Valifenalate; Pesticide Tolerances, 31214-31219 [2019-13990]

Download as PDF 31214 * Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Rules and Regulations * * * I. General Information * [FR Doc. 2019–13523 Filed 6–28–19; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2017–0417; FRL–9994–93] Valifenalate; Pesticide Tolerances Environmental Protection Agency (EPA). AGENCY: ACTION: Final rule. This regulation establishes tolerances for residues of valifenalate in or on bulb vegetable crop group 3–07, celery, cucurbit vegetables crop group 9, fruiting vegetables crop group 8–10, potato, potato-granules/flakes, and tolerances without U.S. registrations in/ on grape; and grape, raisin. FMC Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: This regulation is effective July 1, 2019. Objections and requests for hearings must be received on or before August 30, 2019 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2017–0417, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. ADDRESSES: khammond on DSKBBV9HB2PROD with RULES FOR FURTHER INFORMATION CONTACT: Mike 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: VerDate Sep<11>2014 15:54 Jun 28, 2019 Jkt 247001 A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2017–0417 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 August 30, 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– 2017–0417, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of November 27, 2017 (82 FR 56017) (FRL–9968–5), 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 7F8582) by FMC Corporation, 1735 Market St., Philadelphia, PA 19103. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide valifenalate, methyl N-(isopropoxycarbonyl)-L-valyl(3RS)-3-(4-chlorophenyl)-b-alainate, in or on bulb vegetable crop group 3–07 at 0.40 parts per million (ppm); celery at 6.0 ppm; cucurbit vegetable crop group 9 at 0.3 ppm; fruiting vegetable crop group 8–10 at 0.60 ppm; potato at 0.04 ppm; potato-chips at 0.05 ppm; potatodried pulp at 0.06 ppm; potato-granules/ flakes at 0.15 ppm; tomato, wet-peel at 1.8 ppm; and a tolerance without U.S. registration in/on grape at 3.0 ppm. After that notice of that petition was published, the petitioner made some revisions to the petition, so EPA issued another document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), in the Federal Register of March 6, 2018 (83 FR 9471) (FRL–9973–27), announcing the new petition requests. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide valifenalate, methyl N(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4chlorophenyl)-b-alainate, in or on bulb vegetable crop group 3–07 at 0.40 ppm; celery at 5.0 ppm; cucurbit vegetable crop group 9 at 0.30 ppm; fruiting vegetable crop group 8–10 at 0.50 ppm; potato at 0.01 ppm; tomato, wet-peel at 0.9 ppm; and a tolerance without U.S. registration in/on grape at 5.0 ppm. Summaries of the petition prepared by FMC Corporation, the registrant, are available in the docket, https:// E:\FR\FM\01JYR1.SGM 01JYR1 Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Rules and Regulations www.regulations.gov. Comments were received on both notices of filing. EPA’s response to these comments is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from the petitioner’s request in accordance with section 408(d)(4(A)(i). 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 valifenalate including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with valifenalate follows. khammond on DSKBBV9HB2PROD with RULES A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The liver and the thyroid are the main target organs for valifenalate. Following subchronic exposures to dogs, treatment-related effects in the liver were observed including alterations in liver enzyme parameters and histopathological findings as well as increased liver weights. Following chronic exposures, liver effects included increased liver weight (dog, mouse, rat) and histopathological findings (mouse and/or dog). In mice, at 78 weeks there were treatment-related liver adenomas and carcinomas in males and liver adenomas in females. Based on available data demonstrating a nongenotoxic mode of action for the liver tumors, valifenalate has been classified as ‘‘not likely to be carcinogenic to humans’’ at dose levels that do not cause a proliferative response in the liver. Increases in absolute and relative thyroid weights and follicular cell hypertrophy were observed in the subchronic and chronic dog studies, in the parental animals in the twogeneration reproduction study in rats and in the combined chronic toxicity/ carcinogenicity study in rats (at 52 weeks). Other effects observed following chronic exposures include decreased prostate and spleen weights in males, decreased ovary weights and lack of corpora lutea in dogs, as well as an increased incidence and severity of pelvic/papillary epithelial hyperplasia in the kidney in rats. There was no evidence of increased susceptibility to the fetus or offspring in the available developmental and reproduction toxicity studies. There were no developmental or maternal effects seen in either the rat or rabbit studies and no offspring effects were observed in the two-generation reproduction study in rats up to the limit dose of 1,000 milligram/kilogram/ day (mg/kg/day). There was also no evidence of neurotoxicity in the database. Valifenalate is categorized as having low acute lethality via oral, inhalation, and dermal routes of exposure. It is not 31215 irritating to the eyes or skin and is not a dermal sensitizer. Specific information on the studies received and the nature of the adverse effects caused by valifenalate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in document Valifenalate. Human Health Risk Assessment for the Section 3 Registration Action of the New Active Ingredient on Bulb Vegetables, Cucurbits, Fruiting Vegetables, Celery, and Potatoes and Establishment of a Tolerance Without U.S. Registration on Grapes in docket ID number EPA–HQ– OPP–2017–0417. 