Alpha-cypermethrin; Pesticide Tolerances, 73210-73213 [2014-28934]

Download as PDF 73210 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4). Executive Order 13132: Federalism This action also does not have Federalism implications because it does not 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely disapproves a state rule, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This rule is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks This rule also is not subject to Executive Order 13045 ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997), because it disapproves a state rule. rmajette on DSK2VPTVN1PROD with RULES Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use Because it is not a ‘‘significant regulatory action’’ under Executive Order 12866 or a ‘‘significant energy action,’’ this action is also not subject to Executive Order 13211, ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001). National Technology Transfer Advancement Act In reviewing state submissions, EPA’s role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), EPA has no authority to disapprove a state submission for failure to use VCS. It would thus be inconsistent with applicable law for VerDate Sep<11>2014 12:45 Dec 09, 2014 Jkt 235001 EPA, when it reviews a state submission, to use VCS in place of a state submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA lacks the discretionary authority to address environmental justice in this action. In reviewing SIP submissions, EPA’s role is to approve or disapprove state choices, based on the criteria of the CAA. Accordingly, this action merely disapproves certain state requirements for inclusion into the SIP under section 110 and subchapter I, part D of the CAA and will not in-and-of itself create any new requirements. Accordingly, it does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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 the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 Court of Appeals for the appropriate circuit by February 9, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Volatile organic compounds. Dated: November 25, 2014. Susan Hedman, Regional Administrator, Region 5. 40 CFR part 52 is amended as follows: PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: ■ Authority: 42 U.S.C. 7401 et seq. 2. Section 52.777 is amended by adding paragraph (ss), to read as follows: ■ § 52.777 Control strategy: photochemical oxidents (hydrocarbons). * * * * * (ss) Disapproval. EPA is disapproving Indiana’s December 5, 2012, ozone redesignation request for Lake and Porter Counties for the 2008 ozone standard. EPA is also disapproving Indiana’s motor vehicle emission budgets and ozone maintenance plan submitted with the redesignation request. [FR Doc. 2014–28799 Filed 12–9–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2014–0601; FRL–9918–88] Alpha-cypermethrin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes a tolerance for residues of alphacypermethrin in or on food SUMMARY: E:\FR\FM\10DER1.SGM 10DER1 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations commodities/feed commodities in food/ feed handling establishments. BASF on behalf of Whitmire Micro-Gen Research Laboratories requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation is effective December 10, 2014. Objections and requests for hearings must be received on or before February 9, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2014–0601, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information rmajette on DSK2VPTVN1PROD with RULES 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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). VerDate Sep<11>2014 12:45 Dec 09, 2014 Jkt 235001 73211 B. How can I get electronic access to other related information? II. Summary of Petitioned-For Tolerance 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://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. In the Federal Register of September 5, 2014 (79 FR 53009) (FRL–9914–98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3F8189) by BASF on behalf of Whitmire Micro-Gen Research Laboratories, 3568 Tree Court Industrial Blvd., St. Louis, MO 63122– 6682. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide alpha-cypermethrin, in or on food/feed handling establishments at 0.05 parts per million (ppm). That document referenced a summary of the petition prepared by BASF on behalf of Whitmire Micro-Gen Research Laboratories, the registrant, which is available in the docket, http:// www.regulations.gov. Comments were received on the notice of filing. EPA’s response to these comments is discussed in Unit IV.C. EPA has corrected the proposed commodity definition to read food commodities/feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments. 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–2014–0601 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 February 9, 2015. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2014–0601, 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 CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (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.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 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 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 FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 E:\FR\FM\10DER1.SGM 10DER1 rmajette on DSK2VPTVN1PROD with RULES 73212 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations aggregate exposure for alphacypermethrin including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with alpha-cypermethrin follows. Alpha-cypermethrin is an enriched isomer of the pyrethroid insecticide cypermethrin. In addition, zetacypermethrin is also an enriched isomer of cypermethrin. The toxicology database for the cypermethrins includes studies with cypermethrin and both of its enriched isomers, and is considered complete for the purpose of risk assessment. When considering alphacypermethrin the EPA also considers potential exposures from the other registered cypermethrins (i.e., cypermethrin and zeta-cypermethrin), since the 3 active ingredients are essentially the same active from the mammalian toxicity perspective. The recommended tolerance of 0.05 ppm associated with the food handling establishment use of alphacypermethrin is at the same level as the one currently established for zetacypermethrin. Based on the available alpha-cypermethrin residue data submitted for the food handling establishment use, this use will not result in alpha-cypermethrin residues higher than 0.05 ppm and is the same as the existing tolerance of 0.05 ppm established to support the food handling establishment uses for zetacypermethrin. The existing dietary and aggregate risk assessments already account for the impact of the existing zeta-cypermethrin food handling establishment use (i.e. 100% crop treated for all commodities