82 FR 34877 - Tolpyralate; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 143 (July 27, 2017)
Federal Register Volume 82, Issue 143 (July 27, 2017)
| Page Range | 34877-34882 | |
| FR Document | 2017-15717 |
[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)] [Rules and Regulations] [Pages 34877-34882] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15717] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0405; FRL-9964-15] Tolpyralate; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of tolpyralate in or on field corn, popcorn, and sweet corn. ISK Biosciences Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 27, 2017. Objections and requests for hearings must be received on or before September 25, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0405, 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 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-2015-0405 in the subject line on the first page of your submission. All [[Page 34878]] objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 25, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0405, 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 August 26, 2015 (80 FR 51759) (FRL-9931- 74), 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 5F8359) by ISK Biosciences, Corporation, 7470 Auburn Rd., Suite A, Concord, OH 44077. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide, tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4- (methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate, including its metabolite MT-2153, in or on the raw agricultural commodities of corn that include field corn (corn, field, grain; corn, field, forage; and corn, field, stover); sweet corn (corn, sweet, kernel + cob with husks removed; corn, sweet, forage; and corn, sweet, stover); and popcorn (corn, pop, grain and corn, pop, stover) at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by ISK Biosciences, Corporation the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Consistent with 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 tolpyralate including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with tolpyralate 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 effects in the tolpyralate hazard database are similar to those seen with other hydroxyphenylpyruvate dioxygenase (HPPD) inhibiting chemicals, including eye opacity and developmental skeletal defects. The major target organs identified were the eyes, kidney, liver, thyroid and developing skeleton. Other effects included pancreatic acinar cell single cell necrosis, gall bladder calculi, fur loss and/or tactile hair loss, and decreased body weights. No systemic toxicity was observed following a 28-day dermal exposure in the rat. Neurotoxicity was not observed in the acute or subchronic neurotoxicity studies in the rat. There was no indication of neurotoxicity to the fetus in developmental studies or during early postnatal development in a rat reproductive toxicity study. However, with chronic exposure, rats and mice showed effects on the nervous system that were indicative of a temporally-dependent response for neurotoxicity. Similar findings were not seen in the one-year dog study. Developmental toxicity studies in the rat and rabbit showed that the main effects on fetuses in both species were skeletal variations that are consistent with those observed from exposure to other HPPD inhibitors. These skeletal effects are considered to be evidence of increased quantitative and qualitative prenatal susceptibility. No immunotoxic potential was observed in a mouse immunotoxicity study; however, in the dog, inflammation associated with hyperostosis and lymph node hyperplasia in males was observed. In the rat, an increase in the incidence of squamous cell carcinomas of the eye was observed. The increase in this tumor type is considered to be related to the eye opacities typically observed with compounds producing HPPD inhibition. The Agency has determined that tolpyralate shows ``suggestive evidence of carcinogenicity to humans'' based on an increase in the incidence of squamous cell carcinoma of the eye in male rats in the rat carcinogenicity study. There was no evidence of carcinogenicity in female rats or in the mouse. Most genotoxicity studies did not show evidence of mutagenicity or clastogenicity. A mouse lymphoma cell gene mutation assay showed a dose-dependent, reproducible increase in mutant colonies, but the results of this study are considered inconclusive due to the insolubility of the test compound. However, all other genotoxicity studies, including an in vivo mouse micronucleus assay, were negative. Therefore, when considered as a whole, the available mutagenicity and clastogenicity studies did not indicate genotoxic potential. The Agency concluded that the eye tumors resulted from long-term exposure to increased blood tyrosine levels as a result of HPPD inhibition. The eye is a target organ for HPPD inhibitors and causes opacities and keratitis with subchronic or chronic exposure. Eye tumors have been [[Page 34879]] reported in male rats following chronic exposure to some other HPPD inhibitors. Since the development of the eye tumors in the rat is considered to be dependent upon ocular