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 the NOAEL and the LOAEL are identified. Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// www.epa.gov/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for valifenalate used for human risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR VALIFENALATE FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/scenario Acute dietary (All Populations) VerDate Sep<11>2014 15:54 Jun 28, 2019 Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Endpoint not selected as there are no adverse effects attributable to a single dose observed in the database. Jkt 247001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\FR\FM\01JYR1.SGM 01JYR1 31216 Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Rules and Regulations TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR VALIFENALATE 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 RfD = 0.22 mg/kg/day. cPAD = 0.22 mg/kg/ day Carcinogenicity—Mouse. LOAEL = 97 mg/kg/day based on an increased absolute and relative liver weights, and hepatocyte hypertrophy as well as an increased incidence of macroscopic liver abnormalities (liver masses, pale areas, accentuated lobular patterns, and increased eosinophilic foci) in both sexes and centrilobular vacuolation in males. Chronic dietary (All populations) NOAEL = 22 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Cancer (Oral, dermal, inhalation). ‘‘Not Likely to be Carcinogenic to Humans’’ at dose levels that do not cause a proliferative response in the liver. 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 (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). khammond on DSKBBV9HB2PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to valifenalate, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from valifenalate in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for valifenalate; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA; 2003–2008). The chronic analysis assumed 100% crop treated, tolerancelevel residues or tolerance-level residues adjusted to account for the residues of concern (ROC) for risk assessment, HED’s 2018 default processing factors, and modeled drinking water estimates. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that the chronic assessment will adequately account for all chronic toxicity, including potential carcinogenicity. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for valifenalate. Tolerance level residues VerDate Sep<11>2014 15:54 Jun 28, 2019 Jkt 247001 or 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for valifenalate in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of valifenalate. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/oppefed1/models/ water/index.htm. Based on the Pesticide Root Zone Model Ground Water (PRZM GW) and Pesticide Root Zone Model 5—Variable Volume Water Model (PRZM5-VVWM), the estimated drinking water concentrations (EDWCs) of valifenalate for acute exposures are estimated to be 2.6 parts per billion (ppb) for surface water and 0.05 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 2.6 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). Valifenalate is not registered for any specific use patterns that would result in residential. 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 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found valifenalate to share a common mechanism of toxicity with any other substances, and valifenalate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that valifenalate 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 website at https:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (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 was no evidence of increased quantitative or qualitative susceptibility in the developmental toxicity studies in E:\FR\FM\01JYR1.SGM 01JYR1 Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Rules and Regulations rabbits or rats or the reproduction toxicity study in rats. 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 valifenalate is complete. ii. There is no indication that valifenalate is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity. iii. There is no evidence that valifenalate 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 and upper bound drinking water residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to valifenalate in drinking water. These assessments will not underestimate the exposure and risks posed by valifenalate. khammond on DSKBBV9HB2PROD with RULES E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, valifenalate is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to valifenalate from food and water will utilize 8.6% of the cPAD for children 1–2 years old, the population group receiving the greatest VerDate Sep<11>2014 15:54 Jun 28, 2019 Jkt 247001 exposure. There are no residential uses for valifenalate. 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). A short-term adverse effect was identified; however, valifenalate is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for valifenalate. 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, valifenalate is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediateterm residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for valifenalate. 5. Aggregate cancer risk for U.S. population. EPA concludes that aggregate cancer risk for valifenalate has been accounted for the chronic risk assessment, which does not present a risk of concern. Therefore, EPA concludes that aggregate exposure to valifenalate does not pose a cancer risk. 