Pyroxasulfone; Pesticide Tolerances, 34629-34633 [2014-14251]

Download as PDF Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations were also considered in arriving at this conclusion. This rule is categorically excluded, under figure 2–1, paragraphs (34)(g) and (34)(h) of the Instruction since it involves establishment of safety zones for annually recurring marine events, including marine related fireworks events and special local regulations for regattas. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES. List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: 1. The authority citation for part 165 continues to read as follows: ■ Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Pub. L. 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. [Amended] 2. Amend the table in § 165.173 as follows: ■ a. Add a new category entitled ‘‘5.0 MAY’’ below the category ‘‘1.0 365 DAY JANUARY–DECEMBER’’ and above the category ‘‘6.0 JUNE’’; ■ b. Redesignate item 6.2, ‘‘RI National Guard Air Show’’ as item 5.1, and locate it beneath the category ‘‘5.0 MAY’’; ■ c. Redesignate item 7.12 ‘‘Swim Buzzards Bay’’ as item 6.2, and locate it below item 6.1 ‘‘Oak Bluffs Summer Solstice’’, and reserve item 7.12; ■ d. Revise the entry for ‘‘Date’’ in newly redesignated item 5.1, ‘‘RI Air National Guard Air Show’’ to read ‘‘Date: One weekend (Friday, Saturday, and Sunday) in May, June, or July, as announced in the local Notice to Mariners.’’; and ■ e. Revise the entry for ‘‘Date’’ in newly redesignated item 6.2 ‘‘Swim Buzzards Bay’’ to read ‘‘Date: One Saturday or Sunday in June, July, or August, as announced in the local Notice to Mariners.’’ ehiers on DSK2VPTVN1PROD with RULES ■ Dated: May 21, 2014. J.T. Kondratowicz, Captain, U.S. Coast Guard, Captain of the Port Southeastern New England. [FR Doc. 2014–14238 Filed 6–17–14; 8:45 am] BILLING CODE 9110–04–P VerDate Mar<15>2010 15:22 Jun 17, 2014 Jkt 232001 40 CFR Part 180 [EPA–HQ–OPP–2013–0673; FRL–9911–08] Pyroxasulfone; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation amends tolerances for residues of pyroxasulfone in or on corn, field, forage and corn, field, grain. K–I Chemical U.S.A. Inc. c/o Landis International, Inc. requested these amended tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: This regulation is effective June 18, 2014. Objections and requests for hearings must be received on or before August 18, 2014, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS § 165.173 ENVIRONMENTAL PROTECTION AGENCY The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2013–0673, is available at https://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 https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Lois Rossi, 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: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: 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 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 34629 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 https://www.ecfr.gov/cgi-bin/textidx?&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–2013–0673 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 August 18, 2014. 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– 2013–0673, by one of the following methods: • Federal eRulemaking Portal: https:// 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. E:\FR\FM\18JNR1.SGM 18JNR1 34630 Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations ehiers on DSK2VPTVN1PROD with RULES • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets. II. Summary of Petitioned-for Tolerance In the Federal Register of October 25, 2013 (78 FR 63938) (FRL–9901–96), 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 3F8196) by K–I Chemical U.S.A. Inc. c/o Landis International, Inc., P.O. Box 5126, Valdosta, GA 31603–5126. The petition requested that 40 CFR 180.659 be amended by increasing the tolerance for residues of the herbicide, pyroxasulfone, [3-[[[5(difluoromethoxy)-1-methyl-3(trifluoromethyl)-1H-pyrazol-4yl]methyl]sulfonyl]-4,5-dihydro-5,5dimethylisoxazole] and its metabolite 5difluoromethoxy-1-methyl-3trifluoromethyl-1 H-pyrazol-4carboxylic acid (M3) calculated as the stoichiometric equivalent of pyroxasulfone, in or on corn, field, grain from 0.015 to 0.02 parts per million (ppm); and also increasing the tolerance for residues of pyroxasulfone, [3-[[[5(difluoromethoxy)-1-methyl-3(trifluoromethyl)-1H-pyrazol-4yl]methyl]sulfonyl]-4,5-dihydro-5,5dimethylisoxazole] and its metabolites 5-difluoromethoxy-1-methyl-3trifluoromethyl-1 H-pyrazol-4ylmethanesulfonic acid (M1), 5difluoromethoxy-1-methyl-3trifluoromethyl-1 H-pyrazol-4carboxylic acid (M3), and 5difluoromethoxy-3-trifluoromethyl-1 Hpyrazol-4-yl) methanesulfonic acid (M25) calculated as the stoichiometric equivalent of pyroxasulfone in or on corn, field, forage from 0.06 to 0.09 ppm. The amended tolerances were sought to cover residues that may be found on corn following use of pyroxasulfone with an adjuvant. That document referenced a summary of the petition prepared by K–I Chemical U.S.A. Inc. c/o Landis International, Inc., the registrant, which is available in the docket, https://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 VerDate Mar<15>2010 15:22 Jun 17, 2014 Jkt 232001 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 In the Federal Register of July 31, 2013 (78 FR 46274) (FRL–9393–6), EPA published a final rule (2013 rulemaking) establishing certain tolerances for residues of the herbicide pyroxasulfone and its metabolites based on EPA’s conclusion that aggregate exposure to pyroxasulfone is safe for the general population, including infants and children. Since the 2013 rulemaking, there have been no additional tolerance actions for pyroxasulfone, nor has the toxicity profile for pyroxasulfone changed. Specific information on the studies reviewed for that rulemaking and the nature of the adverse effects caused by pyroxasulfone, as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies are discussed in the 2013 rulemaking which can be found in docket ID number EPA–HQ–OPP–2012– 0439. 