Sulfometuron-methyl; Pesticide Tolerance, 11416-11420 [2019-05877]

Download as PDF 11416 Federal Register / Vol. 84, No. 59 / Wednesday, March 27, 2019 / Rules and Regulations Dated: March 21, 2019. A.W. Demo, Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit Pittsburgh. I. General Information [FR Doc. 2019–05824 Filed 3–26–19; 8:45 am] BILLING CODE 9110–04–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2017–0194; FRL–9989–65] Sulfometuron-methyl; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of sulfometuronmethyl in or on sugarcane, cane. E.I. du Pont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: This regulation is effective March 27, 2019. Objections and requests for hearings must be received on or before May 28, 2019, 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: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2017–0194, 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: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: VerDate Sep<11>2014 16:40 Mar 26, 2019 Jkt 247001 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/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–2017–0194 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 May 28, 2019. 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– 2017–0194, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 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 September 15, 2017 (82 FR 43352) (FRL–9965–43), 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 6E8529) by E. I. du Pont de Nemours and Company, 974 Centre Road, Wilmington, Delaware 19805, now Corteva Agriscience after E.I. du Pont de Nemours and Company merged with Dow AgroScience. The petition requested that 40 CFR 180 be amended by establishing tolerances for residues of the herbicide sulfometuronmethyl, in or on sugarcane, cane; sugarcane, sugar, refined; and sugarcane, molasses at 0.01 parts per million (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. One comment was received in response to the notice of filing, and the Agency’s response can be found in Unit IV.C. Based upon review of the data supporting the petition, EPA has determined a tolerance of 0.1 sugarcane, cane is appropriate, but that tolerances on sugarcane, sugar, refined and sugarcane, molasses is not needed. The reasons for these changes are further explained in Unit IV.D. 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 E:\FR\FM\27MRR1.SGM 27MRR1 Federal Register / Vol. 84, No. 59 / Wednesday, March 27, 2019 / Rules and Regulations 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 sulfometuronmethyl including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with sulfometuronmethyl follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The primary toxic effect in the toxicological database is changes in hematological parameters and body weight decrements. There is no evidence that sulfometuron-methyl is a developmental toxicant based on a prenatal developmental study in rats and increased susceptibility was not commonly observed in the database for other registered sulfonylurea herbicides (SUs). There is no evidence of neurotoxicity or immunotoxicity in the toxicology databased for sulfometuronmethyl. Sulfometuron-methyl is classified as ‘‘not likely to be carcinogenic to humans’’ based on lack of treatment-related increases in tumor incidence compared to controls in the mouse carcinogenicity study and negative findings in the genotoxicity toxicity studies. Sulfometuron-methyl has low acute toxicity via oral, dermal, and inhalation routes of exposure. It shows minimal eye irritation and is not a dermal irritant or sensitizer. Specific information on the studies received and the nature of the adverse effects caused by sulfometuron-methyl 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 ‘‘Sulfometuron-Methyl. Human Health Risk Assessment for a Tolerance without a U.S. Registration for Residues in/on Imported Sugarcane’’ at pages 18– 11417 20 in docket ID number EPA–HQ–OPP– 2017–0194. 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 NOAEL and 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 used for human risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFOMETURON-METHYL FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/scenario Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (All populations) A dose and endpoint of concern attributable to a single dose was not observed at doses relevant for human health risk assessment. Chronic dietary (All populations). NOAEL = 27.5 mg/kg/day UFA = 10× UFH = 10× FQPA SF = 1× Cancer (Oral, dermal, inhalation). Sulfometuron-methyl is classified as ‘‘not likely to be carcinogenic to humans’’ based on lack of treatment-related increases in tumor incidence compared to controls in the mouse carcinogenicity study and negative findings in the mutagenicity/genetic toxicity studies. Chronic RfD = 0.275 mg/kg/ day cPAD = 0.275 mg/kg/day Chronic Oral Toxicity Study (dog) LOAEL = 148.5 mg/kg/day based on decreases in body-weight gain in males, hemolytic anemia, and a slight increase in alkaline phosphates in both sexes. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (c = chronic). RfD = reference dose. 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 sulfometuron-methyl, EPA considered exposure under the VerDate Sep<11>2014 16:40 Mar 26, 2019 Jkt 247001 petitioned-for tolerances. EPA assessed dietary exposures from sulfometuronmethyl in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 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 E:\FR\FM\27MRR1.SGM 27MRR1 11418 Federal Register / Vol. 84, No. 59 / Wednesday, March 27, 2019 / Rules and Regulations identified in the toxicological studies for sulfometuron-methyl; 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 United States Department of Agriculture (USDA) 2003–2008 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed 100% crop treated (CT) and used tolerance-level residues for the sugarcane commodities. The 2018 default processing factors were used (in this case, the factors were 1 for sugarcane commodities). iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that sulfometuron-methyl 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 sulfometuron-methyl. Tolerance level residues and/or 100% CT were assumed for sugarcane. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for sulfometuron-methyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of sulfometuron-methyl. 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. Instead of generating chemicalspecific estimated drinking water concentrations (EDWCs) for sulfometuron-methyl, EPA used model inputs (rate, soil mobility, persistence) from all the sulfonylurea herbicides (sulfometuron-methyl is a sulfonylurea herbicide) to determine coarse-screen estimates that should exceed upperbound, chemical-specific EDWCs for any SU. The resulting coarse-screen EDWCs generated with the Pesticide Root Zone Model Ground Water (PRZM GW) were higher than the surface water estimates and were used as conservative estimates of potential residues from sulfometuron-methyl in drinking water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.492 ppm VerDate Sep<11>2014 16:40 Mar 26, 2019 Jkt 247001 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). Sulfometuron-methyl 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.’’ In 2016, EPA’s Office of Pesticide Programs released a guidance document entitled, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis https://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/ pesticide-cumulative-risk-assessmentframework. EPA has utilized this framework for sulfometuron-methyl and determined that although sulfometuronmethyl shares some chemical and/or toxicological characteristics (e.g., chemical structure or apical endpoint) with other pesticides, the toxicological database does not support a testable hypothesis for a common mechanism of action. No further data are required to determine that no common mechanism of toxicity exists for sulfometuronmethyl and other pesticides, and no further cumulative evaluation is necessary for sulfometuron-methyl. 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 (10×) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10×, 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. There is no evidence that sulfometuronmethyl is a developmental toxicant PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 based on a prenatal developmental study in rats and increased susceptibility was not commonly observed in the database for other registered SUs. 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 1×. That decision is based on the following findings: i. The toxicity database for sulfometuron-methyl is complete. ii. There is no indication that sulfometuron-methyl 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 sulfometuron-methyl results in increased susceptibility in rabbits in a prenatal developmental study. EPA has concluded based on a weight-ofevidence approach that the rat developmental and reproduction toxicity studies are not required for sulfometuron-methyl at this time for the following reasons: (1) Increased susceptibility was not commonly observed in the SU database; and (2) the chronic oral dog study, which is the study used to establish points of departure for sulfometuron-methyl, provides similar or lower NOAEL/ LOAEL values than the rat developmental and rat reproduction toxicity studies across the SU database. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to sulfometuron-methyl in drinking water. These assessments will not underestimate the exposure and risks posed by sulfometuron-methyl. 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 E:\FR\FM\27MRR1.SGM 27MRR1 Federal Register / Vol. 84, No. 59 / Wednesday, March 27, 2019 / Rules and Regulations 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, sulfometuronmethyl 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 sulfometuronmethyl from food and water will utilize 9.7% of the cPAD for all infants (<1 year old), the population group receiving the greatest exposure. There are no residential uses for sulfometuronmethyl; therefore, the chronic aggregate risk assessment is equivalent to the chronic dietary assessment. There are no chronic dietary risks of concern. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no uses for sulfometuron-methyl that result in residential exposures, the short-term aggregate assessment is equivalent to the chronic dietary assessment. There are no chronic dietary risks of concern as described above. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no uses for sulfometuron-methyl that result in residential exposures, the intermediateterm aggregate assessment is equivalent to the chronic dietary assessment. There are no chronic dietary risks of concern as described above. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in the rodent mouse carcinogenicity study and negative findings in the mutagenicity/ genetic toxicity studies, sulfometuronmethyl is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to sulfometuron-methyl residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (high-performance liquid chromatography–tandem mass VerDate Sep<11>2014 16:40 Mar 26, 2019 Jkt 247001 spectrometry (LC–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 a MRL for sulfometuronmethyl. C. Response to Comments One comment was submitted insisting that no residues of sulfometuron-methyl be permitted in food, although no additional information was provided that would support a conclusion that the tolerances requested for sulfometuron-methyl are not safe. Although some individuals do not want pesticides to be used on food, the FFDCA authorizes EPA to establish tolerances that permit certain levels of pesticide residues in or on food when the Agency can determine that such residues are safe. EPA has made that determination for the tolerances subject to this action, and the commenter provided no information to support a determination that the tolerance is not safe. D. Revisions to Petitioned-For Tolerances The petitioner requested a tolerance for residues of 0.01 ppm in/on sugarcane, cane; sugarcane, sugar, refined; and sugarcane, molasses. The residue data support a tolerance on sugarcane, cane of 0.1 ppm. This value is also harmonized with the MRL established in the major exporting country, Brazil. A value of 0.01 ppm PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 11419 may create a perceived trade irritant if the U.S. tolerance is lower than the MRL in the major exporting country. Tolerances for residues in/on sugarcane, sugar, refined and sugarcane, molasses are not needed, since residues are not expected to concentrate in the processed commodities. V. Conclusion Therefore, a tolerance is established for residues of sulfometuron-methyl, in or on sugarcane, cane at 0.1 ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997) nor is considered a regulatory action under Executive Order 13771, entitled ‘‘Reducing Regulations and Controlling Regulatory Costs’’ (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States E:\FR\FM\27MRR1.SGM 27MRR1 11420 Federal Register / Vol. 84, No. 59 / Wednesday, March 27, 2019 / Rules and Regulations rulemaking (ANPRM) published elsewhere in this issue of the Federal Register, on questions related to a potential training, certification, and limited access program as an option for risk management for all of the commercial uses of methylene chloride in paint and coating removal. Parts per DATES: This final rule is effective May Commodity million 28, 2019. Sugarcane, cane 1 ................ 0.1 ADDRESSES: The docket for this action, identified by docket identification (ID) 1 There are no U.S. Registrations on Sugarnumber EPA–HQ–OPPT–2016–0231, is cane as of September 24, 2018. available at https://www.regulations.gov. (b) Section 18 emergency exemptions. A public version of the docket is [Reserved] available for inspection and copying (c) Tolerances with regional between 8:30 a.m. and 4:30 p.m., registrations. [Reserved] Monday through Friday, excluding (d) Indirect or inadvertent residues. Federal holidays, at the U.S. [Reserved] Environmental Protection Agency, EPA Docket Center Reading Room, WJC West [FR Doc. 2019–05877 Filed 3–26–19; 8:45 am] Building, Room 3334, 1301 Constitution BILLING CODE 6560–50–P Avenue NW, Washington, DC 20004. A reasonable fee may be charged for ENVIRONMENTAL PROTECTION copying. AGENCY FOR FURTHER INFORMATION CONTACT: For technical information contact: 40 CFR Part 751 VII. Congressional Review Act Joel Wolf, Chemical Control Division, Pursuant to the Congressional Review [EPA–HQ–OPPT–2016–0231; FRL–9989–29] Office of Pollution Prevention and Toxics, Environmental Protection Act (5 U.S.C. 801 et seq.), EPA will RIN 2070–AK07 Agency, 1200 Pennsylvania Ave. NW, submit a report containing this rule and Washington, DC 20460–0001; telephone Methylene Chloride; Regulation of other required information to the U.S. number: (202) 564–0432; email address: Paint and Coating Removal for Senate, the U.S. House of MCConsumerPR@epa.gov. Consumer Use Under TSCA Section Representatives, and the Comptroller For general information contact: The 6(a) General of the United States prior to TSCA-Hotline, ABVI-Goodwill, 422 publication of the rule in the Federal AGENCY: Environmental Protection South Clinton Ave., Rochester, NY Register. This action is not a ‘‘major Agency (EPA). 14620; telephone number: (202) 554– rule’’ as defined by 5 U.S.C. 804(2). 1404; email address: TSCA-Hotline@ ACTION: Final rule. List of Subjects in 40 CFR Part 180 epa.gov. SUMMARY: Methylene chloride, also Environmental protection, SUPPLEMENTARY INFORMATION: called dichloromethane, is a volatile Administrative practice and procedure, chemical used in paint and coating I. Executive Summary Agricultural commodities, Pesticides removal products. In this final rule, EPA and pests, Reporting and recordkeeping A. Does this action apply to me? has determined that the use of requirements. You may potentially be affected by methylene chloride in consumer paint Dated: March 18, 2019. this final action if you manufacture and coating removal presents an Donna Davis, unreasonable risk of injury to health due (including import), process, or distribute in commerce methylene to acute human lethality. In order to Acting Director, Registration Division, Office of Pesticide Programs. chloride (CASRN 75–09–2). The address the unreasonable risk, EPA is following list of North American prohibiting the manufacture (including Therefore, 40 CFR chapter I is Industrial Classification System import), processing, and distribution in amended as follows: (NAICS) codes is not intended to be commerce of methylene chloride for exhaustive, but rather provides a guide PART 180—[AMENDED] consumer paint and coating removal, to help readers determine whether this including distribution to and by ■ 1. The authority citation for part 180 document applies to them. Potentially retailers; requiring manufacturers continues to read as follows: affected entities may include: (including importers), processors, and distributors, except for retailers, of Authority: 21 U.S.C. 321(q), 346a and 371. • Chemical and Allied Products methylene chloride for any use to Manufacturers (NAICS code 32411) ■ 2. Add § 180.704 to subpart C to read • Chemical and Allied Products and provide downstream notification of as follows: Merchants Wholesalers (NAICS code these prohibitions; and requiring 4246) § 180.704 Sulfometuron-methyl; tolerances recordkeeping. While EPA proposed a for residues. determination of unreasonable risk from • Building Materials and Supplies Dealers (NAICS code 4441) the use of methylene chloride in (a) General. (1) Tolerances are This action may also affect certain established for residues of the herbicide commercial paint and coating removal, EPA is not finalizing that determination entities through pre-existing import sulfometuron-methyl, including its certification and export notification metabolites and degradates, in or on the in this rule. EPA is soliciting comment, through an advance notice of proposed rules under TSCA. Persons who import commodity in the table below. or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VerDate Sep<11>2014 16:40 Mar 26, 2019 Jkt 247001 Compliance with the tolerance levels specified below is to be determined by measuring only sulfometuron-methyl, (methyl 2-[[[[(4,6-dimethyl-2pyrimidinyl)amino]carbonyl]amino] sulfonyl]benzoate), in or on the following raw agricultural commodities: PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\27MRR1.SGM 27MRR1

