Alpha-cypermethrin; Proposed Pesticide Tolerance, 60940-60943 [2017-27806]

Download as PDF 60940 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 60 [EPA–HQ–OAR–2017–0638; FRL–9972–45– OAR] Denial of Petition To List Concentrated Animal Feeding Operations Under Clean Air Act Environmental Protection Agency (EPA). ACTION: Notice of final action denying petition for rulemaking. AGENCY: The U.S. Environmental Protection Agency (EPA) is providing notice that it has responded to a petition for rulemaking titled ‘‘Petition To List Concentrated Animal Feeding Operations under Clean Air Act Section 111(b)(1)(A) of the Clean Air Act, and To Promulgate Standards of Performance Under Clean Air Act Sections 111(b)(1)(B) and 111(d).’’ The Administrator denied the request in a separate letter to the petitioners. The letter, which provides a full explanation of the agency’s rationale for the denial, is in the docket for this action. DATES: This action is effective on December 26, 2017. FOR FURTHER INFORMATION CONTACT: Mrs. Allison Costa, Sector Policies and Programs Division (E143–03), Office of Air Quality Planning and Standards, Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541– 1322; fax number: (919) 541–0516; email address: costa.allison@epa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: ethrower on DSK3G9T082PROD with PROPOSALS I. How can I get copies of this document and other related information? This Federal Register document, the petition for rulemaking, and the letter denying the petition for rulemaking are available in the docket the EPA established under Docket ID No. EPA– HQ–OAR–2017–0638. All documents in the docket are listed on the www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., confidential business information 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 either electronically through www.regulations.gov or in hard copy at the EPA Docket Center (EPA/DC), Room 3334, EPA WJC West Building, 1301 VerDate Sep<11>2014 16:59 Dec 22, 2017 Jkt 244001 Constitution Ave. NW, Washington, DC. 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 Air Docket is (202) 566–1742. II. Judicial Review Section 307(b)(1) of the Clean Air Act indicates which Federal Courts of Appeals have venue for petitions for review of final EPA actions. This section provides, in part, that the petitions for review must be filed in the United States Court of Appeals for the District of Columbia Circuit if: (i) The agency action consists of ‘‘nationally applicable regulations promulgated, or final action taken, by the Administrator,’’ or (ii) such actions are locally or regionally applicable, if ‘‘such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.’’ Any petitions for review of the letter denying the petition to list concentrated animal feeding operations as a source category described in this notice must be filed in the United States Court of Appeals for the District of Columbia Circuit by February 26, 2018. Dated: December 18, 2017. E. Scott Pruitt, Administrator. [FR Doc. 2017–27622 Filed 12–22–17; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2010–0234; FRL–9969–97] Alpha-cypermethrin; Proposed Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: This document proposes to amend existing tolerances for residues of alpha-cypermethrin in or on fruit, citrus, group 10–10 and hog fat under the Federal Food, Drug, and Cosmetic Act (FFDCA). This proposal sets an expiration date for the existing tolerances while establishing new lower tolerance levels that will cover the same commodities when the current tolerances expire. EPA is proposing these changes to correct an error in a previous rulemaking that established these tolerances at an unintended level. SUMMARY: PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 Comments must be received on or before February 26, 2018. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2010–0234, 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), (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. FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Director, 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: DATES: 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. 