Metaflumizone; Pesticide Tolerances, 20290-20294 [2021-07951]

Download as PDF jbell on DSKJLSW7X2PROD with RULES 20290 Federal Register / Vol. 86, No. 73 / Monday, April 19, 2021 / Rules and Regulations change any final action taken by the EPA on March 22, 2021. DATES: Effective on April 21, 2021. ADDRESSES: The EPA has established a docket of all documents for this action at https://www.regulations.gov under Docket ID No. EPA–R06–OAR–2015– 0189. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet. Publicly available docket materials are available electronically through https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: James E. Grady, EPA Region 6 Office, Regional Haze and SO2 Section, 1201 Elm Street, Suite 500, Dallas, TX 72570, 214–665–6745; grady.james@epa.gov. Out of an abundance of caution for members of the public and our staff, the EPA Region 6 office will be closed to the public to reduce the risk of transmitting COVID–19. Please call or email the contact listed above if you need alternative access to material indexed but not provided in the docket. SUPPLEMENTARY INFORMATION: On March 22, 2021 (86 FR 15104), EPA published a final rule action, ‘‘Air Plan Approval; Arkansas; Arkansas Regional Haze and Visibility Transport State Implementation Plan Revisions.’’ The final rule approved revisions to the State Implementation Plan (SIP) for the State of Arkansas concerning requirements of the Clean Air Act and the Regional Haze Rule for visibility protection in mandatory Class I Federal areas for the first implementation period and pertain specifically to the Domtar Ashdown Mill. The final rule also approved revisions concerning Arkansas’ interstate visibility transport obligations for the following national ambient air quality standards (NAAQS): The 2006 24-hour fine particulate matter (PM2.5) NAAQS; the 2012 annual PM2.5 NAAQS; the 2008 and 2015 eight-hour ozone (O3) NAAQS; the 2010 one-hour nitrogen dioxide (NO2) NAAQS; and the 2010 one-hour SO2 NAAQS. For more information, please see the EPA’s rulemaking action at https:// www.regulations.gov under Docket ID No. EPA–R06–OAR–2015–0189. CFR 52.170(e). The EPA finds that there is good cause to make this correction without providing for notice and comment because neither notice nor comment is necessary and would not be in the public interest due to the nature of the correction which is minor, technical and does not change the obligations already existing in the rule. While the ‘‘Identification of Plan’’ section of the regulatory text accurately includes the three new entries added to the ‘‘EPA-Approved Non-Regulatory Provisions and Quasi-Regulatory Measures in the Arkansas SIP’’ table, the amendatory instruction erroneously states that one entry rather than three are being added to the table. Therefore, the EPA finds that the corrections are merely correcting the amendatory instruction without changing any final action taken by the EPA on March 22, 2021. Need for Correction As published, the regulatory text in the final rule contains an error that omits the amendatory instruction for adding two entries to the table entitled ‘‘EPA-Approved Non-Regulatory Provisions and Quasi-Regulatory Measures in the Arkansas SIP’’ in 40 40 CFR Part 180 VerDate Sep<11>2014 16:00 Apr 16, 2021 Jkt 253001 Federal Register Correction In FR Doc. 2021–05362 at 86 FR 15104 in the issue of Monday, March 22, 2021, the following corrections are made: ■ § 52.170 [Corrected] 1. On page 15131, in the third column, in amendment 2.b. the instruction ‘‘In paragraph (e), the third table titled ‘‘EPA-Approved Non-Regulatory Provisions and Quasi-Regulatory Measures in the Arkansas SIP’’ is amended by adding an entry for ‘‘Arkansas Regional Haze Phase III SIP Revision’’ at the end of the table.’’ is corrected to read ‘‘In paragraph (e), the third table titled ‘‘EPA-Approved NonRegulatory Provisions and QuasiRegulatory Measures in the Arkansas SIP’’ is amended by adding entries for ‘‘Arkansas Regional Haze Phase III SIP Revision,’’ ‘‘Arkansas 2015 O3 NAAQS Interstate Transport SIP Revision,’’ and ‘‘Arkansas Regional Haze SO2 and PM SIP Revision’’ at the end of the table.’’ ■ Dated: April 14, 2021. David Gray, Acting Regional Administrator, Region 6. [FR Doc. 2021–08004 Filed 4–16–21; 8:45 am] This regulation establishes tolerances for residues of the insecticide metaflumizone in or on multiple commodities which are identified and discussed later in this document. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective April 19, 2021. Objections and requests for hearings must be received on or before June 18, 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). SUMMARY: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2019–0385, 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. 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. FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460– 0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: I. General Information BILLING CODE 6560–50–P A. Does this action apply to me? ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2019–0385; FRL–10018–60] Metaflumizone; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 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: E:\FR\FM\19APR1.SGM 19APR1 Federal Register / Vol. 86, No. 73 / Monday, April 19, 2021 / Rules and Regulations • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). jbell on DSKJLSW7X2PROD with RULES B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government 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(g), 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–2019–0385 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 June 18, 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– 2019–0385, 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. VerDate Sep<11>2014 16:00 Apr 16, 2021 Jkt 253001 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 August 30, 2019 (84 FR 45702) (FRL–9998–15), 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 8E8707) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. That document stated that BASF’s petition (summarized by BASF Corporation in docket ID EPA–HQ–OPP–2019–0385) requested that 40 CFR 180.657 be amended by establishing tolerances for residues of the insecticide metaflumizone (2-[2-(4-cyanophenyl)-1[3-(trifluoromethyl)phenyl]ethylidene]N-[4-(trifluoromethoxy)phenyl] hydrazinecarboxamide; E and Z isomers), in or on apple at 1.0 parts per million (ppm), apple, wet pomace at 3.0 ppm, coffee at 0.15 ppm, fruit, small, vine climbing, except fuzzy kiwi fruit, subgroup 13–07F at 5.0 ppm, grape, raisin at 10 ppm, lemon/lime subgroup 10–10B at 3.0 ppm, lemon/lime subgroup 10–10B, oil at 42 ppm, melon subgroup 9A at 1.0 ppm, orange subgroup 10–10A at 3.0 ppm, orange subgroup 10–10A, oil at 42 ppm, cattle, fat at 0.05 ppm, goat, fat at 0.05 ppm, horse, fat at 0.05 ppm, sheep, fat at 0.05 ppm, and milk, fat at 0.1 ppm. Although the petition summary did not request a tolerance on apple, wet pomace, the petition itself requested a tolerance on apple, wet pomace, so EPA included that commodity in the document published in the Federal Register. There were no substantive comments received in response to the notice of filing for this pesticide petition. Based upon review of the data supporting the referenced petition, and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA has revised the tolerance levels and commodity definitions for several of the proposed commodities, established additional necessary tolerances, and deleted a number of established tolerances superseded by the newly established import tolerances. The reasons for these changes are explained in full detail in Unit IV.C. 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 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 20291 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 metaflumizone including exposure resulting from the tolerances established by this action. A summary of EPA’s assessment of exposures and risks associated with metaflumizone follows. In an effort to streamline its publications in the Federal Register, EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings and republishing the same sections is unnecessary; EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking. EPA has previously published a number of tolerance rulemakings for metaflumizone, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to metaflumizone and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged. Toxicological Profile. For a discussion of the Toxicological Profile of metaflumizone, see Unit III.A. of the E:\FR\FM\19APR1.SGM 19APR1 jbell on DSKJLSW7X2PROD with RULES 20292 Federal Register / Vol. 86, No. 73 / Monday, April 19, 2021 / Rules and Regulations October 30, 2015 rulemaking (80 FR 66795) (FRL–9934–88). Toxicological Points of Departure/ Levels of Concern. For a summary of the Toxicological Points of Departure/ Levels of Concern used for the safety assessment, see Unit III.B. of the October 30, 2015 rulemaking. Exposure Assessment. Much of the exposure assessment remains unchanged from the previous rulemaking, although some updates have occurred to accommodate exposures from the petitioned-for tolerances. The updates are discussed in this section; for a description of the rest of the EPA approach to and assumptions for the exposure assessment, see Unit III.C. of the October 30, 2015 rulemaking. EPA’s exposure assessments have been updated to include the additional exposure from imported apple, coffee, melon subgroup 9A, orange subgroup 10–10A, lemon/lime subgroup 10–10B, small vine climbing fruit subgroup 13– 07F (except fuzzy kiwifruit), milk fat, and ruminant fat for the combined residues of metaflumizone (E–Z isomer ratio of >9:1). The acute and chronic dietary analyses for metaflumizone for this action assumed tolerance-level residues, 100% crop treated, and 2018 default processing factors when necessary, except for citrus juice, which used empirical processing factor for citrus juice. The modeled estimates of drinking water concentrations and the