Agencies

[Federal Register Volume 84, Number 59 (Wednesday, March 27, 2019)]
[Rules and Regulations]
[Pages 11416-11420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05877]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0194; FRL-9989-65]


Sulfometuron-methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
sulfometuron-methyl in or on sugarcane, cane. 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 March 27, 2019. Objections and 
requests for hearings must be received on or before May 28, 2019, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0194, 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: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: 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-2017-0194 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 
May 28, 2019. 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-2017-0194, 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 September 15, 2017 (82 FR 43352) (FRL-
9965-43), 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 
6E8529) by E. I. du Pont de Nemours and Company, 974 Centre Road, 
Wilmington, Delaware 19805, now Corteva Agriscience after E.I. du Pont 
de Nemours and Company merged with Dow AgroScience. The petition 
requested that 40 CFR 180 be amended by establishing tolerances for 
residues of the herbicide sulfometuron-methyl, in or on sugarcane, 
cane; sugarcane, sugar, refined; and sugarcane, molasses at 0.01 parts 
per million (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. One comment was 
received in response to the notice of filing, and the Agency's response 
can be found in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
determined a tolerance of 0.1 sugarcane, cane is appropriate, but that 
tolerances on sugarcane, sugar, refined and sugarcane, molasses is not 
needed. The reasons for these changes are further explained in Unit 
IV.D.

