82 FR 57860 - Indoxacarb; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 235 (December 8, 2017)
Federal Register Volume 82, Issue 235 (December 8, 2017)
| Page Range | 57860-57866 | |
| FR Document | 2017-26517 |
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)] [Rules and Regulations] [Pages 57860-57866] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26517] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0095; FRL-9970-39] Indoxacarb; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of indoxacarb in or on corn, field, forage; corn, field, stover; corn, field, grain. E. I. du Pont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective December 8, 2017. Objections and requests for hearings must be received on or before February 6, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0095, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- 0001; main telephone number: (703) 305-7090; email address: [email protected]. 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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. 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-2017-0095 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 February 6, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified [[Page 57861]] by docket ID number EPA-HQ-OPP-2017-0095, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961- 14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8536) by E. I. du Pont de Nemours and Company, 974 Centre Road, Wilmington, Delaware 19805. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4- (trifluoromethoxy)-phenyl] amino]carbonyl]indeno[1,2e] [1,3,4]oxadiazine-4a(3H)-carboxylate], and [(R)-methyl 7 chloro-2,5- dihydro-2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] amino]carbonyl]indeno[1,2-e][1,3,4] oxadiazine-4a(3H)-carboxylate], in or on corn, field, forage at 10 parts per million (ppm); corn, field, stover at 15 ppm; corn, field, aspirated grain fractions at 45 ppm; corn, field flour at 0.07 ppm; corn, field, meal at 0.03 ppm; corn, field, oil at 0.05 ppm; corn, field, grain at 0.02 ppm. That document referenced a summary of the petition prepared by E. I. du Pont de Nemours and Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Based on available information, EPA is establishing some tolerances that vary from what the petitioner requested. The reasons for these changes are discussed in Unit IV.C. 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 FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for indoxacarb including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with indoxacarb 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 most common effects resulting from exposure to indoxacarb (defined by the lowest-observed-adverse-effect-level (LOAEL)) were non- specific, and included decreases in body weight, food consumption, and food efficiency. Indoxacarb also affected the hematopoietic system by decreasing the red blood cell count, hemoglobin, and hematocrit in rats, dogs, and mice. There was no evidence of reproductive effects in rats resulting from exposure to indoxacarb. There was no evidence of increased susceptibility in developing fetuses or in offspring following prenatal and/or postnatal exposure to indoxacarb in rats or rabbits. There was no evidence of increased susceptibility in the young in the developmental neurotoxicity study in rats. Neurotoxicity was observed in rats and mice, but at doses much higher than those selected for points of departure (PoDs) (which are based on changes in body weight, food consumption and changes in hematology). There is no evidence indoxacarb is carcinogenic, teratogenic, mutagenic, or immunotoxic. Specific information on the studies received and the nature of the adverse effects caused by indoxacarb 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 the documents, Indoxacarb: Human Health Risk Assessment for Indoxacarb to Support the Proposed New Uses on Corn (Field, Pop, and Grown for Seed) in docket ID number EPA-HQ-OPP-2017- 0095 and Indoxacarb: Human Health Draft Risk Assessment for Indoxacarb to Support Registration Review and the Proposed New Use for Controlling Ants at Ornamental Nurseries, Sod Farms, and Livestock Corrals of non- Food Bearing Animals in docket ID number EPA-HQ-OPP-2013-0367. 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 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 [[Page 57862]] assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for indoxacarb used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Indoxacarb for Use in Human Health Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure and Study and Exposure/scenario uncertainty/ safety RfD, PAD, LOC for risk toxicological factors assessment effects ---------------------------------------------------------------------------------------------------------------- Acute dietary (All populations).. NOAEL = 12 mg/kg/day....... Acute RfD = 0.12 mg/kg/day. Acute oral rate UFA = 10x.................. aPAD = 0.12mg/kg/day....... neurotoxicity UFH = 10x.................. study LOAEL = 50 FQPA SF = 1x............... mg/kg/day based on decreased body weight and body- weight gain in females (MP062). ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) NOAEL= 2.0 mg/kg/day....... Chronic RfD = 0.02 mg/kg/ Weight of evidence day. approach was used from four studies: UFA = 10x cPAD = 0.02 mg/kg/day...... (1) Subchronic UFH = 10x.................. toxicity study-- FQPA SF = 1x............... rat (MP062). MRID 44477129. LOAEL = 6.0 (M), 3.8 (F) mg/kg/day based on decreased body weight, body- weight gain, food consumption and food efficiency. ---------------------------------------------------------------------------------------------------------------- (2) Subchronic neurotoxicity study--rat (MP062). MRID 44477135. LOAEL = 5.6 (M), 3.3 (F) mg/kg/day based on decreased body weight and alopecia. (3) Chronic/ carcinogenicity study--rat (JW062). MRID 44477145. LOAEL = 10 (M), 3.6 (F) mg/ kg/day based on decreased body weight, body- weight gain, and food consumption and food efficiency; decreased HCT, HGB and RBC at 6 months in F only. (4) Two-generation rat reproduction study (JW062). MRID 44477144. LOAEL = 4.4 mg/kg/ day based on