legal Deadline:
None
Abstract:
This rule would establish regulations for the Department's Housing
Counseling program, as authorized by the Housing and Urban Development
Act of 1968, and for which, the past several years, notices of funding
availability are issued on an annual basis. Establishment of
regulations would assist homeowners and tenants in improving their
housing conditions and in meeting the responsibilities of homeownership
and tenancy. This rule would adopt, without substantive change, the
housing counseling program requirements with which grantees and Housing
Counseling agencies are already familiar.
Statement of Need:
Establishment of regulations would reflect the permanency and
importance of this program.
Summary of Legal Basis:
Section 106(a) of the Housing and Urban Development Act of 1968 defines
housing counseling services as ``counseling and advice to tenants and
homeowners with respect to property maintenance, financial management
and such other matters as may be appropriate to assist them in
improving
[[Page 72763]]
their housing conditions and in meeting the responsibilities of
homeownership.'' Under section 106, HUD may provide counseling
directly, or may enter into contracts with, or make grants to, and
provide other types of assistance to eligible private or public
organizations with special competence and knowledge in providing
housing counseling to low- and moderate-income families for the
purposes of providing counseling and advice to tenants and homeowners.
Current law at 12 U.S.C. 1701x extends eligibility of housing
counseling services for virtually all defaulting homeowners and
tenants. In addition, section 255(d)(2)(B) of the National Housing Act,
which authorizes mortgage insurance of home equity conversion mortgages
(HECM) for elderly homeowners, requires that a HECM must be executed by
a mortgagor who received ``adequate counseling by a third party (other
than the lender).'' Certain other HUD housing programs may require
participation in the Housing Counseling program.
Alternatives:
Under the current program, grantees and HUD-approved counseling
agencies must refer to notices of funding availability and HUD
handbooks for specific program procedures. The practice of consulting
numerous sources for program information presents confusion especially
when presented with termination of HUD-approved status and other
related actions. Since the program has been funded annually to date,
regulations are the appropriate vehicle to establish program
requirements.
Anticipated Cost and Benefits:
This rule will benefit tenants, homeowners, potential homebuyers, and
the homeless. Housing counseling assists eligible homebuyers to seek
out and purchase homes, helps renters locate and qualify for assisted
rental units, helps eligible homebuyers to obtain affordable housing
and avoid foreclosures, and helps the homeless to find temporary or
permanent shelter. The program will not add additional costs to housing
counseling agencies or those who seek housing counseling services.
Risks:
This rule poses no risk to public health, safety, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Loyd LaMois
Single Family Program Support Division
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-0317
RIN: 2502-AH99
_______________________________________________________________________
HUD--Office of Community Planning and Development (CPD)
-----------
PROPOSED RULE STAGE
-----------
79. EMPOWERMENT ZONES: RESIDENT BENEFIT AND ECONOMIC DEVELOPMENT
STANDARDS FOR GRANTS (FR-4853)
Priority:
Other Significant
Legal Authority:
26 USC 1391; 42 USC 3535(d)
CFR Citation:
24 CFR 598
Legal Deadline:
None
Abstract:
This rule proposes to establish review standards for determining
whether grant funds provided to Empowerment Zones will provide a
sufficient level of benefit to residents and also be used in
conjunction with economic development activities consistent with the
strategic plan for each Empowerment Zone (EZ).
Statement of Need:
HUD has determined that it is appropriate to require a level of
resident benefit from the use of funds appropriated by Congress for
Round II EZs (HUD EZ Grant Funds). EZ residents are intended to be
among the principal beneficiaries of the EZ program and requiring that
HUD EZ Grant Funds provide a direct benefit to EZ residents is
consistent with promoting such a result. In addition, HUD EZ Grant
Funds have generally been accompanied by the explicit requirement that
the funds be used ``in conjunction with economic development activities
consistent with the strategic plan for each EZ.`` A number of questions
have arisen about whether particular planned activities would fall
within this statutory restriction. This rule proposes the standards
that are to be used for determining whether an activity proposed for
assistance will meet that requirement.
Summary of Legal Basis:
The strategic plan for an EZ required under 26 U.S.C. 1391 must
address, among other issues, the extent to which poor persons and
families will be empowered to become economically self-sufficient. The
statutes appropriating HUD EZ Grant Funds generally require the funds
to be used in conjunction with economic development activities.
Alternatives:
The changes made by this rule would modify regulatory requirements and,
therefore, must also be promulgated through regulation. Nonregulatory
alternatives (such as through HUD notice or handbook) would not be
binding upon HUD program participants.
Anticipated Cost and Benefits:
The requirements proposed by this rule would not impact the costs of
using HUD EZ Grant Funds, but would only provide direction for the use
of such funds consistent with the purposes of EZ designation. The
benefits of having this direction is that it provides more certainty
for planning and executing activities that will promote the purposes of
the authorizing legislation.
Risks:
This rule poses no threat to public safety, health, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
Local
[[Page 72764]]
Agency Contact:
John Haines
Empowerment Zone Division
Department of Housing and Urban Development
Office of Community Planning and Development
Phone: 202 708-6339
RIN: 2506-AC16
_______________________________________________________________________
HUD--Office of Public and Indian Housing (PIH)
-----------
PROPOSED RULE STAGE
-----------
80. CAPITAL FUND PROGRAM (FR-4880)
Priority:
Other Significant
Legal Authority:
42 USC 1437g; 42 USC 1437z-7; 42 USC 3535(d)
CFR Citation:
24 CFR 905
Legal Deadline:
None
Abstract:
This rule will implement the regulatory framework for the Capital Fund
Program for the capital and management improvement needs of public
housing agencies that will govern the use of the assistance made
available from the Capital Fund formula. The new rule at part 905 will
replace and remove several other rules that currently govern a PHA's
use of HUD assistance including part 941 (Public Housing Development)
and part 968 (Public Housing Modernization). This rule will continue
and expand the streamlining of procedures and requirements initiated
under the Comprehensive Grant and Comprehensive Improvement programs
that are included in part 968.
Statement of Need:
Assistance under the Capital Fund Program is the primary, regular
source of funding made available by HUD to a PHA for its capital
activities, including modernization and development of public housing.
This rule will implement the requirements for the use of assistance
made available under the Capital Fund program. The regulations will
provide the appropriate notice of the legal framework for the program,
and clear and uniform guidance for program operation.
Summary of Legal Basis:
Sections 518, 519, and 539 of the Quality Housing and Work
Responsibility Act of 1998 (Pub.L. 105-276, approved October 21, 1998)
(referred to as QHWRA), amending sections 9 and 5, and adding section
35(g) of the U.S. Housing Act of 1937.
Alternatives:
The QHWRA required a formula system to be established to govern funding
of PHAs' public housing capital needs. Guidance for administration of
these funds necessitates a permanent legal framework rather than
informal and sporadic HUD notices.
Anticipated Cost and Benefits:
The costs of the program as administered with one fund from which a PHA
will fund all of its capital needs is the same as under existing
provisions. The benefits of having one funding mechanism for all such
needs, and the provision of additional flexibility to PHAs to manage
their physical assets provides increased benefits to the PHAs.
Likewise, uniform program administration of these funds will provide
increased benefits to the PHAs.
Risks:
This rule poses no threat to public safety, health, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
William Thorson
Director, Office of Capital Improvements
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-1640
RIN: 2577-AC50
_______________________________________________________________________
HUD--PIH
81. OPERATING FUND ALLOCATION FORMULA (FR-4874)
Priority:
Economically Significant
Legal Authority:
42 USC 1437g; 42 USC 3535(d)
CFR Citation:
24 CFR 990
Legal Deadline:
None
Abstract:
This rule will revise the formula system for allocating funds to public
housing agencies (PHAs) for their operation and management of public
housing. The current formula system was developed pursuant to section
519 of the Quality Housing and Work Responsibility Act of 1998 (title V
of Public Law 105-276, approved October 21, 1998, 112 Stat. 2551). That
statute amended section 9 of the United States Housing Act of 1937 to
require development of a new formula that would change the method of
determining the payment of operating subsidies to PHAs.
Statement of Need:
Section 519 of the Quality Housing and Work Responsibility Act requires
HUD to develop this rule to govern funding of PHAs' operating and
management needs.
Summary of Legal Basis:
The Consolidated Appropriations Act of 2004 requires that HUD develop
the rule to govern funding of PHA's operating and management needs.
Alternatives:
The Consolidated Appropriations Act of 2004 requires rulemaking.
Anticipated Cost and Benefits:
The costs of the program as administered with one fund from which a
public housing agency (PHA) will fund all of its operating and
management needs will be the same as under existing provisions. The
benefits of having one funding mechanism for all such needs provides
increased benefits to the PHAs. Likewise, uniform program
administration of these funds will provide increased benefits to the
PHAs.
The costs of the program as administered with one fund from which a PHA
will fund all of its operating and management needs will
[[Page 72765]]
be the same as under existing provisions. The benefits of having one
funding mechanism for all such needs provides increased benefits to the
PHAs. Likewise, uniform program administration of these funds will
provide increased benefits to the PHAs.
Risks:
This rule poses no threat to public safety, health, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Chris Kubacki
Funding and Financial Management Division
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-4932
RIN: 2577-AC51
_______________________________________________________________________
HUD--PIH
82. NATIVE AMERICAN HOUSING ASSISTANCE AND SELF-DETERMINATION ACT
(NAHASDA): REVISIONS TO THE INDIAN HOUSING BLOCK GRANT PROGRAM FORMULA
(FR-4938)
Priority:
Other Significant
Legal Authority:
25 USC 4101 et seq; 42 USC 3535(d)
CFR Citation:
24 CFR 1000
Legal Deadline:
None
Abstract:
This rule would make several revisions to the Indian Housing Block
Grant (IHBG) Program allocation formula authorized under section 302 of
the Native American Housing Assistance and Self-Determination Act of
1996. Through the IHBG Program, HUD provides Federal housing assistance
for Indian tribes in a manner that recognizes the right of Indian self-
determination and tribal self-government. HUD negotiated the rule with
active tribal participation and using the procedures of the Negotiated
Rulemaking Act of 1990. The proposed regulatory changes reflect the
consensus decisions reached by HUD and the tribal representatives on
ways to improve and clarify the current regulations governing the IHBG
Program formula.
Statement of Need:
The regulations for the IHBG program at 24 CFR 1000.306 provide that
the IHBG allocation formula shall be reviewed within five years after
issuance. This five-year period closed in 2003, which prompted HUD to
establish a negotiated rulemaking committee for the purposes of
reviewing and recommending possible changes to the allocation formula.
The committee identified certain areas of the allocation formula that
required clarification, were outdated, or were not operating as
originally intended. The final rule reflects the consensus decisions
reached by HUD and the Indian tribes on the best ways to address the
necessary changes to the IHBG Program allocation formula.
Summary of Legal Basis:
Section 301 of NAHASDA requires that the Secretary of HUD use an
allocation formula to make fiscal year block grants to Indian tribes
under the IHBG program.
Alternatives:
Section 302 of NAHASDA required that the allocation formula for the
IHBG Program be established by regulation. Accordingly, the revisions
to the allocation formula must also be codified in HUD's regulations.
Anticipated Cost and Benefits:
The changes to the allocation formula made by the final rule will not
impact the costs of the IHBG Program. The benefits of having the
changes to the formula developed through negotiated rulemaking is that
it allows Indian tribes directly affected to have a say in how the
allocation formula will operate, and consequently to help foster
constructive, creative and acceptable solutions to difficult problems.
Risks:
This rule poses no threat to public safety, health, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 02/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Rodger Boyd
Deputy Assistant Secretary for Native American Programs
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 401-7914
RIN: 2577-AC57
_______________________________________________________________________
HUD--PIH
-----------
FINAL RULE STAGE
-----------
83. PROJECT-BASED VOUCHER PROGRAM (FR-4636)
Priority:
Other Significant
Legal Authority:
42 USC 1437f(o); 42 USC 3535(d)
CFR Citation:
24 CFR 983
Legal Deadline:
None
Abstract:
The Project-Based Voucher Program replaces the Project-Based
Certificate Program that was in existence for many years. Under the
Project-Based Voucher Program, HUD pays rental assistance for eligible
families to live in specific housing developments or units. A public
housing agency (PHA) that administers a tenant-based housing choice
voucher program may ``project-base'' up to 20 percent of voucher units
funded by HUD. The Project-Based Program was authorized by law in 1998,
as part of the statutory merger of the certificate and voucher tenant-
based programs. In 2000, the Congress substantially revised the
project-based voucher law. The law made a number of changes including
permitting a PHA to pay project-based assistance for a
[[Page 72766]]
term of up to 10 years, permitting a PHA to provide project-based
assistance for existing housing that does not need rehabilitation, as
well as for newly constructed or rehabilitated housing, and allowing a
family to move from a project-based voucher unit after one year and
transfer to the PHA's tenant-based voucher program.
Statement of Need:
This rule will implement the requirements for the new Section 8
Project-Based Voucher program. The regulations will provide the
appropriate notice of the legal framework for the program, and clear
and uniform guidance for program operation for PHAs and the residents
that the PHAs serve.
Summary of Legal Basis:
The statute is not self-implementing. Regulations are needed to present
the legal framework for the program. The Secretary is authorized under
the U.S. Housing Act of 1937 and the Department of Housing and Urban
Development Act to prescribe such rules and regulations as may be
necessary to effectively administer Department programs.
Alternatives:
This is a new program that provides assistance for housing and replaces
a previous HUD program. Effective and fair administration of the
program necessitates a permanent legal framework rather than informal
and sporadic HUD notices.
Anticipated Cost and Benefits:
The new law and the regulations to be implemented by HUD provide
additional flexibility to PHAs to manage their project-based voucher
programs, and also provide more housing choices to the individuals and
families served by the PHA.
Risks:
The rule poses no threat to public safety, health or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Notice 66 FR 3605 01/16/01
NPRM 69 FR 12950 03/18/04
NPRM Comment Period End 05/17/04
Final Action 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Local, State
Agency Contact:
Gerald J. Benoit
Director, Housing Voucher Management and Operations
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-0477
RIN: 2577-AC25
BILLING CODE 4210-01-S
[[Page 72767]]
DEPARTMENT OF THE INTERIOR (DOI)
Statement of Regulatory Priorities
The Department of the Interior (DOI) is the principal Federal steward
of our nation's public lands and resources, including many of our
cultural treasures. We serve as trustee to Native Americans and Alaska
natives and also are responsible for relations with the island
territories under United States jurisdiction. We manage more than 500
million acres of Federal lands, including 388 park units, 545 wildlife
refuges, 24,000 miles of trails, and approximately 1.7 billion acres
submerged in offshore waters. The Department protects natural, historic
and cultural resources, recovers endangered species, manages water
projects, manages forests and fights wildland fires, leases public
lands for coal, oil and gas production to meet the Nation's energy
needs, educates children in Indian schools and provides recreational
opportunities for almost 300 million visitors annually in our national
parks. To fulfill these responsibilities, the Department generates
scientific information relating to land and resource management.
The Department is committed to achieving its stewardship objectives in
partnership with States, communities, landowners, and others through
consultation, cooperation, and communication.
We will review and update the Department's regulations and policies to
ensure that they are effective, efficient, and promote accountability.
Special emphasis will be given to regulations and policies that:
Adopt performance-based approaches focusing on achieving
results in the most cost-effective and timely manner;
Incorporate the best available science, and utilize peer
review where appropriate;
Promote partnerships with States, other groups, and
individuals;
Provide incentives for private landowners to achieve
conservation goals; and
Minimize regulatory and procedural burdens, promoting
fairness, transparency, and accountability by agency
regulators while maintaining performance goals.
Major Regulatory Areas
Among the Department's bureaus and offices, the Office of Surface
Mining Reclamation and Enforcement (OSM) has a significant
concentration of regulatory responsibilities. OSM, in partnership with
the States and Indian tribes, establishes and enforces environmental
standards for coal mining and reclamation operations. In addition, OSM
administers the abandoned mine land reclamation program, which is
funded by a fee assessed on each ton of coal produced. Money from these
fees is placed in a fund that, subject to appropriation, is used to
reclaim lands and waters impacted by historic mining activities
conducted before the enactment of the Surface Mining Control and
Reclamation Act of 1977. The collection of the fee for reclamation
purposes was originally scheduled to expire in 1992 but was extended by
the Energy Policy Act of 1992 to September 30, 2004; language in the
Department's FY 2005 appropriation would further extend it for an as
yet to be determined period.
Other DOI bureaus rely on regulations to implement legislatively
mandated programs that focus on the management of natural resources and
public or trust lands. Some of these regulatory activities include:
Management of migratory birds and preservation of certain
marine mammals and endangered species;
Management of dedicated lands, such as national parks,
wildlife refuges, and American Indian trust lands;
Management of public lands open to multiple use;
Leasing and oversight of development of Federal energy,
minerals, and renewable resources;
Management of revenues from American Indian and Federal
minerals;
Fulfillment of trust and other responsibilities pertaining to
American Indian tribes;
Natural resource damage assessments; and
Management of financial and nonfinancial assistance programs.
Regulatory Policy
How DOI Regulatory Procedures Relate to the Administration's Regulatory
Policies
Within the requirements and guidance in Executive Orders 12866, 12630,
and 13132, DOI's regulatory programs seek to:
Fulfill all legal requirements as specified by statutes or
court orders;
Perform essential functions that cannot be handled by non-
Federal entities;
Minimize regulatory costs to society while maximizing societal
benefits; and
Operate programs openly, efficiently, and in cooperation with
Federal and non-Federal entities.
DOI bureaus have taken the initiative in working with other Federal
agencies, non-Federal government agencies, and public entities to make
our regulations easier to comply with and understand. Regulatory
improvement is a continuing process that requires the participation of
all affected parties. We strive to include all affected entities in the
decisionmaking process and to issue rules efficiently. To better manage
and review the regulatory process, we have revised our internal
rulemaking and information quality guidance. Our regulatory process
ensures that bureaus share ideas on how to reduce regulatory burdens
while meeting the requirements of the laws they enforce and improving
their stewardship of the environment and resources under their purview.
Results have included:
Increased bureau awareness of and responsiveness to the needs
of small businesses and better compliance with the Small
Business Regulatory Enforcement Fairness Act (SBREFA);
A Departmentwide effort to evaluate the economic effects of
planned rules and regulations;
Issuance of guidance in the Departmental Manual to ensure the
use of plain language;
Issuance of new guidance in the Departmental Manual to ensure
that Departmental National Environmental Policy Act reforms
that streamline decisionmaking and enhance citizen
participation are institutionalized; and
In the Natural Resources Damage Assessment Program, de-
emphasizing actions stemming from litigation while
increasing outreach to involved parties and stressing
cooperation and restoration of affected sites.
A Departmentwide effort to streamline decisionmaking
pertaining to fuels reduction projects under the Healthy
Forests Initiative; and
Joint counterpart pesticide regulations for EPA/FWS endangered
species consultations that will allow the agencies to work
together to complete the consultations (25,000 backlog) in
[[Page 72768]]
as timely a manner as possible and as efficiently as
possible.
Implementing the President's National Energy Policy
The President's National Energy Policy promotes ``dependable,
affordable, and environmentally sound production and distribution of
energy for the future.'' The Department of the Interior plays a vital
role in implementing the President's energy policy goals. The lands and
facilities managed by the Department account for nearly 30 percent of
all the energy produced in the United States.
The Department is taking over 100 actions to implement the President's
energy policy, including several regulatory actions. The Department has
diligently completed regulatory tasks assigned to it by the NEP,
including the Bureau of Land Management's rule that provides a
comprehensive set of regulations for managing oil and gas leases in the
National Petroleum Reserve B Alaska, and the Minerals Management
Service's rule that provides an incentive for development of deep gas
resources offshore in order to encourage drilling of these high-risk
wells and help tap into an important new source of natural gas supply.
The Office of Surface Mining is developing regulations that will create
a stable regulatory environment in order to encourage the development
of better mining and reclamation practices that will reduce
environmental damages associated with coal operations, while
maintaining coal production. OSM anticipates that Congress will
reauthorize the Abandoned Mine Land Fee. However, OSM is making
contingency rulemaking plans should Congress decide otherwise. These
and other regulatory actions within the Department are designed to
streamline permitting processes and encourage environmentally sound
energy production.
Encouraging Responsible Management of the Nation's Resources
The Department's mission includes protecting and providing access to
our Nation's natural and cultural heritage and honoring our trust
responsibilities to tribes. We are committed to this mission and to
applying laws and regulations fairly and effectively. The Department's
priorities include protecting public health and safety, restoring and
maintaining public lands, ameliorating land and resource-management
problems on public lands, and ensuring accountability and compliance
with Federal laws and regulations.
Consistent with the President's Executive Order on Cooperative
Conservation, the Department is continuing to work together with State
and local governments, landowners, conservation groups, and the
business community to conserve species and habitat. Building on
successful approaches such as habitat conservation plans, safe harbor
agreements, and candidate conservation agreements, the Department is
reviewing its policies and regulations to identify opportunities to
streamline the regulatory process where possible, consistent with
protection of wildlife, and to enhance incentive-based programs to
encourage landowners and others to implement voluntary conservation
measures. For example, the Fish and Wildlife Service has issued
guidance to promote the establishment of conservation banks as a tool
to offset adverse impacts to species listed under the Endangered
Species Act and restore habitat.
The Department is improving incentives through administrative
flexibility under the Endangered Species Act. Released for public
comment in September 2003 are proposed rule changes intended to provide
greater clarity of what is allowable under incidental take permits and
provide greater private landowner protections under safe harbor
agreements. The first improvements of procedures relate to enhancement
of survival permits (actions intended to improve survival or habitat of
a species) and will refine and clarify the application requirements.
The second, which relates to the issuing of safe harbor permits, will
make the process easier to understand and will provide participating
landowners greater certainty. Comments have been received and are being
reviewed. Final rules on both will follow sometime before the end of
the year.
The Department is also developing a uniform code of scientific conduct
and policy on research. The Code describes ethical conduct for all
Department employees who are engaged in conducting scientific
activities on behalf of the Department. The primary reason for
developing the Code is to implement a Federal policy on research
misconduct as required by the Office of Management and Budget. The
policy applies to all Federal agencies and federally funded research,
whether conducted in-house or by partners at universities or in non-
governmental organizations. This policy meets the expectations of the
Secretary regarding the conduct of scientific activities with honesty,
integrity, and accuracy; to make decisions based on the best science
available; and is consistent with professional codes of conduct of
other organizations.
In 2002, Secretaries Norton and Veneman signed an historic agreement
with 17 western governors, county commissioners and other affected
parties on a plan to make communities safer from wildfires through
coordinating Federal, State and local action. Under the 10-year
Comprehensive Strategy Implementation Plan, Federal wildfire agencies,
affected States, counties, and local governments agreed to the same
goals, implementation outcomes, performance measures and tasks that
need to be accomplished by specific deadlines. The plan covers all
phases of the fire program, including fire preparedness, suppression
and prevention, hazardous fuels management, restoration of burned
areas, community assistance and monitoring of progress.
In 2002, the President announced the Healthy Forests Initiative, in
which he directed Federal agencies to develop administrative and
legislative tools to restore forests and woodlands to more healthy,
natural conditions and to assist in executing core components of the
National Fire Plan. The Healthy Forests Initiative is providing public
land managers the tools to undertake commonsense management of our
forests and woodlands. The initiative focuses on reducing the risk of
catastrophic fire by thinning dense undergrowth and brush in priority
locations that are collaboratively selected by Federal, State, tribal,
and local officials and communities. In 2005, the Department will
continue to implement the administrative and legislative ``tools''
provided for under the Healthy Forests Initiative and the Healthy
Forests Restoration Act.
The National Park Service has completed an Environmental Assessment to
provide for Temporary Winter Use Plan that provides for continued
snowmobile and snowcoach use in Yellowstone and Grand Teton National
Parks and John D. Rockefeller, Jr. Memorial Parkway for up to the next
three winter seasons. This EA will allow the NPS to engage in longer-
term studies and to monitor the impacts of new technology snowmobiles
in the parks, as well as the effects of road grooming in the winter on
bison migration in Yellowstone. The EA will continue to require the use
of cleaner, quieter
[[Page 72769]]
snowmobiles and set caps on the numbers of machines allowed in the
parks each day. The parks are working to provide a more stable winter
use plan to help gateway communities develop a winter economic plan.
The interim plan and longer-term studies are both intended to satisfy
the problems raised by the Federal District Courts in Wyoming and the
District of Columbia, respectively, that have vacated the plans
previously completed by the NPS in 2001 and 2003.
The Bureau of Land Management is working on a grazing administration
rule that would ensure grazing decision rules conform with the
Administrative Procedure Act, compliance with recent court decisions
regarding conservation use permits, require BLM to consider social and
economic factors when considering changes to grazing use, and offer
other improvements to grazing activities on public lands.
On September 20, 2004, the U.S. Oceans Commission issued its report,
which included over 200 recommendations. The Interior Department will
play an active role in developing the Administration's initial response
(the President has 90 days to respond), given the significant ocean and
coastal related activities of many of Interior's agencies. In 2005, it
is expected that significant time will be devoted to policy,
regulatory, and legislative activities likely to occur as a result of
the issuance of the report.
Minimizing Regulatory Burdens
We are using the regulatory process to ease the burdens on various
entities throughout the country while improving results. For instance,
the Endangered Species Act (ESA) allows for the delisting of threatened
and endangered species if they no longer need the protection of the
ESA. We have identified approximately 40 species for which delisting or
downlisting (reclassification from endangered to threatened) may be
appropriate. The eastern gray wolf has been delisted and an ESA section
10(j) rule for S tates with approved management plans will be ready in
December.
The Federal Power Act authorizes the Department to include in
hydropower licenses issued by the Federal Energy Regulatory Commission
conditions and prescriptions necessary to protect Federal and tribal
lands and resources and to provide fishways when navigable waterways or
Federal reservations are used for hydropower generation. Over the past
year, the Department has worked extensively with the Federal Energy
Regulatory Commission (FERC), along with the Departments of Commerce
and Agriculture, to establish a new integrated licensing process that
will reduce both the time and cost of obtaining a FERC hydropower
license. In July 2003 FERC issued its new rules. On September 9, DOI
published a proposed rule on FERC licensing. The public review process
will enable the public and the license applicant to comment on the
Department's preliminary conditions and prescriptions, and to provide
information to assist the Department in its formulation of modified
conditions and prescriptions. The information obtained through this
process will help the Department in refining and developing its
conditions and prescriptions, which an applicant may appeal using the
proposed appeals process to obtain an expeditious policy level review.
These proposed processes are designed to coincide with and complement
the Commission's overall licensing process.
Encouraging Public Participation and Involvement in the Regulatory
Process
The Department is encouraging increased public participation in the
regulatory process to improve results by ensuring that regulatory
policies take into account the knowledge and ideas of our customers,
regulated community, and other interested participants. The Department
is reaching out to communities to seek public input on a variety of
regulatory issues. For example, every year FWS establishes migratory
bird hunting seasons in partnership with ``flyway councils,'' which are
made up of State fish and wildlife agencies. As the process evolves
each year, FWS holds a series of public meetings to give other
interested parties, including hunters and other groups, opportunities
to participate in establishing the upcoming season's regulations.
Similarly, the Bureau of Land Management (BLM) uses Resource Advisory
Councils (RACs) made up of affected parties to help prepare land
management plans and regulations that it issues under the Rangeland
Reform Act.
In addition, the Department has recently completed a review of its
NEPA compliance program and proposed new procedures aimed at improving
public participation and reducing excess paperwork and redundancy of
effort in the field. This has led to concrete reform measures. On March
8, 2004, the Department published its final revised procedures in the
Federal Register. The reforms cover a number of areas. They include:
Consensus-based management, public participation, community-based
training, use of integrated analysis, adaptive management, and tiered
and transferred analysis. Each of these concepts is aimed at ensuring
the field staff have the tools to tailor their approach to the NEPA
process to local needs and interests. Along with the departmental
manual changes, policy guidance was distributed to bureaus earlier this
year on how to implement the major reforms.
We encourage public consultation during the regulatory process. For
example:
OSM is continuing its outreach to interested groups to improve
the substance and quality of rules and, to the greatest
extent possible, achieve consensus on regulatory issues;
The Bureau of Indian Affairs has finalized its roads program
rule that was developed using the negotiated rulemaking
process, which has resulted in a rule that better serves
the diverse needs of the Native American community,
reflecting the importance of the roads program to the
individual tribes and the varying needs of the tribal
governments;
The Golden Gate National Recreation Area, a unit of the
National Park System, has engaged in negotiated rulemaking
to resolve an issue regarding walking dogs off-leash in the
park. Existing NPS regulations require all dogs to be on a
leash while in Golden Gate NRA, and the park has asked
interested parties on both sides of the issue to come to
the table to help draft a proposed rule. The effort has
identified over 20 area organizations that will likely
participate in the negotiated rulemaking process.
Regulatory Actions Related to the Events of September 11, 2001
The Bureau of Reclamation is responsible for protecting 348 reservoirs
and more than 500 Federal dams, 58 hydroelectric plants, and over 8
million acres of Federal property. Public Law 107-69 granted
Reclamation law enforcement authority for its lands. Reclamation
finalized an interim rule published in April 2002 for one year that
implements this authority. It has since been extended through 2005.
Rules of Particular Interest to Small Businesses
The National Park Service snowmobiling rule for Yellowstone and Grand
Teton National Parks and the
[[Page 72770]]
John D. Rockefeller Memorial Parkway is of great interest to small
businesses in the area of the parks, in particular those who rent
snowmobiles. An initial Regulatory Flexibility Analysis points toward
economic benefits to businesses in gateway communities, with some costs
incurred by non-snowmobile users of the parks.
The Fish and Wildlife Service is making critical habitat designations
more site-specific and is using the ESA section 4(b) exclusion process
to reduce regulatory costs on small businesses.
The Future of DOI
Interior has developed a new Departmentwide strategic plan in response
to Congressional, OMB and other appraisals indicating that Interior's
ten separate strategic planning documents are too long and lack the
appropriate agency-level focus. The process of developing the new
strategic plan provides the Secretary with an opportunity to:
Incorporate key Administration and Secretarial priorities into
Interior's goals and performance measures;
Consult with key interested constituents on the future
direction of the Department; and
Make Interior programs more ``results-oriented'' and
accountable to citizens.
Interior also is using the single Strategic Plan as the basis for
preparing a single Departmentwide Annual Performance Plan beginning
with the plan for FY 2004. The Interior bureaus will continue to
prepare internal plans to support their budget initiatives and to meet
management excellence and accountability needs. However, we plan to
submit only Departmentwide strategic and annual plans to the Congress.
Bureaus and Offices Within DOI
The following brief descriptions summarize the regulatory functions of
DOI's major regulatory bureaus and offices.
Bureau of Indian Affairs
The Bureau of Indian Affairs (BIA) is responsible for managing trust
responsibilities to the Indian tribes and encouraging tribal
governments to assume responsibility for BIA programs.
The Bureau's rulemaking and policy development processes are designed
to foster public and tribal awareness of the standards and procedures
that directly affect them. The processes also encourage the public and
the tribes to participate in developing these standards and procedures.
The goals of BIA regulatory policies are to: (a)?Ensure consistent
policies within BIA that result in uniform interactions with the tribal
governments, (b) facilitate tribal involvement in managing, planning,
and evaluating BIA programs and services, and (c) ensure continued
protection of tribal treaties and statutory rights.
Under the No Child Left Behind Act of 2001, the Secretary of the
Interior established a negotiated rulemaking committee to develop
proposed rules to implement several sections of the Act relating to the
Bureau of Indian Affairs-funded school system. The committee is
comprised only of representatives of tribes and tribally operated
schools and the Federal Government. The tribal representative
membership reflects the proportionate share of students from tribes
served by the Bureau-funded school system. This committee has
negotiated rules to implement portions of the No Child Left Behind Act
affecting the definition of ``Adequate Yearly Progress,'' attendance
boundaries for Bureau-funded schools, funding for Bureau-funded
schools, rights of students in the Bureau-funded school system, and
grants under the Tribally Controlled Schools Act. The proposed rule was
published in the Federal Register on February 25, 2004. The Bureau and
the negotiated rulemaking committee have reviewed the comments on the
proposed rule and their recommendations are being incorporated into the
final rule that is now under preparation.
Bureau of Land Management
The BLM manages about 262 million acres of land surface and about 700
million acres of Federal mineral estate. These lands consist of
extensive grasslands, forests, mountains, arctic tundra, and deserts.
Resources on the lands include energy and minerals, timber, forage,
wild horse and burro populations, habitat for fish and wildlife
species, wilderness areas and archaeological and cultural sites. The
BLM manages these lands and resources for multiple purposes and the
sustained yield of renewable resources. Primary statutes under which
the Agency must operate include: the Federal Land Management and Policy
Act of 1976; the General Mining Act of 1872; the Mineral Leasing Act of
1920, as amended; the Recreation and Public Purposes Act; the Taylor
Grazing Act; the Wilderness Act; and the Wild Free-Roaming Horses and
Burros Act.
The Regulatory Program mirrors statutory responsibilities and Agency
objectives including the following:
Providing for a wide variety of public uses while maintaining
the long-term health and diversity of the land while
preserving significant natural, cultural, and historic
resource values;
Understanding the arid, semi-arid, arctic, and other
ecosystems we manage and our commitment to using the best
scientific and technical information to make resource
management decisions;
Understanding the needs of the public that use the BLM-managed
lands and providing them with quality service;
Committing to recover a fair return for using publicly owned
resources and avoiding the creation of long-term
liabilities for American taxpayers; and
Resolving problems and implementing decisions in cooperation
with other agencies, States, tribal governments, and the
public.
The Regulatory Program contains its own objectives. These include
preparing regulations that:
Are the product of communication, coordination, and
consultation with all affected members of the public;
Are easy for the public to understand, especially those who
would be most affected by them; and
Are subject to periodic review to determine whether the rules
are outdated, whether they require updating to reflect
statutory and policy changes and whether they are achieving
desired results.
The BLM's regulatory priorities include:
Completing oil and gas leasing and operations regulations to
make the program more efficiently serve the regulated
public;
Completing updating and consolidating the regulations on
locating, filing, and maintaining mining claims and mill
and tunnel sites, to remove unnecessary and outdated
provisions, reorder the regulations more logically, and
make them easier to read and understand; and
Revising the regulations on administrative rights-of-way on
the public lands to increase cost recovery to levels that
properly compensate BLM for our administrative and
monitoring costs, and to raise the cap on strict liability
for right-of-way
[[Page 72771]]
holders to a reasonable level for costs associated with
environmental cleanup.
Most of BLM's regulations affect small business because many business
entities that operate on public lands meet the definition of a small
business established by the Small Business Administration (SBA). BLM's
regulations do not specifically target small businesses. BLM strives to
ensure that our regulations do not unduly burden entities whether or
not they are considered small businesses.
BLM's mining and grazing projects likely generate the greatest concern
to small businesses because most livestock operators and mining
companies are also considered small businesses, as classified by SBA.
The final grazing rule that BLM intends to publish before the end of
the calendar year will amend grazing regulations that BLM promulgated
on February 22, 1995 (59 FR 29206). The final rule will not
substantively change the existing rules. When published, the rule will
rely on the regulatory flexibility analysis prepared by BLM for the
1995 final rule. At that time, we determined that the 1995 rule should
not have a significant impact on a substantial number of small
entities.
The proposed minerals cost recovery rule will increase many fees and
impose several new fees to cover BLM's costs of processing certain
documents related to its mineral programs. The proposed rule will
affect a large number of small entities since nearly all of them will
face fee increases for activities on public lands. However, we have
concluded that the effects will not be significant. The BLM completed a
threshold analysis, which is available for public review at
www.blm.gov/nhp/news/regulatory/index.htm.
Minerals Management Service
The Minerals Management Service (MMS) has two major responsibilities.
The first is timely and accurate collection, distribution, accounting
for, and auditing of revenues owed by holders of Federal onshore,
offshore, and Indian mineral leases in a manner that meets or exceeds
Federal financial integrity requirements and recipient expectations.
The second is management of the resources of the Outer Continental
Shelf in a manner that provides for safety, protection of the
environment, and conservation of natural resources. These
responsibilities are carried out under the provisions of the Federal
Oil and Gas Royalty Management Act, the Minerals Leasing Act, the Outer
Continental Shelf Lands Act, the Indian Mineral Leasing Act, and other
related statutes.
For the Minerals Revenue Management program (MRM), we issued a final
Federal Oil Valuation Rule (1010-AD04), published in the Federal
Register on May 5, 2004, at 69 FR 24959, with an effective date of
August 1, 2004), which amends current regulations at 30 CFR part 206.
These amendments primarily affect which published market prices are
most appropriate to value crude oil not sold at arm's-length and what
transportation deductions should be allowed. MRM issued another final
rule (1010-AC30, published in the Federal Register on September 13,
2004, at 69 FR 55076, with an effective date of September 13, 2004),
which implements certain provisions in the Federal Oil and Gas Royalty
Simplification and Fairness Act of 1996. These regulations explain how
lessees and their designees can obtain accounting and auditing relief
for production from Federal oil and gas leases and units and
communitization agreements that qualify as marginal properties.
We also plan to continue our review of existing regulations and to
issue rules to refine the Minerals Revenue Management (MRM) regulations
in chapter II of 30 CFR.? MRM is in the process of issuing regulations
to: (1) revise its oil valuation regulations for Indian leases; (2)
revise gas valuation regulations for Federal leases; and (3) codify
provisions in the Federal Oil and Gas Royalty Simplification and
Fairness Act of 1996.
Office of Surface Mining Reclamation and Enforcement
The Office of Surface Mining Reclamation and Enforcement ( OSM) was
created by the Surface Mining Control and Reclamation Act of 1977
(SMCRA) to ``strike a balance between protection of the environment and
agricultural productivity and the Nation's need for coal as an
essential source of energy.''
The principal regulatory provisions contained in title V of SMCRA set
minimum requirements for obtaining a permit for surface coal mining
operations, set standards for those operations, require land
reclamation once mining ends, and require rules and enforcement
procedures to ensure that the standards are met. Under SMCRA, OSM is
the primary enforcer of SMCRA's provisions until the States achieve
``primacy;'' that is, until they demonstrate that their regulatory
programs meet all the specifications in SMCRA and have regulations
consistent with those issued by OSM.
When a primacy State takes over the permitting, inspection, and
enforcement activities of the Federal Government, OSM then changes its
role from regulating mining activities directly to overseeing and
evaluating State programs. Today, 24 of the 26 key coal-producing
States have primacy. In return for assuming primacy, States are
entitled to regulatory grants and to grants for reclaiming abandoned
mine lands. In addition, under cooperative agreements, some primacy
States have agreed to regulate mining on Federal lands within their
borders. Thus, OSM regulates mining directly only in nonprimacy States,
on Federal lands in States where no cooperative agreements are in
effect, and on Indian lands.
SMCRA charges OSM with the responsibility of publishing rules as
necessary to carry out the purposes of the Act. The fundamental
mechanism for ensuring that the purposes of SMCRA are achieved is the
basic policy and guidance established through OSM's permanent
regulatory program and related rulemakings. This regulatory framework
is developed, reviewed, and applied according to policy directives and
legal requirements.
Litigation by the coal industry and environmental groups is responsible
for some of the rules now being considered by OSM. Others are the
result of efforts by OSM to address areas of concern that have arisen
during the course of implementing OSM's regulatory program, and two are
the result of legislation.
OSM has sought to develop an economical, safe, and environmentally
sound program for the surface mining of coal by providing a stable,
consistent regulatory, results-focused framework. At the same time,
however, OSM has recognized the need (a) to respond to local
conditions, (b) to provide flexibility to react to technological
change, (c) to be sensitive to geographic diversity, and (d) to
eliminate burdensome recordkeeping and reporting requirements that over
time have proved unnecessary to ensure an effective regulatory program.
Major regulatory objectives regarding the mining of surface coal
include:
Regulatory certainty so that coal companies know what is
expected of them and citizens know what is intended and how
they can participate;
[[Page 72772]]
Ensuring an affordable, reliable energy supply while
protecting the environment.
Continuing consultation, cooperation, and communication with
interest groups during the rulemaking process in order to
increase the quality of the rulemaking, and, to the
greatest extent possible, reflect consensus on regulatory
issues.
U.S. Fish and Wildlife Service
The mission of the U.S. Fish and Wildlife Service is working with
others to conserve, protect, and enhance fish, wildlife, and plants and
their habitats for the continuing benefit of the American people. Four
principal mission goals include:
The sustainability of fish and wildlife populations.
FWS conserves, protects, restores, and enhances fish,
wildlife, and plant populations entrusted to its care. They
carry out this mission goal through migratory bird
conservation at home and abroad; native fisheries
restoration; recovery and protection of threatened and
endangered species; prevention and control of invasive
species; and work with our international partners.
Habitat conservation through a network of lands and
waters. Cooperating with others, FWS strives to conserve an
ecologically diverse network of lands and waters of various
ownership that provide habitat for fish, wildlife, and
plant resources. This mission goal emphasizes two kinds of
strategic actions: (1) The development of formal agreements
and plans with partners who provide habitat for multiple
species, and (2) the actual conservation work necessary to
protect, restore, and enhance those habitats vital to fish
and wildlife populations. The FWS's habitat conservation
strategy focuses on the interaction and balance of people,
lands and waters, and fish and wildlife through an
ecosystem approach.
Public use and enjoyment. FWS provides opportunities
to the public to enjoy, understand, and participate in the
use and conservation of fish and wildlife resources. The
Service directs activities on national wildlife refuges and
national fish hatcheries that increase opportunities for
public involvement with fish and wildlife resources. Such
opportunities include hunting, fishing, wildlife
observation and photography, and environmental education
and interpretation, as well as hands-on experiences through
volunteer conservation activities on Service lands.
Partnerships in natural resources. FWS supports and
strengthens partnerships with tribal, State, and local
governments and others in their efforts to conserve and
enjoy fish, wildlife, and plants and habitats, consistent
with the President's Executive Order on Cooperative
Conservation. FWS administers Federal grants to States and
territories for restoration of fish and wildlife resources
and has a continuing commitment to work with tribal
governments. FWS also promotes partnerships with other
Federal agencies where common goals can be developed.
The Service carries out these mission goals through several types of
regulations. While carrying out its responsibility to protect the
natural resources entrusted to our care, FWS works continually with
foreign and State governments, affected industries and individuals, and
other interested parties to minimize any burdens associated with its
activities. In carrying out its assistance programs, the Service
administers regulations to help interested parties obtain Federal
assistance and then comply with applicable laws and Federal
requirements.
Some Service regulations permit activities otherwise prohibited by
law. These regulations allow possession, sale or trade, scientific
research, and educational activities involving fish and wildlife and
their parts or products. In general, these regulations supplement State
regulations and cover activities that involve interstate or foreign
commerce.
FWS enforces regulations that govern public access, use, and
recreation on more than 545 national wildlife refuges and in national
fish hatcheries. The Service authorizes only uses that are compatible
with the purpose for which each area was established, are consistent
with State and local laws where practical, and afford the public
appropriate economic and recreational opportunity.
FWS administers regulations to manage migratory bird resources.
Annually, the Service issues a regulation on migratory bird hunting
seasons and bag limits that is developed in partnership with the
States, tribal governments, and the Canadian Wildlife Service. These
regulations are necessary to permit migratory bird hunting that would
otherwise be prohibited by various international treaties.
Finally, FWS implements regulations under the Endangered Species Act
(ESA) to fulfill its statutory obligation to identify and conserve
species faced with extinction and to conserve certain mammals under the
Marine Mammal Protection Act. The ESA dictates that the basis for
determining endangered and threatened species must be limited to
biological considerations. Regulations enhance the conservation of ESA-
listed species and help other Federal agencies comply with the ESA.
Under section 7 of the ESA, all Federal agencies must consult with the
Service on actions that may jeopardize the continued existence of
endangered or threatened species or result in the destruction or
adverse modification of their critical habitats.
In designating critical habitat for listed species, the Service
considers biological information and economic and other impacts of the
designation. Areas may be excluded if the benefits of exclusion
outweigh the benefits of inclusion, provided that such exclusion will
not result in the extinction of the species. The Department is
reviewing guidance for designation of critical habitat. The guidance
will provide policy direction and a process for developing critical
habitat designations
Section 4(f)(1) of the ESA directs the Secretary of the Interior to
develop and implement plans (known as recovery plans) for the
conservation and survival of endangered and threatened species. The
Service has been coordinating with the National Marine Fisheries
Service to revise the joint Recovery Planning Guidance for the recovery
of endangered and threatened species under the ESA. The purpose of the
proposed guidance is to achieve greater consistency in the
implementation of the ESA while working with our partners. In addition,
section 6 of the ESA pertains to cooperation with the States in the
conservation of endangered and threatened species. The Department will
also issue guidance to facilitate better coordination with the States
and provide more opportunities for the States' direct involvement in
managing endangered and threatened species.
National Park Service
The National Park Service is dedicated to conserving the natural and
cultural resources and values of the National Park System for the
enjoyment, education, and inspiration of this and future generations.
The Service also manages a great variety of national and international
programs designed to help
[[Page 72773]]
extend the benefits of natural and cultural resource conservation and
outdoor recreation throughout this country and the world.
There are 388 units in the National Park System, including national
parks and monuments; scenic parkways, preserves, trails, riverways,
seashores, lakeshores, and recreation areas; and historic sites
associated with important movements, events, and personalities of the
American past. The NPS develops and implements park management plans,
and staffs the areas under its administration. It relates the natural
values and historical significance of these areas to the public through
talks, tours, films, exhibits, and other interpretive media. It
operates campgrounds and other visitor facilities and provides, usually
through concessions, lodging, food, and transportation services in many
areas.
The NPS also administers the following programs: the State portion of
the Land and Water Conservation Fund; Federal Lands to Parks;
Nationwide outdoor recreation coordination and information, and State
Comprehensive Outdoor Recreation Planning; Rivers, Trails and
Conservation Assistance; National Trails System; Hydropower Recreation
Assistance; National Register of Historic Places; National Historic
Landmarks; National Natural Landmarks; American Battlefield Protection;
National Maritime Heritage Grants; Native American Graves Protection
and Repatriation; Tribal Heritage Preservation Grants; Technical
Preservation Services; Historic American Buildings Survey; Historic
American Engineering Record; Historic American Landscapes Survey; and
Interagency Archeological Services.
The NPS's regulatory activities focus on management of the National
Park System and management of the programs assigned to it by Congress
(and listed in the previous paragraph). Park-related regulations are
designed to protect park resources while encouraging appropriate uses
of the parks, consistent with each park's mission. Those regulations
help ensure safe and sustainable public use, access, and recreation in
the parks. Program-related regulations establish the procedures and
standards by which the NPS will implement its legislated program
responsibilities regarding, for example, the National Register Program
and the Native American Graves Protection and Repatriation Act. The NPS
regulatory program develops and reviews regulations for consistency
with statutory law, current Administration priorities, and Servicewide
policies.
Bureau of Reclamation
The Bureau of Reclamation's mission is to manage, develop, and protect
water and related resources in an environmentally and economically
sound manner in the interest of the American public. To accomplish this
mission, Reclamation applies management, engineering, and scientific
skills that result in effective and environmentally sensitive
solutions.
Reclamation projects provide for some or all of the following
concurrent purposes: Irrigation water service, municipal and industrial
water supply, hydroelectric power generation, water quality
improvement, groundwater management, fish and wildlife enhancement,
outdoor recreation, flood control, navigation, river regulation and
control, system optimization, and related uses. Reclamation has
increased security at its facilities and is implementing its law
enforcement authorization received in November 2001.
Reclamation's regulatory program is designed to ensure that its mission
is carried out expeditiously, efficiently, and with an emphasis on
cooperative problemsolving.
Office of the Secretary, Natural Resource Damage Assessment and
Restoration Program
The regulatory functions of the Natural Resource Damage Assessment and
Restoration Program (Restoration Program) stem from requirements under
section 301(c) of the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980, as amended (CERCLA). Section
301(c) requires the development of natural resource damage assessment
rules and the biennial review and revisions, as appropriate, of these
rules. Rules have been promulgated for the optional use of natural
resource trustees to assess compensation for damages to natural
resources caused by hazardous substances. The Restoration Program is
overseeing the study and possible promulgation of additional rules
pursuant to section 301(c)(2) and the review and possible revision of
the existing rule in compliance with section 301(c)(3).
_______________________________________________________________________
DOI--Minerals Management Service (MMS)
-----------
PROPOSED RULE STAGE
-----------
84. VALUATION OF OIL FROM INDIAN LEASES
Priority:
Other Significant
Legal Authority:
25 USC 2101 et seq; 25 USC 396 et seq; 25 USC 396a et seq; 30 USC 1701
et seq
CFR Citation:
30 CFR 206
Legal Deadline:
None
Abstract:
This rule would modify the regulations that establish royalty value for
oil produced from Indian leases and create a new form for collecting
value and differential data. These changes would decrease reliance on
oil posted prices and make Indian oil royalty valuation more consistent
with the terms of Indian leases.
Statement of Need:
Current oil valuation regulations rely on posted prices and prices
under arm's-length sales to value oil that is not sold at arm's-length.
Over time, posted prices have become increasingly suspect as a fair
measure of market value. This rulemaking would modify valuation
regulations to place substantial reliance on the higher of crude oil
spot prices, major portion prices, or gross proceeds, and eliminate any
direct reliance on posted prices. This rulemaking would also add more
certainty to valuation of oil produced from Indian leases.
Summary of Legal Basis:
The primary legal basis for this rulemaking is the Federal Oil and Gas
Royalty Management Act of 1982, as amended, which defines the Secretary
of the Interior's (1) authority to implement and maintain a royalty
management system for oil and gas leases on Indian lands, and (2) trust
responsibility to administer Indian oil and gas resources.
Alternatives:
We considered a range of valuation alternatives such as making minor
adjustments to the current gross
[[Page 72774]]
proceeds valuation method, using futures prices, using index-based
prices with fixed adjustments for production from specific geographic
zones, relying on some type of field pricing other than posted prices,
and taking oil in-kind. We chose the higher of the average of the high
daily applicable spot prices for the month, major portion prices in the
field or area, or gross proceeds received by the lessee or its
affiliate. We chose spot prices as one of the three value measures
because: (1) they represent actual trading activity in the market; (2)
they mirror New York Mercantile Exchange futures prices; and (3) they
permit use of an index price for the market center nearest the lease
for oil most similar in quality to that of the lease production.
Anticipated Cost and Benefits:
We estimate compliance with this rulemaking would cost the oil industry
approximately $5.4 million the first year and $4.9 million each year
thereafter. These estimates include the up-front computer programming
and other administrative costs associated with processing the new form.
The monetary benefits of this rulemaking are an estimated $4.7 million
increase in annual royalties collected on oil produced from Indian
leases. Additional benefits include simplification and increased
certainty of oil pricing, reduced audit efforts, and reduced valuation
determinations and associated litigation.
Risks:
The risk of not modifying current oil valuation regulations is that
Indian recipients may not receive royalties based on the highest price
paid or offered for the major portion of oil produced--a common
requirement in most Indian leases. These modifications ensure that the
Department fulfills its trust responsibilities for administering Indian
oil and gas leases under governing mineral leasing laws, treaties, and
lease terms.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 60 FR 65610 12/20/95
NPRM 63 FR 7089 02/12/98
NPRM Comment Period Extended 04/09/98
NPRM Comment Period End 05/13/98
Comment Period E65 FR 1043603/20/2000 02/28/00
Supplemental NPRM 12/00/04
Supplemental NPRM Comment Period End 02/00/05
Final Action 04/00/05
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Tribal
Agency Contact:
Sharron Gebhardt
Regulatory Specialist
Department of the Interior
Minerals Management Service
MS 302B2
P.O. Box 25165
Denver, CO 80225-3211
Phone: 303 231-3211
Fax: 303 231-3385
Email: sharron.gebhardt@mms.gov
Related RIN: Previously reported as 1010-AC24
RIN: 1010-AD00
_______________________________________________________________________
DOI--Bureau of Land Management (BLM)
-----------
FINAL RULE STAGE
-----------
85. GRAZING ADMINISTRATION--EXCLUSIVE OF ALASKA
Priority:
Other Significant
Legal Authority:
43 USC 315; 43 USC 315a to 315r; 43 USC 1181d; 43 USC 1740
CFR Citation:
43 CFR 4100
Legal Deadline:
None
Abstract:
This rule will ensure that BLM documents its consideration of the
social, cultural, environmental, and economic consequences of grazing
changes; provide that changes in grazing use will be phased in under
certain circumstances; allow BLM to share title with permittees and
lessees to range improvements in certain circumstances; make clear how
BLM will authorize grazing if a BLM decision affecting a grazing permit
is stayed pending administratvive appeal; remove provisions in the
present regulations concerning conservation use grazing permits; ensure
adequate time for developing and successfully implementing an
appropriate management action when BLM finds that rangelands do not
meet standards and guidelines for rangeland health and that authorized
grazing is a significant factor in not achieving one or more land
health standards or not conforming with guidelines for grazing
administration; and revise some administrative service charges.
Statement of Need:
This rulemaking is necessary to contribute to improving working
relationships with permittees and lessees, protecting the health of the
rangelands, and increasing administrative efficiency and effectiveness.
Summary of Legal Basis:
The primary laws that govern grazing on public land are the Taylor
Grazing Act (TGA) of 1934, the Federal Land Policy and Management Act
(FLPMA) of 1976, and the Public Rangelands Improvement Act (PRIA) of
1978.
TGA directs that occupation and use of the range be regulated to
preserve the land and its resources from destruction or unnecessary
injury, and to provide for the orderly use, improvement, and
development of the range. FLPMA provides authority and direction for
managing the public lands on the basis of multiple use and sustained
yield and mandates land use planning principles and procedures for the
public lands. PRIA defines rangeland as public lands on which there is
domestic livestock grazing or which are determined to be suitable for
livestock grazing, establishes a national policy to improve the
condition of public rangelands so they will become as productive as
feasible for all rangeland values, requires a national inventory pf
public rangeland conditions and trends, and authorizes funding for
range improvement projects.
Alternatives:
The draft environmental impact statement (DEIS) on the proposed rule
considered two alternatives in addition to the rule as proposed. The
first alternative to the proposed rule considered in the DEIS was to
continue to operate under the existing regulations. The existing
regulations contain provisions that have been found unlawful by the
Federal Courts. They also do too little to promote cooperation between
BLM and grazing
[[Page 72775]]
permittees and lessees. They are also ambiguous at times and hard to
understand.
The DEIS also considered a modified alternative with different
approaches to several provisions in the proposed rule. BLM would have
more discretion in phasing in changes in grazing use, be limited to
five consecutive years in approving nonuse, and have discretion to use
range assessments or monitoring or both to determine whether grazing
management is achieving standards and conforming with guidelines. The
alternative would include a prohibition of failing to comply with weed
seed-free forage requirements, but would not include the current
prohibition of failing to comply with Federal or State laws pertaining
to resources.
In the early stages of planning this rule, BLM considered additional
provisions such as Reserve Common Allotments for grazers to use when
their allotments are unavailable due to fire, drought, or other
factors, and authorizing grazers to lock gates on public lands
temporarily. These provisions were dropped due to public comment on the
advance notice of proposed rulemaking.
Anticipated Cost and Benefits:
BLM anticipates the following benefits: Increased livestock production
as a result of increased forage productivity or increased ability to
maintain grazing when it might otherwise be reduced; increased
managerial flexibility, resulting in increased livestock output;
improved environmental conditions; and potential changes in recreation
values.
The major categories of costs include: BLM administrative costs
(including enforcement and monitoring costs); compliance costs for
permittees and lessees; environmental costs if the rule results in
worsened environmental conditions.
The benefits and costs are thoroughly discussed in the Benefit-Cost/
Unfunded Mandates Act Analysis and Initial Regulatory Flexibility Act
Analysis dated November 14, 2003, and available in the administrative
record of the rule.
Risks:
As with any new rule, the public may at first misunderstand the changes
in regulatory requirements. BLM will work with the public in
implementing the rule and conduct outreach meetings to explain the rule
as necessary.
There is also a risk that the monitoring requirements imposed by the
rule may entail increased administrative costs and the need to
reallocate administrative resources. We expect this risk to be
minimized because of the thresholds in the regulations that must be
crossed before monitoring is required.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 68 FR 9964 03/03/03
NPRM 68 FR 68452 12/08/03
NPRM Comment Period End 03/02/04
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Ted Hudson
Regulatory Analyst
Department of the Interior
Bureau of Land Management
Room 420
Regulatory Affairs Group (WO-630)
1849 C Street NW.
Washington, DC 20240
Phone: 202 452-5042
Fax: 202 653-5287
Email: ted--hudson@blm.gov
RIN: 1004-AD42
BILLING CODE 4310-RK-S
[[Page 72776]]
DEPARTMENT OF JUSTICE (DOJ)
Statement of Regulatory Priorities
The first and overriding priority of the Department of Justice is to
prevent, detect, disrupt, and dismantle terrorism while preserving
constitutional liberties. To fulfill this mission, the Department is
devoting all the resources necessary and utilizing all legal
authorities to eliminate terrorist networks, to prevent terrorist
attacks, and to bring to justice those who kill Americans in the name
of murderous ideologies. It is engaged in an aggressive arrest and
detention campaign of lawbreakers with a single objective: To get
terrorists off the street before they can harm more Americans. In
addition to using investigative, prosecutorial, and other law
enforcement activities, the Department is also using the regulatory
process to enhance its ability to prevent future terrorist acts and
safeguard our borders while ensuring that America remains a place of
welcome to foreigners who come here to visit, work, or live peacefully.
The Department also has wide-ranging responsibilities for criminal
investigations, law enforcement, and prosecutions and, in certain
specific areas, makes use of the regulatory process to better carry out
the Department's law enforcement missions.
The Department of Justice's regulatory priorities focus in particular
on a major regulatory initiative in the area of civil rights.
Specifically, the Department is planning to revise its regulations
implementing titles II and III of the Americans With Disabilities Act.
However, in addition to this specific initiative, several other
components of the Department carry out important responsibilities
through the regulatory process. Although their regulatory efforts are
not singled out for specific attention in this regulatory plan, those
components carry out key roles in implementing the Department's anti-
terrorism and law enforcement priorities.
Civil Rights
The Department is planning to revise its regulations implementing
titles II and III of the ADA to amend the ADA Standards for Accessible
Design (28 CFR part 36, appendix A) to be consistent with the revised
ADA accessibility guidelines published by the U.S. Architectural and
Transportation Barriers Compliance Board (Access Board) in final form
on July 23, 2004. (The Access Board had issued the guidelines in
proposed form in November 1999 and in final draft form in April 2002.)
Title II of the ADA prohibits discrimination on the basis of disability
by public entities, and title III prohibits such discrimination by
places of public accommodation and requires accessible design and
construction of places of public accommodation and commercial
facilities. In implementing these provisions, the Department of Justice
is required by statute to publish regulations that include design
standards that are consistent with the guidelines developed by the
Access Board. The Access Board was engaged in a multiyear effort to
revise and amend its accessibility guidelines. The goals of this
project were: 1) To address issues such as unique State and local
facilities (e.g., prisons, courthouses), recreation facilities, play
areas, and building elements specifically designed for children's use
that were not addressed in the initial guidelines; 2) to promote
greater consistency between the Federal accessibility requirements and
the model codes; and 3) to provide greater consistency between the ADA
guidelines and the guidelines that implement the Architectural Barriers
Act. The Access Board issued guidelines that address all of these
issues. Therefore, to comply with the ADA requirement that the ADA
standards remain consistent with the Access Board's guidelines, the
Department will propose to adopt revised ADA Standards for Accessible
Design that are consistent with the revised ADA Accessibility
Guidelines.
The Department also plans to review its regulations implementing title
II and title III (28 CFR parts 35 and 36) to ensure that the
requirements applicable to new construction and alterations under title
II are consistent with those applicable under title III, to review and
update the regulations to reflect the current state of law, and to
ensure the Department's compliance with section 610 of the Small
Business Regulatory Enforcement Fairness Act (SBREFA).
The Department is planning to adopt and interpret the Access Board's
revised and amended guidelines in three steps. The first step of the
rulemaking process is an advance notice of proposed rulemaking,
published in the Federal Register on September 30, 2004, at 69 FR
58768, which the Department believes will simplify and clarify the
preparation of the proposed rule to follow. In addition to giving
notice of the proposed rule that will adopt revised ADA accessibility
standards, the advance notice raises two sets of questions for public
comment, and proposes a framework for the regulatory analysis that will
accompany the proposed rule. One set of questions addresses
interpretive matters related to adopting revised ADA accessibility
standards, such as what should be the effective date of the revised
standards and how best to apply the revised standards to existing
facilities that have already complied with the current ADA standards.
Another set of questions is directed to collecting data about the
benefits and costs of applying the new standards to existing
facilities. The second step of the rulemaking process will be a
proposed rule proposing to adopt revised ADA accessibility standards
consistent with the Access Board's revised and amended guidelines that
will, in addition to revising the current ADA Standards for Accessible
Design, supplement the standards with specifications for prisons,
jails, court houses, legislative facilities, building elements designed
for use by children, play areas, and recreation facilities. The
proposed rule will also offer proposed answers to the interpretive
questions raised in the advance notice and present an initial
regulatory assessment; it will be followed by a final rule, the third
step of the process. A separate part of the rulemaking process will be
an advanced notice of proposed rulemaking seeking public comment on the
section 610 review of the ADA regulations under SBREFA, with proposed
and final rules to follow.
The Department's revised and supplemented regulations under the ADA
will affect small businesses, small governmental jurisdictions, and
other small organizations (together, small entities). The Access Board
has prepared regulatory assessments (including cost impact analyses) to
accompany its new guidelines, which estimate the annual compliance
costs that will be incurred by covered entities with regard to
construction of new facilities. These assessments include the effect on
small entities and will apply to new construction under the
Department's revised and supplemented regulations. With respect to
existing facilities, the Department will prepare an additional
regulatory assessment of the estimated annual cost of compliance with
regard to existing facilities. In this process, the Department will
give careful consideration to the cost effects on small entities,
including the solicitation of comments specifically designed to obtain
compliance data relating to small entities.
