Mefenoxam; Pesticide Tolerances, 65541-65546 [2018-27764]

Download as PDF Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations * * * * * [FR Doc. 2018–27610 Filed 12–20–18; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2017–0562; FRL–9985–52] Mefenoxam; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of mefenoxam in or on cacao bean; the fruit, small, vine climbing, except grape, subgroup 13– 07E; and wasabi. 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 21, 2018. Objections and requests for hearings must be received on or before February 19, 2019, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2017–0562, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: amozie on DSK3GDR082PROD with RULES SUMMARY: 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 VerDate Sep<11>2014 16:23 Dec 20, 2018 Jkt 247001 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2017–0562 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 19, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2017–0562, 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. PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 65541 • 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 January 26, 2018 (83 FR 3658) (FRL–9971–46), 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 7E8610) by IR–4, IR–4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide mefenoxam, including its metabolites and degradates in or on the raw agricultural commodities cacao bean, bean at 0.2 parts per million (ppm); wasabi, tops at 6.0 ppm; wasabi, stem at 3.0 ppm; and fruit, small, vine climbing, except grape, crop subgroup 13–07E at 0.10 ppm. Additionally, the petition requested to amend 40 CFR 180.546 by removing the tolerance in or on kiwifruit at 0.10 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received in the docket for the notice of filing, but as it raised concerns about the Obama Administration’s application of the National Environmental Protection Agency and Endangered Species Act, it is not relevant to this tolerance action. Based upon review of the data supporting the petition, EPA has modified the commodity definition for cacao and the tolerance level to be consistent with the Agency’s policy on significant figures. 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 E:\FR\FM\21DER1.SGM 21DER1 65542 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 mefenoxam including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with mefenoxam follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Mefenoxam (metalaxyl-m) is a systemic phenylamide fungicide which inhibits protein synthesis in fungi. Mefenoxam is an R-isomer enriched formulation. Metalaxyl is the racemic R/S isomer formulation. The Agency compared the available chemistry and toxicity data for mefenoxam and metalaxyl and concluded that metalaxyl data may be used in support of mefenoxam regulatory actions because the two chemicals have similar toxicity. Therefore, for the purposes of this assessment, mefenoxam will refer to both mefenoxam and metalaxyl-m. In rat and dog repeat dose (i.e., subchronic and chronic) oral toxicity studies, there were no indications of adverse effects up to the highest dose tested (HDT). Adverse effects were only observed from acute exposure to rats. In the rat developmental toxicity study of metalaxyl, maternal toxicity consisted of dose-related increased incidence of convulsions that occurred shortly after dosing, as well as other clinical signs. In a range-finding acute neurotoxicity study of mefenoxam, females showed abnormal functional observation battery (FOB) findings at doses lower than males, but higher than the rat developmental study. However, there was no indication of toxicity up to the HDT in the mefenoxam subchronic neurotoxicity study, which confirms the lack of adverse effects observed in all other repeat-dose studies. There was no indication of developmental toxicity in studies of mefenoxam or metalaxyl. There was no indication of immunotoxicity in a mouse immunotoxicity study of mefenoxam. Metalaxyl and mefenoxam have been classified as ‘‘not likely to be carcinogenic in humans’’ based on the results of the carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats. All toxicity endpoints and points of departure (PODs) are based on convulsions that occurred minutes after dosing in the rat developmental toxicity study of metalaxyl. This POD is appropriate for acute, short-term, and intermediate-term exposure scenarios via the oral and inhalation routes. No hazard was identified for chronic or long-term exposure scenarios, or for exposure via the dermal route. Specific information on the studies received and the nature of the adverse effects caused by mefenoxam 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 the document ‘‘Mefenoxam (Metalaxyl-M). Human Health Risk Assessment for the Establishment of Permanent Tolerances and New Uses in/on Wasabi, Cacao, and Crop Group Expansion from Kiwifruit to Fruit, Small, Vine Climbing, Except Grape, Crop Subgroup 13–07E’’ on pages 23–21 in docket ID number EPA– HQ–OPP–2017–0562. 