decreased body weights, body- weight gain, food consumption and food efficiency and increased spleen weights in the F0 and F1 females. ---------------------------------------------------------------------------------------------------------------- Incidental oral short-term (1 to NOAEL= 2.0 mg/kg/day....... LOC for MOE = 100.......... Weight of evidence 30 days). UFA = 10x.................. approach was used UFH = 10x.................. from four studies: FQPA SF = 1x............... (1) Subchronic toxicity study-- rat (MP062). MRID 44477129. LOAEL = 6.0 (M), 3.8 (F) mg/kg/day based on decreased body weight, body- weight gain, food consumption and food efficiency. ---------------------------------------------------------------------------------------------------------------- (2) Subchronic neurotoxicity study--rat (MP062). MRID 44477135. LOAEL = 5.6 (M), 3.3 (F) mg/kg/day based on decreased body weight and alopecia. (3) Chronic/ carcinogenicity study--rat (JW062). MRID 44477145. LOAEL = 10 (M), 3.6 (F) mg/ kg/day based on decreased body weight, body- weight gain, and food consumption and food efficiency; decreased HCT, HGB and RBC at 6 months in F only. (4) Two-generation rat reproduction study (JW062). MRID 44477144. LOAEL = 4.4 mg/kg/ day based on decreased body weights, body- weight gain, food consumption and food efficiency and increased spleen weights in the F0 and F1 females. ---------------------------------------------------------------------------------------------------------------- Short-Term Dermal (1 to 30 days). A quantitative dermal assessment is not required for indoxacarb, since the Intermediate-Term Dermal (1-6 calculated human dermal LOAEL exceeds the limit dose of 1,000 mg/kg/day. months). ---------------------------------------------------------------------------------------------------------------- Inhalation short-term (1 to 30 Inhalation NOAEL= 23 LOC for MOE = 30........... 28-day rat days). [micro]g/L/day. inhalation UFA = 3x................... toxicity study UFH = 10x.................. (MP062). MRID FQPA SF = 1x............... 45870001. ---------------------------------------------------------------------------------------------------------------- Inhalation (1-6 months).......... The LOAEL of 290 [micro]g/L/day is based on increased spleen weights, pigmentation and hematopoiesis in the spleen, hematological changes, mortality (females), and nasal ulceration and inflammation. ---------------------------------------------------------------------------------------------------------------- [[Page 57863]] Cancer (Oral, dermal, inhalation) ``Not likely'' to be carcinogenic to humans since no evidence of carcinogenicity in either the rat or mouse studies, and no evidence of mutagenicity. ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. [micro]g/L/day = microgram/liter/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to indoxacarb, EPA considered exposure under the petitioned- for tolerances as well as all existing indoxacarb tolerances in 40 CFR 180.564. EPA assessed dietary exposures from indoxacarb in food as follows: 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 indoxacarb. In conducting the acute dietary exposure assessment EPA used food consumption information from the 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/ WWEIA). In estimating acute dietary exposure, EPA used maximum residue levels based on the results of field trials reflecting maximum use patterns in all commodities and used maximum Percent Crop Treated (PCT) estimates. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used food consumption information from the 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). In estimating chronic dietary exposure, EPA used average residue levels based on the results of field trials reflecting maximum use patterns in all commodities and used average PCT estimates. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that indoxacarb does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and PCT information. Average or maximum residues and PCT values were used for food commodities. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) 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. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: Condition a: 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 the pesticide residue. Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group. Condition c: 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 PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The Agency estimated maximum and average PCT values for the acute and chronic dietary assessments, as follows: For acute dietary assessment: Apples: 10%; apricots: 15%; blueberries: 5%; broccoli: 70%, cabbage: 35%; cantaloupe: 10%; cauliflower: 60%; celery: 5%; cherries: 2.5%; cotton: 2.5%; cucumbers: 10%; grapes: 5%; lettuce: 15%; nectarines: 15%; peaches: 10%; peanuts: 10%; pears: 2.5%; peppers: 30%; plums/prunes: 5%; potatoes: 2.5%; soybeans: 2.5%; spinach: 5%; squash: 5%; sweet corn: 10%; and tomatoes: 40%. For chronic dietary assessment: Apples: 5%; apricots: 5%; blueberries: 5% broccoli: 45%, cabbage: 20%; cantaloupe: 5%; cauliflower: 35%; celery: 5%; cherries: 2.5%; cotton: 2.5%; cucumbers: 2.5%; grapes: 2.5%; lettuce: 5%; nectarines: 15%; peaches: 2.5%; peanuts: 5%; pears: 1%; peppers: 15%; plums/prunes: 5%; potatoes: 2.5%; soybeans: 1%; spinach: 2.5%; squash: 2.5%; sweet corn: 2.5%; and tomatoes: 20%. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 to 7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 2.5%. In those cases, estimates of average PCT between 1% and 2.5% are rounded to 2.5% and estimates of average PCT less than 1% are rounded to 1%. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except for those situations in which the maximum PCT is less than 2.5%. In those cases, EPA uses a maximum PCT value of 2.5%. The Agency believes the three conditions discussed in Unit III.C.1.iv. [[Page 57864]] have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, 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 allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which indoxacarb may be applied in a particular area. 2. Dietary exposure from drinking water. The Agency used screening- level water exposure models in the dietary exposure analysis and risk assessment for indoxacarb in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of indoxacarb. 