Other Department Initiatives
1. Immigration Matters
On March 1, 2003, pursuant to the Homeland Security Act of 2002 (HSA),
[[Page 72777]]
the responsibility for immigration enforcement and for providing
immigration-related services and benefits such as naturalization and
work authorization was transferred from the Justice Department's
Immigration and Naturalization Service (INS) to the Department of
Homeland Security (DHS). However, immigration judges and the Board of
Immigration Appeals in the Executive Office for Immigration Review
(EOIR)) remain part of the Department of Justice; the immigration
judges adjudicate approximately 300,000 cases each year to determine
whether the aliens should be ordered removed or should be granted some
form of relief from removal. Accordingly, the Attorney General has a
continuing role in the conduct of removal hearings, the granting of
relief from removal, and the detention or release of aliens pending
completion of removal proceedings. The Attorney General also is
responsible for civil litigation and criminal prosecutions relating to
the immigration laws.
In several pending rulemaking actions, the Department is working to
revise and update the regulations relating to removal proceedings in
order to improve the efficiency and effectiveness of the hearings in
resolving issues relating to removal of aliens and the granting of
relief from removal.
1. Criminal
Law Enforcement
In large part, the Department's criminal law enforcement components do
not rely on the rulemaking process to carry out their assigned
missions. The Federal Bureau of Investigation (FBI), for example, is
responsible for protecting and defending the United States against
terrorist and foreign intelligence threats, upholding and enforcing the
criminal laws of the United States, and providing leadership and
criminal justice services to Federal, State, municipal, and
international agencies and partners. Only in very limited contexts does
the FBI rely on rulemaking.\1\ However, other components do make use of
the rulemaking process in certain significant respects.
The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) issues
regulations to enforce the Federal laws relating to the manufacture and
commerce of firearms and explosives. ATF's mission and regulations are
designed to:
Curb illegal traffic in, and criminal use of, firearms, and to
assist State, local, and other Federal law enforcement
agencies in reducing crime and violence;
Facilitate investigations of violations of Federal explosives
laws and arson-for-profit schemes;
Regulate the firearms and explosives industries, including
systems for licenses and permits;
Assure the collection of all National Firearms Act (NFA)
firearms taxes and obtain a high level of voluntary
compliance with all laws governing the firearms industry;
and
Assist the States in their efforts to eliminate interstate
trafficking in, and the sale and distribution of,
cigarettes and alcohol in avoidance of Federal and State
taxes.
ATF will continue, as a priority during fiscal year 2005, to seek
modifications to its regulations governing commerce in explosives. ATF
continues analysis of its regulations governing storage requirements
for explosives, including fireworks explosive materials. ATF plans to
issue final regulations implementing the provisions of the Safe
Explosives Act, title XI, subtitle C, of Public Law 107-296, the
Homeland Security Act of 2002 (enacted November 25, 2002).
The Drug Enforcement Administration (DEA) is responsible for
controlling abuse of narcotics and dangerous drugs, while ensuring
adequate supplies for legitimate medical purposes, by regulating the
aggregate supply of those drugs. However, now, the growing combination
of drug trafficking and terrorism serves to call us even more urgently
to action. DEA accomplishes its objectives through coordination with
State, local, and other Federal officials in drug enforcement
activities, development and maintenance of drug intelligence systems,
regulation of legitimate controlled substances, and enforcement
coordination and intelligence-gathering activities with foreign
government agencies. DEA continues to develop and enhance regulatory
controls relating to the diversion control requirements for controlled
substances, as well as the requirements of the Comprehensive
Methamphetamine Control Act of 1996 and the Methamphetamine Anti-
Proliferation Act of 2000, which regulate certain chemicals to prevent
them from being diverted for the production of methamphetamine.
The Federal Bureau of Prisons issues regulations to enforce the
Federal laws relating to its mission: To protect society by confining
offenders in the controlled environments of prisons and community-based
facilities that are safe, humane, cost-efficient, and appropriately
secure, and that provide work and other self-improvement opportunities
to assist offenders in becoming law-abiding citizens. During the next
12 months, in addition to other regulatory objectives aimed at
accomplishing its mission, the Bureau will continue its ongoing efforts
to: Reduce the introduction of contraband through various means (such
as clarifying drug and alcohol surveillance testing programs); improve
disciplinary procedures; and improve drug abuse treatment services.
Footnotes:
1. As one recent example, the FBI published a final rule in July 2004,
amending regulations implementing the National Instant Criminal
Background Check System (``NICS'') pursuant to the Brady Handgun
Violence Prevention Act (``Brady Act''). This rule balanced the Brady
Act's mandate that the Department protect legitimate privacy interests
of law-abiding firearm transferees and the Department's obligation to
enforce the Brady Act and the rest of the Gun Control Act and prevent
prohibited persons from receiving firearms. Changes made by the final
rule regarding the amount of time that the NICS retains information
about approved firearm transfers in the system's chronological log of
background check transactions (``Audit Log'') were required by section
617 of H.R. 2673, the Fiscal Year 2004 Consolidated Appropriations
bill, which was signed into law on January 23, 2004.
_______________________________________________________________________
DOJ--Civil Rights Division (CRT)
-----------
PRERULE STAGE
-----------
86. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN PUBLIC
ACCOMMODATIONS AND COMMERCIAL FACILITIES (SECTION 610 REVIEW)
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
5 USC 301; 28 USC 509; 28 USC 510; 42 USC 12186(b)
CFR Citation:
28 CFR 36
[[Page 72778]]
Legal Deadline:
None
Abstract:
In 1991, the Department of Justice published regulations to implement
title III of the Americans With Disabilities Act of 1990 (ADA). Those
regulations include the ADA Standards for Accessible Design, which
establish requirements for the design and construction of accessible
facilities that are consistent with the ADA Accessibility Guidelines
(ADAAG) published by the U.S. Architectural and Transportation Barriers
Compliance Board (Access Board). In the time since the regulations
became effective, the Department of Justice and the Access Board have
each gathered a great deal of information regarding the implementation
of the Standards. The Access Board began the process of revising ADAAG
a number of years ago. It published new ADAAG in final form on July 23,
2004, after having published guidelines in proposed form in November
1999 and in draft final form in April 2002. In order to maintain
consistency between ADAAG and the ADA Standards, the Department is
reviewing its title III regulations and expects to propose, in one or
more stages, to adopt revised ADA Standards consistent with the final
revised ADAAG and to make related revisions to the Department's title
III regulations. In addition to maintaining consistency between ADAAG
and the Standards, the purpose of this review and these revisions will
be to more closely coordinate with voluntary standards; to clarify
areas which, through inquiries and comments to the Department's
technical assistance phone lines, have been shown to cause confusion;
to reflect evolving technologies in areas affected by the Standards;
and to comply with section 610 of the Regulatory Flexibility Act, which
requires agencies once every 10 years to review rules that have a
significant economic impact upon a substantial number of small
entities.
The first step in adopting revised Standards is an advance notice of
proposed rulemaking that was published in the Federal Register on
September 30, 2004, at 69 FR 58768, issued under both title II and
title III. The Department believes that the advance notice will
simplify and clarify the preparation of the proposed rule to follow. In
addition to giving notice that the proposed rule will adopt revised ADA
accessibility standards, the advance notice raises questions for public
comment and proposes a framework for the regulatory analysis that will
accompany the proposed rule.
The adoption of revised ADAAG will also serve to address changes to the
ADA Standards previously proposed in RIN 1190-AA26, RIN 1190-AA38, RIN
1190-AA47, and RIN 1190-AA50, all of which have now been withdrawn from
the Unified Agenda. These changes will include technical specifications
for facilities designed for use by children, accessibility standards
for State and local government facilities, play areas, and recreation
facilities, all of which had previously been published by the Access
Board.
The timetable set forth below refers to the notice of proposed
rulemaking that the Department will issue as the second step of the
above described title III rulemaking. This notice of proposed
rulemaking will be issued under both title II and title III. For
purposes of the title III regulation, this notice will propose to adopt
revised ADA Standards for Accessible Design consistent with the minimum
guidelines of the revised ADAAG. The second stage will initiate the
review of the regulation in accordance with the requirements of section
610 of the Regulatory Flexibility Act, as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA).
Statement of Need:
Section 504 of the ADA requires the Access Board to issue supplemental
minimum guidelines and requirements for accessible design of buildings
and facilities subject to the ADA, including title III. Section 306(c)
of the ADA requires the Attorney General to promulgate regulations
implementing title III that are consistent with the Access Board's ADA
guidelines. Because this rule will adopt standards that are consistent
with the minimum guidelines issued by the Access Board, this rule is
required by statute. Similarly, the Department's review of its title
III regulation is being undertaken to comply with the requirements of
the Regulatory Flexibility Act, as amended by SBREFA.
Summary of Legal Basis:
The summary of the legal basis of authority for this regulation is set
forth above under Legal Authority and Statement of Need.
Alternatives:
The Department is required by the ADA to issue this regulation.
Pursuant to SBREFA, the Department's title III regulation will consider
whether alternatives to the currently published requirements are
appropriate.
Anticipated Cost and Benefits:
The Access Board has analyzed the effect of applying its proposed
amendments to ADAAG to entities covered by titles II and III of the ADA
and has determined that they constitute a significant regulatory action
for purposes of Executive Order 12866. The Access Board's determination
will apply as well to the revised ADA standards published by the
Department. The Department's proposed procedural amendments will not
have a significant impact on small entities.
As part of its revised ADAAG, the Access Board made available in
summary form an updated regulatory assessment to accompany the final
revised ADAAG. The Access Board's regulatory assessment will also apply
to the Department's proposed adoption of revised ADAAG as ADA standards
insofar as the standards apply to new construction and alteration. The
Department will also prepare an additional regulatory assessment of the
estimated annual cost of compliance with the revised standards with
regard to existing facilities.
Risks:
Without the proposed changes to the Department's title III regulation,
the ADA Standards will fail to be consistent with the ADAAG.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 69 FR 58768 09/30/04
ANPRM Comment Period End 01/28/05
NPRM 07/00/05
NPRM Comment Period End 10/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Organizations
Government Levels Affected:
None
Additional Information:
RIN 1190-AA44, which will effect changes to 28 CFR 36 (the Department's
regulation implementing title III of the ADA), is related to another
rulemaking of the Civil Rights Division, RIN 1190-AA46, which will
effect changes to 28
[[Page 72779]]
CFR 35 (the Department's regulation implementing title II of the ADA).
Agency Contact:
John L. Wodatch
Chief, Disability Rights Section
Department of Justice
Civil Rights Division
P.O. Box 66738
Washington, DC 20035
Phone: 800 514-0301
TDD Phone: 800 514-0383
Fax: 202 307-1198
RIN: 1190-AA44
_______________________________________________________________________
DOJ--CRT
87. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN STATE AND LOCAL
GOVERNMENT SERVICES (SECTION 610 REVIEW)
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
5 USC 301; 28 USC 509 to 510; 42 USC 12134; PL 101-336
CFR Citation:
28 CFR 35
Legal Deadline:
None
Abstract:
On July 26, 1991, the Department published its final rule implementing
title II of the Americans With Disabilities Act (ADA). On November 16,
1999, the U.S. Architectural and Transportation Barriers Compliance
Board (Access Board) issued its first comprehensive review of the ADA
Accessibility Guidelines, which form the basis of the Department's ADA
Standards for Accessible Design. The Access Board published an
Availability of Draft Final Guidelines on April 2, 2002, and published
the ADA Accessibility Guidelines in final form on July 23, 2004. The
ADA (section 204(c)) requires the Department's standards to be
consistent with the Access Board's guidelines. In order to maintain
consistency between ADAAG and the Standards, the Department is
reviewing its title II regulations and expects to propose, in one or
more stages, to adopt revised standards consistent with new ADAAG. The
Department will also, in one or more stages, review its title II
regulations for purposes of section 610 of the Regulatory Flexibility
Act and make related changes to its title II regulations.
In addition to the statutory requirement for the rule, the social and
economic realities faced by Americans with disabilities dictate the
need for the rule. Individuals with disabilities cannot participate in
the social and economic activities of the Nation without being able to
access the programs and services of State and local governments.
Further, amending the Department's ADA regulations will improve the
format and usability of the ADA Standards for Accessible Design;
harmonize the differences between the ADA Standards and national
consensus standards and model codes; update the ADA Standards to
reflect technological developments that meet the needs of persons with
disabilities; and coordinate future ADA Standards revisions with
national standards and model code organizations. As a result, the
overarching goal of improving access for persons with disabilities so
that they can benefit from the goods, services, and activities provided
to the public by covered entities will be met.
The first part of the rulemaking process is an advance notice of
proposed rulemaking, published in the Federal Register on September 30,
2004, at 69 FR 58768, issued under both title II and title III. The
Department believes the advance notice will simplify and clarify the
preparation of the proposed rule to follow. In addition to giving
notice of the proposed rule that will adopt revised ADA accessibility
standards, the advance notice raises questions for public comment and
proposes a framework for the regulatory analysis that will accompany
the proposed rule.
The adoption of revised ADA Standards consistent with revised ADAAG
will also serve to address changes to the ADA Standards previously
proposed under RIN 1190-AA26, RIN 1190-AA38, RIN 1190-AA47, and RIN
1190-AA50, all of which have now been withdrawn from the Unified
Agenda. These changes will include technical specifications for
facilities designed for use by children, accessibility standards for
State and local government facilities, play areas, and recreation
facilities, all of which had previously been published by the Access
Board.
The timetable set forth below refers to the notice of proposed
rulemaking that the Department will issue as the second step of the
above-described title II rulemaking. This notice of proposed rulemaking
will be issued under both title II and title III. For purposes of the
title II regulation alone, this notice will also propose to eliminate
the Uniform Federal Accessibility Standards (UFAS) as an alternative to
the ADA Standards for Accessible Design.
Statement of Need:
Section 504 of the ADA requires the Access Board to issue supplemental
minimum guidelines and requirements for accessible design of buildings
and facilities subject to the ADA, including title II. Section 204(c)
of the ADA requires the Attorney General to promulgate regulations
implementing title II that are consistent with the Access Board's ADA
guidelines. Because this rule will adopt standards that are consistent
with the minimum guidelines issued by the Access Board, this rule is
required by statute. Similarly, the Department's review of its title II
regulations is being undertaken to comply with the requirements of the
Regulatory Flexibility Act, as amended by the Small Business Regulatory
Enforcement Fairness Act (SBREFA).
Summary of Legal Basis:
The summary of the legal basis of authority for this regulation is set
forth above under Legal Authority and Statement of Need.
Alternatives:
The Department is required by the ADA to issue this regulation as
described in the Statement of Need above. Pursuant to SBREFA, the
Department's title II regulation will consider whether alternatives to
the currently published requirements are appropriate.
Anticipated Cost and Benefits:
The Administration is deeply committed to ensuring that the goals of
the ADA are met. Promulgating this amendment to the Department's ADA
regulations will ensure that entities subject to the ADA will have one
comprehensive regulation to follow. Currently, entities subject to
title II of the ADA (State and local governments) have a choice between
following the Department's ADA Standards for title III, which were
adopted for places of public accommodation and commercial facilities
and which do not contain standards for common State and local
government buildings (such as courthouses and prisons), or the Uniform
Federal Accessibility Standards (UFAS). By developing one comprehensive
standard, the Department will eliminate the confusion that arises when
governments try to mesh two different standards. As a result, the
overarching goal of improving access to persons with disabilities will
be better served.
[[Page 72780]]
The Access Board has analyzed the effect of applying its proposed
amendments to ADAAG to entities covered by titles II and III of the ADA
and has determined that they constitute a significant regulatory action
for purposes of Executive Order 12866. The Access Board's determination
will apply as well to the revised ADA Standards published by the
Department. The Department's proposed procedural amendments will not
have a significant impact on small entities.
As part of its revised ADAAG, the Access Board made available in
summary form an updated regulatory assessment to accompany the final
revised ADAAG. The Access Board's regulatory assessment will also apply
to the Department's proposed adoption of revised ADAAG as ADA standards
insofar as the standards apply to new construction and alteration. The
Department will also prepare an additional regulatory assessment of the
estimated annual cost of compliance with the revised standards with
regard to existing facilities.
The Access Board has made every effort to lessen the impact of its
proposed guidelines on State and local governments but recognizes that
the guidelines will have some federalism effects. These affects are
discussed in the Access Board's regulatory assessment, which also
applies to the Department's proposed rule.
Risks:
Without this amendment to the Department's ADA regulations, regulated
entities will be subject to confusion and delay as they attempt to sort
out the requirements of conflicting design standards. This amendment
should eliminate the costs and risks associated with that process.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 69 FR 58768 09/30/04
ANPRM Comment Period End 01/28/05
NPRM 07/00/05
NPRM Comment Period End 10/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Governmental Jurisdictions
Government Levels Affected:
Local, State
Federalism:
This action may have federalism implications as defined in EO 13132.
Additional Information:
RIN 1190-AA46, which will effect changes to 28 CFR 35 (the Department's
regulation implementing title II of the ADA), is related to another
rulemaking of the Civil Rights Division, RIN 1190-AA44, which will
effect changes to 28 CFR 36 (the Department's regulation implementing
title III of the ADA). By adopting revised ADAAG, this rulemaking will,
among other things, address changes to the ADA Standards previously
proposed in RINs 1190-AA26, 1190-AA36, and 1190-AA38, which have been
withdrawn and merged into this rulemaking. These changes include
accessibility standards for State and local government facilities that
had been previously published by the Access Board (RIN 1190-AA26) and
the timing for the compliance of State and local governments with the
curb-cut requirements of the title II regulation (RIN 1190-AA36). In
order to consolidate regulatory actions implementing title II of the
ADA, on February 15, 2000, RINs 1190-AA26 and 1190-AA38 were merged
into this rulemaking and on March 5, 2002, RIN 1190-AA36 was merged
into this rulemaking.
Agency Contact:
John L. Wodatch
Chief, Disability Rights Section
Department of Justice
Civil Rights Division
P.O. Box 66738
Washington, DC 20035
Phone: 800 514-0301
TDD Phone: 800 514-0383
Fax: 202 307-1198
RIN: 1190-AA46
BILLING CODE 4410-BP-S
[[Page 72781]]
DEPARTMENT OF LABOR (DOL)
DEPARTMENT OF LABOR (DOL)
2004 Regulatory Plan
Executive Summary: Protecting America's Workers
Since its creation in 1913, the Department of Labor has been guided by
the idea that workers deserve safe and healthy workspaces, as well as
protection of their wages and pensions. Protecting America's workers is
a top priority of the Secretary of Labor. The Department works to
enforce laws and regulations to ensure the health and safety of the
American workforce. The vast majority of employers work hard to keep
their employees and workplaces safe and secure. DOL also strives to
provide employers with the knowledge and tools they need to carry out
their legal obligations. The Secretary has made protecting workers
through the coupling of compliance assistance and tough enforcement one
of her top priorities. Her compliance assistance initiative is based on
the proven success that comes when government, employers, unions and
employees work together.
Compliance assistance works to prevent injuries. Educating and
encouraging employers helps workers far more than enforcement alone,
since no enforcement process can possibly identify every violation of
the law, and fines and penalties can never fully redress losses of
life, health, and economic well-being.
The Department is committed to aggressively enforcing the laws that
protect employees, including the rights of workers returning to their
jobs after military service. Workers also need information about
protection of their health insurance and pension benefits. In addition,
DOL has responsibilities beyond worker protection. The Department
recognizes that workers need constant updating of skills to compete in
a changing marketplace. DOL helps employers and workers bridge the gap
between the requirements of new high-technology jobs and the skills of
the workers who are needed to fill them.
The Secretary of Labor's Regulatory Plan for Accomplishing These
Objectives
In general, DOL tries to help employees and employers meet their needs
in a cooperative fashion. DOL will maintain health and safety standards
and protect employees by working with the regulated community.
DOL considers the following proposals to be proactive, common sense
approaches to the issues most clearly needing regulatory attention.
The Department's Regulatory Priorities
DOL has identified 16 high priority items for regulatory action. Six
items address health and safety issues, which are central to DOL's
mission and which represent a major focus of the Secretary. Two
agencies, the Mine Safety and Health Administration (MSHA) and the
Occupational Safety and Health Administration (OSHA), are responsible
for these initiatives.
MSHA administers the Federal Mine Safety and Health Act of 1977 (Mine
Act). The agency is committed to ensuring safer and healthier
workplaces for the nation's miners in a number of ways, and will
continue to concentrate on improving existing health standards and
addressing emerging health hazards in mining.
MSHA is considering lowering the existing permissible exposure limit
(PEL) for asbestos at metal and nonmetal and coal mines, to reduce the
risk of asbestos-related death and disease among miners. MSHA also is
considering specifying criteria for the method used for sample analysis
(RIN 1219-AB24). MSHA published an advance notice of proposed
rulemaking (ANPRM) and conducted a series of public meetings in 2002 to
allow early participation by interested parties in the rulemaking. MSHA
is preparing a proposed rule that fully considers comments received in
response to the ANPRM, testimony at the public meeting, current
scientific evidence, and the experience of other agencies.
MSHA also continues its rulemaking on Diesel Particulate Matter
Exposure of Underground Metal and Nonmetal Miners (RIN 1219-AB29). A
proposed rule was published in August 2003. MSHA will address several
provisions in the final standard, including changing the diesel
particulate matter surrogate from total carbon to elemental carbon for
the interim and limit changing the interim limit concentration-based
limit to a personal exposure limit (PEL) establishing the hierarchy of
controls that MSHA applies to metal and nonmetal mines pursuant to its
enforcement policy for exposure-based health standards, allowing
Personal Protective Equipment (PPE), and addressing the diesel
particulate matter control plan.
The Occupational Safety and Health Administration oversees a wide range
of measures in the public and private sectors. OSHA is committed to
establishing clear and sensible priorities, and to continuing to reduce
occupational deaths, injuries, and illnesses.
OSHA's high-priority initiatives address health standards. The first, a
revision to the Respiratory Protection Standard, will address Assigned
Protection Factors for different types of respirators (RIN 1218-AA05).
This action will improve respiratory protection for employees required
to wear respirators and will make it easier for employers to choose the
appropriate respirator for a given task. OSHA published an NPRM on June
6, 2003, and informal public hearings were held on January 28-30, 2004.
OSHA's second initiative in the area of health standards addresses
worker exposures to crystalline silica (RIN 1218-AB70). This substance
is one of the most widely found in workplaces and data indicate that
exposure to it may cause silicosis, a debilitating respiratory disease,
and perhaps cancer as well. OSHA has obtained input from small
businesses about regulatory approaches through a Small Business
Regulatory Enforcement Fairness Act (SBREFA) panel, and the Panel
report was submitted to the Assistant Secretary of OSHA on December 19,
2003. OSHA is currently preparing a risk assessment and plans to
complete an external peer review of a draft assessment by February
2005. This rule was discussed in the 2002 OMB Report to Congress on the
Costs and Benefits of Regulations.
OSHA's third health initiative addresses worker exposure to hexavalent
chromium (RIN 1218-AB45). Approximately 380,000 workers are exposed to
this substance in general industry, maritime, construction and
agriculture. Exposure to hexavalent chromium is associated with lung
cancer and dermatoses. OSHA has obtained input from small businesses
about regulatory approaches through a Small Business Regulatory
Enforcement Fairness Act (SBREFA) panel, and the Panel report was
submitted to the Assistant Secretary of OSHA on April 20, 2004. The
proposed rule was published on October 4, 2004. This standard was
discussed in OMB's 2002 Report to Congress on the Costs and Benefits of
Regulation.
The fourth health initiative, OSHA's Standards Improvement Project,
will streamline a number of health standards by removing language that
is outdated, duplicative, unnecessary or inconsistent (RIN 1218-AB81).
These changes will reduce the time and effort needed to
[[Page 72782]]
understand and comply with these standards. An NPRM was published
October 31, 2002. A hearing was held in July 2003, and a final rule has
been prepared.
Protection of pension and health benefits continues to be a priority of
the Secretary of Labor. Consistent with the Secretary's priorities for
FY 2005, the Employee Benefits Security Administration (EBSA) will
focus on compliance assistance for pension and group health plans
through issuance of guidance. Specific initiatives for group health
plans include guidance on the application of the Health Insurance
Portability and Accountability Act (HIPAA) access, portability and
renewability provisions (RIN 1210-AA54); and the HIPAA
nondiscrimination provisions of the Employee Retirement Income Security
Act (ERISA) (RIN 1210-AA77). With respect to pension plans, the
Department will focus on establishing a safe harbor under which
employers will be treated as having made timely deposits of participant
contributions in their 401(k) plan (RIN 1210-AB02). The Department also
will focus on the development of guidance that will facilitate the
payment of benefits from 401(k) and other defined contribution plans
that have been abandoned by their sponsors (RIN 1210-AA97).
ERISA's requirements affect an estimated 730,000 private sector
employee pension benefit plans (covering approximately 99 million
participants); an estimated 2.5 million group health benefit plans
(covering 131 million participants and dependents); and 3.4 million
other welfare benefits plans (covering approximately 190 million
participants).
The Secretary's emphasis on meeting the needs of the 21st century
workforce is reflected in the plan of the Employment and Training
Administration (ETA) to issue regulations reflecting recent changes to
the Trade Adjustment Assistance (TAA) program, as enacted in the Trade
Act of 2002. The regulations will be issued in two parts: regulations
covering TAA program benefits (RIN 1205-AB32), and regulations covering
petition filing, investigations and the new Alternative TAA Program for
Older Workers (RIN 1205-AB40). The proposed rules would address the
many new features of the TAA program: consolidation of the TAA and
NAFTA-TAA programs; rapid response services for workers to facilitate
more rapid reemployment; expanded eligibility; increased benefits,
including health care insurance assistance; and Alternative TAA for
Older Workers program. The new regulations will be written in plain
English, making them easier to read and use.
In its second initiative, ETA proposes to re-engineer the permanent
labor certification process (RIN 1205-AA66). ETA's goals are to make
fundamental changes that will streamline the process, save resources,
improve the effectiveness of the program, and better serve the
Department of Labor's customers. This rule was discussed in the 2002
OMB Report to Congress on the Costs and Benefits of Regulations.
The Employment Standards Administration (ESA) has set forth two
priority regulatory initiatives. ESA's first initiative updates the
child labor rules issued under the Fair Labor Standards Act (FLSA) to
address changes in the nature of the workplace and situations in which
minors may operate certain kinds of machinery (RIN 1215-AA09). While
young workers need employment experiences that will help them gain the
skills needed to find and hold good jobs later in life, they also need
to focus on obtaining a high-quality education, and the assurance that
their work hours are reasonable will help them in doing so.
ESA's second initiative pertains to regulations issued under the Family
and Medical Leave Act (FMLA) that were also discussed in OMB's 2001 and
2002 Reports to Congress on the Costs and Benefits of Regulations.
Revisions will be proposed to the FMLA's implementing regulations to
address issues raised by the decision of the U.S. Supreme Court in
Ragsdale v. Wolverine World Wide, Inc., 122 S. Ct. 1155 (2002), and the
decisions of other courts.
Finally, the Secretary 's commitment to protecting the employment
rights of service members as they return to the civilian workforce is
reflected by the Veterans' Employment and Training Service's (VETS)
initiative to promulgate regulations implementing the Uniformed
Services Employment and Reemployment Rights Act of 1994 (USERRA).
USERRA provides employment and reemployment protections for members of
the uniformed services, including veterans and members of the Reserve
and National Guard. The Department has not previously issued
implementing regulations under USERRA. Authoritative written guidance
interpreting USERRA will ensure that our service members serve secure
in the knowledge that they will be able to return to their jobs with
the same pay, benefits, and status they would have attained had they
not been away on military duty.
_______________________________________________________________________
DOL--Employment Standards Administration (ESA)
-----------
PROPOSED RULE STAGE
-----------
88. FAMILY AND MEDICAL LEAVE ACT OF 1993; CONFORM TO THE SUPREME
COURT'S RAGSDALE DECISION
Priority:
Other Significant
Unfunded Mandates:
Undetermined
Legal Authority:
29 USC 2654
CFR Citation:
29 CFR 825
Legal Deadline:
None
Abstract:
The U.S. Supreme Court, in Ragsdale v. Wolverine World Wide, Inc., 122
S. Ct. 1155 (2002), invalidated regulatory provisions issued under the
Family and Medical Leave Act (FMLA) pertaining to the effects of an
employer's failure to timely designate leave that is taken by an
employee as being covered by the FMLA. The Department intends to
propose revisions to the FMLA regulations to address issues raised by
this and other judicial decisions.
Statement of Need:
The FMLA requires covered employers to grant eligible employees up to
12 workweeks of unpaid, job-protected leave a year for specified family
and medical reasons, and to maintain group health benefits during the
leave as if the employees continued to work instead of taking leave.
When an eligible employee returns from FMLA leave, the employer must
restore the employee to the same or an equivalent job with equivalent
pay, benefits, and other conditions of employment. FMLA makes it
unlawful for an employer to interfere with, restrain, or deny the
exercise of any right provided by the FMLA.
The FMLA regulations require employers to designate if an employee's
use of leave is counting against the employee's FMLA leave entitlement,
[[Page 72783]]
and to notify the employee of that designation (29 CFR section
825.208). Section 825.700(a) of the regulations provides that if an
employee takes paid or unpaid leave and the employer does not designate
the leave as FMLA leave, the leave taken does not count against the
employee's 12 weeks of FMLA leave entitlement.
On March 19, 2002, the U.S. Supreme Court issued its decision in
Ragsdale v. Wolverine World Wide, Inc., 122 S. Ct. 1155 (2002). In that
decision, the Court invalidated regulatory provisions pertaining to the
effects of an employer's failure to timely designate leave that is
taken by an employee as being covered by the FMLA. The Court ruled that
29 CFR section 825.700(a) was invalid absent evidence that the
employer's failure to designate the leave as FMLA leave interfered with
the employee's exercise of FMLA rights. This proposed rule is being
prepared to address issues raised by this and other judicial decisions.
Summary of Legal Basis:
This rule is issued pursuant to section 404 of the Family and Medical
Leave Act, 29 U.S.C. section 2654.
Alternatives:
After completing a review and analysis of the Supreme Court's decision
in Ragsdale and other judicial decisions, regulatory alternatives will
be developed for notice-and-comment rulemaking.
Anticipated Cost and Benefits:
The costs and benefits of this rulemaking action are not expected to
exceed $100 million per year or otherwise trigger economic significance
under Executive Order 12866.
Risks:
This rulemaking action does not directly affect risks to public health,
safety, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 03/00/05
NPRM Comment Period End 05/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses, Governmental Jurisdictions, Organizations
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Alfred B. Robinson
Acting Administrator, Wage and Hour Division
Department of Labor
Employment Standards Administration
200 Constitution Avenue NW.
FP Building
S3502
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1302
RIN: 1215-AB35
_______________________________________________________________________
DOL--ESA
-----------
FINAL RULE STAGE
-----------
89. CHILD LABOR REGULATIONS, ORDERS, AND STATEMENTS OF INTERPRETATION
(ESA/W-H)
Priority:
Other Significant
Legal Authority:
29 USC 203(l)
CFR Citation:
29 CFR 570
Legal Deadline:
None
Abstract:
Section 3(l) of the Fair Labor Standards Act requires the Secretary of
Labor to issue regulations with respect to minors between 14 and 16
years of age ensuring that the periods and conditions of their
employment do not interfere with their schooling, health, or well-
being. The Secretary is also directed to designate occupations that are
particularly hazardous for minors 16 and 17 years of age. Child Labor
Regulation No. 3 sets forth the permissible industries and occupations
in which 14- and 15-year-olds may be employed, and specifies the number
of hours in a day and in a week, and time periods within a day, that
such minors may be employed. The Department has invited public comment
in considering whether changes in technology in the workplace and job
content over the years require new hazardous occupation orders, and
whether changes are needed in some of the applicable hazardous
occupation orders. Comment has also been solicited on whether revisions
should be considered in the permissible hours and time-of-day standards
for 14- and 15-year-olds. Comment has been sought on appropriate
changes required to implement school-to-work transition programs.
Additionally, Congress enacted Public Law 104-174 (August 6, 1996),
which amended FLSA section 13(c) and requires changes in the
regulations under Hazardous Occupation Order No. 12 regarding power-
driven paper balers and compactors, to allow 16- and 17-year-olds to
load, but not operate or unload, machines meeting applicable American
National Standards Institute (ANSI) safety standards and certain other
conditions. Congress also passed the Drive for Teen Employment Act,
Public Law 105-334 (October 31, 1998), which prohibits minors under age
17 from driving automobiles and trucks on public roads on the job and
sets criteria for 17-year-olds to drive such vehicles on public roads
on the job.
Statement of Need:
Because of changes in the workplace and the introduction of new
processes and technologies, the Department is undertaking a
comprehensive review of the regulatory criteria applicable to child
labor. Other factors necessitating a review of the child labor
regulations are changes in places where young workers find employment
opportunities, the existence of differing Federal and State standards,
and the divergent views on how best to correlate school and work
experiences.
Under the Fair Labor Standards Act, the Secretary of Labor is directed
to provide by regulation or by order for the employment of youth
between 14 and 16 years of age under periods and conditions which will
not interfere with their schooling, health and well-being. The
Secretary is also directed to designate occupations that are
particularly hazardous for youth between the ages of 16 and 18 years or
detrimental to their health or well-being. The Secretary has done so by
specifying, in regulations, the permissible industries and occupations
in which 14- and 15-year-olds may be employed, and the number of hours
per day and week and the time periods within a day in which they may be
employed. In addition, these regulations designate the occupations
declared particularly hazardous for minors between 16 and 18 years of
age or detrimental to their health or well-being.
Public comment has been invited in considering whether changes in
[[Page 72784]]
technology in the workplace and job content over the years require new
hazardous occupation orders or necessitate revision to some of the
existing hazardous orders. Comment has also been invited on whether
revisions should be considered in the permissible hours and time-of-day
standards for the employment of 14- and 15-year-olds, and whether
revisions should be considered to facilitate school-to-work transition
programs. When issuing the regulatory proposals (after review of public
comments on the advance notice of proposed rulemaking), the
Department's focus was on assuring healthy, safe and fair workplaces
for young workers, and at the same time promoting job opportunities for
young people and making regulatory standards less burdensome to the
regulated community.
The Department will also be considering what additional revisions to
the hazardous occupation orders will be undertaken to address
recommendations of the National Institute for Occupational Safety and
Health in its May 2002 report to the Department.
Summary of Legal Basis:
These regulations are issued under sections 3(l), 11, 12, and 13 of the
Fair Labor Standards Act, 29 U.S.C. sections 203(l), 211, 212, and 213
which require the Secretary of Labor to issue regulations prescribing
permissible time periods and conditions of employment for minors
between 14 and 16 years old so as not to interfere with their
schooling, health, or well-being, and to designate occupations that are
particularly hazardous or detrimental to the health or well-being of
minors under 18 years old.
Alternatives:
Regulatory alternatives developed based on recent legislation and the
public comments responding to the advance notice of proposed rulemaking
included specific proposed additions or modifications to the paper
baler, teen driving, explosive materials, and roofing hazardous
occupation orders, and proposed changes to the permissible cooking
activities that 14- and 15-year-olds may perform in retail
establishments.
Anticipated Cost and Benefits:
Preliminary estimates of the anticipated costs and benefits of this
regulatory action indicated that the rule was not economically
significant. Benefits will include safer working environments and the
avoidance of injuries with respect to young workers.
Risks:
The child labor regulations, by ensuring that permissible job
opportunities for working youth are safe and healthy and not
detrimental to their education as required by the statute, produce
positive benefits by reducing health and productivity costs employers
may otherwise incur from higher accident and injury rates to young and
inexperienced workers. Given the limited nature of the changes in the
proposed rule, a detailed assessment of the magnitude of risk was not
prepared.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Final Rule 56 FR 58626 11/20/91
Final Rule Effective 12/20/91
ANPRM 59 FR 25167 05/13/94
ANPRM Comment Pe59 FR 40318 08/11/94
NPRM 64 FR 67130 11/30/99
NPRM Comment Period End 01/31/00
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Alfred B. Robinson
Acting Administrator, Wage and Hour Division
Department of Labor
Employment Standards Administration
200 Constitution Avenue NW.
FP Building
S3502
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1302
RIN: 1215-AA09
_______________________________________________________________________
DOL--Employment and Training Administration (ETA)
-----------
PROPOSED RULE STAGE
-----------
90. REVISION TO THE DEPARTMENT OF LABOR BENEFIT REGULATIONS FOR TRADE
ADJUSTMENT ASSISTANCE FOR WORKERS UNDER THE TRADE ACT OF 1974, AS
AMENDED
Priority:
Other Significant
Legal Authority:
19 USC 2320; Secretary's Order No. 3-81, 46 FR 31117
CFR Citation:
29 CFR 90; 20 CFR 617; 20 CFR 618; 20 CFR 665; 20 CFR 671; . . .
Legal Deadline:
None
Abstract:
The Trade Adjustment Assistance Reform Act of 2002, enacted on August
6, 2002, contains provisions amending title 2, chapter 2 of the Trade
Act of 1974, entitled Adjustment Assistance for Workers. The
amendments, effective 90 days from enactment (November 4, 2002), make
additions to where and by whom a petition may be filed, expand
eligibility to workers whose production has been shifted to certain
foreign countries and to worker groups secondarily affected, and make
substantive changes regarding trade adjustment assistance (TAA) program
benefits.
It is the agency's intention to create a new 20 CFR part 618 to
incorporate the amendments and write it in plain English, while
amending the WIA regulations at 20 CFR parts 665 and 671 regarding
Rapid Response and National Emergency Grants as they relate to the TAA
program.
The proposed part 618 consists of nine subparts: subpart A - General;
subpart B--Petitions and Determinations of Eligibility to Apply for
Trade Adjustment Assistance (and Alternative TAA); subpart C---Delivery
of Services throughout the One-Stop Delivery System; subpart D--Job
Search Allowances; subpart E--Relocation Allowances; subpart F--
Training Services; subpart G--Trade Readjustment Allowances (TRA);
subpart H--Administration by Applicable State Agencies; and subpart I--
Alternative Trade Adjustment Assistance for Older Workers. Because of
the complexity of the subject matter and the States' needs for
definitive instructions on providing TAA benefits, the rulemaking for
part 618 is divided into two parts. This notice of proposed rulemaking
covers the general provisions (subpart A) and TAA benefits portions
(subpart C through subpart H) of the regulations. A separate notice of
proposed rulemaking will cover the two remaining subparts (subpart B
and subpart I).
[[Page 72785]]
Statement of Need:
The Trade Adjustment Assistance Reform Act of 2002, enacted August 6,
2002, repeals the North American Free Trade Agreement-Transitional
Adjustment Assistance provisions for workers affected by the NAFTA
Implementation Act and adds significant amendments to worker benefits
under Trade Adjustment Assistance for Workers, as provided for in the
Trade Act of 1974.
The 2002 Trade Act amends where and by whom a petition may be filed.
Program benefits for TAA eligible recipients are expanded to include
for the first time a health care tax credit, and eligible recipients
now include secondarily affected workers impacted by foreign trade.
Income support is extended by 26 weeks and by up to one year under
certain conditions. Waivers of training requirements in order to
receive income support are explicitly defined. Job search and
relocation benefit amounts are increased. Within one year of enactment,
the amendments offer an Alternative TAA for Older Workers program that
targets older worker groups who are certified as TAA eligible and
provides the option of a wage supplement instead of training, job
search, and income support.
The Department is mandated to implement the amendments within 90 days
from enactment (November 4, 2002), and it issued operating instructions
in a guidance letter on October 10, 2002, and later published in the
Federal Register (67 FR 69029-41). State agencies rely on the
regulations to make determinations as to individual eligibility for TAA
program benefits. TAA program regulations as written have been
described as complicated to interpret. With the new TAA program benefit
amendments contained in the Trade Act of 2002, it is imperative that
the regulations be in an easy-to-read and understandable format.
Summary of Legal Basis:
These regulations are authorized by 19 U.S.C. 2320 due to the
amendments to the Trade Act of 1974 by the Trade Adjustment Assistance
Reform Act of 2002.
Alternatives:
The public will be afforded an opportunity to provide comments on the
TAA program changes when the Department publishes the proposed rule in
the Federal Register.
Anticipated Cost and Benefits:
Preliminary estimates of the anticipated costs of this regulatory
action have not been determined at this time and will be determined at
a later date.
Risks:
This action does not affect public health, safety, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, State
Agency Contact:
Timothy F. Sullivan
Director, Trade Adjustment Assistance
Department of Labor
Employment and Training Administration
Room S4231
200 Constitution Avenue NW
FP Building, C5311
Washington, DC 20210
Phone: 202 693-3708
Email: sullivan.timothy@dol.gov
RIN: 1205-AB32
_______________________________________________________________________
DOL--ETA
91. REVISION TO THE DEPARTMENT OF LABOR REGULATIONS FOR
PETITIONS AND DETERMINATIONS OF ELIGIBILITY TO APPLY FOR TRADE
ADJUSTMENT ASSISTANCE FOR WORKERS AND ISSUANCE OF REGULATIONS FOR THE
ALTERNATIVE TAA
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
19 USC 2320; Secretary's Order No. 3-81, 46 FR 31117
CFR Citation:
29 CFR 90; 20 CFR 617; 20 CFR 618; 20 CFR 665; 20 CFR 671; . . .
Legal Deadline:
None
Abstract:
The Trade Adjustment Assistance Reform Act of 2002, enacted on August
6, 2002, contains provisions amending title 2, chapter 2 of the Trade
Act of 1974, entitled Adjustment Assistance for Workers. The
amendments, effective 90 days from enactment (November 4, 2002), make
additions to where and by whom a petition may be filed, expand
eligibility to workers whose production has been shifted to certain
foreign countries and to worker groups secondarily affected, and make
substantive changes regarding trade adjustment assistance (TAA) program
benefits.
It is the agency's intention to create a new 20 CFR part 618 to
incorporate the amendments and write it in plain English, while
amending the WIA regulations at 20 CFR parts 665 and 671 regarding
Rapid Response and National Emergency Grants as they relate to the TAA
program.
The proposed part 618 consists of nine subparts: subpart A--General;
subpart B--Petitions and Determinations of Eligibility to Apply for
Trade Adjustment Assistance (and Alternative TAA); subpart C--Delivery
of Services throughout the One-Stop Delivery System; subpart D--Job
Search Allowances; subpart E--Relocation Allowances; subpart F--
Training Services; subpart G--Trade Readjustment Allowances (TRA);
subpart H--Administration by Applicable State Agencies; and subpart I--
Alternative Trade Adjustment Assistance (ATAA) for Older Workers.
Because of the complexity of the subject matter and the States' needs
for definitive instructions on providing TAA benefits, the rulemaking
for part 618 is divided into two parts. This notice of proposed
rulemaking covers the petitions and determinations (subpart B) and ATAA
(subpart I) of the regulations. A separate notice of proposed
rulemaking will cover the remaining subparts (subpart A and subparts C
through H).
Statement of Need:
The Trade Adjustment Assistance Reform Act of 2002, enacted August 6,
2002, repeals the North American Free Trade Agreement-Transitional
Adjustment Assistance provisions for workers affected by the NAFTA
Implementation Act and adds significant amendments to worker benefits
under Trade Adjustment Assistance for Workers, as provided for in the
Trade Act of 1974.
The 2002 Trade Act amends where and by whom a petition may be filed.
Program benefits for TAA eligible recipients are expanded to include
for the first time a health care tax credit,
[[Page 72786]]
and eligible recipients now include secondarily affected workers
impacted by foreign trade. Income support is extended by 26 weeks and
by up to one year under certain conditions. Waivers of training
requirements in order to receive income support are explicitly defined.
Job search and relocation benefit amounts are increased. Within one
year of enactment, the amendments offer an Alternative TAA for Older
Workers program that targets older worker groups who are certified as
TAA eligible and provides the option of a wage supplement instead of
training, job search, and income support.
The Department is mandated to implement the amendments within 90 days
from enactment (November 4, 2002), and it issued operating instructions
in a guidance letter on October 10, 2002, and later published in the
Federal Register (67 FR 69029-41). State agencies rely on the
regulations to make determinations as to individual eligibility for TAA
program benefits. TAA program regulations as written have been
described as complicated to interpret. With the new TAA program benefit
amendments contained in the Trade Act of 2002, it is imperative that
the regulations be in an easy-to-read and understandable format.
Summary of Legal Basis:
These regulations are authorized by 19 U.S.C. 2320 due to the
amendments to the Trade Act of 1974 by the Trade Adjustment Assistance
Reform Act of 2002.
Alternatives:
The public will be afforded an opportunity to provide comments on the
TAA program changes when the Department publishes the proposed rule in
the Federal Register.
Anticipated Cost and Benefits:
Preliminary estimates of the anticipated costs of this regulatory
action have not been determined at this time and will be determined at
a later date.
Risks:
This action does not affect public health, safety, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/05
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal, State
Agency Contact:
Timothy F. Sullivan
Director, Trade Adjustment Assistance
Department of Labor
Employment and Training Administration
Room S4231
200 Constitution Avenue NW
FP Building, C5311
Washington, DC 20210
Phone: 202 693-3708
Email: sullivan.timothy@dol.gov
RIN: 1205-AB40
_______________________________________________________________________
DOL--ETA
-----------
FINAL RULE STAGE
-----------
92. LABOR CERTIFICATION PROCESS FOR THE PERMANENT EMPLOYMENT OF ALIENS
IN THE UNITED STATES
Priority:
Other Significant
Legal Authority:
29 USC 49 et seq; 8 USC 1182(a)(5)(A), 1189(p)(1)
CFR Citation:
20 CFR 656
Legal Deadline:
None
Abstract:
The Employment and Training Administration (ETA) is in the process of
reengineering the permanent labor certification process. ETA's goals
are to make fundamental changes and refinements that will streamline
the process, save resources, improve the effectiveness of the program
and better serve the Department of Labor's (DOL) customer.
Statement of Need:
The labor certification process has been described as being
complicated, costly and time consuming. Due to the increases in the
volume of applications received and a lack of adequate resources, it
can take up to 2 years or more to complete processing an application.
The process also requires substantial State and Federal resources to
administer and is reportedly costly and burdensome to employers as
well. Cuts in Federal funding for both the permanent labor
certification program and the U.S. Employment Service have made it
difficult for State and Federal administrators to keep up with the
process. ETA, therefore, is taking steps to improve effectiveness of
the various regulatory requirements and the application processing
procedures, with a view to achieving savings in resources both for the
Government and employers, without diminishing protections now afforded
U.S. workers by the current regulatory and administrative requirements.
Summary of Legal Basis:
Promulgation of these regulations is authorized by section 212(a)(5)(A)
of the Immigration and Nationality Act.
Alternatives:
Regulatory alternatives are now being developed by the Department. The
public was afforded an opportunity to comment on the Department's plans
for streamlining the permanent labor certification process in a notice
of proposed rulemaking which was published in the Federal Register on
May 6, 2002.
Anticipated Cost and Benefits:
Preliminary estimates of the anticipated costs and benefits have not
been determined at this time. Preliminary estimates will be developed
after a decision is made as to what regulatory amendments are necessary
and after the implementing forms and automated systems to support a
streamlined permanent labor certification process have been developed.
Risks:
This action does not affect public health, safety, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 67 FR 30465 05/06/02
NPRM Comment Period End 07/05/02
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Federal, State
[[Page 72787]]
Agency Contact:
William L. Carlson
Chief, Division of Foreign Labor Certification
Department of Labor
Employment and Training Administration
200 Constitution Avenue NW.
Room C4312 FP Building
Washington, DC 20210
Phone: 202 693-3010
Fax: 202 693-2768
Email: carlson.william@dol.gov
RIN: 1205-AA66
_______________________________________________________________________
DOL--Employee Benefits Security Administration (EBSA)
-----------
PROPOSED RULE STAGE
-----------
93. RULEMAKING RELATING TO TERMINATION OF ABANDONED INDIVIDUAL ACCOUNT
PLANS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
29 USC 1135; 29 USC 1002(16)(A)
CFR Citation:
29 CFR 2591
Legal Deadline:
None
Abstract:
This rulemaking will establish a procedure and standards for
distributing the benefits of individual account plans that have been
abandoned by their sponsoring employers or plan administrators.
Statement of Need:
Thousands of individual account plans have, for a variety of reasons,
been abandoned by their sponsors, creating problems for plan
participants, administrators, financial institutions (e.g., banks,
insurance companies, mutual funds), the courts and the Federal
Government. At present, the potential liability and costs attendant to
terminating such plans and distributing the assets inhibits financial
institutions and others from taking on this responsibility. Due to
ongoing administrative costs and other factors, the continued
maintenance of such plans is often not in the interest of the
participants and beneficiaries. This rulemaking will establish a
procedure for a financial institution that holds the assets of such a
plan to terminate the plan and distribute its assets to the
participants and beneficiaries. The rulemaking will also include
standards for determining when plans may be terminated pursuant to this
procedure and for carrying out the functions necessary to distribute
benefits and shut down plan operations.
Summary of Legal Basis:
Section 505 of ERISA provides that the Secretary may prescribe such
regulations as the Secretary finds necessary and appropriate to carry
out the provisions of title I of the Act. Section 403(d)(1) provides
that, upon termination of such a plan, the assets shall be distributed
generally in accordance with the provisions that apply to defined
benefit plans, ``except as otherwise provided in regulations of the
Secretary.'' ERISA section 3(16)(A) permits the Secretary to issue
regulations designating an administrator for a plan where the plan
document makes no designation and the plan sponsor cannot be
identified.
Alternatives:
Alternatives will be considered following a determination of the scope
and nature of the regulatory guidance needed by the public.
Anticipated Cost and Benefits:
Preliminary estimates of the anticipated costs and benefits will be
developed, as appropriate, following a determination regarding the
alternatives to be considered.
Risks:
Failure to provide guidance in this area will leave the retirement
benefits of participants and beneficiaries in abandoned plans at risk
of being significantly diminished by ongoing plan administrative
expenses, rather than distributed to participants and beneficiaries in
connection with a timely and orderly termination of the plan.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 01/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses, Organizations
Government Levels Affected:
None
Agency Contact:
Jeffrey Turner
Senior Pension Law Specialist
Department of Labor
Employee Benefits Security Administration
N 5669
200 Constitution Avenue NW
Room N5669
FP Building
Washington, DC 20210
Phone: 202 693-8500
RIN: 1210-AA97
_______________________________________________________________________
DOL--EBSA
94. AMENDMENT OF REGULATION RELATING TO DEFINITION OF PLAN
ASSETS--PARTICIPANT CONTRIBUTIONS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
29 USC 1135
CFR Citation:
29 CFR 2510.3-102
Legal Deadline:
None
Abstract:
This rulemaking will amend the regulation that defines when participant
monies paid to or withheld by an employer for contribution to an
employee benefit plan constitute ``plan assets'' for purposes of title
I of ERISA and the related prohibited transaction provisions of the
Internal Revenue Code. The regulation contains an amendment to the
current regulation that will establish a safe harbor period of a
specified number of business days during which certain monies that a
participant pays to, or has withheld by, an employer for contribution
to a plan would not constitute ``plan assets.''
Statement of Need:
This amendment of the participant contribution regulation would, upon
adoption, establish a ``safe harbor'' period of a specified number of
days during which certain monies that a participant pays to, or has
withheld from wages, by an employer for contribution to an employee
benefit plan, would constitute plan assets for purposes of title I of
ERISA and the related prohibited transaction
[[Page 72788]]
provisions of the Internal Revenue Code. The amendment is needed to
provide greater certainty to employers, participants and beneficiaries,
service providers and others concerning when participant contributions
to a plan constitute plan assets.
Summary of Legal Basis:
Section 505 of ERISA provides that the Secretary may prescribe such
regulations as she finds necessary and appropriate to carry out the
provisions of title I of the Act. Regulation 29 CFR 2510.3-102 provides
that the assets of an employee benefit plan covered by title I of ERISA
includes amounts (other than union dues) that a participant or
beneficiary pays to an employer, or has withheld from wages by an
employer, for contribution to the plan as of the earliest date on which
such contributions can reasonably be segregated from the employer's
general assets; the regulation also specifies the maximum time period
for deposit of such contributions by the employer.
Alternatives:
Alternatives will be considered following a determination of the scope
and nature of the regulatory guidance needed by the public.
Anticipated Cost and Benefits:
Preliminary estimates of the anticipated costs and benefits will be
developed, as appropriate, following a determination regarding the
alternatives to be considered.
Risks:
Failure to provide the safe harbor that would be afforded by the
proposed amendment with regard to monies contributed to employee
benefit plans would deprive employers, other plan fiduciaries, and
service providers of the certainty they need to optimize compliance
with the law. Also, any risk of loss or lost earnings resulting from
permitting employers who would otherwise transmit contributions to the
plan sooner than the time specified in the safe harbor should be
minimal, while the benefits attendant to encouraging employers to
review and modify their systems or practices to take advantage of the
safe harbor may be significant.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/04
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
None
Federalism:
Undetermined
Agency Contact:
Louis J. Campagna
Chief, Division of Fiduciary Interpretations, Office of Regulations and
Interpretations
Department of Labor
Employee Benefits Security Administration
200 Constitution Avenue NW
Rm N5669
FP Building
Washington, DC 20210
Phone: 202 693-8512
Fax: 202 219-7291
RIN: 1210-AB02
_______________________________________________________________________
DOL--EBSA
-----------
FINAL RULE STAGE
-----------
95. REGULATIONS IMPLEMENTING THE HEALTH CARE ACCESS, PORTABILITY, AND
RENEWABILITY PROVISIONS OF THE HEALTH INSURANCE PORTABILITY AND
ACCOUNTABILITY ACT OF 1996
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
29 USC 1027; 29 USC 1059; 29 USC 1135; 29 USC 1171; 29 USC 1172; 29 USC
1191c
CFR Citation:
29 CFR 2590
Legal Deadline:
Other, Statutory, April 1, 1997, Interim Final Rule.
Abstract:
The Health Insurance Portability and Accountability Act of 1996 (HIPAA)
amended title I of ERISA by adding a new part 7, designed to improve
health care access, portability and renewability. This rulemaking will
provide regulatory guidance to implement these provisions.
Statement of Need:
In general, the health care portability provisions in part 7 of ERISA
provide for increased portability and availability of group health
coverage through limitations on the imposition of any preexisting
condition exclusion and special enrollment rights in group health plans
after loss of other health coverage or a life event. Plan sponsors,
administrators and participants need guidance from the Department with
regard to how they can fulfill their respective obligations under these
statutory provisions.
Summary of Legal Basis:
Part 7 of ERISA specifies the portability and other requirements for
group health plans and health insurance issuers. Section 734 of ERISA
provides that the Secretary may promulgate such regulations as may be
necessary or appropriate to carry out the provisions of part 7 of
ERISA. In addition, section 505 of ERISA authorizes the Secretary to
issue regulations clarifying the provisions of title I of ERISA.
Risks:
Failure to provide guidance concerning part 7 of ERISA may impede
compliance with the law.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru62 FR 16894 04/08/97
Interim Final Rule Effective 06/07/97
Interim Final Rule Comment Period End 07/07/97
Request for Info64 FR 57520 10/25/99
Comment Period End 01/25/00
Final Rule 12/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Amy Turner
Pension Law Specialist
Department of Labor
Employee Benefits Security Administration
Room N5677
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-8335
RIN: 1210-AA54
[[Page 72789]]
_______________________________________________________________________
DOL--EBSA
96. PROHIBITING DISCRIMINATION AGAINST PARTICIPANTS AND BENEFICIARIES
BASED ON HEALTH STATUS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
29 USC 1027; 29 USC 1059; 29 USC 1135; 29 USC 1182; 29 USC 1191c; 29
USC 1194
CFR Citation:
29 CFR 2590.702
Legal Deadline:
None
Abstract:
Section 702 of the Employee Retirement Income Security Act of 1974,
amended by the Health Insurance Portability and Accountability Act of
1996 (HIPAA), establishes that a group health plan or a health
insurance issuer may not establish rules for eligibility (including
continued eligibility) of any individual to enroll under the terms of
the plan based on any health status-related factor. These provisions
are also contained in the Internal Revenue Code under the jurisdiction
of the Department of the Treasury, and the Public Health Service Act
under the jurisdiction of the Department of Health and Human Services.
On April 8, 1997, the Department, in conjunction with the Departments
of the Treasury and Health and Human Services (collectively, the
Departments) published interim final regulations implementing the
nondiscrimination provisions of HIPAA. These regulations can be found
at 26 CFR 54.9802-1 (Treasury), 29 CFR 2590.702 (Labor), and 45 CFR
146.121 (HHS). That notice of rulemaking also solicited comments on the
nondiscrimination provisions and indicated that the Departments intend
to issue further regulations on the nondiscrimination rules. This
rulemaking contains additional regulatory interim guidance under
HIPAA's nondiscrimination provisions. In addition, the rulemaking
contains proposed guidance on bona fide wellness programs.
Statement of Need:
Part 7 of ERISA provides that group health plans and health insurance
issuers may not establish rules for eligibility (including continued
eligibility) of any individual to enroll under the terms of the plan
based on any health status-related factor. Plan sponsors,
administrators, and participants need additional guidance from the
Department with regard to how they can fulfill their respective
obligations under these statutory provisions.
Summary of Legal Basis:
Section 702 of ERISA specifies the respective nondiscrimination
requirements for group health plans and health insurance issuers.
Section 734 of ERISA provides that the Secretary may promulgate such
regulations as may be necessary or appropriate to carry out the
provisions of part 7 ERISA. In addition, section 505 of ERISA
authorizes the Secretary to issue regulations clarifying the provisions
of title I of ERISA.
Risks:
Failure to provide guidance concerning part 7 of ERISA may impede
compliance with the law.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru62 FR 16894 04/08/97
Interim Final Rule Comment Period End 07/07/97
NPRM 66 FR 1421 01/08/01
NPRM Comment Period End 04/09/01
Second Interim F66 FR 1378 01/08/01
Interim Final Rule Comment Period End 04/09/01
Final Rule 03/00/05
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Undetermined
Additional Information:
This item has been split off from RIN 1210-AA54.
Agency Contact:
Amy Turner
Pension Law Specialist
Department of Labor
Employee Benefits Security Administration
Room N5677
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-8335
RIN: 1210-AA77
_______________________________________________________________________
DOL--Mine Safety and Health Administration (MSHA)
-----------
PROPOSED RULE STAGE
-----------
97. ASBESTOS EXPOSURE LIMIT
Priority:
Other Significant
Legal Authority:
30 USC 811; 30 USC 813
CFR Citation:
30 CFR 56; 30 CFR 57; 30 CFR 71
Legal Deadline:
None
Abstract:
MSHA's permissible exposure limit (PEL) for asbestos applies to surface
(30 CFR part 56) and underground (30 CFR part 57) metal and nonmetal
mines and to surface coal mines and surface areas of underground coal
mines (30 CFR part 71) and is over 20 years old. MSHA is considering
rulemaking to lower the PEL in order to reduce the risk of miners
developing asbestos-induced occupational disease. A report by the
Office of the Inspector General (OIG) recommended that MSHA lower its
existing permissible exposure limit for asbestos to a more protective
level, and address take-home contamination from asbestos. It also
recommended that MSHA use Transmission Electron Microscopy to analyze
fiber samples that may contain asbestos.
Statement of Need:
Current scientific data indicate that the existing asbestos PEL is not
sufficiently protective of miners' health. MSHA's asbestos regulations
date to 1967 and are based on the Bureau of Mines (MSHA's predecessor)
standard of 5 mppcf (million particles per cubic foot of air). In 1969,
the Bureau proposed a 2 mppcf and 12 fibers/ml standard. This standard
was promulgated in 1969. In 1970, the Bureau proposed to lower the
standard to 5 fibers/ml, which was promulgated in 1974. MSHA issued its
current standard of 2 fibers/ml in 1976 for coal mining (41 FR 10223)
and 1978 for metal and nonmetal mining (43 FR 54064). During
inspections, MSHA routinely takes samples, which are analyzed for
compliance with its standard.
Other Federal agencies have addressed this issue by lowering their PEL
for asbestos. For example, the Occupational Safety and Health
[[Page 72790]]
Administration, working in conjunction with the Environmental
Protection Agency, enacted a revised asbestos standard in 1994 that
lowered the permissible exposure limit to an 8-hour time-weighted
average limit of 0.1 fiber per cubic centimeter of air and the
excursion limit to 1.0 fiber per cubic centimeter of air (1 f/cc) as
averaged over a sampling period of thirty (30) minutes. These lowered
limits reflected increased asbestos-related disease risk to asbestos-
exposed workers.
Summary of Legal Basis:
Promulgation of this regulation is authorized by section 101 of the
Federal Mine Safety and Health Act of 1977.
Alternatives:
The Agency has increased sampling efforts in an attempt to determine
current miners' exposure levels to asbestos, including taking samples
at all existing vermiculite, taconite, talc, and other mines to
determine whether asbestos is present and at what levels. In early
2000, MSHA began an intensive sampling effort at operations with
potential asbestos exposure. These efforts continue. While sampling,
MSHA staff discussed with miners and mine operators the potential
hazards of asbestos and the types of preventive measures that could be
implemented to reduce exposures. The course of action MSHA takes in
addressing asbestos hazards to miners will, in part, be based on these
sampling results.
Anticipated Cost and Benefits:
MSHA will develop a preliminary regulatory economic analysis to
accompany any proposed rule that may be developed.
Risks:
Miners could be exposed to the hazards of asbestos during mine
operations where the ore body contains asbestos. There is also
potential for exposure at facilities in which installed asbestos-
containing material is present. Overexposure to asbestos causes
asbestosis, mesothelioma, and other forms of cancers.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 67 FR 15134 03/29/02
Notice of Public Meetings 03/29/02
Notice of Change67 FR 19140Meetings 04/18/02
ANPRM Comment Period End 06/27/02
NPRM 03/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses
Government Levels Affected:
None
Additional Information:
The Office of the Inspector General's ``Evaluation of MSHA's Handling
of Inspections at the W.R. Grace & Company Mine in Libby, Montana,''
was issued in March 2001.
Agency Contact:
Marvin W. Nichols Jr.
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
Room 2352
1100 Wilson Boulevard
Room 2350
Arlington, VA 22209
Phone: 202 693-9440
Fax: 202 693-9441
Email: nichols-marvin@dol.gov
RIN: 1219-AB24
_______________________________________________________________________
DOL--MSHA
-----------
FINAL RULE STAGE
-----------
98. DIESEL PARTICULATE MATTER EXPOSURE OF UNDERGROUND METAL AND
NONMETAL MINERS
Priority:
Other Significant
Legal Authority:
30 USC 811; 30 USC 813
CFR Citation:
30 CFR 57
Legal Deadline:
None
Abstract:
On January 19, 2001, MSHA published a final rule addressing diesel
particulate matter (DPM) exposure of underground metal and nonmetal
miners (66 FR 5706). The final rule established new health standards
for underground metal and nonmetal mines that use equipment powered by
diesel engines. The rule establishes an interim concentration limit of
400 micrograms of total carbon per cubic meter of air that became
applicable July 20, 2002, and a final concentration limit of 160
micrograms to become applicable after January 19, 2006. Industry
challenged the rule and organized labor intervened in the litigation.
