Ethofumesate; Pesticide Tolerances, 57151-57158 [2017-25828]

Download as PDF Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations ethrower on DSK3G9T082PROD with RULES 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 established MRLs for clothianidin in/on citrus fruits at 0.07 ppm. These MRLs are the same as the tolerance established for clothianidin in/on fruit, citrus, group 10–10 in the United States. The Codex has not established any MRLs for sulfoxaflor in/ on sorghum commodities. IV. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to petitions 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 tolerances 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 VerDate Sep<11>2014 17:52 Dec 01, 2017 Jkt 244001 responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). V. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA has submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: October 20, 2017. Michael L. Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.586, revise the table in paragraph (b) to read as follows: ■ PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 57151 § 180.586 Clothianidin; tolerances for residues. * * * (b) * * * * * Commodity Parts per million Expiration/ revocation date Fruit, citrus, group 10–10 ................ 0.07 12/31/20 3. In § 180.668, revise the table in paragraph (b) to read as follows: ■ § 180. 668 residues. * Sulfoxaflor; tolerances for * * (b) * * * * * Parts per million Commodity Sorghum, forage ... Sorghum, grain ..... Sorghum, stover ... * * * * 0.4 0.3 0.9 Expiration/ revocation date 12/31/20 12/31/20 12/31/20 * [FR Doc. 2017–25826 Filed 12–1–17; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2016–0314; FRL–9969–13] Ethofumesate; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of ethofumesate in or on beet, sugar, molasses and beet, sugar, roots. In addition, this regulation eliminates tolerances for residues of ethofumesate that are superseded by the tolerances established by this final rule. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective December 4, 2017. Objections and requests for hearings must be received on or before February 2, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2016–0314, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) SUMMARY: E:\FR\FM\04DER1.SGM 04DER1 57152 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Director, 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). ethrower on DSK3G9T082PROD with RULES B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/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– VerDate Sep<11>2014 17:52 Dec 01, 2017 Jkt 244001 OPP–2016–0314 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 February 2, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2016–0314, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of July 20, 2016 (81 FR 47150) (FRL–9948–45), 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 6E8472) by IR–4, IR–4 Project Headquarters, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.345 be amended by increasing the existing tolerance for the combined residues of the herbicide ethofumesate (2-ethoxy-2,3-dihydro-3,3-dimethyl-5benzofuranyl methanesulfonate) and its metabolites (2-hydroxy-2,3-dihydro-3,3dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3dimethyl-2-oxo-5-benzofuranyl methanesulfonate) both calculated as the parent compound, in or on beet, sugar, molasses from 0.5 to 2.5 parts per million (ppm); beet, sugar, refined sugar PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 from 0.2 to 1.0 ppm; beet, sugar, roots from 0.3 to 1.5 ppm; and beet, sugar, tops from 4.0 to 30.0 ppm. That document referenced a summary of the petition prepared by Willowood USA, LLC, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA’s response to the comment is found in Unit IV.C. Based upon review of the data supporting the petition, EPA is establishing tolerances that differ from what the petitioner requested. The reasons for these changes are 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 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 ethofumesate including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with ethofumesate follows. A. Toxicological Profile EPA has evaluated the available toxicity database 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. E:\FR\FM\04DER1.SGM 04DER1 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations The liver is the main target organ in rats and dogs, and the major critical effects seen in oral studies are decreased body weight/body weight gain and hepatic toxicity in the rat, dog and/or rabbit. Mice are relatively insensitive to ethofumesate up to the limit dose following subchronic and chronic dietary exposure. Ethofumesate did not demonstrate the potential to cause neurotoxicity in four species (rats, mice, dogs and rabbits). Rats did not show evidence of developmental, maternal, or offspring toxicity or susceptibility in a threegeneration reproduction study or any developmental or maternal toxicity in the developmental toxicity study. Although increased prenatal quantitative sensitivity (increased resorptions, increased post-implantation loss and incomplete ossification of the vertebral arches) was observed in the rabbit developmental toxicity study, the developmental toxicity no observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs) are well characterized. In maternal rabbits, effects included decreased body weight, increased mortality, abortions and complete litter resorption at levels in excess of the limit dose. Ethofumesate is classified as ‘‘Not Likely to be Carcinogenic to Humans’’, based on bioassays in the rat and the mouse, combined with a lack of in vitro or in vivo mutagenicity supported by a battery of mutagenicity studies that showed no evidence of a mutagenic effect. Specific information on the studies received and the nature of the adverse effects caused by ethofumesate 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 http:// www.regulations.gov in document, ‘‘Ethofumesate. Human Health Risk Assessment for an Amended Use on Sugar Beets’’ dated October 4, 2017 at pages 33–36 in docket ID number EPA– HQ–OPP–2016–0314. 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 57153 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 http:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. A summary of the toxicological endpoints for ethofumesate used for human risk assessment is shown in the Table of this unit. TABLE SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETHOFUMESATE FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/scenario Acute dietary (Females 13–49 years of age). Acute Dietary General population including infants and children. Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects NOAEL = 30 mg/kg/ day. UFA = 10x UFH =10x FQPA SF = 1x Total UF = 100 Acute RfD = 0.30 mg/kg/day. aPAD = 0.30 mg/kg/ day Developmental toxicity study in rabbit. Developmental LOAEL = 300 mg/kg/day based on increased resorptions, post-implantation loss and incomplete ossification of the vertebral arches. No appropriate acute endpoint identified for the general population including infants and children. NOAEL = 30 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Total UF = 100 Chronic RfD = 0.30 mg/kg/day. cPAD = 0.30 mg/kg/ day. Developmental toxicity study in rabbit. Developmental LOAEL = 300 mg/kg/day based on increased resorptions, post-implantation loss and incomplete ossification of the vertebral arches. Chronic Dietary, General population including infants and children. ethrower on DSK3G9T082PROD with RULES Chronic dietary (Females 13–49 years of age). NOAEL= 127 mg/kg/ day. UFA=10 UFH=10 FQPA SF = 1X Total UF = 100 cRfD = 1.3 mg/kg/ day. cPAD = 1.3 mg/kg/ day. Chronic oral toxicity/carcinogenicity study (rat). LOAEL = 469 mg/kg/day based on decreased body weight gain in females. VerDate Sep<11>2014 17:52 Dec 01, 2017 Jkt 244001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\04DER1.SGM 04DER1 57154 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations TABLE SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETHOFUMESATE FOR USE IN HUMAN HEALTH RISK ASSESSMENT—Continued Exposure/scenario Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Incidental oral short-term (1 to 30 days) & intermediate-term (1 to 6 months) Infants and children only. NOAEL= 190 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Total UF = 100 Residential LOC for MOE = 100. 