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 valifenalate residues. PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 31217 IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (liquid chromotography with tandem mass spectrometry (LC/MS/MS)) is available to enforce the tolerance expression. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established MRLs for valifenalate in or on the relevant commodities. C. Response to Comments The EPA received several comments during the two 30-day comment periods following the publication of the two notices of filing. All the comments were anonymous public comments. Four comments raised issues related to pesticides, while the remainder raised issues unrelated to pesticides, and thus unrelated to this rulemaking. Of the four comments related to pesticides, one expressed concern about farmworker health, which is not an issue relevant to the assessment of the safety of the tolerances under the FFDCA. The three remaining comments expressed general concern about the potential of pesticide residues in food, although none provided any substantive information to take into consideration in EPA’s safety assessment. The FFDCA authorizes EPA to establish tolerances that permit certain levels of pesticide residues in or on food when the Agency can determine that such residues are safe. EPA has made that determination for the tolerances subject to this action; commenters provided no information relevant to that conclusion. E:\FR\FM\01JYR1.SGM 01JYR1 31218 Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Rules and Regulations D. Revisions to Petitioned-For Tolerances Based on available residue data and using the OECD tolerance calculation procedure, EPA is establishing tolerance values for several commodities that vary slightly from what the petition requested. In addition, EPA has determined based on available data that the tolerance requested for tomato, wet peel is not necessary as residues will be covered by the fruiting vegetables crop group tolerance. Finally, EPA is establishing a separate tolerance for grape, raisin, and for potato, granules/ flakes because the application of processing factors indicates that residues are likely to concentrate in these processed commodities of the raw agricultural commodities on which valifenalate will be used. V. Conclusion Therefore, tolerances are established for residues of valifenalate in or on celery at 5 ppm; grape at 5 ppm; grape, raisin at 6 ppm; potato at 0.04 ppm; potato, granules/flakes at 0.09 ppm; vegetable, bulb, group 3–07 at 0.6 ppm; vegetable, cucurbit, group 9 at 0.3 ppm; vegetable, fruiting, group 8–10 at 1 ppm. khammond on DSKBBV9HB2PROD with RULES 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 VerDate Sep<11>2014 15:54 Jun 28, 2019 Jkt 247001 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). Dated: June 25, 2019. Richard Keigwin, Director, Office of Pesticide Programs, US Environmental Protection Agency. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Add § 180.706 to subpart C to read as follows: ■ § 180.706 Valifenalate; tolerances for residues. (a)(1) Tolerances are established for residues of the fungicide valifenalate, including its metabolites and degradates, in or on the following commodities. Compliance with the tolerance levels is to be determined by measuring only valifenalate (methyl N(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4chlorophenyl)-b-alainate), in or on the following commodities. Commodity Celery ......................................... Grape 1 ........................................ Grape, raisin 1 ............................. Vegetable, bulb, group 3–07 ...... Vegetable, cucurbit, group 9 ...... Vegetable, fruiting, group 8–10 .. Parts per million 5 5 6 0.6 0.3 1 1 As of July 1, 2019, valifenalate is not registered in the United States for use on this commodity. (2) Tolerances are established for residues of the fungicide valifenalate, including its metabolites and degradates, in or on the following commodities. Compliance with the tolerance levels is to be determined by measuring only the sum of valifenalate, methyl N-(isopropoxycarbonyl)-L-valyl(3RS)-3-(4-chlorophenyl)-b-alainate and valifenalate acid, 3-(4-chlorophenyl)-3[[N-(isopropoxycarbonyl)-L-valyl]amino] propionic acid calculated as the stoichiometric equivalent of valifenalate, in or on the following commodities. Commodity Parts per million List of Subjects in 40 CFR Part 180 Potato ......................................... Potato, granules/flakes ............... Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\FR\FM\01JYR1.SGM 01JYR1 0.04 0.09 Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Rules and Regulations (d) Indirect or inadvertent residues. [Reserved] * * * * * [FR Doc. 2019–13990 Filed 6–28–19; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF THE INTERIOR Bureau of Land Management 43 CFR Part 3830 [LLWO320000–L1999000.PP0000] RIN 1004–AE64 Required Fees for Mining Claims or Sites Bureau of Land Management, Interior. ACTION: Final rule. AGENCY: The Bureau of Land Management (BLM) is issuing this final rule to make statutorily required adjustments to its location and maintenance fees for unpatented mining claims, mill sites, and tunnel sites. These adjustments reflect changes in the Consumer Price Index (CPI), which is published by the Bureau of Labor Statistics. SUMMARY: DATES: The final rule is effective July 1, 2019. ADDRESSES: khammond on DSKBBV9HB2PROD with RULES Mail: Director (630), Bureau of Land Management, U.S. Department of the Interior, 1849 C St. NW, Washington, DC 20240, Attention: ‘‘RIN 1004–AE64’’. Personal or messenger delivery: U.S. Department of the Interior, Bureau of Land Management, 20 M St. SE, Room 2134LM, Attention: Regulatory Affairs, Washington, DC 20003. FOR FURTHER INFORMATION CONTACT: Elaine Guenaga at (775) 861–6539 in the Solid Minerals Group as to program matters or the substance of the final rule, or Chandra Little in the Division of Regulatory Affairs at (202) 912–7403 for information relating to the rulemaking process generally. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877– 8339, 24 hours a day, seven days a week to contact the above individuals. SUPPLEMENTARY INFORMATION: I. Background II. Discussion of the Administrative Final Rule III. Procedural Matters I. Background The Mining Law of 1872 allows individuals and corporations to stake (or ‘‘locate’’) a claim on the deposits VerDate Sep<11>2014 15:54 Jun 28, 2019 Jkt 247001 discovered. Historically, annual assessment work and related filings have been required by statute in order to maintain an unpatented mining claim or site. 30 U.S.C. 28–28e; 43 U.S.C. 1744(a) and (c). Beginning in fiscal year 1993, mining claimants have been required to pay an annual fee in lieu of performing annual assessment work and making annual filings. Mining claimants locating new claims or sites must pay an initial ‘‘maintenance’’ fee for the assessment year in which the mining claim was located, and also pay a one-time location fee. See 30 U.S.C. 28f–28l. This rule implements 30 U.S.C. 28j(c), which requires adjustments to the location and maintenance fees ‘‘to reflect changes in the Consumer Price Index (CPI) published by the Bureau of Labor Statistics of the Department of Labor every 5 years after August 10, 1993, or more frequently if the Secretary determines an adjustment to be reasonable.’’ Section 28j(c) also requires that mining claimants be provided ‘‘notice of any adjustment made under this subsection not later than July 1 of any year in which the adjustment is made,’’ and that any fee adjustment ‘‘shall begin to apply the first assessment year which begins after adjustment is made.’’ As enacted in 1993, the one-time location fee was $25, and the annual maintenance fee was $100 per mining claim or site. In 2004, the BLM increased the amount of the location and maintenance fees to $30 and $125 respectively, based on the change in the CPI from September 1, 1993 to December 31, 2003. (69 FR 40294–40296 (July 1, 2004)). In 2009, the BLM increased the amount of the location and maintenance fees to $34 and $140, respectively, based on the change in the CPI from December 31, 2003, to December 31, 2008. (74 FR 30959). On July 27, 2012, the BLM issued a rule (77 FR 44155 (July 27, 2012)), that also amended 43 CFR 3830.21, based on a law that changed the way the maintenance fee is calculated for unpatented placer mining claims. Then in 2014, the BLM increased the amount of the location fee to $37, and increased the maintenance fee to $155 for lode mining claims or sites, and $155 for each 20 acres or portion thereof for placer mining claims, based on the change in the CPI from December 31, 2008, to December 31, 2013. (79 FR 36662). The adjustments made in this rule are based upon the change in the CPI from December 31, 2013, to December 31, 2018, as reported by the Bureau of Labor Statistics (BLS) in the ‘‘CPI Databases’’ PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 31219 (https://www.bls.gov/cpi/data.htm). The particular series used for this update is the ‘‘All Urban Consumers (Current Series) (Consumer Price Index—CPI– U).’’ This is a change from the last adjustment to these fees, made in 2014. The BLM decided to use the CPI–U series as the basis for this update (instead of the Chain CPI for All Urban Consumers (C–CPI–U)), because the release of the CPI–U data is final and timely and because it is the more common series used by Federal agencies for this type of exercise. By contrast, using the C–CPI–U series would necessitate the use of preliminary data. See the Economic and Threshold Analysis for this rule for further explanation of this change. The calculated change is 7.80 percent from December 31, 2013, through December 31, 2018. A calculated value for the fees was obtained by inflating the location and maintenance fees established in the 2014 rulemaking by 7.80 percent. The new location fee is $40, and the new maintenance fee is $165 per lode mining claim or site and $165 for each 20 acres or portion thereof for placer mining claims. The new location fee is based on rounding the calculated value to the nearest $1. The maintenance fee is based on rounding the calculated value to the nearest $5. Mining claimants must pay the new location fee and maintenance fee for any mining claim or site located on or after September 1, 2019. Mining claimants must pay the new maintenance fee to maintain existing mining claims and sites beginning with the 2020 maintenance year. The maintenance fee is due on or before September 1, 2019. Under 43 CFR 3834.23(d), mining claimants who have already submitted maintenance fees for the 2020 assessment year, and those who timely pay the 2020 assessment year maintenance fee based on the fee in effect immediately before the adjustment was made, will be given an opportunity to pay the additional amount without penalty upon notice from the BLM. The BLM will also give claimants the opportunity to cure deficient maintenance and location fee payments for new claims or sites located on or after September 1, 2019, and timely received on or before December 31, 2019. II. Discussion of the Administrative Final Rule Why the Rule Is Being Published on a Final Basis The BLM is adopting this final rule solely to adjust the location and maintenance fee amounts in section E:\FR\FM\01JYR1.SGM 01JYR1