toxicity, and not to a linear (non-threshold), genotoxic mechanism, tumors will not develop at doses that are protective of eye toxicity. Eye effects from exposure to tolpyralate were observed at the LOAEL in males in the rat chronic toxicity/carcinogenicity study but not at the NOAEL. The NOAEL from this study is therefore considered protective of this tumor type and was used as the basis of the chronic reference dose. Quantification of cancer risk is not required because the chronic reference dose, which is protective of eye toxicity, is considered to be protective of cancer risk. The acute toxicity of tolpyralate is low, and it is not an eye or skin irritant or a dermal sensitizer. Specific information on the studies received and the nature of the adverse effects caused by tolpyralate as well as the NOAELs and the LOAELs from the toxicity studies can be found at http://www.regulations.gov in document titled ``Tolpyralate--New Active Ingredient Human Health Risk Assessment for Proposed Uses on Sweet Corn, Field Corn, and Popcorn'' at page 35 in docket ID number EPA-HQ- OPP-2015-405. 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 (LOC) to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. No adverse effects resulting from a single exposure and relevant for the general population were identified for tolpyralate; therefore, a point of departure for assessing acute risk for this population was not established. The fetal skeletal effects noted above are suitable for acute assessment of women of child-bearing age. The no-adverse effect level (NOAEL) for skeletal variations in the rabbit developmental toxicity study is 5 mg/kg body weight (bw)/day (lowest adverse effect level (LOAEL) = 50 mg/kg bw/day). Chronic exposure is being assessed based on the systemic effects (fur loss; eye opacity; liver; pancreas; kidney; thyroid and cerebellar effects) noted in the chronic oral toxicity study in rats, with a NOAEL of 0.93 mg/kg bw/day and a LOAEL of 97/126 (male/female) mg/kg bw/day. A summary of the toxicological endpoints for tolpyralate used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Tolpyralate for Use in Human Health Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (General population .................... ................... An appropriate endpoint was not including infants and children). identified for this exposure scenario. An adverse effect resulting from a single oral exposure was not identified for the general population. Acute dietary (Females 13-49 NOAEL = 5 mg/kg/day. Acute RfD = 0.05 mg/ Developmental toxicity study in years of age). UFA = 10x........... kg/day. the rabbit (gavage; range-finding UFH = 10x........... aPAD = 0.05 mg/kg/ and main studies considered FQPA SF = 1x........ day. together). Developmental LOAEL = 50 mg/kg/day based an increased incidence of skeletal abnormalities (range- finding study). Chronic dietary (All populations NOAEL= 0.925 mg/kg/ Chronic RfD = Chronic oral toxicity in the rat including infants and children day. 0.0093 mg/kg/day. (dietary). and females 13-49 years of age). UFA = 10x........... cPAD = 0.0093 mg/kg/ LOAEL = 97/126 mg/kg/day based on UFH = 10x........... day. fur loss, eye opacity/ FQPA SF = 1x........ neovascularization/keratitis, increased relative liver weight, thyroid follicular cell hypertrophy, hepatocellular centrilobular fatty change, increased pancreatic acinar cell necrosis, renal tubule basophilic change, increased molecular layer vacuolation in the cerebellum (males). ------------------------------------------------------------------------------ Cancer (Oral, dermal, inhalation) Classification: Suggestive evidence of carcinogenic potential in humans, based on squamous cell carcinoma of the eye in male rats. The chronic RfD is protective of carcinogenicity. ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/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. UFH = potential variation in sensitivity among members of the human population (intraspecies). DAF = dermal absorption factor. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to tolpyralate, EPA considered exposure under the petitioned- for tolerances. EPA assessed dietary exposures from tolpyralate 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 tolpyralate. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) [[Page 34880]] under the Continuing Survey of Food Intake by Individuals (CSFII) and the CDC under the National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WEIA) 2003-2008. EPA assumed tolerance-level residues for all commodities and 100% crop treated. There is no expectation of finite residues in either livestock commodities or rotational crops; therefore, no residues have been entered for these commodities. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WEIA 2003-2008. EPA assumed tolerance-level residues for all commodities and 100% crop treated. iii. Cancer. The Agency has determined that quantification of risk using a non-linear approach (i.e., RfD), for tolpyralate will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to tolpyralate. As a result, the chronic dietary exposure assessment is protective for potential cancer risk, and a separate cancer exposure assessment was not conducted. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for tolpyralate. Tolerance level residues and/or 100% CT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for tolpyralate in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of tolpyralate. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. The groundwater value was generated using the Pesticide Root Zone Model for Groundwater (PRZM-GW) Model, and the surface water values were generated using the Pesticide Root Zone Model (PRZM5) and the Variable Volume Water Model (VVWM). The EDWCs of tolpyralate for acute exposures are estimated to be 6.75 parts per billion (ppb) for surface water and 11.53 ppb for ground water. For chronic exposures assessments are estimated to be 0.65 ppb for surface water and 10.18 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 11.53 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 10.18 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). Tolpyralate is not registered for any specific use patterns that would result in residential exposure. 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.'' Although tolpyralate belongs to the class of chemicals whose mechanism of toxicity is the inhibition of HPPD, EPA has not made a common mechanism of toxicity finding as to tolpyralate and other HPPD- inhibiting substances. There are marked differences among species in the ocular toxicity and other effects typically associated with tolpyralate and other substances that the inhibit HPPD. Ocular effects following treatment with HPPD-inhibitor herbicides are seen in the rat but not in the mouse. Monkeys also seem to be recalcitrant to the ocular toxicity induced by HPPD inhibition. One explanation for this species-specific response in ocular opacity may be related to species differences in the clearance of tyrosine. A metabolic pathway that involves the liver enzyme tyrosine aminotransferase (TAT) exists to remove tyrosine from the blood. In contrast to rats where ocular toxicity is observed following exposure to HPPD-inhibiting herbicides, mice and humans are unlikely to achieve the levels of plasma tyrosine necessary to produce ocular opacities because the activity of TAT in these species is much greater compared to rats. HPPD inhibitors (e.g., nitisinone) are used as an effective therapeutic agent to treat patients suffering from rare genetic diseases of tyrosine catabolism. Treatment starts in childhood but is often sustained throughout patient's lifetime. The human experience indicates that a therapeutic dose (1 mg/kg/day dose) of nitisinone has an excellent safety record in infants, children, and adults and that serious adverse health outcomes have not been observed in a population followed for approximately a decade. Rarely, ocular effects are seen in patients with high plasma tyrosine levels; however, these effects are transient and can be readily reversed upon adherence to a restricted protein diet. This observation indicates that an HPPD inhibitor in and of itself cannot easily overwhelm the tyrosine-clearance mechanism in humans. Based on the available information about the potential mechanism of toxicity and the variability of effects between species, EPA has not assumed, for purposes of this tolerance action, that tolpyralate has a common mechanism of toxicity with other substances. 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 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Quantitative and qualitative evidence of increased susceptibility, as compared to adults, of fetuses to in utero exposure to tolpyralate was observed in developmental toxicity studies in rats and rabbits. Concern for this evidence is low because (1) clear NOAELs/LOAELs were identified for the observed effects; (2) the relevant developmental effects were observed at LOAELs that were well above (10-fold greater) the NOAELs; and (3) the selected endpoints are protective of these effects. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings: i. The database for tolpyralate is considered complete with respect to FQPA assessment. ii. There is no concern for neurotoxicity from single or subchronic exposures. Although neuropathology was observed at the LOAELs in the rat [[Page 34881]] and the mouse long-term studies, the chronic LOAELs were almost 100- fold greater than the chronic NOAELs. The POD and endpoint for chronic dietary exposure are selected from the rat chronic study. Therefore, the chronic PAD (cPAD) is protective of potential neuropathology. It is also protective of increased susceptibility of offspring for neurotoxicity in the absence of a developmental neurotoxicity study, since neurotoxicity in adult animals was only observed as an effect following long-term dosing. There was no neurotoxicity observed in the database with exposure up to 90 days, including no evidence of neurotoxicity in the rat or rabbit developmental toxicity studies or the rat reproductive toxicity study. An additional uncertainty factor to account for the absence of data or other data deficiency (10x UFDB) is therefore not needed to account for this study. iii. Evidence of quantitative and qualitative prenatal susceptibility was observed in the rat and rabbit developmental toxicity studies based on findings of fetal skeletal abnormalities at doses below those causing maternal toxicity. However, clear NOAELs and LOAELs were identified in both species and there are no residual uncertainties regarding the points of departure PODs or the endpoints of concern. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to tolpyralate in drinking water. These assessments will not underestimate the exposure and risks posed by tolpyralate. 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 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 tolpyralate will occupy 1.3% of the aPAD for females of child- bearing age (13-49 years old), the only population relevant for assessing acute exposure to tolpyralate. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to tolpyralate from food and water will utilize 6.2% of the cPAD for all infants (<1 year-old), the population group receiving the greatest exposure. There are no residential uses for tolpyralate. 3. Short-term risk. A short-term adverse effect was identified; however, tolpyralate is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short- term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- term risk for tolpyralate. 4. Intermediate-term risk. An intermediate-term adverse effect was identified; however, tolpyralate is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for tolpyralate. 5. Aggregate cancer risk for U.S. population. Based on the discussion in Unit III.A., the chronic dietary exposure assessment is protective for potential cancer risk. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to tolpyralate residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (ISK Biosciences Method JSM0433) for plant commodities is a LC-MS/MS method that can be used to analyze for parent tolpyralate and the metabolite MT-2153 concurrently. It has been developed and independently validated, and is available to enforce the tolerance expression. For all matrices and analytes, the level of quantification (LOQ), defined as the lowest level of method validation (LLMV) or lowest spiking level where acceptable precision and accuracy data were obtained, was determined to be 0.01 ppm. The limit of detection (LOD) was 0.004 ppm. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 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 a MRL for tolpyralate. V. Conclusion Therefore, tolerances are established for residues of the herbicide tolpyralate in or on field corn (corn, field, grain; corn, field, forage; and corn, field, stover), sweet corn (corn, sweet, kernel + cob with husks removed; corn, sweet, forage; and corn, sweet, stover), and popcorn (corn, pop, grain and corn, pop, stover) at 0.01 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 [[Page 34882]] 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: July 11, 2017. Richard P. Keigwin, Jr., Director, 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. Add Sec. 180.696 to subpart C to read as follows: Sec. 180.696 Tolpyralate; tolerances for residues. (a) General. Tolerances are established for residues of tolpyralate, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only tolpyralate, 1- [[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]- 1H-pyrazol-5-yl]oxy]ethyl methyl carbonate, in or on the commodity. ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Corn, field, forage......................................... 0.01 Corn, field, grain.......................................... 0.01 Corn, field, stover......................................... 0.01 Corn, pop, grain............................................ 0.01 Corn, pop, stover........................................... 0.01 Corn, sweet, forage......................................... 0.01 Corn, sweet, kernel plus cob with husks removed............. 0.01 Corn, sweet, stover......................................... 0.01 ------------------------------------------------------------------------ (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. 2017-15717 Filed 7-26-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations 34877
Populations and Low-Income Dated: June 22, 2017. Docket Center (EPA/DC), West William
Populations’’ (59 FR 7629, February 16, Michael Goodis, Jefferson Clinton Bldg., Rm. 3334, 1301
1994). Director Registration Division, Office of Constitution Ave. NW., Washington, DC
Since tolerances and exemptions that Pesticide Programs. 20460–0001. The Public Reading Room
are established on the basis of a petition Therefore, 40 CFR chapter I is is open from 8:30 a.m. to 4:30 p.m.,
under FFDCA section 408(d), such as amended as follows: Monday through Friday, excluding legal
the tolerance in this final rule, do not holidays. The telephone number for the
require the issuance of a proposed rule, PART 180—[AMENDED] Public Reading Room is (202) 566–1744,
the requirements of the Regulatory and the telephone number for the OPP
Flexibility Act (RFA) (5 U.S.C. 601 et ■ 1. The authority citation for part 180 Docket is (703) 305–5805. Please review
seq.), do not apply. continues to read as follows: the visitor instructions and additional
Authority: 21 U.S.C. 321(q), 346a and 371. information about the docket available
This action directly regulates growers, at http://www.epa.gov/dockets.