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 E:\FR\FM\26DEP1.SGM 26DEP1 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Proposed Rules 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 preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/ comments.html. ethrower on DSK3G9T082PROD with PROPOSALS II. This Proposal EPA, on its own initiative under FFDCA section 408(e), 21 U.S.C. 346a(e), is proposing to amend the existing tolerances for the insecticide alpha-cypermethrin to reduce the allowable levels of the pesticide in or on fruit, citrus, group 10–10 from 10 parts per million (ppm) to 0.35 ppm and in or on hog, fat from 1.0 ppm to 0.10 ppm. EPA is proposing this action in order to correct a typographical error that occurred in the final rule establishing these tolerances on February 1, 2013 (78 FR 7266) (FRL–9376–1). In support of the 2013 final rule, EPA had reviewed residue field trial data and determined that the appropriate tolerance levels for fruit, citrus, group 10–10 and for hog, fat were 0.35 ppm and 0.10 ppm, respectively. Unfortunately, the instructions to the Federal Register contained incorrect tolerance values for these commodities and the incorrect tolerance levels were finalized in that rule. To remedy that error, EPA is proposing to correct the tolerance levels. 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 VerDate Sep<11>2014 16:59 Dec 22, 2017 Jkt 244001 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), 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, consistent with FFDCA section 408(b)(2), for tolerances for residues of alpha-cypermethrin. Alpha-cypermethrin and zetacypermethrin are enriched isomers of the pyrethroid insecticide cypermethrin. Although cypermethrin, zetacypermethrin, and alpha-cypermethrin are separate active ingredients with different end-use products, they are included together in the hazard evaluation for the purpose of human health risk assessment. 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 three active ingredients are essentially the same active from the mammalian toxicity perspective. In the final rule published in the Federal Register of February 1, 2013 (78 FR 7266) (FRL–9376–1), EPA established tolerances for residues of alpha-cypermethrin in multiple commodities. Since the publication of that final rule, the toxicity profile of alpha-cypermethrin (as described in that rule) has not changed, and there have been no revisions to the toxicological database for the cypermethrins since that rule. In addition, although new tolerances have been established since that 2013 rule (tolerances for residues of alpha-cypermethrin in or on 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 at 0.05 ppm December 1, 2014 (79 FR 73210) (FRL–9918–88); zetacypermethrin in or on alfalfa, forage at 15 ppm and alfalfa, hay at 30 ppm December 24, 2014 (79 FR 77391) (FRL– 9920–23) and corn, field, forage at 9.0 ppm, corn, field, stover at 30 ppm, corn, pop, stover at 30 ppm July 30, 2015 (80 FR 45435) (FRL–9929–74), these new tolerances have not increased exposure warranting a new risk assessment since the rulemaking in February 2013. PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 60941 Because the risk assessments supporting the establishment of the February 2013 tolerances assessed the correct tolerances associated with fruit, citrus, group 10–10 (0.35 ppm) and hog fat (0.10 ppm) and found them to be adequate, that risk assessment continues to support this proposal. Therefore, EPA is relying on those risk assessments in order to support the corrected tolerances for alpha-cypermethrin in fruit, citrus, group 10–10 and hog fat. EPA did ensure that the percent crop treated information assessed in the 2010 risk assessment is still valid. The most recent Screening Level Usage Analysis (SLUA) dated September 29, 2016 updating PCT data shows that the 2010 estimates are actually overestimates. For a detailed discussion of the aggregate risk assessments and determination of safety, refer to the February 1, 2013 Federal Register final rule and its supporting documents, available at http://www.regulations.gov in docket ID number EPA–HQ–OPP–2010–0234. Based on the risk assessments and information described in this unit, 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. IV. Other Considerations A. Analytical Enforcement Methodology Adequate tolerance-enforcement methods are available in 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 alphacypermethrin (two isomers). 