Thiamethoxam; Pesticide Tolerances, 12731-12740 [2012-4983]

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Download as PDF 12731 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations rmajette on DSK2TPTVN1PROD with PROPOSALS the free form of its acide metabolite CG– 321113 [(E,E)-(methoxyimino)-[2-[1-(3(trifluoromethylphenyl)ethylideneaminooxymethyl]phenyl]acetic acid, in or on imported coffee, green bean at 0.02 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination VerDate Mar<15>2010 15:16 Mar 01, 2012 Jkt 226001 with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104–4). 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), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 17, 2012. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Parts per million Commodity * * * * * * * * * * are no U.S. registrations as of January 18, 2012 for use on coffee, green bean. * * * * * 2 There [FR Doc. 2012–4977 Filed 3–1–12; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2010–1079; FRL–9331–8] Thiamethoxam; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of thiamethoxam in or on multiple commodities which are identified and discussed later in this document. Syngenta Crop Protection, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective March 2, 2012. Objections and requests for hearings must be received on or before May 1, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). SUMMARY: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2010–1079. All documents in the docket are listed in the docket index Therefore, 40 CFR chapter I is available at http://www.regulations.gov. amended as follows: Although listed in the index, some PART 180—[AMENDED] information is not publicly available, e.g., Confidential Business Information ■ 1. The authority citation for part 180 (CBI) or other information whose continues to read as follows: disclosure is restricted by statute. Authority: 21 U.S.C. 321(q), 346a and 371. Certain other material, such as copyrighted material, is not placed on ■ 2. Section 180.555 is amended by the Internet and will be publicly alphabetically adding the following available only in hard copy form. commodity and footnote 2 to the table Publicly available docket materials are in paragraph (a) to read as follows: available in the electronic docket at § 180.555 Trifloxystrobin; tolerances for http://www.regulations.gov, or, if only residues. available in hard copy, at the OPP (a) * * * Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), Parts per 2777 S. Crystal Dr., Arlington, VA. The Commodity million Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket * * * * * Coffee, green bean 2 ................. 0.02 Facility telephone number is (703) 305– 5805. PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 ADDRESSES: E:\FR\FM\02MRR1.SGM 02MRR1 12732 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations FOR FURTHER INFORMATION CONTACT: Gene Benbow, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 347–0235; email address: Benbow.Gene@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/ text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ Title40/40tab_02.tpl. rmajette on DSK2TPTVN1PROD with PROPOSALS C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2010–1079 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 VerDate Mar<15>2010 15:16 Mar 01, 2012 Jkt 226001 received by the Hearing Clerk on or before May 1, 2012. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA–HQ–OPP–2010–1079, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Summary of Petitioned-For Tolerance In the Federal Register of August 26, 2011 (76 FR 53372) (FRL–8884–9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F7805) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.565 be amended by establishing tolerances for residues of the insecticide thiamethoxam, 3-[(2-chloro-5thiazolyl)methyl]tetrahydro-5-methyl-Nnitro-4H-1,3,5-oxadiazin-4-imine and its metabolite, N-[(2-chloro-thiazol-5yl)methyl]-N’-methyl-N’’-nitroguanidine], in or on: buckwheat, grain at 0.02 per million (ppm); buckwheat, forage at 0.50 ppm; buckwheat, hay at 0.02 ppm; buckwheat, straw at 0.02 ppm; oat, grain at 0.02 ppm; oat, forage at 0.50 ppm, oat, hay at 0.02 ppm; oat, straw at 0.02 ppm; millet, pearl, grain at 0.02 ppm; millet, pearl, forage at 0.02 ppm; millet, pearl, stover at 0.02 ppm; millet, proso, grain at 0.02 ppm; millet, proso, forage at 0.02 ppm; millet, proso, PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 stover at 0.02 ppm; millet, proso, straw at 0.02 ppm; rye, grain at 0.02 ppm; rye, forage at 0.50 ppm; rye, straw at 0.02 ppm; teosinte, grain at 0.02 ppm; teosinte, forage at 0.10 ppm; teosinte, stover at 0.05 ppm; triticale, grain at 0.02 ppm; triticale, forage at 0.05 ppm; triticale, hay at 0.02 ppm; triticale, straw at 0.02 ppm; wild rice, grain at 0.02 ppm. That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. 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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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. A. 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. E:\FR\FM\02MRR1.SGM 02MRR1 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations Thiamethoxam shows toxicological effects primarily in the liver, kidney, testes, and hematopoietic system. In addition, developmental neurological effects were observed in rats. This developmental effect is 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. Although thiamethoxam causes liver tumors in mice, the Agency has classified thiamethoxam as ‘‘not likely to be carcinogenic to humans’’ based on convincing evidence that a nongenotoxic mode of action for liver tumors was established in the mouse and that the carcinogenic effects are a result of a mode of action dependent on sufficient amounts of a hepatotoxic metabolite produced persistently. The non-cancer (chronic) assessment is sufficiently protective of the key events (perturbation of liver metabolism, hepatotoxicity/regenerative proliferation) in the animal mode of action for cancer. Specific information on the studies received and the nature of the adverse effects caused by thiamethoxam as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in section 4.5.1 in the document ‘‘Thiamethoxam—Human Health Risk Assessement for Crop Group 15 (including buckwheat, pearl millet, proso millet, oats, rye, teosinte, triticale) and Crop Group 16 Commodities (forage, fodder and straw of cereal grains group)’’ in docket ID number EPA–HQ–OPP–2010–1079 at http://www.regulations.gov. Thiamethoxam produces a metabolite known as CGA–322704 (referred to in the remainder of this rule as clothianidin). Clothianidin is also registered as a pesticide. While some of the toxic effects observed following testing with thiamethoxam and clothianidin are similar, the available information indicates that thiamethoxam and clothianidin have different toxicological effects in mammals and should be assessed separately. A separate risk assessment of clothianidin has been completed in conjunction with the registration of clothianidin. The most recent assessment, which provides details regarding the toxicology of clothianidin, is available in the docket EPA–HQ– OPP–2008–0945, at http:// www.regulations.gov. Refer to the document ‘‘Clothianidin: Human Health Risk Assessment for the Requested New Use on Mustard Seen as well as New Uses of Thiamethoxam on Peanuts, Alfalfa, in Food-Handling Establishments, and as a Seed Treatment for Cereal Grains.’’ B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies 12733 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 (U/S F) 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 nonthreshold 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:// www.epa.gov/pesticides/factsheets/ riskassess.htm. 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 Exposure/scenario Acute dietary (All populations including infants and children). Chronic dietary (All populations including infants and children). rmajette on DSK2TPTVN1PROD with PROPOSALS Incidental oral (all durations). VerDate Mar<15>2010 Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects NOAEL = 34.5 mg/kg/ day UFA = 10x UFH = 10x FQPA SF = 1 NOAEL = 1.2 mg/kg/ day UFA = 10x UFH = 10x FQPA SF = 1 Acute RfD = 0.35 mg/ kg/day. aPAD = 0.35 mg/kg/day Rat Developmental Neurotoxicity study. LOAEL = 298.7 mg/kg/day based on delayed sexual maturation in male pups, and reduced brain morphometric measurements. Chronic RfD = 0.012 mg/kg/day. cPAD = 0.012 mg/kg/ day. NOAEL = 8.23 mg/kg/ day UFA = 10x UFH = 10x FQPA SF = 1 MOE = 100 (residential) 2-Generation reproduction study. 1. LOAEL = 1.8 mg/kg/day based on increased incidence and severity of tubular atrophy in testes of F1 generation males. 2-Generation reproduction study. 2. LOAEL = 3 (males), not determined (females) mg/kg/day based on sperm abnormalities in F1 males. 90-day Dog study. LOAEL = 32 (males) 33.9 (females) mg/kg/day based on slightly prolonged prothrombin times and decreased plasma albumin and A/G ratio (both sexes); decreased calcium levels and ovary weights and delayed maturation in the ovaries (females); decreased cholesterol and phospholipid levels, testis weights, spermatogenesis, and spermatic giant cells in testes (males). 15:16 Mar 01, 2012 Jkt 226001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\02MRR1.SGM 02MRR1 12734 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIAMETHOXAM FOR USE IN HUMAN HEALTH RISK ASSESSMENT—Continued Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Oral study NOAEL = 1.2 mg/kg/day (dermal absorption rate = 5%) UFA = 10x UFH = 10x FQPA SF = 1 Dermal study NOAEL = 60 mg/kg/day UFA = 10x UFH = 10x FQPA SF = 1 Oral study NOAEL = 1.2 mg/kg/day (inhalation absorption rate = 100% of oral absorption) UFA = 10x UFH = 10x FQPA SF = 1 MOE = 100 (residential) 2-Generation reproduction study. LOAEL = 1.8 mg/kg/day based on increased incidence and severity of tubular atrophy in testes of F1 generation males. 2-Generation reproduction study. LOAEL = 3 (males), not determined (females) mg/kg/day based on sperm abnormalities in F1 males. MOE = 100 (residential) Rat 28-Day Dermal Toxicity Study. LOAEL = 250 (females) mg/kg/day based on increased plasma glucose, triglyceride levels, and alkaline phosphatase activity and inflammatory cell infiltration in the liver and necrosis of single hepatocytes in females. 2-Generation reproduction study. LOAEL = 1.8 mg/kg/day based on increased incidence and severity of tubular atrophy in testes of F1 generation males. 2-Generation reproduction study. LOAEL = 3 (males), not determined (females) mg/kg/day based on sperm abnormalities in F1 males. Exposure/scenario Dermal (all durations) (Adults). Dermal (all durations) (infants/children 1–6 yrs). Inhalation (all durations) MOE = 100 (residential) UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. mg/kg/day = milligrams/kilogram/day. rmajette on DSK2TPTVN1PROD with PROPOSALS C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to thiamethoxam, EPA considered exposure under the petitioned-for tolerances as well as all existing thiamethoxam tolerances in 40 CFR 180.565. EPA assessed dietary exposures from thiamethoxam in food as follows: For both acute and chronic exposure assessments for thiamethoxam, EPA combined residues of clothianidin coming from thiamethoxam with residues of thiamethoxam per se. As discussed in this unit, thiamethoxam’s major metabolite is CGA–322704, which is also the registered active ingredient in clothianidin. Available information indicates that thiamethoxam and clothianidin have different toxicological effects in mammals and should be assessed separately; however, these exposure assessments for this action incorporated the total residue of thiamethoxam and clothianidin from use of thiamethoxam because the total residue for each commodity for which thiamethoxam has a tolerance has not been separated between thiamethoxam and its clothianidin metabolite. The combining of these residues, as was done in this assessment, results in highly conservative estimates of dietary exposure and risk. A separate assessment was done for clothianidin. The clothianidin assessment included clothianidin residues from use of VerDate Mar<15>2010 15:16 Mar 01, 2012 Jkt 226001 clothianidin as a pesticide and clothianidin residues from use of thiamethoxam on those commodities for which the pesticide clothianidin does not have a tolerance. As to these commodities, EPA has separated total residues between thiamethoxam and clothianidin. i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for thiamethoxam. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). For residue levels in food, EPA assumed tolerance level residues of thiamethoxam and clothianidin. It was further assumed that 100% of crops with registered or requested uses of thiamethoxam and 100% of crops with registered or requested uses of clothianidin were treated. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA 1994– 1996 and 1998 CSFII. For residue levels in food, EPA assumed tolerance level and/or anticipated residues (averages) from field trial data. It was again assumed that 100% of crops with PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 registered or requested uses of thiamethoxam and 100% of crops with registered or requested uses of clothianidin were treated. A complete listing of the inputs used in these assessments can be found in the following documents: ‘‘Thiamethoxam. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration on Crop Group 15/16 Commodities’’ available in the docket EPA–HQ–OPP–2010–1079, at http:// www.regulations.gov; and ‘‘Clothianidin—Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments to Evaluate Requested Uses on Mustard Seed and Requested uses of Thiamethoxam on Peanuts, in FoodHandling Establishments, and as a Seed Treatment for Cereal Grains,’’ available in the docket EPA–HQ–OPP–2008– 0945, at http://www.regulations.gov. iii. Cancer. EPA concluded that thiamethoxam is ‘‘not likely to be carcinogenic to humans’’ based on convincing evidence that a nongenotoxic mode of action for liver tumors was established in the mouse, and that the carcinogenic effects are a result of a mode of action dependent on sufficient amounts of a hepatotoxic metabolite produced persistently. The non-cancer (chronic) assessment is sufficiently protective of the key events (perturbation of liver metabolism, hepatotoxicity/regenerative proliferation) in the animal mode of E:\FR\FM\02MRR1.SGM 02MRR1 rmajette on DSK2TPTVN1PROD with PROPOSALS Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations action for cancer and thus a separate exposure assessment pertaining to cancer risk is not necessary. Because clothianidin is not expected to pose a cancer risk, a quantitative dietary exposure assessment for the purposes of assessing cancer risk was not conducted. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for thiamethoxam in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of thiamethoxam. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/ oppefed1/models/water/index.htm. Based on the Tier 1 Rice Model for surface water and the Screening Concentration in Ground Water (SCI– GROW) model for ground water, the estimated drinking water concentrations (EDWCs) of thiamethoxam for acute exposures are estimated to be 0.13177 ppm for surface water and 0.00466 ppm for ground water. The chronic exposure for surface water and ground water is estimated to be 0.01131 ppm and 0.00466 ppm respectively. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. Since clothianidin is not a significant degradate of thiamethoxam in surface water or ground water sources of drinking water, it was not included in the EDWCs for the thiamethoxam dietary assessment. For the clothianidin assessments, the EDWC value of 0.0724 ppm for clothianidin was incorporated into the acute and chronic dietary assessments. A complete listing of the inputs used in these assessments can be found in the following documents: ‘‘Thiamethoxam. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration on Crop Group 15/16 Commodities’’ available in the docket EPA–HQ–OPP–2010–1079, at http:// www.regulations.gov; and ‘‘Tier I Drinking Water Exposure Assessment for the Section 3 New Uses of Clothianidin on Rice and Leafy Vegetables,’’ available in the docket EPA–HQ–OPP–2008–0945, at http:// www.regulations.gov. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). VerDate Mar<15>2010 15:16 Mar 01, 2012 Jkt 226001 Thiamethoxam is currently registered for the following uses that could result in residential exposures: Turfgrass on golf courses, residential lawns, commercial grounds, parks, playgrounds, athletic fields, landscapes, interiorscapes, sod farms, and indoor crack and crevice or spot treatments to control insects in residential settings. EPA assessed residential exposure using the assumption that thiamethoxam is applied by commercial applicators only. However, entering areas previously treated with thiamethoxam could lead to exposures for adults and children. As a result, risk assessments have been completed for postapplication scenarios. Short-term postapplication exposures (1 to 30 days of continuous exposure) may occur as a result of activities on treated turf or entering indoor areas previously treated with a thiamethoxam indoor crack and crevice product. EPA combined all non-dietary sources of children’s post application exposure to obtain an estimate of potential combined exposure. These scenarios consisted of dermal postapplication exposure and oral (hand-to-mouth) exposures for children 3 to 6 years of age. A complete listing of the inputs used in these assessments can be found in the document ‘‘Thiamethoxam—Human Health Risk Assessment for Crop Group 15 (including buckwheat, pearl millet, proso millet, oats, rye, teosinte, triticale) and Crop Group 16 Commodities (forage, fodder and straw of cereal grains group)’’ in docket ID number EPA–HQ– OPP–2010–1079 at http:// www.regulations.gov. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/ science/trac6a05.pdf. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ Thiamethoxam is a member of the neonicotinoid class of pesticides and produces, as a metabolite, another neonicotinoid, clothianidin. Structural similarities or common effects do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events. Although clothianidin and thiamethoxam bind PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 12735 selectively to insect nicotinic acetylcholine receptors (nAChR), the specific binding site(s)/receptor(s) for clothianidin, thiamethoxam, and the other neonicotinoids are unknown at this time. Additionally, the commonality of the binding activity itself is uncertain, as preliminary evidence suggests that clothianidin operates by direct competitive inhibition, while thiamethoxam is a non-competitive inhibitor. Furthermore, even if future research shows that neonicotinoids share a common binding activity to a specific site on insect nicotinic acetylcholine receptors, there is not necessarily a relationship between this pesticidal action and a mechanism of toxicity in mammals. Structural variations between the insect and mammalian nAChRs produce quantitative differences in the binding affinity of the neonicotinoids towards these receptors, which, in turn, confers the notably greater selective toxicity of this class towards insects, including aphids and leafhoppers, compared to mammals. While the insecticidal action of the neonicotinoids is neurotoxic, the most sensitive regulatory endpoint for thiamethoxam is based on unrelated effects in mammals, including effects on the liver, kidney, testes, and hematopoietic system. Additionally, the most sensitive toxicological effect in mammals differs across the neonicotinoids (e.g., testicular tubular atrophy with thiamethoxam; mineralized particles in thyroid colloid with imidacloprid). Thus, EPA has not found thiamethoxam or clothianidin to share a common mechanism of toxicity with any other substances. For the purposes of this tolerance action, therefore, EPA has assumed that thiamethoxam and clothianidin do not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s Web site at http:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines, based on reliable data, that a different margin of safety will be safe for infants and children. This additional margin of E:\FR\FM\02MRR1.SGM 02MRR1 rmajette on DSK2TPTVN1PROD with PROPOSALS 12736 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. In the developmental studies, there is no evidence of increased quantitative or qualitative susceptibility of rat or rabbit fetuses to in utero exposure to thiamethoxam. The developmental NOAELs are either higher than or equal to the maternal NOAELs. The toxicological effects in fetuses do not appear to be any more severe than those in the dams or does. In the rat developmental neurotoxicity study, there was no quantitative evidence of increased susceptibility; however, there was increased qualitative susceptibility because the effects in the pups (reduced brain weight and significant changes in brain morphometric measurements) were considered to be more severe than findings in the dams (decreased body weight gain and food consumption). There is evidence of increased quantitative susceptibility for male pups in both 2-generation reproductive studies. In one study, there are no toxicological effects in the dams; whereas, for the pups, reduced bodyweights are observed at the highest dose level, starting on day 14 of lactation. This contributes to an overall decrease in bodyweight gain during the entire lactation period. The reproductive effects in males appear in the F1 generation in the form of increased incidence and severity of testicular tubular atrophy (see developmental/reproductive section). These data are considered to be evidence of increased quantitative susceptibility for male pups (increased incidence of testicular tubular atrophy at 1.8 mg/kg/day) when compared to the parents (hyaline changes in renal tubules at 61 mg/kg/day; NOAEL is 1.8 mg/kg/day). In a more recent 2-generation reproduction study, the most sensitive effect was sperm abnormalities at 3 mg/ kg/day (the NOAEL is 1.2 mg/kg/day) in the F1 males. This study also indicates increased susceptibility for the offspring for this effect. Although there is evidence of increased quantitative susceptibility for male pups in both reproductive studies, NOAELs and LOAELs were established in these studies and the Agency selected the NOAEL for testicular effects in F1 pups as the basis for risk assessment. The Agency has confidence that the NOAEL selected for risk assessment is protective of the most sensitive effect VerDate Mar<15>2010 15:16 Mar 01, 2012 Jkt 226001 (testicular) for the most sensitive subgroup (pups) observed in the toxicological database. 