food processors, food handlers, and food ■ 2. In § 180.663, revise the entry for
FOR FURTHER INFORMATION CONTACT:
retailers, not States or tribes, nor does ‘‘Hop, dried cones’’ in the table in
this action alter the relationships or paragraph (a) to read as follows: Michael Goodis, Registration Division
distribution of power and (7505P), Office of Pesticide Programs,
responsibilities established by Congress § 180.663 Ametoctradin; tolerances for Environmental Protection Agency, 1200
residues. Pennsylvania Ave. NW., Washington,
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency (a) * * * DC 20460–0001; main telephone
has determined that this action will not number: (703) 305–7090; email address:
have a substantial direct effect on States Parts RDFRNotices@epa.gov.
Commodity per SUPPLEMENTARY INFORMATION:
or tribal governments, on the million
relationship between the national I. General Information
government and the States or tribal
governments, or on the distribution of * * * * * A. Does this action apply to me?
power and responsibilities among the Hop, dried cones ........................ 100
You may be potentially affected by
various levels of government or between this action if you are an agricultural
* * * * *
the Federal Government and Indian producer, food manufacturer, or
tribes. Thus, the Agency has determined pesticide manufacturer. The following
* * * * *
that Executive Order 13132, entitled [FR Doc. 2017–15762 Filed 7–26–17; 8:45 am] list of North American Industrial
‘‘Federalism’’ (64 FR 43255, August 10, Classification System (NAICS) codes is
BILLING CODE 6560–50–P
1999) and Executive Order 13175, not intended to be exhaustive, but rather
entitled ‘‘Consultation and Coordination provides a guide to help readers
with Indian Tribal Governments’’ (65 FR ENVIRONMENTAL PROTECTION determine whether this document
67249, November 9, 2000) do not apply AGENCY applies to them. Potentially affected
to this action. In addition, this action entities may include:
does not impose any enforceable duty or 40 CFR Part 180 • Crop production (NAICS code 111).
contain any unfunded mandate as • Animal production (NAICS code
[EPA–HQ–OPP–2015–0405; FRL–9964–15]
described under Title II of the Unfunded 112).
Mandates Reform Act (UMRA) (2 U.S.C. Tolpyralate; Pesticide Tolerances • Food manufacturing (NAICS code
1501 et seq.). 311).
This action does not involve any AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
technical standards that would require Agency (EPA). code 32532).
Agency consideration of voluntary ACTION: Final rule. B. How can I get electronic access to
consensus standards pursuant to section other related information?
SUMMARY: This regulation establishes
12(d) of the National Technology
tolerances for residues of tolpyralate in You may access a frequently updated
Transfer and Advancement Act
or on field corn, popcorn, and sweet electronic version of EPA’s tolerance
(NTTAA) (15 U.S.C. 272 note).
corn. ISK Biosciences Corporation regulations at 40 CFR part 180 through
VII. Congressional Review Act requested these tolerances under the the Government Printing Office’s e-CFR
Federal Food, Drug, and Cosmetic Act site at http://www.ecfr.gov/cgi-bin/text-
Pursuant to the Congressional Review (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Act (5 U.S.C. 801 et seq.), EPA will 40tab_02.tpl.
submit a report containing this rule and DATES: This regulation is effective July
other required information to the U.S. 27, 2017. Objections and requests for C. How can I file an objection or hearing
Senate, the U.S. House of hearings must be received on or before request?
