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Thiamethoxam; Pesticide Tolerance
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[Federal Register: May 23, 2001 (Volume 66, Number 100)] [Rules and Regulations] [Page 28386-28397] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr23my01-14] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP-301132; FRL-6784-7] RIN 2070-AB78 Thiamethoxam; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for combined residues of thiamethoxam and its metabolite in or on tuberous and corm vegetables crop subgroup, fruiting vegetables crop group, tomato paste, cucurbit vegetables crop group, and pome fruits crop group. Syngenta Crop Protection, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996. DATES: This regulation is effective May 23, 2001. Objections and requests for hearings, identified by docket control number OPP-301132, must be received by EPA on or before July 23, 2001. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301132 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Dani Daniel, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: (703) 305-5409; and e-mail address: daniel.dani@epa.gov. SUPPLEMENTARY INFORMATION: [[Page 28387]] I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ------------------------------------------------------------------------ Examples of Potentially Categories NAICS Affected Entities ------------------------------------------------------------------------ Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing ------------------------------------------------------------------------ This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select ``Laws and Regulations'', ``Regulations and Proposed Rules,'' and then look up the entry for this document under the ``Federal Register--Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic version of 40 CFR part 180 is available at http:// www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development. 2. In person. The Agency has established an official record for this action under docket control number OPP-301132. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805. II. Background and Statutory Findings In the Federal Register of May 5, 1999 (64 FR 34153) (FRL-6072-7), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (9F5051) for tolerances by Syngenta Crop Protection, P.O. Box 18300 Greensboro, NC 27419-8300. This notice included a summary of the petition prepared by Syngenta Crop Protection, the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.565 be amended by establishing tolerances for combined 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-ylmethyl)-N '-methyl-N ''-nitro-guanidine) in or on the raw agricultural commodities: tuberous and corm vegetables crop subgroup at 0.02 ppm, cucurbit vegetables crop group at 0.20 ppm, pome fruit crop group at 0.20 ppm, fruiting vegetables crop group at 0.25 ppm and tomato paste at 0.80 ppm. Section 408(b)(2)(A)(i) of the 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) 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) 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....'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7). III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for combined residues of thiamethoxam and its metabolite in or on tuberous and corm vegetables crop subgroup at 0.02 ppm, fruiting vegetables crop group at 0.25 ppm, tomato paste at 0.80 ppm, cucurbit vegetables crop group at 0.20 ppm, and pome fruits crop group at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances 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. The nature of the toxic effects caused by thiamethoxam are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed. [[Page 28388]] Table 1.--Subchronic, Chronic, and Other Toxicity ------------------------------------------------------------------------ Guideline No. Study Type Results ------------------------------------------------------------------------ 870.3100 90-Day oral NOAEL = 1.74 (males), toxicity - rat 92.5 (females) mg/kg/ day LOAEL = 17.64 (males), 182.1 (females) mg/kg/day based on increased incidence of hyaline change of renal tubular epithelium (males), fatty change in adrenal gland of females, liver changes in females, all at the LOAEL. ------------------------------------------------------------------------ 870.3100 90-Day oral NOAEL = 1.41 (males), toxicity - mouse 19.2 (females) mg/kg/ day LOAEL = 14.3 (males), 231 (females) mg/kg/ day based on increased incidence of hepatocellular hypertrophy. At higher dose levels: decrease in bodyweight and bodyweight gain, necrosis of individual hepatocytes, pigmentation of Kupffer cells, and lymphocytic infiltration of the liver in both sexes; slight hematologic effects and decreased absolute and relative kidney weights in males; and ovarian atrophy, decreased ovary and spleen weights and increased liver weights in females. ------------------------------------------------------------------------ 870.3150 90-Day oral NOAEL = 8.23 (males), toxicity - dog 9.27 (females) mg/kg/ day LOAEL = 32.0 (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). ------------------------------------------------------------------------ 870.3200 28-Day dermal NOAEL = 250 (males), toxicity - rat 60 (females) mg/kg/ day LOAEL = 1000 (males), 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 and hyaline change in renal tubules and a very slight reduction in body weight in males. At higher dose levels in females, chronic tubular lesions in the kidneys and inflammatory cell infiltration in the adrenal cortex were observed. ------------------------------------------------------------------------ 870.3700a Prenatal Maternal NOAEL = 30 developmental - mg/kg/day rat LOAEL = 200 mg/kg/day based on decreased body weight, body weight gain, and food consumption. Developmental NOAEL = 200 mg/kg/day LOAEL = 750 mg/kg/day based on decreased fetal body weight and anincreased incidence of skeletal anomalies. ------------------------------------------------------------------------ 870.3700b Prenatal Maternal NOAEL = 50 developmental - mg/kg/day rabbit LOAEL = 150 mg/kg/day based on maternal deaths, hemorrhagic uterine contents and hemorrhagic discharge, decreased body weight and food intake during the dosing period. Developmental NOAEL = 50 mg/kg/day LOAEL = 150 mg/kg/day based on decreased fetal body weights, increased incidence of post-implantation loss and a slight increase in the incidence of a few skeletal anomalies/ variations. ------------------------------------------------------------------------ 870.3800 Reproduction and Parental/Systemic fertility NOAEL = 1.84 effects - rat (males), 202.06 (females)mg/kg/day LOAEL = 61.25 (males), not determined (females) mg/kg/day based on increased incidence of hyaline change in renal tubules in F0 and F1 males. Reproductive NOAEL = 0.61 (males), 202.06 (females) mg/kg/day LOAEL = 1.84 (males), not determined (females) mg/kg/day based on increased incidence and severity of tubular atrophy observed in testes of the F1 generation males. Offspring NOAEL = 61.25 (males), 79.20 (females) mg/kg/day LOAEL = 158.32 (males), 202.06 (females) mg/kg/day based on reduced body weight gain during the lactation period in all litters . ------------------------------------------------------------------------ 870.4100 Chronic toxicity - NOAEL = 4.05 (males), dog 4.49 (females) mg/kg/ day LOAEL = 21.0 (males), 24.6 (females) mg/kg/ day based on increase in creatinine in both sexes, transient decrease in food consumption in females, and occasional increase in urea levels, decrease in ALT, and atrophy of seminiferous tubules in males. ------------------------------------------------------------------------ 870.4200 Carcinogenicity - NOAEL = 2.63 (males), mouse 3.68 (females) mg/kg/ day [[Page 28389]] LOAEL = 63.8 (males), 87.6 (females) mg/kg/ day based on hepatocyte hypertrophy, single cell necrosis, inflammatory cell infiltration, pigment deposition, foci of cellular alteration, hyperplasia of Kupffer cells and increased mitotic activity; also, an increase in the incidence of hepatocellular adenoma (both sexes). At higher doses, there was an increase in the incidence of hepatocellular adenocarcinoma (both sexes) and the number of animals with multiple tumors. evidence of carcinogenicity ------------------------------------------------------------------------ 870.4300 Combined chronic NOAEL = 21.0 (males), carcinogenicity - 50.3 (females) mg/kg/ rat day LOAEL = 63.0 (males), 155 (females) mg/kg/ day based on increased incidence of lymphocytic infiltration of the renal pelvis and chronic nephropathy in males and decreased body weight gain, slight increase in the severity of hemosiderosis of the spleen, foci of cellular alteration in liver and chronic tubular lesions in kidney in females. no evidence of carcinogenicity ------------------------------------------------------------------------ 870.5100 and 870.5265 Gene mutation in No evidence of gene S. typhimurium mutation when tested and E. coli up to 5,000 µ g/plate. There was no evidence of cytotoxicity. ------------------------------------------------------------------------ 870.5265 Gene mutation in No evidence of gene S. typhimurium mutation when tested up to 5,000 µ g/plate.The S9 fraction was from non-induced mouse liver, Aroclor 1254 induced mouseliver, or thiamethoxam induced mouse liver, following dietary administration of thiamethoxam for 14 days at concentrations up to 2,500 ppm. 870.5300 Gene mutation in No evidence of gene chinese hamster mutation when tested V79 cells at up to solubility HGPRT locus limit. ------------------------------------------------------------------------ 870.5375 CHO cell No evidence of cytogenetics chromosomal aberrations when tested up tocytotoxic or solubility limit concentrations. ------------------------------------------------------------------------ 870.5395 In vivo mouse Negative when tested bone marrow up to levels of micronucleus toxicity in whole animals;however no evidence of target cell cytotoxicity. ------------------------------------------------------------------------ 870.5550 UDS assay Negative when tested up to precipitating concentrations ------------------------------------------------------------------------ 870.6200a Acute NOAEL = 100 mg/kg/day neurotoxicity screening battery - rat LOAEL = 500 mg/kg/day based on drooped palpebral closure, decrease in rectal temperature and locomotor activity and increase in forelimb grip strength (males only). At higher