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 Surface Water Concentration Calculator (SWCC) model and the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of indoxacarb for acute exposures are 39 parts per billion (ppb) for surface water and 131 ppb for ground water; for chronic exposures the EDWCs are 11 ppb for surface water and 123 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, a time series distribution of ground water modeled residues was used to assess the contribution to drinking water. For the chronic dietary risk assessment, a single point water concentration value of 123 ppb was used to assess the contribution to drinking 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). Indoxacarb is currently registered for the following uses that could result in residential exposures: Pet spot-on uses, spot, crack and crevice applications indoors, outdoor broadcast (i.e., turf), perimeter and foundations, spot (i.e., direct mount applications for fire ants), and crack and crevice. Based on these use scenarios, EPA assessed residential exposure using the following assumptions: Spot and crack and crevice exposures were not assessed due to formulation types that minimize the potential for handler and post- application exposures (i.e., gels or bait stations). Risks from spot and crack and crevice were not assessed because exposures from these formulation types are expected to be negligible. Residential handler exposure: There is a potential for dermal and inhalation exposure. Residential handler inhalation exposure is considered negligible for applying ready-to-use pet spot-ons. Residential handler dermal exposures are expected for ready-to-use pet spot-ons, however dermal exposures were not assessed due to the lack of a dermal endpoint. Residential handler inhalation and dermal exposures are considered negligible for applying ready-to-use arenas (i.e., baits or stations). Residential post-application dermal and incidental oral exposure: Post-application assessments were not conducted for ant mound uses, because these are considered perimeter/spot uses; residential exposure is expected to be negligible. Spot and crack and crevice exposures were not assessed for gels or bait stations; exposure is considered negligible. A golfer assessment was not conducted, due to the lack of a dermal endpoint. Post-application inhalation exposure is generally not assessed following application to pets and turf. The combination of low vapor pressure (1.9x10-10 mm Hg at 25 [ordm]C for indoxacarb) of active ingredients typically used in pet and turf pesticide products, and the small amounts of pesticide applied to pets is expected to result in only negligible inhalation exposure. Ingestion of granules is considered an episodic event and not a routine behavior. Because the Agency does not expect this to occur on a regular basis, concern for human health is related to acute poisoning rather than short-term residue exposure. For these reasons, the episodic ingestion scenario is not included in the aggregate assessment. The only route of residential exposure for inclusion in the adult aggregate assessment is inhalation. However, inhalation exposures cannot be aggregated with background dietary exposures because the toxicity endpoints for the inhalation and short-term oral routes are different. Therefore, the only residential exposures that were combined are for children 1 to <2 years old in the short-term aggregate assessment that reflects hand-to- mouth exposures from post-application exposure to spot treatment on carpets, and children 1 to <2 years old in the intermediate- and long- term aggregate assessment that reflects exposures from treated pets. 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.'' EPA has not found indoxacarb to share a common mechanism of toxicity with any other substances, and indoxacarb does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA assumed that indoxacarb does 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 safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10 times;, or uses a different additional safety factor when [[Page 57865]] reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There was no evidence of reproductive effects in rats. There was no evidence of increased susceptibility in developing fetuses or in the offspring following prenatal and/or postnatal exposure to indoxacarb in rats or rabbits. There was no evidence of increased susceptibility in the young in the developmental neurotoxicity study in rats. 3. Conclusion. EPA determined reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for indoxacarb is complete. ii. The acute neurotoxicity, subchronic toxicity, and developmental neurotoxicity studies for indoxacarb are available and all endpoints used in the risk assessment are protective of neurotoxic effects. iii. There is no evidence that indoxacarb results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The Agency estimated maximum and average PCT values for the acute and chronic dietary assessments, respectively, as shown in unit III.C.i., and unit III.C.ii. Food residues were taken from the results of supervised field trial studies reflecting maximum use patterns. Drinking water residues were included in the dietary assessments as follows: A point estimate of 123 ppb was used for the chronic assessment and the time series distribution of ground water modeled residues was used in the acute assessment as a residue distribution file (RDF) in the Monte Carlo analysis. For food commodities, RDFs were constructed for the probabilistic acute dietary assessment as appropriate, and average residues were computed for blended commodities and for the chronic dietary assessment. EPA used similarly conservative assumptions to assess post- application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by indoxacarb. 