83 FR 22854 - Pyroxasulfone; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 96 (May 17, 2018)
Federal Register Volume 83, Issue 96 (May 17, 2018)
| Page Range | 22854-22859 | |
| FR Document | 2018-10582 |
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)] [Rules and Regulations] [Pages 22854-22859] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10582] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0787; FRL-9977-25] Pyroxasulfone; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of pyroxasulfone and its metabolites in or on vegetable, tuberous and corm, subgroup 1C; vegetable, bulb, group 3-07; and potatoes, granules/ flakes. K-I Chemical USA, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 17, 2018. Objections and requests for hearings must be received on or before July 16, 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-2015-0787, 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. [[Page 22855]] 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-2015-0787 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 July 16, 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 by docket ID number EPA-HQ-OPP-2015-0787, 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 January 26, 2018 (83 FR 3659) (FRL-9971- 46), 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 5F8521) by K-I Chemical USA, Inc., 11 Martine Ave., Suite 970, White Plains, NY 10606. The petition requested that 40 CFR part 180.659 be amended by establishing tolerances for residues of the herbicide pyroxasulfone, (3-[5-(difluoromethoxy)-1-methyl-3- (trifluoromethyl)pyrazol-4-yl methylsulfonyl]-4,5-dihydro-5,5-dimethyl- 1,2-oxazole) in or on Crop Subgroup 1C, tuberous and corm vegetables (except granular/flakes and chips) at 0.05 parts per million (ppm); Crop Subgroup 3-07, bulb vegetables at 0.15 ppm; potatoes, granular/ flakes at 0.3 ppm; and potato chips at 0.06 ppm. That document referenced a summary of the petition prepared by K-I Chemical USA, Inc., the registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the notice of filing. Because the January 26, 2018, document identified the K-I Chemical petition by the wrong petition number, EPA published another document in the Federal Register assigning the correct petition number to the K- I Chemical petition--PP6F8521. That document was published in the Federal Register on March 15, 2018 (83 FR 11448) (FRL-9974-72). No relevant comments were received on the notice of filing. Based upon review of the data supporting the petition, EPA has modified the levels at which some of the tolerances are being established and also modified some of the crop definitions. The reasons for these changes are explained 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 pyroxasulfone including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyroxasulfone 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 toxicology database for pyroxasulfone is adequate for evaluating and characterizing toxicity and selecting endpoints for purposes of this risk assessment. Pyroxasulfone acute toxicity to mammals is low by all routes of exposure. Subchronic and chronic oral studies in mice, rats and dogs produced a variety of effects including cardiac toxicity (increased cardiomyopathy), liver toxicity (centrilobular hepatocellular hypertrophy, histopathological and/or clinical pathological indicators), kidney toxicity (nephropathy), neurotoxicity (impaired hind limb function, ataxia, tremors, sciatic nerve lesions, axonal/myelin degeneration in the sciatic nerve and spinal cord sections), skeletal muscle myopathy, urinary bladder mucosal hyperplasia, and urinary bladder transitional cell papillomas. Minimal to mild cardiac myofiber degeneration and local inflammation were also seen in a rat dermal toxicity study. Neurotoxicity was also seen in a developmental neurotoxicity study in rats (decreased brain weight, decreased thickness of the hippocampus, corpus callosum and cerebellum in offspring). Dogs appear to be the most sensitive species to the neurotoxic effects of pyroxasulfone. Immunotoxicity studies in rats and mice show no evidence of immunotoxic effects from pyroxasulfone. There is evidence of fetal and offspring susceptibility in the developmental neurotoxicity study in rats as effects occurred in the absence of maternal toxicity. There is no concern for reproductive toxicity. Pyroxasulfone is classified as ``Not Likely to be Carcinogenic to Humans'' at doses that do not cause crystals with subsequent calculi formation resulting in cellular damage of the urinary tract. The Agency has determined that the quantification [[Page 22856]] of risk using a non-linear approach (i.e., reference dose (RfD)) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to pyroxasulfone. Specific information on the studies received and the nature of the adverse effects caused by pyroxasulfone as the no-observed-adverse effect level (NOAEL) and lowest-observed adverse effect level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Pyroxasulfone Human Health Risk Assessment for the Section 3 New Uses of Pyroxasulfone on Crop Subgroup 1C, tuberous and corm vegetables and Crop Group 3-07, bulb vegetables'' at pages 39-53 in docket ID number EPA-HQ-OPP-2015-0787. 