without an existing tolerance). Therefore, the addition of the food handling establishment use for alphacypermethrin will have no impact on the dietary risk estimates, as they are already covered in the existing dietary and aggregate risk assessments. In the Federal Register of February 1, 2013 (78 FR 7266) (FRL–9376–1), the EPA published a final rule to establish tolerances for residues of the insecticide alpha-cypermethrin in or on alfalfa, hay at 15 ppm; citrus, dried pulp at 1.8 ppm; citrus fruit, Group 10 at 0.35 ppm; citrus, oil at 4.0 ppm; corn, grain; cottonseed; cucurbit vegetables, Group 9; dried shelled pea and bean, except soybean, subgroup 6C; edible podded legume vegetable, subgroup 6A; fruiting vegetables, Group 8; head and stem Brassica, subgroup 5A at 2.0 ppm; leafy vegetable, except Brassica, Group 4 at 10 ppm; pop-corn; rice, grain at 1.5 ppm; root and tuber vegetables, Group 1 at 0.1 ppm; sorghum, grain at 0.5 ppm; soybeans; succulent shelled pea and VerDate Sep<11>2014 12:45 Dec 09, 2014 Jkt 235001 bean, subgroup 6B; sugar beet, roots at 0.05 ppm; sugar beet, tops; sweet corn; tree nuts, Group 14; and wheat, grain at 0.2 ppm. Since the publication of the February 1, 2013 final rule, the toxicity profile of alpha-cypermethrin has not changed and since the food handling establishment use for alphacypermethrin will have no impact on the dietary or aggregate risk estimates, the risk assessments that supported the establishment of those alphacypermethrin tolerances published in the February 1, 2013 Federal Register remain valid. Therefore, EPA is relying on those risk assessments in order to support the new food handling tolerance for alpha-cypermethrin. For a detailed discussion of the aggregate risk assessments and determination of safety for the food handling tolerance, please refer to the February 1, 2013 Federal Register document and its supporting documents, available at http:// www.regulations.gov in Docket ID number EPA–HQ–OPP–2010–0234. EPA relies upon those supporting risk assessments and the findings made in the Federal Register document in support of this final rule. Based on the risk assessments and information described above, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to alpha-cypermethrin residues. Further information can also be found in the document, ‘‘Alpha-Cypermethrin— Human Health Risk Assessment for Two New Proposed Products for Use in Commercial/Residential Settings’’ in docket ID number EPA–HQ–OPP–2014– 0601. IV. Other Considerations A. Analytical Enforcement Methodology Adequate tolerance-enforcement methods are available in Pesticide Analytical Manual (PAM) Volume II for determining residues of cypermethrin, zeta-cypermethrin and alphacypermethrin in plant (Method I) and livestock (Method II) commodities. Both methods are gas chromatographic methods with electron-capture detection (GC/ECD), and have undergone successful Agency petition method validations (PMVs). Method I has a limit of detection (LOD) of 0.01 ppm, and Method II has LODs of 0.005 ppm in milk, and 0.01 ppm in livestock tissues. These methods are not stereospecific; thus no distinction is made between residues of cypermethrin (all eight stereoisomers), zeta-cypermethrin PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 (enriched in four isomers) and alphacypermethrin (two isomers). The method 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: residuemethods@ epa.gov. 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 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. There is no Codex MRL for residues of alpha-cypermethrin in or on food commodities/feed commodities (other than those covered by a higher tolerance as a results of use on growing crops) in food/feed handling establishments. C. Response to Comments The EPA received 4 comments in response to this Notice of Filing. Two commenters were opposed to increasing the amount of pesticides being used and did not approve of the proposal. The Agency understands the commenter’s concerns and recognizes that some individuals believe that certain pesticide chemicals should not be permitted in our food. However, the existing legal framework provided by section 408 of the FFDCA states that tolerances may be set when EPA determines that aggregate exposure to that pesticide is safe, i.e., that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. When making this determination, EPA considers the toxicity, including any potential carcinogenicity, of the pesticide and all anticipated dietary exposures and all other exposures for which there is reliable information. EPA also gives special consideration to the potential susceptibility and exposures of infants and children to the pesticide E:\FR\FM\10DER1.SGM 10DER1 73213 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations chemical residue when making this determination. For alpha-cypermethrin, the Agency has considered all the available data, including all available data concerning the potential for carcinogenicity and concluded after conducting a risk assessment, that there is a reasonable certainty that no harm will result from aggregate human exposure to alpha-cypermethrin. Two additional commenters raised concerns regarding exposure to bees. However, the proposed use is for pesticide applications to be made indoors to food/feed handling establishments and therefore, there should be no exposure to bees from the proposed application. V. Conclusion Therefore, the tolerance is established for residues of alpha-cypermethrin, in or on food commodities/feed commodities (other than those covered by a higher tolerance as a results of use on growing crops) in food/feed handling establishments at 0.05 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 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) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action 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: November 26, 2014. Susan Lewis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is 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 § 180.418, revise the section heading and add alphabetically the following commodity to the table in paragraph (a)(3) to read as follows: ■ § 180.418 Cypermethrin and isomers alpha-cypermethrin and zeta-cypermethrin; tolerances for residues. (a) * * * (3) * * * Parts per million Commodity * * * * * * Food commodities/feed commodities (other than those covered by a higher tolerance as a results of use on growing crops) in food/feed handling establishments .................................................................................................................................................. rmajette on DSK2VPTVN1PROD with RULES * * * * * * * * * * * [FR Doc. 2014–28934 Filed 12–9–14; 8:45 am] BILLING CODE 6560–50–P VerDate Sep<11>2014 16:41 Dec 09, 2014 Jkt 235001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\10DER1.SGM 10DER1 * 0.05 *