dose levels, mortality, abnormal body tone, ptosis, impaired respiration, tremors, longer latency to first step in the open field, crouched-over posture, gait impairment, hypo- arousal, decreased number of rears, uncoordinated landing during the righting reflex test, slight lacrimation (females only) and higher mean average input stimulus value in the auditory startle response test (males only). ------------------------------------------------------------------------ 870.6200b Subchronic NOAEL = 95.4 (males), neurotoxicity 216.4 (females) mg/ screening kg/day, both battery - rat highestdose tested. LOAEL = not determined. No treatment-related observations at any dose level. LOAEL was not achieved. May not have been tested at sufficiently high dose levels; however, new study not required because the weight of the evidence from the other toxicity studies indicates no evidence of concern. ------------------------------------------------------------------------ [[Page 28390]] 870.7485 Metabolism and Absorbed rapidly and pharmacokinetics extensively, widely - rat distributed, followed byvery rapid elimination, mostly in urine. Highest tissue concentrations in skeletal muscle: 10- 15% of administered dose. Half life times from tissues ranged from 2-6 hours. Tissue residues after 7 days extremely low. Approximately 84-95% of administered dose excreted in urine and 2.5-6% excreted in feces within 24 hours. Greater than 0.2% detected in expired air. Most excreted as unchanged parent: 70- 80% of dose. The major biotransformation reaction is cleavage of oxadiazine ring to corresponding nitroguanidine compound. Minor pathways: (1) cleavage of nitroguanidine group yielding guanidine derivative, (2) hydrolysis of guanidine group to corresponding urea, (3) demethylation of guanidine group, and (4) substitution of the chlorine of the thiazole ring by glutathione. Cleavage between thiazole- and oxadiazine ring occurs to a small extent. Glutathione derivatives prone to further degradation of the glutathione moiety resulting in various sulfur- containing metabolites (e.g. mercapturates, sulfides, and sulfoxides). Both the thiazole and oxadiazine moiety susceptible to oxidative attack. Small but measurable amounts exhaled, most probably as CO2. Metabolites eliminated very rapidly. Enterohepatic circulation negligible. ------------------------------------------------------------------------ 870.7485 Metabolism and Approximately 72% of pharmacokinetics administered dose - mouse excreted in the urine;19% excreted in feces. Small but measurable amount detected in expired air(approximately 0.2% of dose). Predominant metabolites: unchanged parent (33- 41% of administered dose; 2 other metabolites: 8-12% and 9-18% of administered dose. These are the same structures that were most commonly observed in rat excreta, however the proportions are quite different in mouse excreta. One additional significant metabolite (mouse R6) was isolated from feces samples. Between 30-60% of the administered dose was excreted as metabolites. ------------------------------------------------------------------------ 870.7600 Dermal Estimates of dermal penetration - absorption were rat based on the sum ofradioactivity in skin test site, urine, feces, blood, and carcass. Percentage dermal absorption is 27.0, highest mean dermal absorption value across all groups. This value is considered to represent the potential cumulative dermal absorption of test material that might occur after a 10 hour dermal exposure. As the study design did not permit analysis of the fate of skin bound residues, residues at skin site were included in determination of dermal absorption. ------------------------------------------------------------------------ Hepatic cell proliferation NOAEL = 16 (males), study - mouse 20 (females) mg/kg/ day LOAEL = 72 (males), 87 (females) mg/kg/ day based on proliferative activity of hepatocytes. At higher dose levels, increases in absolute and relative liver wts, speckled liver, hepatocellular glycogenesis/fatty change, hepatocellular necrosis, apoptosis and pigmentation were observed. ------------------------------------------------------------------------ Replicative DNA synthesis 28-day feeding NOAEL = 711 mg/kg/day study - male rat (highest dose tested) LOAEL = not established. Immunohistochemical staining of liver sections from control and high- dose animals for proliferating cell nuclear antigen gave no indication for a treatment-related increase in the fraction of DNA synthesizing hepatocytes in S- phase. CGA 293343 did not stimulate hepatocyte cell proliferation in male rats. ------------------------------------------------------------------------ Special study to assess liver NOAEL = 17 (males), biochemistry in mouse 20 (females) mg/kg/ day LOAEL = 74 (males), 92 (females) mg/kg/ day based on marginal to slight increases in absolute and relative liver weights, a slight increase in the microsomal protein content of the livers, moderate increases in the cytochrome P450 content, slight to moderate increases in the activity of several microsomal enzymes, slight to moderate induction of cytosolic glutathione S- transferase activity. Treatment did not affect peroxisomal fatty acid ß oxidation. ------------------------------------------------------------------------ [[Page 28391]] B. Toxicological Endpoints The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor. For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10-\6\ or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a ``point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for thiamethoxam used for human risk assessment is shown in the following Table 2: Table 2.