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 the NOAEL and the LOAEL are identified. 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 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 use https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for pyroxasulfone used for human risk assessment is shown in the Table 1 of this unit. Table 1--Toxicological Doses and Endpoints for Pyroxasulfone for Use in Dietary Human Health Risk Assessments ---------------------------------------------------------------------------------------------------------------- Point of Uncertainty/ FQPA Study and Exposure/scenario departure safety factors RfD & PAD toxicological effects ---------------------------------------------------------------------------------------------------------------- Acute Dietary (General NOAEL= 100 mg/kg. UFA= 10x......... Acute RfD = 1.0 Developmental Population, including Infants UFH=10x.......... mg/kg. neurotoxicity study and Children). FQPA SF=1x....... aPAD = 1.0 mg/kg. (DNT) in rats. The LOAEL of 300 mg/kg/ day is based on decreased brain weight in both sexes, reduced thickness of the hippocampus, corpus callosum and cerebellum in postnatal day (PND) 21 female offspring. Chronic Dietary (All NOAEL= 2 mg/kg/ UFA= 10x......... Chronic RfD = One- year chronic dog Populations). day. UFH=10x.......... 0.02 mg/kg/day. study FQPA SF=1x....... cPAD = 0.02 mg/kg/ The LOAEL of 10 mg/kg/ day. day is based on impaired hind limb function, ataxia, hind limb twitching and tremors; clinical pathology: increased creatine kinase, aspartate aminotransferase; axonal/myelin degeneration of the sciatic nerve and spinal cord sections. -------------------------------------------------------------------------------- Cancer (all routes)............ ``Not Likely to be Carcinogenic to Humans'' at doses that do not cause crystals with subsequent calculi formation resulting in cellular damage of the urinary tract. Risk is quantified using a non-linear (i.e., RfD) approach. ---------------------------------------------------------------------------------------------------------------- Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyroxasulfone, EPA considered exposure under the petitioned-for tolerances as well as all existing pyroxasulfone tolerances in 40 CFR 180.659. EPA assessed dietary exposures from pyroxasulfone 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 pyroxasulfone. In estimating acute dietary exposure, EPA used food consumption data from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues adjusted for metabolites which are not in the tolerance expression. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 PCT and tolerance-level residues adjusted for metabolites which are not in the tolerance expression. iii. Cancer. Based on the data summarized in Unit III.A., EPA has classified pyroxasulfone as ``Not Likely to be Carcinogenic to Humans'' at doses that do not cause crystals with subsequent calculi formation resulting in cellular damage of the urinary tract. The Agency has determined that the quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to pyroxasulfone. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and PCT information in the dietary assessment for pyroxasulfone. Tolerance-level residues and 100% crop treated (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 pyroxasulfone in drinking water. These simulation models take into [[Page 22857]] account data on the physical, chemical, and fate/transport characteristics of pyroxasulfone. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-riskpesticides. Based on the Pesticide Root Zone Model Ground Water (PRZM version 3.122)/Exposure Analysis Modeling System-Superseded (EXAMS version 2.98.04), the estimated concentrations of pyroxasulfone in surface water were minimal, and the highest estimated drinking water concentrations (EDWCs) of pyroxasulfone residues were from a Tier II PRZM-GW modeling at an application rate of 0.267 lbs active ingredient/ Acre for registered crops. The same EDWCs have been used for the current human health dietary risk assessment. The EDWCs for peak concentration (used in the acute assessment) and 30-year average concentration (used in the chronic assessment) were 0.210 and 0.174 mg/ L (ppm), respectively. Water residues were incorporated in the Dietary Exposure Evaluation Model--Food Commodity Intake Database (DEEM-FCID) into the food categories ``water, direct, all sources'' and ``water, indirect, all sources.'' 