Agencies

[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Rules and Regulations]
[Pages 73210-73213]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28934]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0601; FRL-9918-88]


Alpha-cypermethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for residues of alpha-
cypermethrin in or on food

[[Page 73211]]

commodities/feed commodities in food/feed handling establishments. BASF 
on behalf of Whitmire Micro-Gen Research Laboratories requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 10, 2014. Objections and 
requests for hearings must be received on or before February 9, 2015, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0601, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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://www.ecfr.gov/cgi-bin/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-2014-0601 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 
February 9, 2015. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0601, 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 CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (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.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 5, 2014 (79 FR 53009) (FRL-
9914-98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3F8189) by BASF on behalf of Whitmire Micro-Gen Research Laboratories, 
3568 Tree Court Industrial Blvd., St. Louis, MO 63122-6682. The 
petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the insecticide alpha-cypermethrin, in or on 
food/feed handling establishments at 0.05 parts per million (ppm). That 
document referenced a summary of the petition prepared by BASF on 
behalf of Whitmire Micro-Gen Research Laboratories, the registrant, 
which is available in the docket, http://www.regulations.gov. Comments 
were received on the notice of filing. EPA's response to these comments 
is discussed in Unit IV.C.
    EPA has corrected the proposed commodity definition to read food 
commodities/feed commodities (other than those covered by a higher 
tolerance as a result of use on growing crops) in food/feed handling 
establishments.

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 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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

[[Page 73212]]