--Summary of Toxicological Dose and Endpoints for Thiamethoxam for Use in Human Risk Assessment ---------------------------------------------------------------------------------------------------------------- FQPA SF\*\ and Exposure Scenario Dose Used in Risk Level of Concern Study and Toxicological Effects Assessment, UF for Risk Assessment ---------------------------------------------------------------------------------------------------------------- Acute Dietary general population NOAEL = 100 mg/kg/ FQPA SF = 10; aPAD Acute mammalian neurotoxicity including infantsand children day; UF = 100; = acute RfD/FQPA study in the rat Acute RfD = 1 mg/kg/ SF = 0.1 mg/kg/day day LOAEL = 500 mg/kg/day based on treatment-related neurobehavioraleffects observed in the FOB and LMA testing (drooped palpebral closure,decreased rectal temperature and locomotor activity, increased forelimbgrip strength) ---------------------------------------------------------------------------------------------------------------- Chronic Dietary all populations NOAEL = 0.6 mg/kg/ FQPA SF = 10; cPAD 2-Generation reproduction study day; UF = 100; = chronic RfD/FQPA Chronic RfD = 0.006 SF = 0.0006 mg/kg/ mg/kg/day day LOAEL = 1.8 mg/kg/day based on increased incidence and severity oftubular atrophy in testes of F1 generation males. ---------------------------------------------------------------------------------------------------------------- Oral Nondietary (all durations) NOAEL = 0.6 mg/kg/ LOC for MOE = 1,000 2-Generation reproduction study day (Residential) LOAEL = 1.8 mg/kg/day based on increased incidence and severity of tubular atrophy in testes of F1 generation males. ---------------------------------------------------------------------------------------------------------------- Dermal (all durations) Oral study NOAEL= LOC for MOE = 1,000 2-Generation reproduction study (Residential) 0.6 mg/kg/day (Residential) (dermal absorptionrate = 27%) LOC for MOE = 100 LOAEL = 1.8 mg/kg/day based on (Occupational) increased incidence and severity of tubular atrophy in testes of F1 generation males. ---------------------------------------------------------------------------------------------------------------- Inhalation (all durations) Oral study NOAEL = LOC for MOE = 1,000 2-Generation reproduction study (Residential) 0.6 mg/kg/day (Residential) (inhalation absorption rate =100%) LOC for MOE = 100 LOAEL = 1.8 mg/kg/day based on (Occupational) increased incidence and severity oftubular atrophy in testes of F1 generation males. ---------------------------------------------------------------------------------------------------------------- [[Page 28392]] Cancer (oral, dermal, inhalation) Q1* (mg/kg/day)-\1\ Greater than 1 x 10- Likely carcinogen for humans based is 3.77 x 10-\2\ \6\ on increased incidenceof hepatocellular adenomas and carcinomas in male and female mice.Quantification of risk based on most potent unit risk: male mouse liveradenoma and/or carcinoma combined tumor rate. The upper bound estimateof unit risk, Q1* (mg/kg/day)-\1\ is 3.77 x 10-\2\ in human equivalents. ---------------------------------------------------------------------------------------------------------------- \*\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA. C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.565) for the combined residues of thiamethoxam and its metabolite, in or on a variety of raw agricultural commodities. The following raw agricultural commodities have established tolerances: barley, canola, cotton, sorghum, wheat, milk, and the meat and meat byproducts of cattle, goats, horses, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from thiamethoxam in food as follows: i. Acute exposure. Acute dietary 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 one day or single exposure. The Dietary Exposure Evaluation Model (DEEM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992-nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: tolerence level residues and 100% crop treated. ii. Chronic exposure.In conducting this chronic dietary risk assessment the DEEM analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992-nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: percent crop treated (based on projected market shares) and anticipated residues (Tier 3). iii. Cancer. The dietary exposure for determining cancer risk is based on the chronic exposure explained in the previous paragraph using the same assumptions. Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of percent crop treated (PCT) as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The Agency used percent crop treated (PCT information as follows in Table 3: Table 3.