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). E:\FR\FM\26DEP1.SGM 26DEP1 60942 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Proposed Rules ethrower on DSK3G9T082PROD with PROPOSALS 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 are multiple Codex MRLs for alpha-cypermethrin, but all are in conjunction with MRLs for total cypermethrin isomers (no MRLs have been established solely for alphacypermethrin). However, although the definitions of the isomers covered differ formally between U.S. tolerances and Codex MRLs, the definitions of coverage are effectively harmonized since the tolerance enforcement methods are not stereospecific, and thus do not distinguish between residues of cypermethrin, zeta-cypermethrin and alpha-cypermethrin. For enforcement purposes, the same moiety is being regulated. There is a Codex MRL established for citrus fruits at 0.3 ppm and there is no Codex MRL for hog fat. Because the U.S. use patterns differ from those upon which the Codex MRLs are based, EPA is not proposing to harmonize the U.S. tolerance for citrus fruit. C. International Trade Considerations In this proposal, EPA is proposing to reduce the existing tolerances for commodities in crop group 10–10 from 10 ppm to 0.35 ppm and on hog, fat from 1.0 ppm to 0.1 ppm. The Agency intends to reduce these tolerances to correct the tolerance levels that EPA intended to establish in a previous rulemaking based on available residue data. In accordance with the World Trade Organization’s (WTO) Sanitary and Phytosanitary Measures (SPS) Agreement, EPA will notify the WTO of its intent to revise this tolerance. In addition, the SPS Agreement requires that Members provide a ‘‘reasonable interval’’ between the publication of a regulation subject to the Agreement and its entry into force in order to allow time for producers in exporting Member countries to adapt to the new requirement. At this time, EPA is proposing to allow the existing tolerances remain for a period of six months after the effective date of the final rule, in order to address this requirement. This reduction in tolerance levels is not discriminatory; the same food safety VerDate Sep<11>2014 16:59 Dec 22, 2017 Jkt 244001 standard contained in the FFDCA applies equally to domestically produced and imported foods. V. Conclusion Therefore, EPA is proposing to amend existing tolerances for residues of alphacypermethrin in or on fruit, citrus, group 10–10 and hog, fat at 0.35 ppm and 0.10 ppm, respectively. EPA is also proposing to establish a six-month expiration date for the existing tolerances while establishing new lower tolerances for these commodities. VI. Statutory and Executive Order Reviews This proposed action would amend existing tolerances under FFDCA section 408(e) in an action taken on the Agency’s own initiative. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this proposed action has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed action 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), nor is it subject to Executive Order 13771, entitled ‘‘Reducing Regulations and Controlling Regulatory Costs’’ (82 FR 9339, February 3, 2017). This proposed action 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 (UMRA) (2 U.S.C. 1501 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); or OMB review or any Agency action under Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This proposed 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 (NTTAA) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether establishment of tolerances, exemptions PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 from tolerances, raising of tolerance levels, expansion of exemptions, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations were published in the Federal Register of May 4, 1981 (46 FR 24950) and December 17, 1997 (62 FR 66020) (FRL–5753–1), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. 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. Furthermore, for alpha-cypermethrin, the Agency knows of no extraordinary circumstances that exist as to the present rule that would change EPA’s previous analysis. Taking into account this analysis, and available information concerning the pesticides listed in this rule, EPA hereby certifies that this rule will not have a significant negative economic impact on a substantial number of small entities. In addition, the Agency has determined that this proposed 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 action directly regulates growers, food processors, food handlers, and food retailers, not States. This proposed action does not alter the relationships or distribution of power and responsibilities established by Congress E:\FR\FM\26DEP1.SGM 26DEP1 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Proposed Rules in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this proposed action 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 action 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 action. 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 13, 2017. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR chapter I be amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.418, paragraph (a)(3): a. Revise the existing entries for ‘‘Fruit, citrus, group 10–10’’; and ‘‘Hog, fat’’; and add footnote 1’’; and ■ b. Add alphabetically the following entries for ‘‘Fruit, citrus, group 10–10’’; and ‘‘Hog, fat’’. The additions and revisions read as follows: ■ ethrower on DSK3G9T082PROD with PROPOSALS ■ § 180.418 Cypermethrin and isomers alpha-cypermethrin and zeta-cypermethrin; tolerances for residues. (a)(3) * * * VerDate Sep<11>2014 16:59 Dec 22, 2017 Jkt 244001 60943 Comments must be received by January 25, 2018. ADDRESSES: Submit your comments, identified by Docket ID no. EPA–HQ– * * * * * 1 ......... Fruit, citrus, group 10–10 10 SFUND–1989–0011, by one of the Fruit, citrus, group 10–10 ........... 0.35 following methods: • http://www.regulations.gov. Follow on-line instructions for submitting * * * * * Hog, fat 1 ..................................... 1.0 comments. Hog, fat ....................................... 0.10 • Email: Project Manager: Hadlock.holly@epa.gov or Community * * * * * Involvement Coordinator: Lane.jackie@ 1 This tolerance expires on June 26, 2018. epa.gov. • Mail: Holly Hadlock (SFD–7–3), * * * * * U.S. EPA, 75 Hawthorne Street, San [FR Doc. 2017–27806 Filed 12–22–17; 8:45 am] Francisco, CA 94105. BILLING CODE 6560–50–P • Hand delivery: Holly Hadlock (SFD–7–3), U.S. EPA, 75 Hawthorne Street, San Francisco, California. Such ENVIRONMENTAL PROTECTION deliveries are accepted only during AGENCY EPA’s normal hours of operation, and special arrangements should be made 40 CFR Part 300 for deliveries of boxed information. [EPA–HQ–SFUND–1989–0011; FRL–9972– Instructions: Direct your comments to 58—Region 9] Docket ID no. EPA–HQ–SFUND–1989– 0011. EPA’s policy is that all comments National Oil and Hazardous received will be included in the public Substances Pollution Contingency docket without change and may be Plan; National Priorities List: Partial made available online at http:// Deletion of the Pacific Coast Pipe www.regulations.gov, including any Lines Superfund Site personal information provided, unless the comment includes information AGENCY: Environmental Protection claimed to be Confidential Business Agency. Information (CBI) or other information ACTION: Notice of proposed rulemaking. whose disclosure is restricted by statute. SUMMARY: The Environmental Protection Do not submit information that you Agency (EPA) Region 9 is issuing a consider to be CBI or otherwise Notice of Intent for Partial Deletion of protected through http:// the surface soil portion of the Pacific www.regulations.gov or email. The Coast Pipe Lines (PCPL) Superfund Site http://www.regulations.gov website is (Site) located in Fillmore, California, an ‘‘anonymous access’’ system, which from the National Priorities List (NPL) means EPA will not know your identity and requests public comments on this or contact information unless you proposed action. The NPL, promulgated provide it in the body of your comment. pursuant to section 105 of the If you send an email comment directly Comprehensive Environmental to EPA without going through http:// Response, Compensation, and Liability www.regulations.gov, your email Act (CERCLA) of 1980, as amended, is address will be automatically captured an appendix of the National Oil and and included as part of the comment Hazardous Substances Pollution that is placed in the public docket and Contingency Plan (NCP). EPA and the made available on the internet. If you State of California, through the submit an electronic comment, EPA Department of Toxic Substances Control recommends that you include your (DTSC), have determined that there is name and other contact information in no exposure to contaminated soil at the the body of your comment and with any Site and that all appropriate response disk or CD–ROM you submit. If EPA actions at the identified parcel under cannot read your comment due to CERCLA, other than maintenance, technical difficulties and cannot contact monitoring and five-year reviews, have you for clarification, EPA may not be been completed. However, this deletion able to consider your comment. does not preclude future actions under Electronic files should avoid the use of Superfund. special characters, any form of This partial deletion pertains to the encryption, and be free of any defects or surface soil; a map indicating the area viruses. to be deleted is in the public docket. Docket: All documents in the docket The groundwater will remain on the are listed in the http:// NPL and is not being considered for www.regulations.gov index. Although deletion as part of this action. listed in the index, some information is PO 00000 Parts per million Commodity Frm 00024 Fmt 4702 Sfmt 4702 DATES: E:\FR\FM\26DEP1.SGM 26DEP1