3. Conclusion. i. In the final rule published in the Federal Register of January 5, 2005 (70 FR 708) (FRL–7689– 7), EPA had previously determined that the FQPA SF should be retained at 10X for thiamethoxam, based on the following factors: Effects on endocrine organs observed across species; significant decrease in alanine amino transferase levels in companion animal studies and in dog studies; the mode of action of this chemical in insects (interferes with the nicotinic acetylcholine receptors of the insect’s nervous system); the transient clinical signs of neurotoxicity in several studies across species; and the suggestive evidence of increased quantitative susceptibility in the rat reproduction study. Since that determination, EPA has received and reviewed a developmental neurotoxicity (DNT) study in rats, and an additional reproduction study in rats. Taking the results of these studies into account, as well as the rest of the data on thiamethoxam, EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X (June 23, 2010, 75 FR 35653; FRL– 8830–4); (June 22, 2007, 72 FR 34401). That decision is based on the following findings: a. The toxicity database for thiamethoxam is largely complete, including acceptable/guideline developmental toxicity, 2-generation reproduction, and DNT studies designed to detect adverse effects on the developing organism, which could result from the mechanism that may have produced the decreased alanine amino transferase levels. The available data for thiamethoxam show the potential for immunotoxic effects. In the subchronic dog study, leukopenia (decreased white blood cells) was observed in females only, at the highest dose tested (HDT) of 50 mg/kg/day; the NOAEL for this effect was 34 mg/kg/ day. The overall study NOAEL was 9.3 mg/kg/day in females (8.2 mg/kg/day in males) based on hematology and other clinical chemistry findings at the LOAEL of 34 mg/kg/day (32 mg/kg/day in males). In the subchronic mouse study, decreased spleen weights were observed in females at 626 mg/kg/day; the NOAEL for this effect was the next lowest dose of 231 mg/kg/day. The overall study NOAEL was 1.4 mg/kg/ day (males) based on increased hepatocyte hypertrophy observed at the LOAEL of 14.3 mg/kg/day. The decreased absolute spleen weights were PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 considered to be treatment related, but were not statistically significant at 626 mg/kg/day or at the HDT of 1,163 mg/ kg/day. Since spleen weights were not decreased relative to body weights, the absolute decreases may have been related to the decreases in body weight gain observed at higher doses. Overall, the Agency has a low concern for the potential for immunotoxicity related to these effects for the following reasons: In general, the Agency does not consider alterations in hematology parameters alone to be a significant indication of potential immunotoxicity. In the case of thiamethoxam, high-dose females in the subchronic dog study had slight microcytic anemia as well as leukopenia characterized by reductions in neutrophils, lymphocytes and monocytes; the leukopenia was considered to be related to the anemic response to exposure. Further, endpoints and doses selected for risk assessment are protective of the observed effects on hematology. Spleen weight decreases, while considered treatment-related, were associated with decreases in body weight gain, and were not statistically significant. In addition, spleen weight changes occurred only at very high doses, more than 70 times higher than the doses selected for risk assessment. In addition to the previous considerations, a 28-day immunotoxicity study in female mice was recently received and has undergone a preliminary review. There were no immunotoxic effects observed at doses exceeding the limit dose of 1,000 mg/kg/day. b. For the reasons discussed in Unit III.D.2., there is low concern for an increased susceptibility in the young. c. Although there is evidence of neurotoxicity after acute exposure to thiamethoxam at doses of 500 mg/kg/ day including drooped palpebral closure, decrease in rectal temperature and locomotor activity and increase in forelimb grip strength, no evidence of neuropathology was observed. These effects occurred at doses at least 14-fold and 416-fold higher than the doses used for the acute, and chronic risk assessments, respectively; thus, there is low concern for these effects since it is expected that the doses used for regulatory purposes would be protective of the effects noted at much higher doses. In the developmental neurotoxicity study (DNT), there was no evidence of neurotoxicity in the dams exposed up to 298.7 mg/kg/day; a dose that was associated with decreases in body weight gain and food consumption. In pups exposed to 298.7 mg/kg/day, there E:\FR\FM\02MRR1.SGM 02MRR1 rmajette on DSK2TPTVN1PROD with PROPOSALS Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations were significant reductions in absolute brain weight and size (i.e., length and width of the cerebellum was less in males on day 12, and there were significant decreases in Level 3–5 measurements in males and in Level 4– 5 measurements in females on day 63). However, there is low concern for this increased qualitative susceptibility observed in the DNT study because the doses and endpoints selected for risk assessment are protective of the effects in the offspring. As noted previously, for risk assessment the Agency selected the NOAEL for testicular effects in F1 pups based on two reproductive toxicity studies to be protective of all sensitive subpopulations. d. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed using tolerance-level and/or anticipated residues that are based on reliable field trial data observed in the thiamethoxam field trials. Although there is available information indicating that thiamethoxam and clothianidin have different toxicological effects in mammals and should be assessed separately, the residues of each have been combined in these assessments to ensure that the estimated exposures of thiamethoxam do not underestimate actual potential thiamethoxam exposures. An assumption of 100 percent crop treated (PCT) was made for all foods evaluated in the assessments. For the acute and chronic assessments, the EDWCs of 131.77 parts per billion (ppb) and 11.3 ppb, respectively, were used to estimate exposure via drinking water. Compared to the results from small scale prospective ground water studies where the maximum observed residue levels from any monitoring well were 1.0 ppb for thiamethoxam and 0.73 ppb for clothianidin, the modeled estimates are protective of what actual exposures are likely to be. EPA used similarly conservative (protective) assumptions to assess postapplication exposure to children and adults including incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by thiamethoxam. ii. In the final rule published in the Federal Register of February 6, 2008 (73 FR 6851) (FRL–8346–9), EPA had previously determined that the FQPA SF for clothianidin should be retained at 10X because EPA had required the submission of a developmental immunotoxicity study to address the combination of evidence of decreased absolute and adjusted organ weights of the thymus and spleen in multiple studies in the clothianidin database, and VerDate Mar<15>2010 15:16 Mar 01, 2012 Jkt 226001 evidence showing that juvenile rats in the 2-generation reproduction study appear to be more susceptible to these potential immunotoxic effects. In the absence of a developmental immunotoxicity study, EPA concluded that there was sufficient uncertainty regarding immunotoxic effects in the young that the 10X FQPA factor should be retained as a database uncertainty factor. Since that determination, EPA has received and reviewed an acceptable/ guideline developmental immunotoxicity study, which demonstrated no treatment-related effects. Taking the results of this study into account, as well as the rest of the data on clothianidin, EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF for clothianidin were reduced to 1X (February 11, 2011, 76 FR 7712) (FRL– 8858–3). That decision is based on the following findings: a. The toxicity database for clothianidin is complete. As noted, the prior data gap concerning developmental immunotoxicity has been addressed by the submission of an acceptable developmental immunotoxicity study. b. A rat developmental neurotoxicity study is available and shows evidence of increased quantitative susceptibility of offspring. However, EPA considers the degree of concern for the developmental neurotoxicity study to be low for prenatal and postnatal toxicity because the NOAEL and LOAEL were well characterized, and the doses and endpoints selected for risk assessment are protective of the observed susceptibility; therefore, there are no residual concerns regarding effects in the young. c. While the rat multi-generation reproduction study showed evidence of increased quantitative susceptibility of offspring compared to adults, the degree of concern is low because the study NOAEL and LOAEL have been selected for risk assessment purposes for relevant exposure routes and durations. In addition, the potential immunotoxic effects observed in the study have been further characterized with the submission of a developmental immunotoxicity study that showed no evidence of susceptibility. As a result, there are no concerns or residual uncertainties for prenatal and postnatal toxicity after establishing toxicity endpoints and traditional UFs to be used in the risk assessment for clothianidin. d. There are no residual uncertainties identified in the exposure databases. PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 12737 The dietary food exposure assessments were performed based on assumptions that were judged to be highly conservative and health-protective for all durations and population subgroups, including tolerance-level residues, adjustment factors from metabolite data, empirical processing factors, and 100 PCT for all commodities. Additionally, EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to clothianidin in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children and adults as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by clothianidin. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to thiamethoxam will occupy 9.5% of the aPAD for All infants (<1 year), the population group receiving the greatest exposure. Acute dietary exposure from food and water to clothianidin is estimated to occupy 23% of the aPAD for children 1 to 2 years old, the population group receiving the greatest exposure. 2. Chronic risk. In examining chronic aggregate risk, EPA has assumed that the only pathway of exposure relevant to that time frame is dietary exposure. Using this assumption for chronic exposure, EPA has concluded that chronic exposure to thiamethoxam from food and water will utilize 43% of the cPAD for Children 1 to 2 years old, the population group receiving the greatest exposure. Chronic exposure to clothianidin from food and water will utilize 19% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water E:\FR\FM\02MRR1.SGM 02MRR1 rmajette on DSK2TPTVN1PROD with PROPOSALS 12738 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations (considered to be a background exposure level). Thiamethoxam is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to thiamethoxam. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures for thiamethoxam result in aggregate MOEs of: 370 for the general U.S. population; 490 for all infants; 440 for children 1 to 2 years; 450 for children 3 to 5 years; 370 for children 6 to 12 years; 380 for youth 13 to 19 years, adults 20 to 49 years, adults 50+ years, and females 13 to 49 years. Because EPA’s level of concern for thiamethoxam is a MOE of 100 or below, these MOEs are not of concern. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures for clothianidin result in aggregate MOEs of: 1,200 for the general U.S. population; 480 for all infants (<1 year); 370 for children 1 to 2 years; 490 for children 3 to 5 years; 1,000 for children 6 to 12 years; 1,400 for youth 13 to 19 years, adults 20–49 years, and females 13 to 49 years; and 1,300 for adults 50+ years. Because EPA’s level of concern for clothianidin is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Thiamethoxam is currently registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to thiamethoxam. Using the exposure assumptions described in this unit for intermediateterm exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures for thiamethoxam result in aggregate MOEs of: 370 for the general U.S. population; 540 for all infants (<1 year); 470 for children 1 to 2 years; 490 for children 3 to 5 years; 370 for children 6 to 12 years; 380 for youth 13 to 19 years, adults 20 to 49 years, adults 50+ years, and females 13 to 49 years. Because EPA’s level of concern for VerDate Mar<15>2010 15:16 Mar 01, 2012 Jkt 226001 thiamethoxam is a MOE of 100 or below, these MOEs are not of concern. Using the exposure assumptions described in this unit for intermediate exposures, EPA has concluded the combined intermediate food, water, and residential exposures for clothianidin result in aggregate MOEs of: 1,200 for the general U.S. population; 480 for all infants (<1 year); 370 for children 1 to 2 years; 490 for children 3 to 5 years; 1,000 for children 6 to 12 years; 1,400 for youth 13 to 19 years, adults 20 to 49 years, and females 13 to 49 years; and 1,300 for adults 50+ years. Because EPA’s level of concern for clothianidin is a MOE of 100 or below, these MOEs are not of concern. 