Mefentrifluconazole; Pesticide Tolerances, 70997-71001 [2020-24467]

Download as PDF Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2020–0068; FRL–10015–56] Mefentrifluconazole; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for residues of mefentrifluconazole in or on multiple commodities that are identified and discussed later in this document. BASF Corporation requested these tolerances under section 346a of the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 6, 2020. Objections and requests for hearings must be received on or before January 5, 2021 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–2020–0068, 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 note that due to the public health crisis, visitor access to the Public Reading Room and OPP Docket are subject to restrictions. Please review the visitor instructions and additional information about the docket available at https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305– 8578; 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 VerDate Sep<11>2014 17:13 Nov 05, 2020 Jkt 253001 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 Publishing Office’s eCFR 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–2020–0068 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 January 5, 2021. 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– 2020–0068, 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. PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 70997 • 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. Due to the public health concerns related to COVID–19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of April 15, 2020 (85 FR 20910) (FRL–10006–54), 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 9F8796) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, North Carolina 27709–3528. The petition requested that 40 CFR 180.705 be amended by establishing tolerances for residues of the fungicide mefentrifluconazole, a-[4-(4chlorophenoxy)-2(trifluoromethyl)phenyl]-a-methyl-1H1,2,4-triazole-1-ethanol, in or on berry, low growing, subgroup 13–07G at 2 parts per million (ppm); bushberry, subgroup 13–07B at 5 ppm; caneberry, subgroup 13–07A at 3 ppm; cattle, fat at 0.8 ppm; cattle, kidney at 0.6 ppm; cattle, liver at 1.5 ppm; cattle, meat at 0.07 ppm; cattle, meat byproducts at 1.5 ppm; cotton, gin byproducts at 10 ppm; cottonseed subgroup 20C at 0.2 ppm; egg at 0.01 ppm; goat, fat at 0.8 ppm; goat, kidney at 0.6 ppm; goat, liver at 1.5 ppm; goat, meat at 0.07 ppm; goat, meat byproducts at 1.5 ppm; grass, crop group 17, forage at 50 ppm; grass, crop group 17, hay at 100 ppm; hog, fat at 0.02 ppm; hog, kidney at 0.03 ppm; hog, liver at 0.03 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.03 ppm; horse, fat at 0.8 ppm; horse, kidney at 0.6 ppm; horse, liver at 1.5 ppm; horse, meat at 0.07 ppm; horse, meat byproducts at 1.5 ppm; melon subgroup 9A at 0.5 ppm; milk at 0.09 ppm; milk fat at 2.4 ppm; non-grass animal feed, forage, crop group 18 at 15 ppm; nongrass animal feed, hay, crop group 18 at 40 ppm; onion, bulb, subgroup 3–07A at 0.2 ppm; onion, green, subgroup 3–07B at 4 ppm; poultry, fat at 0.015 ppm; poultry, liver at 0.01 ppm; poultry, meat E:\FR\FM\06NOR1.SGM 06NOR1 70998 Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Rules and Regulations at 0.015 ppm; poultry, meat byproducts at 0.015 ppm; sheep, fat at 0.8 ppm; sheep, kidney at 0.6 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.07 ppm; sheep, meat byproducts at 1.5 ppm; squash/cucumber subgroup 9B at 0.15 ppm; sugarcane, cane at 1.5 ppm; sunflower subgroup 20B at 0.15 ppm; tomato, dried at 5 ppm; vegetable, leafy, except brassica, crop group 4–16 at 30 ppm; vegetables, fruiting, crop group 8– 10 at 0.9 ppm; vegetable, leaves of root and tuber, crop group 2 at 20 ppm; and vegetable, root, except sugar beet, subgroup 1B at 0.7 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA is establishing several tolerances at different levels than the petitioned-for tolerances and revised some commodity definitions. In addition, EPA is not establishing several tolerances that were petitioned-for. 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 mefentrifluconazole including exposure resulting from the tolerances established VerDate Sep<11>2014 17:13 Nov 05, 2020 Jkt 253001 by this action. EPA’s assessment of exposures and risks associated with mefentrifluconazole follows. On June 28, 2019, EPA published in the Federal Register a final rule establishing tolerances for residues of mefentrifluconazole in or on many animal, corn, fruit, grain, nut and vegetable commodities based on the Agency’s conclusion that aggregate exposure to mefentrifluconazole is safe for the general population, including infants and children. See (84 FR 30939) (FRL–9994–51). EPA is incorporating the following portions of that document by reference here, as they have not changed in the Agency’s current assessment of mefentrifluconazole tolerances: The toxicological profile and points of departure, the cancer assessment, the conclusions about cumulative risk, and the Agency’s determination regarding the children’s safety factor. Additionally, EPA is incorporating the assumptions for exposure assessment from the June 28, 2019 final rule including the estimated drinking water concentrations, which have not changed except as explained in the following paragraph. EPA’s dietary (food and drinking water) exposure assessments have been updated to include the additional exposure from the new uses of mefentrifluconazole on root and tuber vegetables (crop group 1B), leaves of root and tuber vegetables (crop group 2), leafy vegetables (crop group 4–16), fruiting vegetables (crop group 8–10), cucurbit vegetables (crop group 9), berries (subgroups 13–07A, 13–07B, and 13–07G), grasses (crop group 17), nongrass animal feeds (crop group 18), sunflower (crop group 20B), and cotton (crop group 20C). EPA conducted an unrefined acute dietary (food and drinking water) exposure and risk assessment that incorporates tolerancelevel residue values, 100% crop treated, and EPA’s 2018 default processing factors. EPA conducted a partially refined chronic dietary (food and drinking water) exposure and risk assessment that incorporates 100% crop treated, empirical processing factors (when available), and average field trial residues for some commodities. As required under FFDCA 408(b)(2)(E), when EPA relies on anticipated residue data for supporting tolerances, EPA