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). Pyroxasulfone 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.'' EPA has not found pyroxasulfone to share a common mechanism of toxicity with any other substances, and pyroxasulfone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pyroxasulfone 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 website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-riskpesticides. 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 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. Pyroxasulfone did not exhibit developmental toxicity in the rat guideline study at the limit dose of 1,000 mg/kg/day and it exhibited slight developmental toxicity in rabbits (reduced fetal weight and resorptions) at the limit dose of 1,000 mg/kg/day. However, developmental effects were noted in offspring at 300 mg/kg/day in the rat DNT study characterized as decreased brain weight and morphometric changes. Developmental effects in the rabbit developmental study and DNT study occurred in the absence of maternal toxicity, indicating potential increased quantitative susceptibility of offspring. In a rat reproductive toxicity study, reduced pup weight and body weight gains during lactation occurred at similar doses causing pronounced maternal toxicity (reduced body weight, body weight gain and food consumption and increased kidney weight, cardiomyopathy and urinary bladder mucosal hyperplasia with inflammation). 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 toxicity database for pyroxasulfone is complete. ii. Available data indicates that pyroxasulfone produces neurotoxic effects in rats. The toxicity database includes specific acute and subchronic neurotoxicity tests, as well as a DNT study. Although the DNT indicated offspring are more sensitive to neurotoxic effects of pyroxasulfone, the dose-response is well characterized for neurotoxicity and a NOAEL is identified; therefore, there is no residual uncertainty with regard to neurotoxic effects for which a 10X must be retained. iii. Evidence of increased susceptibility of fetuses and offspring was seen in a DNT study in rats and a developmental study in rabbits following in utero or post-natal exposure to pyroxasulfone. However, no susceptibility was seen in the rat developmental or reproduction studies. In rabbits, developmental toxicity was only seen at the limit dose of 1000 mg/kg/day as reduced fetal weight and increased fetal resorptions with a NOAEL of 500 mg/kg/day for these effects, compared to no maternal toxicity at these doses. In a DNT study in rats, offspring toxicity was seen at 300 mg/kg/day compared to no maternal toxicity at 900 mg/kg/day. This increased susceptibility is occurring at high doses. NOAELs and LOAELs have been identified for all effects of concern and thus, a clear dose response has been well defined. Therefore, residual uncertainties or concerns for pre- and/or post- natal toxicity are minimal, and EPA concludes that reducing the FQPA safety factor to 1X will be protective of such effects. 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 pyroxasulfone in drinking water. These assessments will not underestimate the exposure and risks posed by pyroxasulfone. 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 population adjusted dose (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 [[Page 22858]] pyroxasulfone will occupy 3.7% of the aPAD for all infants less than 1- year old, 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 pyroxasulfone from food and water will utilize 50% of the cPAD for all infants less than 1-year old, the population group receiving the greatest exposure. 3. Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Although short-term and intermediate-term adverse effects were identified, pyroxasulfone is not registered for any use patterns that would result in residential exposure. Therefore, EPA relies on the chronic dietary risk assessment for evaluating short-term and intermediate-term risk for pyroxasulfone. 4. Aggregate cancer risk for U.S. population. As explained in Unit III.A., the Agency has determined that the quantification of risk using a non-linear (i.e., RfD) approach will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to pyroxasulfone. Therefore, based on the results of the chronic risk assessment discussed in Unit III.E.2., pyroxasulfone is not expected to pose a cancer risk to humans. 