5. Aggregate cancer risk for U.S. population. The Agency has classified thiamethoxam as not likely to be a human carcinogen based on convincing evidence that a non-genotoxic mode of action for liver tumors was established in the mouse and that the carcinogenic effects are a result of a mode of action dependent on sufficient amounts of a hepatotoxic metabolite produced persistently. Therefore, thiamethoxam is not expected to pose a cancer risk. Clothianidin has been classified as ‘‘not likely to be a human carcinogen’’ and is not expected to pose a cancer risk. 6. Determination of safety. Based on these risk assessments, 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 thiamethoxam or clothianidin residues. IV. Other Considerations A. Analytical Enforcement Methodology The High Production Liquid Chromatography (HPLC) Method AG– 675 with ultraviolet (UV) or Mass Spectrometry (MS) detection was previously submitted in conjunction with thiamethoxam petitions. Method AG–675 has been determined to be adequate for enforcing the tolerance expression for residues of thiamethoxam and CGA–322704 in crop and livestock commodities. Syngenta Crop Protection, Inc., has submitted a revised Method AG–675, i.e., Method GRM.009.04A. The full extraction steps for plant and livestock commodities, including the microwave extraction step for liver, have been incorporated. The limits of quantitation (LOQs) of Method GRM.009.04A have been established at 0.01 ppm each for residues of thiamethoxam, CGA–322704 and CGA– 265307. Method validation data are available for Method GRM.009.04A. The method may be requested from: Chief, Analytical Chemistry Branch, PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. 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. EPA is increasing the barley grain tolerance to 0.4 ppm in order to harmonize with the Codex MRL of 0.4 ppm. The MRL expressions continue to remain different, as the Codex MRL is for the parent compound only. C. Revisions to Petitioned-For Tolerances Although the petitioner sought tolerances for many of the commodities in Crop Groups 15 and 16, the petitioner did not request crop group tolerances. EPA has determined that a tolerance for either Crop Group 15 or Crop Group 16 commodities is not appropriate except for Crop Group 15 grains (except barley), because the use pattern is not the same for all Crop Group 15 commodities. Specifically, there is a foliar use on barley and there are much higher tolerances for barley hay and straw associated with this foliar use. It is for similar reasons that a Crop Group 16 tolerance would not be appropriate. In addition, there are also significant differences in the tolerances for the different cereal forages, i.e., wheat forage at 0.5 ppm, corn forage at 0.10 ppm, and sorghum forage at 0.02 ppm. Therefore, tolerances for each individual commodity have been established by translating residue data from the most appropriate representative commodity, except for grains which all have the same tolerance (excluding barley). Tolerances are not required for triticale and wild rice because these commodities are covered by the wheat and rice tolerances, as E:\FR\FM\02MRR1.SGM 02MRR1 12739 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations specified in 40 CFR 180.1. Tolerances are also not needed for teosinte forage and stover as these are not considered significant livestock feed items and are not consumed by humans. rmajette on DSK2TPTVN1PROD with PROPOSALS V. Conclusion Therefore, tolerances are established for residues of thiamethoxam, 3-[(2chloro-5-thiazolyl)methyl]tetrahydro-5methyl-N-nitro-4H-1,3,5-oxadiazin-4imine and its metabolite, N-[(2-chlorothiazol-5-yl)methyl]-N ′-methyl-N ″nitro-guanidine, in or on barley, grain at 0.4 ppm; buckwheat, forage at 0.50 ppm; buckwheat, hay at 0.02 ppm; buckwheat, straw at 0.02 ppm; grain, cereal, group 15, except barley at 0.02 ppm; oat, forage at 0.50 ppm, oat, hay at 0.02 ppm; oat, straw at 0.02 ppm; millet, pearl, forage at 0.02 ppm; millet, pearl, stover at 0.02 ppm; millet, proso, forage at 0.02 ppm; millet, proso, stover at 0.02 ppm; millet, proso, straw at 0.02 ppm; rye, forage at 0.50 ppm; rye, straw at 0.02 ppm. Tolerances are revoked for corn, field, grain; corn, pop, grain; rice, grain; sorghum, grain; wheat, grain. These tolerances are no longer needed, since residues on these commodities will be covered by the crop group 15 tolerances being established in this rule. In addition, administrative corrections are being made to the existing tolerances for grain, aspirated fractions and soybean, hulls, as follows: The tolerance for grain, aspirated fractions at 0.08 ppm is being corrected to grain, aspirated fractions at 2.0 ppm; the tolerance for soybean, hulls at 2.0 ppm is being corrected to soybean, hulls at 0.08 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special VerDate Mar<15>2010 16:28 Mar 01, 2012 Jkt 226001 considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104–4). 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), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 17, 2012. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.565 paragraph (a) is revised to read as follows: ■ § 180.565 Thiamethoxam; tolerances for residues. (a) General. Tolerances are established for residues of the insecticide thiamethoxam, including its metabolites and degradates, in or on the following commodities. Compliance with the tolerance levels specified below is to be determined by measuring only thiamethoxam 3-[(2-chloro-5thiazolyl)methyl]tetrahydro-5-methyl-Nnitro-4H-1,3,5-oxadiazin-4-imine and its metabolite CGA–322704 N-[(2-chlorothiazol-5-yl)methyl]-N′-methyl-N″-nitroguanidine, calculated as the stoichiometric equivalent of thiamethoxam, in or on the following commodities: Commodity Alfalfa, forage ......................... Alfalfa, hay .............................. Almond, hulls .......................... Artichoke, globe ...................... Avocado .................................. Barley, grain ........................... Barley, hay .............................. Barley, straw ........................... Bean, succulent ...................... Berry, low growing, subgroup 13–07G, except cranberry .. Borage, seed .......................... Brassica, head and stem, subgroup 5–A ........................... Brassica, leafy greens, subgroup 5–B ........................... Buckwheat, forage .................. Buckwheat, hay ...................... Buckwheat, straw ................... Bushberry subgroup 13–07B, except lingonberry and blueberry, lowbush .............. Canistel ................................... Canola, seed .......................... Cattle, meat ............................ E:\FR\FM\02MRR1.SGM 02MRR1 Parts per million 0.05 0.12 1.2 0.45 0.40 0.4 0.40 0.40 0.02 0.30 0.02 4.5 3.0 0.50 0.02 0.02 0.20 0.40 0.02 0.02 12740 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations rmajette on DSK2TPTVN1PROD with PROPOSALS Commodity Parts per million Cattle, meat byproducts ......... Citrus, dried pulp .................... Coffee, bean, green 1 ............. Corn, field, forage ................... Corn, field, stover ................... Corn, pop, forage ................... Corn, pop, stover .................... Corn, sweet, forage ................ Corn, sweet, kernel plus cob with husks removed ............ Corn, sweet, stover ................ Cotton, gin byproducts ........... Cotton, undelinted seed ......... Crambe, seed ......................... Cranberry ................................ Flax, seed ............................... Food commodities and feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food/ feed handling establishments .................................. Fruit, citrus, group 10 ............. Fruit, pome, group 11 ............. Fruit, small, vine climbing, subgroup 13–07F, except fuzzy kiwifruit ....................... Fruit, stone, group 12 ............. Goat, meat .............................. Goat, meat byproducts ........... Grain, aspirated fractions ....... Grain, cereal, group 15, except barley .......................... Grape, raisin ........................... Hog, meat ............................... Hog, meat byproducts ............ Hop, dried cones .................... Horse, meat ............................ Horse, meat byproducts ......... Mango ..................................... Milk ......................................... Millet, pearl, forage ................. Millet, pearl, stover ................. Millet, proso, forage ................ Millet, proso, stover ................ Millet, proso, straw ................. Oat, forage .............................. Oat, hay .................................. Oat, straw ............................... Peanut .................................... Peanut, hay ............................ Peanut, meal .......................... Peppermint, tops .................... Pistachio ................................. Potato ..................................... Radish, tops ............................ Rapeseed, seed ..................... Rye, forage ............................. Rye, straw ............................... Sapodilla ................................. Sapote, black .......................... Sapote, mamey ...................... Sheep, meat ........................... Sheep, meat byproducts ........ Sorghum, forage ..................... Sorghum, grain, stover ........... Soybean, hulls ........................ Spearmint, tops ...................... Star apple ............................... Sunflower ................................ Tomato, paste ......................... Vegetable, cucurbit, group 9 .. VerDate Mar<15>2010 15:16 Mar 01, 2012 0.04 0.60 0.05 0.10 0.05 0.10 0.05 0.10 0.02 0.05 1.5 0.10 0.02 0.02 0.02 Parts per million Commodity Vegetable, fruiting, group 8 .... Vegetable, leafy, except brassica, group 4 ....................... Vegetable, legume, group 6 ... Vegetable, root, subgroup 1A Vegetable, tuberous and corm, except potato, subgroup 1D ............................. Wheat, forage ......................... Wheat, hay ............................. Wheat, straw ........................... 0.25 4.0 0.02 0.05 0.02 0.50 0.02 0.02 1 There are no U.S. registrations as of September 17, 2003. * * * * * [FR Doc. 2012–4983 Filed 3–1–12; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 0.02 0.40 0.2 0.20 0.5 0.02 0.04 2.0 0.02 0.30 0.02 0.02 0.10 0.02 0.04 0.40 0.02 0.02 0.02 0.02 0.02 0.02 0.50 0.02 0.02 0.05 0.25 0.15 1.5 0.02 0.25 0.80 0.02 0.50 0.02 0.40 0.40 0.40 0.02 0.04 0.02 0.02 0.08 1.5 0.40 0.02 0.80 0.2 Jkt 226001 40 CFR Part 180 [EPA–HQ–OPP–2010–0524; FRL–9337–9] Trinexapac-ethyl; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of trinexapacethyl in or on multiple commodities which are identified and discussed later in this document. Syngenta Crop Protection, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective March 2, 2012. Objections and requests for hearings must be received on or before May 1, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). SUMMARY: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2010–0524. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) 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 in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– ADDRESSES: PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Bethany Benbow, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 347–8072; email address: benbow.bethany@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/ text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation E:\FR\FM\02MRR1.SGM 02MRR1

