Nicosulfuron; Pesticide Tolerances, 68261-68265 [2015-27887]

Download as PDF Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: October 21, 2015. Jack E. Housenger, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Add § 180.688 to subpart C to read as follows: ■ rmajette on DSK7SPTVN1PROD with RULES § 180.688 residue. Diethofencarb; tolerance for (a) General. (1) Tolerances are established for residues of the fungicide diethofencarb, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only diethofencarb (1methylethyl N-(3,4diethoxyphenyl)carbamate). VerDate Sep<11>2014 13:40 Nov 03, 2015 Jkt 238001 68261 Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone Banana * ............................... 0.10 number: (703) 305–7090; email address: * There is no U.S. registration for use on this RDFRNotices@epa.gov. commodity as of November 4, 2015. SUPPLEMENTARY INFORMATION: (b) Section 18 emergency exemptions. I. General Information [Reserved] A. Does this action apply to me? (c) Tolerances with regional registrations. [Reserved] You may be potentially affected by (d) Indirect or inadvertent residues this action if you are an agricultural [Reserved] producer, food manufacturer, or pesticide manufacturer. The following [FR Doc. 2015–27891 Filed 11–3–15; 8:45 am] list of North American Industrial BILLING CODE 6560–50–P Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers ENVIRONMENTAL PROTECTION determine whether this document AGENCY applies to them. Potentially affected entities may include: 40 CFR Part 180 • Crop production (NAICS code 111). [EPA–HQ–OPP–2013–0034; FRL–9912–40] • Animal production (NAICS code 112). Nicosulfuron; Pesticide Tolerances • Food manufacturing (NAICS code 311). AGENCY: Environmental Protection • Pesticide manufacturing (NAICS Agency (EPA). code 32532). ACTION: Final rule. Parts per million Commodity This regulation establishes tolerances for residues of nicosulfuron in or on sorghum, grain, forage; sorghum, grain, grain; and sorghum, grain, stover. E.I. du Pont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 4, 2015. Objections and requests for hearings must be received on or before January 4, 2016, 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–2013–0034, 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: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, SUMMARY: PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 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–2013–0034 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 January 4, 2016. 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 E:\FR\FM\04NOR1.SGM 04NOR1 68262 Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2013–0034, 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. • 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. rmajette on DSK7SPTVN1PROD with RULES II. Summary of Petitioned-For Tolerance In the Federal Register of July 19, 2013 (78 FR 43117) (FRL–9392–9), 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 2F8132) by E.I. du Pont de Nemours and Company, 1007 Market Street, Wilmington, DE 19898. The petition requested that 40 CFR 180.454 be amended by establishing tolerances for residues of the herbicide nicosulfuron, 3-pyridinecarboxamide, 2((((4,6-dimethoxypyrimidin-2yl)aminocarbonyl)aminosulfonyl))-N,Ndimethyl, in or on sorghum, forage at 0.4 parts per million (ppm); sorghum, grain at 0.8 ppm; and sorghum, stover at 0.05 ppm. That document referenced a summary of the petition prepared by E.I. du Pont de Nemours and Company, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has revised the proposed commodity definitions, revised the proposed tolerance level for ‘‘sorghum, grain, forage’’, and corrected the typographical error in the chemical name of nicosulfuron in the tolerance expression. Also, EPA has removed the expired emergency exemption tolerances for Bermuda grass, forage and Bermuda grass, hay. The reasons for these changes are explained in Unit IV.C. VerDate Sep<11>2014 13:40 Nov 03, 2015 Jkt 238001 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 nicosulfuron including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with nicosulfuron 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. Nicosulfuron has low acute toxicity by oral, dermal, and inhalation routes of exposure. It is moderately irritating to the eye, non-irritating to the skin, and is not a skin sensitizer. In repeated dose studies by the oral route, nicosulfuron is minimally toxic, and rodents are particularly insensitive to its effects. Chronic dietary administrations to rats and mice did not produce any adverse effects at the highest dose tested (HDT). Chronic dietary administration to dogs produced mild effects (increased relative liver and kidney weights of males) at the HDT. PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 Nicosulfuron showed no developmental effects in rats, and no adverse effects were observed in the rat reproductive study. In the rabbit developmental study, abortions occurred at the doses that caused other maternal toxicity effects. There are no indications