--Thiamethoxam Uses and Estimates of Percent Crop Treated ------------------------------------------------------------------------ Crop Percent Crop Treated ------------------------------------------------------------------------ Tuberous and Corm Vegetables - Crop Subgroup 1 9 C............................................. Fruiting Vegetables (Except Cucurbits - Crop 15 Group 8....................................... Cucumbers...................................... 5 Melons......................................... 13 Casabas........................................ 44 Crenshaws...................................... 44 Squash......................................... 44 Pumpkin........................................ 44 Apples......................................... 15-20 Crabapples..................................... 53 Pears.......................................... 9 Quinces........................................ 53 Loquats........................................ 53 ------------------------------------------------------------------------ [[Page 28393]] The Agency used information provided by the registrant to determine percent crop treated based on projected percent market share information. The Agency believes that the procedures used were the best available, because thiamethoxam is a new chemical and has never been used. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and regional populations. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for thiamethoxam in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of thiamethoxam. The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to thiamethoxam they are further discussed in the aggregate risk sections below. Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of thiamethoxam for acute exposures are estimated to be 8.0 parts per billion (ppb) for surface water and 1.94 ppb for ground water. The EECs for chronic exposures are estimated to be 0.6 ppb for surface water, and 1.94 ppb for ground water. 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 not registered for use on any sites that would result in residential exposure. Although such uses have been requested, they are not being assessed at this time. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) 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.'' EPA does not have, at this time, available data to determine whether thiamethoxam has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, thiamethoxam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that thiamethoxam has 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 the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997). D. Safety Factor for Infants and Children 1. Safety factor for infants and children--i. In general. FFDCA section 408 provides that EPA shall apply an additional tenfold 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 that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. ii. Prenatal and postnatal sensitivity. The developmental toxicity studies indicated no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetus to in utero exposure based on the fact that the developmental NOAELs are either higher than or equal to the maternal NOAELs. However, the reproductive studies indicate effects in male rats in the form of increased incidence and severity of testicular tubular atrophy. These data are considered to be evidence of increased quantitative susceptibility for male pups when compared to the parents. iii. Conclusion. Based on: (a) effects on endocrine organs observed across species; (b) the significant decrease in alanine amino transferase levels in the companion animal studies and in the dog studies; (c) the mode of action of this chemical in insects (interferes with the nicotinic acetyl choline receptors of the insect's nervous system) thus a developmental neurotoxicity study is required; (d) the transient clinical signs of neurotoxicity in several studies across species; and (e) the suggestive evidence of increased quantitative susceptibility in the rat reproduction study, the Agency is retaining the FQPA factor which is l0X. E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency [[Page 28394]] calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer. When EECs for surface water and groundwater are less than the calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to thiamethoxam will occupy 3% of the aPAD for the U.S. population, 2% of the aPAD for females 13-50 years old, 8% of the aPAD for all infants less than 1 year old and 7% of the aPAD for children 1-6 years old. In addition, there is potential for acute dietary exposure to thiamethoxam in drinking water. The surface water EEC is 8.0 µg/L and the ground water EEC is 1.94 µg/L. Since the surface water value is greater than the ground water value, the surface water value will be used for comparison purposes and will protect for any concerns for ground water concentrations. After calculating DWLOCs and comparing them to the EECs for surface water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD. Table 4.