Settlement negotiations with the litigants have resulted in further
regulatory actions on several requirements of the rule. One final rule
has been published (67 FR 9180). This new rulemaking will address many
of the remaining issues. MSHA issued an advance notice of proposed
rulemaking (ANPRM) on September 25, 2002 (67 FR 60199) to obtain
additional information and published a notice of proposed rulemaking
(NPRM) in August 2003.
Statement of Need:
As a result of the first partial settlement with the litigants, MSHA
published two documents in the Federal Register on July 5, 2001. One
document delayed the effective date of 57.5066(b) regarding the tagging
provisions of the maintenance standard; clarified the effective dates
of certain provisions of the final rule; and gave correction amendments
(66 FR 35518).
The second document was a proposed rule to clarify 57.5066(b)(1) and
(b)(2) of the maintenance standards and to add a new paragraph (b)(3)
to 57.5067 regarding the transfer of existing diesel equipment from one
underground mine to another underground mine. The final rule on these
issues was published February 27, 2002, and became effective March 29,
2002.
As a result of the second partial settlement agreement, MSHA proposed
specific changes to the 2001 DPM final rule. On September 25, 2002,
MSHA published an ANPRM. In response to commenters, MSHA proposed
changes only to the interim DPM standard of 400 micrograms per cubic
meter of air. In a separate rulemaking, the Agency will propose a rule
to revise the final concentration limit of 160 micrograms per cubic
meter of air. The scope of both rulemakings is limited to the
settlement agreement. The current rulemaking addresses the following
provisions:
57.5060(a) - Whether to change the existing DPM surrogate for the
interim limit from total carbon to elemental carbon; and change the
concentration limit to a comparable permissible exposure limit.
57.5060(c) - Whether to adapt to the interim limit the existing
provision that allows mine operators to apply to the Secretary for
additional time to come into compliance with the final concentration
limit. MSHA also agreed
[[Page 72791]]
to propose to include consideration of economic feasibility, and to
allow for annual renewals of such special extensions.
57.5060(d) -- Whether to remove the existing provision permitting
miners to engage in certain activities in concentrations exceeding the
interim and final limits upon application and approval from the
Secretary, since the Agency agreed to propose the current hierarchy of
controls that MSHA applies in its existing metal and nonmetal exposure
based health standards for abating violations.
57.5060(e) -- Whether to remove the existing prohibition on the use of
personal protective equipment.
57.5060(f) - Whether to remove the prohibition on the use of
administrative controls.
57.5061(a) -- Whether to change the reference from ``concentration'' to
PEL.
57.5061(b) -- Whether to change the reference from ``total carbon'' to
``elemental carbon.''
57.5061(c) - Whether to delete the references to ``area'' and
``occupational'' sampling for compliance.
57.5062 -- Whether to revise the existing diesel control plan.
Summary of Legal Basis:
Promulgation of these regulations is authorized by sections 101 and 103
of the Federal Mine Safety and Health Act of 1977.
Alternatives:
This rulemaking would amend and improve health protection from that
afforded by the existing standard.
Anticipated Cost and Benefits:
MSHA's preliminary economic analysis indicates that making the changes
under consideration would result in a cost savings to the mining
industry.
Risks:
Several epidemiological studies have found that exposure to diesel
exhaust presents potential health risks to miners. These potential
adverse health effects range from headaches and nausea to respiratory
disease and cancer. In the confined space of the underground mining
environment, occupational exposure to diesel exhaust may present a
greater hazard due to ventilation limitations and the presence of other
airborne contaminants, such as toxic mine dusts or mine gases. We
believe that the health evidence forms a reasonable basis for reducing
miners' exposure to diesel particulate matter. Proceeding with
rulemaking on the provisions discussed above will more effectively
reduce miners' exposure to DPM.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 67 FR 60199 09/25/02
ANPRM Comment Period End 11/25/02
NPRM 68 FR 48668 08/14/03
NPRM Comment Period End 10/14/03
Limited Reopenin69 FR 7881omment Period 02/20/04
Limited Reopenin69 FR 7881omment Period End 04/05/04
Final Action 03/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Marvin W. Nichols Jr.
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
1100 Wilson Boulevard, Room 2350
Arlington, VA 22209
Phone: 202 693-9440
Fax: 202 693-9441
Email: nichols-marvin@dol.gov
RIN: 1219-AB29
_______________________________________________________________________
DOL--Occupational Safety and Health Administration (OSHA)
-----------
PRERULE STAGE
-----------
99. OCCUPATIONAL EXPOSURE TO CRYSTALLINE SILICA
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
29 USC 655(b); 29 USC 657
CFR Citation:
29 CFR 1910; 29 CFR 1915; 29 CFR 1917; 29 CFR 1918; 29 CFR 1926
Legal Deadline:
None
Abstract:
Crystalline silica is a significant component of the earth's crust, and
many workers in a wide range of industries are exposed to it, usually
in the form of respirable quartz or, less frequently, cristobalite.
Chronic silicosis is a uniquely occupational disease resulting from
exposure of employees over long periods of time (10 years or more).
Exposure to high levels of respirable crystalline silica causes acute
or accelerated forms of silicosis that are ultimately fatal. The
current OSHA permissible exposure limit (PEL) for general industry is
based on a formula recommended by the American Conference of
Governmental Industrial Hygienists (ACGIH) in 1971 (PEL=10mg/cubic
meter/(% silica + 2), as respirable dust). The current PEL for
construction and maritime (derived from ACGIH's 1962 Threshold Limit
Value) is based on particle counting technology, which is considered
obsolete. NIOSH and ACGIH recommend a 50ug/m3 exposure limit for
respirable crystalline silica.
Both industry and worker groups have recognized that a comprehensive
standard for crystalline silica is needed to provide for exposure
monitoring, medical surveillance, and worker training. The American
Society for Testing and Materials (ASTM) has published a recommended
standard for addressing the hazards of crystalline silica. The Building
Construction Trades Department of the AFL-CIO has also developed a
recommended comprehensive program standard. These standards include
provisions for methods of compliance, exposure monitoring, training,
and medical surveillance.
Statement of Need:
Over two million workers are exposed to crystalline silica dust in
general industry, construction and maritime industries. Industries that
could be particularly affected by a standard for crystalline silica
include: foundries, industries that have abrasive blasting operations,
paint manufacture, glass and concrete product manufacture, brick
making, china and pottery manufacture, manufacture of plumbing
fixtures, and many construction activities including highway repair,
masonry, concrete work, rock drilling, and tuckpointing. The
seriousness of the health hazards associated with silica exposure is
demonstrated by the
[[Page 72792]]
fatalities and disabling illnesses that continue to occur; between 1990
and 1996, 200 to 300 deaths per year are known to have occurred where
silicosis was identified on death certificates as an underlying or
contributing cause of death. It is likely that many more cases have
occurred where silicosis went undetected. In addition, the
International Agency for Research on Cancer (IARC) has designated
crystalline silica as a known human carcinogen. Exposure to crystalline
silica has also been associated with an increased risk of developing
tuberculosis and other nonmalignant respiratory diseases, as well as,
renal and autoimmune respiratory diseases. Exposure studies and OSHA
enforcement data indicate that some workers continue to be exposed to
levels of crystalline silica far in excess of current exposure limits.
Congress has included compensation of silicosis victims on Federal
nuclear testing sites in the Energy Employees' Occupational Illness
Compensation Program Act of 2000. There is a particular need for the
Agency to modernize its exposure limits for construction and maritime,
and to address some specific issues that will need to be resolved to
propose a comprehensive standard.
Summary of Legal Basis:
The legal basis for the proposed rule is a preliminary determination
that workers are exposed to a significant risk of silicosis and other
serious disease and that rulemaking is needed to substantially reduce
the risk. In addition, the proposed rule will recognize that the PELs
for construction and maritime are outdated and need to be revised to
reflect current sampling and analytical technologies.
Alternatives:
Over the past several years, the Agency has attempted to address this
problem through a variety of non-regulatory approaches, including
initiation of a Special Emphasis Program on silica in October 1997,
sponsorship with NIOSH and MSHA of the National Conference to Eliminate
Silicosis, and dissemination of guidance information on its Web site.
OSHA has determined that rulemaking is a necessary step to ensure that
workers are protected from the hazards of crystalline silica. The
Agency is currently evaluating several options for the scope of the
rulemaking.
Anticipated Cost and Benefits:
The scope of the proposed rulemaking and estimates of the costs and
benefits are still under development.
Risks:
A detailed risk analysis is under way.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Completed SBREFA Report 12/19/03
Complete Peer Review of Risk Assessment 02/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB70
_______________________________________________________________________
DOL--OSHA
-----------
PROPOSED RULE STAGE
-----------
100. OCCUPATIONAL EXPOSURE TO HEXAVALENT CHROMIUM (PREVENTING
OCCUPATIONAL ILLNESS: CHROMIUM)
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
29 USC 655(b); 29 USC 657
CFR Citation:
29 CFR 1910
Legal Deadline:
NPRM, Judicial, October 4, 2004.
Abstract:
In July 1993, the Occupational Safety and Health Administration (OSHA)
was petitioned for an emergency temporary standard (ETS) to reduce the
permissible exposure limit (PEL) for occupational exposures to
hexavalent chromium (CrVI). The Oil, Chemical, and Atomic Workers
International Unions (OCAW) and Public Citizen's Health Research Group
(HRG) petitioned OSHA to promulgate an ETS to lower the PEL for CrVI
compounds to 0.5 micrograms per cubic meter of air (ug/m3) as an eight-
hour, time-weighted average (TWA). The current PEL in general industry
is a ceiling value of 100 ug/m3, measured as CrVI and reported as
chromic anhydride (CrO3). The amount of CrVI in the anhydride compound
equates to a PEL of 52 ug/m3. The ceiling limit applies to all forms of
CrVI, including chromic acid and chromates, lead chromate, and zinc
chromate. The current PEL of CrVI in the construction industry is 100
ug/m3 as a TWA PEL, which also equates to a PEL of 52 ug/m3. After
reviewing the petition, OSHA denied the request for an ETS and
initiated a section 6(b)(5) rulemaking.
OSHA began collecting data and performing preliminary analyses relevant
to occupational exposure to CrVI. However, in 1997, OSHA was sued by
HRG OCAW for unreasonable delay in issuing a final CrVI standard. The
3rd Circuit, U.S. Court of Appeals ruled in OSHA's favor and the Agency
continued its data collection and analytic efforts on CrVI. In 2002,
OSHA was sued again by HRG and Paper, Allied-International, Chemical
and Energy Workers Ineternational Union (PACE) for continued
unreasonable delay in issuing a final CrVI standard. In August, 2002
OSHA published a Request for Information on CrVI to solicit additional
information on key issues related to controlling exposures to CrVI and
on December 4, 2002, OSHA announced its intent to proceed with
developing a proposed standard. On December 24, 2002, the 3rd Circuit,
U.S. Court of Appeals ruled in favor of HRG and ordered the Agency to
proceed expeditiously with a CrVI standard.
Statement of Need:
Approximately 380,000 workers are exposed to CrVI in general industry,
maritime, construction, and agriculture. Industries or work processes
that could be particularly affected by a standard for CrVI include:
Electroplating, welding, painting, chromate production, chromate
pigment production, ferrochromium production, iron and steel
production, chromium catalyst production, and chromium dioxide and
sulfate production.
[[Page 72793]]
Exposure to CrVI has been shown to produce lung cancer, an often fatal
disease, among workers exposed to CrVI compounds. The International
Agency for Research on Cancer (IARC) classifies CrVI compounds as a
Group 1 Carcinogen: Agents considered to be carcinogenic in humans. The
Environmental Protection Agency (EPA) and the American Conference of
Governmental Industrial Hygienists (ACGIH) have also designated CrVI
compounds as known and confirmed human carcinogens, respectively.
Similarly, the National Institute for Occupational Safety and Health
(NIOSH) considers CrVI compounds to be potential occupational
carcinogens. OSHA's current standards for CrVI compounds, adopted in
1971, were established to protect against nasal irritation. Therefore,
there is a need to revise the current standard to protect workers from
lung cancer.
Summary of Legal Basis:
The legal basis for the proposed rule is a preliminary determination
that workers are exposed to a significant risk of lung cancer and
dermatoses and that rulemaking is needed to substantially reduce the
risk.
Alternatives:
OSHA had considered non-regulatory approaches, including the
dissemination of guidance on its web site. However, OSHA has determined
that rulemaking is a necessary step to ensure that workers are
protected from the hazards of CrVI and the Agency has been ordered by
the U.S. Court of Appeals to move forward with a final rule.
Anticipated Cost and Benefits:
The proposed rulemaking includes estimates of the costs and benefits
are being developed.
Risks:
A detailed risk analysis is included in the NPRM.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Request for Info67 FR 54389 08/22/02
Comment Period End 11/20/02
Initiate SBREFA Process 12/23/03
SBREFA Report 04/20/04
NPRM 69 FR 59305 10/04/04
NPRM Comment Period End 01/03/05
Public Hearings 02/00/05
Final Rule 01/00/06
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
Undetermined
Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB45
_______________________________________________________________________
DOL--OSHA
-----------
FINAL RULE STAGE
-----------
101. ASSIGNED PROTECTION FACTORS: AMENDMENTS TO THE FINAL RULE ON
RESPIRATORY PROTECTION
Priority:
Other Significant
Legal Authority:
29 USC 655(b); 29 USC 657
CFR Citation:
29 CFR 1910.134
Legal Deadline:
None
Abstract:
In January 1998, OSHA published the final Respiratory Protection
standard (29 CFR 1910.134), except for reserved provisions on assigned
protection factors (APFs) and maximum use concentrations (MUCs). APFs
are numbers that describe the effectiveness of the various classes of
respirators in reducing employee exposure to airborne contaminants
(including particulates, gases, vapors, biological agents, etc.).
Employers, employees, and safety and health professionals use APFs to
determine the type of respirator to protect the health of employees in
various hazardous environments. Maximum use concentrations establish
the maximum airborne concentration of a contaminant in which a
respirator with a given APF may be used.
Currently, OSHA relies on the APFs developed by NIOSH in the 1980s
unless OSHA has assigned a different APF in a substance-specific health
standard. However, many employers follow the more recent APFs published
in the industry consensus standard, ANSI Z88.2-1992. For some classes
of respirators, the NIOSH and ANSI APFs vary greatly.
This rulemaking action will complete the 1998 standard, reduce
compliance confusion among employers, and provide employees with
consistent and appropriate respiratory protection. On June 6, 2003,
OSHA published an NPRM on Assigned Protection Factors in the Federal
Register at 68 FR 34036 containing a proposed APF table, and requesting
public comment. The extended comment period ended October 2, 2003, and
an informal public hearing was held January 28-30, 2004.
Statement of Need:
About five million employees wear respirators as part of their regular
job duties. Due to inconsistencies between the APFs found in the
current industry consensus standard (ANSI Z88.2-1992) and in the NIOSH
Respirator Decision Logic, employers, employees, and safety and health
professionals are often uncertain about what respirator to select to
provide protection against hazardous air contaminants.
Summary of Legal Basis:
The legal basis for this proposed rule is the determination that
assigned protection factors and maximum use concentrations are
necessary to complete the final Respiratory Protection standard and
provide the full protection under that standard.
Alternatives:
OSHA has considered allowing the current situation to continue.
Accordingly, OSHA generally enforces NIOSH APFs, but many employers
follow the more recent consensus standard APFs. However, allowing the
situation to continue results in inconsistent enforcement, lack of
guidance for employers, and the potential for inadequate employee
protection.
Anticipated Cost and Benefits:
The estimated compliance costs for OSHA's proposed APF rule are $4.6
million. The APFs proposed in this rulemaking help to ensure that the
benefits attributed to proper respiratory
[[Page 72794]]
protection under 29 CFR 1910.134 are achieved, as well as provide an
additional degree of protection.
Risks:
The preamble to the final Respiratory Protection rule (63 FR 1270, Jan.
8, 1998) discusses the significance of the risks potentially associated
with the use of respiratory protection. No independent finding of
significant risk has been made for the APF rulemaking since it only
addresses a single provision of the larger rule.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 47 FR 20803 05/14/82
ANPRM Comment Period End 09/13/82
NPRM 59 FR 58884 11/15/94
Final Rule 63 FR 1152 01/08/98
Final Rule Effective 04/08/98
NPRM 68 FR 34036 06/06/03
NPRM Comment Period End 09/04/03
NPRM Comment Per68 FR 53311d 10/02/03
Public Hearing o68 FR 640364 11/12/03
Final Rule: Revo68 FR 75767espiratory Protection M. TB 12/31/03
Public Hearing 01/28/04
Post-Hearing Com69 FR 16510ief Period Extended 03/30/04
Post-Hearing Comment Period End 04/29/04
Post-Hearing Briefs End 05/29/04
Final Action 01/00/05
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal, Local, State, Tribal
Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AA05
_______________________________________________________________________
DOL--OSHA
102. STANDARDS IMPROVEMENT (MISCELLANEOUS CHANGES) FOR GENERAL
INDUSTRY, MARINE TERMINALS, AND CONSTRUCTION STANDARDS (PHASE II)
Priority:
Other Significant
Legal Authority:
29 USC 655(b)
CFR Citation:
29 CFR 1910, subpart Z; 29 CFR 1910.1001 to 1910.1052; 29 CFR 1910.142;
29 CFR 1910.178; 29 CFR 1910.219; 29 CFR 1910.261; 29 CFR 1910.265; 29
CFR 1910.410; 29 CFR 1917.92; 29 CFR 1926.1101; 29 CFR 1926.1127; 29
CFR 1926.1129; 29 CFR 1926.60; 29 CFR 1926.62
Legal Deadline:
None
Abstract:
The Occupational Safety and Health Administration (OSHA) proposed to
remove or revise provisions in its health standards that are out of
date, duplicative, unnecessary, or inconsistent. Where appropriate, the
Agency is primarily changing that provision to reduce the burden
imposed on the regulated community by these requirements. In this
document, substantive changes standards will revise or eliminate
duplicative, inconsistent, or unnecessary regulatory requirements
without diminishing employee protections. Phase I of this Standards
Improvement process was completed in June 1998 (63 FR 33450). OSHA
plans to initiate Phase III of this project at a future date to address
problems in various safety and health standards.
Statement of Need:
Some parts of OSHA's standards are out of date, duplicative,
unnecessary, or inconsistent. The Agency needs to periodically review
its standards and make needed corrections. This effort results in
standards that are easier for employers and employees to follow and
comply with, and thus enhances compliance and worker protection.
Summary of Legal Basis:
The legal basis for the proposed rule is a preliminary finding that the
OSHA standards need to be updated to bring them up to date, reduce
inconsistency, and remove unneeded provisions.
Alternatives:
OSHA has considered updating each standard as problems are discovered,
but has determined that it is better to make such changes to groups of
standards so it is easier for the public to comment on like standards.
OSHA has also considered the inclusion of safety standards that need to
be updated. However, the Agency has decided to pursue a separate
rulemaking for safety issues because the standards to be updated are of
interest to different stakeholders.
Anticipated Cost and Benefits:
This revision of OSHA's standards is a deregulatory action. It will
reduce employers' compliance obligations.
Risks:
The project does not address specific risks, but is intended to improve
OSHA's standards by bringing them up to date and deleting unneeded
provisions. The anticipated changes will have no negative effects on
worker safety and health.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 67 FR 66493 10/31/02
NPRM Comment Period End 12/20/02
NPRM Comment Per68 FR 1023ed 01/08/03
Second NPRM Comment Period End 01/30/03
Public Hearing 07/08/03
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB81
[[Page 72795]]
_______________________________________________________________________
DOL--Office of the Assistant Secretary for Veterans' Employment and
Training (ASVET)
-----------
PROPOSED RULE STAGE
-----------
103. UNIFORMED SERVICES EMPLOYMENT AND REEMPLOYMENT RIGHTS ACT
REGULATIONS
Priority:
Other Significant
Legal Authority:
38 USC 4331(a)
CFR Citation:
20 CFR 1002
Legal Deadline:
None
Abstract:
The Secretary's commitment to protecting the employment rights of
servicemembers as they return to the civilian work force is reflected
by the initiative to promulgate regulations implementing the Uniformed
Services Employment and Reemployment Rights Act of 1994 (USERRA) with
regard to States, local governments and private employers. USERRA
provides employment and reemployment protections for members of the
uniformed services, including veterans and members of the Reserve and
National Guard. The Department has not previously issued implementing
regulations under USERRA, although the law dates back to 1994.
Statement of Need:
The Uniformed Services Employment and Reemployment Rights Act of 1994
(USERRA), 38 U.S.C. 4301-4333, provides employment and reemployment
rights for members of the uniformed services, including veterans and
members of the Reserve and National Guard. Under USERRA, eligible
service members who leave their civilian jobs for military service are
entitled to return to reemployment with their previous employers with
the seniority, status and rate of pay they would have attained had they
not been away on duty. USERRA also assures that they will not suffer
discrimination in employment because of their military service or
obligations.
Following the attacks of September 11, 2001, the President authorized a
major mobilization of National Guard and Reserve forces that has
continued into 2004. In the past three years, the Department has
experienced a tremendous increase in the number of inquiries about
USERRA from employers and members of the Guard and Reserve. The high
volume of requests for technical assistance indicates that there is a
significant need for consistent and authoritative USERRA guidance.
USERRA regulations will provide the Department's interpretations of the
law and procedures for enforcing the law.
Summary of Legal Basis:
USERRA authorizes the Secretary of Labor, in consultation with the
Secretary of Defense, to issue regulations implementing USERRA with
regard to States, local governments and private employers. 38 U.S.C.
4331(a).
Alternatives:
In lieu of regulations, the Department could choose to continue its
compliance assistance efforts, and could issue interpretations of
USERRA in the form of a USERRA Handbook, policy memoranda or other less
formal means. These would not benefit from broad-based public input,
nor would they receive the same level of deference as regulations. See
United States v. Mead Corp., 533 U.S. 218, 230 (2001).
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 56266 09/20/04
NPRM Comment Period End 11/19/04
Final Action 06/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses, Governmental Jurisdictions, Organizations
Government Levels Affected:
Local, State
Agency Contact:
Robert Wilson
Chief, Investigation and Compliance Division
Department of Labor
Office of the Assistant Secretary for Veterans' Employment and Training
200 Constitution Avenue NW.
Room S-1316
Washington, DC 20210
Phone: 202 693-4719
Fax: 202 693-4755
RIN: 1293-AA09
BILLING CODE 4510-23-S
[[Page 72796]]
DEPARTMENT OF TRANSPORTATION (DOT)
Statement of Regulatory Priorities
The Department of Transportation (DOT) consists of nine operating
administrations, the Bureau of Transportation Statistics, and the
Office of the Secretary, each of which has statutory responsibility for
a wide range of regulations. For example, DOT regulates safety in the
aviation, motor carrier, railroad, mass transit, motor vehicle,
commercial space, and pipeline transportation areas. DOT regulates
aviation consumer and economic issues and provides financial assistance
and writes the necessary implementing rules for programs involving
highways, airports, mass transit, the maritime industry, railroads, and
motor vehicle safety. It writes regulations carrying out such disparate
statutes as the Americans with Disabilities Act and the Uniform Time
Act. Finally, DOT has responsibility for developing policies that
implement a wide range of regulations that govern internal programs
such as acquisition and grants, access for the disabled, environmental
protection, energy conservation, information technology, occupational
safety and health, property asset management, seismic safety, and the
use of aircraft and vehicles.
The Department has adopted a regulatory philosophy that applies to all
its rulemaking activities. This philosophy is articulated as follows:
DOT regulations must be clear, simple, timely, fair, reasonable, and
necessary. They will be issued only after an appropriate opportunity
for public comment, which must provide an equal chance for all affected
interests to participate, and after appropriate consultation with other
governmental entities. The Department will fully consider the comments
received. It will assess the risks addressed by the rules and their
costs and benefits, including the cumulative effects. The Department
will consider appropriate alternatives, including nonregulatory
approaches. It will also make every effort to ensure that legislation
does not impose unreasonable mandates.
An important initiative of Secretary Mineta's has been to increase the
timeliness of DOT rulemaking actions and address the large number of
old rulemakings. To implement this, the Secretary has required (1)
regular meetings of senior DOT officials to ensure effective scheduling
of rulemakings and timely decisions, (2) better tracking and
coordination of rulemakings, (3) regular reporting, (4) early briefings
of interested officials, (5) better training of staff, and (6)
necessary resource allocations. The Department has achieved significant
success as a result of this initiative with the number of old
rulemakings as well as the average time to complete rulemakings
decreasing. This is also allowing the Department to use its resources
more effectively and efficiently.
The Department's regulatory policies and procedures provide a
comprehensive internal management and review process for new and
existing regulations and ensure that the Secretary and other
appropriate appointed officials review and concur in all significant
DOT rules. DOT continually seeks to improve its regulatory process. The
Department's development of regulatory process and related training
courses for its employees; creation of an electronic, Internet-
accessible docket that can also be used to submit comments
electronically; a ``list serve'' that allows the public to sign up for
e-mail notification when the Department issues a rulemaking document;
creation of an electronic rulemaking tracking and coordination system;
the use of direct final rulemaking; and the use of regulatory
negotiation are a few examples of this.
In addition, the Department continues to engage in a wide variety of
activities to help cement the partnerships between its agencies and its
customers that will produce good results for transportation programs
and safety. The Department's agencies also have established a number of
continuing partnership mechanisms in the form of rulemaking advisory
committees.
The Department is also actively engaged in the review of existing
rules to determine whether they need to be revised or revoked. These
reviews are in accordance with section 610 of the Regulatory
Flexibility Act, the Department's regulatory policies and procedures,
and Executive Order 12866. This includes determining if the rules would
be more understandable if they are written using a plain language
approach. Appendix D to our Regulatory Agenda highlights our efforts in
this area.
Over the next year, the Department will continue its efforts to use
advances in technology to improve its rulemaking management process.
For example, the Department created an effective tracking system for
significant rulemakings to ensure that rules are either completed in a
timely manner or that delays are identified and fixed. Through this
tracking system, a monthly report is generated. To make its efforts
more transparent, the Department has made this report Internet-
accessible. By doing this, the Department is providing valuable
information concerning our rulemaking activity and is providing
information necessary for the public to evaluate the Department's
progress in meeting its commitment to completing rulemakings in a
timely manner.
The Department will continue to place great emphasis on the need to
complete high quality rulemakings by involving senior Departmental
officials in regular meetings to resolve issues expeditiously.
Office of the Secretary of Transportation (OST)
The Office of the Secretary (OST) oversees the regulatory process for
the Department. OST implements the Department's regulatory policies and
procedures and is responsible for ensuring the involvement of top
management in regulatory decisionmaking. Through the General Counsel's
office, OST is also responsible for ensuring that the Department
complies with Executive Order 12866 and other legal and policy
requirements affecting rulemaking, including new statutes and Executive
orders. Although OST's principal role concerns the review of the
Department's significant rulemakings, this office has the lead role in
the substance of projects concerning aviation economic rules and those
affecting the various elements of the Department.
OST provides guidance and training regarding compliance with
regulatory requirements and process for use by personnel throughout the
Department. OST also plays an instrumental part in the Department's
efforts to improve our economic analyses, risk assessments, and
regulatory flexibility analyses.
OST also leads and coordinates the Department's response to
Administration and congressional proposals that concern the regulatory
process. The General Counsel's Office works closely with
representatives of other agencies, the Office of Management and Budget,
the White House, and congressional staff to provide information on how
various proposals would affect the ability of the Department to perform
its safety, infrastructure, and other missions.
During fiscal year 2005, OST expects to complete work on an NPRM that
will propose accessibility requirements for vessels which involves
complex issues
[[Page 72797]]
unlike those affecting land transportation. This NPRM will propose
feasible requirements to make passenger vessels accessible to, and
usable by, individuals with disabilities.
Federal Aviation Administration (FAA)
The FAA issues regulations to provide a safe, secure, and efficient
global aviation system for civil aircraft. In an effort to make sure
their rules are concise and easy to understand, the FAA reexamined the
use of plain language in its regulations. The initial result of this
review was revisions to 14 CFR part 11, which delineates the process
for rulemaking changes. We have extended this initiative to include
plain language revisions to our regulatory documents, advisory
material, handbook guidance, and all reports and correspondence we
prepare. Other actions include:
Supporting the FAA's Safety Agenda on Safer Skies. This agenda is
based on a comprehensive review of the causes of aviation accidents and
is designed to bring about an 80 percent reduction in fatal accidents.
Projects related to controlled flight into terrain, loss of control of
an aircraft, uncontained engine failures, runway incursions, weather,
pilot decisionmaking, and cabin safety are some of the focus areas
identified that may result in rulemaking advisory and guidance
materials.
Continuing to involve the aviation community early in the regulatory
process. The Aviation Rulemaking Advisory Committee (ARAC) completed
numerous reports and recommendations, leading to the publication of
seven regulatory actions and issuance of several advisory circulars and
other guidance materials. The FAA Aging Transport Nonstructural Systems
Plan addresses concerns with potential safety issues associated with
problems that may develop in transport category airplanes systems as a
result of wear and degradation in service. One important component of
the plan is use of the Aging Transport Nonstructural Systems Rulemaking
Advisory Committee to provide a mechanism for public input to FAA
activities. The FAA will continue to receive recommendations from the
Committee in the form of regulations, guidance materials, and training
requirements supporting enhanced airworthiness for airplane systems.
Continuing to harmonize the U.S. aviation regulations with those of
other countries. The harmonization of the U.S. regulations with the
European Joint Aviation Regulations is the FAA's most comprehensive
long-term rulemaking effort. The differences worldwide in certification
standards, practice and procedures, and operating rules must be
identified and minimized to reduce the regulatory burden on the
international aviation system. The differences between the FAA
regulations and the requirements of other nations impose a heavy burden
on U.S. aircraft manufacturers and operations. Harmonization and
standardization should help the U.S. aerospace industry remain
internationally competitive. While the overall effort to achieve this
is global, it will be accomplished by many small, individual,
nonsignificant rulemaking projects. The FAA has published 41
regulations based on recommendations of ARAC that will lead to
harmonizing FAA regulations and Joint Aviation Requirements.
Continuing to recognize the needs of small entities by complying with
the Small Business Regulatory Enforcement Fairness Act and addressing
small entity concerns whenever appropriate in rulemaking documents. In
response to the Act, the FAA has established a Small Entity Contact, a
website on FAA's home page, a toll-free number, and an e-mail address
for receipt of inquiries.
Ensuring that the congressional mandates for rulemaking deadlines
established by the FAA Reauthorization Act of 1996 are met. One mandate
is the issuance of a final rule 16 months after the close of the
comment period on the proposed rule.
Top regulatory priorities for 2004-2005 include a final rule
concerning flight simulation device requirements and several rulemaking
projects known collectively as the FAA's Aging Airplane Program. The
FAA developed the Aging Airplane Program to address structural and non-
structural system safety issues that may arise as airplanes age and in
response to:
Airplanes being operated beyond their original designservice
goals;
The 1988 Aloha B737 accident; and
The Aging Airplane Safety Act of 1991.
The rulemakings included in the Aging Airplane Program are:
Enhanced Airworthiness Program for Aging Systems/FuelTank
Safety;
Development of Type Certificate and Supplemental
TypeCertificate Holder Data for the Aging Aircraft Safety
Program; and
Widespread Fatigue Damage Program.
Other related rulemakings include withdrawal of a notice of proposed
rulemaking on Corrosion Prevention and Control Program (69 FR 50350,
August 16, 2004) and taking final action on the Aging Airplane Safety
Interim Final Rule issued on December 6, 2002.
We recently performed a comprehensive review of our Aging Airplane
Program and published for public comment an overview of our findings
(69 FR 45936, July 30, 2004).
Federal Highway Administration (FHWA)
The FHWA will continue with ongoing regulatory initiatives in support
of its surface transportation programs. The FHWA will continue to
implement legislation in the least burdensome and restrictive way
possible consistent with the FHWA's mission. The FHWA will continue to
pursue regulatory reform in areas where project development can be
streamlined or accelerated, duplicative requirements can be
consolidated, recordkeeping requirements can be reduced or simplified,
and the decisionmaking authority of our State and local partners can be
increased.
Federal Motor Carrier Safety Administration (FMCSA)
FMCSA commenced operations on January 2, 2000, pursuant to the Motor
Carrier Safety Improvement Act of 1999 (MCSIA) (Public Law 106-159), as
codified at 49 U.S.C. section 113, to improve the administration of the
Federal motor carrier safety program. The agency's primary mission is
to reduce crashes, injuries, and fatalities involving large trucks and
buses. DOT set a safety goal for all its surface transportation
agencies to reduce the fatality rate by 41 percent during the period
from 1996 to 2008. FMCSA has been working to achieve a goal of reducing
the number of large truck- and bus-involved fatalities by 41 percent,
or a reduction to no more than 1.65 commercial motor vehicle (CMV)
fatalities per 100 million truck vehicle miles traveled by the end of
2008. Although any life lost in a traffic crash is too many, FMCSA will
strive to meet and exceed this safety goal. For example, regulations
relating to performance standards for vehicles, drivers, and motor
carriers will help achieve this goal. In MCSIA, Congress put special
emphasis on the importance of timely rulemaking as a way to achieve
reductions in the number and severity of large truck-involved crashes.
FMCSA continues to develop a more effective and efficient regulatory
program to meet the expectations of
[[Page 72798]]
Congress, its stakeholders and partners, and the general public. To
improve both the quality and timeliness of the agency's rulemakings,
FMCSA established a rulemaking process for the development of its motor
carrier safety regulations and updates it periodically.
In fiscal year 2004, FMCSA completed four final rules pursuant to the
settlement agreement entered into by the parties and the court's order
In re Citizens for Reliable and Safe Highways, et al., No. 02-1363
(D.C. Cir.) (February 21, 2003): Safety Performance History of New
Drivers (69 FR 16684, 03/30/2004); Minimum Training Requirements for
Longer Combination Vehicle (LCV) Operators and LCV Driver-Instructor
Requirements (69 FR 16722, 03/30/2004); Minimum Training Requirements
for Entry-Level Commercial Motor Vehicle Operators (69 FR 29384, 05/21/
2004); and Hazardous Materials Safety Permits (69 FR 39350, 06/30/
2004). FMCSA also published implementing procedures covering its
obligations under the National Environmental Policy Act (69 FR 9680,
03/01/2004).
On September 30, Congress passed and the President signed HR 5183, an
extension of the surface transportation program authorizations which
addressed the Hours of Service (HOS) rule announced by FMCSA in April
2003. The action by Congress means the new hours-of-service rule stays
in effect and will be enforced until September 30, 2005, or until such
earlier time as FMCSA issues a revised rule addressing the concerns of
the U.S. Court of Appeals for the District of Columbia Circuit stated
in Public Citizen et al. v. FMCSA. FMCSA has issued an ANPRM on
Electronic On-Board Recorders (EOBRs) under RIN 2126-AA89 as part of
its efforts to meet the concerns of the Court.
As one of its priorities in fiscal year 2005, FMCSA has announced that
it is holding a series of Public Listening Sessions as part of a
Comprehensive Safety Analysis 2010 Initiative (CSA-2010). The listening
sessions will be used to ask motor carriers, insurance and safety
advocacy groups, traffic enforcement professionals, commercial drivers
and the public for their views on the ideal ways to measure the safety
of truck and bus operations (69 FR 51748, 08/20/2004). Based on the
information from the listening sessions, FMCSA hopes to redesign and
improve the way FMCSA conducts compliance and enforcement operations,
and to help in its goal of decreasing CMV fatalities to no more than
1.65 per 100 million miles by the end of 2008.
Other FMCSA priorities in 2005 are a rulemaking that involves
combining the medical certification with the commercial driver's
license (the last remaining MCSIA initiative); rulemakings directed at
strengthening our enforcement activities; and a number of rulemakings
related to operational safety.
National Highway Traffic Safety Administration (NHTSA)
The statutory responsibilities of the National Highway Traffic Safety
Administration (NHTSA) relating to motor vehicles include reducing the
number of, and mitigating the effects of, motor vehicle crashes and
related fatalities and injuries; providing safety performance
information to aid prospective purchasers of vehicles, child
restraints, and tires; and improving automotive fuel efficiency. NHTSA
pursues policies that encourage the development of nonregulatory
approaches when feasible in meeting its statutory mandates. It issues
new standards and regulations or amendments to existing standards and
regulations when appropriate. It ensures that regulatory alternatives
reflect a careful assessment of the problem, consideration of
international standards and harmonization objectives, and a
comprehensive analysis of the benefits, costs, and other impacts
associated with the proposed regulatory action. Finally, it considers
alternatives consistent with the Administration's regulatory
principles.
In the coming year, occupant protection in rear-end crashes will be
improved as a result of a final rule to require more effective head
restraints. Rear seat occupants, especially children, will be better
protected in crashes because of a final rule to require rear center
lap/shoulder belts. NHTSA will propose to alert vehicle owners by a new
Tire Pressure Monitoring System in cars and light trucks when the
vehicle's tires are significantly underinflated. The agency will take
final action on this proposal before September 30, 2005.
In addition to numerous programs that focus on the safe performance of
motor vehicles, the Agency is engaged in a variety of programs to
improve driver and occupant behavior. These programs emphasize the
human aspects of motor vehicle safety and recognize the important role
of the States in this common pursuit. NHTSA has identified two high
priority areas, safety belt use and impaired driving. In 2003, it
released a report analyzing safety belt use problems and describing
actions to address them. A separate report analyzed and described
actions to address the problem of impaired driving. To address this
problem, the Agency is focusing especially on three strategies --
conducting highly visible, well publicized enforcement; supporting
prosecutors who handle impaired driving cases and expanding the use of
DWI/Drug Courts, which hold offenders accountable for receiving and
completing treatment for alcohol abuse and dependency; and the adoption
of alcohol screening and brief intervention by medical and health care
professionals. Other behavioral efforts encourage child safety-seat
use, combat excessive speed and aggressive driving, improve motorcycle,
bicycle, and pedestrian safety, and provide consumer information to the
public.
Federal Railroad Administration (FRA)
The Federal Railroad Administration (FRA) exercises
regulatoryauthority over all areas of railroad safety. Fashioning
regulations that have favorable benefit-to-cost ratios and that, where
feasible, incorporate flexible performance standards, requires
cooperative action by all affected parties. In order to foster an
environment of collaborative rulemaking, FRA established the Railroad
Safety Advisory Committee (RSAC). The purpose of the RSAC is to develop
consensus recommendations for regulatory action on issues referred to
it by FRA. Where consensus is achieved, and FRA believes the consensus
recommendations serve the public interest, the resulting rule is very
likely to be better understood, more widely accepted, more cost-
beneficial, and more correctly applied. Where consensus cannot be
achieved, however, FRA will fulfill its regulatory role without the
benefit of the RSAC's recommendations. The RSAC has met regularly and
currently has working groups actively addressing the following tasks:
(1) The development of safety standards for locomotive crashworthiness;
(2) the development of safety standards for locomotive working
conditions, including occupational noise exposure; and (3) the
development of accident survivability standards for locomotive event
recorders. FRA is also completing a rulemaking based on the RSAC's
recommendations entitled ``Performance Standards for Processor-Based
Signal and Train Control Systems.'' Further, at FRA's request the RSAC
is conducting a preliminary exploration of further opportunities for
improvement of the safety of rail
[[Page 72799]]
passenger service that might lead to recommendations for public or
private actions.
One of the top priorities of FRA for 2004-2005 is a final rule
concerning whistle bans at highway-rail grade crossings.
Federal Transit Administration (FTA)
The Federal Transit Administration (FTA) provides financial assistance
to State and local governments for mass transportation purposes. The
regulatory activity of FTA focuses on establishing the terms and
conditions of Federal financial assistance available under the Federal
transit laws.
FTA's policy regarding regulations is to:
Implement statutory authorities in ways that provide the
maximum net benefits to society;
Keep paperwork requirements to a minimum;
Allow for as much local flexibility and discretion as is
possible within the law;
Ensure the most productive use of limited Federal resources;
Protect the Federal interest in local investments; and
Incorporate good management principles into the grant
management process.
As mass transportation needs have changed over the years, so have the
requirements for Federal financial assistance under the Federal transit
laws and related statutes. FTA's regulatory priorities for 2004-2005
are to continue to amend existing regulations as necessary and
appropriate, with an eye towards reauthorization of the Federal transit
programs in the near future, which may require several significant
rulemakings thereafter.
Maritime Administration (MARAD)
MARAD administers Federal laws and programs designed to promote and
maintain a U.S. merchant marine capable of meeting the Nation's
shipping needs for both national security and domestic and foreign
commerce.
MARAD's regulatory objectives and priorities reflect the Agency's
responsibility of ensuring the availability of adequate and efficient
water transportation services for American shippers and consumers. To
advance these objectives, MARAD issues regulations, which are
principally administrative and interpretive in nature, when
appropriate, in order to provide a net benefit to the U.S. maritime
industry.
MARAD's regulatory priorities are to update existing regulations and
to reduce unnecessary burden on the public.
Research and Special Programs Administration (RSPA)
The Research and Special Programs Administration (RSPA) has
responsibility for rulemaking under two programs. Through the Associate
Administrator for Hazardous Materials Safety, RSPA administers
regulatory programs under Federal hazardous materials transportation
law and the Federal Water Pollution Control Act, as amended by the Oil
Pollution Act of 1990. Through the Associate Administrator for Pipeline
Safety, RSPA administers regulatory programs under the Federal pipeline
safety laws and the Federal Water Pollution Control Act, as amended by
the Oil Pollution Act of 1990.
In the area of hazardous materials transportation, the regulatory
priority is to clarify through rulemaking the applicability of
regulations to the loading, unloading, and storage of hazardous
materials incidental to their movement in commerce. Clarifying the
applicability of the regulations will facilitate compliance with them
and also clarify when other requirements of Federal, State, local, and
tribal governments apply.
Bureau of Transportation Statistics (BTS)
The Bureau of Transportation Statistics (BTS) is responsible for
collecting, compiling, analyzing, and making accessible information on
the Nation's transportation systems; identifying needs for new
information and analysis and implementing programs to meet those needs;
and enhancing the quality and effectiveness of the Department's
statistical programs through the development of guidelines,
coordination with related information-gathering activities conducted by
other Federal agencies, and promotion of improvements in data
acquisition, archiving, dissemination, and use.
BTS's Office of Airline Information (OAI) collects airline financial
and operating statistical data, covering both passenger and cargo
traffic. This information gives the Government consistent and
comprehensive economic and market data on individual airline operations
and is used, for instance, in supporting policy initiatives,
negotiating international bilateral aviation agreements, awarding
international route authorities, and meeting international treaty
obligations. The aviation, travel, and tourism communities value this
information for a variety of purposes, such as conducting analyses of
on-time performance, denied boardings, market trends, and economic
analyses.
Saint Lawrence Seaway Development Corporation (SLSDC)
The Saint Lawrence Seaway Development Corporation (SLSDC) is a wholly
owned Government corporation created by Congress in 1954. The primary
operating service of the SLSDC is to ensure the safe transit of
commercial and noncommercial vessels through the two U.S. locks and
navigation channels of the Saint Lawrence Seaway System. The SLSDC
works jointly with its Canadian counterpart to operate and maintain
this deep draft waterway between the Great Lakes and the Atlantic
Ocean. The SLSDC also works jointly with its Canadian counterpart on
all matters related to rules and regulations, overall operations,
vessel inspection, traffic control, navigation aids, safety, operating
dates, and trade development programs.
The regulatory priority of the SLSDC is to provide its customers with
the safest, most reliable, and most efficient Seaway System possible.
_______________________________________________________________________
DOT--Federal Aviation Administration (FAA)
-----------
PROPOSED RULE STAGE
-----------
104. [rplus]AGING AIRCRAFT PROGRAM (WIDESPREAD FATIGUE DAMAGE)
Priority:
Other Significant
Legal Authority:
49 USC 106(g); 49 USC 40113; 49 USC 40119; 49 USC 41706; . . .
CFR Citation:
14 CFR 121; 14 CFR 129
Legal Deadline:
None
Abstract:
The FAA proposes to require incorporation of a program to preclude
widespread fatigue damage into the FAA-approved maintenance program of
[[Page 72800]]
each operator of large transport category airplanes. This action is the
result of concern for the continued operational safety of airplanes
that are approaching or have exceeded their design service goal. This
proposed rulemaking would require a limit of validity in flight cycles
or hours of the structural maintenance program, where the operator must
incorporate added inspections and/or modification/replacement actions
into its maintenance program to allow continued operation.
Statement of Need:
History has shown that widespread fatigue damage is a significant
safety risk for transport category airplanes. The Aloha B-737 accident
in 1988 showed FAA and industry that WFD could be a problem that could
lead to catastrophic failure of airplane structure. Numerous widespread
fatigue damage incidents since then have confirmed that it is a threat
common to all aging airplanes. Because widespread fatigue damage
results from the interaction of many small cracks, existing inspection
methods are inadequate to reliably detect and prevent it.
Summary of Legal Basis:
Section 44701, Title 49 of the United States Code states that the
Administrator shall promote safety of flight of civil aircraft in air
commerce by prescribing minimum standards required in the interest of
safety.
Alternatives:
The FAA acknowledges the proposed rule may have a significant impact on
a substantial number of small entities. We conclude the current
proposal is the preferred alternative because it provides for a common
WFD system for all operators who fly in the same airspace under the
same operating environment.
We considered the following alternatives:
1.Exclude small entities
2.Extend the compliance deadline for small entities
3.Establish lesser technical requirements for small entities
4.Expand the requirements to cover more airplanes
Anticipated Cost and Benefits:
The cost of this proposal is $358.1 million. The benefits of this
proposal consist of $654 million in accident prevention benefits and
$74 million in detection benefits, for total benefits of $728 million.
Risks:
Because widespread fatigue damage problems will occur as airplanes
operate beyond their initial operational limit, operators are likely to
detect such problems over the 20-year forecast period. The FAA has
assumed that there is a probability of widespread fatigue damage
problems occurring for each fuselage type of five percent in each year.
Under this assumption, there is a 35 percent chance that there will be
zero WFD problems detected for a particular fuselage type over a 20-
year period.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 05/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Brent Bandley
Department of Transportation
Federal Aviation Administration
3960 Paramount Boulevard
Lakewood, CA 90712
Phone: 562 627-5237
RIN: 2120-AI05
_______________________________________________________________________
DOT--FAA
105. [rplus]ENHANCED AIRWORTHINESS PROGRAM FOR AIRPLANE SYSTEMS (EAPAS)
AND SFAR 88
Priority:
Other Significant
Legal Authority:
49 USC 106(g); 49 USC 1155; 49 USC 1372; 49 USC 40103; 49 USC 40119; 49
usc 40120; 49 USC 106(g); 49 USC 40103; 49 USC 40113; 49 USC 40119 to
40120; 49 USC 41706; 49 USC 4401; 49 USC 44111; 49 USC 44701 to 44705;
49 USC 44709 to 44713; 49 USC 44715 to 44717
CFR Citation:
14 CFR 1; 14 CFR 25; 14 CFR 91; 14 CFR 121; 14 CFR 125; 14 CFR 129; 14
CFR 1; 14 CFR 121; 14 CFR 129; 14 CFR 25; 14 CFR 91
Legal Deadline:
None
Abstract:
This rulemaking would change wiring system and fuel tank system
requirements for transport category airplanes. It would organize and
clarify design requirements for wire systems by moving existing
regulatory references to wiring into a single section of the
regulations specifically for wiring and adding new certification rules
to address aging issues in wire systems. This rulemaking would require
holders of type certificates for certain transport category airplanes
to conduct analyses and make necessary changes to existing Instruction
for Continued Airworthiness (ICA) to improve maintenance procedures for
wire systems. It would require operators to incorporate those ICA for
wiring into their maintenance or inspections programs. It would also
clairfy requirements of certain existing operational rules for
operators to incorporate ICA for fuel tank systems into their
maintenance or inspection programs. The intent of this rule is to help
ensure the continued safety of commercial airplanes by improving the
design, installation, and maintenance of their electrical wiring
systems as well as by aligning those requirements as closely as
possible with the requirements for fuel tank system safety.
Statement of Need:
The proposal will address a continuing history of wire-related
failures, resulting in smoke in the cabin/flight deck, fires, arcing
etc. Current maintenance practices have not been adequate to address
issues of aging and degradation in wiring. Wires have not been viewed
as important systems on their own.
Summary of Legal Basis:
Section 44701, title 49 of the United States Code states that the
Administrator shall promote safety of flight of civil aircraft in air
commerce by prescribing minimum standards required in the interest of
safety.
Alternatives:
1. Require operators to clean and inspect each airplane every C-check
or every three years, causing an additional
[[Page 72801]]
$192.5 million in cleaning and inspection costs, and an additional
$104.0 million in downtime. This option would result in additional
costs of $296.5 million with no commensurate increase in benefits.
2. Require electrical wiring interconnection systems training for four
new groups of people (electrical/avionic engineers, individuals
involved in engineering or planning work, flight deck crew, and cabin
crew) in addition to maintenance workers. Training these individuals
would require that operators develop additional courses. The total
estimated additional cost of this alternative is approximately $381.1
million with no commensurate increase in benefits.
3. We also considered voluntary compliance with the intent of this
proposal by the affected parties. Some in industry have suggested
issuing advisory circulars to give guidance on changes that need to be
made. However, previous voluntary safety assessments have been
difficult to complete in a timely manner because they lack
enforceability. Similarly, issuance of guidance material would depend
on voluntary compliance, and would not be enforceable.
Anticipated Cost and Benefits:
Total costs are estimated at $474.3 million ($209.2 million in present
value) over 25 years. Total benefits are estimated at $755.3 million
($340.7 million in present value) over 25 years.
Risks:
The FAA estimates there may be more than 1.2 fatal events caused by
electrical wiring interconnection systems (EWIS) over a 25-year period.
The Poisson distribution provides a measure for this risk. Based on a
mean value of 1.2 fatal EWIS events, there is a 70 percent chance there
will be 1 or more occurrences of a fatal EWIS event, a 34 percent
chance there will be 2 or more fatal EWIS events; and a 12 percent
chance of 3 or more occurrences of fatal EWIS events.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Frederick Sobeck
Aircraft Maintenance Division, Flight Standards Service
Department of Transportation
Federal Aviation Administration
800 Independence Avenue SW.
Washington, DC 20591
Phone: 202 267-7355
Fax: 202 267-7335
Email: frederick.sobeck@faa.gov
Stephen M. Slotte
Aircraft Certification Service
Department of Transportation
Federal Aviation Administration
1601 Lind Avenue SW.
Renton, WA 98055-2315
Phone: 425 227-2315
Fax: 425 227-1320
Email: steve.slotte@faa.gov
RIN: 2120-AI31
_______________________________________________________________________
DOT--FAA
106. [rplus]AGING AIRCRAFT SAFETY--DEVELOPMENT OF TC AND STC HOLDER
DATA
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect State, local or tribal governments and the
private sector.
Legal Authority:
49 USC 106(g); 49 USC 40113; 49 USC 44701; 49 USC 44702; 49 USC 44704
CFR Citation:
14 CFR 25
Legal Deadline:
None
Abstract:
This rulemaking would require type certificate holders and supplemental
type certificate holders of certain transport category airplanes to
develop data to support damage-tolerance-based inspections and
procedures for their airplanes' baseline structure, including repairs,
alterations and modifications to the baseline structure. It would also
help ensure that maintenance of the airplanes age sensitive parts and
components have been adequate and timely. These actions are needed to
assure that 14 CFR part 121 certificate holders have the necessary data
to comply with the damage tolerance requirements of the Aging Airplane
Safety rule.
Statement of Need:
In several recent rules the FAA has adopted operational requirements
without a corresponding requirement for design approval holders to
develop and provide the necessary data and documents to support
operator compliance. The difficulty encountered by operators in
complying with these rules has convinced us that corresponding design
approval holder requirements are necessary to enable operators to
comply by the regulatory deadlines.
Summary of Legal Basis:
Section 44704, title 49 of the United States Code states that the
Administrator shall promote safety of flight of civil aircraft in air
commerce by prescribing minimum standards required in the interest of
safety.
Alternatives:
Issuance of guidance material would depend on voluntary compliance, and
would not be enforceable.
Anticipated Cost and Benefits:
Not yet determined.
Risks:
Without a regulatory requirement imposed on design approval holders,
operators would have to rely on voluntary compliance by design approval
holders to provide data operators needed to comply with the regulatory
requirement to develop damage tolerance programs required by the Aging
Airplane Safety rule.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 09/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Federal, Local, State
Federalism:
This action may have federalism implications as defined in EO 13132.
URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
[[Page 72802]]
Agency Contact:
Greg Schneider
Department of Transportation
Federal Aviation Administration
1601 Lind Avenue SW
Renton, WA 98055
Phone: 425 227-2116
Fax: 425-227-1181
Email: greg.schneider@faa.gov
RIN: 2120-AI32
_______________________________________________________________________
DOT--FAA
-----------
FINAL RULE STAGE
-----------
107. [rplus]FLIGHT SIMULATION DEVICE QUALIFICATION (SECTION 610 REVIEW)
Priority:
Other Significant
Legal Authority:
49 USC 106(g); 49 USC 40113; 49 USC 44701 to 44703; 49 USC 44707; 49
USC 44709; 49 USC 44711; 49 USC 45102 to 45103; 49 USC 45301 to 45302
CFR Citation:
14 CFR 1; 14 CFR 11; 14 CFR 60; 14 CFR 61; 14 CFR 63; 14 CFR 141; 14
CFR 142
Legal Deadline:
None
Abstract:
This action will amend the regulations establishing flight simulation
device qualification requirements for all certificate holders in a new
part. The basis of these requirements currently exists in different
parts of the FAA's regulation and in advisory circulars. The proposed
changes would consolidate and update flight simulation device
requirements.
Statement of Need:
It is important to consolidate and update flight simulation device
requirements to ensure that users of flight simulation devices receive
the best possible training in devices that closely match the
performance and handling characteristics of the aircraft being
simulated.
Summary of Legal Basis:
Section 44701, title 49 of the United States Code states that the
Administrator shall promote safety of flight of civil aircraft in air
commerce by prescribing minimum standards required in the interest of
safety.
Alternatives:
The FAA chartered an Aviation Rulemaking Committee to develop
alternative rule language to Notice No. 02-11.
Anticipated Cost and Benefits:
The FAA has placed a Draft Regulatory Evaluation of the NPRM in the
docket.
Risks:
The purpose of this rulemaking is to ensure that users of flight
simulation devices receive the best possible training in devices that
closely match the performance and handling characteristics of the
aircraft being simulated.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 67 FR 20284 09/25/02
NPRM Comment Per67 FR 69149d 11/15/02
Notice of On-Lin67 FR 70184rum 11/21/02
NPRM Comment Period End 12/24/02
NPRM Extended Comment Period End 02/24/03
Final Action 06/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Edward Cook
Flight Standards Service
Department of Transportation
Federal Aviation Administration
100 Hartsfield Centre Parkway
Suite 400
Atlanta, GA 30354
Phone: 404 832-4700
RIN: 2120-AH07
_______________________________________________________________________
DOT--FAA
108. [rplus]TRANSPORT AIRPLANE FUEL TANK FLAMMABILITY REDUCTION
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect State, local or tribal governments and the
private sector.
Legal Authority:
49 USC 106(g); 49 USC 40113; 49 USC 44701-44702; 49 USC 44704
CFR Citation:
14 CFR 25
Legal Deadline:
None
Abstract:
This rulemaking will require that flammability reduction means be
incorporated into existing airplanes, newly manufactured airplanes, and
new designs. It proposes new design standards for future and pending
applications for type certification as well as new operating rules for
retrofitting existing airplanes.
Statement of Need:
There have been four accidents caused by fuel tank explosions since
1989. Two occurred during flight and two others occurred on the ground.
Terrorists caused one of the four. In the other three cases, no
ignition source was identified as the cause of the explosion. In all
four cases, however, investigators concluded that the center wing fuel
tank in these airplanes contained flammable vapors when the fuel tanks
exploded and the accidents occurred.
Summary of Legal Basis:
Section 44701, title 49 of the United States Code states that the
Administrator shall promote safety of flight of civil aircraft in air
commerce by prescribing minimum standards required in the interest of
safety.
Alternatives:
1. Require flammability reduction means on new production and new
designs without requiring retrofit. The risk analysis for this option
predicted an unacceptable high number of future accidents due to the
high number of airplanes within the current fleet that would remain in
service for many years.
2. Require inerting of all fuel tanks on existing airplanes in the
fleet and new type designs.
3. Exclude all cargo operators.
4. Address unsafe condition through airworthiness directive.
[[Page 72803]]
5. Impose changes on operators as opposed to requiring OEMs to develop
design changes.
Past experience on similar safety initiatives shows the OEMs do not
consistently support these effors and places in undue burden on the
operators.
Anticipated Cost and Benefits:
The FAA is conducting a regulatory evaluation using various
combinations of the value of a human life, the timing of the next
accidents, the passenger load on the next accident airplane, and the
effectiveness of SFAR 88. We anticipate costs and benefits will vary
based upon assumptions used in calculating these values. Using a value
of 3 million per life, average airplane size, average time for the next
accident, the costs could exceed $1 billion and quantitative benefits
will be less than $1 billion.
Risks:
The FAA believes at least one and as many as five accidents will happen
in the next 50 years.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, Local, State
Federalism:
This action may have federalism implications as defined in EO 13132.
URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Mike Dostert
Transport Airplane Directorate, Aircraft Certification Service
Department of Transportation
Federal Aviation Administration
Northwest Mountain Region
1601 Lind Avenue SW
Renton, WA 98055-4056
Phone: 425 227-2132
Fax: 425-227-1320
Email: mike.dostert@faa.gov
RIN: 2120-AI23
_______________________________________________________________________
DOT--Federal Motor Carrier Safety Administration (FMCSA)
-----------
PROPOSED RULE STAGE
-----------
109. [rplus]UNIFIED REGISTRATION SYSTEM
Priority:
Other Significant
Legal Authority:
PL 104-88; 109 Stat. 803, 888 (1995); 49 USC 13908
CFR Citation:
49 CFR 360, 365, 366, 368, 387, and 390
Legal Deadline:
Final, Statutory, January 1, 1998.
Abstract:
This action proposes replacing three current identification and
registration systems--USDOT identification number system, registration/
licensing system, and financial responsibility system--with a unified
registration system. It will consolidate and simplify current Federal
registration processes and increase public accessibility to data about
interstate and foreign motor carriers, property brokers, and freight
forwarders. In addition, the agency invites comments on how it might
replace a fourth system--single-State registration system--in a manner
consistent with conditions imposed by statute.
Statement of Need:
As a result of the ICC Termination Act of 1995 [Public Law 104-88,
December 29, 1995, 109 Stat. 888] (ICCTA), Congress terminated the
Interstate Commerce Commission and transferred its functions concerning
licensing and financial responsibility requirements to the DOT.
Congress mandated that the agency consider unifying the four current
systems with a single, on-line Federal system.
Summary of Legal Basis:
The ICCTA created a new 49 U.S.C. 13908 directing ``[t]he Secretary, in
cooperation with the States, and after notice and opportunity for
public comment,'' . . . to ``issue regulations to replace the current
DOT identification number system, the single State registration system
under section 14504, the registration system contained in this chapter,
and the financial responsibility information system under section 13906
with a single, on-line, Federal system.''
Alternatives:
FMCSA considered several alternatives to the proposal discussed here,
in an effort to minimize the potential new filing burden on small
entities. For instance, we considered exempting existing carriers from
certain new filing requirements (via a grandfather clause), with the
idea that it would minimize the compliance costs of this proposal.
However, while reducing compliance costs (and thereby improving filing
efficiency), it would also have reduced, not enhanced, the fairness of
the motor carrier registration process relative to the status quo by
placing higher burdens on new entrants than existing carriers. As such,
it would have acted as a barrier to entry to small new entrants to the
benefit of existing carriers.
Conversely, we also considered exempting new entrants from these
requirements, but dismissed this on the grounds that it too would have
reduced the fairness of the registration process. Additionally, either
option would have reduced safety relative to the proposal discussed
here. Exempting new entrants from various requirements would not have
assisted small entities over larger ones, given that the composition of
the new entrant carrier universe is similar to that of the overall
existing population (namely, 80 percent have six or fewer power units).
The agency also considered removing the process agent designation
filing requirement on the grounds that it was the most costly of the
initiatives in this proposal. However, the agency dismissed this option
because FMCSA division administrators felt that this particular filing
requirement had the best potential to increase industry safety by
improving the productivity of the agency's safety investigators
(thereby allowing them to initiate additional compliance reviews).
Additionally, the process agent designation filing requirement also
enhances the fairness of the agency's registration process.
Anticipated Cost and Benefits:
The regulatory evaluation for the NPRM will be placed in the docket.
Risks:
FMCSA will decide if a risk assessment is necessary.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 61 FR 43816 08/26/96
[[Page 72804]]
ANPRM Comment Period End 10/25/96
NPRM 02/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, State
Additional Information:
Docket No. FMCSA-97-2349.
URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Valerie Height
Transportation Specialist
Department of Transportation
Federal Motor Carrier Safety Administration
MC-PRR
Office of Policy Plans and Regulation (MC-PRR)
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-0901
RIN: 2126-AA22
_______________________________________________________________________
DOT--FMCSA
110. [rplus]HOURS OF SERVICE OF DRIVERS; SUPPORTING DOCUMENTS
Priority:
Other Significant
Legal Authority:
PL 103-311, sec 113; 108 Stat. 1673, 1676 (1994); 49 USC 504; 49 USC
14122, 31133, 31136, and 31502
CFR Citation:
49 CFR 385, 390, and 395
Legal Deadline:
Final, Statutory, February 1996.