Agencies

[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Rules and Regulations]
[Pages 12731-12740]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4983]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-1079; FRL-9331-8]


Thiamethoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
thiamethoxam in or on multiple commodities which are identified and 
discussed later in this document. Syngenta Crop Protection, Inc. 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective March 2, 2012. Objections and 
requests for hearings must be received on or before May 1, 2012, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-1079. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

[[Page 12732]]


FOR FURTHER INFORMATION CONTACT: Gene Benbow, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 347-0235; email address: Benbow.Gene@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2010-1079 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 
May 1, 2012. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-1079, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0F7805) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR 180.565 be amended by 
establishing tolerances for residues of the insecticide thiamethoxam, 
3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite, N-[(2-chloro-thiazol-5-
yl)methyl]-N'-methyl-N''-nitro-guanidine], in or on: buckwheat, grain 
at 0.02 per million (ppm); buckwheat, forage at 0.50 ppm; buckwheat, 
hay at 0.02 ppm; buckwheat, straw at 0.02 ppm; oat, grain at 0.02 ppm; 
oat, forage at 0.50 ppm, oat, hay at 0.02 ppm; oat, straw at 0.02 ppm; 
millet, pearl, grain at 0.02 ppm; millet, pearl, forage at 0.02 ppm; 
millet, pearl, stover at 0.02 ppm; millet, proso, grain at 0.02 ppm; 
millet, proso, forage at 0.02 ppm; millet, proso, stover at 0.02 ppm; 
millet, proso, straw at 0.02 ppm; rye, grain at 0.02 ppm; rye, forage 
at 0.50 ppm; rye, straw at 0.02 ppm; teosinte, grain at 0.02 ppm; 
teosinte, forage at 0.10 ppm; teosinte, stover at 0.05 ppm; triticale, 
grain at 0.02 ppm; triticale, forage at 0.05 ppm; triticale, hay at 
0.02 ppm; triticale, straw at 0.02 ppm; wild rice, grain at 0.02 ppm. 
That notice referenced a summary of the petition prepared by Syngenta 
Crop Protection, Inc., the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.

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

A. 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 12733]]

    Thiamethoxam shows toxicological effects primarily in the liver, 
kidney, testes, and hematopoietic system. In addition, developmental 
neurological effects were observed in rats. This developmental effect 
is 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. Although thiamethoxam causes liver 
tumors in mice, the Agency has classified thiamethoxam as ``not likely 
to be carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse 
and that the carcinogenic effects are a result of a mode of action 
dependent on sufficient amounts of a hepatotoxic metabolite produced 
persistently. The non-cancer (chronic) assessment is sufficiently 
protective of the key events (perturbation of liver metabolism, 
hepatotoxicity/regenerative proliferation) in the animal mode of action 
for cancer.
    Specific information on the studies received and the nature of the 
adverse effects caused by thiamethoxam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in section 4.5.1 in the document ``Thiamethoxam--
Human Health Risk Assessement for Crop Group 15 (including buckwheat, 
pearl millet, proso millet, oats, rye, teosinte, triticale) and Crop 
Group 16 Commodities (forage, fodder and straw of cereal grains 
group)'' in docket ID number EPA-HQ-OPP-2010-1079 at http://www.regulations.gov.
    Thiamethoxam produces a metabolite known as CGA-322704 (referred to 
in the remainder of this rule as clothianidin). Clothianidin is also 
registered as a pesticide. While some of the toxic effects observed 
following testing with thiamethoxam and clothianidin are similar, the 
available information indicates that thiamethoxam and clothianidin have 
different toxicological effects in mammals and should be assessed 
separately. A separate risk assessment of clothianidin has been 
completed in conjunction with the registration of clothianidin. The 
most recent assessment, which provides details regarding the toxicology 
of clothianidin, is available in the docket EPA-HQ-OPP-2008-0945, at 
http://www.regulations.gov. Refer to the document ``Clothianidin: Human 
Health Risk Assessment for the Requested New Use on Mustard Seen as 
well as New Uses of Thiamethoxam on Peanuts, Alfalfa, in Food-Handling 
Establishments, and as a Seed Treatment for Cereal Grains.''

B. 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 (U/S F) 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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Point of departure and uncertainty/   RfD, PAD, LOC for risk
           Exposure/scenario                      safety  factors                   assessment                  Study and toxicological effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute dietary (All populations          NOAEL = 34.5 mg/kg/day               Acute RfD = 0.35 mg/kg/   Rat Developmental Neurotoxicity study.
 including infants and children).       UFA = 10x                             day.                     LOAEL = 298.7 mg/kg/day based on delayed sexual
                                        UFH = 10x                            aPAD = 0.35 mg/kg/day...   maturation in male pups, and reduced brain
                                        FQPA SF = 1                                                     morphometric measurements.
Chronic dietary (All populations        NOAEL = 1.2 mg/kg/day                Chronic RfD = 0.012 mg/   2-Generation reproduction study.
 including infants and children).       UFA = 10x                             kg/day.                  1. LOAEL = 1.8 mg/kg/day based on increased
                                        UFH = 10x                            cPAD = 0.012 mg/kg/day..   incidence and severity of tubular atrophy in
                                        FQPA SF = 1                                                     testes of F1 generation males.
                                                                                                       2-Generation reproduction study.
                                                                                                       2. LOAEL = 3 (males), not determined (females) mg/
                                                                                                        kg/day based on sperm abnormalities in F1 males.
Incidental oral (all durations).......  NOAEL = 8.23 mg/kg/day               MOE = 100 (residential).  90-day Dog study.
                                        UFA = 10x                                                      LOAEL = 32 (males) 33.9 (females) mg/kg/day based
                                        UFH = 10x                                                       on slightly prolonged prothrombin times and
                                        FQPA SF = 1                                                     decreased plasma albumin and A/G ratio (both
                                                                                                        sexes); decreased calcium levels and ovary
                                                                                                        weights and delayed maturation in the ovaries
                                                                                                        (females); decreased cholesterol and
                                                                                                        phospholipid levels, testis weights,
                                                                                                        spermatogenesis, and spermatic giant cells in
                                                                                                        testes (males).

[[Page 12734]]

 
Dermal (all durations) (Adults).......  Oral study NOAEL = 1.2 mg/kg/day     MOE = 100 (residential).  2-Generation reproduction study.
                                         (dermal absorption rate = 5%)                                 LOAEL = 1.8 mg/kg/day based on increased
                                        UFA = 10x                                                       incidence and severity of tubular atrophy in
                                        UFH = 10x                                                       testes of F1 generation males.
                                        FQPA SF = 1                                                    2-Generation reproduction study.
                                                                                                       LOAEL = 3 (males), not determined (females) mg/kg/
                                                                                                        day based on sperm abnormalities in F1 males.
Dermal (all durations) (infants/        Dermal study NOAEL = 60 mg/kg/day    MOE = 100 (residential).  Rat 28-Day Dermal Toxicity Study.
 children 1-6 yrs).                     UFA = 10x                                                      LOAEL = 250 (females) mg/kg/day based on
                                        UFH = 10x                                                       increased plasma glucose, triglyceride levels,
                                        FQPA SF = 1                                                     and alkaline phosphatase activity and
                                                                                                        inflammatory cell infiltration in the liver and
                                                                                                        necrosis of single hepatocytes in females.
Inhalation (all durations)............  Oral study NOAEL = 1.2 mg/kg/day     MOE = 100 (residential).  2-Generation reproduction study.
                                         (inhalation absorption rate = 100%                            LOAEL = 1.8 mg/kg/day based on increased
                                         of oral absorption)                                            incidence and severity of tubular atrophy in
                                        UFA = 10x                                                       testes of F1 generation males.
                                        UFH = 10x                                                      2-Generation reproduction study.
                                        FQPA SF = 1                                                    LOAEL = 3 (males), not determined (females) mg/kg/
                                                                                                        day based on sperm abnormalities in F1 males.
--------------------------------------------------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
  FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of
  exposure. LOC = level of concern. mg/kg/day = milligrams/kilogram/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to thiamethoxam, EPA considered exposure under the petitioned-
for tolerances as well as all existing thiamethoxam tolerances in 40 
CFR 180.565. EPA assessed dietary exposures from thiamethoxam in food 
as follows:
    For both acute and chronic exposure assessments for thiamethoxam, 
EPA combined residues of clothianidin coming from thiamethoxam with 
residues of thiamethoxam per se. As discussed in this unit, 
thiamethoxam's major metabolite is CGA-322704, which is also the 
registered active ingredient in clothianidin. Available information 
indicates that thiamethoxam and clothianidin have different 
toxicological effects in mammals and should be assessed separately; 
however, these exposure assessments for this action incorporated the 
total residue of thiamethoxam and clothianidin from use of thiamethoxam 
because the total residue for each commodity for which thiamethoxam has 
a tolerance has not been separated between thiamethoxam and its 
clothianidin metabolite. The combining of these residues, as was done 
in this assessment, results in highly conservative estimates of dietary 
exposure and risk. A separate assessment was done for clothianidin. The 
clothianidin assessment included clothianidin residues from use of 
clothianidin as a pesticide and clothianidin residues from use of 
thiamethoxam on those commodities for which the pesticide clothianidin 
does not have a tolerance. As to these commodities, EPA has separated 
total residues between thiamethoxam and clothianidin.
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for thiamethoxam. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). For residue levels in food, EPA 
assumed tolerance level residues of thiamethoxam and clothianidin. It 
was further assumed that 100% of crops with registered or requested 
uses of thiamethoxam and 100% of crops with registered or requested 
uses of clothianidin were treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. For residue levels in food, EPA assumed tolerance level 
and/or anticipated residues (averages) from field trial data. It was 
again assumed that 100% of crops with registered or requested uses of 
thiamethoxam and 100% of crops with registered or requested uses of 
clothianidin were treated.
    A complete listing of the inputs used in these assessments can be 
found in the following documents: ``Thiamethoxam. Acute and Chronic 
Aggregate Dietary (Food and Drinking Water) Exposure and Risk 
Assessments for the Section 3 Registration on Crop Group 15/16 
Commodities'' available in the docket EPA-HQ-OPP-2010-1079, at http://www.regulations.gov; and ``Clothianidin--Acute and Chronic Aggregate 
Dietary (Food and Drinking Water) Exposure and Risk Assessments to 
Evaluate Requested Uses on Mustard Seed and Requested uses of 
Thiamethoxam on Peanuts, in Food-Handling Establishments, and as a Seed 
Treatment for Cereal Grains,'' available in the docket EPA-HQ-OPP-2008-
0945, at http://www.regulations.gov.
    iii. Cancer. EPA concluded that thiamethoxam is ``not likely to be 
carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse, 
and that the carcinogenic effects are a result of a mode of action 
dependent on sufficient amounts of a hepatotoxic metabolite produced 
persistently. The non-cancer (chronic) assessment is sufficiently 
protective of the key events (perturbation of liver metabolism, 
hepatotoxicity/regenerative proliferation) in the animal mode of