Agency’s assessment of residential, or non-occupational exposure remain the same as in the October 30, 2015 rulemaking, as the residues on imported commodities do not impact the drinking water exposures or residential exposures. The Agency’s position regarding cumulative risk also remains the same. Safety Factor for Infants and Children. EPA continues to retain the Food Quality Protection Act (FQPA) safety factor of 10× for inhalation exposure scenarios, while continuing to conclude that there is reliable data showing that the safety of infants and children would be adequately protected if the FQPA SF were reduced from 10× to 3× for all oral exposure scenarios and reduced to 1× for dermal exposures. The reasons for that decision are articulated in Unit III.D. of the October 30, 2015 rulemaking. 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). Short-, intermediate-, and chronic-term risks are evaluated by comparing the VerDate Sep<11>2014 16:45 Apr 16, 2021 Jkt 253001 estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. The acute and chronic dietary estimates for metaflumizone were found not to be of concern for the U.S. general population and all population subgroups and are below the Agency’s level of concern (LOC) (<100% of the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD), respectively). An acute endpoint of concern was not identified in the toxicological database for the general U.S. population including infants and children. Acute dietary risks for metaflumizone are below the Agency’s LOC: 5.3% of the aPAD at the 95th percentile for females 13–49 years of age, the population group with the highest exposure; and chronic risks are below the Agency’s LOC: 65% of the cPAD for children 1–2 years old, the most highly exposed population subgroup. Metaflumizone is classified as ‘‘Not Likely to be Carcinogenic to Humans.’’ Therefore, EPA does not expect exposure to metaflumizone to pose a cancer risk. Since metaflumizone is registered for uses that could result in short-term residential exposure, EPA evaluated the potential for short-term risk by aggregating chronic exposure through food and water with short-term residential exposures to metaflumizone. Since the LOC for the various routes of exposure differ, the aggregate risk estimates were calculated using the Aggregate Risk Index (ARI) approach (LOC for ARI <1). The short-term aggregate assessment combined food + drinking water exposure with the highest potential residential postapplication exposure (high-contact activity on turf). The aggregate ARIs are greater than 1; therefore, EPA concludes there is no short-term risk of concern. Although only short-term residential exposure is anticipated, the short-term assessment is protective of intermediateterm exposure since the short- and intermediate-term PODs/LOCs are identical. Determination of Safety. Based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the U.S. general population, or to infants and children, from aggregate exposure to metaflumizone residues. More detailed information on the subject action can be found at https:// www.regulations.gov in the documents entitled ‘‘Metaflumizone: Human Health PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 Risk Assessment in Support of Section 3 Registrations for Application of Metaflumizone to Pome Fruit (crop group (CG) 11–10) and Stone Fruit (CG 12–12); Updating the CG Designation for Citrus to 10–10 and Tree Nuts to 14–12; and Permitting Aerial Application to Citrus Fruits, Grapes, Tree Nuts, and Nurseries Containing Field-/ContainerGrown Nonbearing Stone and Pome Fruit Trees,’’ dated September 29, 2015 (docket ID EPA–HQ–OPP–2014–0607), and ‘‘Metaflumizone: Human Health Risk Assessment in Support of Tolerances Without a U.S. Registration in/on Apple, Coffee, Melon Subgroup 9A, Orange Subgroup 10–10A, Lemon/ Lime Subgroup 10–10B, Grape, Milk Fat, and Ruminant Fat,’’ dated December 7, 2020 (docket ID EPA–HQ– OPP–2019–0385). IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the October 30, 2015 rulemaking. 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). Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standardssetting organization in trade agreements to which the United States is a party. Although EPA may establish a tolerance that is different from a Codex MRL, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. While Codex has not yet established MRLs on the commodities mentioned in this document, it has proposed MRLs in/on most of the relevant commodities. EPA notes that the U.S. and Codex residue definitions differ in that the U.S. tolerance expression includes metaflumizone (E- and Z-isomers) and M320I04 while Codex includes only metaflumizone (E- and Z-isomers). EPA is harmonizing its U.S. tolerances with most of the proposed Codex MRLs for apple, coffee, grape, melon subgroup 9A, orange subgroup 10–10A, orange oil, raisin, milk fat, and fat (cattle, goat, horse, and sheep). EPA is not E:\FR\FM\19APR1.SGM 19APR1 Federal Register / Vol. 86, No. 73 / Monday, April 19, 2021 / Rules