Abstract:
This rulemaking would amend the hours-of-service recordkeeping
requirements to clarify what supporting documents motor carriers must
have to validate hours of service records. It will clarify: That the
duty of motor carriers is to verify the accuracy of drivers' hours of
service (HOS) and records of duty status (RODS) if including automatic
on-board records; that the driver's duty is to collect and submit to
the motor carrier all supporting documents with the RODS; that carriers
are required to maintain supporting documents with the RODS; and that a
supporting document based on a self-monitoring system is required to be
the primary method for ensuring compliance with the HOS regulations. It
would allow the use of electronic documents as a supplement to, and in
certain instances in lieu of, paper supporting documents in recognition
of developing technologies. It would clarify the definitions of
``supporting documents,'' ``employee,'' and ``driver,'' and the current
requirement that each motor carrier use a self-monitoring system to
verify HOS and RODS.
Statement of Need:
In order for the motor carriers to ensure that drivers are alert and
not fatigued, carriers must maintain self-monitoring systems that
compare records of duty status (RODS) to supporting documents. The
Federal Highway Administration (FHWA) as part of its regulatory
oversight to assist motor carriers in operating safely decided to adopt
this practice of maintaining ``RODS supporting documents.'' On November
26, 1982, FHWA published a final rule which, in part, required motor
carriers operating in interstate commerce to retain supporting
documents, along with drivers' RODS, for at least six months from the
date of receipt (47 FR 53383). 49 CFR 395.8(k). However, FHWA did not
define the term ``supporting document'' in that final rule.
Summary of Legal Basis:
FMCSA is authorized, by 49 U.S.C. 504(c), to inspect and copy any
record of a carrier, lessor, or association and to inspect the
equipment of a carrier, or lessor, or other person controlling,
controlled by, or under common control with a carrier, as long as these
actions were made in furtherance of an investigation and regardless of
whether or not the records were required to be maintained by FMCSA
regultions or orders.
This rulemaking is required by sec. 113 (Driver's Record of Duty
Status) of the Hazardous Materials Transportation Authorization Act of
1994, Pub. L. 103-311, August 26, 1994, 108 Stat. 1673, at 1676.
Section 113 assumes the existence of FMCSA's more general authority to
regulate the HOS of commercial motor vehicle drivers and related
matters. That authority is conferred by the Motor Carrier Act of 1935,
now codified at 49 U.S.C. 31502(b), and the Motor Carrier Safety Act of
1984, 49 U.S.C. 31136(a).
More specifically, sec. 113(b)(2) requires specifying the number and
kind of supporting documents that must be retained by a motor carrier.
Section 113(b)(3) requires a regulatory provision specifying how long a
motor carrier must maintain HOS records. Section 113(b)(4) requires a
provision authorizing motor carriers (individually or in groups), on a
case-by-case basis, to use ``self-compliance systems'' that ensure
driver compliance with the HOS rules and allow enforcement officers to
audit those systems to validate compliance.
Alternatives:
Reducing the length of records retention would reduce costs, but only
slightly. Short retention periods would restrict the investigator's
ability to identify patterns that indicate unsafe practices. The SNPRM
will solicit comments on alternatives the public may want to offer.
Anticipated Cost and Benefits:
The regulatory evaluation for the SNPRM will be placed in the docket.
Risks:
FMCSA will decide if a risk assessment is necessary.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 63 FR 19457 04/20/98
NPRM Comment Period End 06/19/98
Supplemental NPR69 FR 63997 11/03/04
Supplemental NPRM Comment Period End 01/03/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Additional Information:
Docket No. FMCSA-98-3706.
URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
[[Page 72805]]
Agency Contact:
Jerry Fulnecky
Department of Transportation
Federal Motor Carrier Safety Administration
MC-EC
Office of Enforcement and Compliance
400 Seventh Street, SW.
Washington, DC 20590
Phone: 202 366-2096
Related RIN: Split from 2126-AA23
RIN: 2126-AA76
_______________________________________________________________________
DOT--National Highway Traffic Safety Administration (NHTSA)
-----------
PROPOSED RULE STAGE
-----------
111. [rplus]TIRE PRESSURE MONITORING SYSTEMS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
49 USC 322; 49 USC 30111; 49 USC 30115; 49 USC 30117; . . .
CFR Citation:
49 CFR 571.138; 49 CFR 571.101
Legal Deadline:
None
Abstract:
The Transportation Recall Enhancement Accountability and Documentation
(TREAD) Act required the Secretary of Transportation to initiate
rulemaking to require a warning system in new motor vehicles to
indicate to the operator when a tire is significantly under-inflated.
The agency issued a final rule for tire pressure monitoring systems
(TPMS)(establishing FMVSS No. 138) on June 5, 2002; however, the final
rule establishing the standard was vacated by a decision issued by the
U.S. Court of Appeals for the Second Circuit in August 2003.
The agency will take action in accordance with the Administrative
Procedures Act to re-establish FMVSS No. 138, in a manner consistent
with the court's decision, and also provide a new phase-in period.
Statement of Need:
The TPMS rulemaking is one of the rulemakings mandated by the
Transportation Recall Enhancement Accountability and Documentation Act
of 2000. To prevent vehicles from being driven on under-inflated tires,
Congress mandated the installation of tire pressure monitoring systems
that will warn drivers when one or more tires, up to a total of 4, are
under-inflated. Under-inflation can lead to over-heating of the tires
and sudden tire failures (blowouts and tread separations).
Summary of Legal Basis:
49 USC 322, 49 USC 30111, 49 USC 30115, 49 USC 30117, and 49 USC 30166
provide the legal basis.
Alternatives:
Potential alternatives to the TPMS rulemaking proposed by the agency
include:
No rulemaking to require that drivers be warned when a tire(s)
is significantly under-inflated (NB: this alternative is not permitted
under the TREAD Act); and
Variations of the proposed TPMS performance requirements
(especially the threshold level of under-inflation the triggers a
warning to the driver) and test procedures.
Anticipated Cost and Benefits:
The agency estimates that the TPMS rule will prevent approximately 120
fatalities annually, and prevent or reduce in severity approximately
8,400 injuries. The TPMS rule will also provide economic benefits by
reducing tire tread wear, improving vehicle fuel economy, and reducing
property damage when collisions do occur.
The agency estimates the total net cost per vehicle for the TPMS to be
between $26.00 and $100.00.
Risks:
There is a potential risk that some drivers might rely on TPMS and not
check the pressure in their tires on a regular basis. To guard against
that possibility, the agency has proposed requiring vehicle
manufacturers to include in their vehicle owner's manuals a statement
emphasizing the need for motorists to check tire pressure monthly, and
explaining the consequences of not doing so.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 55896 09/16/04
NPRM Comment Period End 11/15/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Federalism:
This action may have federalism implications as defined in EO 13132.
URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Samuel Daniel
General Engineer Office of Crash Avoidance Stds.
Department of Transportation
National Highway Traffic Safety Administration
NVS-122
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4921
RIN: 2127-AJ23
_______________________________________________________________________
DOT--Federal Railroad Administration (FRA)
-----------
FINAL RULE STAGE
-----------
112. [rplus]WHISTLE BANS AT HIGHWAY-RAIL GRADE CROSSINGS
Priority:
Other Significant
Legal Authority:
49 USC 20153
CFR Citation:
49 CFR 222
Legal Deadline:
Final, Statutory, November 2, 1996, subsequent enactment prohibited
issuance prior to July 1, 2001.
Abstract:
This action would govern when train whistles at public grade crossings
must be sounded. FRA has found that failing to use the locomotive horn
can significantly increase the number of collisions with motorists
using the crossing. This action is considered significant because of
substantial public interest. This action is being taken
[[Page 72806]]
pursuant to statutory mandate. Pub. Law 103-440 requires the Secretary
to prohibit local whistle bans, except where there is no significant
risk of accidents, alternative safety measures are adequate, or where
use of a horn as a warning is impractical. After publishing an NPRM,
FRA participated in extensive public hearings to gather comments and
issued an interim final rule to implement the statute.
Statement of Need:
This rule is required by Public Law 103-440. The Act requires the use
of locomotive horns at every public highway-rail grade crossing but
gives FRA the authority to make reasonable exceptions. Studies have
shown that highway-rail grade crossing accidents increase 67 percent at
gated crossings where whistle bans are in effect. Congress amended this
law in 1996 to require that FRA take into account the interest of the
communities with pre-existing restrictions on locomotive horns. In
2000, Congress prohibited FRA from issuing a rule before July 1, 2001.
Summary of Legal Basis:
Issuance of this rule is required by 49 USC 20153.
Alternatives:
There was no alternative to initiating this rulemaking, as it is
required by statute. However, the rule would provide a list of
supplementary measures that FRA has determined to be effective
substitutes for the locomotive horn in the prevention of highway-rail
grade crossing casualties. The rule would also allow for whistle bans
if there are alternative safety measures that compensate for the lack
of a locomotive horn.
Anticipated Cost and Benefits:
The problems considered by this rule are collisions and their
associated casualties and property damage involving vehicles on public
highways and trains at whistle-ban grade crossings.
The costs of this rulemaking will be incurred predominantly by
communities. The most significant impacts from this rule will be on
about 260 governmental jurisdictions whose communities have whistle
bans in place. However, there are also costs to railroads and to the
Federal Government. Approximately 640 small railroads would be
minimally impacted by train horn sound level testing requirements
contained in this rule. In adddition, some small businesses that
operate along or near rail lines that currently have whistle bans in
place could be moderately impacted.
Risks:
As a result of studies conducted on accident rates at crossings at
which locomotive horns are banned, FRA has concluded that such
crossings generally have a higher risk of accident than crossings at
which horns are sounded. FRA has found that the risk of a collision was
67 percent greater at crossings equipped with automatic gates and
flashing lights than at similarly equipped crossings across the nation
without bans. Congress required that FRA issue a regulation requiring
the sounding of locomotive horns at all public highway rail grade
crossings. However, an exception to the requirement is permissible in
circumstances in which there is not a significant risk of loss of life
or serious personal injury, use of the locomotive horn is impractical,
or supplementary safety measures fully compensate for the absence of
the warning provided by the horn. Issuance of the rule would lower the
increased collision risk associated with crossings at which no
locomotive horns are sounded.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 2230 01/13/00
NPRM Comment Period End 05/26/00
Interim Final Ru68 FR 70586 12/18/03
Interim Final Rule Comment Period End 04/19/04
Final Rule 01/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, Local, State
Additional Information:
An Omnibus Bill at the end of the 106th Congress prohibited publication
of a final rule before July 2001.
URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Kathryn E. Shelton
Trial Attorney
Department of Transportation
Federal Railroad Administration
400 Seventh Street, SW
Washington, DC 20590
Phone: 202 493-6063
Fax: 202 493-6068
Email: kathryn.shelton@fra.dot.gov
RIN: 2130-AA71
BILLING CODE 4910-62-S
[[Page 72807]]
DEPARTMENT OF THE TREASURY (TREAS)
Statement of Regulatory Priorities
The primary missions of the Department of the Treasury are:
To promote prosperous and stable American and world economies,
including promoting domestic economic growth and
maintaining our Nation's leadership in global economic
issues, supervising national banks and thrift institutions,
and helping to bring residents of distressed communities
into the economic mainstream.
To manage the Government's finances by protecting the revenue
and collecting the correct amount of revenue under the
Internal Revenue Code, overseeing customs revenue
functions, financing the Federal Government and managing
its fiscal operations, and producing our Nation's coins and
currency.
To safeguard our financial systems by enforcing laws relating
to Federal Government securities and developing regulations
to combat money laundering.
Consistent with these missions, most regulations of the Department and
its constituent bureaus are promulgated to interpret and implement the
laws as enacted by the Congress and signed by the President. Unless
circumstances require otherwise, it is the policy of the Department to
issue a notice of proposed rulemaking and carefully consider public
comments before adopting a final rule. Also, in particular cases, the
Department invites interested parties to submit views on rulemaking
projects while a proposed rule is being developed, and holds public
hearings to discuss proposed rules.
In response to the events of September 11, 2001, the President signed
the USA PATRIOT Act of 2001 into law on October 26, 2001. Since then,
the Department of the Treasury has accorded the highest priority to
developing and issuing regulations to implement the provisions in this
historic legislation that target money laundering and terrorist
financing. These efforts, which will continue during the coming year,
are reflected in the regulatory priorities of the Financial Crimes
Enforcement Network (FinCEN).
On November 26, 2002, the President signed into law the Terrorism Risk
Insurance Act of 2002. The purpose of this legislation is to address
disruptions in the market for terrorism risk insurance. The new law
established a temporary Federal reinsurance program under which the
Federal Government will share the risk of losses associated with
certain types of terrorist acts with commercial property and casualty
insurers. Over the past two years, the Department of the Treasury has
accorded the highest priority to developing and issuing regulations to
implement the provisions of this Act. These efforts, which will
continue during the coming year, are reflected in the regulatory
priorities of the Terrorism Risk Insurance Program Office.
To the extent permitted by law, it is the policy of the Department to
adhere to the regulatory philosophy and principles set forth in
Executive Order 12866, and to develop regulations that maximize
aggregate net benefits to society while minimizing the economic and
paperwork burdens imposed on persons and businesses subject to those
regulations.
Terrorism Risk Insurance Program Office
The Office of the Assistant Secretary for Financial Institutions is
responsible for developing promulgating regulations implementing the
Terrorism Risk Insurance Act of 2002 (TRIA). The Terrorism Risk
Insurance Program Office, which is part of the Office of the Assistant
Secretary for Financial Institutions, is responsible for operational
implementation of the Act. The purposes of this legislation, which was
enacted as a consequence of the events of September 11, 2001, are to
address market disruptions, ensure the continued widespread
availability and affordability of commercial property and casualty
insurance for terrorism risk, and to allow for a transition period for
the private markets to stabilize and build capacity while preserving
State insurance regulation and consumer protections. TRIA established a
temporary Federal program that provides a system of shared public and
private compensation for insured losses resulting from certain types of
terrorist acts.
Over the past year, the Office of the Assistant Secretary has
continued the ongoing work of quickly implementing TRIA. The Office has
issued formal regulations specifying claims procedures for property and
casualty insurers who seek federal reimbursement under TRIA for their
insured losses. The Office has also developed a claims processing
capability and issued a final rule to implement the litigation
management provisions of TRIA. During fiscal year 2005, the Office will
refine regulations and procedures for filing claims under TRIA and
develop regulations for recouping the Federal share of compensation to
insurers through risk-spreading premiums.
Customs Revenue Functions
On November 25, 2002, the President signed the Homeland Security Act
of 2002 (the Act), establishing the Department of Homeland Security
(DHS). The Act transferred the United States Customs Service from the
Department of the Treasury to the DHS, where it is now known as the
Bureau of Customs and Border Protection (CBP). Notwithstanding the
transfer of the Customs Service to DHS, the Act provides that the
Secretary of the Treasury retains sole legal authority over the customs
revenue functions. The Act also authorizes the Secretary of the
Treasury to delegate any of the retained authority over customs revenue
functions to the Secretary of Homeland Security. By Treasury Department
Order No. 100-16, the Secretary of the Treasury delegated to the
Secretary of Homeland Security authority to prescribe regulations
pertaining to the customs revenue functions. This Order further
provided that the Secretary of the Treasury retained the sole authority
to approve any such regulations concerning import quotas or trade bans,
user fees, marking, labeling, copyright and trademark enforcement, and
the completion of entry or substance of entry summary including duty
assessment and collection, classification, valuation, application of
the U.S. Harmonized Schedules, eligibility or requirements for
preferential trade programs, and the establishment of recordkeeping
requirements relating thereto.
During fiscal year 2005, Treasury and CBP plan to finalize several
interim regulations involving the customs revenue functions not
delegated to DHS. Among these are the following interim regulations
that implement the trade benefit provisions of the Trade Act of 2002:
The Andean Trade Promotion and Drug Eradication Act
The Caribbean Basin Economic Recovery Act
The African Growth and Opportunity Act
CBP also plans to issue interim regulations this fiscal year to
implement the preferential trade benefit provisions of the United
States-Chile Free Trade
[[Page 72808]]
Agreement Implementation Act and the United States-Singapore Free Trade
Agreement Implementation Act.
In addition, Treasury and CBP plan to finalize proposed regulations
that will implement two provisions of the Tariff and Suspension Act of
2000. One rule will establish procedures for allowing the duty-free
entry of prototypes that are to be used exclusively in product
development, testing, evaluation or quality control. The other rule
will allow merchandise that is purchased and invoiced as a single
entity but shipped in an unassembled or disassembled condition in
separate shipments due to the size or nature of the merchandise to be
treated for entry purposes as a single transaction.
Treasury and CBP also plan to continue moving forward with amendments
to improve its regulatory procedures began under the authority granted
by the Customs Modernization provisions of the North American Free
Trade Implementation Act (Customs Mod Act). These efforts, in
accordance with the principles of Executive Order 12866, have involved
and will continue to involve significant input from the importing
public. CBP will also continue to test new programs to see if they work
before proceeding with proposed rulemaking to permanently establish the
programs.
Community Development Financial Institutions Fund
The Community Development Financial Institutions Fund (Fund) was
established by the Community Development Banking and Financial
Institutions Act of 1994 (12 U.S.C. 4701 et seq.). The primary purpose
of the Fund is to promote economic revitalization and community
development through a variety of programs: the Community Development
Financial Institutions (CDFI) Program, the Bank Enterprise Award (BEA)
Program, and the New Markets Tax Credit (NMTC) Program.
In fiscal year 2005, the CDFI Program will comprise the Financial
Assistance Component through which the Fund makes investments in and
provides financial assistance to CDFIs, and the Technical Assistance
Component through which the Fund provides technical assistance grants
to CDFIs. In addition, the Fund administers the Native American CDFI
Assistance (NACA) Component, through which the Fund provides technical
assistance grants and financial assistance awards to promote the
development of CDFIs that serve Native American, Alaska Native, and
Native Hawaiian communities.
Through the BEA Program, the Fund provides financial incentives to
encourage insured depository institutions to engage in eligible
development activities and to make equity investments in CDFIs.
In addition, the Fund administers the NMTC Program in coordination
with Treasury's Office of Tax Policy and the Internal Revenue Service.
The NMTC Program is intended to spur investments in businesses located
in low-income communities. Through the NMTC Program, taxpayers are
provided a credit against Federal income taxes for qualified
investments made to acquire stock or other equity interests in
designated Community Development Entities (CDEs). Substantially all of
the proceeds of qualified investments must in turn be used by the CDE
to make qualified investments in low-income communities.
The Fund's fiscal year 2005 regulatory priority will include
developing guidance and/or regulations regarding aspects of the
administration and operation of the NMTC Program.
Financial Crimes Enforcement Network
The regulations of the Financial Crimes Enforcement Network (FinCEN)
constitute the core of Treasury's anti-money laundering initiatives and
are an essential component of Treasury's anti-narcotics effort.
FinCEN's regulations implement the Bank Secrecy Act (BSA), as amended
in October 2001 by the USA PATRIOT Act. The BSA authorizes the
Secretary of the Treasury to issue regulations requiring financial
institutions to keep records and file reports that are determined to
have a high degree of usefulness in criminal, tax, or regulatory
matters, or in the conduct of intelligence or counter-intelligence
activities to protect against international terrorism, and to implement
counter-money laundering programs and compliance procedures. FinCEN is
working closely with the Treasury Offices of the General Counsel,
Terrorism/Violent Crimes, and Financial Institutions to develop
regulations to implement the amendments to the BSA made by the USA
PATRIOT Act that target money laundering and terrorist financing.
FinCEN's regulatory priorities for fiscal year 2005 include the
following projects, all of which are related to the events of September
11, 2001:
Due Diligence for Correspondent Accounts and Private
Banking Accounts. This final rule implements section 312 of
the USA PATRIOT Act, which requires certain financial
institutions to establish due diligence policies,
procedures, and controls reasonably designed to detect and
report money laundering through correspondent accounts and
private baking accounts established or maintained for non-
U.S. persons.
Anti-Money Laundering Programs. These final and
proposed rules implement section 352 of the USA PATRIOT
Act, under which financial institutions must adopt anti-
money laundering programs. FinCEN expects to finalize
interim final rules issued in April 2002 for banks and
other depository institutions, casinos, securities broker-
dealers, futures commission merchants, mutual funds,
operators of credit card systems, and money services
businesses. FinCEN also expects to finalize rules proposed
in September 2002 for insurance companies and unregistered
investment companies, rules proposed in February 2003 for
dealers in precious metals, stones, or jewels, and rules
proposed in May 2003 for investment advisers and commodity
trading advisers. FinCEN will issue a proposed rule for
loan or finance companies (including pawnbrokers). Finally,
FinCEN expects to determine whether to issue a series of
proposed rules for other financial institutions--vehicles
sellers; persons involved in real estate closings and
settlements; and travel agencies--after reviewing comments
received in response to a series of advance notices of
proposed rulemaking.
Suspicious Activity Reporting. FinCEN expects to
finalize several rules proposed under 31 U.S.C. 5318(g)
requiring insurance companies and mutual funds to report
suspicious transactions.
Internal Revenue Service
The Internal Revenue Service, working with the Office of the Assistant
Secretary (Tax Policy), promulgates regulations that interpret and
implement the Internal Revenue Code and related tax statutes. The
purpose of these regulations is to carry out the tax policy determined
by Congress in a fair, impartial and reasonable manner, taking into
account the intent of Congress, the realities of relevant transactions,
the need for the Government to administer the rules and monitor
compliance, and the overall integrity of the Federal tax system. The
goal is to make the
[[Page 72809]]
regulations practical and as clear and simple as possible.
Most Internal Revenue Service regulations interpret tax statutes to
resolve ambiguities or fill gaps in the tax statutes. This includes
interpreting particular words, applying rules to broad classes of
circumstances, and resolving apparent and potential conflicts between
various statutory provisions.
During fiscal year 2005 the Internal Revenue Service will accord
priority to the following regulatory projects:
Transfer Pricing Guidance Initiatives. Treasury and
the IRS anticipate issuing regulatory guidance under
section 482 and other provisions of the Internal Revenue
Code during fiscal year 2005 with respect to accounting for
the economic value of intangible property in the context of
cross-border related-party activities and transactions. The
economic value of intangible property can be a significant
factor in a variety of cross-border transactions, in
addition to those in which intangibles are sold or licensed
directly. The various guidance projects are being
coordinated to ensure that consistent rules govern the
treatment of intangibles in economically similar
transactions, whether intangibles are transferred outright,
transferred via a buy-in pursuant to a cost sharing
arrangement, embedded into services performed, or
transferred as part of an outbound incorporation or
reorganization transfer. The projects include regulatory
guidance regarding related-party cost sharing arrangements
under section 482, regarding intercompany services under
section 482, and regarding outbound transfers of
intangibles in a reorganization under section 367(d).
Elimination or Reduction of Certain Type of Benefits
in Qualified Plans. Section 411(d)(6)(B) of the Internal
Revenue Code generally prohibits an amendment to a tax-
qualified retirement plan that has the effect of
eliminating or reducing an early retirement benefit or a
retirement-type subsidy, or eliminating an optional form of
benefit, with respect to benefits attributable to service
before the amendment. EGTRRA directed the Secretary to
issue regulations providing that section 411(d)(6)(B) does
not apply to any amendment that reduces or eliminates early
retirement benefits or retirement-type subsidies that
create significant burdens or complexities for the plan and
plan participants unless such amendment adversely affects
the rights of any participant in a more than de minimis
manner. The IRS and Treasury issued proposed regulations
that would implement this provision and provide additional
guidance under section 411(d)(6) on March 24, 2004. The IRS
and Treasury intend to finalize these regulations.
Application of the Repeal of the General Utilities
Doctrine in the Context of Consolidated Returns. On March
7, 2002, the IRS and Treasury issued temporary regulations
(26 CFR 1.337(d)-2T) that disallow certain losses
recognized by a member of a consolidated group on the
disposition of stock of another member. These regulations
ensure that the purposes of the General Utilities repeal,
which generally requires a corporation to recognize gain or
loss on a disposition of any asset, may not be circumvented
through the use of the consolidated return regulations.
During the coming fiscal year, the IRS and Treasury plan to
reexamine these regulations.
Safe Harbor Methodology for Determining the Fair
Market Value of Financial Instruments that are Marked to
Market. Section 475 of the Internal Revenue Code requires
dealers in stocks, debt, certain derivative financial
instruments, or other securities to mark their securities
to market at the end of each tax year. That is, those
dealers must compute their taxable income by including
their securities in inventory at their fair market value or
recognizing gain or loss as if their securities had been
sold for their fair market value at the end of the tax
year. Dealers and traders in commodities, and securities
traders are not required to use mark-to-market accounting
but may elect to do so. The IRS and Treasury are
considering whether to publish proposed regulations that
would allow dealers in securities (and perhaps dealers in
commodities or traders in securities or commodities) to use
a safe harbor method to satisfy the statutory requirement
to determine the fair market value of items marked to
market. As a first step in this process, the IRS and
Treasury issued an advance notice of proposed rulemaking
(ANPRM) on May 5, 2003, describing and explaining a
possible framework for a safe harbor that might allow
taxpayers to use as fair market value for section 475
purposes the value used on certain financial statements.
That ANPRM stated certain broad principles that any safe
harbor finally adopted might have to meet. The ANPRM also
requested both general and specific comments concerning the
adoption of a safe harbor based on financial statement
conformity or some other principle. It also requested
comments concerning the scope of any safe harbor, which
taxpayers could use it, what financial statements would
qualify, and what securities (or commodities) would be
covered.
Capitalization of Interest and Carrying Charges
Properly Allocable to Straddles. Sections 1092 and 263(g)
of the Internal Revenue Code were enacted in 1981 to
address tax abuses employing straddles in commodity futures
contracts, but the two sections are worded broadly enough
to deal with other abusive straddles. Section 1092 limits
loss recognition on one leg of a straddle if there is
unrecognized gain with respect to one or more offsetting
positions. Section 263(g) disallows a deduction for
interest and carrying charges properly allocable to
personal property that is part of a straddle.
The IRS and Treasury expect to issue final regulations clarifying the
circumstances in which a taxpayer must capitalize interest and carrying
charges incurred to purchase or carry personal property that is part of
a straddle. The regulations are expected to address the definition of
personal property for purposes of section 263(g), the types of expenses
subject to capitalization, and the operation of the capitalization
rules. In addition, the regulations will indicate when the debtor's
position in a debt instrument will be treated as a position in personal
property that may be part of a straddle. The regulations are also
expected to clarify the application of the straddle anti-abuse rules to
various financial instruments and straddle transactions.
Credit for Household and Dependent Care Services.
Section 21 of the Internal Revenue Code allows a credit for
an amount equal to a percentage of employment-related
expenses paid by an individual who maintains a household
that includes a qualifying individual (usually a child
under age 13). Section 21, originally enacted in 1976, has
been amended repeatedly. The 2001 amendments increased the
credit significantly. The regulations, currently found
under section 1.44A of the Income Tax Regulations, have not
been amended or updated since 1984. This regulation project
will update the regulations to reflect the
[[Page 72810]]
statutory changes and will clarify issues relating to
payments for certain services.
Deduction and Capitalization of Costs for Tangible
Assets. Section 162 of the Internal Revenue Code allows a
current deduction for ordinary and necessary expenses paid
or incurred in carrying on any trade or business. Under
section 263(a), no immediate deduction is allowed for
amounts paid out for new buildings or for permanent
improvements or betterments made to increase the value of
any property or estate. Such expenditures are capital
expenditures that generally may be recovered only in future
taxable years, as the property is used in the taxpayer's
trade or business. It often is not clear whether an
expenditure to repair, improve, or rehabilitate property is
a deductible expense or is a capital expenditure. Although
existing regulations provide that a deductible repair is an
expenditure that does not materially add to the value of
the property nor appreciably prolong its life, the IRS and
Treasury believe that additional clarification is needed to
reduce uncertainty and controversy in this area. In
December 2003, the IRS and Treasury requested public
comment on rules that might be provided to clarify the
application of section 263(a) to repairs and improvements
to tangible property. During fiscal year 2005, the IRS and
Treasury intend to propose regulations in this area.
R&E Credit for Controlled Groups. Section 41 of the
Internal Revenue Code provides a credit for increasing
research expenditures. The R&E Credit has been the subject
of significant controversy between the IRS and taxpayers,
particularly as it relates to the computation and
allocation of the credit for members of a controlled group
of corporations or a group of trades or businesses under
common control. Section 41(f) generally provides that in
determining the amount of the credit, all members of the
same controlled group of corporations are treated as a
single taxpayer. The IRS and Treasury issued proposed
regulations in 2003 providing rules for the computation of
the group research credit, and allocation of that credit
among members of the controlled group. During fiscal year
2005, the IRS and Treasury intend to issue further guidance
on this issue.
Partnership Equity for Services. Like other
businesses, partnerships frequently issue interests in
partnership equity to service providers. Although there
currently is some guidance on a partnership's issuance of a
profits interest to a service provider, there is little
guidance on the Federal income tax consequences (to the
service provider and the partnership) on the issuance, in
connection with the performance of services, of an interest
in partnership capital or an option to acquire such an
interest. More specifically, uncertainty exists as to
whether the principles of section 83 of the Internal
Revenue Code apply to the issuance of such interests and
whether the partnership recognizes gain on the issuance of
a capital interest to, or the exercise of an option by, a
service provider. In this project, the IRS and Treasury
will provide guidance on these and related issues.
Corporate Estimated Tax. Section 6655 of the
Internal Revenue Code sets forth the requirements for the
payment of estimated income taxes by corporations. The
existing regulations under section 6655 do not reflect
significant changes to the tax law since 1984. The IRS and
Treasury expect to issue proposed regulations that will
reflect changes to the tax law since 1984 and that will
provide clear rules for taxpayers to follow and the IRS to
administer. Among other issues, the proposed regulations
will address the alternative methods for computing
quarterly installments of estimated tax and the treatment
of certain items when computing quarterly installments of
estimated tax.
Practice Before the Internal Revenue Service
(Circular 230). Section 330 of title 31 of the United
States Code authorizes the Secretary of the Treasury to
regulate the practice of representatives before the
Treasury Department. The Secretary has published these
regulations in Circular 230 (31 CFR part 10). In 2001, the
IRS and Treasury issued proposed amendments to the
regulations relating to practice before the IRS, which
addressed general matters and proposed standards of
practice for tax shelter opinions. In 2002, final
regulations were issued incorporating only the non-tax
shelter matters. In 2003, amendments to the standards of
practice for tax shelter opinions were reproposed. Those
reproposed regulations set forth best practices for tax
advisors providing advice to taxpayers relating to Federal
tax issues or submissions to the IRS and modified the
standards for certain tax shelter opinions. The IRS and
Treasury expect to finalize the reproposed regulations and
to issue additional regulations regarding practice before
the IRS.
Student FICA Exception. Section 3121(b)(10) of the
Internal Revenue Code provides that for purposes of the
FICA, employment does not include services performed for a
school, college or university by a student who is enrolled
and regularly attending classes at the institution. Thus,
compensation for services that come within this exception
is not subject to FICA tax. As a result of some recent
litigation, questions have arisen as to the scope of the
exception. In particular, there is a need for additional
guidance on who is a student and what constitutes a school,
college or university for purposes of this exception. The
IRS and Treasury issued proposed regulations that would
clarify the application of section 3121(b)(10) on February
25, 2004. The IRS and Treasury intend to finalize these
regulations.
Office of the Comptroller of the Currency
The Office of the Comptroller of the Currency (OCC) charters,
regulates, and supervises national banks to ensure a safe, sound, and
competitive national banking system that supports the citizens,
communities, and economy of the United States. The substantive content
of the OCC's regulations reflects four organizing principles that
support this mission:
The OCC's regulations help ensure safety and soundness by
establishing standards that set the limits of acceptable
conduct for national banks.
The OCC's regulations promote competitiveness by facilitating
a national bank's ability to develop new lines of business,
subject to any safeguards that are necessary to ensure that
the bank has the expertise to manage risk effectively and
adapt its business practices to deal responsibly with its
customers.
Regulations can also affect national banks' ability to compete
by contributing significantly to their costs. The OCC's
goal is to improve efficiency and reduce burden by updating
and streamlining its regulations and eliminating those that
no longer contribute significantly to the fulfillment of
its mission.
The OCC's regulations help assure fair access to financial
services for all Americans by removing unnecessary
[[Page 72811]]
impediments to the flow of credit to consumers and small
businesses, by encouraging national banks' involvement in
community development activities, and by implementing
Federal laws designed to protect consumers of financial
services.
The OCC's regulatory workload and plans are affected directly by
statute. One statute requiring regulatory action is the Economic Growth
and Regulatory Paperwork Reduction Act of 1996 (EGRPRA). The OCC,
together with the Board of Governors of the Federal Reserve System,
Federal Deposit Insurance Corporation, and the Office of Thrift
Supervision (agencies), is conducting a review of its regulations,
pursuant to the EGRPRA. This process will continue through 2006. To
date, the agencies' review has included: (1) issuing three notices,
published in the Federal Register, that solicit comment from the
industries we regulate and the public on ways to reduce regulatory
burden with respect to specific categories of regulations; and (2)
conducting outreach meetings with bankers and consumer groups in cities
across the country for the same purpose. The review process and
outreach meetings have generated a number of helpful suggestions which
we, along with the other agencies, are evaluating on an ongoing basis.
When these processes for obtaining input are complete, the OCC expects
to be able to determine whether revisions to any of its rules are
appropriate in order to further the purposes of the EGRPRA and reduce
burden. The agencies will further report to Congress on their
conclusions at the end of the process, along with any suggestions for
possible legislative changes.
Significant final rules issued during fiscal year 2004 include:
Rules, Policies, and Procedures for Corporate
Activities; Bank Activities and Operations; Real Estate
Lending and Appraisals (12 CFR Parts 3, 5, 6, 7, 9, 28, and
34). The Office of the Comptroller of the Currency issued
this rule revising 12 CFR parts 5 and 7 to implement new
authority provided to national banks by sections 1204,
1205, and 1206 of the American Homeownership and Economic
Opportunity Act of 2000. Section 1204 permits national
banks to reorganize directly to be controlled by a holding
company. Section 1205 increases the maximum term of service
for national bank directors, permits the OCC to adopt
regulations allowing for staggered terms for directors, and
permits national banks to apply for permission to have more
than 25 directors. Section 1206 permits national banks to
merge with one or more of their nonbank affiliates, subject
to OCC approval. The OCC also made other amendments to 12
CFR parts 5, 7, 9, and 34, as well as several technical
corrections. The OCC published a final rule on December 17,
2003, at 68 FR 70122.
Rules, Policies, and Procedures for Corporate
Activities; International Banking Activities (12 CFR Parts
5 and 28). The Office of the Comptroller of the Currency
issued this rule to amend its regulations pertaining to the
foreign operations of national banks, and of Federal
branches and agencies of foreign banks operating in the
United States. The OCC clarified and revised a number of
application procedures, including applicable standards for
approval. The rule permits Federal branches and agencies to
operate with one license in the United States, with a
license issued only for the initial Federal branch or
agency, rather than requiring each office of a foreign bank
to have a separate license. It also permits a Federal
branch to operate a loan production office as part of its
branch license. In addition, the OCC implemented, through
this regulation, a number of OCC interpretations regarding
the capital equivalency deposit required of Federal
branches and agencies. The OCC also revised several
definitions. The OCC published a final rule on December 19,
2003, at 68 FR 70691.
Rules, Policies, and Procedures for Corporate
Activities (12 CFR Part 5). The Office of the Comptroller
of the Currency issued this rule to require a national bank
to receive OCC approval before changing the composition of
all, or substantially all, of its assets (1) through sales
or other dispositions, or (2) after having sold or disposed
of all, or substantially all, of its assets through
subsequent purchase, other acquisitions, or other expansion
of its operations. The rule provides that, in the second
case, the OCC will apply the same standards as it applies
to the establishment of a de novo bank. The OCC published a
final rule on August 16, 2004, at 69 FR 50293.
Reporting and Disclosure Requirements for National
Banks With Securities Registered Under the Securities
Exchange Act of 1934; Securities Offering Disclosure Rules
(12 CFR Parts 11 and 16). The Office of the Comptroller of
the Currency issued this rule to revise its regulations to
reflect amendments to the Securities Exchange Act of 1934
(Exchange Act) made by the Sarbanes-Oxley Act of 2002
(Sarbanes-Oxley Act). These amendments to the Exchange Act
give the OCC the authority to administer and enforce a
number of the Sarbanes-Oxley Act's new reporting,
disclosure, and corporate governance requirements with
respect to national banks that have a class of securities
registered under the Exchange Act. The OCC also made
conforming revisions to its rules that prescribe securities
offering disclosure rules for national banks that issue
securities that are not subject to the registration
requirements of the Securities Act of 1933. The OCC
published a final rule on December 9, 2003, at 68 FR 68489.
Bank Activities and Operations; Real Estate Lending
and Appraisals (12 CFR Parts 7 and 34). The Office of the
Comptroller of the Currency issued this rule to add
provisions to OCC regulations expressly addressing the
applicability of certain types of state laws to national
banks' deposit-taking and lending activities. In new 12 CFR
7.4007 (pertaining to deposit-taking) and 12 CFR 7.4008
(pertaining to non-real estate lending), and in revised 12
CFR 34.4 (pertaining to real estate lending), are listed
particular types of state laws that are preempted by the
rule. Each of these three sections also contains a list of
types of state laws that generally are not preempted. In
addition, in new 12 CFR 7.4007, 7.4008, and 7.4009
(pertaining to other Federally authorized activities), and
in revised 12 CFR 34.4, the rule contains s general
statement that state laws do not apply to national banks if
they ``obstruct, impair, or condition'' the bank's ability
to fully exercise its Federally authorized powers.
The rule operates to preempt, without the need for further analysis,
only those types of State laws that are listed in 12 CFR 7.4007,
7.4008, and 34.4. These are State laws for which substantial precedent
existed, prior to adoption of the preemption rule, recognizing the
interference they pose to the ability of Federally chartered
institutions to operate under uniform Federal standards. Thus, the rule
preempts State laws that impermissibly affect national bank deposit
taking and lending powers and that are listed in the regulation.
[[Page 72812]]
Other types of State laws--those not listed in the regulation--remain
subject to case-by-case evaluation under the longstanding preemption
standards that the U.S. Supreme Court has established. The rule also
prohibits a national bank from making any consumer loan based
predominately on the bank's realization of the foreclosure value of the
borrower's collateral, without regard to the borrower's ability to
repay the loan according to its terms. The OCC published a final rule
on January 13, 2004, at 69 FR 1904.
Risk-Based Capital Guidelines; Capital Adequacy
Guidelines; Capital Maintenance: Interim Capital Treatment
of Consolidated Asset-Backed Commercial Paper Program
Assets (12 CFR Part 3). The Office of the Comptroller of
the Currency, together with the Board of Governors of the
Federal Reserve System, Federal Deposit Insurance
Corporation, and Office of Thrift Supervision (banking
agencies), issued an interim rule with request for comment
on October 1, 2003, at 68 FR 56530. The interim rule
amended the banking agencies' risk-based capital standards
by providing an interim treatment for assets in asset-
backed commercial paper (ABCP) programs that are
consolidated onto the balance sheets of sponsoring banks,
bank holding companies, and thrifts (collectively,
sponsoring banking organizations) as a result of a recently
issued accounting interpretation, Financial Accounting
Standards Board Interpretation No. 46, Consolidation of
Variable Interest Entities (FIN 46). Specifically, the
interim capital treatment allows sponsoring banking
organizations to remove consolidated ABCP program assets
from their risk-weighted asset base for the purpose of
calculating their risk-based capital ratios. The interim
rule was issued in conjunction with a joint agency notice
of proposed rulemaking that would also require sponsoring
banking organizations to hold risk-based capital against
liquidity facilities provided to ABCP programs with an
original maturity of one year or less, and a risk-based
capital charge for early amortization risk associated with
certain types of revolving securitizations. The agencies
issued a final rule covering both documents on July 28,
2004, at 69 FR 44908.
Bank Activities and Operations (12 CFR Part 7). The
Office of the Comptroller of the Currency issued this rule
to clarify the scope of its visitorial powers regulation at
12 CFR 7.4000. The rule identifies the scope of the
activities of national banks for which the OCC's visitorial
powers are exclusive under 12 U.S.C. 484, that is, the
content and conduct of activities authorized for national
banks under Federal law. The rule also clarifies that the
``vested in the courts of justice'' exception in 12 U.S.C.
484 pertains to the powers inherent in the judiciary and
does not grant to state or other authorities any new right
to exercise visitorial powers with respect to national
banks. The OCC published a final rule on January 13, 2004,
at 69 FR 1895.
The OCC's regulatory priorities for fiscal year 2005 include projects
in the following areas:
The OCC plans to issue rules implementing the requirements of the Fair
and Accurate Credit Transactions Act of 2003 as follows:
Proper Disposal of Consumer Information (12 CFR
Parts 30 and 41). The Office of the Comptroller of the
Currency, Board of Governors of the Federal Reserve System,
Federal Deposit Insurance Corporation, and Office of Thrift
Supervision (banking agencies) are planning to issue a
joint rule to implement section 216 of the Fair and
Accurate Credit Transactions Act of 2003. Section 216
requires the banking agencies, the National Credit Union
Administration, the Securities and Exchange Commission, and
the Federal Trade Commission to adopt consistent and
comparable regulations, to the extent possible, requiring
entities subject to their jurisdiction to properly dispose
of consumer information as a means to reduce the risk of
identity theft. The agencies issued a joint notice of
proposed rulemaking on June 8, 2004, at 69 FR 31913.
Fair Credit Reporting Regulations; Use of Medical
Information (12 CFR Part 41). The Office of the Comptroller
of the Currency, Board of Governors of the Federal Reserve
System, Federal Deposit Insurance Corporation, Office of
Thrift Supervision, and National Credit Union
Administration (agencies) are planning to issue a joint
rule to implement section 411 of the Fair and Accurate
Credit Transactions Act of 2003. Section 411(a) requires
the agencies to prescribe regulations that permit creditors
to obtain or use medical information for certain credit
eligibility purposes. Additionally, section 411(b)
authorizes the agencies to issue rules to allow additional
sharing of information determined by the agencies to be
appropriate or necessary. The agencies issued a joint
notice of proposed rulemaking on April 28, 2004, at 69 FR
23380.
Identity Theft Detection, Prevention, and Mitigation
Program for Financial Institutions and Creditors (12 CFR
Parts 30 and 41). The Office of the Comptroller of the
Currency, Board of Governors of the Federal Reserve System,
Federal Deposit Insurance Corporation, Office of Thrift
Supervision, and National Credit Union Administration, and
Federal Trade Commission (agencies) are planning to issue a
rule to establish guidelines and regulations to implement
section 114 of the Fair and Accurate Credit Transactions
Act of 2003. Section 114 requires the agencies to issue
jointly guidelines for financial institutions and creditors
identifying patterns, practices, and specific forms of
activity that indicates the possible existence of identity
theft. In addition, the agencies must issue regulations
requiring each financial institution and creditor to
establish reasonable policies and procedures to implement
the guidelines. The regulations must contain a provision
requiring a card issuer to notify the cardholder if the
card issuer receives a notice of change of address for an
existing account, and a short time later receives a request
for an additional or replacement card.
Fair Credit; Affiliate Marketing Regulations (12 CFR
Part 41). The Office of the Comptroller of the Currency,
Board of Governors of the Federal Reserve System, Federal
Deposit Insurance Corporation, Office of Thrift
Supervision, and National Credit Union Administration
(agencies) are planning to issue a rule to implement the
affiliate-sharing provisions of section 214 of the Fair and
Accurate Credit Transactions Act of 2003 (FACT Act). The
rule would implement the consumer notice and opt-out
provisions of the FACT Act regarding the sharing of
consumer information among affiliates for marketing
purposes. The agencies issued a notice of proposed
rulemaking on July 15, 2004, at 69 FR 42502.
The OCC plans to issue other rules as follows:
Recordkeeping Requirements for Bank Exceptions from
Securities Broker or Dealer Registration (12 CFR To Be
Determined). The Office of the Comptroller of the Currency,
Board of
[[Page 72813]]
Governors of the Federal Reserve System, Federal Deposit
Insurance Corporation, and Office of Thrift Supervision may
issue a notice of proposed rulemaking (NPRM) that contains
recordkeeping requirements that implement section 204 of
the Gramm-Leach-Bliley Act (GLBA). Section 204 directs the
Federal banking agencies to establish recordkeeping
requirements for banks relying on exceptions to the
definitions of ``broker'' and ``dealer'' contained in
paragraphs (4) and (5) of section 3(a) of the Securities
Exchange Act of 1934. Issuance of this NPRM is contingent
on the completion of the Securities and Exchange
Commission's rulemaking to implement the substantive
provisions of the GLBA.
Community Reinvestment Act Regulation (12 CFR 25).
The Office of the Comptroller of the Currency plans to
issue a notice of proposed rulemaking that would revise
certain provisions of our rules implementing the Community
Reinvestment Act (CRA). The OCC plans to take this action
in response to public comments we received on our February
2004 CRA proposal (69 FR 5729). The proposal would address
regulatory burden imposed on smaller national banks by
revising the eligibility requirements for CRA evaluation
under the lending, investment, and service tests.
Specifically, the proposal would provide a simplified
lending test and a flexible and streamlined community
development test for small banks with an asset size between
$250 million and $1 billion. Holding company affiliation
would not be a factor in determining which CRA evaluation
standards applied to a bank. The OCC estimates that this
proposal would reduce burden and costs for national banks.
In particular, banks with assets between $250 million and
$1 billion would have reduced data reporting costs that
include fixed costs (such as purchasing and updating CRA
software and establishing and maintaining internal
processes to collect and check data) and variable costs
(e.g., organizing data, monitoring data quality, and
correcting data).
Electronic Filing and Disclosure of Beneficial
Ownership Reports (12 CFR Part 11). The Office of the
Comptroller of the Currency plans to adopt a final rule
based on the interim rule, issued on September 22, 2003 ,
at 68 FR 54981, to implement provisions enacted in the
Sarbanes-Oxley Act of 2002 (Act). The Act made amendments
to section 16(a) of the Securities Exchange Act of 1934,
which requires the filing of beneficial ownership reports
by officers, directors, and principal shareholders of
issuers of securities. The OCC administers and enforces
section 16(a) with respect to officers, directors, and
principal shareholders of national banks. Effective July
30, 2003, the Act required that beneficial ownership
reports be filed electronically and posted on the issuer's
corporate Web site, if it has a Web site. The interim rule
requires that beneficial ownership reports filed by
officers, directors, and principal shareholders of national
banks be filed electronically pursuant to the FDIConnect
system and that the reports be placed on the Web site on
national banks that have Web sites. The OCC may adopt a
final rule.
Risk-Based Capital Guidelines: Implementation of New
Basel Capital Accord (12 CFR Part 3). The Office of the
Comptroller of the Currency, Board of Governors of the
Federal Reserve System, Federal Deposit Insurance
Corporation, and Office of Thrift Supervision (banking
agencies) plan to issue a notice of proposed rulemaking
based on the International Convergence of Capital
Measurement and Capital Standards: A Revised Framework, the
new capital adequacy framework commonly known as Basel II.
The banking agencies published an advance notice of
proposed rulemaking (ANPRM) on August 4, 2003, at 68 FR
45900 soliciting industry comments on a draft of the
proposed framework for implementing the New Basel Capital
Accord in the United States. In particular, the ANPRM
described significant elements of the Advanced Internal
Ratings-Based approach for credit risk and the Advanced
Measurement Approaches for operational risk (together, the
advanced approaches). The ANPRM specified criteria that a
banking organization must meet to use the advanced
approaches. Under the advanced approaches, a banking
organization would use internal estimates of certain risk
components as key inputs in the determination of their
regulatory capital requirements. The OCC included this
rulemaking project in part II of The Regulatory Plan.
Safety and Soundness Standards; Interagency Guidance
on Response Programs for Unauthorized Access to Customer
Information and Customer Notice (12 CFR Part 30). The
Office of the Comptroller of the Currency, Board of
Governors of the Federal Reserve System, Federal Deposit
Insurance Corporation, Office of Thrift Supervision, and
National Credit Union Administration (agencies) are issuing
an interpretation of section 501(b) of the Gramm-Leach-
Bliley Act and the Interagency Guidelines Establishing
Standards for Safeguarding Customer Information. This
interpretation describes the agencies' expectations
regarding the response programs, including customer
notification procedures, that a financial institution
should develop and implement to address the unauthorized
access to or use of customer information that could result
in substantial harm or inconvenience to a customer. A
proposed interpretation was published for comment on August
12, 2003, at 68 FR 47954.
Office of Thrift Supervision
As the primary Federal regulator of the thrift industry, the Office of
Thrift Supervision (OTS) has established regulatory objectives and
priorities to supervise thrift institutions effectively and
efficiently. These objectives include maintaining and enhancing the
safety and soundness of the thrift industry; a flexible, responsive
regulatory structure that enables savings associations to provide
credit and other financial services to their communities, particularly
housing mortgage credit; and a risk-focused, timely approach to
supervision.
OTS and the Office of the Comptroller of the Currency, the Board of
Governors of the Federal Reserve System, and the Federal Deposit
Insurance Corporation (collectively, the banking agencies) continue to
work together on regulations where the agencies share the
responsibility to implement statutory requirements. The agencies are
working to update capital standards to maintain, and, where necessary,
improve consistency in the agencies' rules, including the International
Convergence of Capital Management and Capital Standards: A Revised
Framework (Basel II). The domestic implementation of the New Basel
Capital Accord was introduced in 2003 with publication of an advanced
notice of proposed rulemaking and draft supervisory guidance. It
included an introduction to the advanced internal ratings-based (IRB)
approach to credit risk, and included modifications to the current
[[Page 72814]]
U.S. domestic capital framework. The agencies plan to issue a proposed
rule by mid-year. Possible changes to capital regulations for U.S.
institutions not subject to the framework-based regulations will be
considered and addressed in this same general time frame.
Also, OTS anticipates implementing sections of the Fair and Accurate
Credit Transactions Act of 2003 (FACT Act) as follows:
Proper Disposal of Consumer Information. The banking
agencies, along with the National Credit Union
Administration (NCUA), the Securities and Exchange
Commission (SEC), and the Federal Trade Commission (FTC),
plan to issue a final rule implementing section 216 of the
FACT Act by amending the Interagency Guidelines
Establishing Standards for Safeguarding Customer
Information to require each financial institution to
develop, implement, and maintain appropriate measures to
properly dispose of consumer information derived from
consumer reports and to address the risks associated with
identity theft as part of its information security program.
Fair Credit Reporting Affiliate Marketing
Regulations. The banking agencies and the NCUA also plan to
issue a final rule implementing section 214 of the FACT
Act, which amended the Fair Credit Reporting Act (FCRA) by
prohibiting a person from using information received from
an affiliate to make a solicitation for marketing purposes
to a consumer, unless the consumer is given notice and an
opportunity and simple method to opt out of the making of
such solicitations.
Fair Credit Reporting Regulations (Medical
Information): The banking agencies and the NCUA also plan
to publish a final rule implementing section 411 of the
FACT Act, which amended the FCRA by (1) prohibiting
creditors from obtaining or using medical information
pertaining to a consumer in connection with any
determination of the consumer's eligibility or continued
eligibility for credit, and (2) creating limited exceptions
to permit affiliates to share medical information with each
other without becoming consumer reporting agencies.
Identity Theft Detection, Prevention, and Mitigation
Program for Financial Institutions and Creditors. The
banking agencies, the NCUA, and the FTC also plan to issue
a proposed rule implementing section 114 of the FACT Act,
which requires the agencies to develop guidelines for use
in identifying patterns, practices, and specific forms of
activity that indicate the possible existence of identity
theft. The agencies are also required to issue regulations
requiring each financial institution and creditor to
establish reasonable policies and procedures to implement
such guidelines. The regulations must contain a provision
requiring a card issuer to notify the cardholder if the
card issuer receives a notice of change of address for an
existing account, and a short time later receives a request
for an additional or replacement card. Related to this
matter, the agencies are also considering issuing an
interpretation of section 501(b) of the Gramm-Leach-Bliley
Act and the Interagency Guidelines Establishing Standards
for Safeguarding Customer Information. This interpretation
would describe the agencies' expectations regarding the
response programs, including customer notification
procedures, that a financial institution should develop and
implement to address the unauthorized access to or use of
customer information that could result in substantial harm
or inconvenience to a customer. A proposed interpretation
was published for comment on August 12, 2003 (68 FR 47954).
OTS, along with the other Federal banking agencies, plan to issue a
final rule revising Community Reinvestment Act (CRA) rules to
incorporate changes in the Standards for Defining Metropolitan and
Micropolitan Statistical Areas, published by the U.S. Office of
Management and Budget in December 2000; census tracts designated by the
U.S. Bureau of the Census; and the Board of Governors of the Federal
Reserve System's Regulation C, which implements the Home Mortgage
Disclosure Act (HMDA).
OTS is also reviewing its CRA rules to ensure that they continue to
encourage institutions to meet their statutory responsibilities while
affording them greater flexibility. For example, OTS is reevaluating
how the investment test works in today's environment, including
considering making the investment test and the lending test mutually
available opportunities; possibly revising the definition of
``community development'' under its CRA rules to encourage all savings
associations to increase their community development activities in
rural areas, with a particular focus on underserved nonmetropolitan
areas; and encouraging institutions to perform community development
activities in any areas affected by natural or other disasters or other
major community disruptions.
OTS plans to issue a proposed rule describing the existing authority
of federal savings associations to engage in various securities broker,
dealer, and underwriting activities under the HOLA, and requiring a
savings association to notify OTS when it begins to conduct certain
securities activities. The proposed rule also updates the existing
prohibition on the sale of debt and equity securities issued by a
savings association or its affiliates at the offices of a savings
association, and eliminates various obsolete OTS securities
regulations.
Moreover, as part of its review of regulations under section 2222 of
the Economic Growth and Regulatory Paperwork Reduction Act of 1996, OTS
plans to issue an interim final rule to reduce regulatory burden on
savings associations by updating and revising various application and
reporting requirements.
Alcohol and Tobacco Tax and Trade Bureau
The Alcohol and Tobacco Tax and Trade Bureau (TTB) issues regulations
to enforce the Federal laws relating to the manufacture and commerce of
alcohol products, tobacco products, and the Federal excise tax on
firearms and ammunition. TTB's mission and regulations are designed to:
Regulate the alcohol and tobacco industries, including systems
for licenses and permits;
Assure the collection of all alcohol, tobacco, and firearms
and ammunition taxes, and obtain a high level of voluntary
compliance with all laws governing those industries;
Suppress commercial bribery, consumer deception, and other
prohibited practices in the alcoholic beverage industry;
and
Assist the States and other Federal agencies in their efforts
to eliminate interstate trafficking in, and the sale and
distribution of, cigarettes in avoidance of State taxes.
In 2005, TTB will continue to pursue its multi-year program of
modernizing its regulations in title 27 of the Code of Federal
Regulations. This program involves updating and revising the
regulations to be more clear, current,
[[Page 72815]]
and concise, with an emphasis on the application of plain language
principles. TTB laid the groundwork for this program in 2002 when it
started to recodify its regulations in order to present them in a more
logical sequence. This continuing revision effort will make the TTB
regulations more accessible and understandable for small businesses and
the general public.
Bureau of the Public Debt
The Bureau of the Public Debt (BPD) administers the following
regulations:
Governing transactions in Government securities by Government
securities brokers and dealers under the Government
Securities Act of 1986 (GSA), as amended.
Implementing Treasury's borrowing authority, including rules
governing the sale and issue of savings bonds, marketable
Treasury securities, and State and local Government
securities.
Setting out the terms and conditions by which Treasury may
redeem (buy back) outstanding, unmatured marketable
Treasury securities through debt buyback operations.
Governing the acceptability and valuation of all collateral
pledged to secure deposits of public monies and other
financial interests of the Federal Government.
Treasury's GSA rules govern financial responsibility, the protection
of customer funds and securities, recordkeeping, reporting, audit, and
large position reporting for all government securities brokers and
dealers, including financial institutions. During fiscal year 2005, BPD
will give priority to expanding an exemption in the GSA regulations to
include savings associations regulated by the Office of Thrift
Supervision (OTS) that hold Government securities in a fiduciary and
custodial capacity. The amendment would make savings associations
regulated and examined by the OTS eligible for the exemption under the
same conditions that currently apply to depository institutions
regulated and examined by the other bank regulators.
The rules setting out the terms and conditions for the sale and issue
of marketable book-entry Treasury bills, notes, and bonds are known as
the Uniform Offering Circular. During fiscal year 2005, BPD will accord
priority to issuing an amendment to the Uniform Offering Circular that
would treat two parties in a merchant banking relationship as separate
bidders rather than as a single bidder in Treasury marketable
securities auctions.
Financial Management Service
The Financial Management Service (FMS) issues regulations to improve
the quality of Government financial management and to administer its
payments, collections, debt collection, and Governmentwide accounting
programs.
During fiscal year 2005, FMS' regulatory priorities include ongoing
initiatives in the following areas:
Payment of Federal Taxes and the Treasury Tax and
Loan Program (TT&L) (31 CFR Part 203): FMS is completing
its revisions to this rule that governs the collection of
corporate withholding taxes and the investment of the
Government's excess operating funds. FMS is streamlining
this rule and writing it in plain language.
Automated Clearing House (ACH) (31 CFR Part 210):
FMS will issue its annual update to this rule that
establishes standards for Federal Government payments and
collections via the ACH system. FMS will revise this rule
in order to stay current with private industry rules and to
facilitate the continued expansion of electronic commerce.
_______________________________________________________________________
TREAS--Comptroller of the Currency (OCC)
-----------
PROPOSED RULE STAGE
-----------
113. IMPLEMENTATION OF A REVISED BASEL CAPITAL ACCORD (BASEL II)
Priority:
Economically Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
12 USC 93a; 12 USC 3907
CFR Citation:
12 CFR 3
Legal Deadline:
None
Abstract:
As part of the OCC's ongoing efforts to develop and refine capital
standards to ensure the safety and soundness of the national banking
system and to implement statutory requirements, the OCC is amending
various provisions of the capital rules for national banks. This change
involves the implementation of the new Basel Capital Accord (Basel II)
(formerly referred to as domestic capital framework). The OCC is
conducting this rulemaking jointly with the other Federal banking
agencies.
Statement of Need:
This rulemaking is necessary to implement an international initiative
regarding the capital adequacy regulation of certain domestic financial
institutions. Specifically, this rulemaking implements the
``International Convergence of Capital Measurement and Capital
Standards'' (Basel II), which comprehensively revises the 1988
``International Convergence of Capital Measurement and Capital
Standards.'' This rulemaking will translate the lengthy and complicated
text of Basel II into the standards and requirements that will govern
the largest banks in the United States.
Summary of Legal Basis:
The OCC is implementing the Basel II capital framework for certain
domestic financial institutions. This initiative is based on the OCC's
general rulemaking authority in 12 U.S.C. 93a and its specific
authority under 12 U.S.C. 3907. 12 U.S.C. 3907(a)(2) specifically
authorizes the OCC to establish minimum capital levels for financial
institutions that the OCC, in its discretion, deems necessary or
appropriate.
Alternatives:
Not yet determined.
Anticipated Cost and Benefits:
Not yet determined.
Risks:
Not yet determined.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 68 FR 45900 08/04/03
NPRM 08/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
[[Page 72816]]
Agency Contact:
Ron Shimabukuro
Special Counsel
Department of the Treasury
Comptroller of the Currency
Legislative and Regulatory Activities Division
250 E Street SW.
Washington, DC 20219
Phone: 202 874-5090
Fax: 202 874-4889
Email: ron.shimabukuro@occ.treas.gov
Related RIN: Split from 1557-AB14
RIN: 1557-AC91
BILLING CODE 4810-25-S
[[Page 72817]]
DEPARTMENT OF VETERANS AFFAIRS (VA)
Statement of Regulatory Priorities
The Department of Veterans Affairs (VA) administers benefit programs
that recognize the important public obligations to those who served
this Nation. VA's regulatory responsibility is almost solely confined
to carrying out mandates of the laws enacted by Congress relating to
programs for veterans and their beneficiaries. VA's major regulatory
objective is to implement these laws with fairness, justice, and
efficiency.
Most of the regulations issued by VA involve at least one of three VA
components: The Veterans Benefits Administration, the Veterans Health
Administration, and the National Cemetery Administration. The primary
mission of the Veterans Benefits Administration is to provide high-
quality and timely nonmedical benefits to eligible veterans and their
beneficiaries. The primary mission of the Veterans Health
Administration is to provide high-quality health care on a timely basis
to eligible veterans through its system of medical centers, nursing
homes, domiciliaries, and outpatient medical and dental facilities. The
primary mission of the National Cemetery Administration is to bury
eligible veterans, members of the Reserve components, and their
dependents in VA National Cemeteries and to maintain those cemeteries
as national shrines in perpetuity as a final tribute of a grateful
Nation to honor the memory and service of those who served in the Armed
Forces.
VA's regulatory priorities include a special project to undertake a
comprehensive review and improvement of its existing regulations. The
first portion of this project is devoted to reviewing, reorganizing,
and rewriting the VA's compensation and pension regulations found in
part 3 of 38 CFR. The goal of the Regulation Rewrite Project is to
improve the clarity and logical consistency of these regulations in
order to better inform veterans and their family members of their
entitlements.
The Department of Veterans Affairs' 2004 regulatory plan contains one
rulemaking action from the Veterans Health Administration. The Veterans
Health Administration rulemaking is RIN 2900-AL51 ``Enrollment--
Provision of Hospital and Outpatient Care to Veterans Subpriorities of
Priority Categories 7 and 8 and Annual Enrollment Level Decision,''
which was published as an interim final rule on January 17, 2003. It
amends the Department's medical regulations to protect the quality and
improve the timeliness of care provided to all veterans by restricting
new enrollments in higher enrollment-priority categories.
_______________________________________________________________________
VA
-----------
FINAL RULE STAGE
-----------
114. ENROLLMENT--PROVISION OF HOSPITAL AND OUTPATIENT CARE TO
VETERANS--SUBPRIORITIES OF PRIORITY CATEGORIES 7 AND 8 AND ENROLLMENT
LEVEL DECISION
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 104-262
CFR Citation:
38 CFR 17.36
Legal Deadline:
None
Abstract:
The Department of Veterans Affairs (VA) published in the Federal
Register on January 17, 2003, an interim final rule amending VA's
medical regulations at 38 CFR part 17 to establish additional
subpriorities within enrollment priority categories 7 and 8 and to
provide that, beginning January 17, 2003, VA will continue to treat all
veterans currently enrolled in any category, and will treat new
enrollees in categories 1 through 7. However, the interim final rule
provided that VA will suspend the enrollment of additional veterans who
are in the lowest statutory enrollment category (priority category 8).