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 indoxacarb will occupy 56% of the aPAD for children ages 1-2, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to indoxacarb from food and water will utilize 35% of the cPAD for all infants less than 1-year old, the population group receiving the greatest exposure. EPA has concluded the combined long-term food, water, and residential exposures result in aggregate MOEs of 260 (food, water, and residential) for children aged 1-2. Because EPA's level of concern for indoxacarb is a MOE of 100 or below, this MOEs is not of concern. For adults, residential inhalation exposures cannot be aggregated because they are based on different effects than for oral exposures. Therefore, long-term aggregate risk for adults is equivalent to the chronic dietary risk noted in this unit. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Indoxacarb 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 to children aged 1-2 years through food and water with short-term residential exposures to indoxacarb. For adults, residential inhalation exposures cannot be aggregated because they are based on different effects than for oral exposures. Therefore, short-term aggregate risk for adults is equivalent to the chronic risk noted in unit III.E.2. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 120 (food, water, and residential) for children aged 1-2. Because EPA's level of concern for indoxacarb is a MOE of 100 or below, this MOEs is 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). Indoxacarb 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 to children aged 1-2 years through food and water with intermediate-term residential exposures to indoxacarb. For adults, residential inhalation exposures cannot be aggregated because they are based on different effects than for oral exposures. Therefore, intermediate-term aggregate risk for adults is equivalent to the chronic risk noted above in unit III.E.2. 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 children aged 1-2 years result in aggregate MOEs of 260. Because EPA's level of concern for indoxacarb is a MOE of 100 or below, this MOE is not of concern. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, indoxacarb is not expected to pose a cancer risk to humans. 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 indoxacarb residues. IV. Other Considerations A. Analytical Enforcement Methodology For the enforcement of tolerances established on crops, two High Performance Liquid Chromatograph/Ultraviolet Detection (HPLC/UV) methods, DuPont protocols AMR 2712-93 and DuPont-11978, are available for use. The limits of quantitation (LOQs) for these methods range from 0.01 to 0.05 ppm for a variety of plant commodities. A third procedure, Gas Chromatograph/Mass-Selective Detection (GC/MSD), DuPont method AMR 3493-95 Supplement No. 4, is also available for the confirmation of residues in plants. 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 [[Page 57866]] safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established MRLs in field corn for indoxacarb. C. Revisions to Petitioned-For Tolerances Based on available data and using the Organisation for Economic Co- operation and Development (OECD) maximum residue limit (MRL) calculation procedures, EPA determined that the appropriate tolerance level for corn, field, forage is 6.0 ppm. Based on the corn processing studies, the Agency determined that there is a low level of residue concentration from processing; therefore, separate tolerances are not needed for the processed corn commodities of flour, meal, or oil because these commodities are covered by the tolerance for corn, field, grain. The ``grain, aspirated fractions'' tolerance does not need to be modified for field corn because 40 CFR 180.564(a) currently lists a tolerance level of 45 ppm for ``grain, aspirated fractions,'' and this tolerance covers potential indoxacarb residues in aspirated grain fractions derived from corn. V. Conclusion Therefore, tolerances are established for residues of indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4- (trifluoromethoxy)-phenyl] amino]carbonyl] indeno[1,2e][1,3,4]oxadiazine-4a(3H)-carboxylate], and [(R)-methyl 7 chloro-2,5-dihydro-2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] amino]carbonyl] indeno [1,2-e][1,3,4] oxadiazine-4a(3H)-carboxylate], in or on corn, field, forage at 6.0 ppm; corn, field, stover at 15 ppm; and corn, field, grain at 0.02 ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances 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). Because this action has been exempted from review under Executive Order 12866, this action 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 action 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 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. This action 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 FFDCA section 408(n)(4). 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). 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 (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 22, 2017. Michael Goodis, 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. In Sec. 180.564, add alphabetically the entries for ``Corn, field, forage'', ``Corn, field, grain'', and ``Corn, field, stover'' to the table in paragraph (a)(1) to read as follows: Sec. 180.564 Indoxacarb; tolerances for residues. (a) * * * (1) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Corn, field, forage..................................... 6.0 Corn, field, grain...................................... 0.02 Corn, field, stover..................................... 15 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2017-26517 Filed 12-7-17; 8:45 am] BILLING CODE 6560-50-P
![57860 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Rules and Regulations
Transfer and Advancement Act Parts per DC 20460–0001; main telephone
Commodity
(NTTAA) (15 U.S.C. 272 note). million number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
VII. Congressional Review Act Tomato ........................................ 1 7.0
SUPPLEMENTARY INFORMATION:
Pursuant to the Congressional Review 1 Some of these tolerances were established
on the basis of data acquired at the public I. General Information
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and hearings held in 1950 (formerly § 180.101) and A. Does this action apply to me?
