Amitraz, Carfentrazone-ethyl, Ethephon, Malathion, Mancozeb, et al.; Proposed Tolerance Actions

Federal Register, Volume 79 Issue 133 (Friday, July 11, 2014)

Federal Register Volume 79, Number 133 (Friday, July 11, 2014)

Proposed Rules

Pages 40043-40054

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2014-16063

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2014-0194; FRL-9910-45

RIN 2070-ZA16

Amitraz, Carfentrazone-ethyl, Ethephon, Malathion, Mancozeb, et al.; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke certain tolerances for the fungicides spiroxamine and triflumizole, the herbicides carfentrazone-

ethyl and quizalofop ethyl; the insecticides amitraz, oxamyl, propetamphos, and spinosad; and the plant growth regulators ethephon and mepiquat. In addition, EPA is proposing to revoke the tolerance on rice straw for multiple active ingredients. Also, EPA is proposing to modify certain tolerances for the fungicides mancozeb, thiram, and triflumizole; and the insecticide malathion. In addition, EPA is proposing to establish new tolerances for the fungicide mancozeb. Also, in accordance with current Agency practice, EPA is proposing to make minor revisions to the tolerance expression for malathion, mepiquat, and thiram.

DATES: Comments must be received on or before September 9, 2014.

ADDRESSES: Submit your comments, identified by docket identification (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 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: Joseph Nevola, Pesticide Re-Evaluation Division (7508P), Office of Pesticide

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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:

1. General Information

   1. 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).

   2. What should I consider as I prepare my comments for EPA?

      1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

      2. Tips for preparing your comments. When submitting comments, remember to:

      i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

      ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

      iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

      iv. Describe any assumptions and provide any technical information and/or data that you used.

      v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

      vi. Provide specific examples to illustrate your concerns and suggest alternatives.

      vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

      viii. Make sure to submit your comments by the comment period deadline identified.

   3. What can I do if I wish the agency to maintain a tolerance that the agency proposes to revoke?

      This proposed rule provides a comment period of 60 days for any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives a comment within the 60-day period to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the Federal Register under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(f), if needed. The order would specify data needed and the timeframes for its submission, and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA.

      EPA issues a final rule after considering comments that are submitted in response to this proposed rule. In addition to submitting comments in response to this proposal, you may also submit an objection at the time of the final rule. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings.

2. Background

   1. What action is the agency taking?

   EPA is proposing to revoke, modify, and establish specific tolerances for residues of the fungicides mancozeb, spiroxamine, thiram, and triflumizole; the herbicides carfentrazone-ethyl and quizalofop ethyl; the insecticides amitraz, malathion, oxamyl, propetamphos, and spinosad; and the plant growth regulators ethephon and mepiquat in or on commodities listed in the regulatory text. In addition, EPA is proposing to revoke the tolerances on rice straw for multiple active ingredients because it is no longer considered by the Agency to be a significant feed item.

   Also, EPA is proposing to make minor revisions to the tolerance expressions for malathion, mepiquat, and thiram in accordance with current Agency practice to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances. The revisions to the tolerance expressions do not substantively change the tolerance or, in any way, modify the permissible level of residues permitted by the tolerances.

   EPA is proposing to revoke certain tolerances because 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).

   The proposed tolerance actions for mancozeb and malathion are consistent with the recommendations in their Reregistration Eligibility Decisions (REDs) of 2005 and 2009, respectively. As part of the tolerance reassessment process, 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 RED. REDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-800-490-9198; fax number: 1-513-489-

   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: 1-800-553-6847 or (703) 605-6000; Internet at http://www.ntis.gov. Electronic copies are available on the Internet for the malathion and mancozeb REDs in dockets EPA-HQ-OPP-2004-0348 and EPA-HQ-OPP-2005-0176, respectively, at http://www.regulations.gov and at http://www.epa.gov/pesticides/reregistration/status.htm.