[[Page 12735]]

action for cancer and thus a separate exposure assessment pertaining to 
cancer risk is not necessary. Because clothianidin is not expected to 
pose a cancer risk, a quantitative dietary exposure assessment for the 
purposes of assessing cancer risk was not conducted.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for thiamethoxam in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of thiamethoxam. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier 1 Rice Model for surface water and the Screening 
Concentration in Ground Water (SCI-GROW) model for ground water, the 
estimated drinking water concentrations (EDWCs) of thiamethoxam for 
acute exposures are estimated to be 0.13177 ppm for surface water and 
0.00466 ppm for ground water. The chronic exposure for surface water 
and ground water is estimated to be 0.01131 ppm and 0.00466 ppm 
respectively. Modeled estimates of drinking water concentrations were 
directly entered into the dietary exposure model.
    Since clothianidin is not a significant degradate of thiamethoxam 
in surface water or ground water sources of drinking water, it was not 
included in the EDWCs for the thiamethoxam dietary assessment. For the 
clothianidin assessments, the EDWC value of 0.0724 ppm for clothianidin 
was incorporated into the acute and chronic dietary assessments.
    A complete listing of the inputs used in these assessments can be 
found in the following documents: ``Thiamethoxam. Acute and Chronic 
Aggregate Dietary (Food and Drinking Water) Exposure and Risk 
Assessments for the Section 3 Registration on Crop Group 15/16 
Commodities'' available in the docket EPA-HQ-OPP-2010-1079, at http://www.regulations.gov; and ``Tier I Drinking Water Exposure Assessment 
for the Section 3 New Uses of Clothianidin on Rice and Leafy 
Vegetables,'' available in the docket EPA-HQ-OPP-2008-0945, at http://www.regulations.gov.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Thiamethoxam is 
currently registered for the following uses that could result in 
residential exposures: Turfgrass on golf courses, residential lawns, 
commercial grounds, parks, playgrounds, athletic fields, landscapes, 
interiorscapes, sod farms, and indoor crack and crevice or spot 
treatments to control insects in residential settings. EPA assessed 
residential exposure using the assumption that thiamethoxam is applied 
by commercial applicators only. However, entering areas previously 
treated with thiamethoxam could lead to exposures for adults and 
children. As a result, risk assessments have been completed for 
postapplication scenarios.
    Short-term postapplication exposures (1 to 30 days of continuous 
exposure) may occur as a result of activities on treated turf or 
entering indoor areas previously treated with a thiamethoxam indoor 
crack and crevice product. EPA combined all non-dietary sources of 
children's post application exposure to obtain an estimate of potential 
combined exposure. These scenarios consisted of dermal postapplication 
exposure and oral (hand-to-mouth) exposures for children 3 to 6 years 
of age.
    A complete listing of the inputs used in these assessments can be 
found in the document ``Thiamethoxam--Human Health Risk Assessment for 
Crop Group 15 (including buckwheat, pearl millet, proso millet, oats, 
rye, teosinte, triticale) and Crop Group 16 Commodities (forage, fodder 
and straw of cereal grains group)'' in docket ID number EPA-HQ-OPP-
2010-1079 at http://www.regulations.gov. Further information regarding 
EPA standard assumptions and generic inputs for residential exposures 
may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Thiamethoxam is a member of the neonicotinoid class of pesticides 
and produces, as a metabolite, another neonicotinoid, clothianidin. 
Structural similarities or common effects do not constitute a common 
mechanism of toxicity. Evidence is needed to establish that the 
chemicals operate by the same, or essentially the same sequence of 
major biochemical events. Although clothianidin and thiamethoxam bind 
selectively to insect nicotinic acetylcholine receptors (nAChR), the 
specific binding site(s)/receptor(s) for clothianidin, thiamethoxam, 
and the other neonicotinoids are unknown at this time. Additionally, 
the commonality of the binding activity itself is uncertain, as 
preliminary evidence suggests that clothianidin operates by direct 
competitive inhibition, while thiamethoxam is a non-competitive 
inhibitor. Furthermore, even if future research shows that 
neonicotinoids share a common binding activity to a specific site on 
insect nicotinic acetylcholine receptors, there is not necessarily a 
relationship between this pesticidal action and a mechanism of toxicity 
in mammals. Structural variations between the insect and mammalian 
nAChRs produce quantitative differences in the binding affinity of the 
neonicotinoids towards these receptors, which, in turn, confers the 
notably greater selective toxicity of this class towards insects, 
including aphids and leafhoppers, compared to mammals. While the 
insecticidal action of the neonicotinoids is neurotoxic, the most 
sensitive regulatory endpoint for thiamethoxam is based on unrelated 
effects in mammals, including effects on the liver, kidney, testes, and 
hematopoietic system. Additionally, the most sensitive toxicological 
effect in mammals differs across the neonicotinoids (e.g., testicular 
tubular atrophy with thiamethoxam; mineralized particles in thyroid 
colloid with imidacloprid).
    Thus, EPA has not found thiamethoxam or clothianidin to share a 
common mechanism of toxicity with any other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
thiamethoxam and clothianidin do not have a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's Web site 
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines, based on reliable data, that a 
different margin of safety will be safe for infants and children. This 
additional margin of

[[Page 12736]]