will require submission of data to demonstrate that the levels in food are not above the levels anticipated no later than 5 years from the date of issuance of these tolerances. Acute dietary (food and drinking water) risks are below the Agency’s level of concern of 100% of the acute population-adjusted dose (aPAD): They PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 are less than 5.4% of the aPAD for females 13 to 49 years old, the only population group of concern. Chronic dietary risks are below the Agency’s level of concern of 100% of the chronic population-adjusted dose (cPAD): They are less than 73% of the cPAD for children 1 to 2 years old, the population subgroup with the highest exposure estimate. There are no handler or postapplication residential exposures anticipated from the new uses of mefentrifluconazole. However, the currently registered use on golf courses will result in short-term (1 to 30 days) residential post-application dermal exposures to adults, youth 11 to less than 16 years old, and children 6 to less than 11 years old. For aggregate risk assessment, the acute and chronic aggregate risk assessments include dietary (food and drinking water) exposures only; therefore, the acute and chronic aggregate assessments are equivalent to the acute and chronic dietary assessments, respectively, and are not of concern. The short-term aggregate risk assessment includes residential exposures (golfing activities on previously treated turf) and average dietary exposures. The short-term aggregate margins of exposure (MOEs) for adults (830) and children (6 to less than 11 years old, 640) are not of concern because they exceed EPA’s level of concern (MOEs less than 100). Therefore, there are no acute, chronic, or short-term aggregate risk estimates of concern for mefentrifluconazole. Based on the information summarized in this unit and in the supporting risk assessment, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to mefentrifluconazole residues. More detailed information can be found in the document titled ‘‘Mefentrifluconazole. Human Health Risk Assessment in Support of the Petition for the Establishment of Permanent Tolerances and Registration for Use on Root and Tuber Vegetables (Crop Group 1B); Leaves of Root and Tuber Vegetables (Crop Group 2); Leafy Vegetables (Crop Group 4–16); Fruiting Vegetables (Crop Group 8–10); Cucurbit Vegetables (Crop Group 9); Berries (Subgroups 13–07A, 13–07B, and 13– 07G), Grasses (Crop Group 17); NonGrass Animal Feeds (Crop Group 18); Sunflower (Crop Group 20B); and Cotton (Crop Group 20C),’’ dated October 9, 2020 in docket ID EPA–HQ– OPP–2020–0068. E:\FR\FM\06NOR1.SGM 06NOR1 Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Rules and Regulations IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodologies are available to enforce the tolerance expression. Multi-residue method QuEChERS (BASF method L0295/01) is the enforcement method for the determination of mefentrifluconazole residues in plant matrices. BASF Analytical Method No. L0272/01 is the enforcement method for the determination of residues of mefentrifluconazole in livestock commodities by liquid chromatography with tandem mass spectroscopy (LC– MS/MS). The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@ epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex has not established MRLs for mefentrifluconazole. C. Revisions to Petitioned-For Tolerances EPA revised the commodity definitions for animal feed, nongrass, group 18, forage; animal feed, nongrass, group 18, hay; grass, forage, fodder and hay, group 17, forage; grass, forage, fodder and hay, group 17, hay; milk, fat; vegetable, leafy, group 4–16; vegetable, fruiting, group 8–10; and vegetable, leaves of root and tuber, group 2. In addition, EPA determined that separate tolerances were not needed for the petitioned-for commodities for cattle, kidney at 0.6 ppm; cattle, liver at 1.5 ppm; goat, kidney at 0.6 ppm; goat, liver at 1.5 ppm; hog, kidney at 0.03 ppm; hog, liver at 0.03 ppm; horse; kidney at 0.6 ppm; horse, liver at 1.5 ppm; poultry, liver at 0.01 ppm; sheep, kidney at 0.6 ppm; and sheep, liver at 1.5 ppm because they are covered under their respective petitioned-for meat byproducts commodities. Both the petitioner and EPA used the Organization for Economic Co-operation and Development (OECD) maximum residue limit (MRL) calculation procedures; however, differences were noted in the process for inputting the VerDate Sep<11>2014 17:13 Nov 05, 2020 Jkt 253001 data. The petitioner appears to have inputted individual sample values, whereas EPA used the field trial average values per the OECD standard operating procedure (SOP). The petitioner also appears to have combined the results of residue data from the individual crops in a crop group for calculation of the crop group tolerance, whereas EPA calculated values for each crop individually. Based on these differences, EPA is establishing the tolerances for animal feed, nongrass, group 18, hay at 30 ppm (instead of 40 ppm) and for squash/cucumber subgroup 9B at 0.2 ppm (instead of 0.15 ppm). For livestock commodities, both the petitioner and EPA used the Langmuir Model (ver. 1.4) to calculate all tolerance levels. In some cases, the values determined by EPA were higher than those determined by the petitioner. It is possible that the petitioner used average values from the livestock feeding studies, while the EPA used maximum values. Therefore, EPA determined the tolerances should be set at different levels for the following commodities (with the petitioned-for level in parentheses): Cattle, goat, horse and sheep, fat at 1 ppm (0.8 ppm); cattle, goat, horse and sheep, meat at 0.15 ppm (0.07 ppm); hog, fat at 0.015 ppm (0.02 ppm); milk at 0.15 ppm (0.09 ppm); and milk, fat at 4 ppm (2.4 ppm). In addition, the tolerance for tomato, dried is being established at 4 ppm because EPA used the median processing factor while the petitioner proposed 5 ppm based on the average processing factor. Finally, EPA is setting a separate tolerance for lettuce, head at 5 ppm because it is more than 5 times less than the tolerance for vegetable, leafy, group 4–16 at 30 ppm. V. Conclusion Therefore, tolerances are established for residues of mefentrifluconazole, a[4-(4-chlorophenoxy)-2(trifluoromethyl)phenyl]-a-methyl-1H1,2,4-triazole-1-ethanol, in or on Animal feed, nongrass, group 18, forage at 15 ppm; Animal feed, nongrass, group 18, hay at 30 ppm; Berry, low growing, subgroup 