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 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 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 https:// www.epa.gov/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for pyroxasulfone used for human risk assessment is also discussed in Unit III.B of the final rule published in the Federal Register of February 29, 2012 (77 FR 12207) (FRL–9334–2). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyroxasulfone, EPA conducted a new dietary exposure and risk assessment that 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 information from the United States Department of Agriculture’s (USDA) 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) at tolerance-level residues adjusted upward to account for metabolites which are not in the E:\FR\FM\18JNR1.SGM 18JNR1 ehiers on DSK2VPTVN1PROD with RULES Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations tolerance expression from specific use patterns. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA/NHANES/WWEIA. As to residue levels in food, EPA made the same assumptions (adjusted tolerancelevel residues and 100 PCT) as in the acute dietary exposure assessment. iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a fooduse pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to pyroxasulfone. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for pyroxasulfone. Adjusted tolerance level residues and/or 100 PCT 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 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 https://www.epa.gov/ oppefed1/models/water/index.htm. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of pyroxasulfone for acute exposures are estimated to be 17 parts per billion (ppb) for surface water and 210 ppb for ground water. EDWCs of pyroxasulfone for chronic exposures for non-cancer assessments are estimated to be 3.2 ppb for surface water and 174 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered VerDate Mar<15>2010 15:22 Jun 17, 2014 Jkt 232001 into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 210 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 174 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 nonoccupational, 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 Web site at https:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (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. The prenatal and postnatal toxicity PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 34631 database for pyroxasulfone includes developmental toxicity studies in rats and rabbits, a DNT study in rats, and a 2-generation reproduction toxicity study in rats. As discussed in the 2013 rulemaking, evidence of increased susceptibility of fetuses and offspring was seen in the DNT study and developmental toxicity study in rabbits following in utero or post-natal exposure to pyroxasulfone. No increased susceptibility was seen in the rat developmental or reproduction toxicity studies. In rabbits, developmental toxicity was only seen at the limit dose of 1,000 milligrams/ kilogram/day (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 (decreased brain weight and morphometric changes on PND 21) was seen at 300 mg/kg/day compared to no maternal toxicity at 900 mg/kg/day. The degree of concern for the increased susceptibility seen in these studies is low and there are no residual uncertainties based on the following considerations: i. The increased susceptibility is occurring at high doses. ii. NOAELs and LOAELs have been identified for all effects of concern, and thus a clear dose response has been well defined. iii. The PODs selected for risk assessment are protective of the fetal/ offspring 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 toxicity database for pyroxasulfone is complete. ii. Pyroxasulfone is a neurotoxic chemical and there is evidence of increased susceptibility of offspring with regard to neurotoxic effects in the rat DNT study. There is also evidence of increased susceptibility of fetuses/ offspring with regard to non-neurotoxic effects in the rabbit developmental toxicity study. However, concern for the increased susceptibility is low for the reasons stated in Unit III.D.2.; therefore, EPA determined that a 10X FQPA SF is not necessary to protect infants and children. iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and adjusted tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface E:\FR\FM\18JNR1.SGM 18JNR1 34632 Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations ehiers on DSK2VPTVN1PROD with RULES 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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to pyroxasulfone will occupy 3.6% of the aPAD for all infants (<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 48% of the cPAD for all infants (<1 year old) the population group receiving the greatest exposure. There are no residential uses for pyroxasulfone. 