   In REDs, Chapter IV on risk management, reregistration, and tolerance reassessment typically describes the regulatory position, cumulative safety determination, determination of safety for U.S. general population, and safety for infants and children. In particular, the human

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   health risk assessment document which supports the RED describes risk exposure estimates and whether the Agency has concerns. EPA also seeks to harmonize tolerances with international standards set by the Codex Alimentarius Commission, as described in Unit III.

   Explanations for proposed modifications in tolerances can be found in the RED document and in more detail in the Residue Chemistry Chapter document which supports the RED. Copies of the Residue Chemistry Chapter documents are found in the Administrative Record and electronic copies for malathion and mancozeb can be found under their respective docket ID numbers, identified in Unit II.A. Electronic copies of other support documents (including explanations for proposed modifications in triflumizole tolerances) are available through EPA's electronic docket and comment system, regulations.gov at http://www.regulations.gov. You may search for this proposed rule under docket ID number EPA-HQ-OPP-

   2014-0194, then click on that docket ID number to view its contents.

   EPA had determined at the time of the RED that the aggregate exposures and risks are not of concern for the above mentioned pesticide active ingredients based upon the data identified in the RED which lists the submitted studies that the Agency found acceptable.

   EPA has found that the tolerances that are proposed in this document to be modified, are safe; i.e., that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residues, in accordance with FFDCA section 408(b)(2)(C). (Note that changes to tolerance nomenclature do not constitute modifications of tolerances). These findings are discussed in detail in each RED. The references are available for inspection as described in this document under SUPPLEMENTARY INFORMATION.

   In addition, it is EPA's general practice to propose revocation of those tolerances for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance to cover residues in or on imported commodities or legally treated domestic commodities.

   EPA is proposing to revoke specific tolerances for residues of mepiquat and triflumizole because the Agency has concluded that there is no reasonable expectation of finite residues in or on the commodities associated with the tolerances, and therefore these tolerances are no longer needed.

   The determinations that there are no reasonable expectations of finite residues for the tolerances listed in this document were made based on feeding studies submitted since the time that the tolerances were originally established. These feeding studies used exaggerated amounts of the compound and did not show measurable residues of the pesticide active ingredient tested. The Agency made the determination that there is no reasonable expectation of finite residues for the pesticides active ingredient/commodity combinations listed in this proposal in memoranda of July 30, 2001 for mepiquat and October 1, 2008 for triflumizole. Copies of these memoranda can be found in the docket for this proposed rule. Because EPA determined that there is no reasonable expectation of finite residues, under 40 CFR 180.6 the tolerances are no longer needed under FFDCA and can be proposed for revocation.

   1. Multiple active ingredients. EPA has determined that rice straw is no longer a significant feed item in the United States, and therefore the tolerance is no longer needed and should be revoked. (The document entitled ``OPPTS Test Guideline 860.1000 Supplement: Guidance on Constructing Maximum Reasonably Balanced Diets (MRBD)'' is available at http://www.regulations.gov under docket ID number EPA-HQ-OPPT-2009-

      0155). Consequently, EPA is proposing to revoke the tolerances for rice, straw in 40 CFR 180.142(a) for 2,4-D; 180.169(a)(1) for carbaryl; 180.205(a) for paraquat; 180.274(a) for propanil; 180.288(a) for 2-

      (thiocyanomethylthio)benzothiazole; 180.293(a)(1) for endothall; 180.301(a) for carboxin; 180.355(a)(1) for bentazon; 180.361(a) for pendimethalin; 180.377(a)(2) for diflubenzuron; 180.383(a) for sodium salt of acifluorfen; 180.399(a)(1) for iprodione; 180.401(a) for thiobencarb; 180.417(a)(1) for triclopyr; 180.418(a)(2) for zeta-

      cypermethrin; 180.425(a) for clomazone; 180.434(a) for propiconazole; 180.438(a)(1) for lambda-cyhalothrin; 180.438(a)(2) for gamma-

      cyhalothrin and its epimer; 180.439(a) for thifensulfuron methyl; 180.445(a) for bensulfuron methyl; 180.447(a)(2) for imazethapyr; 180.451(a) for tribenuron methyl; 180.463(a)(1) for quinclorac; 180.473(a) for glufosinate ammonium; 180.479(a)(2) for halosulfuron-

      methyl; 180.484(a) for flutolanil; 180.507(a)(1) for azoxystrobin; 180.517(a) for fipronil; 180.555(a) for trifloxystrobin; 180.570(a)(2) for isoxadifen-ethyl; 180.577(a) for bispyribac-sodium; 180.605(a) for penoxsulam; and 180.625(a) for orthosulfamuron.