--Aggregate Risk Assessment for Acute Exposure to Thiamethoxam ---------------------------------------------------------------------------------------------------------------- Surface Ground Population Subgroup\a\ aPAD(mg/kg) %aPAD Water DWEC Water Acute DWLOC (Food) (ppb) DWEC(ppb) (ppb)\b\ ---------------------------------------------------------------------------------------------------------------- U.S. General Population 0.1 3 8 1.94 3,400 All infants (< 1 year) 0.1 8 8 1.94 920 Children (1-6 years) 0.1 7 8 1.94 930 Children (7-12 years) 0.1 4 8 1.94 960 Females (13-50 years) 0.1 2 8 1.94 2,900 ---------------------------------------------------------------------------------------------------------------- \a\Population subgroups shown include the U.S. general population and the maximally exposed subpopulation of adults, infants and children, and women of child-bearing age for each exposure scenario. \b\DWLOC = Maximum Water Exposure (mg/kg/day) -- 1,000 µg/mg -- body weight (70 kg general population/ males 13+, 60 kg females 13+, 10 kg infants and children) Water Consumption (2 L/day adults, 1 L/day infants and children). Maximum water exposure = aPAD - dietary exposure (mg/kg/day) 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to thiamethoxam from food will utilize 5% of the cPAD for the U.S. population, 13% of the cPAD for all infants < 1 year old and 13% of the cPAD for children 1-6 years old. Proposed residential uses are not being addressed in this risk assessment. In addition to chronic dietary exposure, there is potential for chronic dietary exposure to thiamethoxam in drinking water. The surface water EEC is 0.6 µg/L and the groundwater EEC is 1.94 µg/L. Since the groundwater value is greater than the surface water value, the groundwater value will be used for comparison purposes and will protect for any concerns for surface water concentrations. After calculating the DWLOCs and comparing them to the EECs for groundwater, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Thiamethoxam ---------------------------------------------------------------------------------------------------------------- Surface Ground Population Subgroup cPAD mg/kg/ cPAD (Food) Water DWEC Water DWEC DWLOC (ppb) day (ppb) (ppb) ---------------------------------------------------------------------------------------------------------------- U.S. Population 0.0006 5 0.6 1.94 20 All infants (< 1 year) 0.0006 13 0.6 1.94 5.2 Children (1-6 years) 0.0006 13 0.6 1.94 5.2 Children (7-12 years) 0.0006 7 0.6 1.94 5.6 Females (13-50 years) 0.0006 3 0.6 1.94 17 ---------------------------------------------------------------------------------------------------------------- [[Page 28395]] 3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Thiamethoxam is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which does not exceed the Agency's level of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Thiamethoxam is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which does not exceed the Agency's level of concern. 5. Aggregate cancer risk for U.S. population. The cancer aggregate dietary risk estimate was calculated in two ways, one using the Agency's 20% estimated market share for apples and the other using a 5% estimated market share for apples (as indicated by the registrant). The dietary (food only) cancer risk is either 1.0 x 10-\6\ or 0.70 x 10-\6\ with the 20% or 5% estimated market share for apples, respectively. With the 20% market share, it is not possible to estimate a DWLOC for cancer based on an assumed negligible risk value of 1.0 x 10-\6\. Using the latter with 5% market share for apples, the DWLOC is extremely low (0.23 ppb). Therefore, for risk management purposes, an assumed negligible risk value of 3.0 x 10-\6\ will be used to estimate the DWLOC for cancer. The DWLOC for cancer aggregate risk (no residential uses) is calculated using the following equations: DWLOCcancer(µg/L) = chronic water exposure(mg/kg/day) x (body weight (kg))/consumption (L) x 10-\3\ mg/µg chronic water exposure (mg/kg/day)=negligible risk/Q* - chronic food exposure(mg/kg/day) Assuming a risk value of 3 x 10-\6\, (which is generally considered to be within the range of 10-\6\, the risk value considered to represent a negligible cancer risk), for the 20% market share for apples, the chronic water exposure value is estimated to be: 3 x 10-\6\/3.77 x 10-\2\ - 0.000027 = 0.0000525 mg/kg/day The DWLOCcancer = 0.0000525 mg/kg/day x 70 kg/2L x 10-\3\ mg/µg = 1.8 µg/L Using the same equation, for the 5% estimated market share for apples, the DWLOCcancer = 2.1 µg/L. The surface water EEC is 0.6 µg/L and the ground water EEC is 1.94 µg/L. Since the ground water value is greater than the surface water value it will be used for comparison purposes and will protect for any concerns for surface water concentrations. The estimated chronic ground water value for thiamethoxam (1.94 µg/ L) is greater than the DWLOCcancer for the general population using the 20% market share for apples. Using the 5% market share, the DWLOCcancer is less than the Agency's level of concern. The Agency used a screening level model designed to estimate pesticide concentrations in shallow groundwater. Although the 20% market share for apples results in EECs that are marginally above the DWLOCcancer, a number of factors lead EPA to believe that the actual lifetime exposure through drinking water will be less than the DWLOCcancer. These reasons are as follows: i. Thiamethoxam is systemic. EPA's Tier 1 groundwater model assumes that all of the product that is applied to the crop is available for runoff. The registrant has submitted data to show that