3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Short- and intermediate-term adverse effects were identified; however, pyroxasulfone is not registered for any use patterns that would result in short- or intermediateterm residential exposure. Because there is no short- or 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 short- and intermediate-term risk), no further assessment of short- or intermediateterm risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for pyroxasulfone. 4. Aggregate cancer risk for U.S. population. 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 VerDate Mar<15>2010 15:22 Jun 17, 2014 Jkt 232001 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 (a liquid chromatography/mass spectrometry/mass spectrometry (LC/ MS/MS) method) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@ epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 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. V. Conclusion Therefore, tolerances are established for residues of pyroxasulfone, [3-[[[5(difluoromethoxy)-1-methyl-3(trifluoromethyl)-1H-pyrazol-4yl]methyl]sulfonyl]-4,5-dihydro-5,5dimethylisoxazole], including its metabolites and degradates, as set forth in the regulatory text. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under FFDCA section 408(d) in PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under 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 final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require E:\FR\FM\18JNR1.SGM 18JNR1 Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act ehiers on DSK2VPTVN1PROD with RULES 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). ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA–HQ–SFUND–1999–0013; FRL–9912– 53–Region 2] National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Federal Creosote Superfund Site Environmental Protection Agency. ACTION: Final rule. AGENCY: The Environmental Protection Agency (EPA) Region 2 announces the deletion of the Federal Creosote List of Subjects in 40 CFR Part 180 Superfund Site (Site) located in the Borough of Manville, New Jersey, from Environmental protection, the National Priorities List (NPL). The Administrative practice and procedure, NPL, promulgated pursuant to section Agricultural commodities, Pesticides and pests, Reporting and recordkeeping 105 of the Comprehensive Environmental Response, requirements. Compensation, and Liability Act Dated: June 12, 2014. (CERCLA) of 1980, as amended, is an Lois Rossi, appendix of the National Oil and Director, Registration Division, Office of Hazardous Substances Pollution Pesticide Programs. Contingency Plan (NCP). The EPA and the State of New Jersey, through the Therefore, 40 CFR chapter I is New Jersey Department of amended as follows: Environmental Protection, have PART 180—[AMENDED] determined that all appropriate response actions under CERCLA, other ■ 1. The authority citation for part 180 than long-term groundwater monitoring, continues to read as follows: and five-year reviews, have been completed. However, this deletion does Authority: 21 U.S.C. 321(q), 346a and 371. not preclude future actions under ■ 2. Section 180.659 is amended by: Superfund. ■ a. Revising the commodity ‘‘Corn, DATES: This action is effective June 18, field, grain’’ in the table in paragraph 2014. (a)(1) and; ADDRESSES: Submit your comments, ■ b. Revising the commodity ‘‘Corn identified by Docket ID no. EPA–HQ– field, forage’’ in the table in paragraph SFUND–1999–0013, by one of the (a)(2) to read as follows: following methods: • https://www.regulations.gov. Follow § 180.659 Pyroxasulfone; tolerances for on-line instructions for submitting residues. comments. • Email: puvogel.rich@epa.gov: Rich (a) General. (1) * * * Puvogel, Remedial Project Manager; Parts per seppi.pat@epa.gov: Pat Seppi, Commodity million Community Involvement Coordinator. • Fax: (212) 637–4429. Corn, field, grain ................... 0.02 • Mail: Rich Puvogel, Remedial Project * * * * * Manager, U.S. Environmental Protection Agency, Emergency & (2) * * * Remedial Response Division, 290 Broadway, 19th Floor, New York, NY Parts per Commodity 10007–1866; million or Corn, field, forage ................. 0.09 Pat Seppi, Community Involvement Coordinator, U.S. Environmental * * * * * Protection Agency, Public Affairs Division, 290 Broadway, 26th Floor, * * * * * New York, NY 10007–1866. [FR Doc. 2014–14251 Filed 6–17–14; 8:45 am] • Hand delivery: U.S. Environmental BILLING CODE 6560–50–P Protection Agency, Emergency & VerDate Mar<15>2010 15:22 Jun 17, 2014 Jkt 232001 SUMMARY: PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 34633 Remedial Response Division, 290 Broadway, 19th Floor, New York, NY 10007–1866. Such deliveries are only accepted during the Docket’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID no. EPA–HQ–SFUND–1999– 0013. EPA’s policy is that all comments received will be included in the public docket without change and may be made available online at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through https:// www.regulations.gov or email. The https://www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through https:// www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: EPA has established a docket for this action under Docket Identification No. EPA–HQ–SFUND– 1999–0013. All documents in the docket are listed on the https:// www.regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through https:// www.regulations.gov or in hard copy at the site information repositories. E:\FR\FM\18JNR1.SGM 18JNR1