13–07G at 2 ppm; Bushberry, subgroup 13–07B at 5 ppm; Caneberry, subgroup 13–07A at 3 ppm; Cotton, gin byproducts at 10 ppm; Cottonseed subgroup 20C at 0.2 ppm; Grass, forage, fodder and hay, group 17, forage at 50 ppm; Grass, forage, fodder and hay, group 17, hay at 100 ppm; Lettuce, head at 5 ppm; Melon subgroup 9A at 0.5 ppm; Onion, bulb, subgroup 3–07A at 0.2 ppm; Onion, green, subgroup 3–07B at 4 ppm; Squash/cucumber subgroup 9B at 0.2 ppm, Sugarcane, cane at 1.5 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 70999 ppm; Sunflower subgroup 20B at 0.15 ppm; Tomato, dried at 4 ppm; Vegetable, fruiting, group 8–10 at 0.9 ppm; Vegetable, leafy, group 4–16, except head lettuce at 30 ppm; Vegetable, leaves of root and tuber, group 2 at 20 ppm; Vegetable, root, except sugar beet, subgroup 1B at 0.7 ppm. In addition, EPA is revising the tolerances for residues of mefentrifluconazole, a-[4-(4chlorophenoxy)-2(trifluoromethyl)phenyl]-a-methyl-1H1,2,4-triazole-1-ethanol, in or on Cattle, fat at 1 ppm; Cattle, meat at 0.15 ppm; Cattle, meat byproducts at 1.5 ppm; Egg at 0.01 ppm; Goat, fat at 1 ppm; Goat, meat at 0.15 ppm; Goat, meat byproducts at 1.5 ppm; Hog, fat at 0.015 ppm; Hog, meat at 0.01 ppm; Hog, meat byproducts at 0.03 ppm; Horse, fat at 1 ppm; Horse, meat at 0.15 ppm; Horse, meat byproducts at 1.5 ppm; Milk at 0.15 ppm; Milk, fat at 4 ppm; Poultry, fat at 0.015 ppm; Poultry, meat at 0.015 ppm; Poultry, meat byproducts at 0.015 ppm; Sheep, fat at 1 ppm; Sheep, meat at 0.15 ppm; and Sheep, meat byproducts at 1.5 ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to petitions submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997), 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). E:\FR\FM\06NOR1.SGM 06NOR1 71000 Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Rules and Regulations Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and 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: October 28, 2020. Marietta Echeverria, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.705, amend paragraph (a) by: ■ a. In the introductory text, removing ‘‘the table below’’ and ‘‘specified below’’ and adding ‘‘Table 1 to this paragraph (a)’’ and ‘‘specified in Table 1 to this paragraph (a)’’, respectively, in their places; ■ b. Designating the table as Table 1 to paragraph (a); and ■ c. In newly designated Table 1 to paragraph (a): ■ i. Adding entries for ‘‘Animal feed, nongrass, group 18, forage’’, ‘‘Animal feed, nongrass, group 18, hay’’, ‘‘Berry, ■ low growing, subgroup 13–07G’’, ‘‘Bushberry, subgroup 13–07B’’ and ‘‘Caneberry, subgroup 13–07A’’ in alphabetical order; ■ ii. Revising the entries for ‘‘Cattle, fat’’, ‘‘Cattle, meat’’ and ‘‘Cattle, meat byproducts’’; ■ iii. Adding entries for ‘‘Cotton, gin byproducts’’ and ‘‘Cottonseed subgroup 20C’’ in alphabetical order; ■ iv. Revising the entries for ‘‘Egg’’, ‘‘Goat, fat’’, ‘‘Goat, meat’’ and ‘‘Goat, meat byproducts’’; ■ v. Adding entries for ‘‘Grass, forage, fodder and hay, group 17, forage’’ and ‘‘Grass, forage, fodder and hay, group 17, hay’’ in alphabetical order; ■ vi. Revising the entries for ‘‘Hog, fat’’, ‘‘Hog, meat’’, ‘‘Hog, meat byproducts’’, ‘‘Horse, fat’’, ‘‘Horse, meat’’ and ‘‘Horse, meat byproducts’’; ■ vii. Adding entries for ‘‘Lettuce, head’’ and ‘‘Melon subgroup 9A’’ in alphabetical order; ■ viii. Revising the entries for ‘‘Milk’’ and ‘‘Milk, fat’’; ■ ix. Adding entries for ‘‘Onion, bulb, subgroup 3–07A’’ and ‘‘Onion, green, subgroup 3–07B’’ in alphabetical order; ■ x. Revising the entries for ‘‘Poultry, fat’’, ‘‘Poultry, meat’’, ‘‘Poultry, meat byproducts’’, ‘‘Sheep, fat’’, ‘‘Sheep, meat’’ and ‘‘Sheep, meat byproducts’’; and ■ xi. Adding entries for ‘‘Squash/ cucumber subgroup 9B’’, ‘‘Sugarcane, cane’’, ‘‘Sunflower subgroup 20B’’, ‘‘Tomato, dried’’, ‘‘Vegetable, fruiting, group 8–10’’, ‘‘Vegetable, leafy, group 4– 16, except head lettuce’’, ‘‘Vegetable, leaves of root and tuber, group 2’’ and ‘‘Vegetable, root, except sugar beet, subgroup 1B’’ in alphabetical order. The additions read as follows: § 180.705 Mefentrifluconazole; tolerances for residues. (a) * * * TABLE 1 TO PARAGRAPH (a) Parts per million Commodity * * * * * * Animal feed, nongrass, group 18, forage ............................................................................................................................................ Animal feed, nongrass, group 18, hay ................................................................................................................................................ * * * * * * * Berry, low growing, subgroup 13–07G ................................................................................................................................................ Bushberry, subgroup 13–07B .............................................................................................................................................................. Caneberry, subgroup 13–07A ............................................................................................................................................................. Cattle, fat ............................................................................................................................................................................................. Cattle, meat ......................................................................................................................................................................................... Cattle, meat byproducts ....................................................................................................................................................................... * * * * * * * Cotton, gin byproducts ......................................................................................................................................................................... Cottonseed subgroup 20C ................................................................................................................................................................... * VerDate Sep<11>2014 17:13 Nov 05, 2020 Jkt 253001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\FR\FM\06NOR1.SGM 06NOR1 15 30 2 5 3 1 0.15 1.5 10 0.2 71001 Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Rules and Regulations TABLE 1 TO PARAGRAPH (a)—Continued Parts per million Commodity Egg ....................................................................................................................................................................................................... 