90-day oral toxicity study (rats). LOAEL = 1900 mg/kg/day based on based on reduced body weight gain, microscopic lesions in the liver and kidney in male rats and reduced body weight/weight gain in females. Dermal short-term (1 to 30 days) Females 13–49 years of age. NOAEL = 30 mg/kg/ day. Dermal absorption rate (DAF) = 27% UFA = 10x UFH = 10x FQPA SF = 1x Total UF = 100 LOC for MOE = 100 Developmental toxicity study (rabbits). Developmental LOAEL = 300 mg/kg/day based on increased resorptions, post-implantation loss and incomplete ossification of the vertebral arches. Dermal short-term General population including infants and children. NOAEL= 190 mg/kg/ day. DAF rate = 27% UFA = 10x UFH = 10x FQPA SF = 1x LOC for MOE = 100 90-day oral toxicity study (rats). LOAEL = 1900 mg/kg/day based on reduced body weight gain, microscopic lesions in the liver and kidney in male rats and reduced body weight/weight gain in females. Inhalation (short and intermediate) Females 13–49 years of age. NOAEL= 30 mg/kg/ day. Inhalation & oral toxicity considered equivalent UFA = 10x UFH = 10x FQPA SF = 1x Total UF = 100 LOC for MOE = 100 Developmental toxicity study (rabbits). Developmental LOAEL = 300 mg/kg/day based on increased resorptions, post-implantation loss and incomplete ossification of the vertebral arches. Inhalation (short and intermediate term) General population including infants and children. NOAEL = 190 .......... Inhalation & oral toxicity considered equivalent UFA = 10x UFH = 10x FQPA SF = 1x Total UF = 100 LOC for MOE = 100 90-day oral toxicity study (rats). LOAEL = 1900 mg/kg/day based on reduced body weight gain, microscopic lesions in the liver and kidney in male rats and reduced body weight/weight gain in females. Cancer (Oral, dermal, inhalation). Classification: ‘‘Not likely to be carcinogenic to humans’’. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). ethrower on DSK3G9T082PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to ethofumesate, EPA considered exposure under the petitioned-for tolerances as well as all existing ethofumesate tolerances in 40 CFR 180.345. EPA assessed dietary exposures from ethofumesate 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 VerDate Sep<11>2014 17:52 Dec 01, 2017 Jkt 244001 exposure. Because no appropriate endpoint was identified for the general population including infants and children, a quantitative acute dietary exposure assessment was not conducted for these populations. Such effects were observed for the population subgroup females 13–49 years of age. In estimating acute dietary exposure for females 13–49 years, EPA used food consumption information from the United States Department of Agriculture (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003 through 2008. As to residue levels in PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 food, EPA used an unrefined determination based on tolerance-level residues, 100 percent crop treated (PCT) information for all commodities, and Dietary Exposure Evaluation Model (DEEM) 7.81 default processing factors, where available. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA’s 2003–2008 NHANES/ WWEIA. As to residue levels in food, EPA used an unrefined determination based on 100 PCT, tolerance-level residues for all commodities, and Dietary Exposure Evaluation Model E:\FR\FM\04DER1.SGM 04DER1 ethrower on DSK3G9T082PROD with RULES Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations (DEEM) 7.81 default processing factors, where available. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that ethofumesate 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. The Agency did not use anticipated residue data or percent crop treated estimates. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for ethofumesate in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of ethofumesate. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/ pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. Based on the Tier I: First Index Reservoir Screening Tool (FIRST) and Tier II: Pesticide Root Zone Model Ground Water (PRZM GW)/PWC, the estimated drinking water concentrations (EDWCs) of ethofumesate (parent compound only) for acute exposures are estimated to be 416 parts per billion (ppb) for surface water and 750 ppb for ground water. For chronic exposures for non-cancer assessments are estimated to be 123 ppb for surface water and 695 ppb for ground water. Modeled estimates of drinking water concentrations of ethofumesate for parent compound only, were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 750 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 695 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). Ethofumesate is currently registered for the following uses that could result in residential exposures: ornamental lawns and turf (including golf courses, parks, cemeteries, and homeowner/ commercial lawns). EPA assessed residential exposure using the following assumptions: All ethofumesate products are intended for either agricultural use or require professional application for VerDate Sep<11>2014 17:52 Dec 01, 2017 Jkt 244001 ornamental turf. Although registered products are labeled for use on home lawns, residential handler exposures are not anticipated because the label language requiring personal protective equipment (PPE) and prohibiting the use of handheld equipment indicate that the product is not intended for homeowner use. Therefore, the Agency has not conducted a residential handler assessment. There is potential for ethofumesate residential post-application exposure for individuals exposed as a result of being in an environment that has been previously treated. Residential postapplication dermal (adults and children) and incidental oral (children only) exposures are anticipated from the registered turf uses. EPA conducted screening level calculations on the scenarios most likely to result in highest possible exposure. These scenarios are: • For children 1 to <2 years old: incidental ingestion (hand-to-mouth), incidental ingestion (turf-to-mouth), incidental ingestion (soil-to-mouth), and dermal exposure • for adults and youths (11 to <16 years old: dermal exposure (golfing, lawn mowing, etc.). Post-application exposures were calculated by considering the potential sources of exposure then calculating dermal and/or incidental oral exposure and risks. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/ standard-operating-proceduresresidential-pesticide. 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.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to ethofumesate and any other substances and ethofumesate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that ethofumesate does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 57155 mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s Web site at http:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There are no concerns or uncertainties for pre- and/or post-natal toxicity resulting from exposure to ethofumesate. There is no evidence that ethofumesate results in increased susceptibility in in utero exposure to ethofumesate in the prenatal developmental study in rats. Increased pre-natal quantitative susceptibility was observed in the rabbit developmental toxicity study. The Agency concluded, however, that there is no concern that the risk assessment will not adequately safeguard against potential pre- and post-natal toxicity because the developmental toxicity NOAELs/ LOAELs are well characterized and are used as endpoints for risk assessment for the appropriate population subgroups. 