Representatives, and the Comptroller September 25, 2017, and must be filed Under FFDCA section 408(g), 21
General of the United States prior to in accordance with the instructions U.S.C. 346a, any person may file an
publication of the rule in the Federal provided in 40 CFR part 178 (see also objection to any aspect of this regulation
Register. This action is not a ‘‘major Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those
rule’’ as defined by 5 U.S.C. 804(2). INFORMATION).
objections. You must file your objection
mstockstill on DSK30JT082PROD with RULES
List of Subjects in 40 CFR Part 180 ADDRESSES: The docket for this action, or request a hearing on this regulation
identified by docket identification (ID) in accordance with the instructions
Environmental protection, number EPA–HQ–OPP–2015–0405, is provided in 40 CFR part 178. To ensure
Administrative practice and procedure, available at http://www.regulations.gov proper receipt by EPA, you must
Agricultural commodities, Pesticides or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
and pests, Reporting and recordkeeping Regulatory Public Docket (OPP Docket) OPP–2015–0405 in the subject line on
requirements. in the Environmental Protection Agency the first page of your submission. All
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![34878 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
objections and requests for a hearing prepared by ISK Biosciences, cell necrosis, gall bladder calculi, fur
must be in writing, and must be Corporation the registrant, which is loss and/or tactile hair loss, and
received by the Hearing Clerk on or available in the docket, http:// decreased body weights. No systemic
before September 25, 2017. Addresses www.regulations.gov. There were no toxicity was observed following a 28-
for mail and hand delivery of objections comments received in response to the day dermal exposure in the rat.
and hearing requests are provided in 40 notice of filing. Neurotoxicity was not observed in the
CFR 178.25(b). acute or subchronic neurotoxicity
In addition to filing an objection or III. Aggregate Risk Assessment and studies in the rat. There was no
hearing request with the Hearing Clerk Determination of Safety indication of neurotoxicity to the fetus
as described in 40 CFR part 178, please Section 408(b)(2)(A)(i) of FFDCA in developmental studies or during
submit a copy of the filing (excluding allows EPA to establish a tolerance (the early postnatal development in a rat
any Confidential Business Information legal limit for a pesticide chemical reproductive toxicity study. However,
(CBI)) for inclusion in the public docket. residue in or on a food) only if EPA with chronic exposure, rats and mice
Information not marked confidential determines that the tolerance is ‘‘safe.’’ showed effects on the nervous system
pursuant to 40 CFR part 2 may be Section 408(b)(2)(A)(ii) of FFDCA that were indicative of a temporally-
disclosed publicly by EPA without prior defines ‘‘safe’’ to mean that ‘‘there is a dependent response for neurotoxicity.
notice. Submit the non-CBI copy of your reasonable certainty that no harm will Similar findings were not seen in the
objection or hearing request, identified result from aggregate exposure to the one-year dog study.
by docket ID number EPA–HQ–OPP– pesticide chemical residue, including Developmental toxicity studies in the
2015–0405, by one of the following all anticipated dietary exposures and all rat and rabbit showed that the main
methods: other exposures for which there is effects on fetuses in both species were
• Federal eRulemaking Portal: http:// reliable information.’’ This includes skeletal variations that are consistent
www.regulations.gov. Follow the online exposure through drinking water and in with those observed from exposure to
instructions for submitting comments. residential settings, but does not include other HPPD inhibitors. These skeletal
Do not submit electronically any occupational exposure. Section effects are considered to be evidence of
information you consider to be CBI or 408(b)(2)(C) of FFDCA requires EPA to increased quantitative and qualitative
other information whose disclosure is give special consideration to exposure prenatal susceptibility. No immunotoxic
restricted by statute. of infants and children to the pesticide potential was observed in a mouse
• Mail: OPP Docket, Environmental chemical residue in establishing a immunotoxicity study; however, in the
Protection Agency Docket Center (EPA/ tolerance and to ‘‘ensure that there is a dog, inflammation associated with
DC), (28221T), 1200 Pennsylvania Ave. reasonable certainty that no harm will hyperostosis and lymph node
NW., Washington, DC 20460–0001. result to infants and children from hyperplasia in males was observed.