0.01 * * * * * * Goat, fat ............................................................................................................................................................................................... Goat, meat ........................................................................................................................................................................................... Goat, meat byproducts ........................................................................................................................................................................ * * * * * * * Grass, forage, fodder and hay, group 17, forage ............................................................................................................................... Grass, forage, fodder and hay, group 17, hay .................................................................................................................................... Hog, fat ................................................................................................................................................................................................ Hog, meat ............................................................................................................................................................................................ Hog, meat byproducts ......................................................................................................................................................................... Horse, fat ............................................................................................................................................................................................. Horse, meat ......................................................................................................................................................................................... Horse, meat byproducts ...................................................................................................................................................................... * * * * * * * Lettuce, head ....................................................................................................................................................................................... Melon subgroup 9A ............................................................................................................................................................................. Milk ....................................................................................................................................................................................................... Milk, fat ................................................................................................................................................................................................ * * * * * * * Onion, bulb, subgroup 3–07A .............................................................................................................................................................. Onion, green, subgroup 3–07B ........................................................................................................................................................... * * * * * * * Poultry, fat ............................................................................................................................................................................................ Poultry, meat ........................................................................................................................................................................................ Poultry, meat byproducts ..................................................................................................................................................................... * * * * * * * Sheep, fat ............................................................................................................................................................................................ Sheep, meat ........................................................................................................................................................................................ Sheep, meat byproducts ...................................................................................................................................................................... * * * * * * * Squash/cucumber subgroup 9B .......................................................................................................................................................... Sugarcane, cane .................................................................................................................................................................................. Sunflower subgroup 20B ..................................................................................................................................................................... Tomato, dried ....................................................................................................................................................................................... * * * * * * * Vegetable, fruiting, group 8–10 ........................................................................................................................................................... Vegetable, leafy, group 4–16, except head lettuce ............................................................................................................................. Vegetable, leaves of root and tuber, group 2 ..................................................................................................................................... * * * * * * * Vegetable, root, except sugar beet, subgroup 1B .............................................................................................................................. * * * * * * * * * * * * [FR Doc. 2020–24467 Filed 11–5–20; 8:45 am] BILLING CODE 6560–50–P VerDate Sep<11>2014 17:13 Nov 05, 2020 Jkt 253001 PO 00000 Frm 00047 Fmt 4700 Sfmt 9990 E:\FR\FM\06NOR1.SGM 06NOR1 1 0.15 1.5 50 100 0.015 0.01 0.03 1 0.15 1.5 5 0.5 0.15 4 0.2 4 0.015 0.015 0.015 1 0.15 1.5 0.2 1.5 0.15 4 0.9 30 20 0.7 *