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 ethofumesate is sufficiently complete and adequate for characterizing potential pre- and/or post-natal risks to infants and children. Available studies supporting this decision include developmental toxicity studies in rats and rabbits, and a three-generation reproduction study in rats. Based on all available hazard and exposure data for ethofumesate, the Agency determined that the subchronic inhalation, acute and subchronic neurotoxicity, and the immunotoxicity E:\FR\FM\04DER1.SGM 04DER1 ethrower on DSK3G9T082PROD with RULES 57156 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations studies for ethofumesate were not necessary and waived those requirements. The existing ethofumesate database is extensive and adequately sufficient to permit a full assessment of risks associated with proposed new uses under consideration. ii. There is no indication that ethofumesate is a neurotoxic chemical. Ethofumesate did not cause clear clinical or histopathological signs of neurotoxicity in four species tested (rats, rabbits, mice and dogs) as evaluated by the current studies within the database. In addition, there was no evidence of neurotoxicity observed in the toxicity databases of chemicals in the same class as ethofumesate. Therefore, EPA is not requiring a developmental neurotoxicity study nor incorporating an additional UFs to account for neurotoxicity. iii. There is no evidence that ethofumesate results in increased susceptibility in in utero exposure to ethofumesate in the prenatal developmental study in rats. No rat developmental effects were seen at the highest dose tested (limit dose of 1000 mg/kg). There is, however, quantitative evidence for increased susceptibility following in utero exposure to ethofumesate in an adequate developmental toxicity study in the rabbit. At 300 mg/kg/day, no maternal toxicity was reported, but developmental toxicity was observed as increased resorptions, post-implantation loss and skeletal abnormalities (incomplete ossification of vertebral arches). However, the developmental toxicity NOAELs and LOAELs are well characterized and are used as endpoints for risk assessment for the appropriate population subgroups. There was no quantitative or qualitative evidence of increased susceptibility in the three-generation reproduction study in rats with ethofumesate since maternal, reproductive and offspring toxicity were not observed at any dose tested up to 5000 ppm (397 and 463 mg/kg/day, males and females, respectively). Although a limit dose was not achieved and no maternal toxicity reported, a new study was not required because the highest dose tested was similar to the dose level that caused toxicity to rats in the chronic/carcinogenicity dietary study. iv. There are no residual uncertainties identified in the exposure databases. The dietary exposure analyses are unlikely to underestimate exposure. The acute and chronic dietary food and drinking water exposure assessments were performed based on 100 PCT information for all commodities, VerDate Sep<11>2014 17:52 Dec 01, 2017 Jkt 244001 tolerance-level residues, and Dietary Exposure Evaluation Model (DEEM) 7.81 default processing factors where available. The dietary exposure analyses also assumed that all drinking water will contain ethofumesate at the highest EDWC levels modeled by EPA. The Agency used similarly conservative assumptions to assess post-application exposure of adults and children. The residential exposure estimates are based on EPA’s 2012 Residential Standard Operations Procedures (SOPs). These assessments will not underestimate the exposure and risks posed by ethofumesate. 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 populationadjusted dose (aPAD) and chronic population-adjusted dose (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 ethofumesate will occupy 14% of the aPAD at the 95th percentile for females 13–49 years old, the only population subgroup for which an acute dietary endpoint attributable to a single exposure was identified. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure from food and drinking water only as chronic exposure from residential uses of ethofumesate is not expected, EPA identified separate chronic dietary endpoints for the general population, including infants and children, as well as for the population subgroup of females 13–49 years of age. Based on the input parameters and assumptions, the chronic dietary risk estimate for the U.S. population was determined to be 1.2% of the cPAD with the population subgroup of females 13–49 years having the highest risk estimate at 5.2% of the cPAD. EPA concluded that ethofumesate risk estimates for all population subgroups were below the level of concern of <100% of the cPAD. 3. Short- and intermediate-term aggregate risk. Short- and intermediateterm aggregate exposures take into account short- and intermediate-term PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Ethofumesate is currently registered for uses that could result in short-term residential exposure. Residential exposure to ethofumesate is not anticipated from the amended uses that are the subject of this regulatory action; however, it is anticipated from currently registered residential uses of ethofumesate. Residential exposures are only expected to be short-term in duration; however, since the point of departure is the same for short and intermediate-term exposures, the shortterm aggregate is protective of any longer-term exposures. Aggregate risk estimates (MOEs) were derived using recommended exposure scenarios including: For adults, dermal post-application exposure from high contact activities on treated turf; for children, including ages 11 to <16 years and 6 to <11 years, dermal postapplication exposure from golfing on treated turf; and for children (1 to <2 years), combined dermal plus hand-tomouth post-application exposure from high contact activities on treated turf. EPA short-term aggregate risk calculations of aggregate MOEs, combining average food and drinking water, plus residential exposures (total exposure), ranged from 120 for females 13–49 years; to 430 for children 1 to <2 years; to 770 for adults, 20–49 years and significantly higher for population subgroups, children 6 to 11 years and youth 11 to <16 years. These short-term aggregate risk estimates are not of concern to EPA (i.e., MOEs are ≥ 100). 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, ethofumesate is not expected to pose a cancer risk to humans. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to ethofumesate residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (Method I in PAM Vol. II is listed as an adequate tolerance enforcement method for plants) 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; E:\FR\FM\04DER1.SGM 04DER1 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations 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. There are no Codex MRLs established for the residues of ethofumesate in/on any sugar beet raw agricultural or processed commodity. ethrower on DSK3G9T082PROD with RULES C. Response to Comments One commenter supported the tolerance action but expressed concerns about the need for additional data to assess the toxicity of ethofumesate to bioaccumulate and to contribute to obesity and diabetes. To the extent the commenter is concerned about impacts on aquatic life, earthworms, and other non-human organisms, this comment is outside the scope of review appropriate for a tolerance safety assessment under section 408 of the FFDCA. If the commenter is raising concerns about potential human harm, the Agency has considered all the available data and determined that the tolerances are safe; there is nothing in the toxicity database that would suggest toxicity concerns related to diabetes or obesity. The octanol-water partition coefficient (log Kow) for ethofumesate is 2.8. Compounds with log Kow values less