Halosulfuron-methyl; Pesticide Tolerances, 55768-55773 [2015-23298]

Download as PDF 55768 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations Documents submitted using that system are considered filed as of the date and time (Eastern Time) reflected in the system. Orders issued by the Hearing Officer shall be considered received by the parties on the date posted to the electronic filing system. § 957.7 Failure to appear at the hearing. If a party fails to appear at the hearing, the Hearing Officer may proceed with the hearing, receive evidence and issue findings of fact without requirement of further notice to the absent party. § 957.8 Hearings. Hearings ordinarily will be conducted in the Judicial Officer Department courtroom at 2101 Wilson Boulevard, Suite 600, Arlington, VA 22201–3078. However, the Hearing Officer, in his or her discretion, may order the hearing to be conducted at another location, or by another means such as by video. § 957.9 Appearances. (a) An individual Respondent may appear in his or her own behalf, a corporation may appear by an officer thereof, a partnership or joint venture may appear by a member thereof, or any of these may appear by a licensed attorney. (b) After a request for a hearing has been filed pursuant to the rules in this part, the General Counsel shall designate a licensed attorney as counsel assigned to handle the case. (c) All counsel, or a self-represented Respondent, shall register in the electronic filing system, and request to be added to the case. Counsel also promptly shall file notices of appearance. (d) An attorney for any party who has filed a notice of appearance and who wishes to withdraw must file a motion requesting withdrawal, explaining the reasons supporting the motion, and identifying the name, email address, mailing address, telephone number, and fax number of the person who will assume responsibility for representation of the party in question. tkelley on DSK3SPTVN1PROD with RULES § 957.10 Conduct of the hearing. The Hearing Officer may approve or disapprove witnesses in his or her discretion. All testimony will be taken under oath or affirmation, and subject to cross-examination. The Hearing Officer may exclude evidence to avoid unfair prejudice, confusion of the issues, undue delay, waste of time, or presentation of irrelevant, immaterial, or cumulative evidence. Although the Hearing Officer will consider the Federal Rules of Evidence for guidance VerDate Sep<11>2014 16:04 Sep 16, 2015 Jkt 235001 regarding admissibility of evidence and other evidentiary issues, he or she is not bound by those rules. The weight to be attached to evidence presented in any particular form will be within the discretion of the Hearing Officer, taking into consideration all the circumstances of the particular case. Stipulations of fact agreed upon by the parties may be accepted as evidence at the hearing. The parties may stipulate the testimony that would be given by a witness if the witness were present. The Hearing Officer may in any case require evidence in addition to that offered by the parties. 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The provisions of 5 U.S.C. 551(14), 556(d), and 557(d) prohibiting ex parte communications are made applicable to proceedings under these rules of practice. Stanley F. Mires, Attorney, Federal Compliance. [FR Doc. 2015–23314 Filed 9–16–15; 8:45 am] BILLING CODE 7710–12–P Transcript. Testimony and argument at hearings shall be reported verbatim, unless the Hearing Officer otherwise orders. Transcripts of the proceedings will be made available or provided to the parties. § 957.13 § 957.16 Frm 00048 Fmt 4700 Sfmt 4700 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2014–0574; FRL–9933–00] Halosulfuron-methyl; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes a tolerance for residues of halosulfuronmethyl in or on the pome fruit group 11–10 and a tolerance with regional registration for residues of halosulfuronmethyl in or on the small vine climbing fruit, except fuzzy kiwifruit, subgroup 13–07F. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective September 17, 2015. Objections and requests for hearings must be received on or before November 16, 2015, 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–2014–0574, 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 SUMMARY: E:\FR\FM\17SER1.SGM 17SER1 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. tkelley on DSK3SPTVN1PROD with RULES 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–2014–0574 in the subject line on the first page of your submission. All objections and requests for a hearing VerDate Sep<11>2014 16:04 Sep 16, 2015 Jkt 235001 must be in writing, and must be received by the Hearing Clerk on or before November 16, 2015. 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– 2014–0574, 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 February 11, 2015 (80 FR 7559) (FRL–9921–94), 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 4E8297) by IR–4, IR–4 Project Headquarters, Rutgers, The State University of New Jersey, Suite 201 W, 500 College Road East, Princeton, NJ 08540. The petition requested that 40 CFR 180.479 be amended by establishing tolerances for residues of the herbicide halosulfuronmethyl, methyl 5-[(4,6-dimethoxy-2pyrimidiny)amino] carbonylaminosulfonyl]-3-chloro-1methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in or on the raw agricultural commodities: Fruit, pome, group 11–10 at 0.05 parts per million (ppm), and fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F at 0.05 ppm (associated with a regional registration). That document referenced a summary of PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 55769 the petition prepared by the Canyon Group, c/o Gowan Company, the registrant, which is available in the docket, https://www.regulations.gov. No comments were received on the notice of filing. Based upon available data, EPA is establishing tolerances as requested. 