• Hand Delivery: To make special aggregate exposure to the pesticide In the rat, an increase in the incidence
arrangements for hand delivery or chemical residue. . . .’’ of squamous cell carcinomas of the eye
delivery of boxed information, please Consistent with FFDCA section was observed. The increase in this
follow the instructions at http:// 408(b)(2)(D), and the factors specified in tumor type is considered to be related
www.epa.gov/dockets/contacts.html. FFDCA section 408(b)(2)(D), EPA has to the eye opacities typically observed
Additional instructions on reviewed the available scientific data with compounds producing HPPD
commenting or visiting the docket, and other relevant information in inhibition. The Agency has determined
along with more information about support of this action. EPA has that tolpyralate shows ‘‘suggestive
dockets generally, is available at http:// sufficient data to assess the hazards of evidence of carcinogenicity to humans’’
www.epa.gov/dockets. and to make a determination on based on an increase in the incidence of
aggregate exposure for tolpyralate squamous cell carcinoma of the eye in
II. Summary of Petitioned for Tolerance
including exposure resulting from the male rats in the rat carcinogenicity
In the Federal Register of August 26, tolerances established by this action. study. There was no evidence of
2015 (80 FR 51759) (FRL–9931–74), EPA’s assessment of exposures and risks carcinogenicity in female rats or in the
EPA issued a document pursuant to associated with tolpyralate follows. mouse. Most genotoxicity studies did
FFDCA section 408(d)(3), 21 U.S.C. not show evidence of mutagenicity or
346a(d)(3), announcing the filing of a A. Toxicological Profile clastogenicity. A mouse lymphoma cell
pesticide petition (PP 5F8359) by ISK EPA has evaluated the available gene mutation assay showed a dose-
Biosciences, Corporation, 7470 Auburn toxicity data and considered its validity, dependent, reproducible increase in
Rd., Suite A, Concord, OH 44077. The completeness, and reliability as well as mutant colonies, but the results of this
petition requested that 40 CFR part 180 the relationship of the results of the study are considered inconclusive due
be amended by establishing tolerances studies to human risk. EPA has also to the insolubility of the test compound.
for residues of the herbicide, tolpyralate, considered available information However, all other genotoxicity studies,
1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2- concerning the variability of the including an in vivo mouse
methyl-4-(methylsulfonyl)benzoyl]-1H- sensitivities of major identifiable micronucleus assay, were negative.
pyrazol-5-yl]oxy]ethyl methyl subgroups of consumers, including Therefore, when considered as a whole,
carbonate, including its metabolite MT– infants and children. the available mutagenicity and
2153, in or on the raw agricultural The effects in the tolpyralate hazard clastogenicity studies did not indicate
commodities of corn that include field database are similar to those seen with genotoxic potential.
corn (corn, field, grain; corn, field, other hydroxyphenylpyruvate The Agency concluded that the eye
mstockstill on DSK30JT082PROD with RULES
forage; and corn, field, stover); sweet dioxygenase (HPPD) inhibiting tumors resulted from long-term
corn (corn, sweet, kernel + cob with chemicals, including eye opacity and exposure to increased blood tyrosine
husks removed; corn, sweet, forage; and developmental skeletal defects. The levels as a result of HPPD inhibition.
corn, sweet, stover); and popcorn (corn, major target organs identified were the The eye is a target organ for HPPD
pop, grain and corn, pop, stover) at 0.01 eyes, kidney, liver, thyroid and inhibitors and causes opacities and
parts per million (ppm). That document developing skeleton. Other effects keratitis with subchronic or chronic
referenced a summary of the petition included pancreatic acinar cell single exposure. Eye tumors have been
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![34882 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
Executive Order 12866, this action is to this action. In addition, this action tolerance levels specified below is to be
not subject to Executive Order 13211, does not impose any enforceable duty or determined by measuring only
entitled ‘‘Actions Concerning contain any unfunded mandate as tolpyralate, 1-[[1-ethyl-4-[3-(2-
Regulations That Significantly Affect described under Title II of the Unfunded methoxyethoxy)-2-methyl-4-
Energy Supply, Distribution, or Use’’ (66 Mandates Reform Act (UMRA) (2 U.S.C. (methylsulfonyl)benzoyl]-1H-pyrazol-5-
FR 28355, May 22, 2001) or Executive 1501 et seq.). yl]oxy]ethyl methyl carbonate, in or on
Order 13045, entitled ‘‘Protection of This action does not involve any the commodity.