than three are unlikely to bioaccumulate substantially. Therefore, further assessment of the bioaccumulation of ethofumesate is not warranted at this time. D. Revisions to Petitioned-For Tolerances EPA is not increasing the existing tolerance for ‘‘Beet, sugar, tops’’ because it is unnecessary due to the fact that this commodity is no longer a significant livestock feed item or a recognized human food. VerDate Sep<11>2014 17:52 Dec 01, 2017 Jkt 244001 Although the petitioner requested an increase in the existing sugar, beet, refined sugar tolerance, EPA has determined that the tolerance is not needed because the limit established for the raw agricultural commodity (RAC) (beet, sugar, roots at 1.5 ppm) is sufficient to cover residues in this processed commodity (at 1.0 ppm). In setting the sugar beet molasses tolerance, EPA used the empirical processing factor previously derived for determining the concentration of residues in this processed commodity, which results in a tolerance of 2.0 ppm rather 2.5 ppm as requested. The tolerance expressions at 180.345 paragraphs (a) and (c) for ethofumesate are being revised to comply with current EPA policies and to accommodate updated tolerance enforcement methods that convert the NC 20645 (2-(2hydroxy-5-methanesulfonyloxyphenyl) methylpropanoic acid) metabolite to NC9607 (3,3-dimethyl-5[(methylsulfonyl)oxy]-2(3H)benzofuranone) prior to quantitation. V. Conclusion Therefore, tolerances are established for residues of the herbicide ethofumesate in or on beet, sugar, molasses at 2.0 ppm and beet, sugar, roots at 1.5 ppm. Also, the tolerance for beet, sugar, refined is deleted because residues in that processed commodity are covered by the tolerance for beet, sugar, roots. 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 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 57157 Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). 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. E:\FR\FM\04DER1.SGM 04DER1 57158 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations Dated: October 26, 2017. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. hydroxy-2,3-dihydro-3,3-dimethyl-5benzofuranyl methanesulfonate, and 2,3-dihydro-3,3-dimethyl-2-oxo-5benzofuranylmethanesulfonate, calculated as the stoichiometric equivalent of ethofumesate, in or on the raw agricultural commodities. * * * * * Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] [FR Doc. 2017–25828 Filed 12–1–17; 8:45 am] 1. The authority citation for part 180 continues to read as follows: ■ BILLING CODE 6560–50–P Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.345: i. Revise the introductory text of paragraph (a); ■ ii. Remove the entry for ‘‘Beet, sugar, refined sugar’’ from the table in paragraph (a); ■ iii. Revise the entries for ‘‘Beet, sugar, molasses’’ and ‘‘Beet, sugar, roots’’ in the table in paragraph (a): and ■ iv. Revise the introductory text of paragraph (c) to read as follows: ■ ■ § 180.345 Ethofumesate; tolerances for residues. 47 CFR Parts 10 and 11 [PS Docket No. 15–91; PS Docket No. 15– 94; FCC 17–143] Wireless Emergency Alerts; Emergency Alert System Federal Communications Commission. ACTION: Final rule. AGENCY: In this document, the Federal Communications Commission (Commission) grants the petition filed by CTIA for reconsideration the Commission’s recent decision to revise its Wireless Emergency Alert (WEA) rules and grants in part and denies in part the Competitive Carrier Association’s (CCA) request for a waiver or extension of time. Specifically, the Commission extends the timeframe for compliance with the requirement in the WEA Report and Order that Participating CMS Providers provide ‘‘clickable’’ embedded references in WEA messages from 12 months to 30 months except for AT&T, Verizon, TMobile, Sprint and U.S. Cellular. This document also clarifies that the requirement for ‘‘clickable’’ embedded Parts per Commodity references encompass phone numbers million and other types of embedded references, and that our embedded reference requirement applies to new devices as * * * * * Beet, sugar, molasses ................ 2.0 well as existing devices capable of Beet, sugar, roots ....................... 1.5 supporting this feature through a software upgrade. Finally, this * * * * * document denies CCA’s request for a waiver or an extension of time for * * * * * compliance with the geo-targeting (c) Tolerances with regional requirements. registrations. Tolerances with a regional DATES: Effective December 4, 2017. registration, as defined in § 180.1(l) are established for residues of the herbicide FOR FURTHER INFORMATION CONTACT: Gregory Cooke of the Public Safety and ethofumesate, including its metabolites Homeland Security Bureau, Policy and and degradates, in or on the Licensing Division, gregory.cooke@ commodities in the table below. fcc.gov, (202) 418–2351. Compliance with the tolerance levels specified is to be determined by SUPPLEMENTARY INFORMATION: This is a measuring only the sum of summary of the Commission’s Order on ethofumesate, 2-ethoxy-2,3-dihydro-3,3- Reconsideration in PS Docket No. 15– dimethyl-5-benzofuranyl 91, No. 15–94, FCC 17–143, released on methanesulfonate, and its metabolites 2- November 1, 2017. The document is (a) General. Tolerance are established for residues of the herbicide ethofumesate, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of ethofumesate, 2-ethoxy-2,3-dihydro-3,3dimethyl-5-benzofuranyl methanesulfonate, and its metabolites 2hydroxy-2,3-dihydro-3,3-dimethyl-5benzofuranyl methanesulfonate, and 2,3-dihydro-3,3-dimethyl-2-oxo-5benzofuranylmethanesulfonate, calculated as the stoichiometric equivalent of ethofumesate, in or on the following food commodities. ethrower on DSK3G9T082PROD with RULES FEDERAL COMMUNICATIONS COMMISSION VerDate Sep<11>2014 17:52 Dec 01, 2017 Jkt 244001 SUMMARY: PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 available for download at https:// apps.fcc.gov/edocs_public/attachmatch/ FCC-17-143A1.pdf. The complete text of this document is also available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY–A257, Washington, DC 20554. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to FCC504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202–418–0530 (voice), 202– 418–0432 (TTY). Supplemental Regulatory Flexibility Analysis 1. This Supplemental Final Regulatory Flexibility Analysis (Supplemental FRFA) supplements the Final Regulatory Flexibility Analysis (FRFA) of the September 2016 WEA Report and Order, 81 FR 75710 (WEA R&O) to reflect the actions taken in this Order on Reconsideration and conforms to the RFA. Need for, and Objective of, the Order 2. In the WEA R&O, we took advantage of the significant technological changes and improvements experienced by the mobile wireless industry since the passage of the Warning, Alert and Response Network (WARN) Act, and deployment of WEA to improve the utility of WEA as a life-saving tool. As pertinent to the Order on Reconsideration we adopt today, in the WEA R&O we adopted rules focused on improving WEA message content by narrowing the rules for the geo-targeting of alerts, requiring Participating Commercial Mobile Service (CMS) Providers to support embedded references (i.e., URLs and phone numbers) included in WEA Alert Messages. In doing so, we set a deadline for compliance with the embedded reference requirement of one year (12 months). 3. In this Order on Reconsideration, we grant, to the extent described herein, CTIA’s Petition for Reconsideration of the WEA R&O and CCA’s Petition for Waiver, or in the Alternative, Extension of Time. In doing so, we deny CCA’s request for a waiver or an extension of time for compliance with the WEA R&O’s best approximates geo-targeting standard, as compliance with the best approximate geo-targeting is well within the capabilities of CCA’s members; and we reconsider the deadline for compliance with the embedded reference requirement from one year (12 months) to 30 months for all E:\FR\FM\04DER1.SGM 04DER1