Agencies

[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Rules and Regulations]
[Pages 34629-34633]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14251]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0673; FRL-9911-08]


Pyroxasulfone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation amends tolerances for residues of 
pyroxasulfone in or on corn, field, forage and corn, field, grain. K-I 
Chemical U.S.A. Inc. c/o Landis International, Inc. requested these 
amended tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective June 18, 2014. Objections and 
requests for hearings must be received on or before August 18, 2014, 
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-2013-0673, is available at https://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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, 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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this Action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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 https://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-2013-0673 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 
August 18, 2014. 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-2013-0673, by one of 
the following methods:
     Federal eRulemaking Portal: https://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.

[[Page 34630]]

     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of October 25, 2013 (78 FR 63938) (FRL-
9901-96), 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 
3F8196) by K-I Chemical U.S.A. Inc. c/o Landis International, Inc., 
P.O. Box 5126, Valdosta, GA 31603-5126. The petition requested that 40 
CFR 180.659 be amended by increasing the tolerance for residues of the 
herbicide, pyroxasulfone, [3-[[[5-(difluoromethoxy)-1-methyl-3-
(trifluoromethyl)-1H-pyrazol-4-yl]methyl]sulfonyl]-4,5-dihydro-5,5-
dimethylisoxazole] and its metabolite 5-difluoromethoxy-1-methyl-3-
trifluoromethyl-1 H-pyrazol-4-carboxylic acid (M3) calculated as the 
stoichiometric equivalent of pyroxasulfone, in or on corn, field, grain 
from 0.015 to 0.02 parts per million (ppm); and also increasing the 
tolerance for residues of pyroxasulfone, [3-[[[5-(difluoromethoxy)-1-
methyl-3-(trifluoromethyl)-1H-pyrazol-4-yl]methyl]sulfonyl]-4,5-
dihydro-5,5-dimethylisoxazole] and its metabolites 5-difluoromethoxy-1-
methyl-3-trifluoromethyl-1 H-pyrazol-4-ylmethanesulfonic acid (M1), 5-
difluoromethoxy-1-methyl-3-trifluoromethyl-1 H-pyrazol-4-carboxylic 
acid (M3), and 5-difluoromethoxy-3-trifluoromethyl-1 H-pyrazol-4-yl) 
methanesulfonic acid (M25) calculated as the stoichiometric equivalent 
of pyroxasulfone in or on corn, field, forage from 0.06 to 0.09 ppm. 
The amended tolerances were sought to cover residues that may be found 
on corn following use of pyroxasulfone with an adjuvant. That document 
referenced a summary of the petition prepared by K-I Chemical U.S.A. 
Inc. c/o Landis International, Inc., the registrant, which is available 
in the docket, https://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 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

    In the Federal Register of July 31, 2013 (78 FR 46274) (FRL-9393-
6), EPA published a final rule (2013 rulemaking) establishing certain 
tolerances for residues of the herbicide pyroxasulfone and its 
metabolites based on EPA's conclusion that aggregate exposure to 
pyroxasulfone is safe for the general population, including infants and 
children. Since the 2013 rulemaking, there have been no additional 
tolerance actions for pyroxasulfone, nor has the toxicity profile for 
pyroxasulfone changed. Specific information on the studies reviewed for 
that rulemaking and the nature of the adverse effects caused by 
pyroxasulfone, as well as the no-observed-adverse-effect-level (NOAEL) 
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity 
studies are discussed in the 2013 rulemaking which can be found in 
docket ID number EPA-HQ-OPP-2012-0439.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological 
endpoints for pyroxasulfone used for human risk assessment is also 
discussed in Unit III.B of the final rule published in the Federal 
Register of February 29, 2012 (77 FR 12207) (FRL-9334-2).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyroxasulfone, EPA conducted a new dietary exposure and 
risk assessment that 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 information from the United States Department of 
Agriculture's (USDA) 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) at tolerance-level residues 
adjusted upward to account for metabolites which are not in the