Agencies

[Federal Register Volume 84, Number 126 (Monday, July 1, 2019)]
[Rules and Regulations]
[Pages 31214-31219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13990]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0417; FRL-9994-93]


Valifenalate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
valifenalate in or on bulb vegetable crop group 3-07, celery, cucurbit 
vegetables crop group 9, fruiting vegetables crop group 8-10, potato, 
potato-granules/flakes, and tolerances without U.S. registrations in/on 
grape; and grape, raisin. FMC Corporation requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 1, 2019. Objections and 
requests for hearings must be received on or before August 30, 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-2017-0417, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Mike 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: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0417 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 
August 30, 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-2017-0417, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of November 27, 2017 (82 FR 56017) (FRL-
9968-5), 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 
7F8582) by FMC Corporation, 1735 Market St., Philadelphia, PA 19103. 
The petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the fungicide valifenalate, methyl N-
(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-[beta]-alainate, 
in or on bulb vegetable crop group 3-07 at 0.40 parts per million 
(ppm); celery at 6.0 ppm; cucurbit vegetable crop group 9 at 0.3 ppm; 
fruiting vegetable crop group 8-10 at 0.60 ppm; potato at 0.04 ppm; 
potato-chips at 0.05 ppm; potato-dried pulp at 0.06 ppm; potato-
granules/flakes at 0.15 ppm; tomato, wet-peel at 1.8 ppm; and a 
tolerance without U.S. registration in/on grape at 3.0 ppm. After that 
notice of that petition was published, the petitioner made some 
revisions to the petition, so EPA issued another document pursuant to 
FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), in the Federal Register 
of March 6, 2018 (83 FR 9471) (FRL-9973-27), announcing the new 
petition requests. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the fungicide 
valifenalate, methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-
chlorophenyl)-[beta]-alainate, in or on bulb vegetable crop group 3-07 
at 0.40 ppm; celery at 5.0 ppm; cucurbit vegetable crop group 9 at 0.30 
ppm; fruiting vegetable crop group 8-10 at 0.50 ppm; potato at 0.01 
ppm; tomato, wet-peel at 0.9 ppm; and a tolerance without U.S. 
registration in/on grape at 5.0 ppm.
    Summaries of the petition prepared by FMC Corporation, the 
registrant, are available in the docket, https://

[[Page 31215]]