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 halosulfuronmethyl including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with halosulfuronmethyl 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. With repeated dosing, the available data on halosulfuron-methyl did not demonstrate a target organ or tissue in any of the test animals. Reduction in body weight was seen in the 90-day and 1-year oral toxicity studies in dogs. Reduced body weights were also seen in E:\FR\FM\17SER1.SGM 17SER1 tkelley on DSK3SPTVN1PROD with RULES 55770 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations rat studies at higher dose levels than those seen in dogs. An effect on the hematological parameters was detected in the dog studies, but the magnitude of changes was slight and the effect was considered to be marginal. Thus, the slight hematological changes were not considered to be adverse. In the prenatal developmental toxicity study in rats, increases in resorptions, soft tissue (dilation of the lateral ventricles) and skeletal variations, and decreases in body weights were seen in the fetuses compared to clinical signs and decreases in body weights and food consumption in the maternal animals at a similar dose level. In the rabbit developmental toxicity study, increases in resorptions and post-implantation losses and decreases in mean litter size were observed in the presence of decreases in body weight and food consumption in maternal animals. The fetal effects seen in developmental toxicity studies in rats and rabbits represented a qualitative increase in susceptibility. However, a clear noobserved-adverse-effect-level (NOAEL) for these effects was established in both rat and rabbit developmental toxicity studies. No quantitative susceptibility was found in studies following pre-and/ or post-natal exposures. Halosulfuronmethyl did not produce any effects on reproductive parameters in the 2generation reproduction study in rats. No neurotoxic effects were observed in the acute or subchronic neurotoxicity studies up to 2,000 mg/kg or 760 mg/kg/ day, respectively. In addition, no adverse effect was found in a 21-day dermal toxicity study at doses up to the limit dose (1,000 mg/kg/day). Halosulfuron-methyl is negative for mutagenicity in a battery of genotoxicity studies and is classified as ‘‘not likely to be carcinogenic to humans’’ based on lack of evidence for carcinogenicity in mice and rats following long-term dietary administration. Specific information on the studies received and the nature of the adverse effects caused by halosulfuron-methyl as well as the NOAEL and the lowestobserved-adverse-effect-level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ‘‘Halosulfuron-Methyl. Human Health Risk Assessment for a Proposed Use on Pome Fruit Crop Group 11–10 and Small Fruit Vine Climbing Subgroup, Except Fuzzy Kiwifruit, Subgroup 13–07F’’ at page 28 in docket ID number EPA–HQ–OPP– 2014–0574. VerDate Sep<11>2014 16:04 Sep 16, 2015 Jkt 235001 B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// www.epa.gov/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for halosulfuron used for human risk assessment is discussed in Unit III. B. of the final rule published in the Federal Register of December 3, 2012 (77 FR 71555) (FRL–9370–6). However, there is one change to the prior toxicity endpoint and point of departure selections for halosulfuronmethyl discussed in the 2012 document. The previous toxicity endpoint for dermal exposure assessments was based on the results of a 21-day dermal toxicity study, where the no observed effect level (NOEL) and lowest observed effect level (LOEL) were established at 100 and 1,000 mg/kg/day, respectively. The LOEL was based on ‘‘total body weight gains in males.’’ However, following a reevaluation of this study according to the current evaluation standard, there was only 4% reduction in absolute body weight in the affected 1,000 mg/kg/day males. This reduction was not considered to be adverse and no other adverse effect was reported in this study. No LOAEL could be established, and the NOAEL was 1,000 mg/kg/day. Based on this re-evaluation, halosulfuron-methyl did not cause adverse effects at the limit dose (1,000 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 mg/kg/day), and no toxicity endpoint could be established for the dermal exposure scenario. In addition, no quantitative susceptibility was found in studies following pre-and/or post-natal exposures. Hence, no dermal exposure assessment was necessary. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to halosulfuron-methyl, EPA considered exposure under the petitioned-for tolerances as well as all existing halosulfuron-methyl tolerances in 40 CFR 180.479. EPA assessed dietary exposures from halosulfuron-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. Such effects were identified for halosulfuron-methyl. Exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM–FCID). This software uses 2003–2008 food consumption data from the United States Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all commodities. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level residues and 100 PCT for all commodities. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that halosulfuron-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 PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for halosulfuron-methyl. Tolerance-level residues and 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 halosulfuron-methyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport E:\FR\FM\17SER1.SGM 17SER1 tkelley on DSK3SPTVN1PROD with RULES Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations characteristics of halosulfuron-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. Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI– GROW) models, the estimated drinking water concentrations (EDWCs) of halosulfuron-methyl for acute exposures are estimated to be 59.2 parts per billion (ppb) for surface water and 0.065 ppb for ground water and for chronic exposures are estimated to be 59.2 ppb for surface water and 0.065 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 59.2 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 59.2 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). Halosulfuron-methyl is currently registered for use by residential handlers on residential turf. EPA reassessed residential exposure for aggregate risk assessment reflecting the removal of the dermal POD. EPA assessed short-term (1–30 days) exposure to halosulfuron-methyl for residential handlers (inhalation exposure) and children 1 to < 2 years old (post-application incidental oral exposures). The residential exposure scenario used in the adult aggregate assessment reflects inhalation exposure from mixing/loading/applying halosulfuronmethyl via backpack sprayer or manually pressurized handwand to turf. The residential exposure scenario used in the children 1 to <2 years old aggregate assessment reflects hand-tomouth incidental oral exposures from post-application exposure to treated turf. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www.epa.gov/pesticides/ trac/science/trac6a05.pdf. 4. Cumulative effects from substances with a common mechanism of toxicity. VerDate Sep<11>2014 16:04 Sep 16, 2015 Jkt 235001 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 halosulfuronmethyl to share a common mechanism of toxicity with any other substances, and halosulfuron-methyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that halosulfuron-methyl 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. There was no quantitative evidence of increased susceptibility following preand/or post-natal exposure to halosulfuron-methyl. Qualitative susceptibility was seen in the prenatal developmental toxicity study in rats and in rabbits; however, this qualitative susceptibility was of low concern because (1) in both studies, there were clear NOAELs/LOAELs for developmental and maternal toxicities; (2) the developmental effects were seen in the presence of maternal toxicity; and (3) the effects were only seen at the high dose levels. In rats, the developmental effects were seen at a dose (750 mg/kg/ day) which was approaching the limitdose (1,000 mg/kg/day). Furthermore, the PODs for risk assessment are PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 55771 protective of the effects which occur at high doses. 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 halosulfuron-methyl is considered complete. ii. There is no indication that halosulfuron-methyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There was no quantitative evidence of increased susceptibility following pre- and/or post-natal exposure and the qualitative susceptibility observed in the developmental toxicity studies in rats and rabbits was of low concern for the reasons outlined in section III.D.2. 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 halosulfuronmethyl in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by halosulfuron-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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to halosulfuron-methyl will occupy <1% of the aPAD for females 13–49 years old, the only population group of concern. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to halosulfuronmethyl from food and water will utilize E:\FR\FM\17SER1.SGM 17SER1 tkelley on DSK3SPTVN1PROD with RULES 55772 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations 5.7% of the cPAD for children 1–2 years old, the population subgroup receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of halosulfuron-methyl is not expected. 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). Halosulfuron-methyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to halosulfuron-methyl. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 25,000 for adults and 1,800 for children 1 to < 2 years old. Because EPA’s level of concern for halosulfuronmethyl is a MOE of 100 or below, these MOEs are not of concern. 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). An intermediate-term adverse effect was identified; however, halosulfuronmethyl is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediateterm risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediateterm risk for halosulfuron-methyl. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, halosulfuron-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 halosulfuron-methyl residues. VerDate Sep<11>2014 16:04 Sep 16, 2015 Jkt 235001 IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography (GC) thermionicspecific detection (TSD, nitrogen specific)) 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 halosulfuron-methyl for any of the crops covered by this Final Rule. V. Conclusion Therefore, a tolerance is established for residues of halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2pyrimidiny)amino] carbonylaminosulfonyl]-3-chloro-1methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in or on the fruit, pome, group 11–10 at 0.05 ppm, and a tolerance with regional registration is established for fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F at 0.05 ppm. In addition, the existing tolerance for the commodity ‘‘Apple’’ in paragraph (a)(2) of § 180.479 is removed since it is covered by the newly established fruit, pome, group 11–10 tolerance. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 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). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary E:\FR\FM\17SER1.SGM 17SER1 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646–4133. The NFIP enables property owners to purchase Federal flood insurance that is not Pursuant to the Congressional Review Parts per Commodity otherwise generally available from million Act (5 U.S.C. 801 et seq.), EPA will private insurers. In return, communities submit a report containing this rule and Fruit, small vine climbing, exagree to adopt and administer local other required information to the U.S. cept fuzzy kiwifruit, subgroup floodplain management measures aimed Senate, the U.S. House of 13–07F .................................. 0.05 at protecting lives and new construction Representatives, and the Comptroller from future flooding. Section 1315 of General of the United States prior to * * * * * the National Flood Insurance Act of publication of the rule in the Federal [FR Doc. 2015–23298 Filed 9–16–15; 8:45 am] 1968, as amended, 42 U.S.C. 4022, Register. This action is not a ‘‘major BILLING CODE 6560–50–P prohibits the sale of NFIP flood rule’’ as defined by 5 U.S.C. 804(2). insurance unless an appropriate public List of Subjects in 40 CFR Part 180 body adopts adequate floodplain DEPARTMENT OF HOMELAND management measures with effective Environmental protection, SECURITY enforcement measures. The Administrative practice and procedure, communities listed in this document no Agricultural commodities, Pesticides Federal Emergency Management longer meet that statutory requirement and pests, Reporting and recordkeeping Agency for compliance with program requirements. regulations, 44 CFR part 59. Dated: September 4, 2015. 44 CFR Part 64 Accordingly, the communities will be Susan Lewis, [Docket ID FEMA–2015–0001: Internal suspended on the effective date in the Director, Registration Division, Office of Agency Docket No. FEMA–8399] third column. As of that date, flood Pesticide Programs. insurance will no longer be available in Suspension of Community Eligibility Therefore, 40 CFR chapter I is the community. We recognize that some amended as follows: AGENCY: Federal Emergency of these communities may adopt and Management Agency, DHS. submit the required documentation of PART 180—[AMENDED] legally enforceable floodplain ACTION: Final rule. management measures after this rule is ■ 1. The authority citation for part 180 SUMMARY: This rule identifies published but prior to the actual continues to read as follows: communities where the sale of flood suspension date. These communities Authority: 21 U.S.C. 321(q), 346a and 371. insurance has been authorized under will not be suspended and will continue the National Flood Insurance Program to be eligible for the sale of NFIP flood ■ 2. In § 180.479: (NFIP) that are scheduled for insurance. A notice withdrawing the ■ a. Remove the entry for ‘‘Apple’’ from suspension on the effective dates listed suspension of such communities will be the table in paragraph (a)(2); within this rule because of published in the Federal Register. ■ b. Add alphabetically the entry for noncompliance with the floodplain ‘‘Fruit, pome, group 11–10’’ to the table In addition, FEMA publishes a Flood management requirements of the in paragraph (a)(2), and Insurance Rate Map (FIRM) that program. If the Federal Emergency ■ c. Revise paragraph (c). identifies the Special Flood Hazard Management Agency (FEMA) receives The additions and revision read as Areas (SFHAs) in these communities. documentation that the community has follows: The date of the FIRM, if one has been adopted the required floodplain published, is indicated in the fourth § 180.479 Halosulfuron-methyl; tolerances management measures prior to the column of the table. No direct Federal for residues. effective suspension date given in this financial assistance (except assistance rule, the suspension will not occur and (a) * * * pursuant to the Robert T. Stafford (2) * * * a notice of this will be provided by publication in the Federal Register on a Disaster Relief and Emergency Assistance Act not in connection with a Parts per subsequent date. Also, information Commodity flood) may be provided for construction million identifying the current participation or acquisition of buildings in identified status of a community can be obtained SFHAs for communities not from FEMA’s Community Status Book * * * * * participating in the NFIP and identified (CSB). for more than a year on FEMA’s initial Fruit, pome, group 11–10 ......... 0.05 DATES: The effective date of each FIRM for the community as having community’s scheduled suspension is flood-prone areas (section 202(a) of the the third date (‘‘Susp.’’) listed in the Flood Disaster Protection Act of 1973, * * * * * third column of the following tables. 42 U.S.C. 4106(a), as amended). This ADDRESSES: The CSB is available at (c) Tolerances with regional prohibition against certain types of https://www.fema.gov/fema/csb.shtm. registrations. Tolerances with regional Federal assistance becomes effective for registrations are established for residues FOR FURTHER INFORMATION CONTACT: If the communities listed on the date of the herbicide halosulfuron-methyl, you want to determine whether a shown in the last column. The methyl 5-[(4,6-dimethoxy-2-pyrimidiny) particular community was suspended Administrator finds that notice and amino]carbonylaminosulfonyl]-3-chloro on the suspension date or for further public comment procedures under 5 -1-methyl-1H-pyrazole-4-carboxylate, information, contact Bret Gates, Federal U.S.C. 553(b), are impracticable and including its metabolites and Insurance and Mitigation unnecessary because communities listed VII. Congressional Review Act tkelley on DSK3SPTVN1PROD with RULES 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 halosulfuron-methyl. 55773 VerDate Sep<11>2014 16:04 Sep 16, 2015 Jkt 235001 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 SUPPLEMENTARY INFORMATION: E:\FR\FM\17SER1.SGM 17SER1