Children from Environmental Health technical standards that would require
Risks and Safety Risks’’ (62 FR 19885, Agency consideration of voluntary Commodity Parts per
April 23, 1997). This action does not consensus standards pursuant to section million
contain any information collections 12(d) of the National Technology
Transfer and Advancement Act Corn, field, forage ....................... 0.01
subject to OMB approval under the Corn, field, grain ......................... 0.01
Paperwork Reduction Act (PRA) (44 (NTTAA) (15 U.S.C. 272 note). Corn, field, stover ....................... 0.01
U.S.C. 3501 et seq.), nor does it require VII. Congressional Review Act Corn, pop, grain .......................... 0.01
any special considerations under Corn, pop, stover ........................ 0.01
Executive Order 12898, entitled Pursuant to the Congressional Review Corn, sweet, forage .................... 0.01
‘‘Federal Actions to Address Act (5 U.S.C. 801 et seq.), EPA will Corn, sweet, kernel plus cob
Environmental Justice in Minority submit a report containing this rule and with husks removed ................ 0.01
Populations and Low-Income other required information to the U.S. Corn, sweet, stover .................... 0.01
Populations’’ (59 FR 7629, February 16, Senate, the U.S. House of
1994). Representatives, and the Comptroller (b) Section 18 emergency exemptions.
Since tolerances and exemptions that General of the United States prior to [Reserved]
are established on the basis of a petition publication of the rule in the Federal (c) Tolerances with regional
under FFDCA section 408(d), such as Register. This action is not a ‘‘major registrations. [Reserved]
the tolerance in this final rule, do not rule’’ as defined by 5 U.S.C. 804(2). (d) Indirect or inadvertent residues.
require the issuance of a proposed rule, List of Subjects in 40 CFR Part 180 [Reserved]
the requirements of the Regulatory [FR Doc. 2017–15717 Filed 7–26–17; 8:45 am]
Environmental protection,
Flexibility Act (RFA) (5 U.S.C. 601 et BILLING CODE 6560–50–P
Administrative practice and procedure,
seq.), do not apply.
Agricultural commodities, Pesticides
This action directly regulates growers,
and pests, Reporting and recordkeeping
food processors, food handlers, and food
requirements. DEPARTMENT OF HOMELAND
retailers, not States or tribes, nor does
this action alter the relationships or Dated: July 11, 2017. SECURITY
distribution of power and Richard P. Keigwin, Jr.,
Coast Guard
responsibilities established by Congress Director, Office of Pesticide Programs.
in the preemption provisions of FFDCA Therefore, 40 CFR chapter I is 46 CFR Part 91
section 408(n)(4). As such, the Agency amended as follows:
has determined that this action will not Inspection and Certification
have a substantial direct effect on States PART 180—[AMENDED]
or tribal governments, on the CFR Correction
relationship between the national ■ 1. The authority citation for part 180
continues to read as follows: ■ In Title 46 of the Code of Federal
government and the States or tribal
Regulations, parts 90 to 139, revised as
governments, or on the distribution of Authority: 21 U.S.C. 321(q), 346a and 371. of October 1, 2016, on page 24, in
power and responsibilities among the 2. Add § 180.696 to subpart C to read
■ § 91.40–3, in paragraph (a)(2), Table
various levels of government or between as follows: 91.40–3(a) is removed and Table 91.40–
the Federal Government and Indian
3(b) is reinstated to read as follows:
tribes. Thus, the Agency has determined § 180.696 Tolpyralate; tolerances for
that Executive Order 13132, entitled residues. § 91.40–3 Drydock examination, internal
‘‘Federalism’’ (64 FR 43255, August 10, (a) General. Tolerances are structural examination, cargo tank internal
1999) and Executive Order 13175, established for residues of tolpyralate, examination, and underwater survey
entitled ‘‘Consultation and Coordination including its metabolites and intervals.
with Indian Tribal Governments’’ (65 FR degradates, in or on the commodities in (a) * * *
67249, November 9, 2000) do not apply the table below. Compliance with the (2) * * *
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Document Created: 2017-07-27 02:07:31
Document Modified: 2017-07-27 02:07:31
| 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 July 27, 2017. Objections and requests for hearings must be received on or before September 25, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 82 FR 34877 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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