[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Rules and Regulations]
[Pages 8746-8749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3157]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0578; FRL-9336-7]


Indoxacarb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
indoxacarb in or on egg, poultry fat, poultry meat, and poultry meat 
byproducts. E.I. du Pont de Nemours and Company requested these

[[Page 8747]]

tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 15, 2012. Objections and 
requests for hearings must be received on or before April 16, 2012, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2011-0578. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (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 in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Julie Chao, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Avenue NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8735; email address: [email protected].

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 those 
engaged in the following activities:
     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 to 
provide 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. 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. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2011-0578 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 16, 2012. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0578, 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 (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1F7873) by E.I. du Pont de Nemours and Company, 1007 Market Street, 
Wilmington, DE 19898-0001. The petition requested that 40 CFR 180.564 
be amended by establishing tolerances for residues of the insecticide 
indoxacarb, (S)-methyl-7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)-phenyl]amino]carbonyl]indeno[1,2e] 
[1,3,4]oxadiazine-4a(3H)-carboxylate, its R-enantiomer, (R)-methyl 7-
chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy) 
phenyl]amino]carbonyl]indeno [1,2-e] [1,3,4] oxadiazine-4a(3H)-
carboxylate, and the metabolites: IN-JT333: Methyl 7-chloro-2,5-
dihydro-2-[[[4-(trifluoromethoxy)phenyl]-amino]carbonyl]indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate; IN-KT319: (E)-methyl 5-chloro-
2,3,-dihydro-2-hydroxy-1- [[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]-carbonyl]hydrazono]-1H-indene-2-
carboxylate; IN-JU873: Methyl 5-chloro-2,3-dihydro-2-hydroxy-1-[[[[4-
(triflurormethoxy)-phenyl]amino]carbonyl]hydrazono]-1H-indene-2-
carboxylate; IN-KG433: Methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-
[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]carbonyl]-
hydrazono]-1H-indene-2-carboxylate; and IN-KB687: Methyl [4-
(trifluoromethoxy)phenyl]carbamate, in or on egg at 0.2 parts per 
million (ppm); poultry, fat at 0.2 ppm; poultry, meat at 0.06 ppm; and 
poultry, meat byproducts at 0.06 ppm. That notice referenced a summary 
of the petition prepared by E.I. du Pont de Nemours and Company, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical

[[Page 8748]]

residue in or on a food) only if EPA determines that the tolerance is 
``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean 
that ``there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information.'' This includes exposure through drinking 
water and in residential settings, but does not include occupational 
exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for indoxacarb including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with indoxacarb 
follows.
    In the Federal Register of July 10, 2009 (74 FR 33159) (FRL-8424-
9), EPA published a Final Rule establishing tolerances for residues of 
the insecticide indoxacarb in or on various beet commodities and the 
bushberry subgroup 13-07B. These tolerances had been requested in PP 
8E7324. When the Agency conducted the risk assessment in support of the 
July 10, 2009 tolerance action, it also considered residues of 
indoxacarb, its R-enantiomer, and its metabolites IN-JT333, IN-KT319, 
IN-JU873, IN-KG433, and IN-KB687 in or on egg; poultry, fat; poultry, 
meat; and poultry, meat byproducts. These tolerances were evaluated by 
EPA based on the results of a previously submitted and accepted poultry 
feeding study; however, because of a deficiency related to a poultry 
storage stability study, EPA was not able to establish tolerances on 
egg and poultry commodities. Since that time, the registrant has 
provided an acceptable poultry storage stability study, which supports 
the establishment of tolerances on egg; poultry, fat; poultry, meat; 
and poultry, meat byproducts. Detailed considerations regarding EPA's 
resolution of these data deficiencies are discussed in the document, 
``Indoxacarb. Petition for the Establishment of Permanent Tolerances on 
Poultry Commodities and Submission of Storage Stability Data for 
Poultry Commodities in Response to HED Memorandum DP297936, 9/
22/04,'' which is available at http://www.regulations.gov in docket 
EPA-HQ-OPP-2011-0578.
    Since EPA considered the additional uses proposed by PP 1F7873 in 
its most recent risk assessments, establishing tolerances on these 
commodities will not change the estimated aggregate risks resulting 
from use of indoxacarb, as discussed in the Federal Register of July 
10, 2009 (74 FR 33159) (FRL-8424-9). In that action, EPA concluded that 
there is a reasonable certainty that no harm will result to the general 
population, and to infants and children from aggregate exposure to 
indoxacarb residues. Refer to the July 10, 2009 (74 FR 33159) (FRL-
8424-9) Federal Register document, available at http://www.regulations.gov in docket EPA-HQ-OPP-2008-0271, for a detailed 
discussion of the aggregate risk assessments and determination of 
safety. The findings in that action apply with equal force here and are 
adopted by EPA in this rulemaking. Accordingly, EPA concludes that 
aggregate exposure to indoxacarb will be safe for the general 
population, including infants and children.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography (HPLC)/column switching/ultraviolet (UV) method AMR 
2712-93 with confirmation/specificity provided by gas chromatography 
(GC)/mass-selective detector method AMR 3493-95, Supplement No. 4) is 
available to enforce the tolerance expression.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. 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 U.N. 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 established MRLs for indoxacarb in or on eggs at 0.02 
mg/kg; poultry meat at 0.01 mg/kg; and poultry, edible offal at 0.01 
mg/kg. These MRLs are lower than the poultry tolerance levels 
determined appropriate for indoxacarb in the United States. The U.S. 
residue definition for poultry commodities includes indoxacarb, its R-
enantiomer, and five metabolites, whereas the Codex residue definition 
includes only indoxacarb and its R-enantiomer. Because the Codex 
residue definition and evaluation procedures for livestock commodities 
differ from those of the United States harmonization of U.S. tolerances 
with Codex MRLs is not possible for poultry commodities.

