美国制定双甲脒，唑酮草酯，乙烯利，马拉硫磷和代森锰锌等限量措施（Amitraz, Carfentrazone-ethyl, Ethephon, Malathion, Mancozeb, et al.; Tolerance Actions）

　　ACTION

　　Final Rule.

　　SUMMARY

　　EPA is revoking certain tolerances for the fungicides spiroxamine and triflumizole, the herbicides carfentrazone-ethyl and quizalofop ethyl; the insecticides amitraz, oxamyl, propetamphos, and spinosad; the plant growth regulators ethephon and mepiquat; and the tolerance on rice straw for multiple active ingredients. Also, EPA is modifying certain tolerances for the fungicides mancozeb, thiram, and triflumizole. In addition, EPA is establishing new tolerances for the fungicide mancozeb. Also, in accordance with current Agency practice, EPA is making minor revisions to the tolerance expressions for mepiquat and thiram. In addition, EPA is restoring the listings of tolerances on bulb onion and pear for methomyl residues to remedy inadvertent drafting errors and cover existing registrations. EPA is deferring a decision on the malathion tolerances at this time.

　　TABLE OF CONTENTS

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　　DATES:

　　ADDRESSES:

　　FOR FURTHER INFORMATION CONTACT:

　　SUPPLEMENTARY INFORMATION:

　　I. General Information

　　A. Does this action apply to me?

　　B. How can I get electronic access to other related information?

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

　　II. Background

　　A. What action is the agency taking?

　　B. What is the agency's authority for taking this action?

　　C. When do these actions become effective?

　　III. International Residue Limits

　　IV. Statutory and Executive Order Reviews

　　V. Congressional Review Act

　　List of Subjects in 40 CFR Part 180

　　PART 180—[AMENDED]

　　DATES:

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　　This regulation is effective May 18, 2016, except for the amendments to 40 CFR 180.253 (the restorations of the bulb onion and pear tolerances for methomyl), which are effective November 20, 2015. Objections and requests for hearings must be received on or before January 19, 2016, 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:

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　　The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0194, 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 reviewthe visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

　　FOR FURTHER INFORMATION CONTACT:

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　　Joseph Nevola, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8037; email address: nevola.joseph@epa.gov.

　　SUPPLEMENTARY INFORMATION:

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　　I. General Information

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　　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 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 the Federal Food, Drug, and Cosmetic Act (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-2014-0194 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 January 19, 2016. 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-2014-0194, 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. Background

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　　A. What action is the agency taking?

　　In the Federal Register of July 11, 2014 (79 FR 40043) (FRL-9910-45), EPA issued a proposed rule, in follow-up to canceled uses, to revoke specific tolerances for amitraz, carfentrazone-ethyl, ethephon, mepiquat, oxamyl, propetamphos, quizalofop ethyl, spinosad, spiroxamine, and triflumizole. Also, because rice straw is no longer considered by the Agency to be a significant feed item, EPA proposed to revoke the tolerance on rice straw for multiple active ingredients. In follow-up to reregistration, EPA proposed to modify tolerances for malathion and mancozeb, and also establish tolerances for mancozeb, and post-reregistration follow-up to modify specific tolerances for thiram and triflumizole. In addition, the Agency proposed minor revisions to the tolerance expressions for malathion, mepiquat, and thiram. The proposal provided a 60-day comment period.

　　Since the proposed rule, in the Federal Register of March 27, 2015 (80 FR 16302) (FRL-9924-86), the Agency published a final rule that removed the expiration/revocation date for the thiram tolerance in 40 CFR 180.132 on banana at 0.80 parts per million (ppm) for thiram residues. Also, in the Federal Register of June 19, 2015 (80 FR 35249) (FRL-9928-82), the Agency published a final rule that established a thiram tolerance in 40 CFR 180.132 on avocado at 15 ppm for thiram residues.

　　EPA is finalizing specific mancozeb tolerance actions in order to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standard of FFDCA. The safety finding determination of “reasonable certainty of no harm” is discussed in detail in each Reregistration Eligibility Decision (RED) and Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decision (TRED) for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications, to reflect current use patterns, to meet safety findings and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: (800) 490-9198; fax number: (513) 489-8695; Internet at http://www.epa.gov/ncepihom and from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161; telephone number: (800) 553-6847 or (703) 605-6000; Internet at http://www.ntis.gov. Electronic copies of REDs and TREDs are available on the Internet at http://www.regulations.gov and http://www.epa.gov/pesticides/reregistration/status.htm.

