[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Proposed Rules]
[Pages 45535-45539]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18508]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0163; FRL-9355-8]
RIN 2070-ZA16
Aldicarb; Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke certain tolerances for the
insecticide and nematocide aldicarb because, in follow-up to voluntary
requests from a registrant, EPA amended an aldicarb registration to
delete specific uses, leaving no aldicarb registrations for those uses.
Also, in accordance with current Agency practice, EPA is proposing to
revise the nomenclature of specific tolerances and make minor revisions
to the tolerance expression for aldicarb.
DATES: Comments must be received on or before October 1, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0163 by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection
Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Pesticide Re-evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone
[[Page 45536]]
number: (703) 308-8037; email address: nevola.joseph@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.A. 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 email. 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).
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.
C. What can I do if I wish the agency to maintain a tolerance that the
agency proposes to revoke?
This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(f), if
needed. The order would specify data needed and the timeframes for its
submission, and would require that within 90 days some person or
persons notify EPA that they will submit the data. If the data are not
submitted as required in the order, EPA will take appropriate action
under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.
II. Background
A. What action is the agency taking?
EPA is proposing to revoke certain tolerances for aldicarb because,
in follow-up to voluntary requests from a registrant, EPA amended an
aldicarb registration to delete specific uses, leaving no aldicarb
registrations for those uses, and therefore the tolerances are no
longer needed. Also, EPA is proposing these revocations in accordance
with a Memorandum of Agreement (MOA) of August 16, 2010 between EPA and
the registrant regarding the registration of a pesticide product
containing aldicarb, which is available in the docket of this proposed
rule.
It is EPA's general practice to propose revocation of those
tolerances for residues of pesticide active ingredients on crop uses
for which there are no active registrations under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), unless any person
submits comments on the proposal that indicate a need for the tolerance
to cover residues in or on imported commodities or legally treated
domestic commodities.
In the Federal Register of October 7, 2010 (75 FR 62129) (FRL-8848-
1), EPA published a notice of receipt of a request to voluntarily amend
an aldicarb registration to terminate uses, including use of aldicarb
in or on citrus commodities and potato.
In the Federal Register of May 9, 2012 (77 FR 27226) (FRL-9348-2)
and May 25, 2012 (77 FR 31355) (FRL-9351-4), EPA issued a cancellation
order and correction that announced its approval for the amendment of a
registration, including the termination of aldicarb uses in or on
citrus commodities and potato, effective immediately, which permitted
no use as of May 9, 2012. Tolerances are subject to the World Trade
Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures
Agreement, including its provisions in Annex B, paragraph 2 and WT/MIN
(01)/17, paragraph 5.2 (available at http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm and http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.htm) which provide a
reasonable interval (6 months) for producers in exporting members to
adapt to the requirements of the importing members. Therefore, the
effective date of a tolerance revocation should normally be delayed at
least 6 months after publication. Consequently, EPA is proposing to
revoke the tolerances for aldicarb in 40 CFR 180.269 on citrus, dried
pulp; grapefruit; lemon; lime; orange, sweet; and potato with an
effective date of revocation that is 6 months after the date of
publication of a final rule in the Federal Register.
Also, in accordance with current Agency practice, EPA is proposing
to
[[Page 45537]]
revise the commodity terminology in 40 CFR 180.269(a) for ``coffee,
bean, green'' to read ``coffee, green bean'' and ``soybean'' to read
``soybean, seed.'' In addition, in accordance with current Agency
practice to describe more clearly the measurement and scope or coverage
of the tolerances, including applicable metabolites and degradates, EPA
is proposing minor revisions to the tolerance expression for aldicarb
in 40 CFR 180.269(a) to read as set out in the proposed regulatory text
at the end of this document. The revisions do not substantively change
the tolerance or, in any way, modify the permissible level of residues
permitted by the tolerance.
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 of FFDCA, 21 U.S.C. 346a,
as amended by the Food Quality Protection Act (FQPA) of 1996, Public
Law 104-170, 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. Without a tolerance
or exemption, food containing pesticide residues is considered to be
unsafe and therefore ``adulterated'' under FFDCA section 402(a), 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.
EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. EPA has historically been
concerned that retention of tolerances that are not necessary to cover
residues in or on legally treated foods may encourage misuse of
pesticides within the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the United States
of food containing such pesticide residues. However, where there are no
imported commodities that require these import tolerances, the Agency
believes it is appropriate to revoke tolerances for unregistered
pesticides in order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under FFDCA section 408, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure to
the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential contributions to
such exposure from all tolerances. If the cumulative risk is such that
the tolerances in aggregate are not safe, then every one of these
tolerances is potentially vulnerable to revocation. Furthermore, if
unneeded tolerances are included in the aggregate and cumulative risk
assessments, the estimated exposure to the pesticide would be inflated.