www.regulations.gov. Comments were received on both notices of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary from the petitioner's request in 
accordance with section 408(d)(4(A)(i). 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 valifenalate including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with valifenalate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The liver and the thyroid are the main target organs for 
valifenalate. Following subchronic exposures to dogs, treatment-related 
effects in the liver were observed including alterations in liver 
enzyme parameters and histopathological findings as well as increased 
liver weights. Following chronic exposures, liver effects included 
increased liver weight (dog, mouse, rat) and histopathological findings 
(mouse and/or dog). In mice, at 78 weeks there were treatment-related 
liver adenomas and carcinomas in males and liver adenomas in females. 
Based on available data demonstrating a non-genotoxic mode of action 
for the liver tumors, valifenalate has been classified as ``not likely 
to be carcinogenic to humans'' at dose levels that do not cause a 
proliferative response in the liver.
    Increases in absolute and relative thyroid weights and follicular 
cell hypertrophy were observed in the subchronic and chronic dog 
studies, in the parental animals in the two-generation reproduction 
study in rats and in the combined chronic toxicity/carcinogenicity 
study in rats (at 52 weeks). Other effects observed following chronic 
exposures include decreased prostate and spleen weights in males, 
decreased ovary weights and lack of corpora lutea in dogs, as well as 
an increased incidence and severity of pelvic/papillary epithelial 
hyperplasia in the kidney in rats.
    There was no evidence of increased susceptibility to the fetus or 
offspring in the available developmental and reproduction toxicity 
studies. There were no developmental or maternal effects seen in either 
the rat or rabbit studies and no offspring effects were observed in the 
two-generation reproduction study in rats up to the limit dose of 1,000 
milligram/kilogram/day (mg/kg/day). There was also no evidence of 
neurotoxicity in the database.
    Valifenalate is categorized as having low acute lethality via oral, 
inhalation, and dermal routes of exposure. It is not irritating to the 
eyes or skin and is not a dermal sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by valifenalate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document Valifenalate. Human Health Risk 
Assessment for the Section 3 Registration Action of the New Active 
Ingredient on Bulb Vegetables, Cucurbits, Fruiting Vegetables, Celery, 
and Potatoes and Establishment of a Tolerance Without U.S. Registration 
on Grapes in docket ID number EPA-HQ-OPP-2017-0417.

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 the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological 
endpoints for valifenalate used for human risk assessment is shown in 
Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Valifenalate 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)..  Endpoint not selected as there are no adverse effects attributable to a
                                    single dose observed in the database.
----------------------------------------------------------------------------------------------------------------

[[Page 31216]]

 
Chronic dietary (All populations)  NOAEL = 22 mg/kg/day  Chronic RfD = 0.22   Carcinogenicity--Mouse.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 97 mg/kg/day based on an
                                   UFH = 10x...........  cPAD = 0.22 mg/kg/    increased absolute and relative
                                   FQPA SF = 1x........   day.                 liver weights, and hepatocyte
                                                                               hypertrophy as well as an
                                                                               increased incidence of
                                                                               macroscopic liver abnormalities
                                                                               (liver masses, pale areas,
                                                                               accentuated lobular patterns, and
                                                                               increased eosinophilic foci) in
                                                                               both sexes and centrilobular
                                                                               vacuolation in males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  ``Not Likely to be Carcinogenic to Humans'' at dose levels that do not cause
                                    a proliferative response in the liver.
----------------------------------------------------------------------------------------------------------------
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 (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 valifenalate, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from valifenalate in 
food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for valifenalate; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA National 
Health and Nutrition Examination Survey, What We Eat in America 
(NHANES/WWEIA; 2003-2008). The chronic analysis assumed 100% crop 
treated, tolerance-level residues or tolerance-level residues adjusted 
to account for the residues of concern (ROC) for risk assessment, HED's 
2018 default processing factors, and modeled drinking water estimates.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that the chronic assessment will adequately account for all 
chronic toxicity, including potential carcinogenicity. Therefore, a 
dietary exposure assessment for the purpose of assessing cancer risk is 
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for valifenalate. Tolerance level residues or 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for valifenalate in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of valifenalate. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW) and 
Pesticide Root Zone Model 5--Variable Volume Water Model (PRZM5-VVWM), 
the estimated drinking water concentrations (EDWCs) of valifenalate for 
acute exposures are estimated to be 2.6 parts per billion (ppb) for 
surface water and 0.05 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 2.6 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). Valifenalate is not 
registered for any specific use patterns that would result in 
residential.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found valifenalate to share a common mechanism of 
toxicity with any other substances, and valifenalate does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
valifenalate 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 website at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (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 was no evidence of 
increased quantitative or qualitative susceptibility in the 
developmental toxicity studies in