Agencies

[Federal Register Volume 85, Number 216 (Friday, November 6, 2020)]
[Rules and Regulations]
[Pages 70997-71001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24467]



[[Page 70997]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0068; FRL-10015-56]


Mefentrifluconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
mefentrifluconazole in or on multiple commodities that are identified 
and discussed later in this document. BASF Corporation requested these 
tolerances under section 346a of the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective November 6, 2020. Objections and 
requests for hearings must be received on or before January 5, 2021 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-2020-0068, 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 note that due to the public health 
crisis, visitor access to the Public Reading Room and OPP Docket are 
subject to restrictions. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-8578; 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 
Publishing 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-2020-0068 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 
January 5, 2021. 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-2020-0068, 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/where-send-comments-epa-dockets.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 15, 2020 (85 FR 20910) (FRL-10006-
54), 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 
9F8796) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, North Carolina 27709-3528. The petition requested that 
40 CFR 180.705 be amended by establishing tolerances for residues of 
the fungicide mefentrifluconazole, [alpha]-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-[alpha]-methyl-1H-1,2,4-triazole-1-ethanol, in 
or on berry, low growing, subgroup 13-07G at 2 parts per million (ppm); 
bushberry, subgroup 13-07B at 5 ppm; caneberry, subgroup 13-07A at 3 
ppm; cattle, fat at 0.8 ppm; cattle, kidney at 0.6 ppm; cattle, liver 
at 1.5 ppm; cattle, meat at 0.07 ppm; cattle, meat byproducts at 1.5 
ppm; cotton, gin byproducts at 10 ppm; cottonseed subgroup 20C at 0.2 
ppm; egg at 0.01 ppm; goat, fat at 0.8 ppm; goat, kidney at 0.6 ppm; 
goat, liver at 1.5 ppm; goat, meat at 0.07 ppm; goat, meat byproducts 
at 1.5 ppm; grass, crop group 17, forage at 50 ppm; grass, crop group 
17, hay at 100 ppm; hog, fat at 0.02 ppm; hog, kidney at 0.03 ppm; hog, 
liver at 0.03 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.03 
ppm; horse, fat at 0.8 ppm; horse, kidney at 0.6 ppm; horse, liver at 
1.5 ppm; horse, meat at 0.07 ppm; horse, meat byproducts at 1.5 ppm; 
melon subgroup 9A at 0.5 ppm; milk at 0.09 ppm; milk fat at 2.4 ppm; 
non-grass animal feed, forage, crop group 18 at 15 ppm; non-grass 
animal feed, hay, crop group 18 at 40 ppm; onion, bulb, subgroup 3-07A 
at 0.2 ppm; onion, green, subgroup 3-07B at 4 ppm; poultry, fat at 
0.015 ppm; poultry, liver at 0.01 ppm; poultry, meat

[[Page 70998]]