and Regulations harmonizing the U.S. tolerance on lemon/lime subgroup 10–10B with the Codex MRL since the Codex MRL is less than that calculated by EPA using the submitted residue data and the OECD tolerance calculation procedure. jbell on DSKJLSW7X2PROD with RULES C. Revisions to Petitioned-For Tolerances Based upon review of data and supporting materials for this petition, EPA is establishing tolerances for the following commodities requested using the Agency’s preferred commodity terminology: Instead of establishing a tolerance for coffee, as requested, the Agency is establishing a tolerance for coffee, green bean. In addition, based upon supporting data and harmonization with proposed Codex MRLs, the Agency is establishing a tolerance level lower than requested for Apple at 0.9 ppm, and tolerance levels higher than requested for grape, raisin at 13 ppm; lemon/lime subgroup 10–10B, oil at 100 ppm; and orange subgroup 10–10A, oil at 100 ppm. Further, since importation of ruminant commodities is also a probability and based on the livestock dietary burdens, EPA is also establishing tolerances for milk fat and ruminant fat tolerances in or on cattle, fat at 0.15 ppm; goat, fat at 0.15 ppm; horse, fat at 0.15 ppm; sheep, fat at 0.15 ppm; and milk, fat at 0.6 ppm. V. Conclusion Therefore, tolerances are established for residues of the insecticide metaflumizone (2-[2-(4-cyanophenyl)-1[3-(trifluoromethyl)phenyl]ethylidene]N-[4-(trifluoromethoxy)phenyl] hydrazinecarboxamide; E and Z isomers), in or on apple at 0.9 parts per million (ppm); apple, wet pomace at 3 ppm; coffee, green bean at 0.15 ppm; grape, raisin at 13 ppm; grapefruit subgroup 10–10C at 0.04 ppm; lemon/ lime subgroup 10–10B at 3 ppm; lemon/ lime subgroup 10–10B, oil at 100 ppm; melon subgroup 9A at 1 ppm; orange subgroup 10–10A at 3 ppm; orange subgroup 10–10A, oil at 100 ppm; cattle, fat at 0.15 ppm; goat, fat at 0.15 ppm; horse, fat at 0.15 ppm; milk, fat at 0.6 ppm; and sheep, fat at 0.15 ppm. In addition, the existing tolerance for ‘‘fruit, pome, group 11–10,’’ is amended to clarify that that entry now excludes apple, due to the establishment of a separate apple tolerance in this rulemaking and the existing tolerance for grape is amended to raise the tolerance level from 0.04 ppm to 5 ppm. Finally, EPA is removing the tolerance for ‘‘fruit, citrus, group 10–10’’ because it is superseded by the newly established tolerances for each of the fruit, citrus, group 10–10 subgroups. VerDate Sep<11>2014 16:00 Apr 16, 2021 Jkt 253001 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) or 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 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 20293 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: April 8, 2021. Marietta Echeverria, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended 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 § 180.657: a. Designate paragraph (a) introductory text as paragraph (a)(1) and revise newly designated paragraph (a)(1) introductory text; ■ b. In the table in newly designated paragraph (a)(1): ■ i. Add a heading for the table; ■ ii. Add entries for ‘‘Apple,’’ ‘‘Apple, wet pomace,’’ and ‘‘Coffee, green bean’’ in alphabetical order; ■ iii. Remove the entries for ‘‘Fruit, citrus, group 10–10,’’ ‘‘Fruit, pome, group 11–10,’’ and ‘‘Fruit, stone, group 12–12’’; ■ iv. Add the entry ‘‘Fruit, pome, group 11–10, except apple’’ in alphabetical order; ■ v. Revise the entry for ‘‘Grape’’; ■ vi. Add entries for ‘‘Grape, raisin,’’ ‘‘Grapefruit subgroup 10–10C,’’ ‘‘Lemon/lime subgroup 10–10B,’’ ■ ■ E:\FR\FM\19APR1.SGM 19APR1 20294 Federal Register / Vol. 86, No. 73 / Monday, April 19, 2021 / Rules and Regulations ‘‘Lemon/lime subgroup 10–10B, oil,’’ ‘‘Melon subgroup 9A,’’ ‘‘Orange subgroup 10–10A,’’ and ‘‘Orange subgroup 10–10A, oil’’ in alphabetical order; and ■ vii. Revise footnote 1; and ■ c. Add paragraph (a)(2). The additions and revisions read as follows: § 180.657 Metaflumizone; tolerances for residues. (a) General. (1) Tolerances are established for residues of the insecticide metaflumizone, including its metabolites and degradates, in or on the commodities listed in table 1 to this paragraph (a)(1). Compliance with the tolerance levels specified in this paragraph (a)(1) is to be determined by measuring only the sum of metaflumizone (E and Z isomers; 2-[2(4-cyanophenyl)-1-[3-(trifluoromethyl) phenyl]ethylidene]-N-[4(trifluoromethoxy)phenyl] hydrazinecarboxamide) and its metabolite 4-{2-oxo-2-[3(trifluoromethyl) phenyl]ethyl}benzonitrile, calculated as the stoichiometric equivalent of metaflumizone, in or on the following commodities: TABLE 1 TO PARAGRAPH (a)(1) Parts per million Commodity * * * * Apple ......................................... Apple, wet pomace ................... Coffee, green bean 1 ................. * * * * Fruit, pome, group 11–10, except apple ............................. Grape ........................................ Grape, raisin ............................. Grapefruit subgroup 10–10C .... Lemon/lime subgroup 10–10B Lemon/lime subgroup 10–10B, oil ........................................... Melon subgroup 9A 1 ................ * * * * Orange subgroup 10–10A ........ Orange subgroup 10–10A, oil .. * * * * * 0.9 3 0.15 * 0.04 5 13 0.04 3 100 1 * 3 100 * 1 There jbell on DSKJLSW7X2PROD with RULES are no U.S. registrations for this commodity as of April 19, 2021. (2) Tolerances are established for residues of the insecticide metaflumizone, including its metabolites and degradates, in or on the commodities listed in table 2 to this paragraph (a)(2). Compliance with the tolerance levels specified in this paragraph (a)(2) is to be determined by measuring only metaflumizone (E and Z VerDate Sep<11>2014 16:00 Apr 16, 2021 Jkt 253001 isomers; 2-[2-(4-cyanophenyl)-1-[3(trifluoromethyl) phenyl]ethylidene]-N[4-(trifluoromethoxy)phenyl] hydrazinecarboxamide) in or on the following animal commodities: This is a summary of the Auction 109 Procedures Public Notice, released on April 1, 2021. The complete text of the Auction 109 Procedures Public Notice, including attachments and any related document, are available on the Commission’s TABLE 2 TO PARAGRAPH (a)(2) website at www.fcc.gov/auction/109 or Parts per by using the search function for AU Commodity million Docket No. 21–39, DA 21–361, on the Commission’s Electronic Comment Cattle, fat .................................. 0.15 Filing System (ECFS) web page at Goat, fat .................................... 0.15 Horse, fat .................................. 0.15 www.fcc.gov/ecfs. Alternative formats Milk, fat ..................................... 0.6 are available to persons with disabilities Sheep, fat ................................. 0.15 by sending an email to FCC504@fcc.gov or by calling the Consumer & Governmental Affairs Bureau at (202) * * * * * 418–0530 (voice), (202) 418–0432 [FR Doc. 2021–07951 Filed 4–16–21; 8:45 am] (TTY). BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 1 and 73 [AU Docket No. 21–39; DA 21–361; FR ID 21109] Auction of AM and FM Broadcast Construction Permits Scheduled for July 27, 2021; Notice of Filing Requirements, Minimum Opening Bids, Upfront Payments, and Other Procedures for Auction 109 Federal Communications Commission. ACTION: Final action; requirements and procedures. AGENCY: This document summarizes the procedures, deadlines, and upfront payment and minimum opening bid amounts for the upcoming auction of certain AM and FM broadcast construction permits. The Auction 109 Procedures Public Notice summarized here is intended to familiarize potential applicants with details of the procedures, terms, and conditions governing participation in Auction 109. DATES: Applications to participate in Auction 109 must be submitted before 6:00 p.m. Eastern Time (ET) on May 11, 2021. Upfront payments for Auction 109 must be received by 6:00 p.m. ET on June 16, 2021. Bidding in Auction 109 is scheduled to start on July 27, 2021. FOR FURTHER INFORMATION CONTACT: General Auction 109 Information: FCC Auctions Hotline at 888–225–5322, option two; or 717–338–2868. Auction 109 Legal Information: Lynne Milne or Lyndsey Grunewald at 202– 418–0660. Licensing Information: Lisa Scanlan or Tom Nessinger or James Bradshaw at (202) 418–2700. SUMMARY: PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 SUPPLEMENTARY INFORMATION: I. General Information 1. Introduction. By the Auction 109 Procedures Public Notice, the Office of Economics and Analytics (OEA), in conjunction with the Media Bureau (MB), establishes the procedures and minimum opening bid amounts for the upcoming auction of certain AM and FM broadcast construction permits. 2. On February 8, 2021, OEA, in conjunction with MB, released a public notice seeking comment on competitive bidding procedures and minimum opening bid amounts to be used in Auction 109. Three parties submitted comments in response to the Auction 109 Comment Public Notice, 86 FR 12556, March 4, 2021. 3. Construction Permits Offered in Auction 109. Auction 109 will offer four AM construction permits and 136 FM construction permits. The construction permits to be auctioned are listed in Attachment A to the Auction 109 Procedures Public Notice. 4. AM Construction Permits. Auction 109 will offer four construction permits in the AM broadcast service. Attachment A to the Auction 109 Procedures Public Notice lists the community of license, channel, class, and coordinates for each AM permit being offered. 5. The construction permits to be auctioned are for four previously licensed AM stations: KFTK(AM), East St. Louis, IL, former Facility ID No. 72815; WQQW(AM), Highland, IL, former Facility ID No. 90598; KZQZ(AM), St. Louis, MO, former Facility ID No. 72391; and KQQZ(AM), Fairview Heights, IL, former Facility ID No. 5281. The license renewals of each of these former AM stations were dismissed with prejudice in a hearing before the Commission’s Administrative Law Judge and the call signs deleted. 6. To facilitate the auction of the four AM permits, the four AM facilities will E:\FR\FM\19APR1.SGM 19APR1