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:// www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. A summary of the toxicological endpoints for mefenoxam used for human risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MEFENOXAM FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/scenario amozie on DSK3GDR082PROD with RULES Acute dietary (All Populations) VerDate Sep<11>2014 16:23 Dec 20, 2018 Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects NOAEL = 50 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Acute RfD = 0.5 mg/ kg/day. aPAD = 0.5 mg/kg/ day Metalaxyl Prenatal Developmental Toxicity—Rat LOAEL = 250 mg/kg/day Based on dose-related increases in clinical signs of toxicity (e.g., post-dosing convulsions). Jkt 247001 PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 E:\FR\FM\21DER1.SGM 21DER1 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 65543 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MEFENOXAM 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 Chronic dietary (All populations) No endpoint was identified. No systemic toxicity was observed in the reproduction and fertility effects study or in any of the chronic and subchronic toxicity studies. Toxicity was only evident in gavage-dosed animals. Incidental oral short-term (1 to 30 days) and intermediateterm (1 to 6 months). NOAEL = 50 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Cancer (Oral, dermal, inhalation). Classification: ‘‘not likely to be carcinogenic to humans’’ based on adequately conducted carcinogenicity studies in rats and mice treated with metalaxyl. LOC for MOE = 100 Metalaxyl Prenatal Developmental Toxicity—Rat LOAEL = 250 mg/kg/day Based on dose-related increases in clinical signs of toxicity (e.g., post-dosing convulsions). 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). amozie on DSK3GDR082PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to mefenoxam, EPA considered exposure under the petitioned-for tolerances as well as all existing mefenoxam tolerances in 40 CFR 180.546. EPA assessed dietary exposures from mefenoxam in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for mefenoxam. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture’s National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 percent crop treated (PCT), DEEM default and empirical processing factors and tolerance level residues. ii. Chronic exposure. No chronic endpoint was identified and therefore no chronic dietary assessment was conducted. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that mefenoxam does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for mefenoxam. Tolerance level residues VerDate Sep<11>2014 16:23 Dec 20, 2018 Jkt 247001 and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency only considered the parent compound metalaxyl as a residue of concern (ROC). Exposure modeling for mefenoxam is not necessary because exposure estimates for metalaxyl are expected to exceed those for mefenoxam, and the two compounds are anticipated to behave identically in the environment. Therefore, EDWCs provided for metalaxyl are protective of exposures to mefenoxam through drinking water. Maximum annual application rates for metalaxyl, up to 12.3 pounds active ingredient/per Acre (lb ai/A), were modeled. These rates are approximately twice those of mefenoxam. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for mefenoxam/metalaxyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of mefenoxam/metalaxyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. Based on the Pesticide Water Calculator (PWC version 1.52) the estimated drinking water concentrations (EDWCs) of mefenoxam/metalaxyl for acute exposures are estimated to be 350 parts per billion (ppb) for surface water and 155 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 350 ppb was PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 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). Mefenoxam and metalaxyl are currently registered for the following uses that could result in residential exposures: Lawns, ornamentals, gardens, and trees. EPA assessed residential exposure using the following assumptions: For residential handlers, all registered metalaxyl and mefenoxam product labels with residential use sites (lawns, ornamentals and garden and trees) require that handlers wear specific clothing (e.g., long sleeve shirt/ long pants) and chemical resistance gloves. Therefore, EPA has made the assumption that these products are not for homeowner use, and has not conducted a quantitative residential handler assessment. There is potential for residential postapplication exposures to mefenoxam (metalaxyl-m). Since no dermal endpoints were identified, only incidental oral post-application exposures to small children ages 1 to <2 have been assessed. Metalaxyl and mefenoxam are registered for use on home lawns; therefore, there is the potential for incidental oral exposure (hand-to-mouth, object-to-mouth, soil ingestion and granular ingestion). The recommended residential exposure for use in the children 1 to <2 years old aggregate assessment reflects hand-to-mouth incidental oral exposures from treated turf using a liquid formulation. Ingestion of granules is considered an episodic event and not a routine behavior. Because the Agency E:\FR\FM\21DER1.SGM 21DER1 65544 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES does not believe that this would occur on a regular basis, the concern for human health is related to acute poisoning rather than short-term residue exposure. Therefore, an acute dietary dose is used to estimate exposure and risk resulting from episodic ingestion of granules. For these same reasons, the episodic ingestion scenario was not included in the aggregate assessment. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.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 metalaxyl and mefenoxam and any other substances and metalaxyl and mefenoxam do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that metalaxyl and mefenoxam 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 website at http:// www2.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 FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable VerDate Sep<11>2014 16:23 Dec 20, 2018 Jkt 247001 data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There was no evidence for qualitative or quantitative offspring susceptibility in developmental toxicity studies in rabbits and rats, or in the reproduction and fertility effects study in rats. In adult rats treated with metalaxyl or mefenoxam, clinical signs and abnormal Functional Observation Battery (FOB) findings were noted only after a bolus gavage dose, but not in repeated dose studies. 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 databases for mefenoxam and metalaxyl are complete. ii. In the rat prenatal developmental toxicity with metalaxyl, maternal animals exhibited clinical signs indicative of neurobehavioral effects as previously discussed. In the range-finding acute neurotoxicity study with mefenoxam, females exhibited abnormal functional observation battery (FOB) findings at doses lower than in males. In the subchronic neurotoxicity study with mefenoxam, there were no indications of neurotoxicity up to the HDT. In metalaxyl and mefenoxam treated adult animals, clinical signs and abnormal FOB findings were noted. However, a developmental neurotoxicity (DNT) study is not required for metalaxyl or mefenoxam because (1) there are no indications of increased susceptibility for infants or children; (2) the convulsions observed in the rat prenatal developmental toxicity study occurred in the maternal animals with no effects being observed in the young; (3) the convulsions occurred only after a bolus dose; (4) the available developmental and range-finding acute neurotoxicity studies provided clear NOAELs and LOAELs for evaluating effects; (5) the current POD is below the level at which any effects were seen in either study, and (6) there were no other indications of neurotoxicity in the mefenoxam or metalaxyl databases, which include a subchronic (adult rat) neurotoxicity study for mefenoxam. Therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that mefenoxam or metalaxyl results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2generation reproduction study. PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to mefenoxam and metalaxyl in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by mefenoxam or metalaxyl. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to mefenoxam will occupy 21% of the aPAD for children 1–2 years old, the population group receiving the greatest exposure. 2. Chronic risk. A chronic aggregate risk assessment takes into account chronic exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from repeated exposure was identified and no chronic dietary endpoint was selected. Therefore, mefenoxam is not expected to pose a chronic risk. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Mefenoxam and metalaxyl are currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to mefenoxam and metalaxyl. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 538 for children. E:\FR\FM\21DER1.SGM 21DER1 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations Because EPA’s level of concern for mefenoxam is a MOE of 100 or below, this MOE is not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, mefenoxam is not registered for any use patterns that would result in intermediate-term residential exposure. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, mefenoxam is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to mefenoxam residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methods are available for determination of the residues of concern in crop commodities. The enforcement methods are common moiety methods which determine residues of metalaxyl/ mefenoxam and metabolites that are convertible to 2,6-dimethylaniline (2,6– DMA). These methods include: (1) Method I in PAM, Vol. II (Method AG– 348), which determines residues in plant commodities using a gas-liquid chromatography procedure employing an alkali flame ionization detector (GLC/AFID); (2) Method AG–395 (submitted for inclusion in PAM, Vol. II as Method III), an improved version of Method AG–348, which determines residues in plant commodities using GLC/nitrogen phosphorus detection (NPD); and (3) the multiresidue method in PAM, Vol. I, Section 302 (Protocol D). Method 456–98, a chiral liquid chromatography/mass spectrometric detection (LC/MS) method, is available to distinguish between R- and Senantiomers, to determine whether metalaxyl or mefenoxam was applied. amozie on DSK3GDR082PROD with RULES 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 VerDate Sep<11>2014 16:23 Dec 20, 2018 Jkt 247001 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. No Codex MRLs have been established for wasabi. The tolerances for the fruit, small, vine climbing, except grape, subgroup 13–07E and cacao bean are harmonized with Codex. C. Revisions to Petitioned-For Tolerances The Agency revised the petitioned-for tolerance on cacao to correct for the significant figures based on current practice, and to correct the commodity definition to reflect the common commodity vocabulary currently used by the Agency. V. Conclusion Therefore, tolerances are established for residues of mefenoxam, including its metabolites and degradates, in or on cacao, dried bean at 0.20 ppm; the fruit, small, vine climbing, except grape, subgroup 13–07E at 0.10 ppm; wasabi, stem at 3.0 ppm; and wasabi, tops at 6.0 ppm. Additionally, the existing tolerance for kiwifruit at 0.10 ppm is removed as unnecessary due to the establishment of the new tolerances. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled ‘‘Reducing Regulations and Controlling Regulatory Costs’’ (82 PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 65545 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States 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). E:\FR\FM\21DER1.SGM 21DER1 65546 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations identified and discussed later in this document. Interregional Research Environmental protection, Project No. 4 (IR–4) requested these Administrative practice and procedure, tolerances under the Federal Food, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective requirements. December 21, 2018. Objections and Dated: December 6, 2018, requests for hearings must be received Michael Goodis, on or before February 19, 2019 and must Director, Registration Division, Office of be filed in accordance with the Pesticide Programs. instructions provided in 40 CFR part Therefore, 40 CFR chapter I is 178 (see also Unit I.C. of the amended as follows: SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, PART 180—[AMENDED] identified by docket identification (ID) number EPA–HQ–OPP–2017–0587, is ■ 1. The authority citation for part 180 available at http://www.regulations.gov continues to read as follows: or at the Office of Pesticide Programs Authority: 21 U.S.C. 321(q), 346a and 371. Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency ■ 2. In § 180.546: Docket Center (EPA/DC), West William ■ i. Remove the entry ‘‘Kiwifruit’’ from Jefferson Clinton Bldg., Rm. 3334, 1301 the table in paragraph (a). ■ ii. Add alphabetically the entries Constitution Ave. NW, Washington, DC ‘‘Cacao, dried bean’’; ‘‘Fruit, small, vine 20460–0001. The Public Reading Room climbing, except grape, subgroup 13– is open from 8:30 a.m. to 4:30 p.m., 07E’’; ‘‘Wasabi, stem’’; and ‘‘Wasabi, Monday through Friday, excluding legal tops’’ to the table in paragraph (a). holidays. The telephone number for the The additions read as follows: Public Reading Room is (202) 566–1744, and the telephone number for the OPP § 180.546 Mefenoxam; tolerances for Docket is (703) 305–5805. Please review residues. the visitor instructions and additional (a) * * * information about the docket available at http://www.epa.gov/dockets. Parts per Commodity FOR FURTHER INFORMATION CONTACT: million Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, * * * * * Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC Cacao, dried bean .................... 0.20 20460–0001; main telephone number: (703) 305–7090; email address: * * * * * RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: Fruit, small, vine climbing, exList of Subjects in 40 CFR Part 180 cept grape, subgroup 13–07E amozie on DSK3GDR082PROD with RULES * * * * 0.10 I. General Information * A. Does this action apply to me? You may be potentially affected by Wasabi, stem ............................ 3.0 Wasabi, tops ............................. 6.0 this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following * * * * * list of North American Industrial [FR Doc. 2018–27764 Filed 12–20–18; 8:45 am] Classification System (NAICS) codes is BILLING CODE 6560–50–P not intended to be exhaustive, but rather provides a guide to help readers ENVIRONMENTAL PROTECTION determine whether this document AGENCY applies to them. Potentially affected entities may include: 40 CFR Part 180 • Crop production (NAICS code 111). • Animal production (NAICS code [EPA–HQ–OPP–2017–0587; FRL–9987–34] 112). • Food manufacturing (NAICS code Tolfenpyrad; Pesticide Tolerances 311). AGENCY: Environmental Protection • Pesticide manufacturing (NAICS Agency (EPA). code 32532). ACTION: Final rule. B. How can I get electronic access to This regulation establishes tolerances for residues of tolfenpyrad in or on multiple commodities which are SUMMARY: VerDate Sep<11>2014 16:23 Dec 20, 2018 Jkt 247001 other related information? You may access a frequently updated electronic version of EPA’s tolerance PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 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. To access the OCSPP test guidelines referenced in this document electronically, please go to https:// www.epa.gov/aboutepa/about-officechemical-safety-and-pollutionprevention-ocspp. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2017–0587 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 19, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2017–0587, 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 https:// www.epa.gov/dockets/where-sendcomments-epa-dockets. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http:// www.epa.gov/dockets. E:\FR\FM\21DER1.SGM 21DER1