Based on the rationale set forth in the interim final rule, VA is
adopting the provisions of the interim final rule as a final rule
without change.
Statement of Need:
Public Law 104-262, the Veterans' Health Care Eligibility Reform Act of
1996, requires the Secretary of Veterans Affairs to make annual
decisions concerning enrollment in VA's health care system in order to
ensure that resources are available to provide medical services that
are both timely and acceptable in quality. This document announces the
enrollment decision to suspend the enrollment of additional veterans
who are in the lowest statutory enrollment category (priority category
8). This also amends existing regulations to establish additional
subpriorities within priority categories 7 and 8.
Summary of Legal Basis:
38 CFR 17.36(c) requires that the Secretary determine which categories
of veterans are eligible to be enrolled and that the Secretary notify
eligible enrollees of the determination by announcing it in the Federal
Register.
Alternatives:
The Department had to consider placing additional enrollees on waiting
lists and extending the waiting period for eligible enrollees seeking
appointments for care as alternatives.
Anticipated Cost and Benefits:
By suspending enrollment of additional priority category 8 veterans, VA
would avoid significant additional medical benefits costs and begin to
bring demand in line with capacity, which will reduce the number of
veterans on waiting lists. Without action to suspend new enrollment,
the cost projection for FY 2003 is $23.455 billion. This is based on
the projected average enrollment for FY 2003 of 6,991,405, together
with the projected expenditures that would be needed to provide the
medical benefits package to all enrollees. Suspending new enrollment
would reduce enrollment in priority category 8 by 164,367 in FY 2003,
which is expected to grow to over 520,000 by FY 2005.
Risks:
Without action to suspend new enrollment, patient safety and quality
and access to care would be adversely affected.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru68 FR 2670 01/17/03
Interim Final Rule Effective 01/17/03
Interim Final Rule Comment Period End 03/18/03
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
[[Page 72818]]
URL For Public Comments:
www.regulations.gov
Agency Contact:
Ruth Hoffman
Office of the Assistant Deputy Secretary for Health (10A5A)
Department of Veterans Affairs
Veterans Health Administration
810 Vermont Avenue NW
Washington, DC 20420
Phone: 202 273-8934
RIN: 2900-AL51
BILLING CODE 8320-01-S
[[Page 72819]]
ENVIRONMENTAL PROTECTION AGENCY (EPA)
Environmental Protection Agency
Statement of Priorities
OVERVIEW
The U.S. Environmental Protection Agency (EPA) is the leading Federal
agency responsible for protecting human health and the environment.
Since its creation in 1970, EPA has taken actions that have led to
measurable improvements in air and water quality, significant
reductions in solid and hazardous wastes, and limitations on the use of
harmful chemicals and pesticides.
Specifically, EPA leads the nation's environmental science, research,
education and assessment efforts by:
Developing and enforcing regulations: EPA works to develop and enforce
regulations that implement environmental laws enacted by Congress. EPA
is responsible for researching and setting national standards for a
variety of environmental programs, and delegates to States and tribes
the responsibility for issuing permits and for monitoring and enforcing
compliance. Where national standards are not met, EPA can issue
sanctions and take other steps to assist the states and tribes in
reaching the desired levels of environmental quality.
Offering financial assistance: In recent years, between 40 and 50
percent of EPA's enacted budgets have provided direct support through
grants to State environmental programs. EPA grants to States, non-
profits and educational institutions support high-quality research that
will improve the scientific basis for decisions on national
environmental issues and help EPA achieve its goals.
EPA provides research grants and graduate fellowships.
The Agency supports environmental education projects that
enhance the public's awareness, knowledge, and skills to
make informed decisions that affect environmental quality.
The Agency also offers information for State and local
governments and small businesses on financing environmental
services and projects.
EPA also provides other financial assistance through programs
as the Drinking Water State Revolving Fund, the Clean Water
State Revolving Fund, and the Brownfields program.
Performing environmental research: At laboratories located throughout
the nation, the Agency works to assess environmental conditions and to
identify, understand, and solve current and future environmental
problems; integrate the work of scientific partners such as nations,
private sector organizations, academia and other agencies; and provide
leadership in addressing emerging environmental issues and in advancing
the science and technology of risk assessment and risk management.
Sponsoring voluntary partnerships and programs: The Agency works
through its headquarters and regional offices with over 10,000
industries, businesses, non-profit organizations, and state and local
governments, on over 40 voluntary pollution prevention programs and
energy conservation efforts. Partners set voluntary pollution-
management goals; examples include conserving water and energy,
minimizing greenhouse gases, slashing toxic emissions, re-using solid
waste, controlling indoor air pollution, and getting a handle on
pesticide risks. In return, EPA provides incentives like vital public
recognition and access to emerging information.
Furthering environmental education: EPA advances educational efforts to
develop an environmentally conscious and responsible public, and to
inspire personal responsibility in caring for the environment.
To view the Agency's complete strategic plan and annual report, go to
http://www.epa.gov/ocfopage/plan/plan.htm.
FOCUSING ON A BETTER WAY
EPA is focusing on finding a better way of environmental protection,
one that can accelerate environmental progress. The existing system has
served the nation well . . . but today's challenges are more complex.
New approaches are needed that can help achieve goals more quickly and
cost-effectively. EPA is relying on four cornerstones to finding a
better way - Collaborative problem-solving, market incentives, new
technology, and a focus on results.
Collaborative problem-solving is a way of achieving more with our
collective resources - bringing all available expertise and resources
to bear in solving problems. For example, EPA is collaborating with
States and other partners in an effort to improve the Great Lakes and
scaling up its National Environmental Performance Track Program.
Performance Track is the flagship EPA voluntary program that recognizes
and rewards top-performing facilities representing all sizes of
businesses from a variety of sectors. This program provides public
recognition to these entities and offers regulatory, policy, and
administrative incentives, such as a low priority for routine EPA
inspections, extended on-site storage times for hazardous waste, and
reduced reporting frequency under the Clean Air Act.
Incentives are the second cornerstone. Market-based approaches or
other incentives can lead businesses, government agencies, and other
organizations to do more than is required. These approaches provide a
way to link environmental and economic interests so that doing more for
the environment nets more for the bottom line. EPA is working to build
more incentives into our programs and policies. For example, EPA is
proposing to use market-based approaches to drastically reduce
emissions of mercury, SOx and NOx.
Technology is the third cornerstone. To continue making progress, it
is critical to harness the latest scientific, technological, and
information capabilities for environmental gain. For example under our
Technology for a Sustainable Environment (TSE) program, after a
competition, we award grants to support fundamental and applied
research related to pollution prevention in industrial processes and
methodologies ultimately leading to a reduction in waste at the source.
Under this program, as an alternative to organic or halogenated
solvents, a CO2-based process was developed. The work was further
supported with a Small Business Innovation Research grant and now a
$400 million commercial facility is being built to exploit it.
Focus on results is the fourth cornerstone. EPA understands that
traditional environmental strategies have sometimes gotten bogged down
in process at the expense of real progress. One of the best examples is
reducing dirty emissions from older diesel school buses. Recognizing
diesel engines have long life spans - sometimes 30 years - and that
many school systems would use current buses until they had ``run their
course,'' EPA launched a nationwide campaign to retrofit older buses
and provide our children with a much cleaner, healthier ride to school.
Hundreds of communities now have retrofitting programs underway.
EPA believes these cornerstones will be the foundation to finding a
better way to environmental progress.
Attention to Small Businesses
[[Page 72820]]
Helping small businesses improve environmental performance is a top
priority for EPA. EPA offers a variety of services for small
businesses, including a toll-free hotline, a semiannual newsletter,
online expert systems, and for some sectors, compliance assistance
centers that focus on the unique environmental management issues facing
specific industries. EPA also maintains a Small Business Ombudsman,
which provides a point of contact for small businesses and ensures
compliance with the Small Business Paperwork Relief Act of 2002.
In FY 2004, EPA is focusing on implementing the Small Business
Strategy. By better coordinating small business activities, EPA aims to
improve its technical assistance and outreach efforts, minimize burdens
to small businesses in its regulations, and simplify small businesses'
participation in its voluntary programs.
A number of rules included in this Plan may be of particular interest
to small businesses (and for a more extensive list of rules affecting
small businesses, please see appendices B and C to the Regulatory
Agenda which is available at epa.gov/regagenda.)
Groundwater Rule (2040-AA97)
Long Term 2 Enhanced Surface Water Treatment Rule (2040-AD37)
Stage 2 Disinfection Byproducts Rule (2040-AD38)
Minimizing Adverse Environmental Impacts from Cooling Water
Intake Structures (316(b) Phase III) Rule (2040-AD70)
Standardized Permit for RCRA Hazardous Waste Management
Facilities Final Rule (2050-AE44)
Office of Solid Waste Burden Reduction Project Final Rule
(2050-AE51)
Recycling of Cathode Ray Tubes and Mercury-Containing
Equipment: Changes to Hazardous Waste Regulations Final
Rule (2050-AE52)
Increase Metals Reclamation from F006 Waste Streams Proposed
Rule (2050-AE97)
Standards and Practices for Conducting ``All Appropriate
Inquiry'' Proposed Rule (2050-AF04)
Control of Emissions from Spark-Ignition Engines and Fuel
Systems from Marine Vessels and Small Equipment (2060-AM34)
HIGHLIGHTS OF EPA'S REGULATORY PLAN
Office of Air and Radiation
The principal regulatory priority of EPA's Office of Air and Radiation
(OAR) for FY 2005 is to protect public health and the environment from
the harmful effects of fine particulate matter and ozone, the two air
pollutants that persist widely in the Nation's air in amounts that
exceed Clean Air Act health standards. Exposure to these pollutants is
associated with numerous harmful effects on human health, including
respiratory problems, heart and lung disease, and premature death.
These pollutants also degrade visibility in National parks and other
scenic areas. In addition to ozone and particulate pollution, OAR is
continuing to address toxic air pollution by implementing a toxics-
control program under the Clean Air Act. OAR is also working to
increase the effectiveness and efficiency of its permitting programs,
which are the main mechanisms through which these protections are
implemented. These efforts are described briefly below.
One of OAR's principal vehicles to mitigate particulate and ozone
pollution is the Clean Air Interstate Rule, which will achieve large
reductions in sulfur dioxide and nitrogen oxide emissions that cause
particulate and ozone pollution. Emissions of sulfur dioxide and
nitrogen oxide, especially from electric powerplants, can be
transported on the wind over long distances from the Midwest to the
east coast. Such emissions can be a major factor in the pollution
problems of eastern cities. This program will achieve its reductions
through use of a ``cap-and-trade'' system similar to the one that has
proved so successful in EPA's Acid Rain program. OAR is also developing
a separate rule to enhance scenic areas by reducing the particulate
pollution that restricts visibility in those areas.
OAR is also developing a rulemaking addressing another category of
emissions that cause particulate and ozone pollution: emissions from
locomotives and smaller marine engines. This rule will enhance the
overall mobile-source control program that has already set stringent
standards for most categories of vehicles, engines, and their fuels.
Even though these Federal rules will go a long way toward reducing the
ozone and particulate pollution in America's cities, they can't do the
job alone. Additional State and local control programs under the Clean
Air Act will need to be instituted or enhanced in many of the most
polluted areas. To help and guide the States and local governments in
these efforts, EPA is developing implementation rulemakings for both
ozone and particulates that will provide technical help and policy
guidance crucial to assuring that State and local efforts achieve their
pollution-control goals.
OAR also continues to assess new scientific information that underlies
the National Ambient Air Quality Standards (NAAQS), which are the
centerpiece of the Clean Air Act and the foundation of OAR's program.
In 2005, EPA expects to announce the results of the latest review of
the particulate matter NAAQS in the form of a proposed rule to either
revise or reaffirm the current standard.
EPA continues to address toxic air pollution under authority of the
Clean Air Act Amendments of 1990. EPA has largely completed
implementing the ``Maximum Achievable Control Technology'' (MACT)
program, which has the goal of controlling toxic air pollution from
major emitters nationwide. Toxic air pollution is a term that covers a
large number of industrial chemicals and other substances that have
been shown to cause cancer, birth defects, and developmental problems
in children. To date, EPA's air toxics program has focused primarily on
reducing emissions from large industrial sources, such as petroleum
refineries and chemical manufacturing plants, through technology-based
standards. When fully implemented, the overall MACT program will reduce
more than one million tons of toxic air emissions per year. The
Electric Utility MACT regulation will address one of the most
significant remaining sources of mercury in the United States. While
working on these standards, OAR is beginning to evaluate those sources
with standards already in place to determine if the remaining risk from
those sources warrants additional regulation.
Since many air quality programs are administered through permitting
programs, OAR continues to work toward improving these programs to
increase efficiency and reduce regulatory burden. Currently, OAR is
developing rulemakings to streamline and improve its New Source Review
(NSR) permitting program. This effort will clarify the circumstances
under which companies must obtain construction permits before building
new facilities or significantly modifying existing facilities. These
revisions will provide more regulatory certainty by clarifying
compliance requirements, and will also make the program easier to
[[Page 72821]]
administer while maintaining its environmental benefits. In developing
these NSR rule revisions, OAR is drawing upon many years of intense
involvement with major stakeholders, who have helped shape a suite of
reforms that are expected to both improve the environmental
effectiveness of these programs and make them easier to comply with.
The annual report on the costs and benefits of regulations, entitled
``Stimulating Smarter Regulation: 2002 Report to Congress on the Costs
and Benefits of Regulations and Unfunded Mandates on State, Local, and
Tribal Entities,'' that is prepared by the Office of Management and
Budget (OMB) and submitted to Congress each year, included several
nominations for reform from the public. In FY2005, OAR expects to
address through regulatory action one of the areas raised: New Source
Review (Comments 16, 30, 77, 187, 188, 189, and 196). (For a
copy of these comments, go to OMB's compilation of the comments at
http://www.whitehouse.gov/omb/inforeg/key--comments.html.)
Office of Environmental Information
EPA's Office of Environmental Information (OEI) continues to ensure
that EPA collects and provides access to high quality environmental
information and data to our partners, stakeholders, and the public. In
keeping with this mandate, one of OEI's top regulatory priorities will
be the finalization of the electronic reporting provisions of the
Cross-Media Electronic Reporting and Record-Keeping Rule (CROMERRR).
EPA is deferring any further action on the CROMERRR electronic record-
keeping provisions until a later time. This final rule will address
electronic reporting by companies regulated under all of EPA's
programs: air, water, pesticides, toxic substances, wastes, and
emergency response. CROMERRR would remove existing regulatory obstacles
to electronic reporting, and it would set requirements for companies
choosing to report electronically. In addition, this rule would set the
conditions for allowing electronic reporting under State, tribal, or
local environmental programs that operate under EPA authorization.
CROMERRR is intended to make electronic reporting as simple,
efficient, and cost-effective as possible for regulated companies,
while ensuring that a transition from paper to electronic reporting
does not compromise EPA's compliance and enforcement programs.
Consequently, the Agency's strategy is to impose as few specific
requirements as possible, and to keep those requirements neutral with
respect to technology, so the rule will pose no obstacles to adopting
new technologies as they emerge.
To ensure that authorized programs at the State, tribal, and local
levels meet CROMERRR's goals, the rule would specify a set of criteria
that these programs must satisfy as they initiate electronic reporting.
The final rule would specify a process for certifying that these
programs meet the criteria. EPA is on schedule to finalize CROMERRR by
the first half of FY2005. In response to public comment, a decision was
made to focus the final rule on electronic reporting only, and to defer
coverage of electronic record keeping until a later time. Also in
response to comments, EPA currently is exploring a streamlined process
to review State programs for electronic reporting.
Another key regulatory priority that OEI is undertaking is the
enactment of burden reduction for the Toxics Release Inventory (TRI)
reporting community. The TRI program collects chemical release and
other waste management data on over 650 chemicals from over 24,000
facilities across the U.S. each year. To provide TRI reporters with
appropriate burden relief, TRI intends to propose two rulemakings to
address both short-term and longer-term reporting requirement
modifications while maintaining the practical utility of the TRI data.
Specifically, OEI intends to propose the TRI Reporting Forms
Modification rule to address noncontroversial modifications to the TRI
reporting requirements (i.e., Form R). At the same time, OEI intends to
continue parallel work on a second rulemaking to examine more
significant reporting modifications with greater potential impact on
reporting burden. The second rulemaking, the ``Toxics Release Inventory
Reporting Burden Reduction Rule,'' focuses on exploring long-term
reporting modifications.
OEI is assessing a number of burden reduction options for both
rulemakings within the criteria of what is technically, practically and
legally feasible in order to meet the goals and statutory obligations
set forth for TRI reporting. Although the primary goal of both efforts
is to reduce burden associated with TRI reporting, these rules will
also maintain EPA's commitment to providing valuable information to the
public.
In addition, EPA is committed to providing electronic means to its
stakeholders to meet EPA's reporting requirements, specifically through
the Central Data Exchange (CDX) system. CDX is an integrated system
that provides electronic reporting services to more than 30,000 users
for 16 data flows in six major EPA media programs, and is on track to
provide electronic reporting services for all significant environmental
data collections over the next two years. By enabling the regulated
community to utilize CDX as a reporting tool, the TRI Program has seen
a 49% increase in the number of reports submitted to EPA via the
Internet for TRI Reporting Year 2003 when compared to Reporting Year
2002. To take advantage of CDX's paperless reporting feature, TRI
reporters must use the EPA-provided TRI Made-Easy (TRI-ME) Software.
This upward trend toward greater Internet reporting via CDX is great
news for the TRI program. Money saved from processing more-costly hard-
copy paper submissions to TRI can now be reinvested in helpful tools
and automated data quality checks to assist facilities and in ways to
provide greater electronic means of accessing TRI data.
CDX also promulgated a number of new data flows, including the Office
of Water's Stormwater Electronic Notice of Intent (an electronic permit
application), the Office of Solid Waste and Emergency Response's Risk
Management Plan WebRC (electronic updates of emergency contact
information), and the Office of Prevention, Pesticides, and Toxic
Substances' Lead Request for Certification (payment transactions
online).
CDX is EPA's point of presence on the Environmental Exchange Network,
known as the ``Node.'' Using CDX, EPA has worked with States to provide
the technical specifications and exchange protocols for the Network.
CDX provides support services, including node building, security and
authentication and help desk. OEI is working with the major programs to
deploy their data flows as ``node'' exchanges, using XML and web
services. These efforts are some examples of EPA's commitment to the
collection and dissemination of the highest quality of environmental
information.
Office of Prevention, Pesticides, and Toxic Substances
EPA's Office of Prevention, Pesticides, and Toxic Substances (OPPTS)
plays an important role in protecting public health and the environment
from potential risk from pesticides and chemicals. In addition to the
daily
[[Page 72822]]
activities related to our licensing programs, OPPTS has identified
several regulatory priorities for the coming year.
Evidence suggests that environmental exposure to man-made chemicals
that mimic hormones (endocrine disruptors) may cause adverse health
effects in human and wildlife populations. The Food Quality Protection
Act directed EPA to develop a chemical screening program (the Endocrine
Disruptor Screening Program, EDSP), using appropriate validated test
systems and other scientifically relevant information, to determine
whether certain substances may have hormonal effects in humans. OPPTS
is implementing recommendations from a scientific advisory committee,
which was established to advise EPA on the EDSP, by developing and
validating test systems for determining whether a chemical may have
effects similar to those produced by naturally occurring hormones. As
part of this program EPA is also designing a regulatory framework for
procedures and processes to use when implementing the EDSP, and will
develop an initial list of chemicals for which testing will be
required. In early 2005, EPA anticipates publishing the final chemical
selection approach for this initial list of chemicals, which was
proposed in December 2002 for public comment.
In 2005, OPPTS will be revising its pesticide emergency exemption
program, under which States and other Federal agencies may obtain
permission to temporarily use a pesticide not in accordance with
registration requirements under emergency conditions. In response to
State concerns, EPA has already reduced the review time for emergency
exemptions significantly. Other changes that EPA is considering have
the potential for further streamlining the exemption program and
allowing more flexibility in its applicability.
OPPTS will propose to update and revise data requirements for the
registration of pesticide products in 40 CFR part 158. The regulations
specify the data required as the basis for the Agency's pesticide risk
assessment and licensing decisions. Although the Agency has kept pace
with evolving scientific understanding of pesticide risks by requiring
the submission of data on a case-by-case basis, the 1984 regulations
have not been updated to reflect these data needs on a routine basis.
The first in a series of proposals will address data requirements for
conventional chemical pesticides for agricultural uses. Subsequent
proposals are planned for antimicrobial, biochemical, microbial
pesticides, and plant-incorporated protectants.
In 2006, OPPTS will begin implementing a program, mandated by section
3(g) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),
to review the registrations of all pesticides at least once each 15
years. The registration review program will replace the tolerance
reassessment program (ending in 2006) and reregistration program
(ending in 2008) currently underway. These two programs are both one-
time reviews that evaluate and manage the risks posed by existing
pesticides. The Agency intends to initiate registration review while it
completes tolerance reassessment and reregistration. FIFRA 3(g)
requires the Agency to establish procedural regulations for the
registration review program. Promulgation of a procedural regulation is
a very high priority for OPP, in order to achieve a smooth transition
into the new registration review program.
EPA anticipates it will develop a policy or regulation concerning the
use of human research to support Agency actions to protect public
health and the environment. In developing a future policy or rule, EPA
will consider the public comments received in response to the Advance
Notice of Proposed Rulemaking issued in May 2003, and will also
carefully consider advice from the National Academy of Sciences
submitted to EPA in February 2004. The policy or rule would establish
rigorous scientific and ethical standards that EPA would apply in its
analysis of various types of research involving people exposed to
toxicants to identify or quantify their effects. The Agency will
particularly focus on ``third-party intentional dosing human studies,''
but recognizes that standards applicable to these studies may also be
applicable to other types of studies. ``Third-party studies'' refers to
research not conducted or supported by EPA or other federal agencies,
and therefore not governed by the regulation for ``Protection of Human
Subjects,'' widely referred to as the ``Common Rule'' (40 CFR part 26).
The Agency launched the HPV Initiative in April 1998 to collect or,
where necessary, develop basic screening level hazard data necessary to
provide critical information about the environmental fate and potential
hazards associated with high production volume (HPV) chemicals. These
chemicals are defined as organic chemicals manufactured (including
imported) at or above 1 million pounds per year based on information
submitted under the 1990 Inventory Update Rule established pursuant to
the Toxic Substances Control Act (TSCA). Data collected and/or
developed under the HPV Initiative will provide critical basic
information about the environmental fate and potential hazards
associated with these chemicals which, when combined with information
about exposure and uses, will allow the Agency and others to evaluate
and prioritize potential health and environmental effects and take
appropriate follow up action. The HPV Initiative includes a voluntary
component, the HPV Challenge Program, and rulemaking under TSCA. Under
the voluntary HPV Challenge Program component, EPA received commitments
from 401 companies individually or through consortia and the
International Council of Chemical Associations (ICCA) to sponsor 2,222
of the estimated 2,800 HPV chemicals included in the HPV Initiative.
OPPTS issued a status report for the HPV Challenge Program on December
1, 2004. The report, ``Status and Future Directions of the HPV
Challenge Program,'' showcases the extensive voluntary participation by
companies that have agreed to provide data to EPA on chemicals they
manufacture or import, and outlines a preliminary strategy for how EPA
will deal with chemicals that are not yet sponsored. More information
about the report and the HPV Chemical Program is available at http://
www.epa.gov/chemrtk/hpvstatr.htm.
In the spring of 2005, OPPTS expects to issue a final rulemaking under
TSCA that will require testing for a number of the HPV chemicals that
were not sponsored as part of the voluntary HPV Challenge Program.
Childhood lead poisoning is an ongoing problem in the United States,
with almost a million young children having more than 10 ug/dl of lead
in their blood (Center for Disease Control's level of concern).
Although there have been dramatic declines in blood-lead levels due to
reductions of lead in paint, gasoline and various food sources,
remaining lead-based paint in older houses continues to be a
significant source of childhood lead poisoning. Section 402(c) of TSCA
directs EPA to address renovation and remodeling activities in these
older houses by first conducting a study of the extent to which persons
engaged in various types of renovation and remodeling activities
[[Page 72823]]
are exposed to lead in the conduct of such activities or disturb lead
and create a lead-based paint hazard on a regular basis. Section 402(c)
further directs the Agency to revise the lead-based paint activities
regulations (40 CFR part 745 Subpart L) to include renovation or
remodeling activities that create lead-based paint hazards. In order to
determine which contractors are engaged in such activities the Agency
is directed to utilize the results of the study and consult with the
representatives of labor organizations, lead-based paint activities
contractors, persons engaged in remodeling and renovation, experts in
health effects, and others. Given the significant number of older
houses affected, such a rule is likely to have a potentially
significant economic impact. In an effort to minimize that impact, the
Agency has worked with stakeholders to explore the development of non-
regulatory approaches for reducing the potential creation of lead-based
paint hazards from renovation or remodeling activities. The Agency will
be pilot testing one such approach, the ``Lead Safety Partnership,''
beginning in the fall of 2004. The Lead Safety Partnership is a public/
private initiative to encourage contractors to use Lead Safe Work
Practices (LSWP) during renovation, repair, and painting. LSWP are a
set of work methods that avoid making and spreading lead-contaminated
dust. Such lead-based paint program activities are intended to insure
that the individuals and firms conducting lead-based paint activities
will do so in a way that safeguards the environment and protects the
health of building occupants, especially children under six years old.
In 2005, OPPT expects to assess the status of the pending
implementation in the U.S. of the Rotterdam Convention on Prior
Informed Consent (PIC), which includes export notification requirements
related to a comment mentioned in OMB's 2002 Report to Congress on the
Costs and Benefits of Regulations. (See OMB's compilation of comments,
summary no. 190, page 10, commenter no. 12 available at http://
www.whitehouse.gov/omb/inforeg/key--comments.html.)
The Agency launched the HPV Initiativein April 1998 to collect or,
where necessary, develop basic screening level hazard data necessary to
provide critical information about the environmental fate and potential
hazards associated with high production volume (HPV) chemicals. These
chemicals are defined as organic chemicals manufactured (including
imported) at or above 1 million pounds per year based on information
submitted under the 1990 Inventory Update Rule established pursuant to
the Toxic Substances Control Act (TSCA). Data collected and/or
developed under the HPV Initiative will provide critical basic
information about the environmental fate and potential hazards
associated with these chemicals which, when combined with information
about exposure and uses, will allow the Agency and others to evaluate
and prioritize potential health and environmental effects and take
appropriate follow up action. The HPV Initiative includes a voluntary
component, the HPV Challenge Program, and rulemaking under TSCA. Under
the voluntary HPV Challenge Program component, EPA received commitments
from 401 companies individually or through consortia and the
International Council of Chemical Associations (ICCA) to sponsor 2,222
of the estimated 2,800 HPV chemicals included in the HPV Initiative.
OPPTS anticipates issuing a status report for the HPV Challenge Program
in the fall of 2004. In the spring of 2005, OPPTS expects to issue a
final rulemaking under TSCA that will require testing for a number of
the HPV chemicals that were not sponsored as part of the voluntary HPV
Challenge Program.
Office of Solid Waste and Emergency Response
The Office of Solid Waste and Emergency Response (OSWER) has a number
of regulatory priorities aimed at improving environmental quality.
Protection of public health and the environment and environmental
stewardship are two key themes, as is reducing burden on the regulated
community where environmental protections are maintained.
EPA will promote and protect air quality by reducing emissions of
arsenic, beryllium, cadmium, chromium, dioxins and furans, hydrogen
chloride, lead, manganese, and mercury, all of which cause adverse
health effects. EPA plans to promulgate national emission standards for
these hazardous air pollutants for hazardous waste combustors. This
rule will also contain a final decision to the Cement Kiln Recycling
Coalition petition of the Administrator to withdraw Agency policy and
technical guidance concerning site-specific risk assessments for
hazardous waste combustors and re-issue them as regulations, if EPA
continues to believe that they are necessary. This rule also supports a
reform nomination for site-specific risk assessments in the Resource
Conservation and Recovery Act (RCRA) that was mentioned in OMB's 2002
Report to Congress on the Costs and Benefits of Regulations.
To promote environmental stewardship, EPA is encouraging recycling.
One of the largest hazardous waste streams amenable to recycling is the
wastewater treatment sludges from electroplating operations (waste code
F006). EPA is considering changes to the existing RCRA regulations to
encourage safe recycling and waste management practices of wastewater
treatment sludges from electroplating operations. These electroplating
sludges are sufficiently high in metal(s) and sufficiently low in other
toxic constituents.
EPA also seeks to remove unnecessary regulatory barriers to recycling
of Cathode Ray Tubes. These tubes, which are found in televisions and
computer monitors, contain lead to protect users from x-rays. To
promote recycling, EPA will seek to streamline RCRA requirements for
managing mercury-containing equipment.
To reduce burden on the regulated community, Agency efforts are
underway to eliminate duplicative and non-essential paperwork burden
imposed by RCRA reporting and recordkeeping requirements. This rule
will eliminate or streamline paperwork requirements that are
unnecessary because they add little to the protectiveness of the RCRA
regulations. This rule also supports a reform nomination for burden
reduction under RCRA that was mentioned in OMB's 2002 Report to
Congress on the Costs and Benefits of Regulations.
EPA also intends to reduce burden on the regulated community by
revising the current RCRA regulations that apply to the wastewater
treatment sludges from the chemical conversion coating (zinc
phosphating) of aluminum. The current federal regulations require that
the wastewater treatment sludges generated from this conversion coating
process be managed as a RCRA hazardous waste. Yet, such sludges do not
contain the constituents for which the F019 hazardous waste was
originally listed (cyanide and chromium).
EPA also plans to streamline both the RCRA permit and hazardous waste
manifest processes. The Agency is creating a standardized permit for
RCRA facilities that generate hazardous waste and routinely manage the
waste on-site in tanks, containers, and containment
[[Page 72824]]
buildings. This standardized permit process would allow facilities to
obtain and modify permits more easily while maintaining the
protectiveness currently existing in the individual RCRA permit
process.
Likewise, the Agency plans to reduce paperwork burden by standardizing
the Uniform Hazardous Waste Manifest, which is a multi-copy form used
to identify the quantity, composition, origin, routing, and destination
of RCRA hazardous waste during its transportation. EPA plans to specify
one format for the manifests that may be used in all states. EPA is
working toward standard requirements for tracking rejected wastes,
container residues, and international shipments of hazardous wastes.
Office of Water
EPA's Office of Water's primary goals are to ensure that drinking
water is safe, restore and maintain oceans, watersheds, and their
aquatic ecosystems to protect human health, support economic and
recreational activities, and provide healthy habitat for fish, plants,
and wildlife. In order to meet these goals, EPA has established a
number of regulatory priorities for the coming year. They include rules
affecting cooling water intakes and drinking water.
In November 2004, EPA issued a proposed rule to control the adverse
environmental impacts associated with cooling water intakes. Many power
plants and factories withdraw large volumes of water from rivers,
lakes, or other water bodies to cool their production equipment. As
required by the Clean Water Act (CWA), EPA must ensure that the
location, design, construction and capacity of these cooling water
intake structures reflect the best technology available for minimizing
adverse environmental impact. EPA's rulemaking may affect existing
facilities that use cooling water intake structures, and whose intake
flow levels exceed a minimum threshold to be determined by EPA during
this rulemaking. EPA will accept comments on the proposed rule until
March 24, 2005.
Finally, EPA is developing three rules to protect the safety of
drinking water. First, EPA is developing a final Long Term 2 Enhanced
Surface Water Treatment Rule (LT2ESWTR). This rule would reduce risks
from microbial pathogens, especially Cryptosporidium, in public water
systems that use surface water sources. LT2ESWTR provisions would
target systems where current standards do not provide sufficient
protection, including both filtered systems with elevated source water
pathogen levels and unfiltered systems. Second, EPA plans to finalize
the Ground Water Rule, a rule that addresses fecal contamination in
public water systems served by ground water sources. Finally, EPA is
developing a final Stage 2 Disinfectants and Disinfection Byproducts
Rule to control exposure to disinfection byproducts beyond the
requirements of the Stage 1 Disinfectants and Disinfection Byproducts
Rule. This rule will respond to new data the Agency has received on:
disinfection byproduct occurrence; bladder, colon, and rectal cancer;
and possible reproductive and developmental health effects.
_______________________________________________________________________
EPA
-----------
PRERULE STAGE
-----------
115. ENDOCRINE DISRUPTOR SCREENING PROGRAM (EDSP); CHEMICAL SELECTION
APPROACH FOR INITIAL ROUND OF SCREENING
Priority:
Other Significant
Legal Authority:
15 USC 2603 TSCA; 21 USC 346(a) FFDCA; 42 USC 300(a)(17) SDWA; 7 USC
136 FIFRA
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
EPA published a proposed policy statement in the Federal Register
setting forth the Endocrine Disruptor Screening Program (EDSP) on
December 28, 1998. In that FR Notice, the Agency described the major
elements of the Program EPA had developed to comply with the
requirements of FFDCA section 408(p) as amended by FQPA. One of those
elements is Priority Setting which was defined as the collection,
evaluation, and analysis of relevant information to determine the
general order in which chemical substances and mixtures will be
subjected to screening and testing. Under this current action, EPA is
developing a priority setting approach to be used by the Agency to
identify the initial list of chemicals for which EDSP Tier 1 testing
will be required. On December 30, 2002, EPA published in the Federal
Register for public comment a proposed chemical selection approach for
this initial list of chemicals. The public comment period on this
proposed approach was extended to April 1, 2003 in a Federal Register
notice dated February 26, 2003. EPA has considered the comments and
will issue a Federal Register notice setting forth its final approach.
EPA will issue an additional Federal Register notice setting forth the
draft initial list of chemicals it proposes for testing. This
additional notice is expected to be published to allow sufficient time
for review and comment prior to actual Tier 1 assay testing. Although
this action is not a rulemaking, the Agency has included it in the
Regulatory Agenda to help inform the public.
Statement of Need:
The Endocrine Disruptor Screening Program fulfills the statutory
requirement to screen pesticide chemicals for their potential to
disrupt the endocrine system and adversely affect human health.
Summary of Legal Basis:
The mandate to screen pesticide chemicals for estrogenic effects that
may affect human health is section 408(p) of the Federal Food, Drug and
Cosmetic Act (FFDCA) (21 U.S.C. 346a(p)). Discretionary authority to
test contaminants in sources of drinking water is in the Safe Drinking
Water Act as amended in 1996 (42 U.S.C. 300j-17). General authority to
require testing of chemicals and pesticides is in TSCA (15 U.S.C. 2603)
and FIFRA (7 U.S.C. 136) respectively.
Alternatives:
A federal role is mandated under cited authority. There is no
alternative to the role of the Federal government on this issue to
ensure that pesticides, commercial chemicals and contaminants are
screened and tested for endocrine disruption potential. A limited
amount of testing may be conducted voluntarily but this will fall far
short of the systematic screening which is necessary to protect public
health and the environment and ensure the public that all important
substances have been adequately evaluated.
Anticipated Cost and Benefits:
None.
Risks:
Evidence is continuing to mount that wildlife and humans may be at risk
[[Page 72825]]
from exposure to chemicals operating through an endocrine mediated
pathway. Preliminary studies show decreases on IQ tests and increases
in aggression in children. Severe malformations of the genitals of boys
has increased steadily over the last two decades and fertility has
decreased in young males. Wildlife effects have been more thoroughly
documented. Abnormalities in birds, marine mammals, fish, amphibians,
alligators, and shellfish have been documented in the U.S., Europe,
Japan, Canada, and Australia which have been linked to specific
chemical exposures. Evidence is sufficient for the U.S. to proceed on a
two track strategy: research on the basic science regarding endocrine
disruption and screening with validated assays to identify which
chemicals are capable of interacting with the endocrine system. The
combination of research and test data submitted in this program will
enable EPA to take action to reduce risks.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Notice: Proposed67 FR 79611 12/30/02
Notice: Final Approach 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Additional Information:
SAN No. 4727, EDocket No. OPPT-2004-0109; Split from RIN 2070-AD26.
URL For More Information:
http://www.epa.gov/scipoly/oscpendo/prioritysetting/index.htm
Agency Contact:
Mary Belefski
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Washington, DC 20460
Phone: 202-564-8461
Fax: 202-564-8452
Email: belefski.mary@epamail.epa.gov
Gary Timm
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Washington, DC 20460
Phone: 202-564-8474
Fax: 202 564-8482
Email: timm.gary@epamail.epa.gov
RIN: 2070-AD59
_______________________________________________________________________
EPA
116. NOTIFICATION OF CHEMICAL EXPORTS UNDER TSCA SECTION 12(B)
Priority:
Other Significant
Legal Authority:
15 USC 2611
CFR Citation:
40 CFR 707
Legal Deadline:
None
Abstract:
Section 12(b)(2) of the Toxic Substances Control Act (TSCA) states, in
part, that any person who exports or intends to export to a foreign
country a chemical substance or mixture for which submission of data is
required under section 4 or 5(b), or for which a rule, action or order
has been proposed or promulgated under section 5, 6, or 7, shall notify
the EPA Administrator of such export or intent to export. The
Administrator in turn will notify the government of the importing
country of EPA's regulatory action with respect to the substance.
Legislation is currently pending to address the implementation in the
United States of the Rotterdam Convention on Prior Informed Consent
(PIC), which itself includes export notification requirements. In order
to address these concerns, and additional concerns expressed by other
stakeholders, EPA has reported to OMB that as of August 2004, the PIC
legislation is not yet in force. EPA further informed OMB that in 2005,
the Agency will reassess the status of the legislation and, if
appropriate, will initiate the rulemaking process for considering
changes to the TSCA section 12(b) regulation, within the scope of
existing statutory authority. This could include holding public
meetings and/or issuing an ANPRM that invites interested parties to
participate in developing amendments to the current TSCA section 12(b)
regulations.
Statement of Need:
Industry has nominated the implementing regulations for reform
consideration in the annual report on the costs and benefits of
regulations, entitled ``Stimulating Smarter Regulation: 2002 Report to
Congress on the Costs and Benefits of Regulations and Unfunded Mandates
on State, Local, and Tribal Entities,'' that is prepared by the Office
of Management and Budget (OMB) and submitted to Congress each year.
(See OMB's compilation of comments, summary no. 190, pg 10, commenter
no. 12 available at http://www.whitehouse.gov/omb/inforeg/key--
comments.html.)
Summary of Legal Basis:
Section 12(b)(2) of the Toxic Substances Control Act (TSCA).
Alternatives:
To be determined.
Anticipated Cost and Benefits:
Minimal, but yet to be determined.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Notice 08/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Additional Information:
SAN 4858.
[[Page 72826]]
Agency Contact:
Greg Schweer
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202-564-8469
Fax: 202 564-4765
Email: schweer.greg@epamail.epa.gov
David Williams
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202 564-8179
Fax: 202 564-4765
Email: williams.daver@epa.gov
RIN: 2070-AJ01
_______________________________________________________________________
EPA
117. LEAD-BASED PAINT ACTIVITIES; VOLUNTARY PROGRAM FOR RENOVATION AND
REMODELING
Priority:
Other Significant
Legal Authority:
15 USC 2682 TSCA 4 402; PL 102-550 sec 402(c)(3)
CFR Citation:
40 CFR 745
Legal Deadline:
None
Abstract:
As an alternative to the regulatory program, EPA is working with
stakeholders to develop a voluntary program for renovations and
remodeling activities. The voluntary program would partner the Agency
and national organizations together to promote an initiative which
could provide incentives to participating contractors and property
owners who incorporate lead safe work practices into their standard
operating procedures. The Agency plans, in a Notice or ANPRM to be
published in the winter of 2004, to introduce the voluntary program,
discuss its component parts, and review how it will be evaluated.
Statement of Need:
Childhood lead poisoning is a pervasive problem in the United States,
with almost a million young children having more than 10 ug/dl of lead
in their blood, (Center for Disease Control's level of concern).
Although there have been dramatic declines in blood-lead levels due to
reductions of lead in paint, gasoline, and food sources, remaining
paint in older houses continues to be a significant source of childhood
lead poisoning. These rules will help insure that individuals and firms
conducting lead-based paint activities will do so in a way that
safeguards the environment and protects the health of building
occupants, especially children under 6 years old.
Summary of Legal Basis:
TSCA section 402(c) directs EPA to address renovation and remodeling
activities by first conducting a study of the extent to which persons
engaged in various types of renovation and remodeling activities are
exposed to lead in the conduct of such activities or disturb lead and
create a lead-based paint hazard on a regular basis. Section 402(c)
further directs the Agency to revise the lead-based paint activities
regulations (40 CFR part 745 subpart L) to include renovation or
remodeling activities that create lead-based paint hazards. In order to
determine which contractors are engaged in such activities the Agency
is directed to utilize the results of the study and consult with the
representatives of labor organizations, lead-based paint activities
contractors, persons engaged in remodeling and renovation, experts in
health effects, and others.
Alternatives:
TSCA section 402(c) states that should the Administrator determine that
any category of contractors engaged in renovation or remodeling does
not require certification; the Administrator may publish an explanation
of the basis for that determination. This voluntary program is one of
the key alternatives considered to developing a more prescriptive
regulatory program.
Anticipated Cost and Benefits:
EPA's quantitative cost estimates fall into four categories: Training
Costs, Work Practice Costs, Clearance Testing Costs, and Administrative
Costs. The estimates vary depending upon the option selected. In most
cases we expect that requirements related to Clearance Testing and Work
Practices will contribute the most to overall rule cost. The benefits
analysis will not provide direct quantitative measures of each (or any)
option. EPA does not have a complete risk assessment (with dose-
response functions) that would permit direct quantitative estimates. We
do have other data, such as estimated loadings of Pb generated by
renovation work, number and type of renovation events, demographics of
the exposed population, and the costs of various health effects
previously linked to Pb exposure. With the available information we are
able to utilize several qualitative approaches to frame the benefits
associated with an effective renovation rule.
Risks:
Like the rules under consideration, this voluntary program is aimed at
reducing the prevalence and severity of lead poisoning, particularly in
children. The Agency has concluded that many R&R work activities can
produce or release large quantities of lead and may be associated with
elevated blood lead levels. These activities include, but are not
limited to: sanding, cutting, window replacement, and demolition. Lead
exposure of R&R workers appears to be less of a problem than that of
building occupants (especially young children). Some workers (and
homeowners) are occasionally exposed to high levels of lead. Any work
activity that produces dust and debris may create a lead exposure
problem.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Notice Announcing 1st Pilot 12/00/04
Notice Announcing 2nd Pilot 05/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, Local, State, Tribal
Additional Information:
SAN No. 3557.1; Split from RIN 2070-AC83.
[[Page 72827]]
Agency Contact:
Mike Wilson
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404T
Washington, DC 20460
Phone: 202-566-0521
Fax: 202 566-0469
Email: wilson.mike@epamail.epa.gov
Julie Simpson
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404T
Washington, DC 20460
Phone: 202-566-1980
Fax: 202 566-0471
Email: simpson.julie@epamail.epa.gov
RIN: 2070-AJ03
_______________________________________________________________________
EPA
-----------
PROPOSED RULE STAGE
-----------
118. CLEAN AIR FINE PARTICLE IMPLEMENTATION RULE
Priority:
Other Significant
Unfunded Mandates:
This action may affect State, local or tribal governments and the
private sector.
Legal Authority:
42 USC 7410; 42 USC 7501 et seq
CFR Citation:
40 CFR 51
Legal Deadline:
None
Abstract:
In 1997, EPA promulgated revised National Ambient Air Quality Standards
(NAAQS) for fine particulate matter (PM-2.5). The rule described in
this paragraph--the Implementation Rule for PM-2.5 NAAQS--will include
requirements and guidance for State and local air pollution agencies to
develop and submit State implementation plans (SIPs) designed to bring
the areas into attainment with the 1997 standards. These SIP-
development activities include conducting technical analyses to
identify effective strategies for reducing emissions contributing to
PM-2.5 levels, and adopting regulations as needed in order to attain
the standards. Ambient air quality monitoring for 1999-2001 shows that
areas exceeding the standards are located throughout the eastern half
of the United States and in California. Estimates show that compliance
with the standards will prevent thousands of premature deaths from
heart and lung disease, tens of thousands of hospital admissions and
emergency room visits, and millions of absences from school and work
every year.
Statement of Need:
This rule is needed in order to provide guidance to State and local
agencies in preparing State Implementation Plans (SIPs) designed to
bring areas into attainment with the 1997 PM-2.5 standards. The
implementation requirements for nonattainment areas are generally
described in subpart 1 of section 172 of the Clean Air Act. This rule
provides further interpretation of those requirements for the PM-2.5
standards.
Summary of Legal Basis:
42 USC 7410 and 42 USC 7501 et seq.
Alternatives:
Alternatives will be explored as the proposal is developed.
Anticipated Cost and Benefits:
This information will be provided as the proposal is developed.
Risks:
The risks addressed by this rule are those addressed by the 1997 NAAQS
rule -- i.e., the health and environmental risks associated with
nonattainment of the NAAQS. These risks were summarized in detail in
the analyses accompanying the 1997 NAAQS rule.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/04
Final Action 06/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Federal, Local, State, Tribal
Additional Information:
SAN No. 4752;
Agency Contact:
Rich Damberg
Environmental Protection Agency
Air and Radiation
C504-02
Washington, DC 20460
Phone: 919-541-5592
Fax: 919 541-5489
Email: damberg.rich@epamail.epa.gov
Joe Paisie
Environmental Protection Agency
Air and Radiation
C504-02
Research Triangle Park, NC 27711
Phone: 919-541-5556
Fax: 919 541-5489
Email: paisie.joe@epamail.epa.gov
RIN: 2060-AK74
_______________________________________________________________________
EPA
119. PREVENTION OF SIGNIFICANT DETERIORATION (PSD) AND NONATTAINMENT
NEW SOURCE REVIEW (NSR): ALLOWABLES PLANTWIDE APPLICABILITY LIMIT
(PAL), AGGREGATION, AND DEBOTTLENECKING
Priority:
Other Significant
Legal Authority:
42 USC 7401 et seq
CFR Citation:
40 CFR 51.165; 40 CFR 51.166; 40 CFR 52.21
Legal Deadline:
None
Abstract:
These rules clarify when less than significant emissions increases from
multiple activities at a single major stationary source must be
considered together for the purposes of determining major new source
review (NSR) applicability (aggregation). We are also changing in the
way emissions from permitted emissions units upstream or downstream
from those undergoing a physical change or change in the method of
operation are considered when determining if a proposed project will
result in a significant emissions increase (debottlenecking). The rules
also provide an allowables plantwide applicability limit (PAL) option
that is based on the allowable emissions from major stationary sources.
A PAL is an optional approach that provides the owners or operators of
major stationary sources with the ability to manage
[[Page 72828]]
facility-wide emissions without triggering major NSR. The added
flexibility of a PAL allows sources to respond rapidly to market
changes consistent with the goals of the NSR program. The regulations
for aggregation and debottlenecking are intended to improve
implementation of the program by articulating principles for
determining major NSR applicability that were previously addressed
through guidance only. The purpose of the allowables PAL rule is to
encourage major stationary sources to install state-of-the-art controls
in exchange for regulatory certainty and flexibility.
Statement of Need:
The current New Source Review program provides for emissions from
multiple projects to be aggregated (aggregation) as one single project
under certain circumstances. Similarly, when making a PSD applicability
calculation, emissions from units whose effective capacity and
potential to emit have been increased as a result of a modification to
another unit (debottlenecked units), must be included in the initial
PSD applicability calculations. Specific questions regarding the
application of these two terms have been addressed on a case-by-case
basis. By completing this rulemaking, regulated entities and regulatory
agencies will be provided an additional level of certainty in
addressing applicability issues. In December 2002 we promulgated NSR
rules for a Plantwide Applicability Limit (PAL) based on actual
emissions that applies to existing major stationary sources. In 2005,
we will propose an allowables PAL based on a facility's allowable
emissions mainly for greenfield sources. If a company commits to keep
its facility emissions below Allowables PAL level, then these
regulations will allow the plant owners to avoid the NSR permitting
process when they make changes at individual units at the plant, as
long as the total emissions from the facility will not increase. This
would provide flexibility for sources to respond rapidly to market
changes without compromising environmental protection.
Summary of Legal Basis:
42 USC 7411(a)(4)
Alternatives:
Alternatives will be developed as the rulemaking proceeds.
Anticipated Cost and Benefits:
Cost and benefit information will be developed as appropriate as the
rulemaking proceeds.
Risks:
Risk information will be developed as appropriate as the rulemaking
proceeds.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 02/00/05
Final Action 10/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State, Tribal
Additional Information:
SAN No. 4793;
Agency Contact:
Juan Santiago
Environmental Protection Agency
Air and Radiation
C33903
Washington, DC 20460
Phone: 919-541-1084
Fax: 919 541-5509
Email: santiago.juan@epamail.epa.gov
Raj Rao
Environmental Protection Agency
Air and Radiation
C339-03
Washington, DC 20460
Phone: 919-541-5344
Fax: 919 541-5509
Email: rao.raj@epamail.epa.gov
RIN: 2060-AL75
_______________________________________________________________________
EPA
120. PESTICIDES; DATA REQUIREMENTS FOR CONVENTIONAL CHEMICALS
Priority:
Other Significant
Legal Authority:
7 USC 136(a) to 136(y)
CFR Citation:
40 CFR 158
Legal Deadline:
None
Abstract:
EPA will propose revisions to its data requirements for the
registration of conventional pesticide products. In this action, the
Agency will propose revisions to the data requirements that pertain to
product chemistry, toxicology, residue chemistry, applicator exposure,
post-application exposure, nontarget terrestrial and aquatic organisms,
nontarget plant protection, and environmental fate. The proposed data
requirements will reflect current scientific knowledge and
understanding. These revisions would improve the Agency's ability to
make regulatory decisions about the human health and environmental
effects of pesticide products to better protect wildlife, the
environment, and people, including sensitive subpopulations. Coupled
with revision of data requirements, EPA will propose to reformat the
requirements and revise its general procedures and policies associated
with data submission. By codifying existing data requirements which are
currently applied on a case-by-case basis, the pesticide industry,
along with other partners in the regulated community, would attain a
better understanding and could better prepare for the pesticide
registration process. EPA intends to propose a series of revisions to
the data requirements, covering different data disciplines and product
types.
Statement of Need:
Since the data requirements were first published in 1984, the
information needed to support the registration of a pesticide has
evolved along with the expanding knowledge base of pesticide chemical
technology. Over the years, updated data requirements have been applied
on a case-by-case basis to support individual registration applications
or imposed by data call-in on registrants of similar products. The
codified data requirements have not been revised to keep pace with the
updated data requirements. EPA will also propose to reformat the data
requirements and revise procedures and policies for data submission.
The changes to be proposed are intended to provide stakeholders with a
more transparent and improved clarity of the potential data
requirements, more focused use patterns that reflect current practice,
and a more efficient registration process.
Summary of Legal Basis:
The planned proposed rule is intended to describe data and information
needed to support multiple pesticide mandates under two statutes,
specifically the registration, reregistration, registration review,
[[Page 72829]]
experimental use permit programs under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA), and the tolerance-setting
program under the Federal Food, Drug and Cosmetic Act (FFDCA). FIFRA
section 3(c) requires that applicants for registration provide the
Agency a full description of tests made and the results that support
the registration of a pesticide product, and requires the Agency to
issue guidelines specifying the kinds of information needed to support
registration. FIFRA section 3(g) requires the Agency to review every 15
years the registration of each pesticide, and determine that it
continues to meet the registration standard. The data requirements
established for registration will be the foundation of the Agency's
registration review. FIFRA section 4 requires the Agency to reregister
pesticides that were registered prior to 1984, and in so doing, to
provide data and summaries of studies previously submitted to support
registration. FIFRA section 5 authorizes the Agency to issue
experimental use permits for which data may be required. FFDCA section
408 authorizes EPA to establish tolerances (or expemptions from
tolerance) for pesticide residues in food, and prescribes generally the
types of data that are to be submitted to support such tolerances.
Alternatives:
The Agency is required by its various statutory mandates to establish
data requirements that support its regulatory decisions. It is
incumbent on the Agency to reevaluate those data requirements in light
of scientific advances, analytical improvements, and new technology, in
order to provide a sound scientific basis for those decisions.
Accordingly, EPA sees no alternative to the overall need to update and
revise its data requirements periodically. As it does so, however, each
individual data requirement is evaluated against current scientific
standards, value and cost, and undergoes an extensive review, including
external and public participation, to assess the continued need for the
data. The Agency also considers whether alternative regulatory methods,
such as restrictions on use, would obviate the need for data, and
explores means of introducing flexibility and clarity to reduce burdens
on the regulated community.
Anticipated Cost and Benefits:
Although estimates may change before the proposal is published, the
following estimates are based on the current draft Economic Analysis.
Using the currently codified requirements as the baseline for the
impact analysis, the total annual impact of the proposed revisions to
the pesticide industry is estimated to be about $50 million. Of this
estimated total annual impact, about $29 million per year represents
new data requirements that were imposed over the years but were not
specified in the existing CFR. As they have been applied to an
increasing number of registrations, these data requirements have become
more regularly required and will be proposed for codification. In
addition, about $22 million represents the cost of the proposed
modified or expanded existing data requirements for certain tests and
use patterns, and about $2 million represents the cost of proposed new
data requirements for data that have not yet been routinely sought. The
benefits are difficult to quantify but were an important part of the
Agency consideration in developing the proposal. The following parties
are expected to benefit: consumers and the general public; farmers and
other workers; registrants; animal welfare concerns; scientific,
environmental and health communities; State and local governments; EPA
and other Federal agencies; and governments outside the United states.
Risks:
The revisions to the data requirements to be proposed, like the
existing requirements in part 158, would require an applicant for
pesticide registration to supply the Agency with information on the
pesticide: composition, toxicity, potential human exposure,
environmental properties and ecological effects, and efficacy in
certain cases. This information is used to assess the human health and
environmental risks associated with the product. The data that would be
required by this regulation in its current form, and as expected to be
proposed, form the foundation of EPA's risk assessment for pesticides,
and provide a sound scientific basis for any licensing decisions that
impose requirements that mitigate or reduce risks, and that ensure that
pesticide residues in food meet the ``reasonable certainty of no harm''
risk standard of the FFDCA.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Additional Information:
SAN 2687.
Sectors Affected:
32532 Pesticide and Other Agricultural Chemical Manufacturing
Agency Contact:
Melissa Chun
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703-305-4027
Fax: 703 305-5884
Email: chun.melissa@epamail.epa.gov
Jean Frane
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703-305-5944
Fax: 703 305-5884
Email: frane.jean@epamail.epa.gov
RIN: 2070-AC12
_______________________________________________________________________
EPA
121. PESTICIDES; EMERGENCY EXEMPTION PROCESS REVISIONS
Priority:
Other Significant
Legal Authority:
7 USC 136p; 7 USC 136w
CFR Citation:
40 CFR 166
Legal Deadline:
None
Abstract:
EPA will publish a Notice of Proposed Rulemaking in the Federal
Register proposing several improvements to the pesticide emergency
exemption process under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide
[[Page 72830]]
Act (FIFRA). Two of these potential improvements are currently being
tested through a limited pilot, and are based on recommendations from
the States which are the primary applicants for emergency exemptions.
EPA has established regulations under section 18 of FIFRA which allow a
Federal or State agency to apply for an emergency exemption to allow an
unregistered use of a pesticide for a limited time when such use is
necessary to alleviate an emergency condition. The proposed revisions
would streamline the application and review process, thereby reducing
the burden to applicants and EPA, while allowing for quicker emergency
response without compromising existing protections for human health and
the environment.
Statement of Need:
In 1996, stakeholders, including States and Federal agencies,
identified a number of issues related to improving the emergency
exemption process. States and Federal agencies are the only applicants
for emergency exemptions. Representatives of States have recommended
modifications to the current process for application, review and
approval of emergency exemptions. If adopted, the changes would reduce
unnecessary burden to both applicants and EPA, and expedite decisions
on applications (which is critical in emergency situations).
Summary of Legal Basis:
FIFRA section 18 authorizes EPA to temporarily exempt States from the
requirements of registration to alleviate an emergency condition.
Alternatives:
EPA has analyzed several measures for streamlining or improving the
emergency exemption process, and has received considerable comment,
both formally and informally, from stakeholders, including specific
recommendations from a group representing States' interests. Since the
modifications would generally constitute regulatory relief, and are not
expected to cause any adverse economic impact, options with varying
cost do not apply.
Anticipated Cost and Benefits:
EPA has assessed the potential economic impacts of the proposed
improvements and found that they would reduce burdens and costs to
States and Federal agencies that apply for emergency exemptions, as
well as reduced burden to EPA. The Agency estimates an annual cost
reduction of $820,000 for applicants and $120,000 for EPA, for a total
of $940,000. Indirect benefits may accrue to users of pesticides under
emergency exemptions if changes result in faster review and approval,
or greater availability of pesticides.
Risks:
In general, the measures being considered are primarily intended to
reduce burdens for States and EPA and achieve efficiencies in the
program. No impact on risk is anticipated.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Notice: Limited 68 FR 20145 04/24/03
NPRM 69 FR 53866 09/03/04
NPRM Comment Period End 11/02/04
Final Action 03/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, State
Additional Information:
SAN No. 4216, EDocket No. OPP-2004-0038;
Sectors Affected:
9241 Administration of Environmental Quality Programs
Agency Contact:
Joe Hogue
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703-308-9072
Fax: 703 305-5884
Email: hogue.joe@epamail.epa.gov
Jean Frane
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703-305-5944
Fax: 703 305-5884
Email: frane.jean@epamail.epa.gov
RIN: 2070-AD36
_______________________________________________________________________
EPA
122. ACCEPTABILITY OF RESEARCH USING HUMAN SUBJECTS
Priority:
Other Significant
Legal Authority:
5 USC 301; 7 USC 136a; 7 USC 136w; 15 USC 2603; 21 USC 346a; 42 USC
300v-1(b); 42 USC 7601; 33 USC 1361; 42 USC 9615; 42 USC 11048; 42 USC
6912; 42 USC 300j-9
CFR Citation:
40 CFR 26 (Revision)
Legal Deadline:
None
Abstract:
EPA is evaluating its current policy with respect to the protection of
human research subjects in testing. Current EPA regulations in 40 CFR
part 26 apply to research conducted or supported by the Agency or
``otherwise subject to regulation.'' No action has been taken yet to
give effect to the ``otherwise subject to regulation'' phrase. In
addition, EPA has received the advice of the National Academy of
Sciences (NAS) on several issues surrounding the acceptability and
interpretation of third party studies involving deliberate dosing of
human subjects for the purpose of defining or quantifying toxic
endpoints and public comment on an ANPRM. EPA will seek public comment
on issues related to Agency use of human research data in its
regulatory decisionmaking. EPA believes the process being initiated
will serve two important Agency goals: ensuring the availability of
sound and appropriate scientific data in its decisions, and protection
of the interests, rights and safety of human research subjects. EPA may
issue one or more documents, which may include policy statements,
rulemaking or requests for public comment.
Statement of Need:
In July 1998, the Agency stated that it had not used any human study
data for final decisions under the FQPA. The Agency subsequently
convened a special joint subcommittee of the FIFRA Scientific Advisory
Panel and the EPA Science Advisory Board to advise on this policy. The
subcommittee completed its report in September 2000 without reaching
consensus on many issues. In December 2001 the Agency sought the advice
of the National Academy of Sciences on remaining scientific and ethical
issues.
[[Page 72831]]
At the same time, the Agency clarified its interim policy, committing,
subject to certain exceptions, not to consider or rely on any third
party studies involving intentional dosing of human subjects with
toxicants for the purpose of defining or quantifying their effects
until a final policy is in place, and clarifying that this interim
policy applies across all Agency programs. In May 2003 the Agency
published an Advance Notice of Proposed Rulemaking on the subject of
the acceptability of human studies, posing an array of questions in
response to which many comments and suggestions were received. The
ANPRM also restated the Agency's intention to issue proposed rules for
comment. In June 2003, the U.S. Court of Appeals vacated the December
2001 interim policy on the ground that it constituted an improperly
promulgated ``rule.'' The court further stated that as a consequence
the Agency's ``previous practice of considering third party human
studies on a case-by-case basis, applying statutory requirements, the
Common Rule, and high ethical standards as a guide,`` was reinstated
''until it is replaced by a lawfully promulgated regulation.`` In
February 2004, the NAS released their report, making many
recommendations now under review by the Agency. Some of the Academy's
recommendations could only be implemented through rulemaking.
Summary of Legal Basis:
Rulemaking concerning human studies is authorized under a variety of
provision of the different environmental statutes EPA administers. With
respect to pesticides, the Federal Insecticide, Fungicide and
Rodenticide Act (7 U.S.C. 136), a licensing statute, requires
applicants for registration to provide a ``full description of tests
made and the results thereof'' and further authorizes EPA to call in
data to maintain a registration under FIFRA sec. 3(c)(2)(B). FIFRA sec.
25(a) provides general rulemaking authority to implement these data
requirements, and also to interpret FIFRA sec. 12(a)(2)(P), which makes
it unlawful to conduct tests using human subjects unless the subjects
volunteer for such tests and are fully informed. Section 408(e) of the
Federal Food, Drug and Cosmetic Act (21 U.S.C. 348) authorizes the
Administrator to issue regulations establishing general procedures and
requirements. The Clean Air Act (42 U.S.C. 7601(a)) gives EPA general
rulemaking authority. The Clean Water Act (33 U.S.C. 1361) authorizes
the Administrator to promulgate regulations. The Comprehensive
Environmental Response, Compensation, and Liability Act (42. U.S.C.
9615) authorizes the President to establish regulations to implement
the statute, this authorizes being delegated to the Administrator under
Executive Order 12580. The Emergency Planning and Community Right-to-
Know Act (42. U.S.C. 11048) contains a general rulemaking authority.
The Resource Conservation and Recovery Act (42 U.S.C. 6912)
specifically authorizes the Administrator to prescribe regulations to
carry out the functions under the Act. The Safe Drinking Water Act (42
U.S.C. 300j-9) authorizes the Administrator to prescribe regulations
that are necessary and appropriate to carry out EPA's functions under
the Act. In addition, EPA has broad authority under 5 U.S.C. 301 and 42
U.S.C. 300v-1(b).
Alternatives:
Still to be identified.
Anticipated Cost and Benefits:
No analysis has been performed yet.