Agencies

[Federal Register Volume 86, Number 73 (Monday, April 19, 2021)]
[Rules and Regulations]
[Pages 20290-20294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07951]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0385; FRL-10018-60]


Metaflumizone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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

DATES: This regulation is effective April 19, 2021. Objections and 
requests for hearings must be received on or before June 18, 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-2019-0385, 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.
    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.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Avenue 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:

[[Page 20291]]

     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(g), 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-2019-0385 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 
June 18, 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-2019-0385, 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 August 30, 2019 (84 FR 45702) (FRL-9998-
15), 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 
8E8707) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 
27709. That document stated that BASF's petition (summarized by BASF 
Corporation in docket ID EPA-HQ-OPP-2019-0385) requested that 40 CFR 
180.657 be amended by establishing tolerances for residues of the 
insecticide metaflumizone (2-[2-(4-cyanophenyl)-1-[3-
(trifluoromethyl)phenyl]ethylidene]-N-[4-
(trifluoromethoxy)phenyl]hydrazinecarboxamide; E and Z isomers), in or 
on apple at 1.0 parts per million (ppm), apple, wet pomace at 3.0 ppm, 
coffee at 0.15 ppm, fruit, small, vine climbing, except fuzzy kiwi 
fruit, subgroup 13-07F at 5.0 ppm, grape, raisin at 10 ppm, lemon/lime 
subgroup 10-10B at 3.0 ppm, lemon/lime subgroup 10-10B, oil at 42 ppm, 
melon subgroup 9A at 1.0 ppm, orange subgroup 10-10A at 3.0 ppm, orange 
subgroup 10-10A, oil at 42 ppm, cattle, fat at 0.05 ppm, goat, fat at 
0.05 ppm, horse, fat at 0.05 ppm, sheep, fat at 0.05 ppm, and milk, fat 
at 0.1 ppm. Although the petition summary did not request a tolerance 
on apple, wet pomace, the petition itself requested a tolerance on 
apple, wet pomace, so EPA included that commodity in the document 
published in the Federal Register. There were no substantive comments 
received in response to the notice of filing for this pesticide 
petition.
    Based upon review of the data supporting the referenced petition, 
and in accordance with its authority under FFDCA section 
408(d)(4)(A)(i), EPA has revised the tolerance levels and commodity 
definitions for several of the proposed commodities, established 
additional necessary tolerances, and deleted a number of established 
tolerances superseded by the newly established import tolerances. The 
reasons for these changes are explained in full detail in Unit IV.C.

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 metaflumizone including 
exposure resulting from the tolerances established by this action. A 
summary of EPA's assessment of exposures and risks associated with 
metaflumizone follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemakings of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemakings and republishing the same sections is 
unnecessary; EPA considers referral back to those sections as 
sufficient to provide an explanation of the information EPA considered 
in making its safety determination for the new rulemaking.
    EPA has previously published a number of tolerance rulemakings for 
metaflumizone, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to metaflumizone and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from those rulemakings as described 
further in this rulemaking, as they remain unchanged.
    Toxicological Profile. For a discussion of the Toxicological 
Profile of metaflumizone, see Unit III.A. of the

[[Page 20292]]