Agencies

[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Rules and Regulations]
[Pages 65541-65546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27764]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0562; FRL-9985-52]


Mefenoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
mefenoxam in or on cacao bean; the fruit, small, vine climbing, except 
grape, subgroup 13-07E; and wasabi. 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 21, 2018. Objections and 
requests for hearings must be received on or before February 19, 2019, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0562, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at 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-2017-0562 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 19, 2019. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2017-0562, 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 January 26, 2018 (83 FR 3658) (FRL-9971-
46), 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 
7E8610) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide mefenoxam, 
including its metabolites and degradates in or on the raw agricultural 
commodities cacao bean, bean at 0.2 parts per million (ppm); wasabi, 
tops at 6.0 ppm; wasabi, stem at 3.0 ppm; and fruit, small, vine 
climbing, except grape, crop subgroup 13-07E at 0.10 ppm. Additionally, 
the petition requested to amend 40 CFR 180.546 by removing the 
tolerance in or on kiwifruit at 0.10 ppm. That document referenced a 
summary of the petition prepared by Syngenta Crop Protection, the 
registrant, which is available in the docket, http://www.regulations.gov. One comment was received in the docket for the 
notice of filing, but as it raised concerns about the Obama 
Administration's application of the National Environmental Protection 
Agency and Endangered Species Act, it is not relevant to this tolerance 
action.
    Based upon review of the data supporting the petition, EPA has 
modified the commodity definition for cacao and the tolerance level to 
be consistent with the Agency's policy on significant figures.

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

[[Page 65542]]