at 0.015 ppm; poultry, meat byproducts at 0.015 ppm; sheep, fat at 0.8 
ppm; sheep, kidney at 0.6 ppm; sheep, liver at 1.5 ppm; sheep, meat at 
0.07 ppm; sheep, meat byproducts at 1.5 ppm; squash/cucumber subgroup 
9B at 0.15 ppm; sugarcane, cane at 1.5 ppm; sunflower subgroup 20B at 
0.15 ppm; tomato, dried at 5 ppm; vegetable, leafy, except brassica, 
crop group 4-16 at 30 ppm; vegetables, fruiting, crop group 8-10 at 0.9 
ppm; vegetable, leaves of root and tuber, crop group 2 at 20 ppm; and 
vegetable, root, except sugar beet, subgroup 1B at 0.7 ppm. That 
document referenced a summary of the petition prepared by BASF 
Corporation, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing several tolerances at different levels than the 
petitioned-for tolerances and revised some commodity definitions. In 
addition, EPA is not establishing several tolerances that were 
petitioned-for. 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 mefentrifluconazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with 
mefentrifluconazole follows.
    On June 28, 2019, EPA published in the Federal Register a final 
rule establishing tolerances for residues of mefentrifluconazole in or 
on many animal, corn, fruit, grain, nut and vegetable commodities based 
on the Agency's conclusion that aggregate exposure to 
mefentrifluconazole is safe for the general population, including 
infants and children. See (84 FR 30939) (FRL-9994-51). EPA is 
incorporating the following portions of that document by reference 
here, as they have not changed in the Agency's current assessment of 
mefentrifluconazole tolerances: The toxicological profile and points of 
departure, the cancer assessment, the conclusions about cumulative 
risk, and the Agency's determination regarding the children's safety 
factor. Additionally, EPA is incorporating the assumptions for exposure 
assessment from the June 28, 2019 final rule including the estimated 
drinking water concentrations, which have not changed except as 
explained in the following paragraph.
    EPA's dietary (food and drinking water) exposure assessments have 
been updated to include the additional exposure from the new uses of 
mefentrifluconazole on root and tuber vegetables (crop group 1B), 
leaves of root and tuber vegetables (crop group 2), leafy vegetables 
(crop group 4-16), fruiting vegetables (crop group 8-10), cucurbit 
vegetables (crop group 9), berries (subgroups 13-07A, 13-07B, and 13-
07G), grasses (crop group 17), non-grass animal feeds (crop group 18), 
sunflower (crop group 20B), and cotton (crop group 20C). EPA conducted 
an unrefined acute dietary (food and drinking water) exposure and risk 
assessment that incorporates tolerance-level residue values, 100% crop 
treated, and EPA's 2018 default processing factors. EPA conducted a 
partially refined chronic dietary (food and drinking water) exposure 
and risk assessment that incorporates 100% crop treated, empirical 
processing factors (when available), and average field trial residues 
for some commodities. As required under FFDCA 408(b)(2)(E), when EPA 
relies on anticipated residue data for supporting tolerances, EPA will 
require submission of data to demonstrate that the levels in food are 
not above the levels anticipated no later than 5 years from the date of 
issuance of these tolerances.
    Acute dietary (food and drinking water) risks are below the 
Agency's level of concern of 100% of the acute population-adjusted dose 
(aPAD): They are less than 5.4% of the aPAD for females 13 to 49 years 
old, the only population group of concern. Chronic dietary risks are 
below the Agency's level of concern of 100% of the chronic population-
adjusted dose (cPAD): They are less than 73% of the cPAD for children 1 
to 2 years old, the population subgroup with the highest exposure 
estimate.
    There are no handler or post-application residential exposures 
anticipated from the new uses of mefentrifluconazole. However, the 
currently registered use on golf courses will result in short-term (1 
to 30 days) residential post-application dermal exposures to adults, 
youth 11 to less than 16 years old, and children 6 to less than 11 
years old.
    For aggregate risk assessment, the acute and chronic aggregate risk 
assessments include dietary (food and drinking water) exposures only; 
therefore, the acute and chronic aggregate assessments are equivalent 
to the acute and chronic dietary assessments, respectively, and are not 
of concern. The short-term aggregate risk assessment includes 
residential exposures (golfing activities on previously treated turf) 
and average dietary exposures. The short-term aggregate margins of 
exposure (MOEs) for adults (830) and children (6 to less than 11 years 
old, 640) are not of concern because they exceed EPA's level of concern 
(MOEs less than 100). Therefore, there are no acute, chronic, or short-
term aggregate risk estimates of concern for mefentrifluconazole.
    Based on the information summarized in this unit and in the 
supporting risk assessment, EPA concludes there is a reasonable 
certainty that no harm will result to the general population, or to 
infants and children from aggregate exposure to mefentrifluconazole 
residues. More detailed information can be found in the document titled 
``Mefentrifluconazole. Human Health Risk Assessment in Support of the 
Petition for the Establishment of Permanent Tolerances and Registration 
for Use on Root and Tuber Vegetables (Crop Group 1B); Leaves of Root 
and Tuber Vegetables (Crop Group 2); Leafy Vegetables (Crop Group 4-
16); Fruiting Vegetables (Crop Group 8-10); Cucurbit Vegetables (Crop 
Group 9); Berries (Subgroups 13-07A, 13-07B, and 13-07G), Grasses (Crop 
Group 17); Non-Grass Animal Feeds (Crop Group 18); Sunflower (Crop 
Group 20B); and Cotton (Crop Group 20C),'' dated October 9, 2020 in 
docket ID EPA-HQ-OPP-2020-0068.

[[Page 70999]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the 
tolerance expression. Multi-residue method QuEChERS (BASF method L0295/
01) is the enforcement method for the determination of 
mefentrifluconazole residues in plant matrices. BASF Analytical Method 
No. L0272/01 is the enforcement method for the determination of 
residues of mefentrifluconazole in livestock commodities by liquid 
chromatography with tandem mass spectroscopy (LC-MS/MS).
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

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 has not established MRLs for 
mefentrifluconazole.