October 30, 2015 rulemaking (80 FR 66795) (FRL-9934-88).
    Toxicological Points of Departure/Levels of Concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern used for the 
safety assessment, see Unit III.B. of the October 30, 2015 rulemaking.
    Exposure Assessment. Much of the exposure assessment remains 
unchanged from the previous rulemaking, although some updates have 
occurred to accommodate exposures from the petitioned-for tolerances. 
The updates are discussed in this section; for a description of the 
rest of the EPA approach to and assumptions for the exposure 
assessment, see Unit III.C. of the October 30, 2015 rulemaking.
    EPA's exposure assessments have been updated to include the 
additional exposure from imported apple, coffee, melon subgroup 9A, 
orange subgroup 10-10A, lemon/lime subgroup 10-10B, small vine climbing 
fruit subgroup 13-07F (except fuzzy kiwifruit), milk fat, and ruminant 
fat for the combined residues of metaflumizone (E-Z isomer ratio of 
>9:1). The acute and chronic dietary analyses for metaflumizone for 
this action assumed tolerance-level residues, 100% crop treated, and 
2018 default processing factors when necessary, except for citrus 
juice, which used empirical processing factor for citrus juice. The 
modeled estimates of drinking water concentrations and the Agency's 
assessment of residential, or non-occupational exposure remain the same 
as in the October 30, 2015 rulemaking, as the residues on imported 
commodities do not impact the drinking water exposures or residential 
exposures. The Agency's position regarding cumulative risk also remains 
the same.
    Safety Factor for Infants and Children. EPA continues to retain the 
Food Quality Protection Act (FQPA) safety factor of 10x for inhalation 
exposure scenarios, while continuing to conclude that there is reliable 
data showing that the safety of infants and children would be 
adequately protected if the FQPA SF were reduced from 10x to 3x for all 
oral exposure scenarios and reduced to 1x for dermal exposures. The 
reasons for that decision are articulated in Unit III.D. of the October 
30, 2015 rulemaking.
    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). 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. For 
linear cancer risks, EPA calculates the lifetime probability of 
acquiring cancer given the estimated aggregate exposure.
    The acute and chronic dietary estimates for metaflumizone were 
found not to be of concern for the U.S. general population and all 
population subgroups and are below the Agency's level of concern (LOC) 
(<100% of the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD), respectively). An acute endpoint of 
concern was not identified in the toxicological database for the 
general U.S. population including infants and children. Acute dietary 
risks for metaflumizone are below the Agency's LOC: 5.3% of the aPAD at 
the 95th percentile for females 13-49 years of age, the population 
group with the highest exposure; and chronic risks are below the 
Agency's LOC: 65% of the cPAD for children 1-2 years old, the most 
highly exposed population subgroup. Metaflumizone is classified as 
``Not Likely to be Carcinogenic to Humans.'' Therefore, EPA does not 
expect exposure to metaflumizone to pose a cancer risk.
    Since metaflumizone is registered for uses that could result in 
short-term residential exposure, EPA evaluated the potential for short-
term risk by aggregating chronic exposure through food and water with 
short-term residential exposures to metaflumizone. Since the LOC for 
the various routes of exposure differ, the aggregate risk estimates 
were calculated using the Aggregate Risk Index (ARI) approach (LOC for 
ARI <1). The short-term aggregate assessment combined food + drinking 
water exposure with the highest potential residential post-application 
exposure (high-contact activity on turf). The aggregate ARIs are 
greater than 1; therefore, EPA concludes there is no short-term risk of 
concern. Although only short-term residential exposure is anticipated, 
the short-term assessment is protective of intermediate-term exposure 
since the short- and intermediate-term PODs/LOCs are identical.
    Determination of Safety. Based on the risk assessments and 
information described above, EPA concludes there is a reasonable 
certainty that no harm will result to the U.S. general population, or 
to infants and children, from aggregate exposure to metaflumizone 
residues. More detailed information on the subject action can be found 
at https://www.regulations.gov in the documents entitled 
``Metaflumizone: Human Health Risk Assessment in Support of Section 3 
Registrations for Application of Metaflumizone to Pome Fruit (crop 
group (CG) 11-10) and Stone Fruit (CG 12-12); Updating the CG 
Designation for Citrus to 10-10 and Tree Nuts to 14-12; and Permitting 
Aerial Application to Citrus Fruits, Grapes, Tree Nuts, and Nurseries 
Containing Field-/Container-Grown Nonbearing Stone and Pome Fruit 
Trees,'' dated September 29, 2015 (docket ID EPA-HQ-OPP-2014-0607), and 
``Metaflumizone: Human Health Risk Assessment in Support of Tolerances 
Without a U.S. Registration in/on Apple, Coffee, Melon Subgroup 9A, 
Orange Subgroup 10-10A, Lemon/Lime Subgroup 10-10B, Grape, Milk Fat, 
and Ruminant Fat,'' dated December 7, 2020 (docket ID EPA-HQ-OPP-2019-
0385).

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the October 30, 2015 rulemaking.

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). Codex 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. 
Although EPA may establish a tolerance that is different from a Codex 
MRL, FFDCA section 408(b)(4) requires that EPA explain the reasons for 
departing from the Codex level.
    While Codex has not yet established MRLs on the commodities 
mentioned in this document, it has proposed MRLs in/on most of the 
relevant commodities. EPA notes that the U.S. and Codex residue 
definitions differ in that the U.S. tolerance expression includes 
metaflumizone (E- and Z-isomers) and M320I04 while Codex includes only 
metaflumizone (E- and Z-isomers). EPA is harmonizing its U.S. 
tolerances with most of the proposed Codex MRLs for apple, coffee, 
grape, melon subgroup 9A, orange subgroup 10-10A, orange oil, raisin, 
milk fat, and fat (cattle, goat, horse, and sheep). EPA is not

[[Page 20293]]

harmonizing the U.S. tolerance on lemon/lime subgroup 10-10B with the 
Codex MRL since the Codex MRL is less than that calculated by EPA using 
the submitted residue data and the OECD tolerance calculation 
procedure.