[[Page 34631]]

tolerance expression from specific use patterns.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA/NHANES/
WWEIA. As to residue levels in food, EPA made the same assumptions 
(adjusted tolerance-level residues and 100 PCT) as in the acute dietary 
exposure assessment.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. EPA has concluded that a nonlinear RfD 
approach is appropriate for assessing cancer risk to pyroxasulfone. 
Cancer risk was assessed using the same exposure estimates as discussed 
in Unit III.C.1.ii.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for pyroxasulfone. Adjusted tolerance level residues 
and/or 100 PCT 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 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 https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of 
pyroxasulfone for acute exposures are estimated to be 17 parts per 
billion (ppb) for surface water and 210 ppb for ground water. EDWCs of 
pyroxasulfone for chronic exposures for non-cancer assessments are 
estimated to be 3.2 ppb for surface water and 174 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 210 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 174 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). 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 Web site at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act (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. The prenatal and postnatal 
toxicity database for pyroxasulfone includes developmental toxicity 
studies in rats and rabbits, a DNT study in rats, and a 2-generation 
reproduction toxicity study in rats. As discussed in the 2013 
rulemaking, evidence of increased susceptibility of fetuses and 
offspring was seen in the DNT study and developmental toxicity study in 
rabbits following in utero or post-natal exposure to pyroxasulfone. No 
increased susceptibility was seen in the rat developmental or 
reproduction toxicity studies. In rabbits, developmental toxicity was 
only seen at the limit dose of 1,000 milligrams/kilogram/day (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 
(decreased brain weight and morphometric changes on PND 21) was seen at 
300 mg/kg/day compared to no maternal toxicity at 900 mg/kg/day. The 
degree of concern for the increased susceptibility seen in these 
studies is low and there are no residual uncertainties based on the 
following considerations:
    i. The increased susceptibility is occurring at high doses.
    ii. NOAELs and LOAELs have been identified for all effects of 
concern, and thus a clear dose response has been well defined.
    iii. The PODs selected for risk assessment are protective of the 
fetal/offspring 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 toxicity database for pyroxasulfone is complete.
    ii. Pyroxasulfone is a neurotoxic chemical and there is evidence of 
increased susceptibility of offspring with regard to neurotoxic effects 
in the rat DNT study. There is also evidence of increased 
susceptibility of fetuses/offspring with regard to non-neurotoxic 
effects in the rabbit developmental toxicity study. However, concern 
for the increased susceptibility is low for the reasons stated in Unit 
III.D.2.; therefore, EPA determined that a 10X FQPA SF is not necessary 
to protect infants and children.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and adjusted tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface

[[Page 34632]]

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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to pyroxasulfone will occupy 3.6% of the aPAD for all infants (<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 48% of the cPAD for all 
infants (<1 year old) the population group receiving the greatest 
exposure. There are no residential uses for pyroxasulfone.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, 
pyroxasulfone is not registered for any use patterns that would result 
in short- or intermediate-term residential exposure. Because there is 
no short- or 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 short- 
and intermediate-term risk), no further assessment of short- or 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for pyroxasulfone.
    4. Aggregate cancer risk for U.S. population. 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 (a liquid chromatography/mass 
spectrometry/mass spectrometry (LC/MS/MS) method) is available to 
enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
email address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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.

V. Conclusion

    Therefore, tolerances are established for residues of 
pyroxasulfone, [3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-
1H-pyrazol-4-yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole], 
including its metabolites and degradates, as set forth in the 
regulatory text.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under 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 final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require

[[Page 34633]]

Agency consideration of voluntary consensus standards pursuant to 
section 12(d) of the National Technology Transfer and Advancement Act 
of 1995 (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: June 12, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. Section 180.659 is amended by:
0
a. Revising the commodity ``Corn, field, grain'' in the table in 
paragraph (a)(1) and;
0
b. Revising the commodity ``Corn field, forage'' in the table in 
paragraph (a)(2) to read as follows:


Sec.  180.659  Pyroxasulfone; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Corn, field, grain......................................            0.02
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.....................................            0.09
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-14251 Filed 6-17-14; 8:45 am]
BILLING CODE 6560-50-P
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