Mono- and bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates where
the alkyl group is even numbered and in the C6-C12 range; Proposed
Revocation of Pesticide Inert Ingredient Tolerance Exemption
[Federal Register: April 19, 2006 (Volume 71, Number 75)]
[Proposed Rules]
[Page 20048-20052]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap06-33]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0253; FRL-8058-3]
Mono- and bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates where
the alkyl group is even numbered and in the C6-C12 range; Proposed
Revocation of Pesticide Inert Ingredient Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document proposes to revoke, under the Federal Food,
Drug, and Cosmetic Act (FFDCA) section 408(e)(1), the existing
exemption from the requirement of a tolerance for residues of the inert
ingredient mono- and bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates
where the alkyl group is
[[Page 20049]]
even numbered and in the C6-C12 range under 40 CFR 180.920 because EPA
cannot determine that it meets the safety requirements of FFDCA section
408(b)(2). The regulatory action proposed in this document contributes
toward the Agency's tolerance reassessment requirements under FFDCA
section 408(q), as amended by the Food Quality Protection Act (FQPA) of
1996. By law, EPA is required by August 2006 to reassess the tolerances
that were in existence on August 2, 1996. The regulatory action
proposed in this document pertains to the proposed revocation of 1
tolerance which would be counted as tolerance reassessment toward the
August 2006 review deadline.
DATES: Comments must be received on or before June 19, 2006. Revocation
would be effective 18 months after publication of the final rule.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0253, by one of the following methods:
? Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
? Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502C), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
? Hand Delivery: OPP Regulatory Public Docket, Environmental
Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. Deliveries are only accepted during the Docket's normal
hours of operation (8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays). Special arrangements should be made for
deliveries of boxed information. The Docket telephone number is (703)
305-5805.
? Important Note: OPP will be moving to a new location the
first week of May 2006. As a result, from Friday, April 28 to Friday,
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any
deliveries at the Crystal Mall #2 address and this facility
will be closed to the public. Beginning on May 8, 2006, the OPP
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA 22202. The mail code for the mailing
address will change to (7502P), but will otherwise remain the same. The
OPP Regulatory Public Docket telephone number and hours of operation
will remain the same after the move.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0253. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket
index. Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov,
or, if only available in hard copy, at the OPP Regulatory Public Docket at
the location identified under ``Delivery'' and ``Important Note.'' The
hours of operation for this docket facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone
number: (703) 306-0404; e-mail address: angulo.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
? Crop production (NAICS code 111)
? Animal production (NAICS code 112)
? Food manufacturing (NAICS code 311)
? Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II. If you have
any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
[[Page 20050]]
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived
at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background and Statutory Findings
A. What Action is the Agency Taking?
EPA is now in the process of reassessing all inert ingredient
exemptions from the requirement of a tolerance (tolerance exemptions)
established prior to August 2, 1996, as required by the Federal Food,
Drug, and Cosmetic Act (FFDCA) section 408(q). Under section 408(q),
tolerance reassessment may lead to regulatory action under section
408(e)(1). When taking action under section 408(e)(1), EPA may leave a
tolerance exemption in effect only if the Agency determines that the
tolerance exemption is safe.
The existing tolerance exemption under 40 CFR 180.920 for the inert
ingredient mono- and bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates
where the alkyl group is even numbered and in the C6-C12 range allows
for its use as a defoaming agent at not more than 0.5% of pesticide
formulation. Due to potential risk from use of these perfluoroalkyl
phosphates EPA is proposing to revoke the tolerance exemption at
180.920 under FFDCA section 408(e)(1) because the Agency is unable to
determine that the tolerance exemption meets the safety requirements of
FFDCA section 408(c)(2).
It has been demonstrated that compounds containing perfluoroalkyl
chains (PFAC), such as the perfluoroalkyl phosphates described in Sec.
180.920 will undergo degradation (chemical, microbial, or photolytic)
of the non-fluorinated portion of the molecule leaving the remaining
perfluorinated acid untouched (Ref.: A. Remde and R. Debus,
Biodegradability of Fluorinated Surfactants Under Aerobic and Anaerobic
Conditions, Chemosphere, 32(8), 1563-1574 (1996)). Among the
degradation compounds that can be produced is perfluorooctanoic acid
(PFOA). Further degradation of the perfluoroalkyl residual compounds is
extremely difficult.
