Preliminary Assessment Information and Health and Safety Data
Reporting; Addition of Chemicals
[Federal Register: October 29, 1996 (Volume 61, Number 210)]
[Rules and Regulations]
[Page 55871-55875]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc96-20]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 712 and 716
[OPPTS-82049; FRL-5397-9]
Preliminary Assessment Information and Health and Safety Data
Reporting; Addition of Chemicals
Agency: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The TSCA Interagency Testing Committee (ITC) in its 38th
Report to EPA revised the Toxic Substances Control Act (TSCA) Section
4(e) Priority Testing List by recommending for testing 18 chemical
substances. The ITC recommendations must be given priority
consideration by EPA in promulgating test rules. EPA is adding certain
of these chemical substances to two model information-gathering rules:
the TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)
and the TSCA Section 8(d) Health and Safety Data Reporting Rule. These
model rules will require manufacturers and importers of the substances
identified herein to report certain production, use, and exposure-
related information, and manufacturers, importers, and processors of
the listed substances to report unpublished health and safety data to
EPA.
DATES: This rule will become effective on November 29, 1996.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, TSCA
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,
Rm. E-543, Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202)
554-0551, e-mail: TSCA-Hotline@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: This rule adds 18 chemical substances to the
PAIR and the section 8(d) Health and Safety Data Reporting Rule.
Manufacturers, importers, and processors of these chemicals will be
required to report unpublished health and safety data, and
manufacturers and importers will be required to report end use,
exposure, and production volume data to EPA.
This rule also corrects the previous TSCA section 8(a) final rule
published in the Federal Register of February 28, 1996 (61 FR 7421)
(FRL-4996-9), by replacing the incorrect CAS number for (1,1,3,3-
tetramethylbutyl)phenol (mixed isomers) 2744-41-6 with the correct CAS
number for that chemical, 62744-41-6.
I. Background
Section 4(e) of TSCA established the ITC and authorized it to
recommend to EPA chemical substances and mixtures (chemicals) to be
given priority consideration in proposing test rules under section 4.
For some of these chemicals, the ITC may designate that EPA must
respond to its recommendations within 12 months. In this time, EPA must
either initiate a rulemaking to test the chemical or publish in the
Federal Register its reasons for not doing so.
On May 31, 1996, EPA announced the receipt of the 38th Report of
the ITC, and it was then published in the Federal Register of July 30,
1996 (61 FR 39832) (FRL-5397-2). The 38th Report revises the
Committee's Priority Testing List of chemicals by recommending for
testing 18 chemical substances to the section 4(e) Priority Testing
List.
This rule adds 18 substances to the PAIR and the section 8(d)
Health and Safety Data Reporting Rule. These two rules are model
information gathering rules which assist the ITC in making testing
recommendations and aid EPA in responding to the ITC recommendations.
EPA issued the PAIR under section 8(a) of TSCA (15 U.S.C. 2607(a)),
and it is codified at 40 CFR part 712. This model section 8(a) rule
establishes standard reporting requirements for manufacturers and
importers of the chemicals listed in the rule at 40 CFR 712.30. These
manufacturers and importers are required to submit a one-time report on
general volume, end use, and exposure-related information using the
Preliminary Assessment Information Manufacturer's Report (EPA Form
7710-35). EPA uses this model section 8(a) rule to gather current
information on chemicals for the ITC quickly.
EPA issued the model Health and Safety Data Reporting Rule under
section 8(d) of TSCA (15 U.S.C. 2607(d)), and it is codified at 40 CFR
part 716. The section 8(d) model rule requires past, current, and
prospective manufacturers, importers, and processors of listed
chemicals to submit to EPA copies and lists of unpublished health and
safety studies on the listed chemicals that they manufacture, import,
or process. These studies provide the ITC and EPA with useful
information for chemical assessment and have provided significant
support for EPA's decisionmaking under TSCA sections 4, 5, 6, 8, and 9.
These model rules provide for the automatic addition of ITC
Priority Testing List chemicals. Whenever EPA announces the receipt of
an ITC report, EPA may, at the same time without further notice and
comment, amend the two model information-gathering rules by adding the
recommended (or designated) chemicals. The amendment adding these
chemicals to the PAIR and the Health and Safety Data Reporting Rule
becomes effective 30 days after publication in the Federal Register.