safety is commonly referred to as the FQPA SF. In applying this 
provision, EPA either retains the default value of 10X, or uses a 
different additional safety factor when reliable data available to EPA 
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. In the developmental 
studies, there is no evidence of increased quantitative or qualitative 
susceptibility of rat or rabbit fetuses to in utero exposure to 
thiamethoxam. The developmental NOAELs are either higher than or equal 
to the maternal NOAELs. The toxicological effects in fetuses do not 
appear to be any more severe than those in the dams or does. In the rat 
developmental neurotoxicity study, there was no quantitative evidence 
of increased susceptibility; however, there was increased qualitative 
susceptibility because the effects in the pups (reduced brain weight 
and significant changes in brain morphometric measurements) were 
considered to be more severe than findings in the dams (decreased body 
weight gain and food consumption).
    There is evidence of increased quantitative susceptibility for male 
pups in both 2-generation reproductive studies. In one study, there are 
no toxicological effects in the dams; whereas, for the pups, reduced 
bodyweights are observed at the highest dose level, starting on day 14 
of lactation. This contributes to an overall decrease in bodyweight 
gain during the entire lactation period. The reproductive effects in 
males appear in the F1 generation in the form of increased 
incidence and severity of testicular tubular atrophy (see 
developmental/reproductive section). These data are considered to be 
evidence of increased quantitative susceptibility for male pups 
(increased incidence of testicular tubular atrophy at 1.8 mg/kg/day) 
when compared to the parents (hyaline changes in renal tubules at 61 
mg/kg/day; NOAEL is 1.8 mg/kg/day).
    In a more recent 2-generation reproduction study, the most 
sensitive effect was sperm abnormalities at 3 mg/kg/day (the NOAEL is 
1.2 mg/kg/day) in the F1 males. This study also indicates 
increased susceptibility for the offspring for this effect.
    Although there is evidence of increased quantitative susceptibility 
for male pups in both reproductive studies, NOAELs and LOAELs were 
established in these studies and the Agency selected the NOAEL for 
testicular effects in F1 pups as the basis for risk 
assessment. The Agency has confidence that the NOAEL selected for risk 
assessment is protective of the most sensitive effect (testicular) for 
the most sensitive subgroup (pups) observed in the toxicological 
database.
    3. Conclusion. i. In the final rule published in the Federal 
Register of January 5, 2005 (70 FR 708) (FRL-7689-7), EPA had 
previously determined that the FQPA SF should be retained at 10X for 
thiamethoxam, based on the following factors: Effects on endocrine 
organs observed across species; significant decrease in alanine amino 
transferase levels in companion animal studies and in dog studies; the 
mode of action of this chemical in insects (interferes with the 
nicotinic acetylcholine receptors of the insect's nervous system); the 
transient clinical signs of neurotoxicity in several studies across 
species; and the suggestive evidence of increased quantitative 
susceptibility in the rat reproduction study. Since that determination, 
EPA has received and reviewed a developmental neurotoxicity (DNT) study 
in rats, and an additional reproduction study in rats. Taking the 
results of these studies into account, as well as the rest of the data 
on thiamethoxam, EPA has determined that reliable data show the safety 
of infants and children would be adequately protected if the FQPA SF 
were reduced to 1X (June 23, 2010, 75 FR 35653; FRL-8830-4); (June 22, 
2007, 72 FR 34401). That decision is based on the following findings:
    a. The toxicity database for thiamethoxam is largely complete, 
including acceptable/guideline developmental toxicity, 2-generation 
reproduction, and DNT studies designed to detect adverse effects on the 
developing organism, which could result from the mechanism that may 
have produced the decreased alanine amino transferase levels. The 
available data for thiamethoxam show the potential for immunotoxic 
effects. In the subchronic dog study, leukopenia (decreased white blood 
cells) was observed in females only, at the highest dose tested (HDT) 
of 50 mg/kg/day; the NOAEL for this effect was 34 mg/kg/day. The 
overall study NOAEL was 9.3 mg/kg/day in females (8.2 mg/kg/day in 
males) based on hematology and other clinical chemistry findings at the 
LOAEL of 34 mg/kg/day (32 mg/kg/day in males). In the subchronic mouse 
study, decreased spleen weights were observed in females at 626 mg/kg/
day; the NOAEL for this effect was the next lowest dose of 231 mg/kg/
day. The overall study NOAEL was 1.4 mg/kg/day (males) based on 
increased hepatocyte hypertrophy observed at the LOAEL of 14.3 mg/kg/
day. The decreased absolute spleen weights were considered to be 
treatment related, but were not statistically significant at 626 mg/kg/
day or at the HDT of 1,163 mg/kg/day. Since spleen weights were not 
decreased relative to body weights, the absolute decreases may have 
been related to the decreases in body weight gain observed at higher 
doses. Overall, the Agency has a low concern for the potential for 
immunotoxicity related to these effects for the following reasons: In 
general, the Agency does not consider alterations in hematology 
parameters alone to be a significant indication of potential 
immunotoxicity. In the case of thiamethoxam, high-dose females in the 
subchronic dog study had slight microcytic anemia as well as leukopenia 
characterized by reductions in neutrophils, lymphocytes and monocytes; 
the leukopenia was considered to be related to the anemic response to 
exposure. Further, endpoints and doses selected for risk assessment are 
protective of the observed effects on hematology. Spleen weight 
decreases, while considered treatment-related, were associated with 
decreases in body weight gain, and were not statistically significant. 
In addition, spleen weight changes occurred only at very high doses, 
more than 70 times higher than the doses selected for risk assessment.
    In addition to the previous considerations, a 28-day immunotoxicity 
study in female mice was recently received and has undergone a 
preliminary review. There were no immunotoxic effects observed at doses 
exceeding the limit dose of 1,000 mg/kg/day.
    b. For the reasons discussed in Unit III.D.2., there is low concern 
for an increased susceptibility in the young.
    c. Although there is evidence of neurotoxicity after acute exposure 
to thiamethoxam at doses of 500 mg/kg/day including drooped palpebral 
closure, decrease in rectal temperature and locomotor activity and 
increase in forelimb grip strength, no evidence of neuropathology was 
observed. These effects occurred at doses at least 14-fold and 416-fold 
higher than the doses used for the acute, and chronic risk assessments, 
respectively; thus, there is low concern for these effects since it is 
expected that the doses used for regulatory purposes would be 
protective of the effects noted at much higher doses.
    In the developmental neurotoxicity study (DNT), there was no 
evidence of neurotoxicity in the dams exposed up to 298.7 mg/kg/day; a 
dose that was associated with decreases in body weight gain and food 
consumption. In pups exposed to 298.7 mg/kg/day, there

[[Page 12737]]

were significant reductions in absolute brain weight and size (i.e., 
length and width of the cerebellum was less in males on day 12, and 
there were significant decreases in Level 3-5 measurements in males and 
in Level 4-5 measurements in females on day 63). However, there is low 
concern for this increased qualitative susceptibility observed in the 
DNT study because the doses and endpoints selected for risk assessment 
are protective of the effects in the offspring. As noted previously, 
for risk assessment the Agency selected the NOAEL for testicular 
effects in F1 pups based on two reproductive toxicity 
studies to be protective of all sensitive subpopulations.
    d. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed using 
tolerance-level and/or anticipated residues that are based on reliable 
field trial data observed in the thiamethoxam field trials. Although 
there is available information indicating that thiamethoxam and 
clothianidin have different toxicological effects in mammals and should 
be assessed separately, the residues of each have been combined in 
these assessments to ensure that the estimated exposures of 
thiamethoxam do not underestimate actual potential thiamethoxam 
exposures. An assumption of 100 percent crop treated (PCT) was made for 
all foods evaluated in the assessments. For the acute and chronic 
assessments, the EDWCs of 131.77 parts per billion (ppb) and 11.3 ppb, 
respectively, were used to estimate exposure via drinking water. 
Compared to the results from small scale prospective ground water 
studies where the maximum observed residue levels from any monitoring 
well were 1.0 ppb for thiamethoxam and 0.73 ppb for clothianidin, the 
modeled estimates are protective of what actual exposures are likely to 
be. EPA used similarly conservative (protective) assumptions to assess 
postapplication exposure to children and adults including incidental 
oral exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by thiamethoxam.
    ii. In the final rule published in the Federal Register of February 
6, 2008 (73 FR 6851) (FRL-8346-9), EPA had previously determined that 
the FQPA SF for clothianidin should be retained at 10X because EPA had 
required the submission of a developmental immunotoxicity study to 
address the combination of evidence of decreased absolute and adjusted 
organ weights of the thymus and spleen in multiple studies in the 
clothianidin database, and evidence showing that juvenile rats in the 
2-generation reproduction study appear to be more susceptible to these 
potential immunotoxic effects. In the absence of a developmental 
immunotoxicity study, EPA concluded that there was sufficient 
uncertainty regarding immunotoxic effects in the young that the 10X 
FQPA factor should be retained as a database uncertainty factor.
    Since that determination, EPA has received and reviewed an 
acceptable/guideline developmental immunotoxicity study, which 
demonstrated no treatment-related effects. Taking the results of this 
study into account, as well as the rest of the data on clothianidin, 
EPA has determined that reliable data show the safety of infants and 
children would be adequately protected if the FQPA SF for clothianidin 
were reduced to 1X (February 11, 2011, 76 FR 7712) (FRL-8858-3). That 
decision is based on the following findings:
    a. The toxicity database for clothianidin is complete. As noted, 
the prior data gap concerning developmental immunotoxicity has been 
addressed by the submission of an acceptable developmental 
immunotoxicity study.
    b. A rat developmental neurotoxicity study is available and shows 
evidence of increased quantitative susceptibility of offspring. 
However, EPA considers the degree of concern for the developmental 
neurotoxicity study to be low for prenatal and postnatal toxicity 
because the NOAEL and LOAEL were well characterized, and the doses and 
endpoints selected for risk assessment are protective of the observed 
susceptibility; therefore, there are no residual concerns regarding 
effects in the young.
    c. While the rat multi-generation reproduction study showed 
evidence of increased quantitative susceptibility of offspring compared 
to adults, the degree of concern is low because the study NOAEL and 
LOAEL have been selected for risk assessment purposes for relevant 
exposure routes and durations. In addition, the potential immunotoxic 
effects observed in the study have been further characterized with the 
submission of a developmental immunotoxicity study that showed no 
evidence of susceptibility. As a result, there are no concerns or 
residual uncertainties for prenatal and postnatal toxicity after 
establishing toxicity endpoints and traditional UFs to be used in the 
risk assessment for clothianidin.
    d. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on assumptions that were judged to be highly conservative and health-
protective for all durations and population subgroups, including 
tolerance-level residues, adjustment factors from metabolite data, 
empirical processing factors, and 100 PCT for all commodities. 
Additionally, EPA made conservative (protective) assumptions in the 
ground water and surface water modeling used to assess exposure to 
clothianidin in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure of children and adults 
as well as incidental oral exposure of toddlers. These assessments will 
not underestimate the exposure and risks posed by clothianidin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to thiamethoxam will occupy 9.5% of the aPAD for All infants (<1 year), 
the population group receiving the greatest exposure. Acute dietary 
exposure from food and water to clothianidin is estimated to occupy 23% 
of the aPAD for children 1 to 2 years old, the population group 
receiving the greatest exposure.
    2. Chronic risk. In examining chronic aggregate risk, EPA has 
assumed that the only pathway of exposure relevant to that time frame 
is dietary exposure. Using this assumption for chronic exposure, EPA 
has concluded that chronic exposure to thiamethoxam from food and water 
will utilize 43% of the cPAD for Children 1 to 2 years old, the 
population group receiving the greatest exposure. Chronic exposure to 
clothianidin from food and water will utilize 19% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water

[[Page 12738]]