5. 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 pyroxasulfone residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (high performance liquid chromatography/triple quadrupole mass spectrometry (LC/MS/MS) methods) are available to enforce the tolerance expression. These methods 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 pyroxasulfone in any of the proposed commodities. C. Revisions to Petitioned-For Tolerances The vegetable, tuberous and corm, subgroup 1C tolerance is being established at 0.08 ppm instead of 0.05 ppm. The petitioner's requested tolerance level included only residues from the parent and M1 metabolite. The Agency is establishing this tolerance at 0.08 ppm to account for the measurement of parent and four metabolites. Applying processing factors in accordance with the Agency's policy for determining such factors when measuring multiple pesticide residues, the Agency has determined that 0.20 ppm is an appropriate tolerance level for granules/flakes. In addition, The Agency has determined that a tolerance for potato chips is not required because residues will be within the tolerance level established for subgroup 1C. V. Conclusion Therefore, tolerances are established for residues of pyroxasulfone including its metabolites and degradates, in or on potatoes, granules/ flakes at 0.20 ppm; vegetable, bulb, group 3-07 at 0.15 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.08 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); Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). 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). [[Page 22859]] 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: May 8, 2018. Daniel Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. In Sec. 180.659, add alphabetically ``Potato, granules/flakes'', ``Vegetable, bulb, group 3-07'', and ``Vegetable, tuberous and corm, subgroup 1C'' to the table in paragraph (a)(5) to read as follows: Sec. 180.659 Pyroxasulfone; tolerances for residues. (a) * * * (5) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Potato, granules/flakes..................................... 0.20 * * * * * Vegetable, bulb, group 3-07................................. 0.15 * * * * * Vegetable, tuberous and corm, subgroup 1C................... 0.08 ------------------------------------------------------------------------ * * * * * [FR Doc. 2018-10582 Filed 5-16-18; 8:45 am] BILLING CODE 6560-50-P
![22854 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations
Representatives, and the Comptroller not be challenged later in proceedings to PART 52—APPROVAL AND
General of the United States prior to enforce its requirements (See section PROMULGATION OF
publication of the rule in the Federal 307(b)(2)). IMPLEMENTATION PLANS
Register. A major rule cannot take effect
List of Subjects in 40 CFR Part 52
until 60 days after it is published in the ■ 1. The authority citation for part 52
Federal Register. This action is not a Environmental protection, Air continues to read as follows:
‘‘major rule’’ as defined by 5 U.S.C. pollution control, Carbon monoxide,
Authority: 42 U.S.C. 7401 et seq.
804(2). Incorporation by reference,
Under section 307(b)(1) of the Clean Intergovernmental relations, Lead, Subpart MM—Oregon
Air Act, petitions for judicial review of Nitrogen dioxide, Ozone, Particulate
this action must be filed in the United matter, Reporting and recordkeeping ■ 2. In § 52.1970, amend the table
States Court of Appeals for the requirements, Sulfur oxides, Volatile ‘‘STATE OF OREGON AIR QUALITY
appropriate circuit by July 16, 2018. organic compounds. CONTROL PROGRAM’’ in paragraph (e)
Filing a petition for reconsideration by Authority: 42 U.S.C. 7401 et seq. by adding a new entry immediately
the Administrator of this final rule does Dated: May 7, 2018. above the entry for ‘‘Section 6—
not affect the finality of this action for Ambient Air Quality Monitoring
Chris Hladick,
the purposes of judicial review nor does Program’’ to read as follows:
it extend the time within which a Regional Administrator, Region 10.
petition for judicial review may be filed, For the reasons set forth in the § 52.1970 Identification of plan.
and shall not postpone the effectiveness preamble, 40 CFR part 52 is amended as * * * * *
of such rule or action. This action may follows: (e) * * *
STATE OF OREGON AIR QUALITY CONTROL PROGRAM
State effective
SIP citation Title/subject EPA approval date Explanation
date
* * * * * * *
7/13/2012 5/17/2018, [Insert Federal Register cita- Regional Haze Progress Report
tion].