EPA has received significant and troubling data on PFOA. Biological
sampling recently revealed the presence of PFOA in fish, birds, and
mammals, including humans, across the United States and in other
countries. The widespread distribution of the chemical suggests that
PFOA may bioaccumulate. PFOA has shown liver, developmental, and
reproductive toxicity at very low dose levels in exposed laboratory
animals (Ref.: (AR226-1093) Seed, Jennifer. Hazard Assessment of
Perfluorooctanoic Acid and Its Salts-USEPA/EPA/RAD. Washington, DC.
November 4, 2002.).
EPA issued a draft preliminary risk assessment on PFOA in April
2003, and simultaneously initiated an enforceable consent agreement
(ECA) process under section 4 of the Toxic Substances Control Act
(TSCA), 15 U.S.C. 2603, and 40 CFR part 790 to develop information on
the sources of PFOA in the environment and the pathways leading to
exposure in order to reduce uncertainties in the assessment. (68 FR
18626, April 16, 2003 (FRL-7303-8)). The ECA process and PFOA risk
assessment activity are still underway.
On January 25, 2006, EPA invited fluoropolymer and telomer
manufacturers doing business in the United States to participate in a
global stewardship program on PFOA and related chemicals. Participating
companies will commit to reducing PFOA, PFOA precursors (meaning
chemicals that can degrade to PFOA), and higher homologues from
facility emissions and product content by 95 percent no later than
2010, and to work toward eliminating these chemicals from emissions and
product content no later than 2015. More information on the global
stewardship program, the enforceable consent agreement process, the
PFOA risk assessment, and PFOA in general is found at:
http://www.epa.gov/oppt/pfoa.
On March 7, 2006, EPA published a proposal to amend the polymer
exemption rule to exclude certain perfluorinated polymers (71 FR 11484,
March 7, 2006, FRL-7735-5). EPA believes this change to the current
regulation is necessary because, based on recent information, including
the data on PFOA and the potential for these perfluorinated polymers to
degrade to PFOA, EPA can no longer conclude that these polymers will
not present an unreasonable risk to human health or the environment,
which is the determination necessary to support an exemption under
section 5(h)(4) of TSCA, 15 U.S.C. 2604(h)(4), such as the Polymer
Exemption Rule.
Because (1) PFOA and other PFACs are produced from the degradation
of the perfluoroalkyl phosphates described in Sec. 180.920 and (2) the
potential risks to human health and the environment associated with
PFOA, EPA is unable to determine that there is a reasonable certainty
that no harm will result from exposure residues of the perfluoroalkyl
phosphates described in Sec. 180.920. Therefore, the tolerance
exemption does not meet requirements of FFDCA section 408(c)(2), and
EPA is proposing to revoke this tolerance exemption in Sec. 180.920 in
accordance with FFDCA section 408(e)(1).
B. What is the Agency's Authority for Taking this Action?
A tolerance represents the maximum level for residues of pesticide
chemicals legally allowed in or on raw agricultural commodities and
processed foods. Section 408(e) of FFDCA, 21 U.S.C. 346a(e) authorizes
the establishment of tolerances, exemptions from tolerance
requirements, modifications in tolerances, and revocation of tolerances
for residues of pesticide chemicals in or on raw agricultural
commodities and processed foods. Pursuant to section 408(c)(2), in
action under section 408(e)(1), EPA may leave in effect an exemption
from the requirement for a tolerance only if the Agency determines that
the exemption is safe. Without a tolerance or exemption, food
containing pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of the FFDCA, 21 U.S.C. 342(a).
Such food may not be distributed in interstate commerce (21 U.S.C.
331(a)). For a food-use pesticide to be sold and distributed, the
pesticide must not only have appropriate tolerances under the FFDCA,
but also must be registered under FIFRA (7 U.S.C. 136 et seq.). Food-
use pesticides not registered in the United States must have tolerances
in order for commodities treated with those pesticides to be imported
into the United States.