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

[[Page 11417]]

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 sulfometuron-methyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with sulfometuron-
methyl follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The primary toxic effect in the toxicological database is changes 
in hematological parameters and body weight decrements. There is no 
evidence that sulfometuron-methyl is a developmental toxicant based on 
a prenatal developmental study in rats and increased susceptibility was 
not commonly observed in the database for other registered sulfonylurea 
herbicides (SUs). There is no evidence of neurotoxicity or 
immunotoxicity in the toxicology databased for sulfometuron-methyl. 
Sulfometuron-methyl is classified as ``not likely to be carcinogenic to 
humans'' based on lack of treatment-related increases in tumor 
incidence compared to controls in the mouse carcinogenicity study and 
negative findings in the genotoxicity toxicity studies. Sulfometuron-
methyl has low acute toxicity via oral, dermal, and inhalation routes 
of exposure. It shows minimal eye irritation and is not a dermal 
irritant or sensitizer. Specific information on the studies received 
and the nature of the adverse effects caused by sulfometuron-methyl 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 ``Sulfometuron-Methyl. 
Human Health Risk Assessment for a Tolerance without a U.S. 
Registration for Residues in/on Imported Sugarcane'' at pages 18-20 in 
docket ID number EPA-HQ-OPP-2017-0194.

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 NOAEL and 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 used for human risk 
assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Sulfometuron-methyl for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)......  A dose and endpoint of concern attributable to a single dose was not
                                        observed at doses relevant for human health risk assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 27.5 mg/kg/day   Chronic RfD = 0.275 mg/  Chronic Oral Toxicity
                                       UFA = 10x..............   kg/day                   Study (dog) LOAEL =
                                       UFH = 10x..............  cPAD = 0.275 mg/kg/day.   148.5 mg/kg/day based
                                       FQPA SF = 1x...........                            on decreases in body-
                                                                                          weight gain in males,
                                                                                          hemolytic anemia, and
                                                                                          a slight increase in
                                                                                          alkaline phosphates in
                                                                                          both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Sulfometuron-methyl is classified as ``not likely to be carcinogenic to
                                        humans'' based on lack of treatment-related increases in tumor incidence
                                        compared to controls in the mouse carcinogenicity study and negative
                                        findings in the mutagenicity/genetic toxicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (c = chronic). RfD = reference dose. 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 sulfometuron-methyl, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
sulfometuron-methyl 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

[[Page 11418]]

identified in the toxicological studies for sulfometuron-methyl; 
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 United States 
Department of Agriculture (USDA) 2003-2008 Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII). As to residue levels in 
food, EPA assumed 100% crop treated (CT) and used tolerance-level 
residues for the sugarcane commodities. The 2018 default processing 
factors were used (in this case, the factors were 1 for sugarcane 
commodities).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that sulfometuron-methyl 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 sulfometuron-methyl. Tolerance level residues 
and/or 100% CT were assumed for sugarcane.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for sulfometuron-methyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of sulfometuron-methyl. 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.
    Instead of generating chemical-specific estimated drinking water 
concentrations (EDWCs) for sulfometuron-methyl, EPA used model inputs 
(rate, soil mobility, persistence) from all the sulfonylurea herbicides 
(sulfometuron-methyl is a sulfonylurea herbicide) to determine coarse-
screen estimates that should exceed upper-bound, chemical-specific 
EDWCs for any SU. The resulting coarse-screen EDWCs generated with the 
Pesticide Root Zone Model Ground Water (PRZM GW) were higher than the 
surface water estimates and were used as conservative estimates of 
potential residues from sulfometuron-methyl in drinking water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.492 ppm 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). Sulfometuron-methyl 
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.''
    In 2016, EPA's Office of Pesticide Programs released a guidance 
document entitled, Pesticide Cumulative Risk Assessment: Framework for 
Screening Analysis https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. EPA has 
utilized this framework for sulfometuron-methyl and determined that 
although sulfometuron-methyl shares some chemical and/or toxicological 
characteristics (e.g., chemical structure or apical endpoint) with 
other pesticides, the toxicological database does not support a 
testable hypothesis for a common mechanism of action. No further data 
are required to determine that no common mechanism of toxicity exists 
for sulfometuron-methyl and other pesticides, and no further cumulative 
evaluation is necessary for sulfometuron-methyl.