Agencies

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Rules and Regulations]
[Pages 57151-57158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25828]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0314; FRL-9969-13]


Ethofumesate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
ethofumesate in or on beet, sugar, molasses and beet, sugar, roots. In 
addition, this regulation eliminates tolerances for residues of 
ethofumesate that are superseded by the tolerances established by this 
final rule. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective December 4, 2017. Objections and 
requests for hearings must be received on or before February 2, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0314, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket)

[[Page 57152]]

in the Environmental Protection Agency Docket Center (EPA/DC), West 
William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC 20460-0001. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805. Please review 
the visitor instructions and additional information about the docket 
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Director, 
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 http://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-2016-0314 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 
February 2, 2018. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0314, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 20, 2016 (81 FR 47150) (FRL-9948-
45), 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 
6E8472) by IR-4, IR-4 Project Headquarters, 500 College Road East, 
Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 
180.345 be amended by increasing the existing tolerance for the 
combined residues of the herbicide ethofumesate (2-ethoxy-2,3-dihydro-
3,3-dimethyl-5-benzofuranyl methanesulfonate) and its metabolites (2-
hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 
2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate) both 
calculated as the parent compound, in or on beet, sugar, molasses from 
0.5 to 2.5 parts per million (ppm); beet, sugar, refined sugar from 0.2 
to 1.0 ppm; beet, sugar, roots from 0.3 to 1.5 ppm; and beet, sugar, 
tops from 4.0 to 30.0 ppm. That document referenced a summary of the 
petition prepared by Willowood USA, LLC, the registrant, which is 
available in the docket, http://www.regulations.gov. One comment was 
received on the notice of filing. EPA's response to the comment is 
found in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that differ from what the petitioner requested. 
The reasons for these changes are 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 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 ethofumesate including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with ethofumesate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity database 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.

[[Page 57153]]

    The liver is the main target organ in rats and dogs, and the major 
critical effects seen in oral studies are decreased body weight/body 
weight gain and hepatic toxicity in the rat, dog and/or rabbit. Mice 
are relatively insensitive to ethofumesate up to the limit dose 
following subchronic and chronic dietary exposure.
    Ethofumesate did not demonstrate the potential to cause 
neurotoxicity in four species (rats, mice, dogs and rabbits).
    Rats did not show evidence of developmental, maternal, or offspring 
toxicity or susceptibility in a three-generation reproduction study or 
any developmental or maternal toxicity in the developmental toxicity 
study. Although increased prenatal quantitative sensitivity (increased 
resorptions, increased post-implantation loss and incomplete 
ossification of the vertebral arches) was observed in the rabbit 
developmental toxicity study, the developmental toxicity no observed 
adverse effect levels (NOAELs) and lowest observed adverse effect 
levels (LOAELs) are well characterized. In maternal rabbits, effects 
included decreased body weight, increased mortality, abortions and 
complete litter resorption at levels in excess of the limit dose.
    Ethofumesate is classified as ``Not Likely to be Carcinogenic to 
Humans'', based on bioassays in the rat and the mouse, combined with a 
lack of in vitro or in vivo mutagenicity supported by a battery of 
mutagenicity studies that showed no evidence of a mutagenic effect.
    Specific information on the studies received and the nature of the 
adverse effects caused by ethofumesate 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 http://www.regulations.gov in document, ``Ethofumesate. Human Health Risk 
Assessment for an Amended Use on Sugar Beets'' dated October 4, 2017 at 
pages 33-36 in docket ID number EPA-HQ-OPP-2016-0314.

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 http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for ethofumesate used for 
human risk assessment is shown in the Table of this unit.