* * * * * * *
[FR Doc. 2018–10569 Filed 5–16–18; 8:45 am] ADDRESSES: The docket for this action, I. General Information
BILLING CODE 6560–50–P identified by docket identification (ID)
A. Does this action apply to me?
number EPA–HQ–OPP–2015–0787, is
available at http://www.regulations.gov You may be potentially affected by
ENVIRONMENTAL PROTECTION or at the Office of Pesticide Programs this action if you are an agricultural
AGENCY Regulatory Public Docket (OPP Docket) producer, food manufacturer, or
in the Environmental Protection Agency pesticide manufacturer. The following
40 CFR Part 180
Docket Center (EPA/DC), West William list of North American Industrial
Jefferson Clinton Bldg., Rm. 3334, 1301 Classification System (NAICS) codes is
[EPA–HQ–OPP–2015–0787; FRL–9977–25] Constitution Ave. NW, Washington, DC not intended to be exhaustive, but rather
Pyroxasulfone; Pesticide Tolerances 20460–0001. The Public Reading Room provides a guide to help readers
is open from 8:30 a.m. to 4:30 p.m., determine whether this document
AGENCY: Environmental Protection Monday through Friday, excluding legal applies to them. Potentially affected
Agency (EPA). holidays. The telephone number for the entities may include:
Public Reading Room is (202) 566–1744,
ACTION: Final rule. • Crop production (NAICS code 111).
and the telephone number for the OPP
SUMMARY: This regulation establishes Docket is (703) 305–5805. Please review • Animal production (NAICS code
tolerances for residues of pyroxasulfone the visitor instructions and additional 112).
and its metabolites in or on vegetable, information about the docket available • Food manufacturing (NAICS code
tuberous and corm, subgroup 1C; at http://www.epa.gov/dockets. 311).
vegetable, bulb, group 3–07; and • Pesticide manufacturing (NAICS
FOR FURTHER INFORMATION CONTACT:
potatoes, granules/flakes. K–I Chemical code 32532).
USA, Inc. requested these tolerances Michael Goodis, Registration Division
under the Federal Food, Drug, and (7505P), Office of Pesticide Programs, B. How can I get electronic access to
Cosmetic Act (FFDCA). Environmental Protection Agency, 1200 other related information?
Pennsylvania Ave. NW, Washington, DC
DATES: This regulation is effective May You may access a frequently updated
20460–0001; main telephone number:
17, 2018. Objections and requests for
amozie on DSK3GDR082PROD with RULES
(703) 305–7090; email address: electronic version of EPA’s tolerance
hearings must be received on or before regulations at 40 CFR part 180 through
RDFRNotices@epa.gov.
July 16, 2018, and must be filed in
the Government Printing Office’s e-CFR
accordance with the instructions SUPPLEMENTARY INFORMATION:
site at http://www.ecfr.gov/cgi-bin/text-
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
INFORMATION).
40tab_02.tpl.
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C. How can I file an objection or hearing amended by establishing tolerances for and other relevant information in
request? residues of the herbicide pyroxasulfone, support of this action. EPA has
Under FFDCA section 408(g), 21 (3-[5-(difluoromethoxy)-1-methyl-3- sufficient data to assess the hazards of
U.S.C. 346a, any person may file an (trifluoromethyl)pyrazol-4-yl and to make a determination on
objection to any aspect of this regulation methylsulfonyl]-4,5-dihydro-5,5- aggregate exposure for pyroxasulfone
and may also request a hearing on those dimethyl-1,2-oxazole) in or on Crop including exposure resulting from the
objections. You must file your objection Subgroup 1C, tuberous and corm tolerances established by this action.
vegetables (except granular/flakes and EPA’s assessment of exposures and risks
or request a hearing on this regulation
chips) at 0.05 parts per million (ppm); associated with pyroxasulfone follows.
in accordance with the instructions
Crop Subgroup 3–07, bulb vegetables at
provided in 40 CFR part 178. To ensure A. Toxicological Profile
0.15 ppm; potatoes, granular/flakes at
proper receipt by EPA, you must EPA has evaluated the available
0.3 ppm; and potato chips at 0.06 ppm.
identify docket ID number EPA–HQ– toxicity data and considered its validity,
That document referenced a summary of
OPP–2015–0787 in the subject line on completeness, and reliability as well as
the petition prepared by K–I Chemical
the first page of your submission. All the relationship of the results of the
USA, Inc., the registrant, which is
objections and requests for a hearing studies to human risk. EPA has also
available in the docket, http://
must be in writing, and must be considered available information
www.regulations.gov. No comments
received by the Hearing Clerk on or were received in response to the notice concerning the variability of the
before July 16, 2018. Addresses for mail of filing. sensitivities of major identifiable
and hand delivery of objections and Because the January 26, 2018, subgroups of consumers, including
hearing requests are provided in 40 CFR document identified the K–I Chemical infants and children.