Risks:
No analysis has been performed yet.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 68 FR 24410 05/07/03
Notice 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
Additional Information:
SAN No. 4610, EDocket No. OPP-2003-0132;
Sectors Affected:
32532 Pesticide and Other Agricultural Chemical Manufacturing
Agency Contact:
William Jordan
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7501C
Washington, DC 20460
Phone: 703-305-1049
Fax: 703-308-4776
Email: jordan.william@epamail.epa.gov
John Carley
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7501C
Washington
Phone: 703-305-7019
Fax: 703-305-5060
Email: carley.john@epamail.epa.gov
RIN: 2070-AD57
_______________________________________________________________________
EPA
123. INCREASE METALS RECLAMATION FROM F006 WASTE STREAMS
Priority:
Other Significant
Unfunded Mandates:
Undetermined
Legal Authority:
Not Yet Determined
CFR Citation:
40 CFR 261
Legal Deadline:
None
Abstract:
Many metal finishers and other industrial sectors generate an
electroplating sludge as part of their production process that is
amenable to recycling, i.e., the sludge contains economically
recoverable amounts of metals such as copper, nickel, zinc, etc.
Currently, these sludges (F006) are listed hazardous wastes subject to
RCRA regulations. Many generators continue to send these sludges for
treatment and disposal when they could be recycled. Similarly,
generators currently sending their sludges for recycling receive no
economic benefit for this practice. Since the mid-1990s, EPA has been
working with industry and the States to create incentives for safe
recycling and has promulgated rules to foster this practice. However,
EPA is interested in exploring whether further regulatory changes are
warranted.
[[Page 72832]]
EPA is currently evaluating several options that would provide
regulatory relief to generators and handlers of F006. All options would
reduce regulatory costs to generators and handlers relative to the
current RCRA subtitle C regulatory program.
Statement of Need:
F006 represents one of the largest hazardous waste streams amenable to
recycling. Currently, there is no differentiation in regulatory
requirements between the land disposal and recycling of F006
electroplating sludges. This effort seeks to evaluate different
regulatory options that would eliminate existing disincentives to the
safe recycling of F006 with the ultimate objective of possibly
proposing changes to the existing regulatory framework. Potential
benefits to be achieved include increasing the economic competitiveness
of small businesses, increasing the waste minimization and recycling of
F006, and increasing natural resource conservation by reducing
emissions from landfills and surface waters.
Summary of Legal Basis:
RCRA sections 2002, 3001-3004, 42 U.S.C. 6912, 6921-6924. No aspect of
this action is required by statute or court order.
Alternatives:
Regulatory options being examined would affect generators and possibly
other handlers of F006, i.e., consolidators, commercial hazardous waste
recyclers and mineral processing facilities. EPA is also considering
various options for the minimum amount of recoverable metals contained
in F006 electroplating sludges.
Anticipated Cost and Benefits:
This rule is designed to provide regulatory relief to generators and
possibly other handlers of F006. Potential benefits to be achieved
include increasing the economic competitiveness of small businesses,
increasing the waste minimization and recycling of F006 and increasing
natural resource conservation by reducing emissions from landfills and
surface waters.
Risks:
Options being evaluated would ensure that the risks posed from
recycling F006 would not increase. These include risks from storage and
management of the materials throughout the recycling process, as well
risks from any non-recyclable constituents included in the F006.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 09/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Additional Information:
SAN No. 4651
Agency Contact:
Jim OLeary
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8827
Fax: 703 308-0514
Email: oleary.jim@epamail.epa.gov
James Michael
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8610
Fax: 703 308-0514
Email: michael.james@epamail.epa.gov
RIN: 2050-AE97
_______________________________________________________________________
EPA
124. REGULATORY AMENDMENTS TO THE F019 HAZARDOUS WASTE LISTING TO
EXCLUDE WASTEWATER TREATMENT SLUDGES FROM CHEMICAL CONVERSION COATING
PROCESS (ZINC PHOSPHATING) OF AUTOMOBILE BODIES OF ALUMINUM
Priority:
Other Significant
Unfunded Mandates:
Undetermined
Legal Authority:
42 USC 1006 et seq
CFR Citation:
40 CFR 261.31; 40 CFR 302.4
Legal Deadline:
None
Abstract:
Automobile manufacturers are adding aluminum or aluminized components
to automobiles to reduce the weight of vehicles to increase fuel
economy. When aluminum components are added to the automobile assembly
process, the current Federal regulations require that the wastewater
treatment sludges generated from this conversion coating process be
managed as a hazardous waste under the Resource Conservation and
Recovery Act. EPA intends to reduce burden on the regulated community
by revising the current RCRA regulations that apply to the wastewater
treatment sludges from the chemical conversion coating (zinc
phosphating) of aluminum.
Statement of Need:
This action when finalized will reduce the burden on the automobile
industry from treating sludges from the process of zinc phosphating of
aluminum as hazardous wastes. The applicable listed hazardous waste
(F019) was listed as such because it contains cyanide and chromium. The
sludges from the zinc phosphating of aluminum do not contain any of
these constituents.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Undetermined
Additional Information:
SAN No. 4834;
Agency Contact:
James Michael
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8610
Fax: 703 308-0514
Email: michael.james@epamail.epa.gov
Gail Cooper
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-8419
Fax: 703 308-0514
Email: cooper.gailann@epamail.epa.gov
RIN: 2050-AG15
[[Page 72833]]
_______________________________________________________________________
EPA
125. TOXICS RELEASE INVENTORY REPORTING BURDEN REDUCTION RULE
Priority:
Other Significant
Legal Authority:
42 USC 11023 et seq
CFR Citation:
40 CFR 372
Legal Deadline:
None
Abstract:
The primary goal of this effort by EPA is to reduce burdens associated
with Toxics Release Inventory (TRI) reporting while at the same time
continuing to provide valuable information to the public consistent
with the goals and statutory requirements of the TRI program.
Statement of Need:
EPA is looking to explore various options with the intention of
identifying a specific burden reduction initiative that effectively
lessens the burden on facilities but at the same time ensures that TRI
continues to provide communities with the same high level of
significant chemical release and other waste management information.
Summary of Legal Basis:
Section 313 of the Emergency Planning and Community Right-to-Know Act
(EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA)
of 1990.
Alternatives:
Still under analysis.
Anticipated Cost and Benefits:
Still under analysis.
Risks:
Not applicable.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 01/00/05
Final Action 02/00/07
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, State
Additional Information:
SAN No. 4896;
URL For More Information:
www.epa.gov/tri
Agency Contact:
Cassandra Vail
Environmental Protection Agency
Office of Environmental Information
2844T
Washington, DC 20460
Phone: 202-566-0753
Fax: 202 566-0741
Email: vail.cassandra@epa.gov
Kevin Donovan
Environmental Protection Agency
Office of Environmental Information
2844T
Washington, DC 20460
Phone: 202-566-0676
Fax: 202-566-0715
Email: donovan.kevin-e@epa.gov
RIN: 2025-AA14
_______________________________________________________________________
EPA
-----------
FINAL RULE STAGE
-----------
126. CLEAN AIR VISIBILITY RULE
Priority:
Economically Significant
Legal Authority:
42 USC 7410; 42 USC 7414; 42 USC 7421; 42 USC 7470 to 7479; 42 USC
7491; 42 USC 7492; 42 USC 7601; 42 USC 7602
CFR Citation:
40 CFR 51.308(e)(1); 40 CFR 51 app Y (New)
Legal Deadline:
NPRM, Judicial, April 15, 2004, Consent Decree: April 15, 2004.
Final, Judicial, April 15, 2005, Consent Decree: April 15, 2005.
Abstract:
To meet the Clean Air Act's requirements, EPA published the regional
haze rule on July 1, 1999 (64 FR 35714). On May 24, 2002, the DC
Circuit vacated certain provisions of the regional haze rule related to
best available retrofit technology (BART). Because of this court
decision, we need to propose and publish revised BART provisions in the
regional haze rule. The purpose of this effort is to provide the
appropriate changes to the BART requirements and guidelines, and to
address additional issues related to reasonable progress goals for the
visibility program. On July 20, 2001, we proposed guidelines intended
to add further clarifications to the BART requirements in the regional
haze rule. Since then, due to additional information that has come to
light since that proposal, we have decided that a supplemental proposal
is needed. The supplemental proposal was published on May 5, 2004.
Statement of Need:
This action is needed in response to the May 2002 ruling of the U.S.
Court of Appeals for the D.C. Circuit (American Corn Growers et al. V.
EPA,, 291 F.3d 1) vacating the Best Available Retrofit Technology
(BART) provisions of the regional haze rule. The Clean Air Act requires
that States to include BART in their visibility State Implementation
Plans (SIPs). The Clean Air Act also requires that a State take steps
to prevent emissions from sources located within its boundaries from
interfering with a downwind State's ability to meet air quality
standards, or interfering with measures to protect visibility.
Summary of Legal Basis:
Clean Air Act section 169A requires States to include BART in their
visibility SIPs. Clean Air Act section 110(a)(2)(D) (42 USC
7410(a)(2)(D)) requires that each state's implementation plan include
the ``good neighbor'' provisions of prohibiting sources in the State
from emitting air pollutants in amounts that contribute significantly
to nonattainment in a downwind state, or interfere with measures to
protect visibility in a Class I areas. Section 110(a)(1) (42 USC
7410(a)(1)) requires States to submit implementation plans within a
specified period of time after the promulgation of a new or revised
national ambient air quality standard. In addition, EPA has authority
under section 110(k)(5) (42 USC 7410(k)(5)) to require States to revise
existing implementation plans whenever EPA finds that those plans are
inadequate to comply with any requirement. Further, section 301(a)(1)
(42 USC 7601(a)(1)) confers general authority upon the EPA
Administrator. These provisions of the Clean Air Act confer authority
on EPA to promulgate the present regulations.
Alternatives:
This entry comprises the action the Agency plans to take to implement
the
[[Page 72834]]
BART provisions of the Clean Air Act. The major alternatives facing the
Agency include: (1) How to structure the process for exempting
individual emission sources from BART that is mandated by the court
ruling, and (2) whether to include prescriptive control levels for
visibility-impairing pollution from large electric generating units,
and what control levels to prescribe.
Anticipated Cost and Benefits:
EPA prepared a regulatory impact analysis (RIA) for the proposed BART
rule. Updated cost and benefit calculations will be made as development
of the RIA proceeds for the final rulemaking.
Risks:
The risks addressed are the health and welfare impacts resulting from
emissions that interfere with measures to protect visibility in Class I
areas. These effects were outlined in detail in the Regulatory Impact
Analysis for the proposed BART rulemaking.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 66 FR 38108 07/20/01
Supplemental NPR69 FR 25184 05/05/04
Final Action 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State, Tribal
Federalism:
Undetermined
Additional Information:
SAN No. 4450;
Agency Contact:
Kathy Kaufman
Environmental Protection Agency
Air and Radiation
C504-02
Washington, DC 20460
Phone: 919-541-0102
Fax: 919 541-5489
Email: kaufman.kathy@epamail.epa.gov
Todd Hawes
Environmental Protection Agency
Air and Radiation
C504-02
Washington, DC 20460
Phone: 919-541-5591
Fax: 919 541-5489
Email: hawes.todd@epamail.epa.gov
RIN: 2060-AJ31
_______________________________________________________________________
EPA
127. CLEAN AIR MERCURY RULE--ELECTRIC UTILITY STEAM GENERATING UNITS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect State, local or tribal governments and the
private sector.
Legal Authority:
42 USC 7412; 42 USC 7411
CFR Citation:
40 CFR 63; 40 CFR 60
Legal Deadline:
NPRM, Judicial, December 15, 2003.
Final, Judicial, March 15, 2005.
Abstract:
On January 30, 2004, the EPA proposed alternative approaches to
regulating mercury emissions from coal-fired electric utility steam
generating units and nickel emissions from oil-fired electric utility
steam generating units.
Statement of Need:
Oil and coal-fired electric utility steam generating units were added
(December 20, 2000) to the list of source categories to be regulated
under section 112 of the Clean Air Act, as amended. On January 30,
2004, EPA proposed to remove oil- and coal-fired electric utility steam
generating units from the list so that they could be regulated under
section 111 of the Clean Air Act.
Summary of Legal Basis:
Sections 111 and 112 of the Clean Air Act, as amended.
Alternatives:
Alternative approaches to regulating electric utility steam generating
units were proposed on January 30, 2004.
Anticipated Cost and Benefits:
It is anticipated that this rule will result in significant costs to
the affected industry, including Federal, State, and local entities
that own/operate electric utility steam generating units. These costs
will be identified as the final rule is developed.
Risks:
Risk information will become available as the final rule is developed.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 4754 01/30/04
Supplemental NPR69 FR 12298 03/16/04
Notice of Reopen69 FR 25052 Period 05/05/04
NODA 11/00/04
Final Action 03/15/05
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, Local, State, Tribal
Additional Information:
SAN No. 4571, EDocket No. OAR-2002-0056;
Sectors Affected:
221112 Fossil Fuel Electric Power Generation
URL For More Information:
www.epa.gov/ttn/atw/utility/utiltoxpg.html
Agency Contact:
Robert Wayland
Environmental Protection Agency
Air and Radiation
C439-01
Research Triangle Park, NC 27711
Phone: 919-541-1045
Fax: 919 541-5450
Email: wayland.robertj@epa.gov
Bill Maxwell
Environmental Protection Agency
Air and Radiation
C439-01
Research Triangle Park, NC 27711
Phone: 919-541-5430
Fax: 919 541-5450
Email: maxwell.bill@epamail.epa.gov
RIN: 2060-AJ65
_______________________________________________________________________
EPA
128. CLEAN AIR OZONE IMPLEMENTATION RULE (PART 1 AND PART 2)
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
42 USC 7408; 42 USC 7410; 42 USC 7501 to 7511f; 42 USC 7601(a)(1)
[[Page 72835]]
CFR Citation:
40 CFR 51; 40 CFR 50; 40 CFR 81
Legal Deadline:
None
Abstract:
This rule would provide specific requirements for State and local air
pollution control agencies and Tribes to prepare State Implementation
Plans (SIPs) and Tribal Implementation Plans (TIPs) under the 8-hour
national ambient air quality standard (NAAQS) for ozone, published by
EPA on July 18, 1997. The Clean Air Act (CAA) requires EPA to set
ambient air quality standards and requires States to submit SIPs to
implement those standards. The 1997 standards were challenged in court,
but in February 2001, the Supreme Court determined that EPA has
authority to implement a revised ozone standard, but ruled that EPA
must reconsider its implementation plan for moving from the 1-hour
standard to the revised standard. The Supreme Court identified
conflicts between different parts of the CAA related to implementation
of a revised NAAQS, provided some direction to EPA for resolving the
conflicts, and left it to EPA to develop a reasonable approach for
implementation. Thus, this rulemaking must address the requirements of
the CAA and the Supreme Court's ruling. This rule would provide
detailed provisions to address the CAA requirements for SIPs and TIPs
and would thus affect States and tribes. States with areas that are not
attaining the 8-hour ozone NAAQS will have to develop--as part of their
SIPs--emission limits and other requirements to attain the NAAQS within
the timeframes set forth in the CAA. Tribal lands that are not
attaining the 8-hour ozone standard may be affected, and could
voluntarily submit a TIP, but would not be required to submit a TIP. In
cases where a TIP is not submitted, EPA would have the responsibility
for planning in those areas.
Statement of Need:
This action is needed in response to the U.S. Supreme Court's ruling in
February 2001 (Whitman v. American Trucking Assoc., 121 S.Ct.903) that
stated that EPA has the authority to implement a revised ozone NAAQS
but that EPA could not ignore the provisions of subpart 2 when
implementing the 8-hour NAAQS. The Supreme Court identified several
portions of subpart 2 that are ill-fitted to the revised NAAQS but left
it to EPA to develop a reasonable implementation approach.
Consequently, EPA is developing a rule to implement the 8-hour ozone
NAAQS under the provisions of subpart 2 of the CAA.
Summary of Legal Basis:
Title I of the Clean Air Act
Alternatives:
This entry comprises the action the Agency plans to take to implement
the 8-hour ozone NAAQS. The major alternatives facing the Agency is
whether the 8-hour O3 NAAQS should be implemented under the less
prescriptive part of the Clean Air Act (title I, part D, subpart 1) or
the more prescriptive part of the Act (subpart 2). Another major set of
alternatives concern the kind of transition EPA should make from
implementation of the current 1-hour ozone standard to the new 8-hr
ozone standard.
Anticipated Cost and Benefits:
EPA prepared a regulatory impact analysis for the final ozone NAAQS,
and has prepared a cost analysis for the proposed implementation rule.
The benefits of the rule are those associated with attainment of the
ozone NAAQS including significant improvements in premature mortality,
chronic asthma, chronic and acute bronchitis, upper and lower
respiratory symptoms, work days lost, decreased worker productivity,
visibility in urban and suburban areas, and increases in yields of
commercial forests currently exposed to elevated ozone levels.
Risks:
The risks addressed by this action are the likelihood of experiencing
increased health and environmental effects associated with
nonattainment of the National Ambient Air Quality Standard for ozone.
These effects are briefly described above in the ``costs and benefits''
section, and they were outlined in detail in the Regulatory Impact
Analysis for the ozone NAAQS rulemaking. The results are summarized in
the Federal Register notice for that rulemaking (62 FR 38856, July 18,
1997).
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 32802 06/02/03
Final Action (Ph69 FR 23951 04/30/04
Final Action (Phase 2) 11/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Local, State, Tribal
Additional Information:
SAN No. 4625;
Agency Contact:
John Silvasi
Environmental Protection Agency
Air and Radiation
C539-02
Research Triangle Park, NC 20460
Phone: 919 541-5666
Fax: 919 541-0824
Email: silvasi.john@epamail.epa.gov
Denise Gerth
Environmental Protection Agency
Air and Radiation
C539-02
Research Triangle Park, NC 20460
Phone: 919 541-5550
Fax: 919 541-0824
Email: gerth.denise@epamail.epa.gov
RIN: 2060-AJ99
_______________________________________________________________________
EPA
129. NONATTAINMENT MAJOR NEW SOURCE REVIEW (NSR)
Priority:
Other Significant
Legal Authority:
42 USC 7401 et seq
CFR Citation:
40 CFR 51, app S
Legal Deadline:
None
Abstract:
This final action will promulgate changes to regulations that govern
NSR permitting of major stationary sources in nonattainment areas where
there is no approved SIP. Appendix S of 40 CFR part 51 contains the
permitting program for major stationary sources in nonattainment areas
in transition periods before approval of a SIP to implement part D of
title I. This final action will revise appendix S to conform it to the
changes made to regulations at 40 CFR 51.165 for SIP programs for
nonattainment major NSR. (67 FR 80816; December 31, 2002)
Statement of Need:
In August 1992, EPA voluntarily initiated a comprehensive effort to
reform the NSR process. This effort was
[[Page 72836]]
initiated to examine complaints from the regulated community that the
current regulatory scheme is too complex, needlessly delays projects,
and unduly restricts source flexibility. Currently there are no
applicable statutory or judicial deadlines for the NSR reform
rulemaking effort. The goal of this effort is to address industry's
concerns without sacrificing the environmental benefits embodied in the
present approach; that is, protecting and improving local air quality,
and stimulating pollution prevention and advances in control
technologies. In July 1993, the NSR Reform Subcommittee of the CAA
Advisory Committee was formed. The Subcommittee's purpose is to provide
independent advice and counsel to EPA on policy and technical issues
associated with reforming the NSR rules. The Subcommittee was composed
of representatives from industry, State/local air pollution control
agencies, environmental organizations, EPA headquarters and regions,
and other Federal agencies (National Park Service and Forest Service,
Department of Energy, and the Office of Management and Budget).
Summary of Legal Basis:
Clean Air Act sections 165 and 173.
Alternatives:
The Subcommittee discussed numerous options for implementing NSR
reform. However, EPA's primary focus has been to consider the specific
recommendations developed by the Subcommittee and, where appropriate,
use them in this rulemaking effort. In January 1996, EPA, as part of
another regulatory streamlining measure, merged portions of a separate
rulemaking to implement the 1990 CAA Amendments with the Reform effort.
The combined package was proposed in the Federal Register on July 23,
1996. On July 24, 1998, EPA issued another Federal Register Notice
seeking comment on two applicability provisions. On February 2-3, 1999,
EPA convened a public meeting to listen to new stakeholder proposals
for streamlining NSR applicability and control technology requirements.
Stakeholder groups submitted written proposals during May and June
1999.
Anticipated Cost and Benefits:
From a cost perspective, the proposed rulemaking represents a decrease
in applications and recordkeeping costs to industry of at least $13
million per year, as compared to the preexisting program, based
primarily on the fact that fewer sources will need to apply for major
source permits. In addition, the cost to State and local agencies will
be reduced by approximately $1.4 million per year. The Federal
Government should realize a savings of approximately $116,000 per year.
Additional cost reductions, which are difficult to quantify, will be
realized due to the streamlining effect of the rulemaking on the
permitting process, for example, the opportunity costs for shorter time
periods between permit application and project completion and reduced
uncertainty in planning for future source growth.
Risks:
This is a procedural rule applicable to a wide variety of source
categories. Moreover, it applies to criteria pollutants for which NAAQS
have been established. This action is considered environmentally
neutral. However, any potential risks are considered in the NAAQS
rulemaking from a national perspective.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Final Action 11/00/04
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Federal, Local, State
Additional Information:
SAN No. 3259.2; Split from RIN 2060-AE11. See also SAN 4390
Agency Contact:
Janet McDonald
Environmental Protection Agency
Air and Radiation
C339-03
Washington, DC 20460
Phone: 919-541-1450
Fax: 919 541-5509
Email: mcdonald.janet@epamail.epa.gov
Lynn Hutchinson
Environmental Protection Agency
Air and Radiation
C339-03
Research Triangle Park, NC 27711
Phone: 919-541-5795
Fax: 919 541-5509
Email: hutchinson.lynn@epamail.epa.gov
RIN: 2060-AM59
_______________________________________________________________________
EPA
130. TEST RULE; TESTING OF CERTAIN HIGH PRODUCTION VOLUME (HPV)
CHEMICALS
Priority:
Other Significant
Legal Authority:
15 USC 2603; 15 USC 2611 to 2612; 15 USC 2625 to 2626
CFR Citation:
40 CFR 790 to 799
Legal Deadline:
None
Abstract:
EPA is proposing test rules under section 4(a) of the Toxic Substances
Control Act (TSCA) to require testing and recordkeeping requirements
for certain high production volume (HPV) chemicals (i.e., chemicals
which are manufactured (including imported) in the aggregate at more
than 1 million pounds on an annual basis) that have not been sponsored
under the voluntary HPV Challenge Program. Although varied based on
specific data needs for the particular chemical, the data generally
collected under these rules may include: Acute toxicity, repeat dose
toxicity, developmental and reproductive toxicity, mutagenicity,
ecotoxicity, and environmental fate. The first rule proposed testing
for 37 HPV chemicals with substantial worker exposure. The number of
chemicals included in the first final rule may be reduced based on new
information on annual production volumes, worker exposure, and
commitments to the voluntary HPV Challenge Program. Subsequent test
rules will require similar screening level testing for other
unsponsored HPV Challenge Program chemicals.
Statement of Need:
EPA has found that, of those non-polymeric organic substances produced
or imported in amounts equal to or greater than 1 million pounds per
year based on 1990 reporting for EPA's Inventory Update Rule (IUR),
only 7 percent have a full set of publicly available internationally
recognized basic health and environmental fate/effects screening test
data. Of the over 2,800 HPV chemicals based on 1990 data, 43 percent
have no publicly available basic hazard data. For the remaining
chemicals, limited amounts of the data are available. This lack of
available hazard data compromises EPA's and others' ability to
determine
[[Page 72837]]
whether these HPV chemicals pose potential risks to human health or the
environment, as well as the public's right to know about the hazards of
chemicals that are found in their environment, their homes, their
workplaces, and the products that they buy. It is EPA's intent to close
this knowledge gap. EPA believes that for most of the HPV chemicals,
insufficient data are readily available to reasonably determine or
predict the effects on health or the environment from the manufacture
(including importation), distribution in commerce, processing, use, or
disposal of the chemicals, or any combination of these activities. EPA
has concluded that a program to collect and, where needed, develop
basic screening level toxicity data is necessary and appropriate to
provide information in order to assess the potential hazards/risks that
may be posed by exposure to HPV chemicals. On April 21, 1998, a
national initiative, known as the Chemical Right-To-Know Initiative,
was announced in order to empower citizens with knowledge about the
most widespread chemicals in commerce--chemicals that people may be
exposed to in the places where they live, work, study, and play. A
primary component of EPA's Chemical Right-To-Know (ChemRTK) initiative
is the voluntary HPV Challenge Program, which was created in
cooperation with industry, environmental groups, and other interested
parties, and is designed to assemble basic screening level test data on
the potential hazards of HPV chemicals while avoiding unnecessary or
duplicative testing. Data needs which remain unmet in the voluntary HPV
Challenge Program may be addressed through the international efforts or
rulemaking.
Summary of Legal Basis:
These test rules will be issued under section 4(a)(1)(B) of TSCA.
Section 2(b)(1) of TSCA states that it is the policy of the United
States that ``adequate data should be developed with respect to the
effect of chemical substances and mixtures on health and the
environment and that the development of such data should be the
responsibility of those who manufacture (which is defined by statute to
include import) and those who process such chemical substances and
mixtures(.)'' To implement this policy, TSCA section 4(a) mandates that
EPA require by rule that manufacturers and processors of chemical
substances and mixtures conduct testing if the Administrator finds
that: (1)(A)(i) the manufacture, distribution in commerce, processing,
use, or disposal of a chemical substance or mixture, or that any
combination of such activities, may present an unreasonable risk of
injury to health or the environment, (ii) there are insufficient data
and experience upon which the effects of such manufacture, distribution
in commerce, processing, use, or disposal of such substance or mixture
or of any combination of such activities on health or the environment
can reasonably be determined or predicted, and (iii) testing of such
substance or mixture with respect to such effects is necessary to
develop such data; or (B)(i) a chemical substance or mixture is or will
be produced in substantial quantities, and (I) it enters or may
reasonably be anticipated to enter the environment in substantial
quantities or (II) there is or may be significant or substantial human
exposure to such substance or mixture, (ii) there are insufficient data
and experience upon which the effects of the manufacture, distribution
in commerce, processing, use, or disposal of such substance or mixture
or of any combination of such activities on health or the environment
can reasonably be determined or predicted, and (iii) testing of such
substance or mixture with respect to such effects is necesssary to
develop such data.
Alternatives:
The strategy and overall approach that EPA is using to address data
collection needs for U.S. HPV chemicals includes a voluntary component
(the HPV Challenge Program), certain international efforts, and these
rulemakings under TSCA. The issuance of a rulemaking is often the
Agency's final mechanism for obtaining this important information.
Anticipated Cost and Benefits:
The potential benefits of these test rules are substantial, as no one--
whether in industry, government, or the public--can make reasoned risk
management decisions in the absence of reliable health and
environmental information. The cost of the baseline screening testing
that would be imposed is estimated to be about $200,000 per chemical
for a full set of tests. It is unlikely, however, for a chemical to
need a full set of tests, which would only occur if none of the data in
question already exists.
Risks:
Data collected and/or developed under these test rules, when combined
with information about exposure and uses, will allow the Agency and
others to evaluate and prioritize potential health and environmental
effects and take appropriate follow up action.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 81658 12/26/00
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Additional Information:
SAN 3990. See also the Regulatory Plan entry entitled Chemical Right-
to-Know Initiative (RIN 2070-AD25; SAN 4176).
Sectors Affected:
325 Chemical Manufacturing; 32411 Petroleum Refineries
URL For More Information:
www.epa.gov/opptintr/chemtest/sect4rule.htm
Agency Contact:
Catherine Roman
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202-564-8172
Fax: 202 564-4765
Email: roman.catherine@epamail.epa.gov
Greg Schweer
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202-564-8469
Fax: 202 564-4765
Email: schweer.greg@epamail.epa.gov
RIN: 2070-AD16
_______________________________________________________________________
EPA
131. NESHAPS: STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR HAZARDOUS
WASTE COMBUSTORS (PHASE I FINAL REPLACEMENT STANDARDS AND PHASE II)
Priority:
Other Significant
[[Page 72838]]
Legal Authority:
42 USC 6924 RCRA 3004; 42 USC 6925 RCRA 3005; 42 USC 7412 CAA 112; 42
USC 7414 CAA 114
CFR Citation:
40 CFR 63; 40 CFR 264; 40 CFR 265; 40 CFR 266; 40 CFR 270
Legal Deadline:
NPRM, Judicial, March 31, 2004, Consent decree for Phase 2 portion of
rule.
Final, Judicial, June 14, 2005, Consent decree.
Abstract:
On September 30, 1999, EPA promulgated standards to control emissions
of hazardous air pollutants from incinerators, cement kilns, and
lightweight aggregate kilns that burn hazardous waste (referred to as
the Phase I Rule). A number of parties, representing interests of both
industry and the environmental community, sought judicial review of the
rule. The Court ruled against EPA and vacated the Phase I rule. On
October 19, 2001, EPA, together with all petitioners, filed a joint
motion asking the Court to stay the issuance of its mandate to allow
them time to develop interim standards. These stop-gap interim
standards were promulgated on February 13 and 14, 2002. They replace
the vacated standards temporarily, until revised replacement standards
are promulgated by June 14, 2005. EPA will ultimately finalize the
Phase I replacement standards. Also, EPA is developing emission
standards for hazardous waste burning industrial, institutional,
commercial boilers, process heaters, and hydrochloric acid production
furnaces. These sources are referred to as Phase II Sources because the
standards were originally scheduled to be promulgated after Phase I
source standards were finalized; however, a separate consent decree now
requires us to finish developing emission standards for the Phase II
sources by the same date as those for Phase I (June 14, 2005). EPA has
developed options for calculating the emission standards that are
considered to be consistent with both the statutory requirements and
the opinion of the Court. EPA has proposed emission standards and
compliance provisions for both the Phase I and Phase II sources.
Statement of Need:
Section 112 of the Clean Air Act requires that the EPA promulgate
regulations requiring the control of hazardous air pollutants from
major and certain area sources. The control of hazardous air pollutants
is achieved through promulgation of emission standards under sections
112(d) and (f) and, in appropriate circumstances, work practice
standards under section 112(h).
On September 30, 1999 EPA promulgated standards to control emissions of
hazardous air pollutants from incinerators, cement kilns, and
lightweight aggregate kilns that burn hazardous waste (referred to as
the Phase I Rule). A number of parties, representing interests of both
industry and the environmental community, sought judicial review of the
rule. The Court ruled against EPA and vacated the Phase I rule.
Summary of Legal Basis:
On October 19, 2001, EPA, together with all petitioners, filed a joint
motion asking the Court to stay the issuance of its mandate to allow
time to develop interim standards. These stop-gap interim standards
were promulgated on February 13 and 14, 2002. They replace the vacated
standards temporarily, until revised replacement standards are
promulgated by June 14, 2005. EPA is working towards promulgation by
this date. EPA is also developing emission standards for hazardous
waste burning industrial, institutional, commercial boilers, process
heaters, and hydrochloric acid production furnaces. These sources are
referred to as Phase II Sources because the standards were originally
scheduled to be promulgated after Phase I source standards were
finalized; however, a separate consent decree now requires us to finish
developing emission standards for the Phase II sources by the same date
as those for Phase I (June 14, 2005).
Alternatives:
EPA has developed several options for calculating the emission
standards and has included these options in the April 20, 2004
proposal.
Anticipated Cost and Benefits:
Estimated costs and benefits for the proposed standards are summarized
in the April 20, 2004 proposal.
Risks:
For the 1999 rule, we estimated the avoided incidence of mortality and
morbidity associated with reductions in particulate matter (PM)
emissions. Estimates of cases of mortality and morbidity avoided were
made for children and the elderly, as well as the general population,
using concentration-response functions derived from human
epidemiological studies. Morbidity effects included respiratory and
cardiovascular illnesses requiring hospitalization, as well as other
illnesses not requiring hospitalization, such as acute and chronic
bronchitis and acute upper and lower respiratory symptoms. For this
rule, we are comparing characteristics of the sources covered by the
1999 rule to the sources covered by the replacement rule that are
related to risk. These characteristics include emissions, stack
characteristics, meteorology, and population. Based on the results of
the statistical comparisons, we will infer whether the risks will be
about the same, less than, or greater than the 1999 rule. Risk
inferences for boilers and HCl production furnaces will be based on
comparisons with incinerators for the 1999 rule. The risk estimates for
the proposed standards are summarized in the April 20, 2004 proposal.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM-CK 61 FR 17358 04/19/96
Final-Fasttrack 63 FR 33782 06/19/98
Final-CK 64 FR 52828 09/30/99
NODA 65 FR 39581 07/27/00
DF 1 66 FR 35087 07/03/01
NPRM-Phase1 66 FR 35126 07/03/01
Parallel Proposa66 FR 35124 07/03/01
Direct Final Act66 FR 52361 10/15/01
Final Compliance66 FR 63313 12/06/01
Interim Final Ac67 FR 6792 02/13/02
Final HAP 67 FR 6968 02/14/02
NPRM-Phases 1&2 69 FR 21197 04/20/04
Final Action 06/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, State, Tribal
Additional Information:
SAN No. 3333, EDocket No. OAR-2004-0022; For information on the Phase I
portion of this effort, see SAN 4418, RIN 2050-AE79.
Sectors Affected:
3335 -; 3343 Audio and Video Equipment Manufacturing; 3251 Basic
Chemical Manufacturing; 3273 Cement and Concrete Product Manufacturing;
3271 Clay Product and Refractory Manufacturing; 3328 Coating,
Engraving, Heat Treating and Allied
[[Page 72839]]
Activities; 3342 Communications Equipment Manufacturing; 3341 Computer
and Peripheral Equipment Manufacturing; 2211 Electric Power Generation,
Transmission and Distribution; 45431 Fuel Dealers; 3332 Industrial
Machinery Manufacturing; 3274 Lime, Gypsum and Gypsum Product
Manufacturing; 3327 Machine Shops, Turned Product, and Screw, Nut and
Bolt Manufacturing; 3362 Motor Vehicle Body and Trailer Manufacturing;
3361 Motor Vehicle Manufacturing; 3363 Motor Vehicle Parts
Manufacturing; 2123 Non-Metallic Mineral Mining and Quarrying; 3259
Other Chemical Product Manufacturing; 3329 Other Fabricated Metal
Product Manufacturing; 3339 Other General Purpose Machinery
Manufacturing; 3279 Other Nonmetallic Mineral Product Manufacturing;
3255 Paint, Coating, Adhesive, and Sealant Manufacturing; 3253
Pesticide, Fertilizer and Other Agricultural Chemical Manufacturing;
3241 Petroleum and Coal Products Manufacturing; 4227 Petroleum and
Petroleum Products Wholesalers; 3254 Pharmaceutical and Medicine
Manufacturing; 3231 Printing and Related Support Activities; 5629
Remediation and Other Waste Management Services; 3252 Resin, Synthetic
Rubber, and Artificial and Synthetic Fibers and Filaments
Manufacturing; 3344 Semiconductor and Other Electronic Component
Manufacturing; 22132 Sewage Treatment Facilities; 5622 Waste Treatment
and Disposal
URL For More Information:
www.epa.gov/hwcmact/
Agency Contact:
Michael Galbraith
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington, DC 20460
Phone: 703-605-0567
Fax: 703 308-8433
Email: galbraith.michael@epamail.epa.gov
Frank Behan
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington, DC 20460
Phone: 703-308-8476
Fax: 703 308-8433
Email: behan.frank@epamail.epa.gov
RIN: 2050-AE01
_______________________________________________________________________
EPA
132. HAZARDOUS WASTE MANIFEST REGULATION
Priority:
Other Significant
Legal Authority:
42 USC 6922 RCRA 3002; 42 USC 6923 RCRA 3003; 42 USC 6924 RCRA 3004; 42
USC 6926 RCRA 3006; PL 105-277; Government Paperwork Elimination Act 17
CFR Citation:
40 CFR 260; 40 CFR 262; 40 CFR 263; 40 CFR 264; 40 CFR 265; 40 CFR 271
Legal Deadline:
None
Abstract:
The Uniform Hazardous Waste Manifest (Form 8700-22) is a multi-copy
form used to identify the quantity, composition, origin, routing, and
destination of hazardous waste during its transportation. Waste
handlers (e.g., generators and transporters) are required to use the
manifest, and States may not require a different manifest in its place.
However, the manifest has State blocks which allow States, at their
option, to require the entry of additional specific information to
serve their State's regulatory needs. Under the current regulations
more than 20 states print the manifest form in accordance with the
format specified in Federal regulations. However, the variability among
State manifest programs associated with State optional blocks,
different copy distribution schemes, and the manifest hierarchical
acquisition scheme has drawn complaints from the regulated community.
Variability among States' manifest programs and the manifest system's
current reliance on paper result in significant paperwork and cost
burden to waste handlers and States who choose to collect manifest
information. The Agency intends to standardize further the manifest
form elements, and to specify one format for the manifests that may be
used in all States. In addition, the Agency intends to announce
standard requirements for tracking rejected wastes, container residues,
and international shipments of hazardous wastes. Finally, the Agency
intends to pursue an optional approach that would use information
technologies to conduct the manifest process electronically, thereby
reducing paperwork burden, and improving the speed and accuracy of
preparing, transmitting, and recordkeeping the manifest form. However,
the Agency will bifurcate the manifest rule so that the form revisions
may be expedited, while additional analysis on the e-manifest
continues.
Statement of Need:
Since the adoption of the Uniform Manifest by EPA and the Department of
Transportation (DOT) in 1984, the regulated community and authorized
States have pressed EPA to adopt changes that would simplify and
further reduce the variability among the hazardous waste manifest forms
required and distributed by the States. In addition, the recent focus
on electronic government has highlighted the potential advantages of an
electronic manifest system in terms of reduced paperwork burdens and
more timely waste tracking. This action responds to these needs with a
truly universal set of manifest data elements and a manifest format
that will be identical in all States, as well as standards that will
allow the manifest data to be completed, signed, transmitted, and
recorded electronically.
Summary of Legal Basis:
EPA's regulations implementing the manifest are based on section
3002(a)(5) of the RCRA statute, which requires that EPA include in its
hazardous waste generator regulations requirements addressing the ``use
of a manifest system and ony other reasonable means necessary'' to
assure that all such hazardous waste is designated for and arrives at
treatment, storage, or disposal facilities that have been permitted
under RCRA subtitle C requirements. Secion 3003(a)(3) of the Act
requires transporters of hazardous waste to comply with the manifest
system, while section 3004(a)(2) requires compliance with the manifest
system by treatment, storage, and disposal facilities. Moreover,
according to section 1004(12) of the Act, the manifest is defined as
the ``form used for identifying the quantity, composition, and the
origin, routing, and destination of hazardous waste during its
transportation from the point of generation to the point of disposal,
treatment, or storage.'' The manifest also serves as the ``shipping
paper'' meeting DOT requirements for the transportation of hazardous
materials under the Federal Hazardous Materials laws and regulations.
EPA's current manifest regulations require generators to obtain
manifest forms from the authorized States. The generator must complete
the paper form by identifying the type and quantity of
[[Page 72840]]
hazardous waste in off-site shipments, as well as the identities of the
transporters and waste receiving facilities that will manage the waste.
The regulations require waste handlers to sign the manifest form by
hand when they receive a waste shipment, and to retain copies of the
signed manifests that document the chain of custody of a shipment, and
any discrepancies.
EPA and DOT have authority to eliminate variability among State
manifests, since DOT's hazardous materials laws generally call for
uniformity in the use of hazardous materials shipping papers such as
the manifest, and EPA must regulate transportation consistently with
DOT. EPA and DOT consented in 1984 to the inclusion of several
``optional'' data fields, but our experience with the manifest system
has demonstrated that the inclusion of optional fields introduces
excessive variability and burden for waste handlers. EPA also has
authority to automate the waste tracking functions of the manifest,
since the Act states that EPA can employ any reasonable means necessary
to track waste shipments under a manifest system. There is nothing in
the statute that precludes EPA from establishing standards allowing
electronic manifesting of shipments, as well as use of the traditional
paper forms.
Alternatives:
The form revisions part of the rulemaking examines alternatives to the
current system that allows authorized States to print and distribute
slightly varying manifest forms (typically for a fee) to waste handlers
generating or shipping waste in a particular State. This rule would
establish a precise Federal specification for the manifest that would
preclude variability in manifest forms, wherever they are used. This
option was proposed in May 2001, and was supported by the great
preponderance of commenters who submitted written comments to the
docket.
The rule also examines alternative electronic formats for completing
electronic manifests, and alternative methods for signing manifests
electronically. Moreover, EPA has been examining in response to
comments whether electronic manifest systems should be developed in a
decentralized fashion by private companies in adherence with standards
announced by EPA (the proposed approach), or developed and hosted
centrally in a national system. We expect that additional stakeholder
outreach will be necessary to determine the appropriate design and
functionality of the e-manifest approach for the final rule. Therefore,
the e-manifest part of the rulemaking has been separated from the form
revisions part of the rule, so that final action on the form revisions
will not be delayed by future outreach and analysis conducted in
connection with the e-manifest.
Anticipated Cost and Benefits:
The baseline manifest system results in annual paperwork burdens of 4.6
million hours and annual costs of about $193 million. In developing the
May 2001, proposed rule, EPA estimated that the proposed revisions to
the hazardous waste manifest system (form changes and electronic
manifest) would reduce the paperwork burdens imposed by the manifest by
765,000 to 1.24 million hours annually, and would reduce annual costs
by $24 to $37 million. The rule should also eliminate much of the
complexity that arises from having to obtain and comply with States'
slightly varying manifest forms, and the burden and complexity of
having to supply information to satisfy the current so-called
``optional'' State fields. The ability to complete and transmit
manifest data electronically should improve the accuracy of manifest
data, and the timeliness and effectiveness of waste shipment tracking.
Risks:
This rule addresses only administrative requirements for tracking waste
shipments. The rule does not address risks posed by particular
substances or waste management activities, and no risk assessments have
been prepared to support this action.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 66 FR 28240 05/22/01
Final Action 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, State
Additional Information:
SAN No. 3147, EDocket No. RCRA-2001-0032; Because of significant issues
identified during the public comment period on the electronic manifest
part of the rule, this part of the rule has been separated from the
form revisions part of the rule for purposes of publishing a final
action. The form revisions part of the rule will be finalized first.
Sectors Affected:
325 Chemical Manufacturing; 2211 Electric Power Generation,
Transmission and Distribution; 332 Fabricated Metal Product
Manufacturing; 2122 Metal Ore Mining; 2111 Oil and Gas Extraction; 326
Plastics and Rubber Products Manufacturing; 331 Primary Metal
Manufacturing; 323 Printing and Related Support Activities; 3221 Pulp,
Paper, and Paperboard Mills; 482 Rail Transportation; 484 Truck
Transportation; 5621 Waste Collection; 5622 Waste Treatment and
Disposal; 483 Water Transportation
URL For More Information:
http://www.epa.gov/epaoswer/hazwaste/gener/manifest/index.htm
Agency Contact:
Rich Lashier
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8796
Fax: 703 308-0522
Email: lashier.rich@epamail.epa.gov
Bryan Groce
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8750
Fax: 703 308-0522
Email: groce.bryan@epamail.epa.gov
RIN: 2050-AE21
_______________________________________________________________________
EPA
133. STANDARDIZED PERMIT FOR RCRA HAZARDOUS WASTE MANAGEMENT FACILITIES
Priority:
Other Significant
Legal Authority:
42 USC 6905; 42 USC 6912; 42 USC 6924; 42 USC 6925; 42 USC 6927; 42 USC
6974
CFR Citation:
40 CFR 124; 40 CFR 267; 40 CFR 270
Legal Deadline:
None
[[Page 72841]]
Abstract:
EPA has proposed creating a new type of general permit, called a
standardized permit, for facilities that generate waste and routinely
manage the waste on-site in tanks, containers, and containment
buildings. Under the standardized permit, facility owners and operators
would certify compliance with generic design and operating conditions
set on a national basis. The permitting agency would review the
certifications submitted by the facility owners and operators. The
permitting agency would also be able to impose additional site-specific
terms and conditions for corrective action or other purposes, as called
for by RCRA. Ensuring compliance with the standardized permit's terms
and conditions would occur during inspection of the facility after the
permit has been issued. The standardized permit should streamline the
permit process by allowing facilities to obtain and modify permits more
easily while maintaining the protectiveness currently existing in the
individual RCRA permit process. EPA estimates that the potential
average annual cost savings to eligible facilities from implementation
of this rule will range from approximately $100 to $5,800 (i.e., 2 to
140 burden hours) per permit action, depending on such things as the
type of permit and the type of storage equipment. The proposal raised
issues for public comment on how all facilities receiving RCRA permits
can satisfy RCRA corrective action requirements under appropriate
alternative State cleanup programs and on financial assurance issues.
The Agency is developing a final rule addressing this topic.
Statement of Need:
The Agency convened a special task force in 1994 to look at permitting
activities throughout its different programs and to make specific
recommendations to improve these permitting programs. This task force,
known as the Permits Improvement Team (PIT), spent two years working
with stakeholders from the Agency, State permitting agencies, industry,
and the environmental community. The PIT stakeholders mentioned, among
other things, that permitting activities should be commensurate with
the complexity of the activity. The stakeholders felt that current
Agency permitting programs were not flexible enough to allow
streamlined procedures for routine permitting activities. Currently,
facilities that store, treat, or dispose of hazardous waste must obtain
site-specific ``individual'' permits prescribing conditions for each
``unit'' (e.g., tank, container area, etc.) in which hazardous waste is
managed. Experience gained by the Agency and States over the past 15
years has shown that not all the waste management activities are at the
same level of complexity. Some activities, such as thermal treatment or
land disposal of hazardous wastes, are more complex than storage of
hazardous waste. The Agency believes that thermal treatment and land
disposal activities continue to warrant ``individual'' permits,
prescribing unit-specific conditions. However, the Agency believes that
some accommodation can be made for hazardous waste management practices
in standardized units such as tanks, container storage areas, and
containment buildings. In April 1996, the PIT tentatively recommended,
among other things, that regulations be developed to allow
``standardized permits'' for on-site storage and non-thermal treatment
of hazardous waste in tanks, containers, and containment buildings. On
October 12, 2001, the Agency proposed revising the RCRA regulations to
allow for this type of permit, and is preparing to finalize the rule.
Summary of Legal Basis:
Facilities that manage hazardous waste are required under RCRA to
obtain a permit and carry out corrective action as necessary (see: RCRA
sections 3004, 3005, 3008, and 3010). EPA has discretion under these
statutory provisions to apply different permitting procedures to
different types of facilities. No aspect of this streamlining action is
required by court order.
Alternatives:
EPA considered several options regarding RCRA permits and corrective
action alternatives. The Agency proposed to limit the scope of the rule
to facilities that generate waste and manage it on-site, but asked for
comment on whether to expand that scope to facilities that manage
wastes generated off-site. The Agency also asked for comment on the
option of allowing a facility's RCRA corrective action activities to be
postponed if corrective action is being carried out under an approved
State remedial program.
Anticipated Cost and Benefits:
The RCRA standardized permit is an optional rule designed to streamline
the regulatory burden to EPA/States, as well as to private sector
facilities covered by the rule, by reducing the amount of information
collected, submitted, and reviewed for RCRA hazardous waste permit
actions (i.e., new permit applications, permit modifications, and
permit renewals). Because the rule proposed to streamline existing RCRA
regulation, rather than add new RCRA regulation, implementation of the
rule by the EPA and by States with EPA-authorized permitting programs
is expected to result in economic benefits in the form of national cost
savings from reducing both government and private sector resources
required for the RCRA permit process. The national workload level of
RCRA permit actions involving on-site hazardous waste storage and non-
thermal treatment units has averaged 92 permit determinations per year
over the 10-year period 1990-1999. Relative to this average annual
workload, EPA estimates that the potential average annual cost savings
to eligible facilities from implementation of this rule will range from
approximately $100 to $5,800 (i.e., 2 to 140 burden hours) per permit
action, depending on such things as the type of permit and the type of
storage equipment. On a national basis, the rule is expected to
generate a minimum of $0.36 to $0.53 million in average annual
paperwork cost savings, based on the scope of the proposed rule, which
was limited to on-site waste management facilities. However, the final
rule may expand the initial scope of eligible facilities, which could
easily double or triple the national cost savings benefits (i.e., $1.1
to $1.6 million per year in cost savings).
Risks:
The purpose of this rule is to streamline existing RCRA permit
application and issuance procedures to achieve national paperwork
burden reduction. Because of the facts that facilities covered by this
rule: (a) Are currently already required to obtain RCRA permits, and
(b) are relatively simple to design, install/construct, operate, and
clean-close, this rule is expected to have minimal incremental effects
on existing levels of human health and environmental risk for these
types of hazardous waste management facilities.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 66 FR 52192 10/12/01
Final Action 04/00/05
Regulatory Flexibility Analysis Required:
No
[[Page 72842]]
Small Entities Affected:
No
Government Levels Affected:
Federal, State
Additional Information:
SAN No. 4028;
Sectors Affected:
3251 Basic Chemical Manufacturing; 332813 Electroplating, Plating,
Polishing, Anodizing and Coloring; 32551 Paint and Coating
Manufacturing; 32532 Pesticide and Other Agricultural Chemical
Manufacturing; 32411 Petroleum Refineries; 325211 Plastics Material and
Resin Manufacturing; 3252 Resin, Synthetic Rubber, and Artificial and
Synthetic Fibers and Filaments Manufacturing
Agency Contact:
Jeff Gaines
Environmental Protection Agency
Solid Waste and Emergency Response
5303W
Washington, DC 20460
Phone: 703-308-8655
Fax: 703-308-8609
Email: gaines.jeff@epamail.epa.gov
RIN: 2050-AE44
_______________________________________________________________________
EPA
134. RCRA BURDEN REDUCTION INITIATIVE
Priority:
Other Significant
Legal Authority:
42 USC 6907; 42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6923; 42
USC 6924; 42 USC 6925; 42 USC 6926; 42 USC 6927; 42 USC 6930; 42 USC
6934; 42 USC 6935; 42 USC 6937; 42 USC 6938; 42 USC 6939; 42 USC 6944;
42 USC 6949(a); 42 USC 6974; PL 104-13
CFR Citation:
40 CFR 261.38; 40 CFR 264.16; 40 CFR 264.52; 40 CFR 264.56; 40 CFR
264.73; 40 CFR 264.98 et seq; 40 CFR 265.16; 40 CFR 265.52; 40 CFR
265.56; 40 CFR 265.73; 40 CFR 265.98 et seq; 40 CFR 266.103; 40 CFR
261.4; 40 CFR 268.7; 40 CFR 268.9
Legal Deadline:
None
Abstract:
EPA plans to reduce the burden imposed by the RCRA reporting and
recordkeeping requirements to help meet the Federal Governmentwide goal
established by the Paperwork Reduction Act (PRA).
In June 1999, EPA published a Notice of Data Availability (NODA) in the
Federal Register (64 FR 32859) to seek comment on a number of burden
reduction ideas to eliminate duplicative and nonessential paperwork.
After reviewing the comments received on the NODA, EPA proposed (67 FR
2518, 1/17/02) to implement many of these ideas. EPA issued a notice
(68 FR 61662; 10/29/03) seeking further input on a number of changes we
proposed. EPA plans to finalize this burden reduction effort.
Statement of Need:
The Paperwork Reduction Act of 1995 establishes a Federal
Governmentwide goal to reduce the paperwork and reporting burden it
imposes. The RCRA Burden Reduction Initiative Proposed Rulemaking makes
the regulatory changes necessary to meet this goal.
Summary of Legal Basis:
This action is not required by statute or court order.
Alternatives:
Reducing recordkeeping and reporting will require changes in our
regulations. There was no alternative to doing a rulemaking. The Agency
sought opinions from the regulated community on various burden
reduction possibilities.
Anticipated Cost and Benefits:
Our cost-benefit analysis showed a savings of $120 million and 929,000
hours for the final rule. The rule will have minimal impact on the
protectiveness of the RCRA regulations. It will eliminate or streamline
paperwork requirements that are unnecessary because they add little to
the protectiveness of the RCRA regulations.
Risks:
The rule will have no risk impacts.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NODA 1 64 FR 32859 06/18/99
NPRM 67 FR 2518 01/17/02
NODA 2 68 FR 61662 10/29/03
Final Action 08/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State, Tribal
Additional Information:
SAN No. 4084; Applicable SIC codes: Chemicals and Allied Products (28),
Primary Metal Industries (33), Fabricated Metals (34), Industrial
Machinery and Equipment (35), Electrical Equipment (36), Transportation
Equipment (37), Other Manufacturing, Transportation and Utilities (40-
49), Wholesale Trade (50-51), Services (70-89) and Other SIC Groups
Sectors Affected:
325 Chemical Manufacturing; 334 Computer and Electronic Product
Manufacturing; 332 Fabricated Metal Product Manufacturing; 324
Petroleum and Coal Products Manufacturing; 326 Plastics and Rubber
Products Manufacturing; 331 Primary Metal Manufacturing; 323 Printing
and Related Support Activities; 562 Waste Management and Remediation
Services
Agency Contact:
Elaine Eby
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington, DC 20460
Phone: 703-308-8449
Fax: 703 308-8433
Email: eby.elaine@epamail.epa.gov
RIN: 2050-AE50
_______________________________________________________________________
EPA
135. RECYCLING OF CATHODE RAY TUBES (CRTS): CHANGES TO HAZARDOUS WASTE
REGULATIONS
Priority:
Other Significant
Legal Authority:
42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6923; 42 USC 6924; 42
USC 6925
CFR Citation:
40 CFR 261; 40 CFR 273
Legal Deadline:
None
Abstract:
This action will ultimately revise the existing Federal hazardous waste
regulations to encourage recycling and better management of Cathode Ray
[[Page 72843]]
Tubes (CRTs) by providing a conditional exclusion from the definition
of solid waste for CRTs being recycled. A CRT is the display component
of a television or computer monitor. A CRT is made largely of
specialized glasses, some of which contain lead to protect the user
from X-rays inside the CRT. Due to the lead, when they are disposed of
or reclaimed, some CRTs are hazardous wastes under the Federal Resource
Conservation and Recovery Act (RCRA) regulations.
Statement of Need:
This rule is needed to respond to recommendations of the Electronics
Subcommittee of the CSI Council regarding CRT recycling. It is also
needed to streamline RCRA requirements for these materials to encourage
better management and recycling.
Summary of Legal Basis:
This action is not required by statute or court order.
Alternatives:
EPA solicited comments on alternative management requirements,
including notification and tracking, accumulation requirements,
requirements for CRT glass processors, export requirements, and
disposal requirements.
Anticipated Cost and Benefits:
EPA estimates that, if finalized, this action would result in annual
savings of up to 3 million dollars to reduce administrative,
transportation, and management costs compared to current regulations.
Risks:
The risks are undetermined.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 67 FR 40507 06/12/02
Final Action 08/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State, Tribal
Additional Information:
SAN No. 4092, EDocket No. RCRA-2004-0010 (CRTs) RCRA-2004-0012 (Mercury
devices);
Sectors Affected:
334411 Electron Tube Manufacturing
Agency Contact:
Marilyn Goode
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8800
Fax: 703 308-0514
Email: goode.marilyn@epamail.epa.gov
RIN: 2050-AE52
_______________________________________________________________________
EPA
136. HAZARDOUS WASTE MANAGEMENT SYSTEM; MODIFICATION OF THE
HAZARDOUS WASTE PROGRAM: MERCURY-CONTAINING EQUIPMENT
Priority:
Other Significant
Legal Authority:
42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6923; 42 USC 6924; 42
USC 6925
CFR Citation:
40 CFR 261; 40 CFR 273
Legal Deadline:
None
Abstract:
Mercury-containing equipment (MCE) consists of devices, items, or
articles that contain varying amounts of elemental mercury that is
integral to their functions, including several types of instruments
that are used throughout the electric utility industry and other
industries, municipalities, and households. Some commonly recognized
devises are thermostats, barometers, manometers, and mercury switches,
such as light switches in automobiles. This definition does not include
mercury waste that is generated as a byproduct through the process of
manufacturing or treatment. This action will add mercury-containing
equipment to the federal list of universal wastes regulated under the
Resource Conservation and Recovery Act (RCRA) hazardous waste
regulations. Handlers of universal wastes are subject to less stringent
standards for storing, transporting, and collecting these wastes. EPA
believes that regulating spent mercury-containing equipment as a
universal waste will lead to better management of this equipment and
will facilitate compliance with hazardous waste requirements.
Statement of Need:
This rule is needed to respond to a petition from the Utilities Solid
Waste Activities Group regarding management of mercury-containing
equipment. It is also needed to streamline RCRA requirements for these
materials to encourage better management and recycling and to reduce
management of mercury in the municipal waste system.
Summary of Legal Basis:
This action is not required by statute or court order.
Alternatives:
EPA solicited comments on alternative management requirements and
alternative approaches for meeting its goals with respect to mercury
equipment management.
Anticipated Cost and Benefits:
EPA estimates that, if finalized, this action would result in annual
savings of up to $270,000 to reduce administrative, transportation, and
management costs compared to current regulations. In addition, this
action would improve management of mercury wastes from small and large
generators and increase collection of these materials for proper
management.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Final Action 06/00/05
Regulatory Flexibility Analysis Required:
DATA MISSING
Government Levels Affected:
Federal, Local, State, Tribal
Additional Information:
SAN No. 4092.1, EDocket No. RCRA-2004-0010 (CRTs) RCRA-2004-0012
(Mercury devices); Split from RIN 2050-AE52.
Agency Contact:
Katherine Blanton
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-605-0761
Fax: 703 308-0514
Email: blanton.katherine@epamail.epa.gov
RIN: 2050-AG21
[[Page 72844]]
_______________________________________________________________________
EPA
137. NATIONAL PRIMARY DRINKING WATER REGULATIONS: GROUNDWATER RULE
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
42 USC 300 g-1 SDWA 1412 (b)(8); 42 USC 300j-4 SDWA 1445
CFR Citation:
40 CFR 141; 40 CFR 142
Legal Deadline:
Other, Statutory, Not later than promulgation of the Stage 2
Disinfection Byproducts Rule (currently scheduled for July 2005).
Abstract:
EPA has proposed a targeted risk-based regulatory strategy for all
public water systems served by groundwater. The proposed requirements
provide a meaningful opportunity to reduce public health risk for a
significant number of people served by groundwater sources from the
exposure to waterborne pathogens from fecal contamination. The proposed
strategy addresses risks through a multiple-barrier approach that
relies on five major components: periodic sanitary surveys of
groundwater systems requiring the evaluation of eight elements and the
identification of significant deficiencies; hydrogeologic assessments
to identify wells sensitive to fecal contamination; source water
monitoring for systems drawing from sensitive wells without treatment
or with other indications of risk; a requirement for correction of
significant deficiencies and fecal contamination through the following
actions: eliminate the source of contamination, correct the significant
deficiency, provide an alternative source water, or provide a treatment
which achieves at least 99.99 percent (4-log) inactivation or removal
of viruses; and compliance monitoring to insure disinfection treatment
is reliably operated where it is used.
Statement of Need:
Public water systems (PWSs) that use groundwater as their sole source
of water, as opposed to surface water PWSs, are not federally regulated
as to treatment for microorganisms. There is data that indicates that a
number of groundwater PWSs are contaminated with microorganisms of
fecal origin that can and have caused illness.
Summary of Legal Basis:
Section 1412(b)(8) of the Safe Drinking Water Act requires that EPA
develop regulations specifying the use of disinfectants for ground
water systems as necessary and ``. . .(as part of the regulations)
promulgate criteria. . .to determine whether disinfection shall be
required as a treatment technique for any public water system served by
ground water.''
Alternatives:
EPA considered four regulatory alternatives in the development of the
GWR proposal; the proposed regulatory alternative (multi-barrier
option), the sanitary survey option, the sanitary survey and triggered
monitoring option, and the across-the-board disinfection option. All
options include the sanitary survey provision. The sanitary survey
option would require the primacy agency to perform surveys every three
to five years, depending on the type of system. If any significant
deficiency is identified, a system is required to correct it. The
sanitary survey and triggered monitoring option adds a source water
fecal indicator monitoring requirement triggered by a total coliform
positive sample in the distribution system. The multi-barrier option,
which was proposed by EPA, adds a hydrogeologic sensitivity assessment
to these elements which, if a system is found to be sensitive, results
in a routine source water fecal indicator monitoring requirement. The
multi-barrier option and the sanitary survey and triggered monitoring
options are targeted regulatory approaches designed to identify wells
that are fecally contaminated or are at a high risk for contamination.
The across-the-board disinfection option would require all systems to
install treatment instead of trying to identify only the high risk
systems; therefore, it has no requirement for sensitivity assessment or
microbial monitoring.
Anticipated Cost and Benefits:
EPA estimates the cost of the proposed GWR will be $183 million dollars
per year (using a 3 percent discount rate). More than half of the
estimated costs are for corrective actions which systems will be
required to take to fix or prevent fecal contamination. The remainder
of the costs are due to increased scope and frequency of sanitary
surveys, hydrogeologic sensitivity assessments and source water
monitoring. System costs are expected to be $162 million per year for
implementation of the GWR. States are expected to incur costs of $21
million per year. Cost estimates do not include land acquisition,
public notification or the potential cost of illness due to exposure to
disinfection by-products. The total estimated value of these benefits
is $205 million per year, $139 million from avoided illness and $66
million from avoided deaths. These benefits are monetized based on a
cost of illness and a value of statistical life. These estimates do not
include pain and suffering associated with viral and bacterial illness
avoided outbreak response costs (such as the costs of providing public
health warnings and boiling drinking water), and possibly the avoided
costs of averting behavior and reduced uncertainty about drinking water
quality.
Risks:
EPA estimates that currently over 200,000 illnesses and 18 deaths occur
each year due to viral and bacterial contamination of public
groundwater systems. Children, the elderly and the immunocompromised
are particularly sensitive to the waterborne pathogens and account for
between 20 and 30 percent of the illnesses and deaths. As proposed, the
GWR is expected to reduce the total number of illnesses by 115,000 and
the total number of deaths by 11 each year. The GWR in conjunction with
the Surface Water Treatment Rule (SWTR), Total Coliform Rule (TCR) the
Interim Enhanced Surface Water Treatment Rule (IESWTR), the Filter
Backwash Rule (FBR) and the Long Term Enhanced Surface Water Treatment
Rules (LT1ESWTR and LT2ESWTR) will provide protections to the consumers
of public water supply systems from waterborne pathogens.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 30194 05/10/00
Final Action 05/00/05
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, Local, State, Tribal
[[Page 72845]]
Additional Information:
SAN No. 2340; Statutory deadline for final rule: After August 6, 1999,
but not later than the Administrator promulgates a Stage II rulemaking
for disinfection byproducts (currently scheduled for July 2005).