　　In this final rule, EPA is revoking certain tolerances and/or tolerance exemptions because either they are no longer needed or are associated with food uses that are no longer registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the United States. Those instances where registrations were canceled were because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide active ingredient. The tolerances revoked by this final rule are no longer necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but imported into the United States. It is EPA's general practice to issue a final rule revoking those tolerances and tolerance exemptions for residues ofpesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance or tolerance exemption to cover residues in or on imported commodities or legally treated domestic commodities.

　　EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States.

　　Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed in Unit II.A. if one of the following conditions applies:

　　1. Prior to EPA's issuance of a FFDCA section 408(f) order requesting additional data or issuance of a FFDCA section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained.

　　2. EPA independently verifies that the tolerance is no longer needed.

　　3. The tolerance is not supported by data that demonstrate that the tolerance meets the requirements under the Food Quality Protection Act (FQPA).

　　This final rule does not revoke those tolerances for which EPA received comments stating a need for the tolerance to be retained. Among the comments received by EPA, are the following:

　　1. General—i. Comment by private citizen. An anonymous comment was received which expressed concerns about the toxicity of pesticides in general.

　　Agency response. The commenter did not take issue with the Agency's specific conclusions to revoke, modify, establish tolerances, or revise tolerance expressions. Also, the commenter did not refer to any specific studies which pertain to those conclusions. The Agency has not changed its previous determination that the tolerances in question are safe and is therefore not making any changes in response to these comments.

　　2. Specific chemical comments—i. Oxamyl-Comment by DuPont Crop Protection. The commenter requested that the soybean seed tolerance for oxamyl be retained for possible future actions. DuPont noted that since the soybean use was deleted from oxamyl labels in 2006 via EPA's approval of its request for voluntary cancellation, growers have experienced an increasing need for management of soybean cyst nematode.

　　Agency response. The use of oxamyl on soybean was officially canceled under section 6(f)(1) of FIFRA, 7 U.S.C. 136d(f)(1), under which a registrant of a pesticide product may request that the product registration be canceled or amended to terminate one or more uses. Because EPA canceled the soybean use in response to DuPont's request, and no other oxamyl products include a use on soybeans, there is currently no legal use of oxamyl on soybeans. EPA will not retain the tolerance based on the possibility that someone may apply for a new use on soybean in the future. Tolerances are generally maintained for current uses. Therefore, EPA is revoking the tolerance for oxamyl in 40 CFR 180.303(a) on soybean, seed.

　　EPA is considering the public comments received on malathion in response to the proposed rule of July 11, 2014 and is thus deferring a decision on the malathion tolerances at this time. The Agency will respond to the comments in a future notice to be published in the Federal Register.

　　With the exception of malathion and oxamyl, the Agency did not receive any specific comments in the docket, during the 60-day comment period, concerning proposed tolerance actions associated with pesticide active ingredients, as described in the Federal Register of July 11, 2014. Therefore, the exceptions of malathion, EPA is finalizing amendments in the proposed rule of July 11, 2014. Also, EPA is maintaining both the establishment of the thiram tolerance on avocado (now in newly codified 40 CFR 180.132(a)(1) for thiram residues), and the removal of the expiration/revocation date on the thiram tolerance on banana (now in newly codified 40 CFR.180.132(a)(2) for carbon disulfide residues). In addition, EPA is finalizing the amendments in the proposed rule of July 11, 2014 for thiram tolerances on apple, banana, peach, and strawberry (now in newly codified 40 CFR 180.132(a)(2) for carbon disulfide residues). For a detailed discussion of the Agency's rationale for the finalized tolerance actions, refer to the proposed rule of July 11, 2014.

　　In this final rule EPA is also making corrections to two unrelated provisions. In the Federal Register of May 9, 2012 (77 FR 27164) (FRL-9345-2), EPA issued a proposed rule covering multiple pesticide active ingredients, including methomyl. In that rule, in order to conform to current Agency practice, EPA proposed to revise the tolerance commodity terminology, in 40 CFR 180.253 for methomyl, for vegetable, root (an outdated term) at 0.2(N) ppm to vegetable, root and tuber, group 1 at 0.2 ppm. Also, EPA proposed to make minor revisions to the tolerance expressions for methomyl in 40 CFR 180.253(a) and (c). In follow-up, EPA promulgated a final rule in the Federal Register of September 26, 2012 (77 FR 59120) (FRL-9358-8) with an effective date of March 25, 2013. However, the outdated tolerance term “vegetable, root” had covered the use on bulb onions. Therefore, the terminology revision by EPA inadvertently removed a tolerance which covered methomyl residues in or on bulb onions. Also, while EPA revised the methomyl tolerance expressions in 180.253(a) and (c), EPA inadvertently removed the table under paragraph (c), which contained an entry for a regional tolerance on pear at 4 ppm. Yet, active registrations for use of methomyl on bulb onions and pears existed at that time and now. Consequently, in this final rule, EPA is restoring coverage for methomyl residues on the bulb onion commodity as an individual tolerance in 40 CFR 180.253(a) for onion, dry bulb at 0.2 ppm and in 40 CFR 180.253(c) on pear at 4 ppm.