   Table Summary of Toxicological Doses and Endpoints for ethofumesate for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49       NOAEL = 30 mg/kg/day  Acute RfD = 0.30 mg/ Developmental toxicity study in
 years of age).                    UFA = 10x...........   kg/day.              rabbit.
                                   UFH =10x............  aPAD = 0.30 mg/kg/   Developmental LOAEL = 300 mg/kg/
                                   FQPA SF = 1x........   day.                 day based on increased
                                   Total UF = 100......                        resorptions, post-implantation
                                                                               loss and incomplete ossification
                                                                               of the vertebral arches.
----------------------------------------------------------------------------------------------------------------
Acute Dietary General population   No appropriate acute endpoint identified for the general population including
 including infants and children.                                infants and children.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (Females 13-49     NOAEL = 30 mg/kg/day  Chronic RfD = 0.30   Developmental toxicity study in
 years of age).                    UFA = 10x...........   mg/kg/day.           rabbit.
                                   UFH = 10x...........  cPAD = 0.30 mg/kg/   Developmental LOAEL = 300 mg/kg/
                                   FQPA SF = 1x........   day.                 day based on increased
                                   Total UF = 100......                        resorptions, post-implantation
                                                                               loss and incomplete ossification
                                                                               of the vertebral arches.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary, General           NOAEL= 127 mg/kg/day  cRfD = 1.3 mg/kg/    Chronic oral toxicity/
 population including infants and  UFA=10..............   day.                 carcinogenicity study (rat).
 children.                         UFH=10..............  cPAD = 1.3 mg/kg/    LOAEL = 469 mg/kg/day based on
                                   FQPA SF = 1X........   day.                 decreased body weight gain in
                                   Total UF = 100......                        females.
----------------------------------------------------------------------------------------------------------------

[[Page 57154]]

 
Incidental oral short-term (1 to   NOAEL= 190 mg/kg/day  Residential LOC for  90-day oral toxicity study (rats).
 30 days) & intermediate-term (1   UFA = 10x...........   MOE = 100.          LOAEL = 1900 mg/kg/day based on
 to 6 months) Infants and          UFH = 10x...........                        based on reduced body weight
 children only.                    FQPA SF = 1x........                        gain, microscopic lesions in the
                                   Total UF = 100......                        liver and kidney in male rats and
                                                                               reduced body weight/weight gain
                                                                               in females.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   NOAEL = 30 mg/kg/day  LOC for MOE = 100..  Developmental toxicity study
 Females 13-49 years of age.       Dermal absorption                           (rabbits).
                                    rate (DAF) = 27%.                         Developmental LOAEL = 300 mg/kg/
                                   UFA = 10x...........                        day based on increased
                                   UFH = 10x...........                        resorptions, post-implantation
                                   FQPA SF = 1x........                        loss and incomplete ossification
                                   Total UF = 100......                        of the vertebral arches.
----------------------------------------------------------------------------------------------------------------
Dermal short-term General          NOAEL= 190 mg/kg/day  LOC for MOE = 100..  90-day oral toxicity study (rats).
 population including infants and  DAF rate = 27%......                       LOAEL = 1900 mg/kg/day based on
 children.                         UFA = 10x...........                        reduced body weight gain,
                                   UFH = 10x...........                        microscopic lesions in the liver
                                   FQPA SF = 1x........                        and kidney in male rats and
                                                                               reduced body weight/weight gain
                                                                               in females.
----------------------------------------------------------------------------------------------------------------
Inhalation (short and              NOAEL= 30 mg/kg/day.  LOC for MOE = 100..  Developmental toxicity study
 intermediate) Females 13-49       Inhalation & oral                           (rabbits).
 years of age.                      toxicity considered                       Developmental LOAEL = 300 mg/kg/
                                    equivalent.                                day based on increased
                                   UFA = 10x...........                        resorptions, post-implantation
                                   UFH = 10x...........                        loss and incomplete ossification
                                   FQPA SF = 1x........                        of the vertebral arches.
                                   Total UF = 100......
----------------------------------------------------------------------------------------------------------------
Inhalation (short and              NOAEL = 190.........  LOC for MOE = 100..  90-day oral toxicity study (rats).
 intermediate term) General        Inhalation & oral                          LOAEL = 1900 mg/kg/day based on
 population including infants and   toxicity considered                        reduced body weight gain,
 children.                          equivalent.                                microscopic lesions in the liver
                                   UFA = 10x...........                        and kidney in male rats and
                                   UFH = 10x...........                        reduced body weight/weight gain
                                   FQPA SF = 1x........                        in females.
                                   Total UF = 100......
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)           Classification: ``Not likely to be carcinogenic to humans''.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ethofumesate, EPA considered exposure under the petitioned-
for tolerances as well as all existing ethofumesate tolerances in 40 
CFR 180.345. EPA assessed dietary exposures from ethofumesate 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. Because no appropriate 
endpoint was identified for the general population including infants 
and children, a quantitative acute dietary exposure assessment was not 
conducted for these populations. Such effects were observed for the 
population subgroup females 13-49 years of age.
    In estimating acute dietary exposure for females 13-49 years, EPA 
used food consumption information from the United States Department of 
Agriculture (USDA's) National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA) from 2003 through 2008. As to 
residue levels in food, EPA used an unrefined determination based on 
tolerance-level residues, 100 percent crop treated (PCT) information 
for all commodities, and Dietary Exposure Evaluation Model (DEEM) 7.81 
default processing factors, where available.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used an unrefined 
determination based on 100 PCT, tolerance-level residues for all 
commodities, and Dietary Exposure Evaluation Model

[[Page 57155]]