Sectors Affected:
22131 Water Supply and Irrigation Systems
Agency Contact:
Crystal Rodgers
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202-564-5275
Fax: 202 564-3767
Email: rodgers.crystal@epamail.epa.gov
Tracy Bone
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202-564-5257
Fax: 202 564-3767
Email: bone.tracy@epamail.epa.gov
RIN: 2040-AA97
_______________________________________________________________________
EPA
138. NATIONAL PRIMARY DRINKING WATER REGULATIONS: LONG TERM 2 ENHANCED
SURFACE WATER TREATMENT RULE
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect State, local or tribal governments and the
private sector.
Legal Authority:
42 USC 300f; 42 USC 300g-1; 42 USC 300g-2; 42 USC 300g-3; 42 USC 300g-
4; 42 USC 300g-5; 42 USC 300g-6; 42 USC 300j-4; 42 USC 300j-9; 42 USC
300j-11
CFR Citation:
40 CFR 141 to 142; 40 CFR 9
Legal Deadline:
None
Abstract:
The Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) will
control risk from microbial pathogens, specifically cryptosporidium, in
drinking water. It is being developed simultaneously with the Stage 2
Disinfectants and Disinfection Byproducts Rule (DBPR), which will
address risk caused by the use of disinfectants in drinking water. This
rule could affect all public water systems that use surface water as a
source. Promulgating the LT2ESWTR and the Stage 2 DBPR as a paired
rulemaking is necessary to ensure that adequate protection from
microbial risk is maintained while EPA manages risk from disinfection
byproducts. In developing the LT2ESWTR, EPA has analyzed a significant
body of new survey data on microbial pathogens in source and finished
waters, as well as data on parameters which could serve as indicators
of microbial risk. This survey data, which was collected under the
Information Collection Rule (ICR), Supplemental Surveys to the ICR, and
additional research projects, has provided a substantially more
comprehensive and complete picture of the occurrence of waterborne
pathogens than was previously available. EPA has also used significant
new data on the efficiency of treatment processes for the removal and
inactivation of microorganisms, as well as new information on the
pathogenicity of certain microbes, to determine effective regulatory
requirements for controlling microbial risk. On March 30, 1999, EPA
established a committee of stakeholders under the Federal Advisory
Committee Act (FACA) to assist in the development of these rules; an
agreement in principle was signed in September 2000 outlining the
proposed rule options.
Statement of Need:
The purpose of the Long Term 2 Enhanced Surface Water Treatment Rule
(LT2ESWTR) is to reduce health risks posed by Cryptosporidium and other
microbial pathogens in drinking water. Cryptosporidium is a protozoa
which causes cryptosporidiosis, a severe gastrointestinal disease.
While cryptosporidiosis is generally self limiting in healthy
individuals, it can be fatal for people with compromised immune
systems. Cryptosporidium is removed to a degree by filtration but is
highly resistant to conventional drinking water disinfectants,
including chlorine and chloramines. EPA has recently collected a
significant amount of data on occurrence of Cryptosporidium in drinking
water sources through the Information Collection Rule (ICR) and ICR
Supplemental Surveys. These data indicate that a subset of drinking
water systems have an unacceptably high risk for Cryptosporidium in
their treated water. The LT2ESWTR is intended to identify systems at
high risk for Cryptosporidium through monitoring and prescribe an
appropriate level of additional treatment. In addition, the LT2ESWTR
will be promulgated simultaneously with the Stage 2 Disinfectants and
Disinfection Byproducts Rule (DBPR). This will help to ensure that
drinking water utilities do not compromise adequate microbial
protection while they take steps to control DBPs.
Summary of Legal Basis:
Section 1412(b)(7)(A) of SDWA authorizes the Administrator to
promulgate a national primary drinking water regulation that requires
the use of a treatment technique in establishing a maximum contaminant
level if the Administrator makes a finding that it is not feasible to
ascertain the level of the contaminant. The MCLG for Cryptosporidium is
zero and it is not feasible for public water systems to measure
Cryptosporidium concentrations in treated water. Consequently, under
Section 1412(b)(1)(A), the Administrator may establish a treatment
technique for Cryptosporidium if this presents a meaningful opportunity
for health risk reduction. Although the 1996 Amendments do not require
EPA to finalize a Long Term 2 Enhanced Surface Water Treatment Rule
concurrently with the Stage 2 Disinfectants and Disinfection Byproducts
Rule, Congress did emphasize the importance of ensuring proper balance
between microbial and DBP risks and, therefore, EPA believes it is
important to finalize these rules together.
Alternatives:
EPA is considering various rule scenarios to reduce risk from
Cryptosporidium. These scenarios include treatment requirements that
would apply to all systems, such as requiring all conventional plants
to achieve 2-log inactivation of Cryptosporidium. Alternative scenarios
have involved assigning systems to bins based on mean Crypto source
water concentrations. Additional treatment requirements would then
depend on the bin to which a system was assigned. Issues associated
with the binning approach include: amount of monitoring necessary to
assign systems to bins, appropriate Crypto concentrations to demarcate
bin boundaries, and appropriate level of additional treatment for a
given bin.
[[Page 72846]]
EPA is exploring analyses that evaluate the impact of these issues on
costs and benefits. EPA has also considered options to reduce the
impact on small systems.
Anticipated Cost and Benefits:
EPA estimates that the LT2ESWTR, as proposed will have an annual cost
of $73 to $111 million per year. The majority of people (approximately
67 percent) are served by public water systems that use a surface water
or ground water under the direct influence of surface water. Thus, a
large number of people will benefit from the LT2ESWTR. EPA estimates
that the proposed LT2ESWTR would prevent up to 1,020,000 cases of
cryptsporidiosis annually with an economic benefit of up to $1.4
billion. In addition, EPA has recently identified UV light as a
technology that can achieve high levels of Cryptosporidium inactivation
at relatively low cost.
Risks:
Approximately 67 percent of consumers are served by drinking water
systems that use surface water sources or ground water under the direct
influence of surface water. Survey data indicate that Cryptosporidium
is prevalent in drinking water sources and current levels of treatment
may not be adequate to control highly resistant pathogens like
Cryptosporidium. Cryptosporidiosis is a potentially fatal disease in
people with weak immune systems, such as infants, the elderly, people
with AIDS, and people taking immune suppressing drugs like cancer and
transplant patients. By requiring additional treatment for those
systems with the highest concentrations of Cryptosporidium in their
source waters, EPA expects to significantly reduce current risk.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 47639 08/11/03
Final Action 07/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, Local, State, Tribal
Federalism:
This action may have federalism implications as defined in EO 13132.
Additional Information:
SAN 4341.
Sectors Affected:
22131 Water Supply and Irrigation Systems
Agency Contact:
Dan Schmelling
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202-564-5281
Fax: 202 564-3767
Email: schmelling.dan@epamail.epa.gov
Thomas Grubbs
Environmental Protection Agency
Water
4607M
4607
Washington, DC 20460
Phone: 202-564-5262
Fax: 202 564-3767
Email: grubbs.thomas@epamail.epa.gov
RIN: 2040-AD37
_______________________________________________________________________
EPA
139. NATIONAL PRIMARY DRINKING WATER REGULATIONS: STAGE 2 DISINFECTION
BYPRODUCTS RULE
Priority:
Economically Significant
Unfunded Mandates:
This action may affect State, local or tribal governments and the
private sector.
Legal Authority:
42 USC 300f; 42 USC 300g-2; 42 USC 300g-3; 42 USC 300g-4; 42 USC 300g-
5; 42 USC 300g-6; 42 USC 300j-4; 42 USC 300j-9; 42 USC 300j-11
CFR Citation:
40 CFR 141 to 142; 40 CFR 9
Legal Deadline:
Final, Statutory, July 14, 2003.
Abstract:
This Regulation, along with a Long Term 2 Enhanced Surface Water
Treatment Rule (LT2ESWTR) that will be promulgated simultaneously, is
intended to expand existing public health protections and address
concerns about risk trade-offs between pathogens and disinfection
byproducts. This rule could affect all public water systems that add a
disinfectant to the drinking water during any part of the treatment
process, although the impacts may be limited to community water systems
(CWSs) and non-transient non-community water systems (NTNCWSs).
Promulgating the LT2ESWTR and the Stage 2 DBPR as a paired rulemaking
is necessary to ensure that adequate protection from microbial risk is
maintained while EPA manages risk from disinfection byproducts. In
developing the Stage 2 DBPR, EPA analyzed a significant body of new
survey data on source water quality parameters, treatment data and
disinfection byproduct occurrence. This survey data, which was
collected under the Information Collection Rule (ICR), Supplemental
Surveys to the ICR, and additional research projects, provide a
substantially more comprehensive and complete picture of the occurrence
of DBPs and microbiological pathogens than was previously available.
EPA also used new information on the health effects of exposure to DBPs
to determine effective regulatory requirements for controlling risk. On
March 30, 1999, EPA reconvened a committee of stakeholders under the
Federal Advisory Committee Act (FACA) to assist in the development of
these rules; an Agreement in Principle was signed in September 2000
outlining the proposed rule options.
Statement of Need:
The purpose of the Stage 2 Disinfectants/Disinfection Byproducts Rule
(DBPR) is to reduce potential health risks posed by disinfection
byproducts (DBPs). Certain DBPs have been shown in laboratory tests to
be carcinogens or to cause adverse reproductive and developmental
health effects. In addition, epidemiology studies have indicated that
exposure to chlorinated water may increase the risk of bladder cancer,
miscarriage, and certain developmental defects. The Stage 2 DBPR is
designed to reduce peak events in DBP exposure in order to mitigate
these potential health risks.
Summary of Legal Basis:
Section 1412(b)(2)(C) of SDWA, as amended in 1996, requires EPA to
promulgate a Stage 2 Disinfectants/Disinfection Byproducts Rule no
later than July 14, 2003. Although the 1996 Amendments do not require
EPA to finalize a Long Term 2 Enhanced Surface Water Treatment Rule
concurrently with the Stage 2 Disinfectants and Disinfection Byproducts
Rule, Congress did emphasize the importance of ensuring proper balance
between microbial and DBP risks and, therefore, EPA believes
[[Page 72847]]
it is important to finalize these rules together.
Alternatives:
EPA is considering various rule scenarios to achieve reductions in
disinfection byproduct exposure. These alternatives include: decreasing
the standard set in the Stage 1 DBPR (0.080 mg/L total trihalomethanes
(TTHM) and 0.060 mg/L the sum of 5 haloacetic acids (HAA5)) by half and
maintaining a running annual average compliance calculation;
maintaining 80/60 TTHM/HAA5 standards but revising the compliance
calculation to a stricter locational running annual average; setting
the 80/60 TTHM/HAA5 standard as a never to be exceeded maximum; and
revising the standard for bromate which is currently 0.010 mg/L. EPA
has also considered options to reduce the impact on small systems.
Anticipated Cost and Benefits:
EPA estimates that the Stage 2 DBPR will have an annual economic impact
of $59-65 million. Over 200 million people are served by public water
systems that apply a disinfectant (e.g., chlorine) to water in order to
provide protection against microbial contaminants and potentially
exposed to DBPs. Thus, a large number of people will benefit from the
Stage 2 DBPR.
Risks:
Over 200 million people are served by public water systems that apply a
disinfectant (e.g., chlorine) to water in order to provide protection
against microbial contaminants. Due to the large number of people
exposed to DBPs, there is a substantial concern for any risks
associated with DBPs that may impact public health. EPA estimates that
the Stage 2 DBPR will decrease exposure to DBPs on average but more
importantly, the rule will significantly reduce exposure to peak
occurrences of DBPs.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 49548 08/18/03
Final Action 07/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, Local, State, Tribal
Federalism:
This action may have federalism implications as defined in EO 13132.
Additional Information:
SAN 4342.
Sectors Affected:
22131 Water Supply and Irrigation Systems
Agency Contact:
Tom Grubbs
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 564-5262
Fax: 202 564-3767
Email: grubbs.thomas@epa.gov
Stig Regli
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202 564-5270
Fax: 202 564-3767
Email: regli.stig@epamail.epa.gov
RIN: 2040-AD38
_______________________________________________________________________
EPA
140. MINIMIZING ADVERSE ENVIRONMENTAL IMPACT FROM COOLING WATER INTAKE
STRUCTURES AT EXISTING FACILITIES UNDER SECTION 316(B) OF THE CLEAN
WATER ACT, PHASE 3
Priority:
Other Significant
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
33 USC 1311 CWA 301; 33 USC 1316 CWA 306; 33 USC 1326 CWA 316; 33 USC
1361 CWA 501
CFR Citation:
40 CFR 9; 40 CFR 122; 40 CFR 123; 40 CFR 124; 40 CFR 125
Legal Deadline:
NPRM, Judicial, November 1, 2004.
Final, Judicial, June 1, 2006.
Abstract:
This rulemaking will affect existing facilities that use cooling water
intake structures, and whose intake flow levels exceed a minimum
threshold to be determined by EPA during this rulemaking. The proposed
rule addresses all existing facilities if they meet the proposed
threshold levels, including those in the following industries: (1)
Electricity generating facilities not covered by Phase 2 regulations;
(2) pulp and paper manufacturing facilities; (3) chemicals and allied
products manufacturing facilities; (4) petroleum and coal products
manufacturing facilities; and (5) primary metals manufacturing
facilities. EPA also proposed regulations for new offshore and coastal
oil and gas extraction facilities, which EPA excluded from the Phase I
rule for other, land-based facilities. Section 316(b) of the Clean
Water Act provides that any standard established pursuant to sections
301 or 306 of the Clean Water Act and applicable to a point source
shall require that the location, design, construction, and capacity of
cooling water intake structures reflect the best technology available
for minimizing adverse environmental impact. A primary purpose of this
action is to minimize the impingement and entrainment of fish and other
aquatic organisms by cooling water intake structures. Impingement
occurs when fish and other aquatic life are trapped against cooling
water intake structures. Entrainment occurs when aquatic organisms,
eggs and larvae are drawn into a cooling system and then pumped back
out, resulting in significant injury or mortality to the entrained
organisms.
Statement of Need:
In the absence of national regulations, Permit Directors have regulated
cooling water intake structures incompletely and inconsistently,
especially with respect to the manufacturing sector. In some instances,
permit issuance or reissuance has been significantly delayed or permit
decisions from 20 or more years ago have not been reevaluated.
Significant numbers of fish and other aquatic organisms may be cropped
annually as a result of cooling water intake structures at a single
large intake or through the cumulative impact at multiple small intakes
on the same waterbody. By court order, EPA must propose and take final
action on this regulation. This regulation may have substantial
ecological benefits.
Summary of Legal Basis:
This action is required under an Amended Consent Decree in Riverkeeper
Inc. et al. v. Whitman, 93 Civ. 0314 (AGS)(U.S. District Court,
Southern District of New York, November 21, 2000).
[[Page 72848]]
Alternatives:
This analysis will cover various sizes and types of potentially
regulated facilities. EPA is considering whether to regulate on a site-
specific, waterbody category, or national basis. EPA is also
considering several flow thresholds, below which the regulation would
not apply and permits would continue to be issued on a case-by-case
basis by Permit Directors using their best professional judgment.
Anticipated Cost and Benefits:
Costs are yet to be determined, but are not expected to exceed $100
million. While monetized use benefits are expected to be lower than
monetized costs, a qualitative assessment of ecological benefits at
several large facilities indicates the potential for additional
benefits when intakes are controlled. Costs and benefits are generally
expected to be smaller at facilities that use smaller amounts of
cooling water.
Risks:
Cooling water intake structures may pose significant risks for aquatic
ecosystems.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/04
Final Action 06/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, Local, State, Tribal
Additional Information:
SAN No. 4543; Split from RIN 2040-AC34.
Sectors Affected:
312 Beverage and Tobacco Product Manufacturing; 325 Chemical
Manufacturing; 61131 Colleges, Universities and Professional Schools;
334 Computer and Electronic Product Manufacturing; 211111 Crude
Petroleum and Natural Gas Extraction; 22111 Electric Power Generation;
335 Electrical Equipment, Appliance and Component Manufacturing; 332
Fabricated Metal Product Manufacturing; 311 Food Manufacturing; 333
Machinery Manufacturing; 21 Mining; 211112 Natural Gas Liquid
Extraction; 327 Nonmetallic Mineral Product Manufacturing; 322 Paper
Manufacturing; 324 Petroleum and Coal Products Manufacturing; 326
Plastics and Rubber Products Manufacturing; 331 Primary Metal
Manufacturing; 22133 Steam and Air-Conditioning Supply; 313 Textile
Mills; 336 Transportation Equipment Manufacturing; 321 Wood Product
Manufacturing
Agency Contact:
Paul Shriner
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202-566-1076
Fax: 202 566-1053
Email: shriner.paul@epamail.epa.gov
Martha Segall
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202-566-1041
Fax: 202 566-1053
Email: segall.martha@epamail.epa.gov
RIN: 2040-AD70
_______________________________________________________________________
EPA
141. CROSS-MEDIA ELECTRONIC REPORTING (ER) AND RECORDKEEPING RULE
(CROMERRR)
Priority:
Other Significant
Legal Authority:
PL 104-13; PL 105-277
CFR Citation:
40 CFR 3 (New); 40 CFR 9 (Revision)
Legal Deadline:
None
Abstract:
As proposed, the Cross-Media Electronic Reporting (ER) and
Recordkeeping Rule (CROMERRR) was intended to provide a uniform legal
framework for paperless electronic reporting and recordkeeping,
including electronic signature/certification, across EPA's
environmental compliance programs. Based on public comment, however,
EPA now plans to focus on finalizing the electronic reporting
components of proposed CROMERRR, and to defer further action on the
electronic recordkeeping components until a later time. Under current
plans, the final electronic reporting (ER) rule will address electronic
reporting by companies regulated under all of EPA's programs: air,
water, pesticides, toxic substances, wastes, and emergency response.
The final rule would remove existing regulatory obstacles to electronic
reporting, and it would set requirements for companies choosing to
report electronically. In addition, the rule would set the conditions
for allowing electronic reporting under State, tribal or local
environmental programs that operate under EPA authorization. The final
ER rule is intended to make electronic reporting as simple, efficient,
and cost-effective as possible for regulated companies, while ensuring
that a transition from paper to electronic reporting does not
compromise EPA's compliance and enforcement programs. Consequently, the
Agency's strategy is to impose as few specific requirements as
possible, and to keep those requirements neutral with respect to
technology, so the rule will pose no obstacles to adopting new
technologies as they emerge. To ensure that authorized programs at the
State, tribal, and local levels meet EPA's electronic reporting goals,
the final ER rule would specify a set of criteria that these programs
must satisfy as they initiate electronic reporting. In response to
public comments, EPA is also planning to include provisions for a
streamlined process for EPA to review and approve authorized program
revisions or modifications to allow electronic reporting.
Statement of Need:
EPA is required by the Government Paperwork Elimination Act (GPEA) of
1998 to make the option of electronic reporting and recordkeeping
available, where practicable, to its regulated community by 2003. To
meet this deadline and comply with GPEA, EPA believes that it needs to
put a new legal framework in place for electronic reporting. A final ER
rule would provide for this legal framework by: (1) Removing legal
obstacles to electronic reporting posed by explicit references to paper
and paper-based processes in EPA regulations; and (2) assuring that
electronically submitted documents will have the same legal and
evidentiary force as their paper counterparts, whether the submission
is directly to EPA or under an EPA-authorized program.
Summary of Legal Basis:
Government Paperwork Elimination Act (GPEA) of 1998. GPEA requires
Federal agencies to provide, where practicable, the option of
electronic reporting and
[[Page 72849]]
recordkeeping to their regulated communities by 2003.
Alternatives:
One alternative to an EPA cross-media ER rule that applies to most
compliance reports under 40 CFR would be individual rulemakings by each
of the program offices. EPA's past experience with program-by-program
ER rulemakings has demonstrated that such an approach would be more
costly and take much longer to complete. EPA also considered the use of
guidance instead of rulemaking, but rejected this alternative based
principally on a concern that program enforceability depends greatly on
the ability to mandate a certain level of functionality for systems
that will be used to receive electronic reports and other electronic
documents.
Anticipated Cost and Benefits:
EPA received a number of comments on the assumptions used to generate
the cost and benefit estimates for the electronic reporting components
of proposed CROMERRR; based on this feedback, EPA decided to develop a
new analysis of the costs and benefits for the final ER rule. As a part
of this effort, EPA has conducted extensive follow-up interviews with
commenters, reevaluated existing sources of information, and conducted
new market research on ER technologies. The results have led EPA to
revise certain assumptions associated with the CROMERRR proposal that
bear on the ER rule's costs and benefits to regulated entities and to
Federal, State, and local governments. Proposed CROMERRR had assumed
that the costs and benefits of electronic reporting under authorized
programs could be attributed entirely to the rule. EPA has since
learned that a significant number of electronic reporting systems
already operate under such programs; correspondingly, the ER rule
cannot take credit for the costs and benefits of electronic reporting
in such cases, but only for the costs or benefits that result from
changes that occur as a result of the rule. With respect to regulated
entities, EPA has had to adjust a number of assumptions associated with
electronic signature requirements, including those related to the
number of registered signature-holders at each facility, and the
availability of acceptable alternatives to Public Key Infrastructure-
based electronic signature approaches in many instances. EPA is also
refining its estimate of the number of potentially affected regulated
entities. With respect to the Federal government, EPA has reconsidered
the general costs and benefits of electronic reporting based on
experience operating EPA's Central Data Exchange and other EPA systems,
and based also on an in-depth analysis of business processes and
associated costs for several major EPA programs implementing electronic
reporting. Based on these and other revisions to our assumptions, EPA
has developed preliminary new cost/benefit results. They indicate that
regulated entities and State and local government agencies will incur
modest net costs from the ER rule; EPA will experience modest net
benefits. Qualitative benefits of electronic reporting were also
identified, including: enhanced data quality, faster public access to
submitted data, better tracking of compliance submissions, and
opportunities for re-engineering current paper processes. Finally,
comments on the CROMERRR also indicated the need for substantial
reworking of the cost and benefit analyses with respect to the
electronic recordkeeping components of the proposal. Given EPA's
current focus on electronic reporting, EPA will defer additional
economic analysis in this area until the Agency resumes work on
electronic recordkeeping.
Risks:
The risks are undetermined.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 66 FR 46162 08/31/01
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State, Tribal
Federalism:
This action may have federalism implications as defined in EO 13132.
Additional Information:
SAN No. 4270; Formerly listed as RIN 2020-AA41.
Agency Contact:
Evi Huffer
Environmental Protection Agency
Office of Environmental Information
2823T
Washington, DC 20460
Phone: 202-566-1697
Fax: 202 566-1684
Email: huffer.evi@epa.gov
David Schwarz
Environmental Protection Agency
Office of Environmental Information
2823T
Washington, DC 20460
Phone: 202-566-1704
Fax: 202 566-1684
Email: schwarz.david@epa.gov
RIN: 2025-AA07
BILLING CODE 6560-50-S
[[Page 72850]]
EQUAL EMPLOYMENT OPPORTUNITY COMMISSION (EEOC)
Statement of Regulatory and Deregulatory Priorities
The mission of the Equal Employment Opportunity Commission (EEOC,
Commission, or Agency) is to ensure equality of opportunity in
employment by vigorously enforcing six Federal statutes. These statutes
are: Title VII of the Civil Rights Act of 1964, as amended (prohibits
employment discrimination on the basis of race, color, sex, religion,
or national origin); the Equal Pay Act of 1963, as amended; the Age
Discrimination in Employment Act of 1967 (ADEA), as amended; title I of
the Americans with Disabilities Act of 1990, as amended, and sections
501 and 505 of the Rehabilitation Act of 1973, as amended (disability);
and the Government Employee Rights Act of 1991, which extends
protections against employment discrimination to certain employees who
were not previously covered.
The significant action of a regulatory nature now under consideration
is amending regulations governing age discrimination in employment to
exempt from the prohibitions of the Age Discrimination in Employment
Act (ADEA) the practice of altering, reducing, or eliminating employer-
sponsored retiree health benefits when retirees become eligible for
Medicare or comparable State retiree health benefits. This rule will
ensure that the application of the ADEA does not discourage employers
from providing health benefits to their retirees. The Commission does
not believe that the proposed exemption will have a significant impact
on small business entities under the Regulatory Flexibility Act because
it imposes no economic or reporting burdens on such firms.
Consistent with section 4(c) of Executive Order 12866, this statement
was reviewed and approved by the Chair of the Agency. The statement has
not been reviewed or approved by the other members of the Commission.
_______________________________________________________________________
EEOC
-----------
FINAL RULE STAGE
-----------
142. COORDINATION OF RETIREE HEALTH BENEFITS WITH MEDICARE AND STATE
HEALTH BENEFITS
Priority:
Other Significant
Legal Authority:
29 USC 628
CFR Citation:
29 CFR 1625
Legal Deadline:
None
Abstract:
The Commission proposes to exempt from the prohibitions of the Age
Discrimination in Employment Act of 1967, 29 U.S.C. 621 et seq. (ADEA
or Act), the practice of altering, reducing, or eliminating employer-
sponsored retiree health benefits when retirees become eligible for
Medicare or comparable State retiree health benefits.
Statement of Need:
In August 2001, the Commission announced that it would consider the
relationship between the ADEA and employer-sponsored retiree health
benefit plans that alter, reduce, or eliminate benefits upon
eligibility for Medicare or a comparable State-sponsored retiree health
benefits program. There has been a decline in the number of employers
providing retiree health benefits over the last 10 years. Various
factors have contributed to this erosion, including the increased cost
of health care coverage, an increased demand for such coverage as large
numbers of workers near retirement age, and changes in the way
accounting rules treat the long-term costs of providing retiree health
benefits. Another factor has been employer concern about the potential
application of the ADEA to employer-sponsored retiree health benefits.
The Commission is proposing a narrowly drawn ADEA exemption that
permits the practice of coordinating employer-provided retiree health
coverage with eligibility for Medicare or a State-sponsored retiree
health benefits program, so that the ADEA does not discourage employers
from providing, or continuing to provide, health benefits to their
retirees.
Summary of Legal Basis:
Pursuant to section 9 of the ADEA, the Commission is authorized to
establish reasonable exemptions to and from any or all provisions of
the Act as it may find necessary and proper in the public interest.
Alternatives:
The Commission considered various alternatives in developing this
proposal. The Commission will consider all alternatives offered by the
public commenters.
Anticipated Cost and Benefits:
The Commission recognizes that while employers are under no legal
obligation to offer retiree health benefits, some employers choose to
do so in order to maintain a competitive advantage in the marketplace,
using these and other benefits to attract and retain the best talent
available to work for their organizations. The proposed rule will
ensure that the application of the ADEA does not discourage employers
from providing, or continuing to provide, health benefits to their
retirees who otherwise would have to obtain such coverage in the
private individual marketplace at significant personal expense. The
Commission believes that it is in the best interest of both employers
and employees for the Commission to pursue a policy that permits
employers to offer these benefits to the greatest extent possible. It
is not anticipated that the proposal will result in increased costs.
Risks:
The proposed regulatory action will reduce the risks of liability for
noncompliance with the statute by exempting certain employer practices
from regulation. This proposal does not address risks to public safety
or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 41542 07/14/03
NPRM Comment Period End 09/12/03
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State
[[Page 72851]]
Agency Contact:
Dianna B. Johnston
Assistant Legal Counsel, Office of Legal Counsel
Equal Employment Opportunity Commission
1801 L Street NW
Washington, DC 20507
Phone: 202 663-4638
TDD Phone: 202 663-7026
Fax: 202 663-4639
Email: dianna.johnston@eeoc.gov
RIN: 3046-AA72
BILLING CODE 6570-01-S
[[Page 72852]]
GENERAL SERVICES ADMINISTRATION (GSA)
Statement of Regulatory and Deregulatory Priorities
The General Services Administration (GSA) establishes Governmentwide
policy for construction and operation of buildings, procurement and
distribution of supplies, travel and transportation, acquisition,
electronic commerce, management of advisory committees, and utilization
and disposal of real and personal property.
GSA's fiscal year 2005 regulatory priority is to complete conversion
of the Federal Property Management Regulations to the Federal
Management Regulation (FMR).
GSA is writing the FMR so that its contents are consistent and
sensible and limit the regulatory burden placed on Government officials
and the public. GSA has adopted a question and answer, plain language
format for its regulations to make them easier to read and understand.
Non-regulatory guidance is being moved into other, less formal
publications such as customer service guides.
As necessary, GSA will prepare its regulations so that they address
national health and security concerns, particularly those created as a
result of the events of September 11, 2001.
BILLING CODE 6840-34-S
[[Page 72853]]
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (NASA)
Statement of Regulatory Priorities
The National Aeronautics and Space Administration (NASA) was
established by the National Aeronautics and Space Act of 1958 (the
Act), 42 United States Code (U.S.C.) 2451 et seq., which laid the
foundation for NASA's mission. The Act authorizes NASA, among other
things, to conduct space activities devoted to peaceful purposes for
the benefit of humankind; to preserve the leadership of the United
States in aeronautics and space science and technology; and to expand
knowledge of the Earth and space. To carry out this mission, NASA is
authorized to conduct research for the solution of problems of flight
within and outside the Earth's atmosphere; to develop, construct, test,
and operate aeronautical and space vehicles for research purposes; to
operate space transportation systems, including the Space Shuttle and
the International Space Station; and to perform such other activities
as may be required for the exploration of space. NASA conducts
activities required for the exploration of space with human-tended,
robotic, and expendable vehicles and arranges for the most effective
utilization of the scientific and engineering resources of the United
States with other nations engaged in aeronautical and space activities
for peaceful purposes.
NASA's mission, as documented in its 2003 Strategic Plan, is to
understand and protect our home planet, to explore the universe and
search for life, and to inspire the generation of explorers as only
NASA can.
Our mission is driven by science, exploration, and discovery, and it
will be carried out with a firm commitment to fiscal responsibility. We
will study climate change and the natural and human-induced hazards to
Earth's ecosystem. We will help to counter the threat of international
terrorism by developing technologies that can improve the security and
safety of our air transportation system. We will lead the world into a
new understanding of our planet, our solar system, and the universe
around us, and in so doing, we will begin to understand whether life
may have developed elsewhere in the cosmos.
The following are narrative descriptions of the most important
regulations being planned for publication in the Federal Register
during fiscal year (FY) 2005.
The Federal Acquisition Regulation (FAR), 48 CFR chapter 1, contains
procurement regulations that apply to NASA and other Federal agencies.
NASA implements and supplements FAR requirements through the NASA FAR
Supplement (NFS), 48 CFR chapter 18. Major revisions are not expected
in FY 2005, except to conform to FAR changes that are currently being
promulgated in part 27, Patents, Data, and Copyrights; part 45,
Government Property; and part 47, Transportation. In a continuing
effort to keep the NFS current with NASA initiatives and Federal
procurement policy, minor revisions to the NFS will be published.
To reduce the time and cost spent by the Agency and our industry
partners in the procurement of basic and applied research under
cooperative agreements, NASA is focusing on streamlining our processes.
To go forward in this effort, policy and guidance associated with the
generation and review of Cooperative Agreements Notices (CAN) is being
considered. Additionally, changes necessary for implementing a common
format for grant announcements and addressing other internal management
practices will be made.
NASA is continuing consideration of revisions to the cross-waiver of
liability regulation at 14 CFR part 1266. Specifically, NASA is
considering implementation of the cross-waiver of liability provision
of the intergovernmental agreement of the International Space Station
and refinement and clarification of contractual cross-waivers in NASA
agreements involving launch services.
BILLING CODE 7510-13-S
[[Page 72854]]
NATIONAL ARCHIVES AND RECORDS ADMINISTRATION (NARA)
Statement of Regulatory Priorities
Overview
The National Archives and Records Administration (NARA) issues
regulations directed to other Federal agencies and to the public.
Records management regulations directed to Federal agencies concern the
proper management and disposition of Federal records. Through the
Information Security Oversight Office (ISOO), NARA also issues
Governmentwide regulations concerning information security
classification and declassification programs. NARA regulations directed
to the public address access to and use of our historically valuable
holdings, including archives, donated historical materials, Nixon
Presidential materials, and Presidential records. NARA also issues
regulations relating to the National Historical Publications and
Records Commission (NHPRC) grant programs.
NARA has four regulatory priorities for fiscal year 2005. The first,
included in The Regulatory Plan, is to revise and update our records
management regulations in 36 CFR ch. XII, subchapter B. We began work
on this priority in fiscal year 2004 with a proposal for a new
organizational framework for the records management regulations to make
them easier to use. We will be issuing the revised regulations in
stages. We are issuing certain priority revisions relating to records
scheduling and disposition in advance of the overall subchapter B
revision. This regulatory activity is part of a major NARA initiative
to review and redesign our records management program that started in
2000.
The second priority is to complete the revision of our records center
facility standards regulation in 36 CFR part 1228, subpart K. This
regulation affects small businesses and is discussed in greater detail
in the following section.
Our third priority regulatory action is reviewing and revising our
records declassification regulation in 36 CFR part 1260 to reflect
changes in the Executive Order governing declassification of national
security classified information (E.O. 12958, as amended, Classified
National Security Information). Our regulations in part 1260 establish
procedures for the automatic declassification of records in NARA's
legal custody and revise requirements for reclassification of
information as provided for in the Executive Order. NARA serves the
public and Federal agencies by specifying the declassification process
we use.
Our fourth priority regulatory action is reviewing and updating our
NHPRC grants program regulations in 36 CFR part 1206. The NHPRC grants
program participates in the Grants.gov eGovernment Initiative, and our
review will ensure that the regulations reflect that participation. The
NHPRC makes grants to preserve and to deliver historical records for
use by the American people. The Commission each year receives over 150
applications requesting over $15 million of which less than $10 million
is available to award.
NARA does not have any planned regulatory actions that relate to the
events of September 11, 2001.
Regulations of Particular Concern to Small Businesses
NARA's regulation specifying facility standards for records storage
facilities that house Federal records (RIN 3095-AA81) has been
identified as being of particular concern to small businesses. The
current regulation went into effect in 2000 and was among the public
reform nominations in the Office of Management and Budget's (OMB) 2003
Report to Congress on the Costs and Benefits of Regulations. OMB
referred this regulation to NARA for evaluation. After reviewing the
regulation and extensive discussions with the records center industry
association to which many small business records centers belong, NARA
issued a proposed rule on September 7, 2004, that will still ensure
protection of Federal records while reducing the burden on records
centers that are small businesses.
_______________________________________________________________________
NARA
-----------
PROPOSED RULE STAGE
-----------
143. FEDERAL RECORDS MANAGEMENT
Priority:
Other Significant
Legal Authority:
44 USC 2104(a); 44 USC ch 21; 44 USC ch 29; 44 USC ch 33
CFR Citation:
36 CFR 1220 to 1238
Legal Deadline:
None
Abstract:
As part of its initiative to redesign Federal records management, NARA
is revising its records management regulations in 36 CFR ch. XII,
subchapter B to ensure that the regulations are appropriate, effective,
and clear. During fiscal year 2005, we will publish several rules
relating to the redesign.
Statement of Need:
NARA's records management program was developed in the 20th century in
a paper environment. This program has not kept up with a Federal
Government that creates and uses most of its records electronically.
Today's Federal records environment requires different management
strategies and techniques.
The revision of NARA's records disposition policies, processes, and
tools is identified in our Strategic Plan as a key Strategy to meet the
primary goal that ``essential evidence will be created, identified,
appropriately scheduled, and managed for as long as needed`` Without
effective records management, records needed to document citizens
rights, actions for which Federal officials are responsible, and the
historical experience of our Nation will be at risk of loss,
deterioration, or destruction.
Summary of Legal Basis:
Under the Federal Records Act, the Archivist of the United States is
responsible for: 1) providing guidance and assistance to Federal
agencies to ensure adequate and proper documentation of the policies
and transactions of the Federal Government and ensuring proper records
disposition (44 U.S.C. 2904); 2) approving the disposition of Federal
records (44 U.S.C. ch. 33); and 3) preserving and making available the
Federal records of continuing value that have been transferred to the
National Archives of the United States (44 U.S.C. ch. 21).
The Federal Records Act also makes the heads of Federal agencies
responsible for making and preserving records containing adequate and
proper documentation of the organization, functions, policies,
decisions, procedures, and essential transactions of the agency and is
designed to furnish the information necessary to protect the legal and
financial rights of the Government and of persons directly affected by
the agency's activities (44 U.S.C. 3101). Agency heads must also
[[Page 72855]]
have an active, continuing records management program (44 U.S.C. 3102).
Alternatives:
None.
Anticipated Cost and Benefits:
The revision of NARA's records disposition policies and processes, of
which this regulation review is a part, is intended to reduce the
burden on agencies and NARA in the area of records disposition
activities.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Begin Review 09/17/02
ANPRM 69 FR 12100 03/15/04
ANPRM Comment Period End 05/14/04
NPRM 11/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
URL For More Information:
www.archives.gov/records--management/initiatives/strategic--
directions.html
URL For Public Comments:
www.regulations.gov
Agency Contact:
Nancy Allard
Regulatory Contact
National Archives and Records Administration
Room 4100, NPOL
8601 Adelphi Road
College Park, MD 20740-6001
Phone: 301 837-1850
Fax: 301 837-0319
Email: nancy.allard@nara.gov
Related RIN: Related to 3095-AB05, Related to 3095-AB41, Related to
3095-AB43, Related to 3095-AB39
RIN: 3095-AB16
BILLING CODE 7515-01-S
[[Page 72856]]
OFFICE OF PERSONNEL MANAGEMENT (OPM)
Statement of Regulatory Priorities
The Office of Personnel Management (OPM) is the human resources and
personnel manager for the President and the Federal Government. The
primary focus of OPM's regulatory efforts in the coming year will
continue to be the modernization and improvement of human resources
management to support the President's goal of creating a Government
that is citizen-centered, results-oriented and market-based. To this
end, OPM's primary regulatory objective is to implement improvements to
human resources management that will enable the Federal Government to
recruit, manage, develop, and retain the high-quality, diverse
workforce that departments and agencies require to carry out their
respective missions.
The President's Management Agenda recognizes the critical role that
human resources management must play in reforming Government by
identifying the Strategic Management of Human Capital as the first of
its five core Governmentwide initiatives. OPM is the managing partner
on this Presidential initiative and has aggressively implemented a
program to assist other agencies in achieving success in this area
through aligning human resources management practices with agency
missions and objectives. OPM will implement this initiative by way of
collaboration, coordination, and regulation as necessary and
appropriate during the coming year.
Department of Homeland Security
The Homeland Security Act of 2002 authorized the creation of the
Department of Homeland Security (DHS) through the combination of
components of 22 other departments and agencies. In addition, the Act
granted the President flexibility in the management of the Department's
human resources (HR). OPM has been working with DHS and stakeholders
for 18 months to design a new HR system in the areas of pay,
performance management, labor management relations, adverse actions and
appeals, and to issue enabling regulations that are responsive to the
critical needs of the Department. We anticipate that final joint DHS/
OPM regulations establishing a new HR system will be issued in early
fiscal year 2005.
National Security Personnel System
The 2004 National Defense Authorization Act (NDAA) authorizes the
creation of a National Security Personnel System (NSPS) at the
Department of Defense (DoD). OPM has collaborated extensively with DoD
to identify the regulatory requirements needed to establish a flexible
and contemporary human resources management system as called for in the
statute. The NSPS must be fair and credible, adhere to merit
principles, honor veterans' preference, protect against prohibited
personnel practices, and include a performance management system that
incorporates pay for performance. In addition, the Act permits the
establishment of a new labor relations system and a new employee
appeals process, and grants flexibilities in recruitment and assignment
actions and in the adjustment of overall agency staff. The NSPS is
vital to DoD's national security mission and will remain a regulatory
priority for OPM in the year ahead.
Compensation Reform
OPM continues to study Governmentwide compensation reform and to
gather information from stakeholders following the publication of OPM
Director Kay Coles James' white paper on Federal compensation reform:
``A Fresh Start for Federal Pay: The Case for Modernization.'' In
addition, because compensation reform is a necessary element of
improving the management of human capital?a central goal of the
President's Management Agenda?OPM anticipates making promulgation of
compensation reform regulations a priority in 2005, including the final
regulations necessary to implement the SES pay for performance system,
which was authorized under NDAA. OPM will also proceed with
promulgating regulations to implement the provisions of the Human
Capital Performance Fund, which was authorized under NDAA as well.
e-Government
OPM has been designated as the managing partner on 5 of the 24 e-
Government initiatives in the President's Management Agenda.
Specifically, OPM is the managing partner for Recruitment One Stop, e-
Clearance, e-Training, e-Payroll, and e-Enterprise HR Integration (e-
EHRI). These initiatives will require promulgation of new or modified
regulations. In addition, OPM has been designated the managing partner
of the Human Resources Line of Business (HR LOB). The objective of HR
LOB is to create a framework for a Governmentwide, modern, cost
effective, standardized, and interoperable Human Resources (HR)
solution that provides common core functionality and maximizes
automation of processes to support the strategic management of human
capital. The current suite of e-Government initiatives managed by OPM
will be transitioned and integrated into the HR LOB. This initiative
will also require promulgation of new or modified regulations in 2005.
No FEAR Regulations
In July 2003, the President delegated responsibility for promulgating
regulations pursuant to title II of the Notification and Federal
Employee Antidiscrimination and Retaliation Act of 2002 to OPM. The
provisions of title II relate to reimbursement of the Treasury
Department's judgment fund, notice and training for applicants and
employees, and reporting requirements by agencies. Regulations
concerning reimbursement of the judgment fund were promulgated on an
interim final basis on January 22, 2004. In the coming year, working
with the EEOC and Office of Special Counsel, OPM will promulgate
regulations for the remaining provisions of title II of the Act.
Human Resources (HR) Flexibilities
In 2003, OPM issued interim regulations to implement five new HR
authorities enacted in the Chief Human Capital Officers Act (CHCO Act,
title XIII of the Homeland Security Act). These included Voluntary
Separation Incentive Program regulations that provided agencies with
Governmentwide buyout authority. Upon OPM approval, agencies may use
this authority as an important workforce reshaping tool in support of
their human capital needs. OPM also provided agencies with four
additional flexibilities. These new authorities provide agencies with:
(1) increased flexibility in assessing applicants using alternative
(category-based) rating and selection procedures; (2) the ability to
select qualified candidates for competitive service positions using
direct-hire procedures; (3) authority to pay or reimburse academic
degree training costs from appropriated or other available funds and
increased flexibility in academic degree training to address agency-
specific human capital objectives; and (4) revised voluntary early
retirement authority criteria to address reshaping and restructuring
issues. These authorities provide agencies with additional tools to
recruit, retain, and reshape their workforce to meet critical mission
goals and objectives. These interim regulations
[[Page 72857]]
allowed agencies immediate access to these new tools while
simultaneously soliciting comments on potential program improvements.
OPM is currently reviewing the comments received and will publish final
regulations during the coming year.
Human Capital Management
The CHCO Act also established a new chapter 14, Agency Chief Human
Capital Officers, within title 5, U.S. Code, as well as a requirement
for OPM to establish by regulation systems for assessing the management
of human capital in Federal agencies. Provisions of the NDAA
established a related requirement for agencies to conduct annual
employee surveys under regulations issued by OPM. In the coming year,
OPM will be addressing these and related general human capital
management requirements through implementing regulations.
BILLING CODE 6325-44-S
[[Page 72858]]
PENSION BENEFIT GUARANTY CORPORATION (PBGC)
Statement of Regulatory and Deregulatory Priorities
PBGC Insurance Programs
The Pension Benefit Guaranty Corporation (PBGC) administers two
insurance programs for private defined benefit plans under title IV of
the Employee Retirement Income Security Act of 1974 (ERISA): A single-
employer plan termination insurance program and a multiemployer plan
insolvency insurance program. The PBGC protects the pensions of over 44
million working men and women in about 31,000 private defined benefit
plans, including about 1,600 multiemployer plans.
The PBGC receives no funds from general tax revenues. Operations are
financed by insurance premiums, investment income, assets from pension
plans trusteed by the PBGC, and recoveries from the companies formerly
responsible for the trusteed plans.
To carry out these functions, the PBGC must issue regulations
interpreting such matters as the termination process, establishment of
procedures for the payment of premiums, and assessment and collection
of employer liability.
Single-Employer Program
Under the single-employer program, the PBGC pays guaranteed and
certain other pension benefits to participants and beneficiaries if
their plan terminates with insufficient assets (distress and
involuntary terminations). At the end of fiscal year 2003, the PBGC was
trustee of about 3,300 plans and paid $2.5 billion in benefits to about
459,000 people during 2003. Another 475,000 people will receive
benefits when they retire in the future.
Most terminating single-employer plans terminate with sufficient
assets to pay all benefits. The PBGC has administrative responsibility
for these terminations (standard terminations), but its role is limited
to seeing that proper procedures are followed and participants and
beneficiaries receive their plan benefits.
The private defined benefit pension system has been under pressure for
some time and has become a matter of public concern. In July 2003, the
Administration issued an initial set of legislative proposals that
would: (1) Improve the accuracy of pension liability measurements by
modifying the discount interest rate; (2) increase the transparency of
pension plan information and make public pension underfunding
information provided to PBGC for companies with over $50 million in
underfunding; and (3) require immediate funding of accruals, benefit
increases, and lump sum payments in certain situations involving a
financially distressed company and fix PBGC's guarantee limit as of the
date a plan sponsor files for bankruptcy. In addition, the
Administration is developing comprehensive pension reform proposals to
improve retirement security for workers and to strengthen the pension
insurance system.
Multiemployer Program
The multiemployer program (which covers about 9.7 million workers and
retirees in about 1,600 insured plans) is funded and administered
separately from the single-employer program and differs in several
significant ways. The multiemployer program covers only collectively
bargained plans involving more than one unrelated employer. The PBGC
provides financial assistance (in the form of a loan) to the plan if
the plan is unable to pay benefits at the guaranteed level. Guaranteed
benefits are less than single-employer guaranteed benefits. PBGC
financial assistance occurs infrequently.
Objectives and Priorities
PBGC regulatory objectives and priorities are developed in the context
of the statutory purposes of title IV: (1) To encourage continuation
and maintenance of voluntary private pension plans, (2) to provide for
the timely and uninterrupted payment of pension benefits to
participants and beneficiaries, and (3) to maintain the premiums that
support the insurance programs at the lowest possible levels consistent
with carrying out the PBGC's statutory obligations (ERISA section
4002(a)). In addition, PBGC receives no taxpayer monies. It is a self-
financing government corporation. Principal revenue sources are
premiums paid by plan sponsors and income generated by assets held by
PBGC.
The PBGC implements its statutory purposes by developing regulations
designed: (1) To assure the security of the pension benefits of
workers, retirees, and beneficiaries; (2) to improve services to
participants; (3) to ensure that the statutory provisions designed to
minimize losses for participants and PBGC in the event of plan
termination are effectively implemented; (4) to encourage the
continuation and maintenance of voluntary private pension plans; (5) to
facilitate the collection of monies owed to plans and to the PBGC,
while keeping the related costs and burdens as low as possible; (6) to
simplify the termination process; and (7) to minimize reporting and
other burdens.
Regulatory Priorities
The PBGC regulatory priorities are focused on changes to improve
transparency and to simplify filing with PBGC by increasing use of
electronic filing. PBGC policymaking gives consideration to the special
needs and concerns of small business.
Improve Transparency of Information
PBGC is developing a regulatory package to improve transparency of
information to enable plan participants, investors, and PBGC to make
more informed decisions and to encourage more responsible funding of
pension plans. The transparency proposals relate to three areas--plan
actuarial information and employer financial information that is
required of certain employers with large amounts of pension
underfunding, notice to PBGC that is required for certain events that
threaten plan funding, and funding information that is required to be
provided in an annual Participant Notice by certain underfunded plans.
In addition, in order to improve compliance with the Participant Notice
requirements, PBGC, in May 2004, published a Notice in the Federal
Register providing a voluntary correction program designed to encourage
correction of recent compliance failures and to facilitate future
compliance. At the same time, PBGC proposed a new Participant Notice
penalty policy that will be used for future violations of the
Participant Notice requirements.
Simplify Filing by Increasing Use of Electronic Filing
The PBGC introduced optional electronic filing of premiums in 2004
with an online filing system that employs PBGC software. PBGC will be
specifying a common data standard so that private vendors can develop
software that filers can use in lieu of PBGC software. PBGC will be
moving toward requiring electronic premium filing for all plans, which
will simplify their paperwork, improve accuracy of PBGC's premium
records and database, and enable more prompt payment of premium
refunds. In addition, electronic filing will be required for plan
actuarial and employer financial information reported to PBGC by
employers with large amounts of pension underfunding. Electronic filing
will reduce the filing burden, improve
[[Page 72859]]
accuracy, and better enable PBGC to monitor and manage risks posed by
these plans.
Relief for Small Businesses
A large percentage of the plans insured by the PBGC are small or
maintained by small employers. The PBGC takes the special needs and
concerns of small entities into account in developing its regulatory
policies. For example, the May 2004 proposed revisions to the penalty
structure for failure to comply with the Participant Notice
requirements scale down the penalty rate based on the number of plan
participants.
The PBGC will continue to review its regulations to look for further
simplification opportunities. The PBGC's regulatory plan for October 1,
2004, to September 30, 2005, consists of two significant regulatory
actions.
_______________________________________________________________________
PBGC
-----------
PROPOSED RULE STAGE
-----------
144. ALLOCATION OF ASSETS IN SINGLE-EMPLOYER PLANS; VALUATION OF
BENEFITS AND ASSETS
Priority:
Other Significant
Legal Authority:
29 USC 1302(b)(3); 29 USC 1341; 29 USC 1301(a); 29 USC 1344; 29 USC
1362
CFR Citation:
29 CFR 4044, subpart B
Legal Deadline:
None
Abstract:
The PBGC is considering amending its benefit valuation and asset
allocation regulations by adopting more current mortality tables and
otherwise simplifying and improving its valuation assumptions and
methods.
Statement of Need:
The PBGC's regulations prescribe rules for valuing a terminating plan's
benefits for several purposes, including (1) determining employer
liability and (2) allocating assets to determine benefit entitlements.
The PBGC's interest assumption for valuing benefits, when combined with
the PBGC's mortality assumption, is intended to reflect the market
price of single-premium, nonparticipating group annuity contracts for
terminating plans. In developing its interest assumptions, the PBGC
uses data from surveys conducted by the American Council of Life
Insurers. The PBGC currently uses a mortality assumption based on the
1983 Group Annuity Mortality Table in its benefit valuation and asset
allocation regulations (29 CFR parts 4044 and 4281).
In May 1995, the Society of Actuaries Group Annuity Valuation Table
Task Force issued a report that recommends new mortality tables for a
new Group Annuity Reserve Valuation Standard and a new Group Annuity
Mortality Valuation Standard. In December 1996, the National
Association of Insurance Commissioners adopted the new tables as models
for determining reserve liabilities for group annuities. The PBGC is
considering incorporating these tables into its regulations and making
other modifications.
Summary of Legal Basis:
The PBGC has the authority to issue rules and regulations necessary to
carry out the purposes of title IV of ERISA.
Alternatives:
Not yet determined.
Anticipated Cost and Benefits:
Cost estimates are not yet available. However, the PBGC expects that
this regulation will not have a material effect on costs.
Risks:
Not applicable.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 62 FR 12982 03/19/97
ANPRM Comment Period End 05/19/97
NPRM 12/00/04
NPRM Comment Period End 02/00/05
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
URL For More Information:
www.pbgc.gov/regs
URL For Public Comments:
www.pbgc.gov/regs
Agency Contact:
James L. Beller
Attorney
Pension Benefit Guaranty Corporation
Office of the General Counsel
1200 K Street NW
Washington, DC 20005-4026
Phone: 202 326-4024
TDD Phone: 800 877-8339
Fax: 202 326-4112
RIN: 1212-AA55
_______________________________________________________________________
PBGC
145. TRANSPARENCY OF INFORMATION RELATED TO PLAN LIABILITIES
Priority:
Other Significant
Legal Authority:
29 USC 1302(b)(3); 29 USC 1310; 29 USC 1311; 29 USC 1343
CFR Citation:
29 CFR 4010; 29 CFR 4011; 29 CFR 4043
Legal Deadline:
None
Abstract:
The PBGC is considering amending its regulations on required reporting
or disclosure of certain plan actuarial and employer financial
information (29 CFR 4010), participant notices (29 CFR 4011), and
reportable events (29 CFR 4043) to improve disclosure and provide for
electronic filing of certain information.
Statement of Need:
The PBGC's regulations require disclosure of various information to
PBGC relating to employer financial condition and plan liabilities (29
CFR 4010) and events that may threaten future funding of a plan
(``reportable events'') (29 CFR 4043). PBGC is considering proposing a
standard format and electronic filing of section 4010 information and
inclusion of additional detail to assist PBGC in evaluating currently
reported data. PBGC also is considering proposing to add several new
reportable events and eliminate some existing waivers from reporting,
in order to provide PBGC better information about events that may
threaten plan funding. PBGC regulations also require disclosure of plan
funding status to participants (``Participant Notice'') by certain
underfunded plans (29 CFR 4011). PBGC is considering proposing that a
[[Page 72860]]
more accurate measure of plan liabilities be used for purposes of the
Participant Notice.
Summary of Legal Basis:
The PBGC has the authority to issue rules and regulations necessary to
carry out the purposes of title IV of ERISA.
Alternatives:
Not yet determined.
Anticipated Cost and Benefits:
Cost estimates are not yet available. However, the PBGC expects that
this regulation will not have a material effect on costs.
Risks:
Not applicable.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/04
NPRM Comment Period End 12/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
URL For More Information:
www.pbgc.gov/regs
URL For Public Comments:
www.pbgc.gov/regs
Agency Contact:
Mr. Harold J. Ashner
Assistant General Counsel
Pension Benefit Guaranty Corporation
Office of the General Counsel
Suite 340
1200 K Street NW
Washington, DC 20005-4026
Phone: 202 326-4024
Fax: 202 326-4112
Email: ashner.harold@pbgc.gov
RIN: 1212-AB01
BILLING CODE 7708-01-S
[[Page 72861]]
SMALL BUSINESS ADMINISTRATION (SBA)
Statement of Regulatory Priorities
Overview
The Small Business Administration's (SBA) mission is to maintain and
strengthen the Nation's economy by enabling the establishment and
viability of small businesses and by assisting in economic recovery of
communities after disasters. In order to accomplish this mission, SBA
focuses on improving the economic environment for small businesses;
bridging the competitive opportunity gap facing small business
entrepreneurs; and providing financial assistance for the restoration
of homes and businesses affected by disasters.
SBA is committed to:
Working with its financial partners to improve small
businesses'access to capital through SBA's loan and venture
capital programs;
Providing technical assistance to small businesses throughits
resource partners;
Increasing contracting and business opportunities forsmall
businesses;
Providing affordable, timely, and easily accessible
financialassistance to businesses, homeowners, and renters
after a disaster;
Measuring outcomes, such as revenue growth, job
creation,business longevity, and recovery rate after a
disaster to ensure that SBA's programs and services are
delivered efficiently and effectively.
SBA's regulatory actions reflect the goals and objectives of the Agency
and are designed to provide the small business and residential
communities with the information and guidance they need to succeed as
entrepreneurs and restore their homes or other property after a
disaster. All of SBA's rules concern small businesses and programs that
promote small businesses. During the coming year, SBA's regulatory
priorities will focus on strengthening SBA's management of its programs
and services, increasing subcontracting opportunities for small
businesses, facilitating their involvement in innovative manufacturing,
modernizing the Small Business Technology Transfer Program, and
strengthening the management of the Small Business Lending Company
Program.
_______________________________________________________________________
SBA
-----------
PROPOSED RULE STAGE
-----------
146. SMALL BUSINESS LENDING COMPANIES REGULATIONS
Priority:
Other Significant
Legal Authority:
15 USC 634(b)(6); 15 USC 636(a); 15 USC 636(b)
CFR Citation:
13 CFR 120.470
Legal Deadline:
None
Abstract:
This rulemaking would amend 13 CFR 120.470 to clarify and strengthen
the rules regarding Small Business Lending Companies (SBLCs) monitoring
and oversight for safety and soundness, compliance, and related areas.
Statement of Need:
Section 7(a) of the Small Business Act states that the Small Business
Administration (SBA) may provide financing to small businesses
``directly or in cooperation with banks or other financial
institutions.'' Presently, SBA guarantees loans through approximately
7,000 lenders. Of these lenders, about 14 are Small Business Lending
Companies (SBLCs) that are not otherwise regulated by Federal or State
chartering, licensing, or similar regulatory control. SBA examines or
audits these SBLCs periodically. Congressional and Administration
policy to privatize SBA lending and levels in loan volume require that
SBA increase its SBLC oversight. To that end, SBA will draft
regulations that strengthen the Agency's management of the SBLC
Program.
Summary of Legal Basis:
Not required by statute or court order.
Alternatives:
This rulemaking amends and expands SBA's existing regulations on the
SBLC Program.
Anticipated Cost and Benefits:
This rulemaking is designed to strengthen SBA's regulations regarding
the SBLC Program. Some additional costs associated with additional
reporting by the SBLCs to the SBA is anticipated.
Risks:
This regulation poses no risks to the public health and safety or to
the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 03/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Janet A. Tasker
Associate Administrator for Lender Oversight
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-3049
Email: janet.tasker@sba.gov
RIN: 3245-AE14
_______________________________________________________________________
SBA
147. PROPOSED SMALL BUSINESS INNOVATION RESEARCH (SBIR) POLICY
DIRECTIVE
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
15 USC 638(j)(1)
CFR Citation:
None
Legal Deadline:
None
Abstract:
This proposed policy directive incorporates Executive Order 13329
``Encouraging Innovation in Manufacturing,'' issued February 24, 2004,
and its requirements into SBA's current SBIR Policy Directive.
Statement of Need:
On February 24, 2004, the President signed Executive Order 13329
``Encouraging Innovation in Manufacturing.'' The purpose of the
Executive order is to ensure that Federal Government agencies and
[[Page 72862]]
departments properly and effectively assist the private sector in its
manufacturing innovation efforts including through the Small Business
Innovation Research (SBIR) and the Small Business Technology Transfer
(STTR) programs. Specifically, the Small Business Administration (SBA)
is required to: 1) Establish, after consultation with the Director of
the Office and Science and Technology Policy, formats and schedules for
submission of reports by the heads of departments and agencies; 2)
issue to departments and agencies guidelines and directives (in
addition to the formats and schedules) as the Administrator determines
from time to time are necessary to implement the Executive order, after
such guidelines and directives are submitted to the President, through
the Director of the Office of Science and Technology Policy, for
approval and are approved by the President. In addition, the heads of
the agencies and departments with one or more SBIR or STTR programs are
required: 1) To the extent permitted by law and in a manner consistent
with the mission of that department or agency, to give high priority
within such programs to manufacturing-related research and development
to advance innovation including innovation in manufacturing and 2) to
submit reports annually to the Administrator of the SBA and the
Director of the Office of Science and Technology Policy concerning the
efforts of such departments or agencies in implementing this order.
Summary of Legal Basis:
In 1982, Congress enacted the Small Business Innovation Development Act
of 1982 (SBIDA), Public Law 97-219 (codified at 15 U.S.C. 638), which
established the Small Business Innovation Research Program (SBIR
Program). SBIDA requires the SBA to ``issue Policy Directives for the
general conduct of the SBIR programs within the Federal Government.''
(15 U.S.C. 638(j)(1)) In December of 2000, Congress enacted the Small
Business Innovation Research Program Reauthorization Act of 2000
(Reauthorization Act), Public Law 106-554. The Reauthorization Act
extends the SBIR Program through September 30, 2008. SBA published its
first Policy Directive, Policy Directive No. 65-01, 22 years ago (47 FR
52966, November 24, 1982). The last SBIR Policy Directive amendments
were published 2 years ago (67 FR 60072-60098, September 24, 2002).
Alternatives:
There are no practical alternatives that accomplish the objectives
established by Executive Order 13329. An alternative to amending the
SBIR and STTR Policy Directives that was considered was to issue a
Special Policy Information Notice (SPIN) to the participating SBIR and
STTR agencies and departments. SPINs have been used in the past in
order to provide clarifying guidance on existing definitions or policy
matters to the participating SBIR and STTR agencies and departments. As
Executive Order 13329 was a new Presidential initiative, a SPIN was not
deemed the appropriate medium for providing guidance to the
participants. Amending the Policy Directives was identified as the
method for effective implementation of Executive Order 13329.
Anticipated Cost and Benefits:
This Policy Directive does not impose any new substantive costs to
small businesses. Further, implementing the Executive Order does not
impose any substantive cost to the Federal Government. Instead,
implementing this Executive Order ensures that the Federal agencies and
departments are assisting the private sector in its manufacturing
innovation efforts.
Risks:
The amendments to the SBIR and STTR Policy Directives and the
implementation of Executive Order 13329 pose no risks to the public
health and safety or to the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/04
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Edsel Brown
Assistant Administrator for Technology, Office of Government
Contracting/Business Development
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-6450
Email: edsel.brown@sba.gov
RIN: 3245-AF21
_______________________________________________________________________
SBA
-----------
FINAL RULE STAGE
-----------
148. SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM POLICY DIRECTIVE
Priority:
Other Significant
Legal Authority:
15 USC 638; PL 107-50
CFR Citation:
None
Legal Deadline:
Final, Statutory, February 15, 2002, Small Business Technology Transfer
Program Reauthorization Act of 2001, enacted 10/15/2001, requires
publication of policy directive modifications.
Abstract:
This policy directive will incorporate recently enacted statutory
requirements. The purpose of the directive is to provide guidance to
participating Federal agencies for the general conduct of the Small
Business Technology Transfer Program.
Statement of Need:
In 1992, Congress enacted the Small Business Technology Transfer Act of
1992 (STTR Act), Public Law No. 102-564 (codified at 15 U.S.C. 638).
