Thiamethoxam; Pesticide Tolerance

Federal Register, Volume 82 Issue 30 (Wednesday, February 15, 2017)

Federal Register Volume 82, Number 30 (Wednesday, February 15, 2017)

Rules and Regulations

Pages 10712-10718

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

FR Doc No: 2017-03075

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2015-0705; FRL-9957-00

Thiamethoxam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of thiamethoxam in or on bananas. Syngenta Crop Protection, LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 15, 2017. Objections and requests for hearings must be received on or before April 17, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0705, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

Page 10713

FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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:

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

      You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

      Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0705 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 17, 2017. 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-2015-0705, 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.

  2. Summary of Petitioned-For Tolerance

    In the Federal Register of November 23, 2015 (80 FR 72941) (FRL-

    9936-73), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5E8401) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27409-8300. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the insecticide, thiamethoxam, in or on banana at 0.04 parts per million (ppm). That document referenced a summary of the petition prepared by Syngenta, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

    Based upon review of the data supporting the petition, EPA has modified the level at which the tolerance is being established. The reason for this change is explained in Unit IV.D.

  3. 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. . . .''

    Tolerances for residues of thiamethoxam are listed in 40 CFR 180.565 and are expressed in terms of the combined residues of the insecticide thiamethoxam and its metabolite CGA-322704. Metabolite CGA-

    322704 is also the registered active ingredient clothianidin (tolerance listings in 40 CFR 180.586). Clothianidin (hereinafter referred to as CGA-322704) has a complete toxicological database and appears to have effects in mammals that are different from those of thiamethoxam. A separate risk assessment that addresses risks from CGA-322704 residues resulting from the direct application of CGA-322704 (clothianidin), as well as risks from residues of CGA-322704 coming from thiamethoxam uses has been conducted, and there are no risk estimates of concern as a result of the proposed tolerance for thiamethoxam residues in imported bananas. This risk assessment can be found at http:www.regulations.gov in docket ID number EPA-HQ-OPP-2015-0705.

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for thiamethoxam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with thiamethoxam follows.

    1. Toxicological Profile

      EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

      Page 10714

      In mammals, toxicological effects are seen primarily in the liver, kidney, testes, and blood cellular system. In addition, developmental neurological effects were observed in rats. These developmental effects are being used to assess risks associated with acute exposures to thiamethoxam, and the liver and testicular effects are the basis for assessing longer-term exposures.

      There is no indication of quantitative or qualitative susceptibility in the developmental toxicity studies. There is evidence of quantitative susceptibility in the developmental neurotoxicity study and both two-generation reproductive studies. However, clear no observed adverse effects levels (NOAELs) were identified for the susceptibility in the 2-generation reproduction and developmental neurotoxicity (DNT) studies and the endpoints and doses chosen for risk assessment are protective of the susceptibility observed in these studies.

      Thiamethoxam is classified as ``not likely to be carcinogenic to humans'' at levels below which certain amounts of metabolites are produced. The liver tumors that were observed in the mouse have been demonstrated to be a result of a non-genotoxic mode of action dependent on sufficient amounts of a hepatotoxic metabolite being produced. Although humans are qualitatively capable of producing the active metabolite, thiamethoxam is unlikely to pose a cancer risk to humans unless sufficient amounts of metabolites are persistently formed to drive a carcinogenic response. The chronic endpoint selected for regulating exposure to thiamethoxam is sufficiently protective of the key events (perturbation of liver metabolism, hepatotoxicity/

      regenerative proliferation) in the animal mode of action. At those levels, the Agency does not expect sufficient generation of the necessary metabolites to elicit a carcinogenic response; therefore, separate quantification of carcinogenic potential is not required.

      Specific information on the studies received and the nature of the adverse effects caused by thiamethoxam as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http:www.regulations.gov in the document titled ``Thiamethoxam. Human Health Risk Assessment for Tolerances on Imported Bananas'' on page 33 in docket ID number EPA-HQ-OPP-2015-0705.

    2. Toxicological Points of Departure/Levels of Concern

      Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

      A summary of the toxicological endpoints for thiamethoxam used for human risk assessment is shown in Table 1 of this unit.

      Table 1--Summary of Toxicological Doses and Endpoints for Thiamethoxam for Use in Human Health Risk Assessment

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      Point of departure

      Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects

      safety factors risk assessment

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      Acute dietary (All populations NOAEL = 34.5 mg/kg/ Acute RfD = 0.35 mg/ Rat Developmental Neurotoxicity

      including infants and children). day UFA = 10x. kg/day. study.

      UFH = 10x........... aPAD = 0.35 mg/kg/ LOAEL = 298.7 mg/kg/day based on

      FQPA SF = 1x........ day. decreased body weight and

      reduced brain morphometric

      measurements.

      Chronic dietary (All populations) NOAEL= 1.2 mg/kg/day Chronic RfD = 0.012 2-Generation reproduction study.

      UFA = 10x. mg/kg/day. LOAEL = 1.8 mg/kg/day based on

      UFH = 10x........... cPAD = 0.012 mg/kg/ increased incidence and severity

      FQPA SF = 1x........ day. of tubular atrophy in testes of

      F1 generation males.

      2-Generation reproduction study,

      LOAEL = 156 mg/kg/day (males),

      not determined (females) based

      on sperm abnormalities and germ

      cell loss in F1 males.

      Incidental oral short-term NOAEL= 31.6 mg/kg/ LOC for MOE = 100... 28-day Dog study.

      infants/children

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