(DEEM) 7.81 default processing factors, where available.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that ethofumesate 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. 
The Agency did not use anticipated residue data or percent crop treated 
estimates.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for ethofumesate in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of ethofumesate. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier I: First Index Reservoir Screening Tool (FIRST) 
and Tier II: Pesticide Root Zone Model Ground Water (PRZM GW)/PWC, the 
estimated drinking water concentrations (EDWCs) of ethofumesate (parent 
compound only) for acute exposures are estimated to be 416 parts per 
billion (ppb) for surface water and 750 ppb for ground water. For 
chronic exposures for non-cancer assessments are estimated to be 123 
ppb for surface water and 695 ppb for ground water.
    Modeled estimates of drinking water concentrations of ethofumesate 
for parent compound only, were directly entered into the dietary 
exposure model. For acute dietary risk assessment, the water 
concentration value of 750 ppb was used to assess the contribution to 
drinking water. For chronic dietary risk assessment, the water 
concentration value of 695 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).
    Ethofumesate is currently registered for the following uses that 
could result in residential exposures: ornamental lawns and turf 
(including golf courses, parks, cemeteries, and homeowner/commercial 
lawns). EPA assessed residential exposure using the following 
assumptions: All ethofumesate products are intended for either 
agricultural use or require professional application for ornamental 
turf. Although registered products are labeled for use on home lawns, 
residential handler exposures are not anticipated because the label 
language requiring personal protective equipment (PPE) and prohibiting 
the use of handheld equipment indicate that the product is not intended 
for homeowner use. Therefore, the Agency has not conducted a 
residential handler assessment.
    There is potential for ethofumesate residential post-application 
exposure for individuals exposed as a result of being in an environment 
that has been previously treated. Residential post-application dermal 
(adults and children) and incidental oral (children only) exposures are 
anticipated from the registered turf uses. EPA conducted screening 
level calculations on the scenarios most likely to result in highest 
possible exposure. These scenarios are:
     For children 1 to <2 years old: incidental ingestion 
(hand-to-mouth), incidental ingestion (turf-to-mouth), incidental 
ingestion (soil-to-mouth), and dermal exposure
     for adults and youths (11 to <16 years old: dermal 
exposure (golfing, lawn mowing, etc.).

Post-application exposures were calculated by considering the potential 
sources of exposure then calculating dermal and/or incidental oral 
exposure and risks. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to ethofumesate and any other 
substances and ethofumesate does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that ethofumesate 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 http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There are no concerns or 
uncertainties for pre- and/or post-natal toxicity resulting from 
exposure to ethofumesate. There is no evidence that ethofumesate 
results in increased susceptibility in in utero exposure to 
ethofumesate in the prenatal developmental study in rats. Increased 
pre-natal quantitative susceptibility was observed in the rabbit 
developmental toxicity study. The Agency concluded, however, that there 
is no concern that the risk assessment will not adequately safeguard 
against potential pre- and post-natal toxicity because the 
developmental toxicity NOAELs/LOAELs are well characterized and are 
used as endpoints for risk assessment for the appropriate population 
subgroups.
    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 ethofumesate is sufficiently complete 
and adequate for characterizing potential pre- and/or post-natal risks 
to infants and children. Available studies supporting this decision 
include developmental toxicity studies in rats and rabbits, and a 
three-generation reproduction study in rats.
    Based on all available hazard and exposure data for ethofumesate, 
the Agency determined that the subchronic inhalation, acute and 
subchronic neurotoxicity, and the immunotoxicity

[[Page 57156]]

studies for ethofumesate were not necessary and waived those 
requirements. The existing ethofumesate database is extensive and 
adequately sufficient to permit a full assessment of risks associated 
with proposed new uses under consideration.
    ii. There is no indication that ethofumesate is a neurotoxic 
chemical. Ethofumesate did not cause clear clinical or 
histopathological signs of neurotoxicity in four species tested (rats, 
rabbits, mice and dogs) as evaluated by the current studies within the 
database. In addition, there was no evidence of neurotoxicity observed 
in the toxicity databases of chemicals in the same class as 
ethofumesate. Therefore, EPA is not requiring a developmental 
neurotoxicity study nor incorporating an additional UFs to account for 
neurotoxicity.
    iii. There is no evidence that ethofumesate results in increased 
susceptibility in in utero exposure to ethofumesate in the prenatal 
developmental study in rats. No rat developmental effects were seen at 
the highest dose tested (limit dose of 1000 mg/kg). There is, however, 
quantitative evidence for increased susceptibility following in utero 
exposure to ethofumesate in an adequate developmental toxicity study in 
the rabbit. At 300 mg/kg/day, no maternal toxicity was reported, but 
developmental toxicity was observed as increased resorptions, post-
implantation loss and skeletal abnormalities (incomplete ossification 
of vertebral arches). However, the developmental toxicity NOAELs and 
LOAELs are well characterized and are used as endpoints for risk 
assessment for the appropriate population subgroups.
    There was no quantitative or qualitative evidence of increased 
susceptibility in the three-generation reproduction study in rats with 
ethofumesate since maternal, reproductive and offspring toxicity were 
not observed at any dose tested up to 5000 ppm (397 and 463 mg/kg/day, 
males and females, respectively). Although a limit dose was not 
achieved and no maternal toxicity reported, a new study was not 
required because the highest dose tested was similar to the dose level 
that caused toxicity to rats in the chronic/carcinogenicity dietary 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary exposure analyses are unlikely to underestimate 
exposure. The acute and chronic dietary food and drinking water 
exposure assessments were performed based on 100 PCT information for 
all commodities, tolerance-level residues, and Dietary Exposure 
Evaluation Model (DEEM) 7.81 default processing factors where 
available. The dietary exposure analyses also assumed that all drinking 
water will contain ethofumesate at the highest EDWC levels modeled by 
EPA. The Agency used similarly conservative assumptions to assess post-
application exposure of adults and children. The residential exposure 
estimates are based on EPA's 2012 Residential Standard Operations 
Procedures (SOPs). These assessments will not underestimate the 
exposure and risks posed by ethofumesate.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute population-adjusted dose (aPAD) and chronic population-adjusted 
dose (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 ethofumesate will occupy 14% of the aPAD at the 95th percentile for 
females 13-49 years old, the only population subgroup for which an 
acute dietary endpoint attributable to a single exposure was 
identified.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure from food and drinking water only as chronic 
exposure from residential uses of ethofumesate is not expected, EPA 
identified separate chronic dietary endpoints for the general 
population, including infants and children, as well as for the 
population subgroup of females 13-49 years of age. Based on the input 
parameters and assumptions, the chronic dietary risk estimate for the 
U.S. population was determined to be 1.2% of the cPAD with the 
population subgroup of females 13-49 years having the highest risk 
estimate at 5.2% of the cPAD. EPA concluded that ethofumesate risk 
estimates for all population subgroups were below the level of concern 
of <100% of the cPAD.
    3. Short- and intermediate-term aggregate risk. Short- and 
intermediate-term aggregate exposures take into account short- and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Ethofumesate is currently registered for uses that could result in 
short-term residential exposure. Residential exposure to ethofumesate 
is not anticipated from the amended uses that are the subject of this 
regulatory action; however, it is anticipated from currently registered 
residential uses of ethofumesate. Residential exposures are only 
expected to be short-term in duration; however, since the point of 
departure is the same for short and intermediate-term exposures, the 
short-term aggregate is protective of any longer-term exposures.
    Aggregate risk estimates (MOEs) were derived using recommended 
exposure scenarios including: For adults, dermal post-application 
exposure from high contact activities on treated turf; for children, 
including ages 11 to <16 years and 6 to <11 years, dermal post-
application exposure from golfing on treated turf; and for children (1 
to <2 years), combined dermal plus hand-to-mouth post-application 
exposure from high contact activities on treated turf.
    EPA short-term aggregate risk calculations of aggregate MOEs, 
combining average food and drinking water, plus residential exposures 
(total exposure), ranged from 120 for females 13-49 years; to 430 for 
children 1 to <2 years; to 770 for adults, 20-49 years and 
significantly higher for population subgroups, children 6 to 11 years 
and youth 11 to <16 years. These short-term aggregate risk estimates 
are not of concern to EPA (i.e., MOEs are >= 100).
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, ethofumesate is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to ethofumesate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method I in PAM Vol. II is listed 
as an adequate tolerance enforcement method for plants) 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;