The STTR Act established the Small Business Technology Transfer Program
(STTR Program) as a pilot program that required Federal agencies with
extramural budgets for research or research and development (R/R&D) in
excess of $1 billion per fiscal year to enter into funding agreements
with small business concerns (SBCs) that engage in a collaborative
relationship with a research institution. The purpose of the STTR
Program is to stimulate a partnership of ideas and technologies between
innovative SBCs and research institutions. The program assists the
small business and research communities by developing commercially
viable technologies. The STTR Program is a phased process, uniform
throughout the Federal Government, of soliciting proposals and awarding
funding agreements for R/R&D to meet stated agency needs or missions.
The STTR Act requires the U.S. Small Business Administration (SBA) to
``issue a policy directive for the general conduct of the STTR
[[Page 72863]]
Programs within the Federal Government.'' (15 U.S.C. 638(p)(1)) SBA
published its first STRR Policy Directive in 1993 (58 FR 42607-42620,
August 10, 1993). This Policy Directive fulfills SBA's statutory
obligation to provide guidance to the participating Federal agencies
for the general operation of the STTR Program. Federal agencies
participating in the STTR Program (STTR agencies) are obligated to
follow the guidance provided by this Policy Directive. Each agency is
required to review its rules, policies, and guidance on the STTR
Program to ensure consistency with this Policy Directive and to make
any necessary changes in accordance with each agency's normal
procedures. This is consistent with the statutory authority provided to
the SBA concerning the STTR Program.
Summary of Legal Basis:
In 1992, Congress enacted the Small Business Technology Transfer Act of
1992 (STTR Act), Public Law No. 102-564 (codified at 15 U.S.C. 638).
Congress has since amended the STTR Act, most recently with the
enactment of the Small Business Technology Transfer Program
Reauthorization Act of 2001 (Reauthorization Act), Public Law No. 107-
50. The Reauthorization Act extends the STTR Program through September
30, 2009, and changed its status from a pilot program to a permanent
one.
Alternatives:
There are no alternatives since it is mandated by law to issue a policy
directive for the general conduct of the program.
Anticipated Cost and Benefits:
This directive does not impose any new substantive costs to small
businesses or to the Federal Government. Instead, the directive ensures
that the Federal agencies and departments are assisting the private
sector consistent with the directive. The Small Business Technology
Transfer Program Reauthorization Act of 2001 benefits small businesses
by requiring participating agencies to increase the amount of their
extramural budget to be reserved for the STTR Program from 0.15 percent
to 0.3 percent and permits agencies to increase the dollar value of
STTR Phase II awards from $500,000 to $750,000.
Risks:
This policy directive poses no risks to the public health and safety or
to the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Notice of Propos68 FR 35748irective 06/16/03
Comment Period End 07/16/03
Final Action 04/00/05
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal
Agency Contact:
Edsel Brown
Assistant Administrator for Technology, Office of Government
Contracting/Business Development
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-6450
Email: edsel.brown@sba.gov
RIN: 3245-AE96
_______________________________________________________________________
SBA
149. SMALL BUSINESS GOVERNMENT CONTRACTING PROGRAMS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
15 USC 634(b)(6); 15 USC 637; 15 USC 644; 31 USC 9701; 31 USC 9702
CFR Citation:
13 CFR 125
Legal Deadline:
None
Abstract:
The U.S. Small Business Administration (SBA) proposes to amend its
regulation governing small business subcontracting assistance. As
proposed, the rule would implement additional subcontracting goals
required by statute, clarify prime contractor responsibilities in
providing subcontracting opportunities for small businesses, and
provide additional guidance on evaluating the good faith efforts of
large businesses to comply with subcontracting plans.
Statement of Need:
On January 31, 2003, SBA published a proposed rule in the Federal
Register, 67 FR 47244, to solicit comments on its proposal to implement
several recommendations included in the Office of Management and
Budget's October 2002 report entitled ``Contract Bundling: A Strategy
for Increasing Federal Contracting Opportunities for Small Business.''
Several of the commenters identified the need for additional guidance
on evaluating large prime contractor performance and their efforts to
achieve subcontracting plan goals for small business participation,
including examples of what constitute ``good-faith'' efforts to comply
with subcontracting plans. SBA accepted these comments and, in addition
to the Final Bundling Rule published on October 20, 2003, published a
proposed rule on that date addressing the major issues in
subcontracting. In addition to providing guidance on evaluating large
prime contractor performance and good-faith efforts, the proposed rule
also authorized the use of goals in subcontracting plans, and/or past
performance in meeting such goals, as a factor in source selection when
placing orders against Federal Supply Schedules, Governmentwide
acquisition contracts, and multi-agency contracts; implemented
statutory provisions and other administrative procedures relating to
subcontracting goals and assistance; listed the various categories of
small businesses that must be afforded maximum practicable
subcontracting opportunities; and clarified the responsibilities of
prime contractors and SBA's Commercial Market Representatives (CMRs)
under the subcontracting assistance program.
Summary of Legal Basis:
The subcontracting assistance program described in this rule is
authorized by section 8(d) of the Small Business Act. The new
regulatory provisions incorporated into SBA's regulations at 13 CFR
125.3 by means of this rule are intended to strengthen SBA's
implementation of the statute and to respond to the President's agenda
for small business.
Alternatives:
The alternatives to this rule considered are: (a) To work with the
Federal Acquisition Regulation (FAR) Council to strengthen the coverage
in 48 CFR, subpart 19.7, and the related FAR clauses or (b) leave the
existing coverage in 13 and 48 CFR unchanged. The first of these
alternatives has been attempted in the past and has proven to be a
lengthy process, difficult to implement, and the second is unacceptable
because SBA would have to publish Fact Sheets, Standard Operating
Procedures, and Best Practice Guides, which do not carry the same
weight or authority as a regulation and
[[Page 72864]]
would not, therefore, be as effective in strengthening the program.
Anticipated Cost and Benefits:
This rule does not impose any new substantive responsibilities, nor
does it require any new reporting or recordkeeping requirements on
small business. Instead, this proposed rule clarifies the existing
statutory responsibilities under the subcontracting assistance program,
including the responsibilities of prime contractors to maximize small
business subcontracting opportunities. It also provides guidance to
Government officials in monitoring and determining the achievements of
subcontracting goals. In fiscal year 2002, the most recent year for
which the Government has reliable subcontracting data, small business
received approximately $34.4 billion in subcontract awards representing
more than 35 percent of all subcontract dollars. As a result of this
regulation, subcontracting opportunities in the year(s) following
publication of the Final Rule.
Risks:
This regulation poses no risks to the public health and safety or to
the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 60015 10/20/03
NPRM Comment Period End 12/19/03
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Dean Robert Koppel
Assistant Administrator, Policy and Research
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-7322
Email: dean.koppel@sba.gov
RIN: 3245-AF12
BILLING CODE 8025-01-S
[[Page 72865]]
SOCIAL SECURITY ADMINISTRATION (SSA)
Statement of Regulatory Priorities
The Social Security Administration (SSA) administers the retirement,
survivors, and disability insurance programs under title II of the
Social Security Act (the Act) and the Supplemental Security Income
(SSI) program under title XVI of the Act. As directed by Congress, we
also assist in administering portions of the Medicare program. Our
regulations codify the requirements for eligibility and entitlement to
benefits under the programs that we administer. Generally, SSA's
regulations do not impose burdens on the private sector or on State or
local governments.
Our 19 entries for the Regulatory Plan represent areas of major
importance to the administration of the retirement, survivors,
disability, SSI, and Medicare benefit programs. Each individual
initiative is described more fully after this Statement of Regulatory
Priorities. Several of these regulatory priorities reflect the
provisions of two major laws that were recently enacted--the Medicare
Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L.
108-173) and the Social Security Protection Act of 2004 (Pub. L. 108-
203).
Serve the Public
Providing the best service possible to the public remains a principal
objective of SSA. To that end, we have included in the Plan three
initiatives to improve public service.
We plan to revise our regulations to permit an Administrative Law Judge
to incorporate into the written decision, when wholly favorable, the
findings and reasons stated orally at a hearing, if they remain
applicable. We believe this revision may reduce the time needed to
issue wholly favorable decisions after a hearing.
We are including a proposed rule that would describe additional
safeguards against inappropriate disclosure of personal information and
set out special procedures concerning access to medical records.
Furthermore, we are including another proposed rule that would, among
other changes, revise our privacy and disclosure rules to further
preserve the anonymity and protect the physical well being of employees
who are threatened by others.
Improve the Disability Process
As the continued improvement of the disability program is an area of
vital interest to SSA, we have included in the Plan seven initiatives
that address disability.
Two initiatives would update the medical listings used to determine
disability: a final rule on neoplastic diseases and a proposed rule on
immune system disorders. The revisions will ensure that the listings
reflect advances in medical knowledge, treatment, and methods of
evaluating these impairments.
A final rule will provide for continued benefit payments to certain
individuals who recover medically while participating in certain
vocational rehabilitation programs.
A proposed rule would revise several areas of our regulations on the
Ticket to Work program to improve the support of disabled individuals
who want and need assistance to return to the workforce.
Another proposed rule would establish time limits and other criteria
for individuals receiving disability benefits who wish to initiate
plans to achieve self-support.
A proposed rule would explain the standards we use to evaluate the work
activity of an individual receiving disability benefits, and when we
will conduct a continuing disability review.
Another proposed rule would, among other changes, require us to issue a
receipt when an individual receiving disability benefits reports a
change in work activity or earnings. This rule would also include home
schooling as a form of regular school attendance for purposes of the
Student Earned Income Exclusion. This rule reflects provisions of the
Social Security Protection Act of 2004.
Improve Stewardship
SSA bears a responsibility to ensure we are effective stewards of the
public trust placed in us. We are including in the Plan several
regulatory initiatives designed to strengthen our stewardship and
program integrity activities; some also reflect the goal to improve
financial performance contained in the President's Management Agenda.
For beneficiaries who are not able to manage their own benefits due to
legal incompetence or medical infirmity, we must assure that benefits
paid to representatives on their behalf are used properly. We are
developing proposed rules that reflect provisions of the Social
Security Protection Act of 2004 intended to strengthen our oversight of
the representative payee program.
The Debt Collection Improvement Act of 1996, as amended by the Foster
Care Independence Act of 1999, provided SSA with new tools for our
efforts in collecting debts, including the use of administrative wage
garnishment. We are developing a proposed rule on Federal salary offset
that will enable us to collect qualifying, delinquent title II and XVI
debts owed by former beneficiaries who are currently employed by the
Federal government.
One final rule will expand our ability to recover overpayments made in
one of our programs from benefits payable under other programs we
administer. This final rule reflects a provision of the Social Security
Protection Act of 2004.
A proposed rule would prohibit title II benefits to persons fleeing
prosecution, custody, or confinement after conviction, and to persons
violating probation or parole. This proposed rule reflects a provision
of the Social Security Protection Act of 2004.
Another proposed rule would enhance our program integrity efforts by
expanding our civil monetary penalties program. Included, among other
activities, would be solicitations or mailings by outside individuals
or entities that mislead the public into believing that SSA either
approves, endorses, or authorizes the solicitations or mailings.
Simplify the SSI Program
SSA is including two rules that would simplify our SSI regulations.
One final rule will modify three areas concerning what we consider as
income or resources available to an applicant or recipient. We will no
longer consider gifts of clothing as income when we decide whether a
person can receive SSI benefits or when we compute the amount of
benefits. We will also exclude, from our determination of resources,
one automobile if it is used for transportation, without consideration
of its value. Finally, we will no longer count household goods and
personal effects as resources when we decide whether a person can
receive SSI benefits.
A proposed rule would change our rules for deeming of income and
resources from a stepparent to an eligible child when the child resides
with a stepparent but not the natural or adoptive parent. We believe
this change will simplify the rules concerning deeming under these
circumstances.
[[Page 72866]]
Implement Medicare Legislation
SSA does not have overall responsibility for the Medicare program under
title XVIII of the Social Security Act. However, the Medicare
Prescription Drug, Improvement and Modernization Act of 2003 directs
SSA to assist in administering portions of the Medicare program. We are
including in the Plan two proposed rules that would implement the
legislation.
First, we propose to include rules concerning Medicare Prescription
Drug premium and cost-sharing subsidies (Medicare part D).
Second, we propose rules on reduction of premium subsidies for the
Supplementary Medical Insurance Benefit program (Medicare part B).
_______________________________________________________________________
SSA
-----------
PROPOSED RULE STAGE
-----------
150. PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND INFORMATION (711P)
Priority:
Other Significant
Legal Authority:
5 USC 552; 5 USC 552a; 42 USC 1306(a); 42 USC 902(a)(5)
CFR Citation:
20 CFR 401.30; 20 CFR 401.45; 20 CFR 401.55; 20 CFR 401.150; 20 CFR
401.180
Legal Deadline:
None
Abstract:
We propose to revise our privacy and disclosure rules to:
1. More fully describe the role and function of the Privacy Officer;
2. Describe safeguards against inappropriate disclosure of personal
information when individuals request information about themselves by
electronic means (e.g., through the Internet);
3. Conform to special procedures on an individual's access to medical
records; and
4. Add a new section to grant direct access to a minor's medical
records by the minor's parent or legal guardian acting on the minor's
behalf.
Statement of Need:
These revised regulations are necessary to:
1. Provide the expanded regulatory support for the existing
responsibilities and functions of the Privacy Officer as required by
the Privacy Act and related Office of Management and Budget (OMB)
guidelines;
2. Articulate the safeguards that ensure the appropriate procedures for
access to and disclosure of personally identifiable information in the
electronic environment;
3. Conform the regulations to our practice and systems of records,
which set out special procedures under which individuals whose medical
records may potentially present an adverse effect may have access to
this information; and
4. Conform to the special procedures in our systems of records for
access to medical records.
Summary of Legal Basis:
Revisions are needed to incorporate into the regulations special
procedures for providing individuals access to their medical records to
ensure the ultimate disclosure of the records to the requesting
individual, as set out in our systems of records.
Alternatives:
None.
Anticipated Cost and Benefits:
1. Revised role of Privacy Officer:
Cost - To be determined.
Benefit - Increased public awareness of the privacy officer's role and
responsibility in protecting the privacy and disclosure of the
information SSA collects and maintains; general oversight to the Agency
on privacy and disclosure activities.
2. Description of safeguards against inappropriate disclosure of
personal information by electronic means:
Cost - To be determined.
Benefit - Increase public awareness of the safeguards employed by SSA
to maintain the security, confidentiality, and integrity of the
information we collect and maintain.
3. Conform to special procedures on an individual's access to medical
records; and
4. Add a new section to grant direct access to a minor's medical
records by the minor's parent or legal guardian acting on the minor's
behalf:
Cost - To be determined.
Benefit - Regulatory guidelines will facilitate access for individuals
whose medical records may have adverse effects.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 03/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Chris W. Johnson
Social Insurance Specialist
Social Security Administration
Office of the General Counsel
Office of Public Disclosure
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-8563
Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AE88
_______________________________________________________________________
SSA
151. FEDERAL SALARY OFFSET (WITHHOLDING A PORTION OF A FEDERAL
EMPLOYEE'S SALARY TO COLLECT A DELINQUENT DEBT OWED TO THE SOCIAL
SECURITY ADMINISTRATION) (721P)
Priority:
Other Significant
Legal Authority:
42 USC 404; 42 USC 405; 42 USC 902; 42 USC 1383; 5 USC 5514
CFR Citation:
20 CFR 422
Legal Deadline:
None
Abstract:
This initiative would enable the Social Security Administration (SSA)
to
[[Page 72867]]
collect from Federal salaries qualifying, delinquent title II and title
XVI overpayment debts, and administrative debts owed by individuals who
are currently Federal employees. The debt collection would be
accomplished by the partial reduction of the employee's disposable
salary.
Statement of Need:
This regulation is required by 5 U.S.C. 5514(b) and by regulations of
the Department of the Treasury (Treasury) and the Office of Personnel
Management (OPM) in order for SSA to participate in the Federal Salary
Offset program. Treasury's regulation is 31 CFR 285.7; OPM's regulation
is 5 CFR 550.1104.
Summary of Legal Basis:
SSA's use of the Federal Salary Offset program is authorized by 42
U.S.C. 404(f), 42 U.S.C. 1383(b) and 5 U.S.C. 5514.
Alternatives:
None. SSA must have regulations, approved by OPM, in order to use
Federal salary offset to collect debts owed by Federal employees. See 5
U.S.C. 5514(b), 5 CFR 550.1104, and 31 CFR 285.7.
Anticipated Cost and Benefits:
Undetermined at this time.
Risks:
At this time we have not identified any risks associated with the
proposal.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 03/00/05
Final Action 09/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
Agency Contact:
Edward Johns
Financial Management Analyst
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0392
Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AE89
_______________________________________________________________________
SSA
152. EXEMPTION OF WORK ACTIVITY AS A BASIS FOR A CONTINUING DISABILITY
REVIEW (TICKET TO WORK AND WORK INCENTIVES IMPROVEMENT ACT OF 1999)
(725P)
Priority:
Other Significant
Legal Authority:
42 USC 421(m)
CFR Citation:
20 CFR 404.903; 20 CFR 404.1574; 20 CFR 404.1575; 20 CFR 404.1590; 20
CFR 404.1592a; 20 CFR 404.1594; 20 CFR 416.974; 20 CFR 416.990; 20 CFR
416.994; 20 CFR 416.1403
Legal Deadline:
None
Abstract:
We are proposing to amend our regulations to explain how we will
implement section 221(m) of the Social Security Act (the Act). We are
also proposing to amend our regulation to eliminate the use of the
secondary substantial gainful activity amount for evaluating work done
by an employee prior to January 2001. Section 221(m) affects our rules
for when we will conduct a continuing disability review if a
beneficiary works and receives benefits under title II of the Act based
on disability. (We interpret this section to include beneficiaries who
receive both title II disability benefits and Supplemental Security
Income (SSI) payments based on disability.) It also affects the way we
evaluate work activity when deciding if a beneficiary has engaged in
substantial gainful activity, and affects the standards we use when we
determine whether disability continues or ends.
Statement of Need:
This regulation is necessary to clarify how SSA will implement section
221(m) of the Social Security Act, which prohibits starting continuing
disability reviews for certain beneficiaries based on work activity,
and limits the use of the work activity of certain beneficiaries as
evidence that the individual is no longer disabled.
Summary of Legal Basis:
This regulation implements section 221(m) of the Social Security Act,
which was added by section 111 of Public Law 106-170.
Alternatives:
None.
Anticipated Cost and Benefits:
Over a five year period, this regulation will result in a net
administrative cost of about $10 million and an SSA workyear savings of
420 workyears. The estimates for costs are $165 million in the first
five years.
Risks:
At this time we have not identified any risks associated with this
proposal.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Kristine Erwin-Tribbitt
Social Insurance Specialist
Social Security Administration
Office of Program Development and Research
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-3353
Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AE93
[[Page 72868]]
_______________________________________________________________________
SSA
153. REVISED MEDICAL CRITERIA FOR EVALUATING IMMUNE SYSTEM DISORDERS
(804P)
Priority:
Other Significant
Legal Authority:
42 USC 405; 42 USC 902(a)(5); 42 USC 1383
CFR Citation:
20 CFR 404.1500, app 1
Legal Deadline:
None
Abstract:
We propose to update and revise the rules that we use to evaluate
immune system disorders of adults and children who apply for, or
receive, disability benefits under title II and Supplemental Security
Income (SSI) payments based on disability under title XVI of the Social
Security Act (the Act). The rules we plan on revising are sections
14.00 and 114.00 in the Listing of Impairments in appendix 1 to subpart
P of part 404 of our regulations (the listings). These listings include
such disorders as HIV infection, other Immunoglobulin deficiency
syndromes or deficiencies of cell-mediated immunity, System Lupus
Erythematosus, Scleroderma, Polymyositis, Inflammatory Arthritis, and
other connective tissue disorders.
Statement of Need:
These regulations are necessary to update the listings for evaluating
immune system disorders to reflect advances in medical knowledge,
treatment, and methods of evaluating these diseases. They ensure the
determinations of disability have a sound medical basis, that claimants
receive equal treatment through the use of specific criteria, and that
individuals who are disabled can be readily identified and awarded
benefits if all other factors of entitlement or eligibility are met.
Summary of Legal Basis:
Administrative-not required by statute or court order
Alternatives:
We considered not revising the listings or making only minor technical
changes. However, we believe that proposing these revisions is
preferable because of the medical advances that have been made in
treating and evaluating these types of diseases. The current listings
are now over 11 years old. Medical advances in disability evaluation
and treatment and our program experience make clear that the current
listings do not reflect state-of-art medical knowledge and technology.
Anticipated Cost and Benefits:
We anticipate that if finalized, these proposed rules would result in
negligible program and administrative costs.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 68 FR 24896 05/09/03
ANPRM Comment Period End 07/08/03
NPRM 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Paul J. Scott
Social Insurance Specialist
Social Security Administration
Office of Disability Programs
Office of Disability Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-1192
Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF33
_______________________________________________________________________
SSA
154. AMENDMENTS TO THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM
(967P)
Priority:
Economically Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
42 USC 902(a)(5); 42 USC 1320b-19; PL 106-170, sec 101
CFR Citation:
20 CFR 411.115; 20 CFR 411.125 to 411.140; 20 CFR 411.150 to 411.155;
20 CFR 411.171; 20 CFR 411.350 to 411.375; 20 CFR 411.385 to 411.395;
20 CFR 411.500 to 411.510; 20 CFR 411.525 to 411.565; 20 CFR 411.575 to
411.585
Legal Deadline:
None
Abstract:
These proposed rules are intended to amend the final rules implementing
the Ticket to Work and Self-Sufficiency Program under section 1148 of
the Social Security Act: to expand beneficiary eligibility to receive
tickets under this program; to clarify the rules for assignment of a
beneficiaries' ticket to a State vocational rehabilitation (VR) agency;
to revise the rules for payment when a beneficiary receives services
from both a State VR agency and an employment network (EN); and,
consistent with the Commissioner's authority in section 1148(h) of the
Act, to revise the rules for milestone and outcome payments to ENs, in
order to increase the incentives for providers of employment and other
support services to participate in this program.
Statement of Need:
This proposed regulatory action is necessary to respond to our
experience and recommendations we have received since we began
implementation of the Ticket to Work and Self-Sufficiency Program in
February 2002, in order to increase the incentives for providers of
employment services, vocational rehabilitation services, and other
support services to participate in this program, and to expand the
options available to beneficiaries with disabilities to obtain services
to assist them to go to work and attain self-sufficiency.
Summary of Legal Basis:
None.
Alternatives:
We considered not revising the current regulations implementing the
Ticket to Work program. However, we believe that these revisions to
eligibility to receive a ticket, to clarify the rules for assignment of
a ticket to a State VR agency, and to amend the rules for paying ENs
are necessary to increase participation in the Ticket to Work program
by providers of services and by beneficiaries with disabilities, in
order to ensure that these beneficiaries can seek the services
necessary to obtain and retain employment and reduce their dependency
on cash benefit programs.
[[Page 72869]]
Anticipated Cost and Benefits:
We anticipated initial costs to increase due to up-front payments to
ENs, and potential savings in later years as ENs are encouraged to
serve additional beneficiaries and assist them to achieve self-
sufficiency and reduce their dependency on cash benefit programs,
including the Supplemental Security Income and Social Security
Disability Insurance programs.
Risks:
At this time, we have not identified any risks associated with this
proposal.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 01/00/05
Final Action 05/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
State
Agency Contact:
Barbara Leary
Social Insurance Specialist
Social Security Administration
Office of Employment Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7764
Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF89
_______________________________________________________________________
SSA
155. ELIMINATION OF PARENT-TO-CHILD DEEMING FOR INDIVIDUALS WHO NO
LONGER MEET THE DEFINITION OF SPOUSE OF THE NATURAL OR ADOPTIVE PARENT
(793P)
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
Sec 1614(f)(2) of the Social Security Act
CFR Citation:
20 CFR 416.1160; 20 CFR 416.1165; 20 CFR 416.1202; 20 CFR 416.1851
Legal Deadline:
None
Abstract:
We propose to change the Supplemental Security Income (SSI) parent-to-
child deeming rules to no longer consider the income and resources of a
stepparent when an eligible child resides in the household with a
stepparent, but not his or her natural or adoptive parent. We will
clarify that a stepparent no longer meets the definition of a
``parent'' when his or her spouse dies or leaves the household. Thus,
an eligible child is not subject to deeming from a stepparent unless
the child lives with both his or her natural or adoptive parent and the
stepparent. We also propose changing the age at which an individual is
no longer considered an ineligible child for purposes of deeming from
21 to 22. We believe this change will simplify our rules for both the
public and our public contact employees.
Statement of Need:
The U.S. Court of Appeals, Second Circuit, ruled on a case involving a
natural parent who abandoned the family home leaving her spouse with
sole physical custody of an eligible child. Social Security
Acquiescence Ruling 99-1(2) currently applies the Court's decision to
the States of Connecticut, Vermont, and New York. The proposed rules
will set uniform national policy with respect to this issue. Further,
changing the definition of ``ineligible child'' for purposes of deeming
will make uniform all regulatory definitions of ``child'' for SSI
purposes. This will simplify our rules, making them less cumbersome to
administer and easier for the public to understand and follow.
Summary of Legal Basis:
None.
Alternatives:
None.
Anticipated Cost and Benefits:
We estimate that the program costs and administrative costs for these
regulatory changes would be negligible.
Risks:
These proposed rules will ensure our parent-to-child deeming rules are
consistent with respect to our current regulatory definition of
``parent'' and ``child.'' Policy will uniformly be set nationwide and
will make our rules less difficult for the public to understand.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/04
Final Action 09/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Karen E. Kerwath
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9835
Richard M. Bresnick
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1758
Related RIN: Related to 0960-AF24
RIN: 0960-AF96
_______________________________________________________________________
SSA
156. RULES FOR HELPING BLIND AND DISABLED INDIVIDUALS ACHIEVE SELF-
SUPPORT (506P)
Priority:
Other Significant
Legal Authority:
42 USC 902(a)(5); 42 USC 1381a; 42 USC 1382; 42 USC 1382a; 42 USC
1382b; 42 USC 1382c(f); 42 USC 1382j; 42 USC 1383; 42 USC 1382 note
CFR Citation:
20 CFR 416.1180; 20 CFR 416.1181; 20 CFR 416.1226
Legal Deadline:
None
Abstract:
We are proposing to amend our regulations to explain how we implement
section 203 of the Social Security Independence and Program
Improvements Act of 1994 (Pub. L. 103-296). Section 203 of this law
amended section 1633 of the Social Security Act
[[Page 72870]]
to require us to establish by regulations criteria for time limits and
other criteria related to plans to achieve self-support (PASS). The law
requires that the time limits take into account the length of time that
a person needs to achieve his or her occupational goal, within a
reasonable period, and other factors as determined by the Commissioner
to be appropriate.
Statement of Need:
This regulation is necessary to implement the changes in section 1633
of the Social Security Act regarding time limits and other criteria
deemed necessary by the Commissioner.
Summary of Legal Basis:
42 U.S.C. 1383b authorizes the Commissioner to promulgate regulations
for the purpose of establishing criteria for time-limits and other
criteria deemed necessary related to the PASS program.
Alternatives:
None.
Anticipated Cost and Benefits:
We estimate that the administrative impact would be negligible.
Risks:
At this time we have not identified any risks associated with this
proposal.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 06/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Mary Hoover
Social Insurance Specialist
Social Security Administration
Office of Program Development and Research
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-5651
Fran O. Thomas
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-9822
Fax: 410 966-2830
Email: fran.o.thomas@ssa.gov
Related RIN: Previously reported as 0960-AE17
RIN: 0960-AG00
_______________________________________________________________________
SSA
157. MEDICARE PRESCRIPTION DRUG PREMIUM AND COST-SHARING (1024P)
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
PL 108-173; 42 USC 405
CFR Citation:
None
Legal Deadline:
None
Abstract:
We propose to add to our regulations, a new part 418 that would contain
our rules applicable to claims for premium and cost-sharing subsidies
under Medicare and to include a new subpart D, Medicare part D
Subsidies. These rules would describe: how we determine whether an
individual is eligible for premium and cost-sharing subsidies; how we
determine subsidy eligibility; how we redetermine subsidy eligibility;
the subsidy application process; when eligibility for premium and cost-
sharing subsidies terminates; reporting requirements; and how
individuals may appeal a determination we make under the part D subsidy
Program.
Statement of Need:
SSA is responsible for determining premium and cost-sharing subsidy
eligibility for the new Medicare Prescription Drug Benefit. The
provision will be implemented in January 2007.
Summary of Legal Basis:
Section 1860D-14 of the Social Security Act provides for premium and
cost-sharing subsidies for certain low-income individuals, and directs
the Social Security Administration to develop a simplified application
process.
Alternatives:
None.
Anticipated Cost and Benefits:
The Centers for Medicare and Medicaid Services (CMS) has developed
detailed cost estimates for implementation of the Prescription Drug
Benefits program. These costs are explained in a CMS Notice of Proposed
Rulemaking (CMS-4068P; 69 FR 46632; 08/03/2004). SSA administrative
costs are not yet known. The benefit of developing agency regulations
for a simplified subsidy application are that many beneficiaries with
incomes below 150 percent of the poverty level, and limited resources,
will be able to get help with paying premiums and cost-sharing for
Medicare part D coverage.
Risks:
There are inherent risks in any form of public benefit which requires
means-testing. The risks for the prescription drug benefit premium and
cost-sharing subsidy program are increased by the requirement that SSA
use a simplified application process.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/04
Final Action 09/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Undetermined
[[Page 72871]]
Agency Contact:
Craig Street
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9793
Lois A. Berg
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1713
RIN: 0960-AG03
_______________________________________________________________________
SSA
158. CIVIL MONETARY PENALTIES, ASSESSMENTS, AND RECOMMENDED
EXCLUSIONS (2362P)
Priority:
Other Significant
Legal Authority:
42 USC 902(a)(5); 42 USC 1320a-8; 42 USC 1320b-10
CFR Citation:
20 CFR 498.100 TO 498.104; 20 CFR 498.106; 20 CFR 498.109; 20 CFR
498.114; 20 CFR 498.128
Legal Deadline:
None
Abstract:
The mission of the Social Security Administration, Office of the
Inspector General (SSA/OIG), is to protect SSA programs and operations
from fraud, waste, and abuse. Critical to this mission is ensuring that
SSA provide Social Security benefits in the correct amount to those who
meet the applicable requirements. Therefore, anyone who makes a false
statement of material fact to obtain or retain benefits to which they
are not entitled adversely impacts both SSA programs and the mission of
the OIG to protect those programs. Also critical to SSA's operations is
the relationship of trust that it has established with citizens of this
country; particularly the elderly and/or disabled individuals for who
Social Security is vital to their continued existence. Therefore, it is
imperative that outside individuals/entities not abuse or damage that
trust by using certain words associated with SSA in any solicitation/
mailing in such a way to mislead the public into believing that SSA
either approves, endorses, or authorizes such solicitation/mailing. The
Social Security Act provides authority to impose civil monetary
penalties and assessments against anyone who knowingly submits a false
statement of material fact to SSA to obtain or retain benefits to which
they are not entitled and civil monetary penalties against any
individual or organization who misleads the public into believing that
they are affiliated with or approved or endorsed by SSA by utilizing
SSA's symbols and program words. Congress determined that expansion of
the civil monetary penalty authority was needed to assure the integrity
of SSA's programs and operations. These proposed regulations are
required to enhance our program integrity efforts.
Statement of Need:
These proposed regulations, would reflect certain provisions of Public
Law 106-169 and 108-203, modify the existing procedures for the
imposition of a civil monetary penalty and assessment, as applicable,
under sections 1129 of the Social Security Act (42 U.S.C. 1320a-8) by:
(1) amending the regulations to reflect the expanded authority under
section 1129 to impose a civil monetary penalty and assessment for
fraud involved in the receipt of benefits under title VIII of the
Social Security Act; and (2) adding as new categories for civil
monetary penalty and assessment under section 1129 (i) representative
payees with respect to wrongful conversions, and (ii) individuals who
withhold the disclosure of material facts to the SSA.
These proposed regulations would also reflect certain provisions of
Public Law 108-203 and modify the existing procedures for the
imposition of a civil monetary penalty under section 1140 of the Social
Security Act (42 U.S.C. 1320b-10) by: (1) requiring an advertiser or
direct marketer who offers to assist an individual in obtaining
products or services for a fee, that SSA otherwise provides free of
charge, to include a written notice on the solicitation/mailing that
the product or service is available from SSA free of charge; and (2)
expanding the list of terms in section 1140 that encompass the scope of
words or phrases that the statute prohibits from being used in a
misleading manner.
Summary of Legal Basis:
These proposed regulations would implement section 251(b)(6) of Public
Law 106-169 and sections 111, 201, 204 and 207 of Public Law 108-203.
Alternatives:
None.
Anticipated Cost and Benefits:
Cost--None.
Benefits--These regulations are required to enhance our program
integrity efforts.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Kathy Buller
Chief Counsel to the Inspector General
Social Security Administration
Office of the Inspector General
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-2827
Fran O. Thomas
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-9822
Fax: 410 966-2830
Email: fran.o.thomas@ssa.gov
RIN: 0960-AG08
_______________________________________________________________________
SSA
159. REPRESENTATIVE PAYMENT; ADDITIONAL PROTECTIONS FOR
PERSONS WITH REPRESENTATIVE PAYEES (2422P)
Priority:
Other Significant
Legal Authority:
42 USC 405(j); 42 USC 1007; 42 USC 1383(a)(2)
CFR Citation:
20 CFR 404.2022; 20 CFR 404.2035; 20 CFR 404.2040(a); 20 CFR 404.2045;
20 CFR 404.2065; 20 CFR 408.622; 20 CFR
[[Page 72872]]
408.635; 20 CFR 408.645; 20 CFR 408.665; 20 CFR 416.622; 20 CFR
416.635; 20 CFR 416.640(a); 20 CFR 416.645
Legal Deadline:
None
Abstract:
Effective stewardship of SSA programs requires mechanisms to assure
that benefits are used to meet the needs of beneficiaries judged
incapable of managing or directing someone else to manage their
benefits. Congress determined that improvements to the representative
payment procedures were needed to assure program integrity. These
proposed regulations are required to further our program integrity
efforts.
Statement of Need:
These proposed regulations, which reflect certain provisions of Public
Law 108-203, would modify existing representative payee procedures by:
(1) expanding the scope of disqualification to prohibit an individual
from serving as representative payee if he or she is convicted of
offenses resulting in imprisonment for more than one year or is fleeing
to avoid prosecution, custody, or confinement after conviction; (2)
requiring annual certifications from nongovernmental fee for service
organizational payees that they are licensed and bonded; (3) requiring
a fee for service representative payee to forfeit their fee for the
months during which funds were misused; (4) requiring a representative
payee to receive benefits in person at a local social security field
office if they fail to provide an annual accounting of benefits; and
(5) explaining financial requirements for representative payees.
Summary of Legal Basis:
These proposed regulations implement sections 102, 103, 104 and 106 of
Public Law 108-203.
Alternatives:
None.
Anticipated Cost and Benefits:
Any costs associated with these regulations are reflected in the
President's budget as part of legislative implementation. They are
required to further our program integrity efforts.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/04
Final Action 08/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Organizations
Government Levels Affected:
None
Agency Contact:
Betsy Byrd
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7981
Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AG09
_______________________________________________________________________
SSA
160. ISSUANCE OF WORK REPORT RECEIPTS, PAYMENT OF TRIAL WORK
PERIOD MONTHS AFTER A FRAUD CONVICTION AND CHANGES TO THE STUDENT
EARNED INCOME EXCLUSION (2502P)
Priority:
Other Significant
Legal Authority:
42 USC 402; 42 USC 403; 42 USC 404(a); 42 USC 404(e); 42 USC 405(a) to
405(d); 42 USC 405(h); 42 USC 405 note; 42 USC 416(1); 42 USC 421(a);
42 USC 421(i); 42 USC 421 note ; 42 USC 422(c); 42 USC 423(e); 42 USC
425; 42 USC 902(a); 42 USC 902(5); 42 USC 902 note; 42 USC 1320 a-8a;
42 USC 1320 b-17; 42 USC 1381; 42 USC 1382; 42 USC 1382 note; 42 USC
1383
CFR Citation:
20 CFR 404.401a; 20 CFR 404.471; 20 CFR 404.903; 20 CFR 404.1588; 20
CFR 404.1592; 20 CFR 416.708(c); 20 CFR 416.1112(c)(3); 20 CFR
416.1403; 20 CFR 416.1861
Legal Deadline:
None
Abstract:
We are proposing to amend our rules to carry out sections 202, 208, and
432 of the Social Security Protection Act (SSPA) of 2004. The SSPA
provides safeguards to Social Security and Supplemental Security Income
(SSI) beneficiaries who have representative payees and enhances program
protections. Section 202 of the SSPA requires us to issue a receipt to
you each time you report a change in your work activity or give us
documentation of a change in your earnings if you receive benefits
based on disability under titles II or XVI of the Act. In section 208,
benefits for certain months during the trial work period becomes
nonpayable if you are convicted by a Federal court of fraudulently
concealing work activity. Section 432 changes the way we decide if you
are eligible for the Student Earned Income Exclusion. We also propose
to change the SSI student policy to include home schooling as a form of
regular school attendance.
Statement of Need:
This regulation is necessary to implement the program improvements
established in the SSPA. The regulation will improve our service to
individual beneficiaries who attempt to work and improve our ability to
protect the programs from certain types of fraud.
Summary of Legal Basis:
This regulation implements sections 202, 208, and 432 of Public Law
108-203.
Alternatives:
None.
Anticipated Cost and Benefits:
Improved service to beneficiaries and improved protections from fraud
for the programs.
Risks:
At this time we have not identified any risks to this proposal.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 03/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
[[Page 72873]]
Agency Contact:
Cindy Duzan
Social Insurance Specialist
Social Security Administration
Office of Program Development and Research
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-4203
Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AG10
_______________________________________________________________________
SSA
161. INCOME RELATED MEDICARE PART B PREMIUM SUBSIDY REDUCTION
(2101P)
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
42 USC 405; PL 108-173
CFR Citation:
20 CFR 418 (New)
Legal Deadline:
None
Abstract:
We propose to add to our regulations a new part 418 that would include
our rules applicable to reduction of premium subsidies for high income
beneficiaries. Section 811 of the Medicare Prescription Drug,
Improvement and Modernization Act of 2003 amends section 1839 of the
Act. Starting in 2007, the new subsection 1839(i) requires that
Medicare part B enrollees with high income receive a reduced part B
premium subsidy. The statute establishes four income range ``notches''
above a threshold, and prescribes a percentage adjustment of premiums
for each notch. As income increases, the premium subsidy decreases; in
effect, the higher the income, the higher the part B premium. All
beneficiaries will continue to receive some part B premium subsidy. The
income threshold in 2007 is $80,000 ($160,000 for an individual who
files a joint income tax return). The premium adjustments will be
phased in over a five year period between 2007 and 2011. After 2007,
the threshold amount and all of the notch amounts will be annually
adjusted for inflation.
Statement of Need:
Regulations required by statute.
Summary of Legal Basis:
Section 1839(i) of the Social Security Act.
Alternatives:
None. The Social Security Act directs the Commissioner to establish
regulations to implement this provision. The statute requires the
Commissioner to establish regulations regarding temporary use of tax
year data from a year other than the year ordinarily used to determine
premium adjustments, establishment of premiums for Medicare part B
enrollees who do not file income taxes, and specification of ``life-
changing events'' that meet the standard for use of more recent tax
year data.
Anticipated Cost and Benefits:
The Income Related Medicare part B premium adjustment was established
to produce Federal savings in the Medicare program. The Congressional
Budget Office estimates that this provision will produce $13.3 billion
in savings between 2007 and 2013. SSA will have administrative costs in
implementing the provision, which have been considered in the savings
estimates.
Risks:
None identified.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 07/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Undetermined
Agency Contact:
Craig Street
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9793
Lois A. Berg
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1713
RIN: 0960-AG11
_______________________________________________________________________
SSA
162. DENIAL OF TITLE II BENEFITS TO PERSONS FLEEING
PROSECUTION, CUSTODY, OR CONFINEMENT, AND TO PERSONS VIOLATING
PROBATION OR PAROLE (2222P)
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
42 USC 402(x)
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
These regulations will propose rules for prohibiting title II benefits
to persons fleeing prosecution or custody, or confinement after
conviction and to persons violating probation or parole. We will also
propose rules for establishing that good cause exists for continuing to
pay such benefits.
Statement of Need:
Public Law 108-203, the Social Security Protection Act of 2004, extends
the fugitive felon nonpayment provision to title II beneficiaries
effective January 2005. It also provides a good cause provision for
titles II and XVI. The good cause provision requires the Commissioner
to apply good cause if a court finds the person not guilty, charges are
dismissed, a warrant for arrest is vacated, there are similar
exonerating circumstances identified by the court, or the individual
establishes that he or she was the victim of identity fraud and the
warrant was issued on such basis. Public Law 108-
[[Page 72874]]
203 also gives the Commissioner the discretionary authority to
establish good cause based on mitigating factors if the criminal
offense is non-violent and not drug-related, and in the case of
probation or parole violators, both the violation and the underlying
offense are non-violent and not drug-related.
Summary of Legal Basis:
Section 203 of Public Law 108-203.
Alternatives:
None.
Anticipated Cost and Benefits:
There are no anticipated costs and benefits resulting from this
regulatory action. Any program savings from nonpayment to fugitive
felons will be the result of implementing Public Law 108-203.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/05
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Judy Sale
Social Insurance Specialist
Social Security Administration
Office of Income Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-8581
Richard M. Bresnick
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1758
RIN: 0960-AG12
_______________________________________________________________________
SSA
163. PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND
INFORMATION; AVAILABILITY OF INFORMATION AND RECORDS TO THE PUBLIC
(2562P)
Priority:
Other Significant
Legal Authority:
5 USC 552; 5 USC 552a; 42 USC 1306(a); 42 USC 902(a)(5)
CFR Citation:
20 CFR 401 app A(c)(4); 20 CFR 402.45(e)
Legal Deadline:
None
Abstract:
We propose to revise our privacy and disclosure rules to:
1. Add a new section to set out detailed procedures to further preserve
the anonymity and protect the physical well-being of employees in
abusive relationships or who fear for their physical well-being because
of threats from others.
2. Conform SSA's Freedom of Information Act regulations in this respect
more closely to Office of Personnel Management (OPM) regulations; and
3. Develop procedures for the protection in the electronic environment
of personally identifiable information for at-risk employees.
Statement of Need:
The revised regulations are needed to:
1. Set out detailed procedures to ensure uniform application of the
policy and equal protection for all at-risk employees;
2. Conform the regulations to our practice and systems of records,
which set out guidelines to guard against the inappropriate release of
personally identifiable information for at-risk employees; and
3. Describe the safeguards that ensure the appropriate procedures for
the protection of personally identifiable information in the electronic
environment.
Summary of Legal Basis:
Revisions are needed to incorporate into the regulations detailed
procedures for the protection of personally identifiable information
for at-risk employees.
Alternatives:
None.
Anticipated Cost and Benefits:
1. Develop uniform procedures for providing protection for all at-risk
employees.
Cost--None.
Benefit--Protects the anonymity and physical well-being, as
appropriate, of those at-risk employees who fear for their physical
safety.
2. Conform the regulations more closely to the OPM regulations.
Cost--None.
Benefit--Regulatory guidelines will allow decision makers to use their
own discretion to determine whether release of personally identifiable
information would constitute an unwarranted invasion of personal
privacy under the Freedom of Information Act, thereby placing employees
at risk.
3. Description of safeguards against inappropriate disclosure of
personal information by electronic means.
Cost--None.
Benefit--Increase employee awareness of the safeguards employed by SSA
to maintain the security, confidentiality, and integrity of the
information maintained for the well-being of all employees.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 07/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Edie McCracken
Social Insurance Specialist
Social Security Administration
Office of the General Counsel
Office of Public Disclosure
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-6117
RIN: 0960-AG14
_______________________________________________________________________
SSA
-----------
FINAL RULE STAGE
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164. REVISED MEDICAL CRITERIA FOR EVALUATING MALIGNANT NEOPLASTIC
DISEASES (399F)
Priority:
Other Significant
[[Page 72875]]
Legal Authority:
42 USC 405; 42 USC 902(a)(5); 42 USC 1383
CFR Citation:
20 CFR 404.1500, app 1
Legal Deadline:
None
Abstract:
Sections 13.00 and 113.00 (malignant neoplastic diseases) of appendix 1
to subpart P of part 404 of our regulations (404.1501 through 404.1599)
describe those impairments that are considered severe enough to prevent
a person from doing any gainful activity, or for a child claiming SSI
payments under title XVI, that causes marked and severe functional
limitations. We are revising these sections to ensure that the medical
evaluation criteria are up-to-date and consistent with the latest
advances in medical knowledge and treatment. The Supplemental Security
Income program incorporates and uses the same medical criteria as the
Old-Age, Survivors, and Disability Insurance program.
Statement of Need:
These regulations are necessary to update the listings for evaluating
malignant neoplastic diseases to reflect advances in medical knowledge,
treatment and methods of evaluating these diseases. They ensure that
determinations of disability have a sound medical basis, that claimants
receive equal treatment through the use of specific criteria, and that
individuals who are disabled can be readily identified and awarded
benefits if all other factors of entitlement or eligibility are met.
Summary of Legal Basis:
Administrative-not required by statute or court order.
Alternatives:
In the NPRM, We proposed changes to the childhood listings for
malignant solid tumors and neuroblastoma. As we reviewed our proposed
changes in response to public comments, we realized that we need to
further consider how to include these disorders in our listings. In the
interim, we have decided to retain our current criteria for malignant
solid tumors in children and neuroblastoma.
We also considered continuing to use current rules for malignant
neoplastic diseases. However, we believe that proposing these revisions
is preferable because of the medical advances that have been made in
treating and evaluating these types of diseases. The current listings
are now over 15 years old. Medical advances in disability evaluation
and treatment and our program experience make clear that the current
listings do not reflect state-of-the-art medical knowledge and
technology.
Anticipated Cost and Benefits:
1. Title II
We estimate that, if finalized, these proposed rules would result in
increased program outlays (in millions of dollars) to the title II
program ($18 million total in a 10-year period beginning in fiscal year
2004).
2. Title XVI
We estimate that, if finalized, these proposed rules will result in
reduced program outlays resulting in the following program savings (in
the millions of dollars) to the SSI program ($4 million total in a 10-
year period beginning in fiscal year 2004). (Note: Totals may not be
equal to the sum of the annual totals due to rounding-out.)
(Note: Federal SSI payments due on October 1st in fiscal years 2006,
2007, and 2012 are included with payments for the prior fiscal year.)
Administrative Savings-
We do not expect any administrative savings to result from these
proposed regulations.
Administrative Costs-
We expect, if finalized, there will be some administrative costs
associated with these proposed rules. If finalized, the proposed rules
are expected to result in administrative costs less than 25 work years
and less than $2 million per year.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 66 FR 59305 11/27/01
NPRM Comment Period End 01/28/02
NPRM Comment Per67 FR 19138ended 04/18/02
Final Action 01/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Michelle Hungerman
Social Insurance Specialist
Social Security Administration
Office of Disability Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-2289
Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AD67
_______________________________________________________________________
SSA
165. ELIMINATION OF CLOTHING FROM THE DEFINITIONS OF INCOME AND IN-KIND
SUPPORT AND MAINTENANCE, EXCLUSIONS OF ONE AUTOMOBILE, AND HOUSEHOLD
GOODS AND PERSONAL EFFECTS UNDER SSI FROM RESOURCES (950F)
Priority:
Other Significant
Legal Authority:
Sec 1612 of the Social Security Act; Sec 1613(a)(2)(A) of the Social
Security Act
CFR Citation:
20 CFR 416.1102 to 416.1104; 20 CFR 416.1121; 20 CFR 416.1124; 20 CFR
416.1130; 20 CFR 416.1133; 20 CFR 416.1140; 20 CFR 416.1142; 20 CFR
416.1144 to 416.1145; 20 CFR 416.1147 to 416.1149; 20 CFR 416.1157; 20
CFR 416.1210; 20 CFR 416.1216; 20 CFR 416.1218
Legal Deadline:
None
Abstract:
We will make the following changes to our rules on determining income
and resources under the Supplemental Security Income (SSI) program.
1. We will remove clothing from the definition of income and from the
definition of in-kind support and maintenance. As a result, we
generally will not count gifts of clothing as income when we decide
whether a person can receive SSI benefits or when we compute the amount
of benefits.
[[Page 72876]]
2. We will simplify our rules on how we exclude an automobile in
determining the resources of a SSI applicant or recipient.
Specifically, we will exclude one automobile from resources if it is
used for transportation, without consideration of its value.
3. We will change our resources counting rules in the SSI program by
eliminating the dollar value limit for the exclusion of household goods
and personal effects. As a result, we would not count household goods
and personal effects as resources when we decide whether a person can
receive SSI benefits.
Statement of Need:
These changes will simplify our rules, making them less cumbersome to
administer and easier for the public to understand and follow, thereby
reducing the potential for payment errors. These changes also will make
SSI financial eligibility rules more consistent with those of other
means-tested Federal programs. The changes also will eliminate the need
to ask claimants, beneficiaries, and other members of their households
certain questions that have been viewed as intrusive. By no longer
counting gifts of clothing as income, we will remove a disincentive for
family members to help needy relatives.
Summary of Legal Basis:
None.
Alternatives:
Clothing -
None.
Automobile -
We considered revising the regulations to provide that SSA will assume
that the recipient's automobile meets the use requirements for total
exclusion of one automobile, absent evidence to the contrary. We did
not select this option because it would not change the rule but only
how we apply it. It does not go far enough in simplifying the SSI
program. By revising the use requirements to exclude a car if it is
used for transportation, thus replacing the four present specific
transportation exclusion criteria, we will simplify the process.
We considered excluding the value of one automobile, regardless of use.
We did not select this option because it would allow for the routine
exclusion of an automobile even if it were not used for transportation.
Such an approach would exclude an inoperable vehicle, a vehicle not
being used at all, or a vehicle only used for recreation (such as a
dune buggy). We maintain that it is unreasonable to exclude from
resources the value of a vehicle that is not used for transportation.
We also considered increasing the excludable value of an automobile not
meeting the use test to $11,000. We did not select this option because
it would not simplify the SSI program.
Household Goods and Personal Effects -
Instead of excluding the entire value of household goods and personal
effects, we considered raising the excludable limit to $10,000 from the
current level of $2,000. We decided not to pursue this option because
it would not provide any policy simplification. It would increase the
amount excluded but it would not eliminate the need for the current
time-consuming and complex procedures for determining the market value
of an individual's household goods and personal effects.
Anticipated Cost and Benefits:
We estimate that the program costs and administrative costs for these
regulatory changes would be negligible.
The proposed rules will simplify the administrative process of valuing
noncash items. The change to the household goods and personal effects
exclusion would simplify our rules and improve work efficiency by
eliminating the need to inventory an individual's household goods and
personal effects and determine their current market value. The changes
will also serve to make our rules less intrusive and more protective of
the dignity of individuals seeking SSI benefits.
Risks:
These changes will simplify complex SSI rules without disadvantaging
SSI applicants or recipients or significantly increasing program or
administrative costs.
Clothing -
There are no significant concerns.
Automobile -
Our experience shows that most SSI beneficiaries do not own expensive
cars. Still, it is possible that a beneficiary may, under our proposal,
own an automobile that is used for transportation (and therefore
excluded) and that is worth a considerable amount of money.Household
Goods and Personal Effects -
Under the proposed change to the household goods and personal effects
exclusion, we would continue to recognize that individuals applying for
SSI may own items that have investment value and which may be quite
valuable. Such items as gems, jewelry, and collectibles would still be
considered countable resources and subject to the SSI resource limit.
Thus, the proposed exclusion for household goods and personal effects
would not create an unintended exclusion for items that have investment
value.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 554 01/06/04
NPRM Comment Period End 03/08/04
Final Action 12/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Albert Fatur
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9855
Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AF84
_______________________________________________________________________
SSA
166. CONTINUATION OF BENEFIT PAYMENTS TO CERTAIN INDIVIDUALS WHO ARE
PARTICIPATING IN A PROGRAM OF VOCATIONAL REHABILITATION SERVICES,
EMPLOYMENT SERVICES, OR OTHER SUPPORT SERVICES (925F)
Priority:
Other Significant
Legal Authority:
42 USC 902(a)(5); 42 USC 425(b); 42 USC 1383(a)(6)
CFR Citation:
20 CFR 404.316; 20 CFR 404.327 (New); 20 CFR 404.328 (New); 20 CFR
404.337;
[[Page 72877]]
20 CFR 404.352; 20 CFR 404.902; 20 CFR 404.1586; 20 CFR 404.1596; 20
CFR 404.1597; 20 CFR 416.1320; 20 CFR 416.1331; 20 CFR 416.1338; 20 CFR
416.1402
Legal Deadline:
None
Abstract:
These final rules revise the regulations that provide for the
continuation of benefit payments to certain individuals who recover
medically while participating in a vocational rehabilitation program
with a State vocational rehabilitation agency. We are revising these
regulations because of statutory amendments, which extend eligibility
for these continued benefit payments to certain individuals who recover
medically while participating in another appropriate program of
vocational rehabilitation services. These include individuals
participating in the Ticket to Work and Self-Sufficiency Program or
another program of vocational rehabilitation services, employment
services, or other support services approved by the Commissioner of
Social Security.
Prior to November 1991, the Social Security Act provided for the
continuation of payment of Social Security Disability Insurance and
Supplemental Security Income disability and blindness benefits to
individuals whose disability or blindness ended for medical reasons
while they were participating in an approved State vocational
rehabilitation program under title I of the Rehabilitation Act of 1973,
if the Commissioner of Social Security determined that completion or
continuation of the program would increase the likelihood of the
individual's permanent removal from the disability benefit rolls. The
Omnibus Budget Reconciliation Act of 1987 extended eligibility for
continued benefits to individuals who receive Supplemental Security
Income benefits based on blindness. (We implemented this change by
issuing operating instructions effective April 1, 1988, the effective
date of the amendment.) The Omnibus Budget Reconciliation Act of 1990
extended eligibility for continued benefits to individuals
participating in an approved non-State vocational rehabilitation
program at the time their disability ended. (We implemented this change
by issuing operating instructions effective November 1991, the
effective date of the amendments.) The Personal Responsibility and Work
Opportunity Reconciliation Act of 1996 requires the redetermination of
eligibility based on disability of individuals who attain age 18, based
on the rules for determining initial eligibility for adults. These
redeterminations are not continuing disability reviews, however, we are
revising our regulations to provide that an individual whose disability
has ended as a result of an age-18 redetermination may qualify for
continued benefits based on participation in an approved program and
increased likelihood of permanent removal from the disability rolls, if
the individual meets all other requirements for continued benefits. The
Ticket to Work and Work Incentives Improvement Act of 1999 authorizes
continued benefits for a person who medically recovers while
participating in a program consisting of the Ticket to Work program or
another program of vocational rehabilitation services, employment
services, or other support services approved by the Commissioner of
Social Security, provided that the other requirements for benefit
continuation are met.
These final rules will also explain what we mean by ``an appropriate
program of vocational rehabilitation services, employment services, or
other support services.'' They will explain when an individual will be
considered to be ``participating'' in the program. They will explain
how we will determine whether an individual's completion of or
continuation in an appropriate program of vocational rehabilitation
services, employment services, or other support services will increase
the likelihood that the individual will not have to return to the
disability rolls. They will also explain that, for students age 18
through 21, ``an appropriate program of vocational rehabilitation
services, employment services, or other support services'' includes an
individualized education plan developed under policies and procedures
approved by the Secretary of Education for assistance to States for the
education of children under the Individuals with Disabilities Education
Act, as amended.
Statement of Need:
These final regulations are necessary to conform our regulations to
amendments enacted in the Ticket to Work and Work Incentives
Improvement Act of 1999, as well as the amendments enacted in the
Omnibus Budget Reconciliation Act of 1990 and the Omnibus Budget
Reconciliation Act of 1987; and as the result of a provision enacted in
the Personal Responsibility and Work Opportunity Reconciliation Act of
1996.
Summary of Legal Basis:
None.
Alternatives:
None.
Anticipated Cost and Benefits:
For the five-year period from fiscal year *2004 through 2008, the
estimated effects on Federal Supplemental Security Income payments for
increased payments for children range from $4 million in fiscal year
2004 to $46 million in fiscal year 2008. The estimated impact on the
Federal share of Medicaid payments during this five-year period range
from $3 million in fiscal year 2004 to $41 million in fiscal year 2008.
*Updated estimates for the five-year period from fiscal 2005 through
2009, are pending.
Risks:
At this time, we have not identified any risks associated with this
proposal.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 68 FR 45180 08/01/03
NPRM Comment Period End 09/30/03
Final Action 11/00/04
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
State
Agency Contact:
Barbara Leary
Social Insurance Specialist
Social Security Administration
Office of Employment Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7764
Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF86
[[Page 72878]]
_______________________________________________________________________
SSA
167. ADMINISTRATIVE REVIEW PROCESS; INCORPORATION BY REFERENCE OF ORAL
FINDINGS OF FACT AND RATIONALE IN WHOLLY FAVORABLE WRITTEN DECISIONS
(964I)
Priority:
Other Significant
Legal Authority:
42 USC 405(a); 42 USC 405(b); 42 USC 902(a)(5); 42 USC 1383
CFR Citation:
20 CFR 404.953; 20 CFR 416.1453
Legal Deadline:
None
Abstract:
These interim final rules revise our regulations to provide that if an
Administrative Law Judge (ALJ) enters a wholly favorable, oral decision
into the record of a hearing, the ALJ may subsequently issue a written
decision that gives the findings and reasons for the decision by
incorporating by reference the findings and reasons stated orally at
the hearing, provided that the ALJ does not determine subsequent to the
hearing that the oral findings and reasons should be changed.
Statement of Need:
In fiscal year 2002, we announced a number of short-term actions to
reduce delays in processing requests for ALJ hearings. One of these
actions was to allow ALJs to issue oral decisions from the bench at the
close of the hearing. We have found that ALJs are not frequently
issuing oral decisions from the bench because of the duplication of
work involved in issuing the oral decision and then subsequently
issuing a written decision that fulfills existing provisions of our
regulations requiring ALJs to issue written decisions that give the
findings of fact and the reasons for the decision. We believe we can
make it easier to use the bench decision procedure to reduce the time
required to issue wholly favorable decisions by amending our
regulations to explicitly authorize ALJs to issue wholly favorable
written decisions that incorporate by reference the findings and
rational stated orally in a bench decision.
Summary of Legal Basis:
None.
Alternatives:
Interpret our existing regulations to allow ALJs to issue written,
wholly favorable decisions that give the findings of fact and rationale
for the decision by incorporating by reference the findings and
rationale stated in an oral decision that the ALJ entered into the
record at the hearing.
Anticipated Cost and Benefits:
Improved public service by facilitating use of the oral decision
procedure to reduce the time required to issue wholly favorable
decisions.
The administrative savings resulting from these interim final rules
have been determined to be negligible (i.e., less than $2 million or 25
workyears).
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Interim Final Ru69 FR 61594 10/20/04
Interim Final Rule Comment Period End 12/20/04
Final Action 04/00/05
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AF92
_______________________________________________________________________
SSA
168. EXPANDED AUTHORITY FOR CROSS-PROGRAM RECOVERY OF BENEFIT
OVERPAYMENTS (2221F)
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
42 USC 404; 42 USC 405(a); 42 USC 902(a); 42 USC 1008; 42 USC 1010(a);
42 USC 1320b-17; 42 USC 1383(b); 42 USC 1383(d)
CFR Citation:
20 CFR 404.530; 20 CFR 404.535; 20 CFR 404.540; 20 CFR 404.545; 20 CFR
408.930; 20 CFR 408.931; 20 CFR 408.932; 20 CFR 408.933; 20 CFR
416.570; 20 CFR 416.572; 20 CFR 416.573; 20 CFR 416.574; 20 CFR 416.575
Legal Deadline:
None
Abstract:
To implement section 210 of the Social Security Protection Act (SSPA)
of 2004 (Pub. L. 108-203, enacted on March 2, 2004), we will revise our
regulations on the recovery of overpayments incurred under one of our
programs from benefits payable to the overpaid individual under other
programs we administer. Provisions of the SSPA expand the authority for
cross-program recovery of overpayments made in our various programs.
These programs are Social Security benefits under title II of the
Social Security Act (the Act), Special Veterans Benefits under title
VIII of the Act and Supplemental Security Income (SSI) benefits under
title XVI of the Act. Implementation of these regulatory revisions when
they become effective will yield significant program savings.
Section 210 of the SSPA repealed 42 USC 1320b-18 and cross-program
recovery provisions in 42 USC 1008 and amended 42 USC 1320b-17 of the
Act. It allows recovery from monthly benefits generally at a rate not
to exceed 10 percent of the monthly benefit and unlimited withholding
of past-due benefits in one program to recover an overpayment paid
under another program. It also allows for cross-program recovery even
if the individual is entitled under the program in which the
overpayment was made.
Statement of Need:
These revisions of our regulations are needed to implement section 210
of the Social Security Protection Act (SSPA) of 2004.
Summary of Legal Basis:
These regulations implement section 210 of Public Law 108-203.
Alternatives:
None.
[[Page 72879]]
Anticipated Cost and Benefits:
We anticipate significant program savings (approximately $150 million
over 5 years) because these final rules, will allow the Agency to
recover more overpaid funds, and to recover them more quickly, than it
could under prior statutory authority. The net administrative impact
estimate is pending. Decisions regarding implementation are not final.
However, any administrative impact is attributable to Public Law 108-
203 and not to this regulation.
Risks:
This regulation will protect the trust funds and general funds by
recovering outstanding overpayments (paid under three titles of the
Act) more quickly. It will also reduce the administrative cost of
recontacting beneficiaries to attempt to obtain refunds of outstanding
overpayments.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 69 FR 51962 08/24/04
NPRM Comment Period End 09/23/04
Final Action 11/00/04
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
None
Agency Contact:
Robin Weber
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7944
Richard M. Bresnick
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1758
RIN: 0960-AG06
BILLING CODE 4191-02-S
[[Page 72880]]
CONSUMER PRODUCT SAFETY COMMISSION (CPSC)
Statement of Regulatory Priorities
The U.S. Consumer Product Safety Commission is charged with protecting
the public from unreasonable risks of death and injury associated with
consumer products. To achieve this goal, the Commission:
participates in the development or revision of voluntary
product safety standards;