C. Revisions to Petitioned-For Tolerances

    EPA revised the commodity definitions for animal feed, nongrass, 
group 18, forage; animal feed, nongrass, group 18, hay; grass, forage, 
fodder and hay, group 17, forage; grass, forage, fodder and hay, group 
17, hay; milk, fat; vegetable, leafy, group 4-16; vegetable, fruiting, 
group 8-10; and vegetable, leaves of root and tuber, group 2. In 
addition, EPA determined that separate tolerances were not needed for 
the petitioned-for commodities for cattle, kidney at 0.6 ppm; cattle, 
liver at 1.5 ppm; goat, kidney at 0.6 ppm; goat, liver at 1.5 ppm; hog, 
kidney at 0.03 ppm; hog, liver at 0.03 ppm; horse; kidney at 0.6 ppm; 
horse, liver at 1.5 ppm; poultry, liver at 0.01 ppm; sheep, kidney at 
0.6 ppm; and sheep, liver at 1.5 ppm because they are covered under 
their respective petitioned-for meat byproducts commodities.
    Both the petitioner and EPA used the Organization for Economic Co-
operation and Development (OECD) maximum residue limit (MRL) 
calculation procedures; however, differences were noted in the process 
for inputting the data. The petitioner appears to have inputted 
individual sample values, whereas EPA used the field trial average 
values per the OECD standard operating procedure (SOP). The petitioner 
also appears to have combined the results of residue data from the 
individual crops in a crop group for calculation of the crop group 
tolerance, whereas EPA calculated values for each crop individually. 
Based on these differences, EPA is establishing the tolerances for 
animal feed, nongrass, group 18, hay at 30 ppm (instead of 40 ppm) and 
for squash/cucumber subgroup 9B at 0.2 ppm (instead of 0.15 ppm).
    For livestock commodities, both the petitioner and EPA used the 
Langmuir Model (ver. 1.4) to calculate all tolerance levels. In some 
cases, the values determined by EPA were higher than those determined 
by the petitioner. It is possible that the petitioner used average 
values from the livestock feeding studies, while the EPA used maximum 
values. Therefore, EPA determined the tolerances should be set at 
different levels for the following commodities (with the petitioned-for 
level in parentheses): Cattle, goat, horse and sheep, fat at 1 ppm (0.8 
ppm); cattle, goat, horse and sheep, meat at 0.15 ppm (0.07 ppm); hog, 
fat at 0.015 ppm (0.02 ppm); milk at 0.15 ppm (0.09 ppm); and milk, fat 
at 4 ppm (2.4 ppm).
    In addition, the tolerance for tomato, dried is being established 
at 4 ppm because EPA used the median processing factor while the 
petitioner proposed 5 ppm based on the average processing factor. 
Finally, EPA is setting a separate tolerance for lettuce, head at 5 ppm 
because it is more than 5 times less than the tolerance for vegetable, 
leafy, group 4-16 at 30 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of 
mefentrifluconazole, [alpha]-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-[alpha]-methyl-1H-1,2,4-triazole-1-ethanol, in 
or on Animal feed, nongrass, group 18, forage at 15 ppm; Animal feed, 
nongrass, group 18, hay at 30 ppm; Berry, low growing, subgroup 13-07G 
at 2 ppm; Bushberry, subgroup 13-07B at 5 ppm; Caneberry, subgroup 13-
07A at 3 ppm; Cotton, gin byproducts at 10 ppm; Cottonseed subgroup 20C 
at 0.2 ppm; Grass, forage, fodder and hay, group 17, forage at 50 ppm; 
Grass, forage, fodder and hay, group 17, hay at 100 ppm; Lettuce, head 
at 5 ppm; Melon subgroup 9A at 0.5 ppm; Onion, bulb, subgroup 3-07A at 
0.2 ppm; Onion, green, subgroup 3-07B at 4 ppm; Squash/cucumber 
subgroup 9B at 0.2 ppm, Sugarcane, cane at 1.5 ppm; Sunflower subgroup 
20B at 0.15 ppm; Tomato, dried at 4 ppm; Vegetable, fruiting, group 8-
10 at 0.9 ppm; Vegetable, leafy, group 4-16, except head lettuce at 30 
ppm; Vegetable, leaves of root and tuber, group 2 at 20 ppm; Vegetable, 
root, except sugar beet, subgroup 1B at 0.7 ppm.
    In addition, EPA is revising the tolerances for residues of 
mefentrifluconazole, [alpha]-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-[alpha]-methyl-1H-1,2,4-triazole-1-ethanol, in 
or on Cattle, fat at 1 ppm; Cattle, meat at 0.15 ppm; Cattle, meat 
byproducts at 1.5 ppm; Egg at 0.01 ppm; Goat, fat at 1 ppm; Goat, meat 
at 0.15 ppm; Goat, meat byproducts at 1.5 ppm; Hog, fat at 0.015 ppm; 
Hog, meat at 0.01 ppm; Hog, meat byproducts at 0.03 ppm; Horse, fat at 
1 ppm; Horse, meat at 0.15 ppm; Horse, meat byproducts at 1.5 ppm; Milk 
at 0.15 ppm; Milk, fat at 4 ppm; Poultry, fat at 0.015 ppm; Poultry, 
meat at 0.015 ppm; Poultry, meat byproducts at 0.015 ppm; Sheep, fat at 
1 ppm; Sheep, meat at 0.15 ppm; and Sheep, meat byproducts at 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to petitions submitted to the Agency. The Office of Management 
and Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 
FR 51735, October 4, 1993). Because this action has been exempted from 
review under Executive Order 12866, this action is not subject to 
Executive Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997), 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).