aggregate exposure for alpha-cypermethrin including exposure resulting 
from the tolerances established by this action. EPA's assessment of 
exposures and risks associated with alpha-cypermethrin follows.
    Alpha-cypermethrin is an enriched isomer of the pyrethroid 
insecticide cypermethrin. In addition, zeta-cypermethrin is also an 
enriched isomer of cypermethrin. The toxicology database for the 
cypermethrins includes studies with cypermethrin and both of its 
enriched isomers, and is considered complete for the purpose of risk 
assessment. When considering alpha-cypermethrin the EPA also considers 
potential exposures from the other registered cypermethrins (i.e., 
cypermethrin and zeta-cypermethrin), since the 3 active ingredients are 
essentially the same active from the mammalian toxicity perspective. 
The recommended tolerance of 0.05 ppm associated with the food handling 
establishment use of alpha-cypermethrin is at the same level as the one 
currently established for zeta-cypermethrin. Based on the available 
alpha-cypermethrin residue data submitted for the food handling 
establishment use, this use will not result in alpha-cypermethrin 
residues higher than 0.05 ppm and is the same as the existing tolerance 
of 0.05 ppm established to support the food handling establishment uses 
for zeta-cypermethrin. The existing dietary and aggregate risk 
assessments already account for the impact of the existing zeta-
cypermethrin food handling establishment use (i.e. 100% crop treated 
for all commodities without an existing tolerance). Therefore, the 
addition of the food handling establishment use for alpha-cypermethrin 
will have no impact on the dietary risk estimates, as they are already 
covered in the existing dietary and aggregate risk assessments.
    In the Federal Register of February 1, 2013 (78 FR 7266) (FRL-9376-
1), the EPA published a final rule to establish tolerances for residues 
of the insecticide alpha-cypermethrin in or on alfalfa, hay at 15 ppm; 
citrus, dried pulp at 1.8 ppm; citrus fruit, Group 10 at 0.35 ppm; 
citrus, oil at 4.0 ppm; corn, grain; cottonseed; cucurbit vegetables, 
Group 9; dried shelled pea and bean, except soybean, subgroup 6C; 
edible podded legume vegetable, subgroup 6A; fruiting vegetables, Group 
8; head and stem Brassica, subgroup 5A at 2.0 ppm; leafy vegetable, 
except Brassica, Group 4 at 10 ppm; pop-corn; rice, grain at 1.5 ppm; 
root and tuber vegetables, Group 1 at 0.1 ppm; sorghum, grain at 0.5 
ppm; soybeans; succulent shelled pea and bean, subgroup 6B; sugar beet, 
roots at 0.05 ppm; sugar beet, tops; sweet corn; tree nuts, Group 14; 
and wheat, grain at 0.2 ppm. Since the publication of the February 1, 
2013 final rule, the toxicity profile of alpha-cypermethrin has not 
changed and since the food handling establishment use for alpha-
cypermethrin will have no impact on the dietary or aggregate risk 
estimates, the risk assessments that supported the establishment of 
those alpha-cypermethrin tolerances published in the February 1, 2013 
Federal Register remain valid. Therefore, EPA is relying on those risk 
assessments in order to support the new food handling tolerance for 
alpha-cypermethrin.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for the food handling tolerance, please refer 
to the February 1, 2013 Federal Register document and its supporting 
documents, available at http://www.regulations.gov in Docket ID number 
EPA-HQ-OPP-2010-0234. EPA relies upon those supporting risk assessments 
and the findings made in the Federal Register document in support of 
this final rule.
    Based on the risk assessments and information described above, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to alpha-cypermethrin residues. Further information can also 
be found in the document, ``Alpha-Cypermethrin--Human Health Risk 
Assessment for Two New Proposed Products for Use in Commercial/
Residential Settings'' in docket ID number EPA-HQ-OPP-2014-0601.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance-enforcement methods are available in Pesticide 
Analytical Manual (PAM) Volume II for determining residues of 
cypermethrin, zeta-cypermethrin and alpha-cypermethrin in plant (Method 
I) and livestock (Method II) commodities. Both methods are gas 
chromatographic methods with electron-capture detection (GC/ECD), and 
have undergone successful Agency petition method validations (PMVs). 
Method I has a limit of detection (LOD) of 0.01 ppm, and Method II has 
LODs of 0.005 ppm in milk, and 0.01 ppm in livestock tissues. These 
methods are not stereospecific; thus no distinction is made between 
residues of cypermethrin (all eight stereoisomers), zeta-cypermethrin 
(enriched in four isomers) and alpha-cypermethrin (two isomers).
    The method 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: 
residuemethods@epa.gov.

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 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.
    There is no Codex MRL for residues of alpha-cypermethrin in or on 
food commodities/feed commodities (other than those covered by a higher 
tolerance as a results of use on growing crops) in food/feed handling 
establishments.

C. Response to Comments

    The EPA received 4 comments in response to this Notice of Filing. 
Two commenters were opposed to increasing the amount of pesticides 
being used and did not approve of the proposal. The Agency understands 
the commenter's concerns and recognizes that some individuals believe 
that certain pesticide chemicals should not be permitted in our food. 
However, the existing legal framework provided by section 408 of the 
FFDCA states that tolerances may be set when EPA determines that 
aggregate exposure to that pesticide is safe, i.e., that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue. When making this determination, EPA 
considers the toxicity, including any potential carcinogenicity, of the 
pesticide and all anticipated dietary exposures and all other exposures 
for which there is reliable information. EPA also gives special 
consideration to the potential susceptibility and exposures of infants 
and children to the pesticide

[[Page 73213]]

chemical residue when making this determination. For alpha-
cypermethrin, the Agency has considered all the available data, 
including all available data concerning the potential for 
carcinogenicity and concluded after conducting a risk assessment, that 
there is a reasonable certainty that no harm will result from aggregate 
human exposure to alpha-cypermethrin.
    Two additional commenters raised concerns regarding exposure to 
bees. However, the proposed use is for pesticide applications to be 
made indoors to food/feed handling establishments and therefore, there 
should be no exposure to bees from the proposed application.

V. Conclusion

    Therefore, the tolerance is established for residues of alpha-
cypermethrin, in or on food commodities/feed commodities (other than 
those covered by a higher tolerance as a results of use on growing 
crops) in food/feed handling establishments at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: November 26, 2014.
Susan Lewis,
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. In Sec.  180.418, revise the section heading and add alphabetically 
the following commodity to the table in paragraph (a)(3) to read as 
follows:


Sec.  180.418  Cypermethrin and isomers alpha-cypermethrin and zeta-
cypermethrin; tolerances for residues.

    (a) * * *
    (3) * * *

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Food commodities/feed commodities (other than those                0.05
 covered by a higher tolerance as a results of use on
 growing crops) in food/feed handling establishments...
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-28934 Filed 12-9-14; 8:45 am]
BILLING CODE 6560-50-P