of neurotoxic or immunotoxic effects elicited by nicosulfuron in animal studies; this includes recently submitted acute and subchronic neurotoxicity studies and an immunotoxicity study. There is no evidence of mutagenicity. Nicosulfuron is classified as ‘‘Not Likely to be Carcinogenic to Humans’’ based on lack of evidence of carcinogenicity in rats and mice studies and lack of mutagenic effects in the in vitro and in vivo genotoxicity studies. Specific information on the studies received and the nature of the adverse effects caused by nicosulfuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in document ‘‘Nicosulfuron: Human Health Risk Assessment for Proposed Use on ALS Inhibitor Tolerant Sorghum,’’ pp. 24–27 in docket ID number EPA–HQ–OPP– 2013–0034. 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:// E:\FR\FM\04NOR1.SGM 04NOR1 Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations www.epa.gov/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for nicosulfuron used for 68263 human risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NICOSULFURON FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/scenario Chronic dietary (All populations) Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects NOAEL= 125 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Chronic RfD = 1.25 mg/kg/day. cPAD = 1.25 mg/kg/ day Chronic oral toxicity—Dog. LOAEL = 500 mg/kg/day based on increased relative liver and kidney weights in males. Supported by rabbit developmental toxicity study (NOAEL = 100 mg/kg/day, LOAEL = 500 mg/kg/day). FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. cPAD = chronic population adjusted dose. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). rmajette on DSK7SPTVN1PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to nicosulfuron, EPA considered exposure under the petitioned-for tolerances as well as all existing nicosulfuron tolerances in 40 CFR 180.454. EPA assessed dietary exposures from nicosulfuron 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. No such effects were identified in the toxicological studies for nicosulfuron; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA’s 2003–2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed that nicosulfuron residues were present at tolerance levels in all commodities for which tolerances have been established or proposed, and that 100% of those crops were treated with nicosulfuron. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that nicosulfuron does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for nicosulfuron. Tolerance level residues and/or 100 PCT were assumed for all food commodities. VerDate Sep<11>2014 13:40 Nov 03, 2015 Jkt 238001 2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for nicosulfuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of nicosulfuron. 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 nicosulfuron for chronic exposures for non-cancer assessments are estimated to be 2.8 ppb for surface water and 19.2 ppb for ground water. Based on the Screening Concentration in Ground Water (SCI–GROW) model, the EDWC of nicosulfuron for chronic exposures for non-cancer assessments are estimated to be 1.42 ppb. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 19.2 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). Nicosulfuron 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 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 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 nicosulfuron to share a common mechanism of toxicity with any other substances, and nicosulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that nicosulfuron 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 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. No evidence of increased sensitivity or susceptibility in the developing or young animal was observed in the current database. No treatment-related E:\FR\FM\04NOR1.SGM 04NOR1 68264 Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations rmajette on DSK7SPTVN1PROD with RULES effects were seen for maternal or developmental toxicity up to and including the HDT in the rat prenatal developmental study, and no adverse effects were noted in the rat reproductive study. Although increases in abortions and post-implantation losses were observed in the rabbit developmental study, those effects occurred at the same doses as other maternal toxicity, indicating that they were a secondary effect of maternal toxicity, rather than a developmental or reproductive effect. 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 nicosulfuron is complete. ii. There is no indication that nicosulfuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that nicosulfuron results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to nicosulfuron in drinking water. These assessments will not underestimate the exposure and risks posed by nicosulfuron. 