C. When do These Actions Become Effective?
EPA is proposing to revoke the current tolerance exemption Mono-
and bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates where the alkyl
group is even numbered and in the C6-C12 range in 40 CFR 180.920
effective 18 months
[[Page 20051]]
after the date of publication of the final rule in the Federal
Register. Any commodities listed in this proposal treated with
pesticide products containing the inert ingredient, and in the channels
of trade following the tolerance revocations, shall be subject to FFDCA
section 408(1)(5), as established by FQPA. Under this section, any
residues of these pesticide chemicals in or on such food shall not
render the food adulterated so long as it is shown to the satisfaction
of the Food and Drug Administration that:
1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA,
and
2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates when the
pesticide was applied to such food.
D. What Is the Contribution to Tolerance Reassessment?
By law, EPA is required by August 2006 to reassess the tolerances
and exemptions from tolerances that were in existence on August 2,
1996. This document proposes to revoke one inert ingredient tolerance
exemption, which will be counted in a final rule as a tolerance
reassessment toward the August 2006 review deadline under FFDCA section
408(q), as amended by FQPA in 1996.
III. Are the Proposed Actions Consistent with International Obligations?
The tolerance revocation in this proposal is not discriminatory and
is designed to ensure that both domestically-produced and imported
foods meet the food safety standard established by the FFDCA. The same
food safety standards apply to domestically produced and imported foods.
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. It is EPA's policy to
harmonize U.S. tolerances with Codex MRLs to the extent possible,
provided that the MRLs achieve the level of protection required under
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual Reregistration Eligibility
Decision documents. EPA has developed guidance concerning submissions
for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3).
This guidance will be made available to interested persons. Electronic
copies are available on the internet at http://www.epa.gov. On the Home
Page select ``Laws, Regulations, and Dockets,'' then select
``Regulations and Proposed Rules'' and then look up the entry for this
document under ``Federal Register--Environmental Documents.'' You can
also go directly to the Federal Register listings at
http://www.epa.gov/fedrgstr.
IV. Statutory and Executive Order Reviews
This proposed rule establishes a tolerance under section 408(d) of
the FFDCA in response to a petition submitted to the Agency. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency previously assessed whether establishment of
tolerances, exemptions from tolerances, raising of tolerance levels,
expansion of exemptions, or revocations might significantly impact a
substantial number of small entities and concluded that, as a general
matter, these actions do not impose a significant economic impact on a
substantial number of small entities. These analyses for tolerance
establishments and modifications, and for tolerance revocations were
published on May 4, 1981 (46 FR 24950) and on December 17, 1997
(62 FR 66020), respectively, and were provided to the Chief Counsel for
Advocacy of the Small Business Administration. Taking into account this
analysis, and available information concerning the pesticides listed in
this proposed rule, the Agency hereby certifies that this proposed
action will not have a significant negative economic impact on a
substantial number of small entities. Specifically, the Agency has
concluded in a memorandum dated May 25, 2001 that for import tolerance
revocation there is a negligible joint probability of certain defined
conditions holding simultaneously which would indicate an RFA/SBREFA
concern and require more analysis. (This Agency document is available
in the docket of this proposed rule). Furthermore, for the pesticide
named in this proposed rule, the Agency knows of no extraordinary
circumstances that exist as to the present proposal that would change
the EPA's previous analysis. Any comments about the Agency's
determination should be submitted to the EPA along with comments on the
proposal, and will be addressed prior to issuing a final rule.
In addition, the Agency has determined that this action will not
have a substantial direct effect on 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, as
specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). Executive Order 13132 requires EPA to develop an
accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
[[Page 20052]]
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (59 FR 22951,
November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 12, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.920 is amended by revising the entry for Mono- and
bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates where the alkyl group
is even numbered and in the C6-C12 range in the table as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * *
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Mono- and bis-(1H, 1H, 2H, 2H-perfluoroalkyl) Expires [insert date 18 months Defoaming agent.
phosphates where the alkyl group is even after the date of publication of
numbered and in the C6-C12 range the final rule in the Federal
Register]
Not more than 0.5% of
pesticide formulation.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[FR Doc. E6-5883 Filed 4-18-06; 8:45 am]
BILLING CODE 6560-50-S