Agencies

[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Pages 55768-55773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23298]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0574; FRL-9933-00]


Halosulfuron-methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
halosulfuron-methyl in or on the pome fruit group 11-10 and a tolerance 
with regional registration for residues of halosulfuron-methyl in or on 
the small vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 17, 2015. Objections and 
requests for hearings must be received on or before November 16, 2015, 
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-2014-0574, 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

[[Page 55769]]

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-2014-0574 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 
November 16, 2015. 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-2014-0574, 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 February 11, 2015 (80 FR 7559) (FRL-
9921-94), 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 
4E8297) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, Suite 201 W, 500 College Road East, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.479 be 
amended by establishing tolerances for residues of the herbicide 
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino] 
carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, 
including its metabolites and degradates, in or on the raw agricultural 
commodities: Fruit, pome, group 11-10 at 0.05 parts per million (ppm), 
and fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F 
at 0.05 ppm (associated with a regional registration). That document 
referenced a summary of the petition prepared by the Canyon Group, c/o 
Gowan Company, the registrant, which is available in the docket, https://www.regulations.gov. No comments were received on the notice of 
filing.
    Based upon available data, EPA is establishing tolerances as 
requested.

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 halosulfuron-methyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with halosulfuron-
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.
    With repeated dosing, the available data on halosulfuron-methyl did 
not demonstrate a target organ or tissue in any of the test animals. 
Reduction in body weight was seen in the 90-day and 1-year oral 
toxicity studies in dogs. Reduced body weights were also seen in

[[Page 55770]]