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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was VerDate Sep<11>2014 13:40 Nov 03, 2015 Jkt 238001 selected. Therefore, nicosulfuron is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to nicosulfuron from food and water will utilize <1% of the cPAD for the general U.S. population and all population subgroups including infants and children. There are no residential uses for nicosulfuron. 3. Short- and intermediate-term risks. 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). Because there are no residential uses, no short- or intermediate-term aggregate risk assessments were conducted. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, nicosulfuron 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 nicosulfuron residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (Method DuPont-32277, a high performance liquid chromatography with tandem mass spectroscopy (HPLC/ MS/MS)) 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 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established MRLs for nicosulfuron. C. Revisions to Petitioned-For Tolerances The Agency is revising the proposed commodity definitions of ‘‘sorghum, forage’’ to ‘‘sorghum, grain, forage’’; ‘‘sorghum, grain’’ to ‘‘sorghum, grain, grain’’; and ‘‘sorghum, stover’’ to ‘‘sorghum, grain, stover’’ for consistency with EPA’s Food and Feed Commodity Vocabulary. The proposed tolerance level of 0.4 ppm for ‘‘sorghum, forage’’ is revised to 0.3 ppm for ‘‘sorghum, grain, forage’’ based on analysis of the residue field trial data using the Organization for the Economic Cooperation and Development’s tolerance calculation procedure. The tolerance expression is revised to correct the typographical error in the chemical name for nicosulfuron. V. Conclusion Therefore, tolerances are established for residues of nicosulfuron, 2-[[[[(4,6dimethoxy-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N-dimethyl3-pyridinecarboxamide, including its metabolites and degradates, in or on sorghum, grain, forage at 0.3 ppm; sorghum, grain, grain at 0.8 ppm; and sorghum, grain, stover at 0.05 ppm. In addition, as a housekeeping measure, the Agency is removing the expired emergency exemption tolerances on ‘‘Bermuda grass, forage’’ and ‘‘Bermuda grass, hay’’. The tolerances expired on December 31, 2011. 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 E:\FR\FM\04NOR1.SGM 04NOR1 Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations 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 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). rmajette on DSK7SPTVN1PROD with RULES 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 VerDate Sep<11>2014 13:40 Nov 03, 2015 Jkt 238001 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: October 21, 2015. G. Jeffrey Herndon, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.454, revise paragraph (a) introductory text and add alphabetically the following commodities to the table and revise paragraph (b) to read as follows: ■ § 180.454 Nicosulfuron; tolerances for residues. (a) General. Tolerances are established for residues of the herbicide nicosulfuron, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only nicosulfuron, 2-[[[[(4,6-dimethoxy-2pyrimidinyl)amino]carbonyl]amino] sulfonyl]-N,N-dimethyl-3-pyridine carboxamide. 68265 DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 150121066–5717–02] RIN 0648–XE242 Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; inseason quota transfer. AGENCY: NMFS is transferring 35 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the Harpoon category and 65 mt from the Reserve category to the General category for the remainder of the 2015 fishing year. This transfer results in adjusted quotas of 566.7 mt, 43.6 mt and 82.1 mt for the General, Harpoon, and Reserve categories, respectively. This action is based on consideration of the regulatory determination criteria regarding inseason adjustments and applies to Atlantic tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels when fishing commercially for BFT. SUMMARY: Effective October 30, 2015 through December 31, 2015. DATES: FOR FURTHER INFORMATION CONTACT: Sarah McLaughlin or Brad McHale, 978–281–9260. SUPPLEMENTARY INFORMATION: Regulations implemented under the Parts per authority of the Atlantic Tunas Commodity million Convention Act (ATCA; 16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act * * * * * Sorghum, grain, forage ............. 0.3 (Magnuson-Stevens Act; 16 U.S.C. 1801 Sorghum, grain, grain ............... 0.8 et seq.) governing the harvest of BFT by Sorghum, grain, stover ............. 0.05 persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. (b) Section 18 emergency exemptions. BFT quota recommended by the [Reserved] International Commission for the * * * * * Conservation of Atlantic Tunas (ICCAT) [FR Doc. 2015–27887 Filed 11–3–15; 8:45 am] among the various domestic fishing BILLING CODE 6560–50–P categories, per the allocations established in the 2006 Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006), as amended by the recently published Amendment 7 to the 2006 Consolidated HMS FMP (Amendment 7) (79 FR 71510, December 2, 2014). NMFS PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\04NOR1.SGM 04NOR1