[[Page 57157]]

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.
    There are no Codex MRLs established for the residues of 
ethofumesate in/on any sugar beet raw agricultural or processed 
commodity.

C. Response to Comments

    One commenter supported the tolerance action but expressed concerns 
about the need for additional data to assess the toxicity of 
ethofumesate to bioaccumulate and to contribute to obesity and 
diabetes. To the extent the commenter is concerned about impacts on 
aquatic life, earthworms, and other non-human organisms, this comment 
is outside the scope of review appropriate for a tolerance safety 
assessment under section 408 of the FFDCA. If the commenter is raising 
concerns about potential human harm, the Agency has considered all the 
available data and determined that the tolerances are safe; there is 
nothing in the toxicity database that would suggest toxicity concerns 
related to diabetes or obesity.
    The octanol-water partition coefficient (log Kow) for 
ethofumesate is 2.8. Compounds with log Kow values less than 
three are unlikely to bioaccumulate substantially. Therefore, further 
assessment of the bioaccumulation of ethofumesate is not warranted at 
this time.

D. Revisions to Petitioned-For Tolerances

    EPA is not increasing the existing tolerance for ``Beet, sugar, 
tops'' because it is unnecessary due to the fact that this commodity is 
no longer a significant livestock feed item or a recognized human food.
    Although the petitioner requested an increase in the existing 
sugar, beet, refined sugar tolerance, EPA has determined that the 
tolerance is not needed because the limit established for the raw 
agricultural commodity (RAC) (beet, sugar, roots at 1.5 ppm) is 
sufficient to cover residues in this processed commodity (at 1.0 ppm).
    In setting the sugar beet molasses tolerance, EPA used the 
empirical processing factor previously derived for determining the 
concentration of residues in this processed commodity, which results in 
a tolerance of 2.0 ppm rather 2.5 ppm as requested.
    The tolerance expressions at 180.345 paragraphs (a) and (c) for 
ethofumesate are being revised to comply with current EPA policies and 
to accommodate updated tolerance enforcement methods that convert the 
NC 20645 (2-(2-hydroxy-5-methanesulfonyloxyphenyl) methylpropanoic 
acid) metabolite to NC9607 (3,3-dimethyl-5-[(methylsulfonyl)oxy]-2(3H)-
benzofuranone) prior to quantitation.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide 
ethofumesate in or on beet, sugar, molasses at 2.0 ppm and beet, sugar, 
roots at 1.5 ppm. Also, the tolerance for beet, sugar, refined is 
deleted because residues in that processed commodity are covered by the 
tolerance for beet, sugar, roots.

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 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.


[[Page 57158]]


    Dated: October 26, 2017.
Michael Goodis,
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.  180.345:
0
i. Revise the introductory text of paragraph (a);
0
ii. Remove the entry for ``Beet, sugar, refined sugar'' from the table 
in paragraph (a);
0
iii. Revise the entries for ``Beet, sugar, molasses'' and ``Beet, 
sugar, roots'' in the table in paragraph (a): and
0
iv. Revise the introductory text of paragraph (c) to read as follows:


Sec.  180.345  Ethofumesate; tolerances for residues.

    (a) General. Tolerance are established for residues of the 
herbicide ethofumesate, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
ethofumesate, 2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl 
methanesulfonate, and its metabolites 2-hydroxy-2,3-dihydro-3,3-
dimethyl-5-benzofuranyl methanesulfonate, and 2,3-dihydro-3,3-dimethyl-
2-oxo-5-benzofuranylmethanesulfonate, calculated as the stoichiometric 
equivalent of ethofumesate, in or on the following food commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, molasses.......................................         2.0
Beet, sugar, roots..........................................         1.5
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with a 
regional registration, as defined in Sec.  180.1(l) are established for 
residues of the herbicide ethofumesate, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance 
with the tolerance levels specified is to be determined by measuring 
only the sum of ethofumesate, 2-ethoxy-2,3-dihydro-3,3-dimethyl-5-
benzofuranyl methanesulfonate, and its metabolites 2-hydroxy-2,3-
dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate, and 2,3-dihydro-
3,3-dimethyl-2-oxo-5-benzofuranylmethanesulfonate, calculated as the 
stoichiometric equivalent of ethofumesate, in or on the raw 
agricultural commodities.
* * * * *
[FR Doc. 2017-25828 Filed 12-1-17; 8:45 am]
BILLING CODE 6560-50-P