the remainder were established on the basis
other required information to the U.S. of pesticide petitions presented under the pro- You may be potentially affected by
Senate, the U.S. House of cedure specified in the amendment to the this action if you are an agricultural
Representatives, and the Comptroller Federal Food, Drug, and Cosmetic Act by
Public Law 518, 83d Congress (68 Stat. 511). producer, food manufacturer, or
General of the United States prior to pesticide manufacturer. The following
publication of the rule in the Federal * * * * * list of North American Industrial
Register. This action is not a ‘‘major [FR Doc. 2017–25713 Filed 12–7–17; 8:45 am]
Classification System (NAICS) codes is
rule’’ as defined by 5 U.S.C. 804(2). BILLING CODE 6560–50–P
not intended to be exhaustive, but rather
List of Subjects in 40 CFR Part 180 provides a guide to help readers
determine whether this document
Environmental protection, ENVIRONMENTAL PROTECTION
applies to them. Potentially affected
Administrative practice and procedure, AGENCY
entities may include:
Agricultural commodities, Pesticides • Crop production (NAICS code 111).
40 CFR Part 180
and pests, Reporting and recordkeeping • Animal production (NAICS code
requirements. [EPA–HQ–OPP–2017–0095; FRL–9970–39] 112).
Dated: November 9, 2017. • Food manufacturing (NAICS code
Indoxacarb; Pesticide Tolerances 311).
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
of Pesticide Programs. Agency (EPA). code 32532).
Therefore, 40 CFR chapter I is ACTION: Final rule. B. How can I get electronic access to
amended as follows: other related information?
SUMMARY: This regulation establishes
tolerances for residues of indoxacarb in You may access a frequently updated
PART 180—[AMENDED] electronic version of EPA’s tolerance
or on corn, field, forage; corn, field,
stover; corn, field, grain. E. I. du Pont de regulations at 40 CFR part 180 through
■ 1. The authority citation for part 180 the Government Printing Office’s e-CFR
Nemours and Company requested these
continues to read as follows: site at http://www.ecfr.gov/cgi-bin/text-
tolerances under the Federal Food,
Authority: 21 U.S.C. 321(q), 346a and 371. Drug, and Cosmetic Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
DATES: This regulation is effective
40tab_02.tpl.
■ 2. In § 180.116, revise paragraph (a) to
read as follows: December 8, 2017. Objections and C. How can I file an objection or hearing
requests for hearings must be received request?
§ 180.116 Ziram; tolerances for residues. on or before February 6, 2018, and must
Under FFDCA section 408(g), 21
(a) General. Tolerances are be filed in accordance with the
U.S.C. 346a, any person may file an
established for residues of the fungicide instructions provided in 40 CFR part
objection to any aspect of this regulation
ziram (zinc dimethyldithiocarbamate), 178 (see also Unit I.C. of the
and may also request a hearing on those
including its metabolites and SUPPLEMENTARY INFORMATION).
objections. You must file your objection
degradates, in or on the commodities in ADDRESSES: The docket for this action, or request a hearing on this regulation
the table below as a result of the identified by docket identification (ID) in accordance with the instructions
application of ziram. Compliance with number EPA–HQ–OPP–2017–0095, is provided in 40 CFR part 178. To ensure
the tolerance levels specified below is to available at http://www.regulations.gov proper receipt by EPA, you must
be determined by measuring total or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
dithiocarbamates, determined as CS2, Regulatory Public Docket (OPP Docket) OPP–2017–0095 in the subject line on
evolved during acid digestion and in the Environmental Protection Agency the first page of your submission. All
expressed as zinc Docket Center (EPA/DC), West William objections and requests for a hearing
ethylenebisdithiocarbamate. Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
Commodity Parts per 20460–0001. The Public Reading Room before February 6, 2018. Addresses for
million is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections
1 0.10
Monday through Friday, excluding legal and hearing requests are provided in 40
Almond ........................................
Apple ........................................... 1 7.0 holidays. The telephone number for the CFR 178.25(b).