II. Chemicals To Be Added
In its 38th Report to EPA, the ITC recommended adding a group of 18
nonylphenol ethoxylates to the section 8(a) PAIR and the section 8(d)
Health and Safety Data Reporting Rule. While 18 chemical substances are
identified in the regulatory text, 23 CAS numbers are listed. Three
chemical substances, nonylphenol polyethylene glycol ether, p-
nonylphenol polyethylene glycol ether and nonylphenoxypolyoxyethanol
are characterized with multiple CAS numbers. Four chemical substances
are not identified by CAS numbers.
For a complete listing of the subtances being added to the section
8(d) model rule and the PAIR, see the regulatory text of this document.
III. Reporting Requirements
A. Preliminary Assessment Information Rule
All persons who manufactured or imported the chemical substances
named in this rule during their latest complete corporate fiscal year
must submit a Preliminary Assessment Information Manufacturer's Report
(EPA Form No. 7710-35) for each manufacturing or importing site at
which they manufactured or imported a named substance. A separate form
must be completed for each substance and submitted to the Agency no
later than January 27, 1997. Persons who have previously and
voluntarily submitted a Manufacturer's Report to the ITC or EPA may be
able to submit a copy of the original Report to EPA or to notify EPA by
letter of their desire to have this voluntary submission accepted in
lieu of a current data submission. See Sec. 712.30(a)(3).
Details of the reporting requirements, the basis for exemptions,
and a facsimile of the reporting form, are provided in 40 CFR part 712.
Copies of the form are available from the TSCA Environmental Assistance
Division at the address listed under FOR FURTHER INFORMATION CONTACT.
B. Health and Safety Data Reporting Rule
Listed below are the general reporting requirements of the section
8(d) model rule.
[[Page 55873]]
1. Persons who, in the 10 years preceding the date a substance is
listed, either have proposed to manufacture, import, or process, or
have manufactured, imported, or processed, the listed substance must
submit to EPA: A copy of each health and safety study which is in their
possession at the time the substance is listed.
2. Persons who, at the time the substance is listed, propose to
manufacture, import, or process; or are manufacturing, importing, or
processing the listed substance must submit to EPA:
a. A copy of each health and safety study which is in their
possession at the time the substance is listed.
b. A list of health and safety studies known to them but not in
their possession at the time the substance is listed.
c. A list of health and safety studies that are ongoing at the time
the substance is listed and are being conducted by or for them.
d. A list of each health and safety study that is initiated after
the date the substance is listed and is conducted by or for them.
e. A copy of each health and safety study that was previously
listed as ongoing or subsequently initiated and is now complete--
regardless of completion date.
3. Persons who, after the time the substance is listed, propose to
manufacture, import, or process the listed substance must submit to
EPA:
a. A copy of each health and safety study which is in their
possession at the time they propose to manufacture, import, or process
the listed substance.
b. A list of health and safety studies known to them but not in
their possession at the time they propose to manufacture, import, or
process the listed substance.
c. A list of health and safety studies that are ongoing at the time
they propose to manufacture, import, or process the listed substance,
and are being conducted by or for them.
d. A list of each health and safety study that is initiated after
the time they propose to manufacture, import, or process the listed
substance, and is conducted by or for them.
e. A copy of each health and safety study that was previously
listed as ongoing or subsequently initiated and is now complete--
regardless of the completion date.
The bulk of reporting is required at the time the substance is
listed. Persons described in categories 1 and 2 do all or most of their
health and safety data reporting at the start of the reporting period.
The remaining reporting requirements, specifically categories 2(d),
2(e), and 3, continue prospectively. Guidance for reporting unpublished
health and safety data is provided at 40 CFR part 716.
4. Special exemptions.--Explanations of reporting exemptions are
found at 40 CFR 716.20. For this final rule all the chemicals listed
have a special exemption referenced at Sec. 716.20(b)(4) which states
that studies on mixtures containing the listed substances at levels
below one percent of the mixture, except when a purpose of the study
includes the investigation of the effects of the listed substance at
the levels below one percent, are not subject to the reporting
requirements.