Agencies

[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Proposed Rules]
[Pages 60940-60943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27806]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0234; FRL-9969-97]


Alpha-cypermethrin; Proposed Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to amend existing tolerances for 
residues of alpha-cypermethrin in or on fruit, citrus, group 10-10 and 
hog fat under the Federal Food, Drug, and Cosmetic Act (FFDCA). This 
proposal sets an expiration date for the existing tolerances while 
establishing new lower tolerance levels that will cover the same 
commodities when the current tolerances expire. EPA is proposing these 
changes to correct an error in a previous rulemaking that established 
these tolerances at an unintended level.

DATES: Comments must be received on or before February 26, 2018.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0234, 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), (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.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Director, 
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: 
[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. 
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. 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

[[Page 60941]]

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 preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. This Proposal

    EPA, on its own initiative under FFDCA section 408(e), 21 U.S.C. 
346a(e), is proposing to amend the existing tolerances for the 
insecticide alpha-cypermethrin to reduce the allowable levels of the 
pesticide in or on fruit, citrus, group 10-10 from 10 parts per million 
(ppm) to 0.35 ppm and in or on hog, fat from 1.0 ppm to 0.10 ppm. EPA 
is proposing this action in order to correct a typographical error that 
occurred in the final rule establishing these tolerances on February 1, 
2013 (78 FR 7266) (FRL-9376-1). In support of the 2013 final rule, EPA 
had reviewed residue field trial data and determined that the 
appropriate tolerance levels for fruit, citrus, group 10-10 and for 
hog, fat were 0.35 ppm and 0.10 ppm, respectively. Unfortunately, the 
instructions to the Federal Register contained incorrect tolerance 
values for these commodities and the incorrect tolerance levels were 
finalized in that rule. To remedy that error, EPA is proposing to 
correct the tolerance levels.

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), 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, consistent with FFDCA 
section 408(b)(2), for tolerances for residues of alpha-cypermethrin.
    Alpha-cypermethrin and zeta-cypermethrin are enriched isomers of 
the pyrethroid insecticide cypermethrin. Although cypermethrin, zeta-
cypermethrin, and alpha-cypermethrin are separate active ingredients 
with different end-use products, they are included together in the 
hazard evaluation for the purpose of human health risk assessment. 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 three active ingredients are essentially the same active from 
the mammalian toxicity perspective.
    In the final rule published in the Federal Register of February 1, 
2013 (78 FR 7266) (FRL-9376-1), EPA established tolerances for residues 
of alpha-cypermethrin in multiple commodities. Since the publication of 
that final rule, the toxicity profile of alpha-cypermethrin (as 
described in that rule) has not changed, and there have been no 
revisions to the toxicological database for the cypermethrins since 
that rule. In addition, although new tolerances have been established 
since that 2013 rule (tolerances for residues of alpha-cypermethrin in 
or on 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 at 0.05 ppm December 1, 2014 (79 FR 73210) 
(FRL-9918-88); zeta-cypermethrin in or on alfalfa, forage at 15 ppm and 
alfalfa, hay at 30 ppm December 24, 2014 (79 FR 77391) (FRL-9920-23) 
and corn, field, forage at 9.0 ppm, corn, field, stover at 30 ppm, 
corn, pop, stover at 30 ppm July 30, 2015 (80 FR 45435) (FRL-9929-74), 
these new tolerances have not increased exposure warranting a new risk 
assessment since the rulemaking in February 2013. Because the risk 
assessments supporting the establishment of the February 2013 
tolerances assessed the correct tolerances associated with fruit, 
citrus, group 10-10 (0.35 ppm) and hog fat (0.10 ppm) and found them to 
be adequate, that risk assessment continues to support this proposal. 
Therefore, EPA is relying on those risk assessments in order to support 
the corrected tolerances for alpha-cypermethrin in fruit, citrus, group 
10-10 and hog fat. EPA did ensure that the percent crop treated 
information assessed in the 2010 risk assessment is still valid. The 
most recent Screening Level Usage Analysis (SLUA) dated September 29, 
2016 updating PCT data shows that the 2010 estimates are actually 
overestimates. For a detailed discussion of the aggregate risk 
assessments and determination of safety, refer to the February 1, 2013 
Federal Register final rule and its supporting documents, available at 
http://www.regulations.gov in docket ID number EPA-HQ-OPP-2010-0234.
    Based on the risk assessments and information described in this 
unit, 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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance-enforcement methods are available in 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).

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).

[[Page 60942]]

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 are multiple Codex MRLs for alpha-cypermethrin, but all are 
in conjunction with MRLs for total cypermethrin isomers (no MRLs have 
been established solely for alpha-cypermethrin). However, although the 
definitions of the isomers covered differ formally between U.S. 
tolerances and Codex MRLs, the definitions of coverage are effectively 
harmonized since the tolerance enforcement methods are not 
stereospecific, and thus do not distinguish between residues of 
cypermethrin, zeta-cypermethrin and alpha-cypermethrin. For enforcement 
purposes, the same moiety is being regulated.
    There is a Codex MRL established for citrus fruits at 0.3 ppm and 
there is no Codex MRL for hog fat. Because the U.S. use patterns differ 
from those upon which the Codex MRLs are based, EPA is not proposing to 
harmonize the U.S. tolerance for citrus fruit.