   2. Amitraz. There have been no active U.S. registrations for use of amitraz on cotton since May 3, 2006 and the manufacturer, Arysta Life Sciences, notified EPA in July 2011 that it no longer is interested in supporting the tolerance for amitraz use on cotton, undelinted seed for import purposes. The tolerance is no longer needed and therefore should be revoked. Consequently, EPA is proposing to revoke the tolerance for amitraz in 40 CFR 180.287(a) on cotton, undelinted seed.

   3. Carfentrazone-ethyl. Because the first cotton processing study submitted by the registrant was conducted at 1.0x the seasonal application rate and resulted in residues less than the Limit of Quantitation (LOQ) of 0.05 ppm, EPA requested that a processing study be conducted at an application rate sufficient to generate residues in/

      on cottonseed and set tolerances for cotton hulls, meal, and oil using theoretical processing factors and the highest average cottonseed field trial residue. Based on an available second processing study conducted at 2.0x the seasonal application rate, which showed that carfentrazone-

      ethyl residues of concern in or on cottonseed were detected (Limit of Detection 0.015-0.020 ppm) but were less than the LOQ of 0.05 ppm, EPA determined that the tolerances for carfentrazone-ethyl residues of concern are no longer needed on cottonseed hull, meal, and oil and therefore should be revoked. Consequently, EPA is proposing to revoke the tolerances for carfentrazone-ethyl in 40 CFR 180.515(a) on cotton, hulls; cotton, meal; and cotton, refined oil.

      Because uses supported by the carfentrazone-ethyl tolerance for caneberry subgroup 13A at 0.1 ppm are covered by the tolerance for berry group 13 at 0.10 ppm, there is no longer any need for the separate subgroup tolerance and therefore it should be revoked. In addition, because EPA no longer considers rice straw to be a significant feed item, the tolerance is no longer needed and should be revoked. Consequently, EPA is proposing to revoke the tolerances for carfentrazone-ethyl in 40 CFR 180.515(a) on caneberry subgroup 13A and rice, straw.

   4. Ethephon. Because the last product label amendment has been completed which limits the use of ethephon to cucumbers grown for seed production only and restricts the harvesting of treated cucumbers for human or animal consumption, a food tolerance for ethephon is no longer needed and therefore should be revoked.

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      Consequently, EPA is proposing to revoke the tolerance for ethephon in 40 CFR 180.300(a) on cucumber.

   5. Malathion. EPA is proposing to modify the plant tolerance commodity levels for certain existing malathion tolerances in 40 CFR 180.111(a)(1) based on available field trial data and product label changes. Currently, those tolerances are established for residues of malathion. However, as stated in the 2009 amended RED for malathion, based on available plant metabolism data, EPA determined that the residues of concern in plants consist of malathion and its metabolite, malaoxon, and therefore the tolerance expression for plant commodities should be revised. Because EPA is not proposing to modify all of the plant commodity tolerances in 40 CFR 180.111(a)(1) at this time, EPA is proposing that those specific tolerances which it is proposing to modify herein be redesignated from 40 CFR 180.111(a)(1) to 40 CFR 180.111(a)(2), where tolerances are currently established for malathion and its metabolite malaoxon. Also, in accordance with current Agency practice to describe more clearly the measurement and scope or coverage of the tolerances, EPA is proposing to revise the introductory text containing the tolerance expression in 40 CFR 180.111(a)(2) to read as set out in the proposed regulatory text at the end of this document.

      Based on product label changes to their use patterns and available field trial data that showed malathion residues of concern in or on apricot as high as