Apricot ......................................... 1 7.0 Public Reading Room is (202) 566–1744, In addition to filing an objection or
Blueberry .................................... 1 7.0 and the telephone number for the OPP hearing request with the Hearing Clerk
Cherry, sweet ............................. 1 7.0 Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
Cherry, tart .................................. 1 7.0 the visitor instructions and additional submit a copy of the filing (excluding
sradovich on DSK3GMQ082PROD with RULES
Grape .......................................... 7.0 information about the docket available any Confidential Business Information
Hazelnut ...................................... 0.10 at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
Huckleberry ................................. 7.0
FOR FURTHER INFORMATION CONTACT: Information not marked confidential
Peach .......................................... 7.0
Pear ............................................ 1 7.0 Michael L. Goodis, Registration Division pursuant to 40 CFR part 2 may be
Pecan .......................................... 0.10 (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
Quince ........................................ 1 7.0 Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
Strawberry .................................. 7.0 Pennsylvania Ave. NW., Washington, objection or hearing request, identified
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![Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Rules and Regulations 57861
by docket ID number EPA–HQ–OPP– III. Aggregate Risk Assessment and exposure to indoxacarb in rats or
2017–0095, by one of the following Determination of Safety rabbits. There was no evidence of
methods: Section 408(b)(2)(A)(i) of FFDCA increased susceptibility in the young in
• Federal eRulemaking Portal: http:// allows EPA to establish a tolerance (the the developmental neurotoxicity study
www.regulations.gov. Follow the online legal limit for a pesticide chemical in rats. Neurotoxicity was observed in
residue in or on a food) only if EPA rats and mice, but at doses much higher
instructions for submitting comments.
determines that the tolerance is ‘‘safe.’’ than those selected for points of
Do not submit electronically any
departure (PoDs) (which are based on
information you consider to be CBI or Section 408(b)(2)(A)(ii) of FFDCA
changes in body weight, food
other information whose disclosure is defines ‘‘safe’’ to mean that ‘‘there is a
consumption and changes in
restricted by statute. reasonable certainty that no harm will
hematology). There is no evidence
• Mail: OPP Docket, Environmental result from aggregate exposure to the
indoxacarb is carcinogenic, teratogenic,
Protection Agency Docket Center (EPA/ pesticide chemical residue, including
mutagenic, or immunotoxic.
DC), (28221T), 1200 Pennsylvania Ave. all anticipated dietary exposures and all Specific information on the studies
NW., Washington, DC 20460–0001. other exposures for which there is received and the nature of the adverse
reliable information.’’ This includes effects caused by indoxacarb as well as
• Hand Delivery: To make special exposure through drinking water and in
arrangements for hand delivery or the no-observed-adverse-effect-level
residential settings, but does not include (NOAEL) and the lowest-observed-
delivery of boxed information, please occupational exposure. Section
follow the instructions at http:// adverse-effect-level (LOAEL) from the
408(b)(2)(C) of FFDCA requires EPA to toxicity studies can be found at http://
www.epa.gov/dockets/contacts.html. give special consideration to exposure
Additional instructions on commenting www.regulations.gov in the documents,
of infants and children to the pesticide Indoxacarb: Human Health Risk
or visiting the docket, along with more chemical residue in establishing a Assessment for Indoxacarb to Support
information about dockets generally, is tolerance and to ‘‘ensure that there is a the Proposed New Uses on Corn (Field,
available at http://www.epa.gov/ reasonable certainty that no harm will Pop, and Grown for Seed) in docket ID
dockets. result to infants and children from number EPA–HQ–OPP–2017–0095 and
II. Summary of Petitioned-For aggregate exposure to the pesticide Indoxacarb: Human Health Draft Risk
Tolerance chemical residue . . .’’ Assessment for Indoxacarb to Support
Consistent with FFDCA section Registration Review and the Proposed
In the Federal Register of June 8, 2017 408(b)(2)(D), and the factors specified in New Use for Controlling Ants at
(82 FR 26641) (FRL–9961–14), EPA FFDCA section 408(b)(2)(D), EPA has Ornamental Nurseries, Sod Farms, and
issued a document pursuant to FFDCA reviewed the available scientific data Livestock Corrals of non-Food Bearing
section 408(d)(3), 21 U.S.C. 346a(d)(3), and other relevant information in Animals in docket ID number EPA–HQ–
announcing the filing of a pesticide support of this action. EPA has OPP–2013–0367.