C. International Trade Considerations

    In this proposal, EPA is proposing to reduce the existing 
tolerances for commodities in crop group 10-10 from 10 ppm to 0.35 ppm 
and on hog, fat from 1.0 ppm to 0.1 ppm. The Agency intends to reduce 
these tolerances to correct the tolerance levels that EPA intended to 
establish in a previous rulemaking based on available residue data.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA will notify the WTO of 
its intent to revise this tolerance. In addition, the SPS Agreement 
requires that Members provide a ``reasonable interval'' between the 
publication of a regulation subject to the Agreement and its entry into 
force in order to allow time for producers in exporting Member 
countries to adapt to the new requirement. At this time, EPA is 
proposing to allow the existing tolerances remain for a period of six 
months after the effective date of the final rule, in order to address 
this requirement.
    This reduction in tolerance levels is not discriminatory; the same 
food safety standard contained in the FFDCA applies equally to 
domestically produced and imported foods.

V. Conclusion

    Therefore, EPA is proposing to amend existing tolerances for 
residues of alpha-cypermethrin in or on fruit, citrus, group 10-10 and 
hog, fat at 0.35 ppm and 0.10 ppm, respectively. EPA is also proposing 
to establish a six-month expiration date for the existing tolerances 
while establishing new lower tolerances for these commodities.

VI. Statutory and Executive Order Reviews

    This proposed action would amend existing tolerances under FFDCA 
section 408(e) in an action taken on the Agency's own initiative. The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993). Because this 
proposed action has been exempted from review under Executive Order 
12866 due to its lack of significance, this proposed action 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), nor is it subject to Executive Order 
13771, entitled ``Reducing Regulations and Controlling Regulatory 
Costs'' (82 FR 9339, February 3, 2017). This proposed action 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 (UMRA) (2 U.S.C. 1501 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); or OMB review or any Agency action under 
Executive Order 13045, entitled ``Protection of Children from 
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 
1997). This proposed 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 (NTTAA) (15 U.S.C. 272 note). Pursuant to the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency 
previously assessed whether establishment of tolerances, exemptions 
from tolerances, raising of tolerance levels, expansion of exemptions, 
or revocations might significantly impact a substantial number of small 
entities and concluded that, as a general matter, these actions do not 
impose a significant economic impact on a substantial number of small 
entities. These analyses for tolerance establishments and 
modifications, and for tolerance revocations were published in the 
Federal Register of May 4, 1981 (46 FR 24950) and December 17, 1997 (62 
FR 66020) (FRL-5753-1), respectively, and were provided to the Chief 
Counsel for Advocacy of the Small Business Administration. 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. Furthermore, for alpha-cypermethrin, the Agency 
knows of no extraordinary circumstances that exist as to the present 
rule that would change EPA's previous analysis. Taking into account 
this analysis, and available information concerning the pesticides 
listed in this rule, EPA hereby certifies that this rule will not have 
a significant negative economic impact on a substantial number of small 
entities. In addition, the Agency has determined that this proposed 
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 action directly regulates 
growers, food processors, food handlers, and food retailers, not 
States. This proposed action does not alter the relationships or 
distribution of power and responsibilities established by Congress

[[Page 60943]]

in the preemption provisions of FFDCA section 408(n)(4). For these same 
reasons, the Agency has determined that this proposed action 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 action 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 action.

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 13, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be 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, paragraph (a)(3):
0
a. Revise the existing entries for ``Fruit, citrus, group 10-10''; and 
``Hog, fat''; and add footnote 1''; and
0
b. Add alphabetically the following entries for ``Fruit, citrus, group 
10-10''; and ``Hog, fat''.
    The additions and revisions read as follows:


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

    (a)(3) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, citrus, group 10-10 \1\..............................          10
Fruit, citrus, group 10-10..................................        0.35
 
                                * * * * *
Hog, fat \1\................................................         1.0
Hog, fat....................................................        0.10
 
                                * * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on June 26, 2018.

* * * * *
[FR Doc. 2017-27806 Filed 12-22-17; 8:45 am]
 BILLING CODE 6560-50-P