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Mefenoxam (metalaxyl-m) is a systemic phenylamide fungicide which 
inhibits protein synthesis in fungi. Mefenoxam is an R-isomer enriched 
formulation. Metalaxyl is the racemic R/S isomer formulation. The 
Agency compared the available chemistry and toxicity data for mefenoxam 
and metalaxyl and concluded that metalaxyl data may be used in support 
of mefenoxam regulatory actions because the two chemicals have similar 
toxicity. Therefore, for the purposes of this assessment, mefenoxam 
will refer to both mefenoxam and metalaxyl-m.
    In rat and dog repeat dose (i.e., subchronic and chronic) oral 
toxicity studies, there were no indications of adverse effects up to 
the highest dose tested (HDT). Adverse effects were only observed from 
acute exposure to rats. In the rat developmental toxicity study of 
metalaxyl, maternal toxicity consisted of dose-related increased 
incidence of convulsions that occurred shortly after dosing, as well as 
other clinical signs. In a range-finding acute neurotoxicity study of 
mefenoxam, females showed abnormal functional observation battery (FOB) 
findings at doses lower than males, but higher than the rat 
developmental study. However, there was no indication of toxicity up to 
the HDT in the mefenoxam subchronic neurotoxicity study, which confirms 
the lack of adverse effects observed in all other repeat-dose studies.
    There was no indication of developmental toxicity in studies of 
mefenoxam or metalaxyl. There was no indication of immunotoxicity in a 
mouse immunotoxicity study of mefenoxam. Metalaxyl and mefenoxam have 
been classified as ``not likely to be carcinogenic in humans'' based on 
the results of the carcinogenicity study in mice and the combined 
chronic toxicity and carcinogenicity study in rats.
    All toxicity endpoints and points of departure (PODs) are based on 
convulsions that occurred minutes after dosing in the rat developmental 
toxicity study of metalaxyl. This POD is appropriate for acute, short-
term, and intermediate-term exposure scenarios via the oral and 
inhalation routes. No hazard was identified for chronic or long-term 
exposure scenarios, or for exposure via the dermal route.
    Specific information on the studies received and the nature of the 
adverse effects caused by mefenoxam 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 the document ``Mefenoxam (Metalaxyl-M). Human 
Health Risk Assessment for the Establishment of Permanent Tolerances 
and New Uses in/on Wasabi, Cacao, and Crop Group Expansion from 
Kiwifruit to Fruit, Small, Vine Climbing, Except Grape, Crop Subgroup 
13-07E'' on pages 23-21 in docket ID number EPA-HQ-OPP-2017-0562.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for mefenoxam used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Mefenoxam 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 (All Populations)..  NOAEL = 50 mg/kg/day  Acute RfD = 0.5 mg/  Metalaxyl Prenatal Developmental
                                   UFA = 10x...........   kg/day.              Toxicity--Rat
                                   UFH = 10x...........  aPAD = 0.5 mg/kg/    LOAEL = 250 mg/kg/day
                                   FQPA SF = 1x........   day.                Based on dose-related increases in
                                                                               clinical signs of toxicity (e.g.,
                                                                               post-dosing convulsions).
----------------------------------------------------------------------------------------------------------------

[[Page 65543]]