Consequently, it may be more difficult for others to obtain needed
tolerances or to register needed new uses. To avoid potential trade
restrictions, the Agency is proposing to revoke tolerances for residues
on crops uses for which FIFRA registrations no longer exist, unless
someone expresses a need for such tolerances. Through this proposed
rule, the Agency is inviting individuals who need these import
tolerances to identify themselves and the tolerances that are needed to
cover imported commodities.
Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if the Agency
determines that additional information is reasonably required to
support the continuation of a tolerance, EPA may require that parties
interested in maintaining the tolerances provide the necessary
information. If the requisite information is not submitted, EPA may
issue an order revoking the tolerance at issue.
C. When do these actions become effective?
EPA is proposing that the actions herein become effective 6 months
after the date of publication of the final rule in the Federal
Register. EPA is proposing this effective date for these actions to
allow a reasonable interval for producers in exporting members of the
WTO's SPS Measures Agreement to adapt to the requirements of a final
rule. EPA believes that treated commodities will have sufficient time
for passage through the channels of trade. If you have comments
regarding existing stocks and whether the effective date allows
sufficient time for treated commodities to clear the channels of trade,
please submit comments as described under SUPPLEMENTARY INFORMATION.
Any commodities listed in this proposal treated with the pesticides
subject to this proposal, 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 unit, any residues of these pesticides
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.
III. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established an MRL for aldicarb in or on potato,
but has established MRLs for aldicarb, including an MRL in or on citrus
fruits at 0.2 milligrams/kilogram (mg/kg), which is covered by U.S.
tolerances for aldicarb at a higher level of 0.3 ppm on grapefruit,
lemon, lime, and orange,
[[Page 45538]]
sweet, and 0.6 ppm on citrus, dried pulp. These MRLs are different than
the tolerances established for aldicarb in the United States because of
differences in use patterns and/or good agricultural practices.
IV. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to revoke specific
tolerances established under FFDCA section 408. The Office of
Management and Budget (OMB) has exempted this type of action (e.g.,
tolerance revocation for which extraordinary circumstances do not
exist) 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, entitled ``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) (Pub. L. 104-4). Nor does
it require any special considerations as required by 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 other 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 revocations of
tolerances 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. This analysis was published on December 17, 1997 (62 FR
66020) (FRL-5753-1), and was 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 rule
will not have a significant negative economic impact on a substantial
number of small entities. In a memorandum dated May 25, 2001, EPA
determined that eight conditions must all be satisfied in order for an
import tolerance or tolerance exemption revocation to adversely affect
a significant number of small entity importers, and that there is a
negligible joint probability of all eight conditions holding
simultaneously with respect to any particular revocation. (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 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 FFDCA section 408(n)(4). 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'' (65 FR
67249, November 9, 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: July 18, 2012.
Steven Bradbury,
Director, 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. In Sec. 180.269 paragraph (a) is revised to read as follows:
Sec. 180.269 Aldicarb; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide and nematocide aldicarb, including its metabolites and
degradates, in or on the commodities in the table in this paragraph.
Compliance with the tolerance levels specified in this paragraph is to
be determined by measuring only the sum of aldicarb (2-methyl-2-
(methylthio)propanal O-((methylamino)carbonyl)oxime), and its
cholinesterase-inhibiting metabolites 2-methyl-2-
(methylsulfinyl)propanal O-((methylamino)carbonyl)oxime and 2-methyl-2-
(methylsulfonyl)propanal O-((methylamino)carbonyl)oxime, calculated as
the stoichiometric equivalent of aldicarb, in or on the commodity.
[[Page 45539]]
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Parts per
Commodity million
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Bean, dry, seed......................................... 0.1
Beet, sugar, roots...................................... 0.05
Beet, sugar, tops....................................... 1
Coffee, green bean...................................... 0.1
Cotton, undelinted seed................................. 0.1
Cotton, hulls........................................... 0.3
Peanut.................................................. 0.05
Pecan................................................... 0.5
Sorghum, grain, bran.................................... 0.5
Sorghum, grain, grain................................... 0.2
Sorghum, grain, stover.................................. 0.5
Soybean, seed........................................... 0.02
Sugarcane, cane......................................... 0.02
Sweet potato, roots..................................... 0.1
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[FR Doc. 2012-18508 Filed 7-31-12; 8:45 am]
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