Agencies

[Federal Register Volume 80, Number 213 (Wednesday, November 4, 2015)]
[Rules and Regulations]
[Pages 68261-68265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27887]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0034; FRL-9912-40]


Nicosulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
nicosulfuron in or on sorghum, grain, forage; sorghum, grain, grain; 
and sorghum, grain, stover. E.I. du Pont de Nemours and Company 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective November 4, 2015. Objections and 
requests for hearings must be received on or before January 4, 2016, 
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-2013-0034, 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: Susan Lewis, 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-2013-0034 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 
January 4, 2016. 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

[[Page 68262]]

notice. Submit the non-CBI copy of your objection or hearing request, 
identified by docket ID number EPA-HQ-OPP-2013-0034, 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.
     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 July 19, 2013 (78 FR 43117) (FRL-9392-
9), 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 
2F8132) by E.I. du Pont de Nemours and Company, 1007 Market Street, 
Wilmington, DE 19898. The petition requested that 40 CFR 180.454 be 
amended by establishing tolerances for residues of the herbicide 
nicosulfuron, 3-pyridinecarboxamide, 2-((((4,6-dimethoxypyrimidin-2-
yl)aminocarbonyl)aminosulfonyl))-N,N-dimethyl, in or on sorghum, forage 
at 0.4 parts per million (ppm); sorghum, grain at 0.8 ppm; and sorghum, 
stover at 0.05 ppm. That document referenced a summary of the petition 
prepared by E.I. du Pont de Nemours and Company, the registrant, which 
is available in the docket, https://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed commodity definitions, revised the proposed 
tolerance level for ``sorghum, grain, forage'', and corrected the 
typographical error in the chemical name of nicosulfuron in the 
tolerance expression. Also, EPA has removed the expired emergency 
exemption tolerances for Bermuda grass, forage and Bermuda grass, hay. 
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 nicosulfuron including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with nicosulfuron 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.
    Nicosulfuron has low acute toxicity by oral, dermal, and inhalation 
routes of exposure. It is moderately irritating to the eye, non-
irritating to the skin, and is not a skin sensitizer. In repeated dose 
studies by the oral route, nicosulfuron is minimally toxic, and rodents 
are particularly insensitive to its effects. Chronic dietary 
administrations to rats and mice did not produce any adverse effects at 
the highest dose tested (HDT). Chronic dietary administration to dogs 
produced mild effects (increased relative liver and kidney weights of 
males) at the HDT.
    Nicosulfuron showed no developmental effects in rats, and no 
adverse effects were observed in the rat reproductive study. In the 
rabbit developmental study, abortions occurred at the doses that caused 
other maternal toxicity effects. There are no indications of neurotoxic 
or immunotoxic effects elicited by nicosulfuron in animal studies; this 
includes recently submitted acute and subchronic neurotoxicity studies 
and an immunotoxicity study. There is no evidence of mutagenicity.
    Nicosulfuron is classified as ``Not Likely to be Carcinogenic to 
Humans'' based on lack of evidence of carcinogenicity in rats and mice 
studies and lack of mutagenic effects in the in vitro and in vivo 
genotoxicity studies.
    Specific information on the studies received and the nature of the 
adverse effects caused by nicosulfuron as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Nicosulfuron: Human Health Risk 
Assessment for Proposed Use on ALS Inhibitor Tolerant Sorghum,'' pp. 
24-27 in docket ID number EPA-HQ-OPP-2013-0034.

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://

[[Page 68263]]