178.25(b). petition by the wrong petition number, The toxicology database for
In addition to filing an objection or EPA published another document in the pyroxasulfone is adequate for evaluating
hearing request with the Hearing Clerk Federal Register assigning the correct and characterizing toxicity and selecting
as described in 40 CFR part 178, please petition number to the K–I Chemical endpoints for purposes of this risk
submit a copy of the filing (excluding petition—PP6F8521. That document assessment. Pyroxasulfone acute
any Confidential Business Information was published in the Federal Register toxicity to mammals is low by all routes
(CBI)) for inclusion in the public docket. on March 15, 2018 (83 FR 11448) (FRL– of exposure. Subchronic and chronic
Information not marked confidential 9974–72). No relevant comments were oral studies in mice, rats and dogs
pursuant to 40 CFR part 2 may be received on the notice of filing. produced a variety of effects including
disclosed publicly by EPA without prior Based upon review of the data cardiac toxicity (increased
notice. Submit the non-CBI copy of your supporting the petition, EPA has cardiomyopathy), liver toxicity
objection or hearing request, identified modified the levels at which some of the (centrilobular hepatocellular
by docket ID number EPA–HQ–OPP– tolerances are being established and also hypertrophy, histopathological and/or
2015–0787, by one of the following modified some of the crop definitions. clinical pathological indicators), kidney
methods: The reasons for these changes are toxicity (nephropathy), neurotoxicity
• Federal eRulemaking Portal: http:// explained in Unit IV.C. (impaired hind limb function, ataxia,
www.regulations.gov. Follow the online tremors, sciatic nerve lesions, axonal/
instructions for submitting comments. III. Aggregate Risk Assessment and myelin degeneration in the sciatic nerve
Do not submit electronically any Determination of Safety and spinal cord sections), skeletal
information you consider to be CBI or Section 408(b)(2)(A)(i) of FFDCA muscle myopathy, urinary bladder
other information whose disclosure is allows EPA to establish a tolerance (the mucosal hyperplasia, and urinary
restricted by statute. legal limit for a pesticide chemical bladder transitional cell papillomas.
• Mail: OPP Docket, Environmental residue in or on a food) only if EPA Minimal to mild cardiac myofiber
Protection Agency Docket Center (EPA/ determines that the tolerance is ‘‘safe.’’ degeneration and local inflammation
DC), (28221T), 1200 Pennsylvania Ave. Section 408(b)(2)(A)(ii) of FFDCA were also seen in a rat dermal toxicity
NW, Washington, DC 20460–0001. defines ‘‘safe’’ to mean that ‘‘there is a study. Neurotoxicity was also seen in a
• Hand Delivery: To make special reasonable certainty that no harm will developmental neurotoxicity study in
arrangements for hand delivery or result from aggregate exposure to the rats (decreased brain weight, decreased
delivery of boxed information, please pesticide chemical residue, including thickness of the hippocampus, corpus
follow the instructions at http:// all anticipated dietary exposures and all callosum and cerebellum in offspring).
www.epa.gov/dockets/contacts.html. other exposures for which there is Dogs appear to be the most sensitive
Additional instructions on reliable information.’’ This includes species to the neurotoxic effects of
commenting or visiting the docket, exposure through drinking water and in pyroxasulfone. Immunotoxicity studies
along with more information about residential settings, but does not include in rats and mice show no evidence of
dockets generally, is available at http:// occupational exposure. Section immunotoxic effects from
www.epa.gov/dockets. 408(b)(2)(C) of FFDCA requires EPA to pyroxasulfone.