petition (PP 6F8536) by E. I. du Pont de sufficient data to assess the hazards of
and to make a determination on B. Toxicological Points of Departure/
Nemours and Company, 974 Centre
aggregate exposure for indoxacarb Levels of Concern
Road, Wilmington, Delaware 19805. The
petition requested that 40 CFR part 180 including exposure resulting from the Once a pesticide’s toxicological
be amended by establishing tolerances tolerances established by this action. profile is determined, EPA identifies
for residues of the insecticide EPA’s assessment of exposures and risks toxicological points of departure (PoD)
indoxacarb, [(S)-methyl 7-chloro-2,5- associated with indoxacarb follows. and levels of concern to use in
dihydro-2-[[(methoxycarbonyl)[4- evaluating the risk posed by human
A. Toxicological Profile
(trifluoromethoxy)-phenyl] exposure to the pesticide. For hazards
amino]carbonyl]indeno[1,2e] EPA has evaluated the available that have a threshold below which there
[1,3,4]oxadiazine-4a(3H)-carboxylate], toxicity data and considered its validity, is no appreciable risk, the toxicological
and [(R)-methyl 7 chloro-2,5-dihydro- completeness, and reliability as well as PoD is used as the basis for derivation
2[[(methoxycarbonyl)[4- the relationship of the results of the of reference values for risk assessment.
studies to human risk. EPA has also PoDs are developed based on a careful
(trifluoromethoxy)phenyl]
considered available information analysis of the doses in each
amino]carbonyl]indeno[1,2-e][1,3,4]
concerning the variability of the toxicological study to determine the
oxadiazine-4a(3H)-carboxylate], in or on
sensitivities of major identifiable dose at which no adverse effects are
corn, field, forage at 10 parts per million
subgroups of consumers, including observed (the NOAEL) and the lowest
(ppm); corn, field, stover at 15 ppm;
infants and children. dose at which adverse effects of concern
corn, field, aspirated grain fractions at
The most common effects resulting are identified (the LOAEL). Uncertainty/
45 ppm; corn, field flour at 0.07 ppm;
from exposure to indoxacarb (defined by safety factors are used in conjunction
corn, field, meal at 0.03 ppm; corn, with the PoD to calculate a safe
the lowest-observed-adverse-effect-level
field, oil at 0.05 ppm; corn, field, grain (LOAEL)) were non-specific, and exposure level—generally referred to as
at 0.02 ppm. That document referenced included decreases in body weight, food a population-adjusted dose (PAD) or a
a summary of the petition prepared by consumption, and food efficiency. reference dose (RfD)—and a safe margin
E. I. du Pont de Nemours and Company, Indoxacarb also affected the of exposure (MOE). For non-threshold
the registrant, which is available in the hematopoietic system by decreasing the risks, the Agency assumes that any
docket, http://www.regulations.gov. red blood cell count, hemoglobin, and amount of exposure will lead to some
sradovich on DSK3GMQ082PROD with RULES
There were no comments received in hematocrit in rats, dogs, and mice. degree of risk. Thus, the Agency
response to the notice of filing. There was no evidence of estimates risk in terms of the probability
Based on available information, EPA reproductive effects in rats resulting of an occurrence of the adverse effect
is establishing some tolerances that vary from exposure to indoxacarb. There was expected in a lifetime. For more
from what the petitioner requested. The no evidence of increased susceptibility information on the general principles
reasons for these changes are discussed in developing fetuses or in offspring EPA uses in risk characterization and a
in Unit IV.C. following prenatal and/or postnatal complete description of the risk
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![57866 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Rules and Regulations
safety standards and agricultural response to a petition submitted to the Agency consideration of voluntary
practices. EPA considers the Agency. The Office of Management and consensus standards pursuant to section
international maximum residue limits Budget (OMB) has exempted these types 12(d) of the National Technology
(MRLs) established by the Codex of actions from review under Executive Transfer and Advancement Act
Alimentarius Commission (Codex), as Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note).
required by FFDCA section 408(b)(4). Planning and Review’’ (58 FR 51735,
The Codex Alimentarius is a joint October 4, 1993). Because this action VII. Congressional Review Act
United Nations Food and Agriculture has been exempted from review under
Pursuant to the Congressional Review
Organization/World Health Executive Order 12866, this action is
Organization food standards program, not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will
and it is recognized as an international entitled ‘‘Actions Concerning submit a report containing this rule and
food safety standards-setting Regulations That Significantly Affect other required information to the U.S.
organization in trade agreements to Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of
which the United States is a party. EPA FR 28355, May 22, 2001) or Executive Representatives, and the Comptroller
may establish a tolerance that is Order 13045, entitled ‘‘Protection of General of the United States prior to
different from a Codex MRL; however, Children from Environmental Health publication of the rule in the Federal
FFDCA section 408(b)(4) requires that Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major
EPA explain the reasons for departing April 23, 1997). This action does not rule’’ as defined by 5 U.S.C. 804(2).
from the Codex level. contain any information collections
The Codex has not established MRLs subject to OMB approval under the List of Subjects in 40 CFR Part 180
in field corn for indoxacarb. Paperwork Reduction Act (PRA) (44 Environmental protection,
U.S.C. 3501 et seq.), nor does it require Administrative practice and procedure,
C. Revisions to Petitioned-For
any special considerations under Agricultural commodities, Pesticides
Tolerances
Executive Order 12898, entitled
Based on available data and using the and pests, Reporting and recordkeeping
‘‘Federal Actions to Address
Organisation for Economic Co-operation requirements.