www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for nicosulfuron used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Nicosulfuron for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 125 mg/kg/day  Chronic RfD = 1.25   Chronic oral toxicity--Dog.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 500 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 1.25 mg/kg/    increased relative liver and
                                   FQPA SF = 1x........   day.                 kidney weights in males.
                                                                              Supported by rabbit developmental
                                                                               toxicity study (NOAEL = 100 mg/kg/
                                                                               day, LOAEL = 500 mg/kg/day).
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. cPAD = chronic population adjusted dose. RfD
  = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
  potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to nicosulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing nicosulfuron tolerances in 40 
CFR 180.454. EPA assessed dietary exposures from nicosulfuron 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. No such effects were 
identified in the toxicological studies for nicosulfuron; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA assumed that 
nicosulfuron residues were present at tolerance levels in all 
commodities for which tolerances have been established or proposed, and 
that 100% of those crops were treated with nicosulfuron.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that nicosulfuron does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for nicosulfuron. 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 nicosulfuron in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of nicosulfuron. 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 
nicosulfuron for chronic exposures for non-cancer assessments are 
estimated to be 2.8 ppb for surface water and 19.2 ppb for ground 
water. Based on the Screening Concentration in Ground Water (SCI-GROW) 
model, the EDWC of nicosulfuron for chronic exposures for non-cancer 
assessments are estimated to be 1.42 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration value of 19.2 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). Nicosulfuron 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 nicosulfuron to share a common mechanism of 
toxicity with any other substances, and nicosulfuron does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
nicosulfuron 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 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. No evidence of increased 
sensitivity or susceptibility in the developing or young animal was 
observed in the current database. No treatment-related

[[Page 68264]]

effects were seen for maternal or developmental toxicity up to and 
including the HDT in the rat prenatal developmental study, and no 
adverse effects were noted in the rat reproductive study. Although 
increases in abortions and post-implantation losses were observed in 
the rabbit developmental study, those effects occurred at the same 
doses as other maternal toxicity, indicating that they were a secondary 
effect of maternal toxicity, rather than a developmental or 
reproductive effect.
    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 nicosulfuron is complete.
    ii. There is no indication that nicosulfuron is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that nicosulfuron results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to nicosulfuron in drinking water. These assessments 
will not underestimate the exposure and risks posed by nicosulfuron.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
nicosulfuron is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
nicosulfuron from food and water will utilize <1% of the cPAD for the 
general U.S. population and all population subgroups including infants 
and children. There are no residential uses for nicosulfuron.
    3. Short- and intermediate-term risks. 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). Because there are no 
residential uses, no short- or intermediate-term aggregate risk 
assessments were conducted.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, nicosulfuron 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 nicosulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method DuPont-32277, a high 
performance liquid chromatography with tandem mass spectroscopy (HPLC/
MS/MS)) 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 MRLs for nicosulfuron.

C. Revisions to Petitioned-For Tolerances

    The Agency is revising the proposed commodity definitions of 
``sorghum, forage'' to ``sorghum, grain, forage''; ``sorghum, grain'' 
to ``sorghum, grain, grain''; and ``sorghum, stover'' to ``sorghum, 
grain, stover'' for consistency with EPA's Food and Feed Commodity 
Vocabulary. The proposed tolerance level of 0.4 ppm for ``sorghum, 
forage'' is revised to 0.3 ppm for ``sorghum, grain, forage'' based on 
analysis of the residue field trial data using the Organization for the 
Economic Cooperation and Development's tolerance calculation procedure. 
The tolerance expression is revised to correct the typographical error 
in the chemical name for nicosulfuron.

V. Conclusion

    Therefore, tolerances are established for residues of nicosulfuron, 
2-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N-
dimethyl-3-pyridinecarboxamide, including its metabolites and 
degradates, in or on sorghum, grain, forage at 0.3 ppm; sorghum, grain, 
grain at 0.8 ppm; and sorghum, grain, stover at 0.05 ppm.
    In addition, as a housekeeping measure, the Agency is removing the 
expired emergency exemption tolerances on ``Bermuda grass, forage'' and 
``Bermuda grass, hay''. The tolerances expired on December 31, 2011.

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

[[Page 68265]]

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 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: October 21, 2015.
G. Jeffrey Herndon,
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.  180.454, revise paragraph (a) introductory text and add 
alphabetically the following commodities to the table and revise 
paragraph (b) to read as follows:


Sec.  180.454  Nicosulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide nicosulfuron, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only nicosulfuron, 2-[[[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]amino]sulfonyl]-N,N-dimethyl-3-
pyridinecarboxamide.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sorghum, grain, forage.....................................          0.3
Sorghum, grain, grain......................................          0.8
Sorghum, grain, stover.....................................         0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2015-27887 Filed 11-3-15; 8:45 am]
 BILLING CODE 6560-50-P
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