give special consideration to exposure There is evidence of fetal and
II. Summary of Petitioned-For offspring susceptibility in the
of infants and children to the pesticide
Tolerance developmental neurotoxicity study in
chemical residue in establishing a
In the Federal Register of January 26, tolerance and to ‘‘ensure that there is a rats as effects occurred in the absence of
2018 (83 FR 3659) (FRL–9971–46), EPA reasonable certainty that no harm will maternal toxicity. There is no concern
issued a document pursuant to FFDCA result to infants and children from for reproductive toxicity. Pyroxasulfone
amozie on DSK3GDR082PROD with RULES
section 408(d)(3), 21 U.S.C. 346a(d)(3), aggregate exposure to the pesticide is classified as ‘‘Not Likely to be
announcing the filing of a pesticide chemical residue. . . .’’ Carcinogenic to Humans’’ at doses that
petition (PP 5F8521) by K–I Chemical Consistent with FFDCA section do not cause crystals with subsequent
USA, Inc., 11 Martine Ave., Suite 970, 408(b)(2)(D), and the factors specified in calculi formation resulting in cellular
White Plains, NY 10606. The petition FFDCA section 408(b)(2)(D), EPA has damage of the urinary tract. The Agency
requested that 40 CFR part 180.659 be reviewed the available scientific data has determined that the quantification
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VII. Congressional Review Act ENVIRONMENTAL PROTECTION Forsyth Street SW, Mailcode 9T25,
AGENCY Atlanta, GA 30303; 404/562–8637.
Pursuant to the Congressional Review • Todd Quesada, Region 5 (IL, IN, MI,
Act (5 U.S.C. 801 et seq.), EPA will 40 CFR Part 300 MN, OH, WI), U.S. EPA Superfund
submit a report containing this rule and Division Librarian/SFD Records
[EPA–HQ–OLEM–2017–0604, 0606, 0607,
other required information to the U.S. 0609, 0611 and 0612; FRL–9978–14–OLEM] Manager SRC–7J, Metcalfe Federal
Senate, the U.S. House of Building, 77 West Jackson Boulevard,
Representatives, and the Comptroller National Priorities List Chicago, IL 60604; 312/886–4465.
General of the United States prior to • Brenda Cook, Region 6 (AR, LA,
publication of the rule in the Federal AGENCY: Environmental Protection NM, OK, TX), U.S. EPA, 1445 Ross
Register. This action is not a ‘‘major Agency (EPA). Avenue, Suite 1200, Mailcode 6SFTS,
rule’’ as defined by 5 U.S.C. 804(2). ACTION: Final rule. Dallas, TX 75202–2733; 214/665–7436.
• Kumud Pyakuryal, Region 7 (IA,
List of Subjects in 40 CFR Part 180 SUMMARY: The Comprehensive KS, MO, NE), U.S. EPA, 11201 Renner
Environmental Response, Blvd., Mailcode SUPRSTAR, Lenexa, KS
Environmental protection, Compensation, and Liability Act of 1980 66219; 913/551–7956.
Administrative practice and procedure, (‘‘CERCLA’’ or ‘‘the Act’’), as amended, • Victor Ketellapper, Region 8 (CO,
Agricultural commodities, Pesticides requires that the National Oil and MT, ND, SD, UT, WY), U.S. EPA, 1595
and pests, Reporting and recordkeeping Hazardous Substances Pollution Wynkoop Street, Mailcode 8EPR–B,
requirements. Contingency Plan (‘‘NCP’’) include a list Denver, CO 80202–1129; 303/312–6578.
Dated: May 8, 2018. of national priorities among the known • Sharon Murray, Region 9 (AZ, CA,
releases or threatened releases of HI, NV, AS, GU, MP), U.S. EPA, 75
Daniel Rosenblatt,
hazardous substances, pollutants or Hawthorne Street, Mailcode SFD 6–1,
Acting Director, Registration Division, Office contaminants throughout the United San Francisco, CA 94105; 415/947–
of Pesticide Programs. States. The National Priorities List 4250.