(considered to be a background exposure level). Thiamethoxam is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to thiamethoxam.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures for thiamethoxam result in aggregate MOEs of: 
370 for the general U.S. population; 490 for all infants; 440 for 
children 1 to 2 years; 450 for children 3 to 5 years; 370 for children 
6 to 12 years; 380 for youth 13 to 19 years, adults 20 to 49 years, 
adults 50+ years, and females 13 to 49 years. Because EPA's level of 
concern for thiamethoxam is a MOE of 100 or below, these MOEs are not 
of concern.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures for clothianidin result in aggregate MOEs of: 
1,200 for the general U.S. population; 480 for all infants (<1 year); 
370 for children 1 to 2 years; 490 for children 3 to 5 years; 1,000 for 
children 6 to 12 years; 1,400 for youth 13 to 19 years, adults 20-49 
years, and females 13 to 49 years; and 1,300 for adults 50+ years. 
Because EPA's level of concern for clothianidin is a MOE of 100 or 
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Thiamethoxam is currently registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to thiamethoxam.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures for 
thiamethoxam result in aggregate MOEs of: 370 for the general U.S. 
population; 540 for all infants (<1 year); 470 for children 1 to 2 
years; 490 for children 3 to 5 years; 370 for children 6 to 12 years; 
380 for youth 13 to 19 years, adults 20 to 49 years, adults 50+ years, 
and females 13 to 49 years. Because EPA's level of concern for 
thiamethoxam is a MOE of 100 or below, these MOEs are not of concern.
    Using the exposure assumptions described in this unit for 
intermediate exposures, EPA has concluded the combined intermediate 
food, water, and residential exposures for clothianidin result in 
aggregate MOEs of: 1,200 for the general U.S. population; 480 for all 
infants (<1 year); 370 for children 1 to 2 years; 490 for children 3 to 
5 years; 1,000 for children 6 to 12 years; 1,400 for youth 13 to 19 
years, adults 20 to 49 years, and females 13 to 49 years; and 1,300 for 
adults 50+ years. Because EPA's level of concern for clothianidin is a 
MOE of 100 or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has 
classified thiamethoxam as not likely to be a human carcinogen based on 
convincing evidence that a non-genotoxic mode of action for liver 
tumors was established in the mouse and that the carcinogenic effects 
are a result of a mode of action dependent on sufficient amounts of a 
hepatotoxic metabolite produced persistently. Therefore, thiamethoxam 
is not expected to pose a cancer risk. Clothianidin has been classified 
as ``not likely to be a human carcinogen'' and is not expected to pose 
a cancer risk.
    6. Determination of safety. Based on these risk assessments, 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 thiamethoxam or clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The High Production Liquid Chromatography (HPLC) Method AG-675 with 
ultraviolet (UV) or Mass Spectrometry (MS) detection was previously 
submitted in conjunction with thiamethoxam petitions. Method AG-675 has 
been determined to be adequate for enforcing the tolerance expression 
for residues of thiamethoxam and CGA-322704 in crop and livestock 
commodities. Syngenta Crop Protection, Inc., has submitted a revised 
Method AG-675, i.e., Method GRM.009.04A. The full extraction steps for 
plant and livestock commodities, including the microwave extraction 
step for liver, have been incorporated. The limits of quantitation 
(LOQs) of Method GRM.009.04A have been established at 0.01 ppm each for 
residues of thiamethoxam, CGA-322704 and CGA-265307. Method validation 
data are available for Method GRM.009.04A.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. 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.
    EPA is increasing the barley grain tolerance to 0.4 ppm in order to 
harmonize with the Codex MRL of 0.4 ppm. The MRL expressions continue 
to remain different, as the Codex MRL is for the parent compound only.

C. Revisions to Petitioned-For Tolerances

    Although the petitioner sought tolerances for many of the 
commodities in Crop Groups 15 and 16, the petitioner did not request 
crop group tolerances. EPA has determined that a tolerance for either 
Crop Group 15 or Crop Group 16 commodities is not appropriate except 
for Crop Group 15 grains (except barley), because the use pattern is 
not the same for all Crop Group 15 commodities. Specifically, there is 
a foliar use on barley and there are much higher tolerances for barley 
hay and straw associated with this foliar use. It is for similar 
reasons that a Crop Group 16 tolerance would not be appropriate.
    In addition, there are also significant differences in the 
tolerances for the different cereal forages, i.e., wheat forage at 0.5 
ppm, corn forage at 0.10 ppm, and sorghum forage at 0.02 ppm. 
Therefore, tolerances for each individual commodity have been 
established by translating residue data from the most appropriate 
representative commodity, except for grains which all have the same 
tolerance (excluding barley). Tolerances are not required for triticale 
and wild rice because these commodities are covered by the wheat and 
rice tolerances, as

[[Page 12739]]

specified in 40 CFR 180.1. Tolerances are also not needed for teosinte 
forage and stover as these are not considered significant livestock 
feed items and are not consumed by humans.

V. Conclusion

    Therefore, tolerances are established for residues of thiamethoxam, 
3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite, N-[(2-chloro-thiazol-5-
yl)methyl]-N '-methyl-N ''-nitro-guanidine, in or on barley, grain at 
0.4 ppm; buckwheat, forage at 0.50 ppm; buckwheat, hay at 0.02 ppm; 
buckwheat, straw at 0.02 ppm; grain, cereal, group 15, except barley at 
0.02 ppm; oat, forage at 0.50 ppm, oat, hay at 0.02 ppm; oat, straw at 
0.02 ppm; millet, pearl, forage at 0.02 ppm; millet, pearl, stover at 
0.02 ppm; millet, proso, forage at 0.02 ppm; millet, proso, stover at 
0.02 ppm; millet, proso, straw at 0.02 ppm; rye, forage at 0.50 ppm; 
rye, straw at 0.02 ppm. Tolerances are revoked for corn, field, grain; 
corn, pop, grain; rice, grain; sorghum, grain; wheat, grain. These 
tolerances are no longer needed, since residues on these commodities 
will be covered by the crop group 15 tolerances being established in 
this rule.
    In addition, administrative corrections are being made to the 
existing tolerances for grain, aspirated fractions and soybean, hulls, 
as follows: The tolerance for grain, aspirated fractions at 0.08 ppm is 
being corrected to grain, aspirated fractions at 2.0 ppm; the tolerance 
for soybean, hulls at 2.0 ppm is being corrected to soybean, hulls at 
0.08 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 17, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.565 paragraph (a) is revised to read as follows:


Sec.  180.565  Thiamethoxam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide thiamethoxam, including its metabolites and degradates, in 
or on the following commodities. Compliance with the tolerance levels 
specified below is to be determined by measuring only thiamethoxam 3-
[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite CGA-322704 N-[(2-chloro-thiazol-5-
yl)methyl]-N'-methyl-N''-nitro-guanidine, calculated as the 
stoichiometric equivalent of thiamethoxam, in or on the following 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage...........................................          0.05
Alfalfa, hay..............................................          0.12
Almond, hulls.............................................          1.2
Artichoke, globe..........................................          0.45
Avocado...................................................          0.40
Barley, grain.............................................          0.4
Barley, hay...............................................          0.40
Barley, straw.............................................          0.40
Bean, succulent...........................................          0.02
Berry, low growing, subgroup 13-07G, except cranberry.....          0.30
Borage, seed..............................................          0.02
Brassica, head and stem, subgroup 5-A.....................          4.5
Brassica, leafy greens, subgroup 5-B......................          3.0
Buckwheat, forage.........................................          0.50
Buckwheat, hay............................................          0.02
Buckwheat, straw..........................................          0.02
Bushberry subgroup 13-07B, except lingonberry and                   0.20
 blueberry, lowbush.......................................
Canistel..................................................          0.40
Canola, seed..............................................          0.02
Cattle, meat..............................................          0.02

[[Page 12740]]

 
Cattle, meat byproducts...................................          0.04
Citrus, dried pulp........................................          0.60
Coffee, bean, green \1\...................................          0.05
Corn, field, forage.......................................          0.10
Corn, field, stover.......................................          0.05
Corn, pop, forage.........................................          0.10
Corn, pop, stover.........................................          0.05
Corn, sweet, forage.......................................          0.10
Corn, sweet, kernel plus cob with husks removed...........          0.02
Corn, sweet, stover.......................................          0.05
Cotton, gin byproducts....................................          1.5
Cotton, undelinted seed...................................          0.10
Crambe, seed..............................................          0.02
Cranberry.................................................          0.02
Flax, seed................................................          0.02
Food commodities and feed commodities (other than those             0.02
 covered by a higher tolerance as a result of use on
 growing crops) in food/feed handling establishments......
Fruit, citrus, group 10...................................          0.40
Fruit, pome, group 11.....................................          0.2
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy          0.20
 kiwifruit................................................
Fruit, stone, group 12....................................          0.5
Goat, meat................................................          0.02
Goat, meat byproducts.....................................          0.04
Grain, aspirated fractions................................          2.0
Grain, cereal, group 15, except barley....................          0.02
Grape, raisin.............................................          0.30
Hog, meat.................................................          0.02
Hog, meat byproducts......................................          0.02
Hop, dried cones..........................................          0.10
Horse, meat...............................................          0.02
Horse, meat byproducts....................................          0.04
Mango.....................................................          0.40
Milk......................................................          0.02
Millet, pearl, forage.....................................          0.02
Millet, pearl, stover.....................................          0.02
Millet, proso, forage.....................................          0.02
Millet, proso, stover.....................................          0.02
Millet, proso, straw......................................          0.02
Oat, forage...............................................          0.50
Oat, hay..................................................          0.02
Oat, straw................................................          0.02
Peanut....................................................          0.05
Peanut, hay...............................................          0.25
Peanut, meal..............................................          0.15
Peppermint, tops..........................................          1.5
Pistachio.................................................          0.02
Potato....................................................          0.25
Radish, tops..............................................          0.80
Rapeseed, seed............................................          0.02
Rye, forage...............................................          0.50
Rye, straw................................................          0.02
Sapodilla.................................................          0.40
Sapote, black.............................................          0.40
Sapote, mamey.............................................          0.40
Sheep, meat...............................................          0.02
Sheep, meat byproducts....................................          0.04
Sorghum, forage...........................................          0.02
Sorghum, grain, stover....................................          0.02
Soybean, hulls............................................          0.08
Spearmint, tops...........................................          1.5
Star apple................................................          0.40
Sunflower.................................................          0.02
Tomato, paste.............................................          0.80
Vegetable, cucurbit, group 9..............................          0.2
Vegetable, fruiting, group 8..............................          0.25
Vegetable, leafy, except brassica, group 4................          4.0
Vegetable, legume, group 6................................          0.02
Vegetable, root, subgroup 1A..............................          0.05
Vegetable, tuberous and corm, except potato, subgroup 1D..          0.02
Wheat, forage.............................................          0.50
Wheat, hay................................................          0.02
Wheat, straw..............................................          0.02
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of September 17, 2003.

* * * * *
[FR Doc. 2012-4983 Filed 3-1-12; 8:45 am]
BILLING CODE 6560-50-P