C. Submission of PAIR Reports and Section 8(d) Studies
PAIR reports and section 8(d) health and safety studies must be
sent to:
TSCA Document Processing Center (7407), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460, ATTN: (insert either PAIR or 8(d) Reporting).
D. Removal of Chemical Substances from the Rules
Any person who believes that section 8(a) or 8(d) reporting
required by this rule is unwarranted, should promptly submit to EPA in
detail the reasons for that belief. EPA, in its discretion, may remove
the substance from this rule for good cause (40 CFR 716.105). When
withdrawing a substance from the rule, EPA will issue a rule amendment
for publication in the Federal Register.
IV. Economic Analysis
A. Preliminary Assessment Information Rule
The economic analysis for the addition of the 18 chemicals to the
TSCA Section 4(e) Priority List will be based largely on the methods
and data sources developed for the analyses of the original Section
8(a) Preliminary Assessment Information Rule (PAIR). These analyses
are:
1. Economic Impact and Small Business Definition Analysis for TSCA
Section 8(a) Preliminary Assessment Information Rule. Office of
Regulatory Analysis, OTS, U.S. EPA. February 1980.
2. Economic Analysis of the Final Section 8(a) Preliminary
Assessment Information Rule. R.A. Horner, Regulatory Impacts Branch,
OTS, U.S. EPA. November 12, 1981.
The Chemical Update System (CUS) was searched to determine the
manufacturers and importers of the 18 chemicals. However, only 5 of
these 18 chemicals were located in CUS. Thus, this report shall
estimate burden and costs based upon 5 chemical compounds. This search
identified 6 firms manufacturing or importing the 5 chemicals at a
total of 6 sites. Manufacturing and/or importing sites were identified
for all the chemicals.
Reporting Costs (dollars)
(a) 6 reports estimated at $1,515 per report = $9,090
(b) 6 sites at $476.18 per site = $2,857.08
Total Cost = $11,947.08
Mean cost per site = $11,947.08/6 sites = $1,991.18
Mean cost per firm = $11,947.08/6 firms = $1,991.18
Reporting Burden (hours)
(a) Rule familiarization: 7 hours/site x 6 sites = 42
(b) Reporting: 22.61 hours/report x 6 reports = 135.66
Total burden hours = 177.66
Average burden per site = 177.66 hours/6 sites = 29.61
Average burden per firm = 177.66 hours/6 firms = 29.61
EPA Costs (dollars)
It is estimated that the annual cost to the Federal Government will
be 1.315 FTEs (or 2,735 hours annually). At an estimated $69,370 per
FTE, the total of 1,315 FTEs will cost EPA $91,222.
B. Health and Safety Data Reporting Rule
EPA estimates the total reporting costs for establishing section
8(d) reporting requirements for the five chemicals will be $15,527.
This cost estimate is high because the Agency is uncertain about the
likely number of respondents to the rule. Although EPA has used the
best available data to make its economic projections, much of the
information is based upon the 1994 TSCA Inventory Update. Therefore,
EPA tends to overestimate rather than underestimate reporting burden.
The estimated reporting costs are broken down as follows:
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Initial corporate review $952
Site identification 1,427
File searches at site 3,217
Photocopying existing studies 1,256
Title listing 145
Managerial review for CBI 7,296
Reporting on newly-initiated studies 62
[[Page 55874]]
Submissions after initial reporting period 1,116
Additional costs 56
Total $15,527
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Reporting Burden (hours)
(a) Initial review: 2 hours/firm x 6 firms = 12 hrs
(b) Reporting: 39.33 hours/firm x 6 firms = 236 hrs
Total reporting burden hours = 248 hrs
V. Rulemaking Record
The following documents constitute the record for this rule (docket
control number OPPTS-82049). All of these documents are available to
the public in the TSCA Nonconfidential Information Center (NCIC),
formerly the TSCA Public Docket Office, from 12 noon to 4 p.m., Monday
through Friday, excluding legal holidays. The TSCA NCIC is located at
EPA Headquarters, Rm. NE-B607, 401 M St., SW., Washington, DC 20460.
