Document ID: EPA-HQ-OPP-2005-0163-0316
Agency: epa
Document Type: Proposed Rule
Title: Tolerance Actions: Aldicarb
Posted Date: 2012-08-01T04:00Z

[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
------------------------------------------------------------------------
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]
BILLING CODE 6560-50-P