 
Chronic dietary (All populations)  No endpoint was identified. No systemic toxicity was observed in the
                                    reproduction and fertility effects study or in any of the chronic and
                                    subchronic toxicity studies. Toxicity was only evident in gavage-dosed
                                    animals.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL = 50 mg/kg/day  LOC for MOE = 100..  Metalaxyl Prenatal Developmental
 30 days) and intermediate-term    UFA = 10x...........                        Toxicity--Rat
 (1 to 6 months).                  UFH = 10x...........                       LOAEL = 250 mg/kg/day
                                   FQPA SF = 1x........                       Based on dose-related increases in
                                                                               clinical signs of toxicity (e.g.,
                                                                               post-dosing convulsions).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``not likely to be carcinogenic to humans'' based on
                                    adequately conducted carcinogenicity studies in rats and mice treated with
                                    metalaxyl.
----------------------------------------------------------------------------------------------------------------
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 mefenoxam, EPA considered exposure under the petitioned-for 
tolerances as well as all existing mefenoxam tolerances in 40 CFR 
180.546. EPA assessed dietary exposures from mefenoxam in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for mefenoxam. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture's National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA assumed 100 percent crop treated (PCT), 
DEEM default and empirical processing factors and tolerance level 
residues.
    ii. Chronic exposure. No chronic endpoint was identified and 
therefore no chronic dietary assessment was conducted.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that mefenoxam does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
mefenoxam. Tolerance level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency only considered 
the parent compound metalaxyl as a residue of concern (ROC). Exposure 
modeling for mefenoxam is not necessary because exposure estimates for 
metalaxyl are expected to exceed those for mefenoxam, and the two 
compounds are anticipated to behave identically in the environment. 
Therefore, EDWCs provided for metalaxyl are protective of exposures to 
mefenoxam through drinking water. Maximum annual application rates for 
metalaxyl, up to 12.3 pounds active ingredient/per Acre (lb ai/A), were 
modeled. These rates are approximately twice those of mefenoxam.
    The Agency used screening level water exposure models in the 
dietary exposure analysis and risk assessment for mefenoxam/metalaxyl 
in drinking water. These simulation models take into account data on 
the physical, chemical, and fate/transport characteristics of 
mefenoxam/metalaxyl. Further information regarding EPA drinking water 
models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Water Calculator (PWC version 1.52) the 
estimated drinking water concentrations (EDWCs) of mefenoxam/metalaxyl 
for acute exposures are estimated to be 350 parts per billion (ppb) for 
surface water and 155 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 350 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).
    Mefenoxam and metalaxyl are currently registered for the following 
uses that could result in residential exposures: Lawns, ornamentals, 
gardens, and trees. EPA assessed residential exposure using the 
following assumptions: For residential handlers, all registered 
metalaxyl and mefenoxam product labels with residential use sites 
(lawns, ornamentals and garden and trees) require that handlers wear 
specific clothing (e.g., long sleeve shirt/long pants) and chemical 
resistance gloves. Therefore, EPA has made the assumption that these 
products are not for homeowner use, and has not conducted a 
quantitative residential handler assessment.
    There is potential for residential post-application exposures to 
mefenoxam (metalaxyl-m). Since no dermal endpoints were identified, 
only incidental oral post-application exposures to small children ages 
1 to <2 have been assessed. Metalaxyl and mefenoxam are registered for 
use on home lawns; therefore, there is the potential for incidental 
oral exposure (hand-to-mouth, object-to-mouth, soil ingestion and 
granular ingestion).
    The recommended residential exposure for use in the children 1 to 
<2 years old aggregate assessment reflects hand-to-mouth incidental 
oral exposures from treated turf using a liquid formulation. Ingestion 
of granules is considered an episodic event and not a routine behavior. 
Because the Agency

[[Page 65544]]

does not believe that this would occur on a regular basis, the concern 
for human health is related to acute poisoning rather than short-term 
residue exposure. Therefore, an acute dietary dose is used to estimate 
exposure and risk resulting from episodic ingestion of granules. For 
these same reasons, the episodic ingestion scenario was not included in 
the aggregate assessment.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.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 metalaxyl and mefenoxam 
and any other substances and metalaxyl and mefenoxam do not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
metalaxyl and mefenoxam 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 website at http://www2.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 FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence for 
qualitative or quantitative offspring susceptibility in developmental 
toxicity studies in rabbits and rats, or in the reproduction and 
fertility effects study in rats. In adult rats treated with metalaxyl 
or mefenoxam, clinical signs and abnormal Functional Observation 
Battery (FOB) findings were noted only after a bolus gavage dose, but 
not in repeated dose studies.
    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 databases for mefenoxam and metalaxyl are complete.
    ii. In the rat prenatal developmental toxicity with metalaxyl, 
maternal animals exhibited clinical signs indicative of neurobehavioral 
effects as previously discussed.
    In the range-finding acute neurotoxicity study with mefenoxam, 
females exhibited abnormal functional observation battery (FOB) 
findings at doses lower than in males. In the subchronic neurotoxicity 
study with mefenoxam, there were no indications of neurotoxicity up to 
the HDT. In metalaxyl and mefenoxam treated adult animals, clinical 
signs and abnormal FOB findings were noted. However, a developmental 
neurotoxicity (DNT) study is not required for metalaxyl or mefenoxam 
because (1) there are no indications of increased susceptibility for 
infants or children; (2) the convulsions observed in the rat prenatal 
developmental toxicity study occurred in the maternal animals with no 
effects being observed in the young; (3) the convulsions occurred only 
after a bolus dose; (4) the available developmental and range-finding 
acute neurotoxicity studies provided clear NOAELs and LOAELs for 
evaluating effects; (5) the current POD is below the level at which any 
effects were seen in either study, and (6) there were no other 
indications of neurotoxicity in the mefenoxam or metalaxyl databases, 
which include a subchronic (adult rat) neurotoxicity study for 
mefenoxam. Therefore, there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that mefenoxam or metalaxyl results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to mefenoxam and metalaxyl in drinking water. EPA 
used similarly conservative assumptions to assess post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by mefenoxam or metalaxyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to mefenoxam will occupy 21% of the aPAD for children 1-2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account chronic exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from repeated exposure was 
identified and no chronic dietary endpoint was selected. Therefore, 
mefenoxam is not expected to pose a chronic risk.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Mefenoxam and metalaxyl are currently registered for uses that 
could result in short-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short-term residential exposures to mefenoxam and 
metalaxyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in an aggregate MOE of 538 for 
children.