　　EPA is issuing these tolerance actions for methomyl in this final rule for this purpose without notice and opportunity to comment. Section 553(b)(3)(B) of the Administrative Procedure Act provides that notice and comment is not necessary “when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” EPA finds good cause here because restoring the listings of tolerance coverages on bulb onion and pear for methomyl residues merely corrects two inadvertent drafting errors. As such, notice and comment is unnecessary.

　　B. What is the agency's authority for taking this action?

　　EPA may issue a regulation establishing, modifying, or revoking a tolerance under FFDCA section 408(e). In this final rule, EPA is establishing, modifying, and revoking tolerances to implement the tolerance recommendations made in the RED for mancozeb during the reregistration and tolerance reassessment processes, and as follow-up on canceled uses of pesticides.

　　C. When do these actions become effective?

　　As stated in the DATES section, this regulation is effective May 18, 2016, except for the restorations of the bulb onion and pear tolerances for methomyl, which are effective November 20, 2015. With the exception of methomyl, for which EPA is restoring tolerancesinadvertently removed, EPA is delaying the effective date of these finalized actions to allow a reasonable interval for producers in exporting members of the World Trade Organization's Sanitary and Phytosanitary Measures Agreement to adapt to the requirements of a final rule. EPA believes that existing stocks of the canceled or amended pesticide products labeled for the uses associated with the revoked tolerances have been completely exhausted and that treated commodities have had sufficient time for passage through the channels of trade.

　　Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this unit, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:

　　1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA.

　　2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food.

　　III. International Residue Limits

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　　In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

　　The Codex has not established a MRL for carfentrazone-ethyl, mepiquat, propetamphos, quizalofop ethyl, spiroxamine, triflumizole, ethephon in or on cucumber, oxamyl in or on soybean seed, spinosad in or on coriander leaves, or total dithiocarbamates in or on barley bran, barley flour, field corn grain, oat flour, oat grain, rye bran, rye grain, wheat bran, wheat flour, and wheat, shorts.

　　The Codex has established MRLs for total dithiocarbamates determined as carbon disulfide in or on various commodities, including barley and wheat, each at 1 milligrams/kilogram (mg/kg). These MRLs are the same as the tolerances finalized for mancozeb in the United States.

　　The Codex has established MRLs for total dithiocarbamates determined as carbon disulfide in or on various commodities, including papaya at 5 mg/kg. This MRL will be covered by a finalized U.S. tolerance at a higher level than the MRL. The MRL is different than the finalized U.S. tolerance for mancozeb in the United States because of differences in residue definition, use patterns, and/or good agricultural practices.

　　The Codex has established a MRL for amitraz in or on various commodities, including cotton seed at 0.5 mg/kg. This MRL is covered by the current U.S. tolerance at a higher level than the MRL, but would no longer be covered due to the revocation of the U.S. tolerance.

　　The Codex has established MRLs for total dithiocarbamates determined as carbon disulfide in or on various commodities, including banana at 2 mg/kg, peach at 7 mg/kg, and strawberry at 5 mg/kg. The MRLs for banana and peach are the same as the U.S. tolerances proposed for thiram in the United States. The MRL for strawberry will be covered by a finalized U.S. tolerance at a higher level than the MRL. The MRL for strawberry is different than the tolerance finalized for thiram in the United States because of differences in use patterns, and/or good agricultural practices.

　　IV. Statutory and Executive Order Reviews

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　　In this final rule, EPA establishes tolerances under FFDCA section 408(e), and also modifies and revokes specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions (i.e., establishment and modification of a tolerance and tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This 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.), or 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.). Nor does it require any special considerations as required by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (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 on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020) (FRL-5753-1), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis and available information concerning the pesticides listed in this rule, the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect toany particular revocation. (This Agency document is available in the docket of the proposed rule). Furthermore, for the pesticides named in this final rule, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

　　V. Congressional Review Act

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　　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

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　　Environmental protection

　　Administrative practice and procedure

　　Agricultural commodities

　　Pesticides and pests

　　Reporting and recordkeeping requirements

　　Dated: October 20, 2015.

　　Jack E. Housenger,

　　Director, Office of Pesticide Programs.