Environmental Justice in Minority
and Development (OECD) maximum Populations and Low-Income Dated: November 22, 2017.
residue limit (MRL) calculation Populations’’ (59 FR 7629, February 16, Michael Goodis,
procedures, EPA determined that the 1994). Director, Registration Division, Office of
appropriate tolerance level for corn, Since tolerances and exemptions that Pesticide Programs.
field, forage is 6.0 ppm. Based on the are established on the basis of a petition
corn processing studies, the Agency under FFDCA section 408(d), such as Therefore, 40 CFR chapter I is
determined that there is a low level of the tolerance in this final rule, do not amended as follows:
residue concentration from processing; require the issuance of a proposed rule,
therefore, separate tolerances are not the requirements of the Regulatory PART 180—[AMENDED]
needed for the processed corn Flexibility Act (RFA) (5 U.S.C. 601 et
commodities of flour, meal, or oil seq.), do not apply. ■ 1. The authority citation for part 180
because these commodities are covered This action directly regulates growers, continues to read as follows:
by the tolerance for corn, field, grain. food processors, food handlers, and food
retailers, not States or tribes, nor does Authority: 21 U.S.C. 321(q), 346a and 371.
The ‘‘grain, aspirated fractions’’
tolerance does not need to be modified this action alter the relationships or ■ 2. In § 180.564, add alphabetically the
for field corn because 40 CFR 180.564(a) distribution of power and entries for ‘‘Corn, field, forage’’, ‘‘Corn,
currently lists a tolerance level of 45 responsibilities established by Congress field, grain’’, and ‘‘Corn, field, stover’’ to
ppm for ‘‘grain, aspirated fractions,’’ in the preemption provisions of FFDCA the table in paragraph (a)(1) to read as
and this tolerance covers potential section 408(n)(4). As such, the Agency follows:
indoxacarb residues in aspirated grain has determined that this action will not
fractions derived from corn. have a substantial direct effect on States § 180.564 Indoxacarb; tolerances for
or tribal governments, on the residues.
V. Conclusion relationship between the national
Therefore, tolerances are established government and the States or tribal (a) * * *
for residues of indoxacarb, [(S)-methyl governments, or on the distribution of (1) * * *
7-chloro-2,5-dihydro-2- power and responsibilities among the
[[(methoxycarbonyl)[4- various levels of government or between Commodity Parts per
(trifluoromethoxy)-phenyl] the Federal Government and Indian million
amino]carbonyl] tribes. Thus, the Agency has determined
indeno[1,2e][1,3,4]oxadiazine-4a(3H)- that Executive Order 13132, entitled
* * * * *
carboxylate], and [(R)-methyl 7 chloro- ‘‘Federalism’’ (64 FR 43255, August 10,
Corn, field, forage ................. 6.0
2,5-dihydro-2[[(methoxycarbonyl)[4- 1999) and Executive Order 13175,
Corn, field, grain ................... 0.02
(trifluoromethoxy)phenyl] entitled ‘‘Consultation and Coordination
Corn, field, stover ................. 15
amino]carbonyl] indeno [1,2-e][1,3,4] with Indian Tribal Governments’’ (65 FR
oxadiazine-4a(3H)-carboxylate], in or on 67249, November 9, 2000) do not apply
* * * * *
corn, field, forage at 6.0 ppm; corn, to this action. In addition, this action
sradovich on DSK3GMQ082PROD with RULES
field, stover at 15 ppm; and corn, field, does not impose any enforceable duty or
* * * * *
grain at 0.02 ppm. contain any unfunded mandate as
described under Title II of the Unfunded [FR Doc. 2017–26517 Filed 12–7–17; 8:45 am]
VI. Statutory and Executive Order Mandates Reform Act (UMRA) (2 U.S.C. BILLING CODE 6560–50–P
Reviews 1501 et seq.).
This action establishes tolerances This action does not involve any
under FFDCA section 408(d) in technical standards that would require
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Document Created: 2017-12-08 01:43:55
Document Modified: 2017-12-08 01:43:55
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective December 8, 2017. Objections and requests for hearings must be received on or before February 6, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- | |
| FR Citation | 82 FR 57860 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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