C. Revisions to Petitioned-For Tolerances

    Based upon review of data and supporting materials for this 
petition, EPA is establishing tolerances for the following commodities 
requested using the Agency's preferred commodity terminology: Instead 
of establishing a tolerance for coffee, as requested, the Agency is 
establishing a tolerance for coffee, green bean. In addition, based 
upon supporting data and harmonization with proposed Codex MRLs, the 
Agency is establishing a tolerance level lower than requested for Apple 
at 0.9 ppm, and tolerance levels higher than requested for grape, 
raisin at 13 ppm; lemon/lime subgroup 10-10B, oil at 100 ppm; and 
orange subgroup 10-10A, oil at 100 ppm. Further, since importation of 
ruminant commodities is also a probability and based on the livestock 
dietary burdens, EPA is also establishing tolerances for milk fat and 
ruminant fat tolerances in or on cattle, fat at 0.15 ppm; goat, fat at 
0.15 ppm; horse, fat at 0.15 ppm; sheep, fat at 0.15 ppm; and milk, fat 
at 0.6 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide metaflumizone (2-[2-(4-cyanophenyl)-1-[3-
(trifluoromethyl)phenyl]ethylidene]-N-[4-
(trifluoromethoxy)phenyl]hydrazinecarboxamide; E and Z isomers), in or 
on apple at 0.9 parts per million (ppm); apple, wet pomace at 3 ppm; 
coffee, green bean at 0.15 ppm; grape, raisin at 13 ppm; grapefruit 
subgroup 10-10C at 0.04 ppm; lemon/lime subgroup 10-10B at 3 ppm; 
lemon/lime subgroup 10-10B, oil at 100 ppm; melon subgroup 9A at 1 ppm; 
orange subgroup 10-10A at 3 ppm; orange subgroup 10-10A, oil at 100 
ppm; cattle, fat at 0.15 ppm; goat, fat at 0.15 ppm; horse, fat at 0.15 
ppm; milk, fat at 0.6 ppm; and sheep, fat at 0.15 ppm. In addition, the 
existing tolerance for ``fruit, pome, group 11-10,'' is amended to 
clarify that that entry now excludes apple, due to the establishment of 
a separate apple tolerance in this rulemaking and the existing 
tolerance for grape is amended to raise the tolerance level from 0.04 
ppm to 5 ppm. Finally, EPA is removing the tolerance for ``fruit, 
citrus, group 10-10'' because it is superseded by the newly established 
tolerances for each of the fruit, citrus, group 10-10 subgroups.

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) or 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: April 8, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended 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.  180.657:
0
a. Designate paragraph (a) introductory text as paragraph (a)(1) and 
revise newly designated paragraph (a)(1) introductory text;
0
b. In the table in newly designated paragraph (a)(1):
0
i. Add a heading for the table;
0
ii. Add entries for ``Apple,'' ``Apple, wet pomace,'' and ``Coffee, 
green bean'' in alphabetical order;
0
iii. Remove the entries for ``Fruit, citrus, group 10-10,'' ``Fruit, 
pome, group 11-10,'' and ``Fruit, stone, group 12-12'';
0
iv. Add the entry ``Fruit, pome, group 11-10, except apple'' in 
alphabetical order;
0
v. Revise the entry for ``Grape'';
0
vi. Add entries for ``Grape, raisin,'' ``Grapefruit subgroup 10-10C,'' 
``Lemon/lime subgroup 10-10B,''

[[Page 20294]]

``Lemon/lime subgroup 10-10B, oil,'' ``Melon subgroup 9A,'' ``Orange 
subgroup 10-10A,'' and ``Orange subgroup 10-10A, oil'' in alphabetical 
order; and
0
vii. Revise footnote 1; and
0
c. Add paragraph (a)(2).
    The additions and revisions read as follows:


Sec.  180.657  Metaflumizone; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide metaflumizone, including its metabolites and degradates, in 
or on the commodities listed in table 1 to this paragraph (a)(1). 
Compliance with the tolerance levels specified in this paragraph (a)(1) 
is to be determined by measuring only the sum of metaflumizone (E and Z 
isomers; 2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl) 
phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl] hydrazinecarboxamide) 
and its metabolite 4-{2-oxo-2-[3-(trifluoromethyl) phenyl]ethyl{time} -
benzonitrile, calculated as the stoichiometric equivalent of 
metaflumizone, in or on the following commodities:

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Apple......................................................          0.9
Apple, wet pomace..........................................            3
Coffee, green bean 1.......................................         0.15
 
                                * * * * *
Fruit, pome, group 11-10, except apple.....................         0.04
Grape......................................................            5
Grape, raisin..............................................           13
Grapefruit subgroup 10-10C.................................         0.04
Lemon/lime subgroup 10-10B.................................            3
Lemon/lime subgroup 10-10B, oil............................          100
Melon subgroup 9A 1........................................            1
 
                                * * * * *
Orange subgroup 10-10A.....................................            3
Orange subgroup 10-10A, oil................................          100
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of April 19,
  2021.

    (2) Tolerances are established for residues of the insecticide 
metaflumizone, including its metabolites and degradates, in or on the 
commodities listed in table 2 to this paragraph (a)(2). Compliance with 
the tolerance levels specified in this paragraph (a)(2) is to be 
determined by measuring only metaflumizone (E and Z isomers; 2-[2-(4-
cyanophenyl)-1-[3-(trifluoromethyl) phenyl]ethylidene]-N-[4-
(trifluoromethoxy)phenyl] hydrazinecarboxamide) in or on the following 
animal commodities:

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.15
Goat, fat..................................................         0.15
Horse, fat.................................................         0.15
Milk, fat..................................................          0.6
Sheep, fat.................................................         0.15
------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-07951 Filed 4-16-21; 8:45 am]
BILLING CODE 6560-50-P
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