V. Conclusion

    Therefore, tolerances are established for residues of indoxacarb, 
(S)-methyl-7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)-phenyl]amino]carbonyl]indeno[1,2e] 
[1,3,4]oxadiazine-4a(3H)-carboxylate; its R-enantiomer (R)-methyl 7-
chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy) 
phenyl]amino]carbonyl]indeno [1,2-e] [1,3,4] oxadiazine-4a(3H)-
carboxylate; and the metabolites: IN-JT333: Methyl 7-chloro-2,5-
dihydro-2-[[[4-(trifluoromethoxy)phenyl]-amino]carbonyl]indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate; IN-KT319: (E)-methyl 5-chloro-
2,3,-dihydro-2-hydroxy-1-[[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]-carbonyl]hydrazono]-1H-indene-2-
carboxylate; IN-JU873: Methyl 5-chloro-2,3-dihydro-2-hydroxy-1-[[[[4-
(triflurormethoxy)-phenyl]amino]carbonyl]hydrazono]-1H-indene-2-
carboxylate; IN-KG433: Methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-
[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]carbonyl]-
hydrazono]-1H-indene-2-carboxylate; and IN-KB687: Methyl [4-
(trifluoromethoxy)phenyl]carbamate, in or on egg at 0.20 parts per 
million (ppm); poultry, fat at 0.20 ppm; poultry, meat at 0.06 ppm; and 
poultry, meat byproducts at 0.06 ppm.

[[Page 8749]]

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
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 final rule has been 
exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 1, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.564 is amended by adding the designation ``(1)'' after 
the heading ``General'' in paragraph (a), and by adding paragraph 
(a)(2) to read as follows:


Sec.  180.564  Indoxacarb; tolerances for residues.

    (a) General. (1) * * *
    (2) Tolerances are established for residues of indoxacarb, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only the sum of indoxacarb, (S)-
methyl-7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)-
phenyl]amino]carbonyl]indeno[1,2e] [1,3,4]oxadiazine-4a(3H)-
carboxylate, its R-enantiomer, (R)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxycarbonyl)[4-(trifluoromethoxy) phenyl]amino]carbonyl]indeno 
[1,2-e] [1,3,4] oxadiazine-4a(3H)-carboxylate, and the metabolites: IN-
JT333, methyl 7-chloro-2,5-dihydro-2-[[[4-(trifluoromethoxy)phenyl]-
amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate; IN-
KT319, (E)-methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-
[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]-
carbonyl]hydrazono]-1H-indene-2-carboxylate; IN-JU873, methyl 5-chloro-
2,3-dihydro-2-hydroxy-1-[[[[4-(triflurormethoxy)-
phenyl]amino]carbonyl]hydrazono]-1H-indene-2-carboxylate; IN-KG433, 
methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-[[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]-hydrazono]-1H-indene-2-
carboxylate; and IN-KB687, methyl [4-
(trifluoromethoxy)phenyl]carbamate, calculated as the stoichiometric 
equivalent of indoxacarb in the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Egg.........................................................        0.20
Poultry, fat................................................        0.20
Poultry, meat...............................................        0.06
Poultry, meat byproducts....................................        0.06
------------------------------------------------------------------------

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[FR Doc. 2012-3157 Filed 2-14-12; 8:45 am]
BILLING CODE 6560-50-P