1. This final rule.
2. The economic analysis for this rule.
3. The Thirty-eighth Report of the ITC.
VI. Regulatory Assessment Requirements
A. Executive Orders 12866 and 12898
The Office of Management (OMB) has exempted actions under TSCA
section 8(a) and 8(d) from the requirements of Executive Order l2866
(58 FR 51735, October 4, 1993). In addition, this action does not
require prior consultation with State officials as specified by
Executive Order 12875 (58 FR 58093, October 28, 1993) nor does it
involve specified considerations of environmental justice related
issues as required by Executive Order 12898 (59 FR 7629, February 16,
1994).
B. Unfunded Mandates Reform Act and Executive Order 12875
This action will not result in the annual expenditure of $100
million or more, for State, local or tribal governments, in the
aggregate or the private sector, and is not a Federal mandate, as
defined by the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4), nor does it uniquely affect small government in any way. As
such, the requirements of sections 202, 203, and 205 of Title II of the
UMRA do not apply to this action.
C. Regulatory Flexibility Act
EPA has determined that this action does not impose any adverse
economic impacts on small entities. Pursuant to 605(b) of the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.), this action will not
impose a significant economic impact on a substantial number of small
entities. Information relating to this determination is included in the
docket for rulemaking. Any comments regarding the economic impacts that
this action imposes on small entities should be submitted to the Agency
at the address listed under FOR FURTHER INFORMATION CONTACT.
D. Paperwork Reduction Act
In accordance with the Paperwork Reduction Act (PRA), 44 U.S.C.
3501 et seq., an agency may not conduct or sponsor, and a person is not
required to respond to an information collection request unless it
displays a currently valid control number assigned by OMB. The OMB
control number for EPA's regulations are listed in 40 CFR part 9 and 48
CFR chapter 15. The information collection requirements related to this
action have already been approved by OMB, under OMB control number
2070-0054 (EPA ICR No. 586) for PAIR reporting and OMB control number
2070-0004 (EPA ICR No. 575) for TSCA section 8(d) reporting. This
action does not impose any burdens requiring additional OMB approval.
The public reporting burden for this collection of information is
estimated to be 248 hours. Of that total, an estimated 12 hours are
spent performing an initial review of the rule. The remaining 236 hours
are associated with the actual reporting activities.
E. Submission to Congress and the General Accounting Office
This action in not a ``major rule'' as defined by 5 U.S.C. 804(2).
Pursuant to 5 U.S.C. 801(a)(1)(A), EPA submitted this action to the
U.S. Senate, the U.S. House of Representatives, and the Comptroller
General of the General Accounting Office prior to its publication in
today's Federal Register.
List of Subjects in 40 CFR Parts 712 and 716
Environmental protection, Chemicals, Hazardous substances, Health
and safety data, Reporting and recordkeeping requirements.
Dated: October 21, 1996.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR Chapter I is amended as follows:
PART 712--[AMENDED]
1. In part 712:
a. The authority citation for part 712 continues to read as
follows:
Authority: 15 U.S.C. 2607(a).
b. Section 712.30(e) is amended by revising the CAS number entry
for ``2744-41-6'' under the category ``Alkylphenols and Alkylphenol
Ethoxylates'' and alphabetically adding the new category ``Nonylphenol
ethoxylates'' to read as follows:
Sec. 712.30 Chemical lists and reporting periods.
* * * * *
(e) * * *
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CAS No. Substance Effective date Reporting date
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* * * * * * *
Alkylphenols and Alkylphenol Ethoxylates
* * * * * * *
62744-41-6 * * * * * * * * *
* * * * * * *
Nonylphenol ethoxylates
07311-27-5.............................. Ethanol, 2-[2-[2-[2-(p- 11/29/96 1/27/97
nonylphenoxy)ethoxy]ethoxy]et
hoxy]-
09016-45-9 and 20636-48-0............... Nonylphenol polyethylene 11/29/96 1/27/97
glycol ether
20427-84-3.............................. Ethanol, 2-[2-(p- 11/29/96 1/27/97
nonylphenoxy)ethoxy]-
[[Page 55875]]
26027-38-3 and 26064-02-8............... p-Nonylphenol polyethylene 11/29/96 1/27/97
glycol ether
26571-11-9.............................. Nonylphenol 11/29/96 1/27/97
octa(oxyethylene)ethanol
27176-93-8 and 27177-01-1............... Nonylphenoxydiglycol 11/29/96 1/27/97
27177-05-5.............................. Nonylphenol 11/29/96 1/27/97
hepta(oxyethylene)ethanol
27177-08-8.............................. Nonylphenolnona(oxyethylene) 11/29/96 1/27/97
ethanol
27986-36-3.............................. Nonylphenoxy ethanol 11/29/96 1/27/97
37205-87-1.............................. Poly(oxy-1,2-ethanediyl), 11/29/96 1/27/97
alpha-(isononylphenyl)-omega-
hydroxy
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PART 716--[AMENDED]
2. In part 716:
a. The authority citation for part 716 continues to read as
follows:
Authority: 15 U.S.C. 2607(d).