[[Page 31217]]

rabbits or rats or the reproduction toxicity study in rats.
    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 valifenalate is complete.
    ii. There is no indication that valifenalate is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that valifenalate 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 and upper bound drinking water 
residues. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to valifenalate in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by valifenalate.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
valifenalate is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
valifenalate from food and water will utilize 8.6% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for valifenalate.
    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). A short-term 
adverse effect was identified; however, valifenalate is not registered 
for any use patterns that would result in short-term residential 
exposure. Short-term risk is assessed based on short-term residential 
exposure plus chronic dietary exposure. Because there is no short-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess short-term risk), no further 
assessment of short-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short-term risk for 
valifenalate.
    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, 
valifenalate is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
valifenalate.
    5. Aggregate cancer risk for U.S. population. EPA concludes that 
aggregate cancer risk for valifenalate has been accounted for the 
chronic risk assessment, which does not present a risk of concern. 
Therefore, EPA concludes that aggregate exposure to valifenalate does 
not pose a cancer risk.
    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 valifenalate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromotography with tandem 
mass spectrometry (LC/MS/MS)) is available to enforce the tolerance 
expression.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established MRLs for valifenalate in or on the 
relevant commodities.

C. Response to Comments

    The EPA received several comments during the two 30-day comment 
periods following the publication of the two notices of filing. All the 
comments were anonymous public comments. Four comments raised issues 
related to pesticides, while the remainder raised issues unrelated to 
pesticides, and thus unrelated to this rulemaking. Of the four comments 
related to pesticides, one expressed concern about farmworker health, 
which is not an issue relevant to the assessment of the safety of the 
tolerances under the FFDCA. The three remaining comments expressed 
general concern about the potential of pesticide residues in food, 
although none provided any substantive information to take into 
consideration in EPA's safety assessment. The FFDCA authorizes EPA to 
establish tolerances that permit certain levels of pesticide residues 
in or on food when the Agency can determine that such residues are 
safe. EPA has made that determination for the tolerances subject to 
this action; commenters provided no information relevant to that 
conclusion.

[[Page 31218]]

D. Revisions to Petitioned-For Tolerances

    Based on available residue data and using the OECD tolerance 
calculation procedure, EPA is establishing tolerance values for several 
commodities that vary slightly from what the petition requested. In 
addition, EPA has determined based on available data that the tolerance 
requested for tomato, wet peel is not necessary as residues will be 
covered by the fruiting vegetables crop group tolerance. Finally, EPA 
is establishing a separate tolerance for grape, raisin, and for potato, 
granules/flakes because the application of processing factors indicates 
that residues are likely to concentrate in these processed commodities 
of the raw agricultural commodities on which valifenalate will be used.

V. Conclusion

    Therefore, tolerances are established for residues of valifenalate 
in or on celery at 5 ppm; grape at 5 ppm; grape, raisin at 6 ppm; 
potato at 0.04 ppm; potato, granules/flakes at 0.09 ppm; vegetable, 
bulb, group 3-07 at 0.6 ppm; vegetable, cucurbit, group 9 at 0.3 ppm; 
vegetable, fruiting, group 8-10 at 1 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is 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).

List of Subjects in 40 CFR Part 180

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

    Dated: June 25, 2019.
Richard Keigwin,
Director, Office of Pesticide Programs, US Environmental Protection 
Agency.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. Add Sec.  180.706 to subpart C to read as follows:


Sec.  180.706  Valifenalate; tolerances for residues.

    (a)(1) Tolerances are established for residues of the fungicide 
valifenalate, including its metabolites and degradates, in or on the 
following commodities. Compliance with the tolerance levels is to be 
determined by measuring only valifenalate (methyl N-
(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-[beta]-alainate), 
in or on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Celery......................................................           5
Grape \1\...................................................           5
Grape, raisin \1\...........................................           6
Vegetable, bulb, group 3-07.................................         0.6
Vegetable, cucurbit, group 9................................         0.3
Vegetable, fruiting, group 8-10.............................           1
------------------------------------------------------------------------
\1\ As of July 1, 2019, valifenalate is not registered in the United
  States for use on this commodity.

    (2) Tolerances are established for residues of the fungicide 
valifenalate, including its metabolites and degradates, in or on the 
following commodities. Compliance with the tolerance levels is to be 
determined by measuring only the sum of valifenalate, methyl N-
(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-[beta]-alainate 
and valifenalate acid, 3-(4-chlorophenyl)-3-[[N-(isopropoxycarbonyl)-L-
valyl]-amino] propionic acid calculated as the stoichiometric 
equivalent of valifenalate, in or on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Potato......................................................        0.04
Potato, granules/flakes.....................................        0.09
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 31219]]

    (d) Indirect or inadvertent residues. [Reserved]
* * * * *
[FR Doc. 2019-13990 Filed 6-28-19; 8:45 am]
BILLING CODE 6560-50-P
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