[[Page 65545]]

Because EPA's level of concern for mefenoxam is a MOE of 100 or below, 
this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
mefenoxam is not registered for any use patterns that would result in 
intermediate-term residential exposure.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, mefenoxam is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to mefenoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determination of the 
residues of concern in crop commodities. The enforcement methods are 
common moiety methods which determine residues of metalaxyl/mefenoxam 
and metabolites that are convertible to 2,6-dimethylaniline (2,6-DMA). 
These methods include: (1) Method I in PAM, Vol. II (Method AG-348), 
which determines residues in plant commodities using a gas-liquid 
chromatography procedure employing an alkali flame ionization detector 
(GLC/AFID); (2) Method AG-395 (submitted for inclusion in PAM, Vol. II 
as Method III), an improved version of Method AG-348, which determines 
residues in plant commodities using GLC/nitrogen phosphorus detection 
(NPD); and (3) the multiresidue method in PAM, Vol. I, Section 302 
(Protocol D). Method 456-98, a chiral liquid chromatography/mass 
spectrometric detection (LC/MS) method, is available to distinguish 
between R- and S-enantiomers, to determine whether metalaxyl or 
mefenoxam was applied.

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.
    No Codex MRLs have been established for wasabi. The tolerances for 
the fruit, small, vine climbing, except grape, subgroup 13-07E and 
cacao bean are harmonized with Codex.

C. Revisions to Petitioned-For Tolerances

    The Agency revised the petitioned-for tolerance on cacao to correct 
for the significant figures based on current practice, and to correct 
the commodity definition to reflect the common commodity vocabulary 
currently used by the Agency.

V. Conclusion

    Therefore, tolerances are established for residues of mefenoxam, 
including its metabolites and degradates, in or on cacao, dried bean at 
0.20 ppm; the fruit, small, vine climbing, except grape, subgroup 13-
07E at 0.10 ppm; wasabi, stem at 3.0 ppm; and wasabi, tops at 6.0 ppm. 
Additionally, the existing tolerance for kiwifruit at 0.10 ppm is 
removed as unnecessary due to the establishment of the new tolerances.

VI. Statutory and Executive Order Reviews

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

[[Page 65546]]

List of Subjects in 40 CFR Part 180

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

    Dated: December 6, 2018,
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.  180.546:
0
i. Remove the entry ``Kiwifruit'' from the table in paragraph (a).
0
ii. Add alphabetically the entries ``Cacao, dried bean''; ``Fruit, 
small, vine climbing, except grape, subgroup 13-07E''; ``Wasabi, 
stem''; and ``Wasabi, tops'' to the table in paragraph (a).
    The additions read as follows:


Sec.  180.546  Mefenoxam; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cacao, dried bean..........................................         0.20
 
                                * * * * *
Fruit, small, vine climbing, except grape, subgroup 13-07E.         0.10
 
                                * * * * *
Wasabi, stem...............................................          3.0
Wasabi, tops...............................................          6.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-27764 Filed 12-20-18; 8:45 am]
 BILLING CODE 6560-50-P