b. Section 716.120(d) is amended by revising the table heading for
the second column and alphabetically adding the new category
``Nonylphenol ethoxylates'' to read as follows:
Sec. 716.120 Substances and listed mixtures to which this subpart
applies.
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(d) * * *
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Category CAS number Special exemptions Effective date Sunset date
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* * * * * * *
Nonylphenol ethoxylates
alpha-(p-Nonylphenol)-omega- NA Sec. 716.20(b)(4) 11/29/96 11/29/06
hydroxypoly(oxyethylene). applies
Decaethylene glycol, 65455-72-3 Sec. 716.20(b)(4) 11/29/96 11/29/06
isononylphenyl ether. applies
Ethanol, 2-[2-(p- 20427-84-3 Sec. 716.20(b)(4) 11/29/96 11/29/06
nonylphenoxy)ethoxy]-. applies
Ethanol, 2-[2-[2-[2-(p- 07311-27-5 Sec. 716.20(b)(4) 11/29/96 11/29/06
nonylphenoxy) applies
ethoxy]ethoxy]ethoxy]-.
Nonoxynol-2................... NA Sec. 716.20(b)(4) 11/29/96 11/29/06
applies
Nonoxynol-3................... NA Sec. 716.20(b)(4) 11/29/96 11/29/06
applies
Nonoxynol-7................... NA Sec. 716.20(b)(4) 11/29/96 11/29/06
applies
Nonylphenol 27177-05-5 Sec. 716.20(b)(4) 11/29/96 11/29/06
hepta(oxyethylene)ethanol. applies
Nonylphenol 26571-11-9 Sec. 716.20(b)(4) 11/29/96 11/29/06
octa(oxyethylene)ethanol. applies
Nonylphenol polyethylene 09016-45-9, 20636- Sec. 716.20(b)(4) 11/29/96 11/29/06
glycol ether. 48-0, 26027-38-3, applies
26064-02-8, 27177-
01-1, 37205-87-1,
127087-87-0
Nonylphenol polyethylene 27177-08-8 Sec. 716.20(b)(4) 11/29/96 11/29/06
glycol ether. applies
Nonylphenolnona(oxyethylene) 27986-36-3 Sec. 716.20(b)(4) 11/29/96 11/29/06
ethanol. applies
Nonylphenoxy ethanol.......... 27176-93-8 Sec. 716.20(b)(4) 11/29/96 11/29/06
applies
Nonylphenoxydiglycol.......... 68412-54-4 Sec. 716.20(b)(4) 11/29/96 11/29/06
applies
Nonylphenoxypolyoxyethanol.... 152143-22-1, 26027- Sec. 716.20(b)(4) 11/29/96 11/29/06
38-3 applies
p-Nonylphenol polyethylene 27986-36-3, 37205- Sec. 716.20(b)(4) 11/29/96 11/29/06
glycol ether. 87-1, 98113-10-1 applies
Poly(oxy-1,2-ethanediyl), 37205-87-1 Sec. 716.20(b)(4) 11/29/96 11/29/06
alpha-(isononylphenyl)-omega- applies
hydroxy.
Poly(oxy-1,2-ethanediyl), 51938-25-1 Sec. 716.20(b)(4) 11/29/96 11/29/06
alpha-(2-nonylphenyl)-omega- applies
hydroxy.
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[FR Doc. 96-27588 Filed 10-28-96; 8:45 am]
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