[[Page 71000]]

    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
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: October 28, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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.  180.705, amend paragraph (a) by:
0
a. In the introductory text, removing ``the table below'' and 
``specified below'' and adding ``Table 1 to this paragraph (a)'' and 
``specified in Table 1 to this paragraph (a)'', respectively, in their 
places;
0
b. Designating the table as Table 1 to paragraph (a); and
0
c. In newly designated Table 1 to paragraph (a):
0
i. Adding entries for ``Animal feed, nongrass, group 18, forage'', 
``Animal feed, nongrass, group 18, hay'', ``Berry, low growing, 
subgroup 13-07G'', ``Bushberry, subgroup 13-07B'' and ``Caneberry, 
subgroup 13-07A'' in alphabetical order;
0
ii. Revising the entries for ``Cattle, fat'', ``Cattle, meat'' and 
``Cattle, meat byproducts'';
0
iii. Adding entries for ``Cotton, gin byproducts'' and ``Cottonseed 
subgroup 20C'' in alphabetical order;
0
iv. Revising the entries for ``Egg'', ``Goat, fat'', ``Goat, meat'' and 
``Goat, meat byproducts'';
0
v. Adding entries for ``Grass, forage, fodder and hay, group 17, 
forage'' and ``Grass, forage, fodder and hay, group 17, hay'' in 
alphabetical order;
0
vi. Revising the entries for ``Hog, fat'', ``Hog, meat'', ``Hog, meat 
byproducts'', ``Horse, fat'', ``Horse, meat'' and ``Horse, meat 
byproducts'';
0
vii. Adding entries for ``Lettuce, head'' and ``Melon subgroup 9A'' in 
alphabetical order;
0
viii. Revising the entries for ``Milk'' and ``Milk, fat'';
0
ix. Adding entries for ``Onion, bulb, subgroup 3-07A'' and ``Onion, 
green, subgroup 3-07B'' in alphabetical order;
0
x. Revising the entries for ``Poultry, fat'', ``Poultry, meat'', 
``Poultry, meat byproducts'', ``Sheep, fat'', ``Sheep, meat'' and 
``Sheep, meat byproducts''; and
0
xi. Adding entries for ``Squash/cucumber subgroup 9B'', ``Sugarcane, 
cane'', ``Sunflower subgroup 20B'', ``Tomato, dried'', ``Vegetable, 
fruiting, group 8-10'', ``Vegetable, leafy, group 4-16, except head 
lettuce'', ``Vegetable, leaves of root and tuber, group 2'' and 
``Vegetable, root, except sugar beet, subgroup 1B'' in alphabetical 
order.
    The additions read as follows:


Sec.  180.705  Mefentrifluconazole; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Animal feed, nongrass, group 18, forage.................              15
Animal feed, nongrass, group 18, hay....................              30
 
                              * * * * * * *
Berry, low growing, subgroup 13-07G.....................               2
Bushberry, subgroup 13-07B..............................               5
Caneberry, subgroup 13-07A..............................               3
Cattle, fat.............................................               1
Cattle, meat............................................            0.15
Cattle, meat byproducts.................................             1.5
 
                              * * * * * * *
Cotton, gin byproducts..................................              10
Cottonseed subgroup 20C.................................             0.2

[[Page 71001]]

 
Egg.....................................................            0.01
 
                              * * * * * * *
Goat, fat...............................................               1
Goat, meat..............................................            0.15
Goat, meat byproducts...................................             1.5
 
                              * * * * * * *
Grass, forage, fodder and hay, group 17, forage.........              50
Grass, forage, fodder and hay, group 17, hay............             100
Hog, fat................................................           0.015
Hog, meat...............................................            0.01
Hog, meat byproducts....................................            0.03
Horse, fat..............................................               1
Horse, meat.............................................            0.15
Horse, meat byproducts..................................             1.5
 
                              * * * * * * *
Lettuce, head...........................................               5
Melon subgroup 9A.......................................             0.5
Milk....................................................            0.15
Milk, fat...............................................               4
 
                              * * * * * * *
Onion, bulb, subgroup 3-07A.............................             0.2
Onion, green, subgroup 3-07B............................               4
 
                              * * * * * * *
Poultry, fat............................................           0.015
Poultry, meat...........................................           0.015
Poultry, meat byproducts................................           0.015
 
                              * * * * * * *
Sheep, fat..............................................               1
Sheep, meat.............................................            0.15
Sheep, meat byproducts..................................             1.5
 
                              * * * * * * *
Squash/cucumber subgroup 9B.............................             0.2
Sugarcane, cane.........................................             1.5
Sunflower subgroup 20B..................................            0.15
Tomato, dried...........................................               4
 
                              * * * * * * *
Vegetable, fruiting, group 8-10.........................             0.9
Vegetable, leafy, group 4-16, except head lettuce.......              30
Vegetable, leaves of root and tuber, group 2............              20
 
                              * * * * * * *
Vegetable, root, except sugar beet, subgroup 1B.........             0.7
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-24467 Filed 11-5-20; 8:45 am]
BILLING CODE 6560-50-P


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