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. There is no evidence that 
sulfometuron-methyl is a developmental toxicant based on a prenatal 
developmental study in rats and increased susceptibility was not 
commonly observed in the database for other registered SUs.
    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 sulfometuron-methyl is complete.
    ii. There is no indication that sulfometuron-methyl 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 sulfometuron-methyl results in 
increased susceptibility in rabbits in a prenatal developmental study. 
EPA has concluded based on a weight-of-evidence approach that the rat 
developmental and reproduction toxicity studies are not required for 
sulfometuron-methyl at this time for the following reasons: (1) 
Increased susceptibility was not commonly observed in the SU database; 
and (2) the chronic oral dog study, which is the study used to 
establish points of departure for sulfometuron-methyl, provides similar 
or lower NOAEL/LOAEL values than the rat developmental and rat 
reproduction toxicity studies across the SU database.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to sulfometuron-methyl in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
sulfometuron-methyl.

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

[[Page 11419]]

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, sulfometuron-
methyl 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 
sulfometuron-methyl from food and water will utilize 9.7% of the cPAD 
for all infants (<1 year old), the population group receiving the 
greatest exposure. There are no residential uses for sulfometuron-
methyl; therefore, the chronic aggregate risk assessment is equivalent 
to the chronic dietary assessment. There are no chronic dietary risks 
of concern.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Because there 
are no uses for sulfometuron-methyl that result in residential 
exposures, the short-term aggregate assessment is equivalent to the 
chronic dietary assessment. There are no chronic dietary risks of 
concern as described above.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because there are no uses for sulfometuron-methyl that result 
in residential exposures, the intermediate-term aggregate assessment is 
equivalent to the chronic dietary assessment. There are no chronic 
dietary risks of concern as described above.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in the rodent mouse carcinogenicity study 
and negative findings in the mutagenicity/genetic toxicity studies, 
sulfometuron-methyl is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to sulfometuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography-tandem mass spectrometry (LC-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 a MRL for sulfometuron-methyl.

C. Response to Comments

    One comment was submitted insisting that no residues of 
sulfometuron-methyl be permitted in food, although no additional 
information was provided that would support a conclusion that the 
tolerances requested for sulfometuron-methyl are not safe. Although 
some individuals do not want pesticides to be used on food, the FFDCA 
authorizes EPA to establish tolerances that permit certain levels of 
pesticide residues in or on food when the Agency can determine that 
such residues are safe. EPA has made that determination for the 
tolerances subject to this action, and the commenter provided no 
information to support a determination that the tolerance is not safe.

D. Revisions to Petitioned-For Tolerances

    The petitioner requested a tolerance for residues of 0.01 ppm in/on 
sugarcane, cane; sugarcane, sugar, refined; and sugarcane, molasses. 
The residue data support a tolerance on sugarcane, cane of 0.1 ppm. 
This value is also harmonized with the MRL established in the major 
exporting country, Brazil. A value of 0.01 ppm may create a perceived 
trade irritant if the U.S. tolerance is lower than the MRL in the major 
exporting country. Tolerances for residues in/on sugarcane, sugar, 
refined and sugarcane, molasses are not needed, since residues are not 
expected to concentrate in the processed commodities.

V. Conclusion

    Therefore, a tolerance is established for residues of sulfometuron-
methyl, in or on sugarcane, cane at 0.1 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997) nor is considered a regulatory 
action under Executive Order 13771, entitled ``Reducing Regulations and 
Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). This 
action does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et 
seq.), nor does it require any special considerations under Executive 
Order 12898, entitled ``Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations'' (59 FR 
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States

[[Page 11420]]

or tribal governments, on the relationship between the national 
government and the States or tribal governments, or on the distribution 
of power and responsibilities among the various levels of government or 
between the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 18, 2019.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. Add Sec.  180.704 to subpart C to read as follows:


Sec.  180.704   Sulfometuron-methyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide sulfometuron-methyl, including its metabolites and 
degradates, in or on the commodity in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only sulfometuron-methyl, (methyl 2-[[[[(4,6-dimethyl-2-
pyrimidinyl)amino]carbonyl]amino]sulfonyl]benzoate), in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Sugarcane, cane \1\.....................................             0.1
------------------------------------------------------------------------
\1\ There are no U.S. Registrations on Sugarcane as of September 24,
  2018.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2019-05877 Filed 3-26-19; 8:45 am]
 BILLING CODE 6560-50-P
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