a percentage (15-25%) of the product is absorbed by the plant, resulting in that much less product available to leach into groundwater. Although the registrant has submitted data on only 2 crops, beans and cucumbers, it is likely that the total amount of thiamethoxam that is available to leach into groundwater is less than the amount EPA uses as an input into its model. Due to a limited data on the amount absorbed, EPA is unable to quantify this. ii. Although the Agency model is based on aerobic soil half lives, EPA's risk assessment for cancer estimate is for lifetime exposure. Data indicate the anaerobic aquatic half life for thiamethoxam is shorter than the aerobic soil half life and longer than the aerobic aquatic half life. Although EPA is unable to predict with a high degree of certainty about what happens to thiamethoxam over time in groundwater, this does provide some support for an expectation that concentrations in groundwater will decline between annual applications. iii. Shallow groundwater modeling is not the perfect model for representing all drinking water from ground water sources. It is likely to be an overestimate of most drinking water, which tends to originate from deeper sources. EPA's experience is that the model is reasonably accurate for shallow drinking water, but the Agency believes that it is less accurate for drinking water from deeper sources. iv. Currently there is no exposure to thiamethoxam through drinking water. The Agency is establishing conditions of registration for the subject uses of this document which will include two prospective ground water studies and a retrospective monitoring study, so that the reasonable certainty of no harm finding will be sustained. v. The cancer risk from the food uses alone is 1.0 x 10-\6\. The dietary risk is based on residue data derived from the average of field trials, which were performed at a higher applied on rate than were accepted by the EPA. It is not unusual in the Agency's experience for field trial data to be an order of magnitude above actual monitoring. Since thiamethoxam is not registered (for uses other than very recently registered seed treatments), actual monitoring data is not available. It is likely that the actual risk contribution from food will be much lower than current data indicate, which would result in a larger DWLOCcancer. EPA expects that this refined DWLOCcancer would be larger than the EECs for the proposed uses. Thus, EPA does not expect that the general population would be exposed to levels exceeding the DWLOCcancer over a lifetime. 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, and to infants and children from aggregate exposure to thiamethoxam residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (HPLC/UV or MS) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov. B. International Residue Limits There are no international residue limits for thiamethoxam. C. Conditions Registration of the proposed uses will include the requirement for two prospective groundwater studies, as well as monitoring of drinking water in a number of states selected for high cropping density and vulnerable soils. V. Conclusion Therefore, the tolerances are established for combined residues of [[Page 28396]] 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-ylmethyl)-N 'methyl-N ''-nitro-guanidine, in or on tuberous and corm vegetables crop subgroup at 0.02 ppm, fruiting vegetables crop group at 0.25 ppm, tomato paste at 0.80 ppm, cucurbit vegetables crop group at 0.20 ppm, and pome fruits crop group at 0.20 ppm. VI. Objections and Hearing Requests Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to ``object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301132 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before July 23, 2001. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301132, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). VII. Regulatory Assessment Requirements This final rule establishes a tolerance under FFDCA section 408(d) 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). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since [[Page 28397]] tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any tribal implications as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications. Policies that have tribal implications is defined in the Executive Order to include regulations that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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:May 14, 2001. James Jones, 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), 346(a) and 371. 2. Section 180.565 is amended by alphabetically adding commodities to the table in paragraph (a) to read as follows: Sec. 180.565 Thiamethoxam; tolerances for resdues. (a) General. * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Cucurbit Vegetables Crop Group............................. 0.2 Fruiting Vegetables Crop Group............................. 0.25 * * * * * Pome Fruit Crop Group...................................... 0.2 * * * * * Tomato Paste............................................... 0.80 Tuberous and Corm Vegetables Crop Subgroup................. 0.02 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 01-12899 Filed 5-22-01; 8:45 am] BILLING CODE 6560-50-S