rat studies at higher dose levels than those seen in dogs. An effect on 
the hematological parameters was detected in the dog studies, but the 
magnitude of changes was slight and the effect was considered to be 
marginal. Thus, the slight hematological changes were not considered to 
be adverse.
    In the prenatal developmental toxicity study in rats, increases in 
resorptions, soft tissue (dilation of the lateral ventricles) and 
skeletal variations, and decreases in body weights were seen in the 
fetuses compared to clinical signs and decreases in body weights and 
food consumption in the maternal animals at a similar dose level. In 
the rabbit developmental toxicity study, increases in resorptions and 
post-implantation losses and decreases in mean litter size were 
observed in the presence of decreases in body weight and food 
consumption in maternal animals. The fetal effects seen in 
developmental toxicity studies in rats and rabbits represented a 
qualitative increase in susceptibility. However, a clear no-observed-
adverse-effect-level (NOAEL) for these effects was established in both 
rat and rabbit developmental toxicity studies. No quantitative 
susceptibility was found in studies following pre-and/or post-natal 
exposures. Halosulfuron-methyl did not produce any effects on 
reproductive parameters in the 2-generation reproduction study in rats. 
No neurotoxic effects were observed in the acute or subchronic 
neurotoxicity studies up to 2,000 mg/kg or 760 mg/kg/day, respectively. 
In addition, no adverse effect was found in a 21-day dermal toxicity 
study at doses up to the limit dose (1,000 mg/kg/day).
    Halosulfuron-methyl is negative for mutagenicity in a battery of 
genotoxicity studies and is classified as ``not likely to be 
carcinogenic to humans'' based on lack of evidence for carcinogenicity 
in mice and rats following long-term dietary administration.
    Specific information on the studies received and the nature of the 
adverse effects caused by halosulfuron-methyl as well as the NOAEL and 
the lowest-observed-adverse-effect-level (LOAEL) from the toxicity 
studies can be found at https://www.regulations.gov in document 
``Halosulfuron-Methyl. Human Health Risk Assessment for a Proposed Use 
on Pome Fruit Crop Group 11-10 and Small Fruit Vine Climbing Subgroup, 
Except Fuzzy Kiwifruit, Subgroup 13-07F'' at page 28 in docket ID 
number EPA-HQ-OPP-2014-0574.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for halosulfuron used for 
human risk assessment is discussed in Unit III. B. of the final rule 
published in the Federal Register of December 3, 2012 (77 FR 71555) 
(FRL-9370-6). However, there is one change to the prior toxicity 
endpoint and point of departure selections for halosulfuron-methyl 
discussed in the 2012 document. The previous toxicity endpoint for 
dermal exposure assessments was based on the results of a 21-day dermal 
toxicity study, where the no observed effect level (NOEL) and lowest 
observed effect level (LOEL) were established at 100 and 1,000 mg/kg/
day, respectively. The LOEL was based on ``total body weight gains in 
males.'' However, following a reevaluation of this study according to 
the current evaluation standard, there was only 4% reduction in 
absolute body weight in the affected 1,000 mg/kg/day males. This 
reduction was not considered to be adverse and no other adverse effect 
was reported in this study. No LOAEL could be established, and the 
NOAEL was 1,000 mg/kg/day. Based on this re-evaluation, halosulfuron-
methyl did not cause adverse effects at the limit dose (1,000 mg/kg/
day), and no toxicity endpoint could be established for the dermal 
exposure scenario. In addition, no quantitative susceptibility was 
found in studies following pre-and/or post-natal exposures. Hence, no 
dermal exposure assessment was necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to halosulfuron-methyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing halosulfuron-methyl 
tolerances in 40 CFR 180.479. EPA assessed dietary exposures from 
halosulfuron-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.
    Such effects were identified for halosulfuron-methyl. Exposure and 
risk assessments were conducted using the Dietary Exposure Evaluation 
Model software with the Food Commodity Intake Database (DEEM-FCID). 
This software uses 2003-2008 food consumption data from the United 
States Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA assumed tolerance-level residues and 100 
percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance-level 
residues and 100 PCT for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that halosulfuron-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 PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
halosulfuron-methyl. Tolerance-level residues and 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 halosulfuron-methyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport

[[Page 55771]]

characteristics of halosulfuron-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.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of halosulfuron-methyl 
for acute exposures are estimated to be 59.2 parts per billion (ppb) 
for surface water and 0.065 ppb for ground water and for chronic 
exposures are estimated to be 59.2 ppb for surface water and 0.065 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 59.2 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 59.2 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).
    Halosulfuron-methyl is currently registered for use by residential 
handlers on residential turf. EPA re-assessed residential exposure for 
aggregate risk assessment reflecting the removal of the dermal POD. EPA 
assessed short-term (1-30 days) exposure to halosulfuron-methyl for 
residential handlers (inhalation exposure) and children 1 to < 2 years 
old (post-application incidental oral exposures).
    The residential exposure scenario used in the adult aggregate 
assessment reflects inhalation exposure from mixing/loading/applying 
halosulfuron-methyl via backpack sprayer or manually pressurized 
handwand to turf.
    The residential exposure scenario used in the children 1 to <2 
years old aggregate assessment reflects hand-to-mouth incidental oral 
exposures from post-application exposure to treated turf.
    Intermediate-term exposures are not likely because of the 
intermittent nature of applications by homeowners.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 halosulfuron-methyl to share a common mechanism 
of toxicity with any other substances, and halosulfuron-methyl does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
halosulfuron-methyl 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. There was no quantitative 
evidence of increased susceptibility following pre- and/or post-natal 
exposure to halosulfuron-methyl. Qualitative susceptibility was seen in 
the prenatal developmental toxicity study in rats and in rabbits; 
however, this qualitative susceptibility was of low concern because (1) 
in both studies, there were clear NOAELs/LOAELs for developmental and 
maternal toxicities; (2) the developmental effects were seen in the 
presence of maternal toxicity; and (3) the effects were only seen at 
the high dose levels. In rats, the developmental effects were seen at a 
dose (750 mg/kg/day) which was approaching the limit-dose (1,000 mg/kg/
day). Furthermore, the PODs for risk assessment are protective of the 
effects which occur at high doses.
    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 halosulfuron-methyl is considered 
complete.
    ii. There is no indication that halosulfuron-methyl is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There was no quantitative evidence of increased susceptibility 
following pre- and/or post-natal exposure and the qualitative 
susceptibility observed in the developmental toxicity studies in rats 
and rabbits was of low concern for the reasons outlined in section 
III.D.2.
    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 halosulfuron-methyl in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
halosulfuron-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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to halosulfuron-methyl will occupy <1% of the aPAD for females 13-49 
years old, the only population group of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
halosulfuron-methyl from food and water will utilize

[[Page 55772]]

5.7% of the cPAD for children 1-2 years old, the population subgroup 
receiving the greatest exposure. Based on the explanation in Unit 
III.C.3., regarding residential use patterns, chronic residential 
exposure to residues of halosulfuron-methyl is not expected.
    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).
    Halosulfuron-methyl is currently registered for uses that could 
result in short-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short-term residential exposures to halosulfuron-
methyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 25,000 for adults 
and 1,800 for children 1 to < 2 years old. Because EPA's level of 
concern for halosulfuron-methyl is a MOE of 100 or below, these MOEs 
are not of concern.
    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).
    An intermediate-term adverse effect was identified; however, 
halosulfuron-methyl is not registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for halosulfuron-methyl.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, halosulfuron-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 halosulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC) 
thermionic-specific detection (TSD, nitrogen specific)) 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 halosulfuron-methyl for any 
of the crops covered by this Final Rule.

V. Conclusion

    Therefore, a tolerance is established for residues of halosulfuron-
methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino] 
carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, 
including its metabolites and degradates, in or on the fruit, pome, 
group 11-10 at 0.05 ppm, and a tolerance with regional registration is 
established for fruit, small vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 0.05 ppm. In addition, the existing tolerance for 
the commodity ``Apple'' in paragraph (a)(2) of Sec.  180.479 is removed 
since it is covered by the newly established fruit, pome, group 11-10 
tolerance.

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). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary

[[Page 55773]]

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: September 4, 2015.
Susan Lewis,
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.  180.479:
0
a. Remove the entry for ``Apple'' from the table in paragraph (a)(2);
0
b. Add alphabetically the entry for ``Fruit, pome, group 11-10'' to the 
table in paragraph (a)(2), and
0
c. Revise paragraph (c).
    The additions and revision read as follows:


Sec.  180.479  Halosulfuron-methyl; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Fruit, pome, group 11-10...................................         0.05
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for residues of the herbicide 
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidiny)amino]carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, 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 halosulfuron-methyl.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Fruit, small vine climbing, except fuzzy kiwifruit,                 0.05
 subgroup 13-07F...........................................
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-23298 Filed 9-16-15; 8:45 am]
BILLING CODE 6560-50-P
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