Therefore, 40 CFR chapter I is (‘‘NPL’’) constitutes this list. The NPL is • Ken Marcy, Region 10 (AK, ID, OR,
intended primarily to guide the WA), U.S. EPA, 1200 6th Avenue,
amended as follows:
Environmental Protection Agency (‘‘the Mailcode ECL–112, Seattle, WA 98101;
PART 180—[AMENDED] EPA’’ or ‘‘the agency’’) in determining 206/463–1349.
which sites warrant further FOR FURTHER INFORMATION CONTACT:
■ 1. The authority citation for part 180 investigation. These further Terry Jeng, phone: (703) 603–8852,
continues to read as follows: investigations will allow the EPA to email: jeng.terry@epa.gov Site
assess the nature and extent of public Assessment and Remedy Decisions
Authority: 21 U.S.C. 321(q), 346a and 371. health and environmental risks Branch, Assessment and Remediation
■ 2. In § 180.659, add alphabetically associated with the site and to Division, Office of Superfund
‘‘Potato, granules/flakes’’, ‘‘Vegetable, determine what CERCLA-financed Remediation and Technology
bulb, group 3–07’’, and ‘‘Vegetable, remedial action(s), if any, may be Innovation (Mailcode 5204P), U.S.
tuberous and corm, subgroup 1C’’ to the appropriate. This rule adds six sites to Environmental Protection Agency; 1200
the General Superfund section of the Pennsylvania Avenue NW, Washington,
table in paragraph (a)(5) to read as
NPL. DC 20460; or the Superfund Hotline,
follows:
DATES: The document is effective on phone (800) 424–9346 or (703) 412–
§ 180.659 Pyroxasulfone; tolerances for June 18, 2018. 9810 in the Washington, DC,
residues. metropolitan area.
ADDRESSES: Contact information for the
SUPPLEMENTARY INFORMATION:
(a) * * * EPA Headquarters:
(5) * * * • Docket Coordinator, Headquarters; Table of Contents
U.S. Environmental Protection Agency; I. Background
Parts per CERCLA Docket Office; 1301 A. What are CERCLA and SARA?
Commodity Constitution Avenue NW, William
million B. What is the NCP?
Jefferson Clinton Building West, Room C. What is the National Priorities List
3334, Washington, DC 20004, 202/566– (NPL)?
* * * * * 0276. D. How are sites listed on the NPL?
Potato, granules/flakes ............... 0.20 The contact information for the E. What happens to sites on the NPL?
regional dockets is as follows: F. Does the NPL define the boundaries of
sites?
* * * * * • Holly Inglis, Region 1 (CT, ME, MA,
Vegetable, bulb, group 3–07 ...... 0.15 G. How are sites removed from the NPL?
NH, RI, VT), U.S. EPA, Superfund H. May the EPA delete portions of sites
Records and Information Center, 5 Post from the NPL as they are cleaned up?
* * * * * Office Square, Suite 100, Boston, MA I. What is the Construction Completion List
Vegetable, tuberous and corm, 02109–3912; 617/918–1413. (CCL)?
subgroup 1C ........................... 0.08 • Ildefonso Acosta, Region 2 (NJ, NY, J. What is the Sitewide Ready for
PR, VI), U.S. EPA, 290 Broadway, New Anticipated Use measure?
* * * * * York, NY 10007–1866; 212/637–4344. K. What is state/tribal correspondence
[FR Doc. 2018–10582 Filed 5–16–18; 8:45 am]
• Lorie Baker (ASRC), Region 3 (DE, concerning NPL Listing?
amozie on DSK3GDR082PROD with RULES
BILLING CODE 6560–50–P DC, MD, PA, VA, WV), U.S. EPA, II. Availability of Information to the Public
A. May I review the documents relevant to
Library, 1650 Arch Street, Mailcode this final rule?
3HS12, Philadelphia, PA 19103; 215/ B. What documents are available for review
814–3355. at the EPA Headquarters docket?
• Cathy Amoroso, Region 4 (AL, FL, C. What documents are available for review
GA, KY, MS, NC, SC, TN), U.S. EPA, 61 at the EPA regional dockets?
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Document Created: 2018-05-17 00:51:10
Document Modified: 2018-05-17 00:51:10
| 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 May 17, 2018. Objections and requests for hearings must be received on or before July 16, 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 Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone | |
| FR Citation | 83 FR 22854 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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