Bicyclopyrone; Pesticide Tolerances, 15335-15339 [2022-05737]

Download as PDF Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Rules and Regulations (b) meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards. 4. Federalism (E.O. 13132) Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. This rule merely adjusts the level of civil monetary penalties that BOEM may impose on its lessees and has no effects on any action of State or local governments. Therefore, a federalism summary impact statement is not required. 5. Consultation and Coordination With Indian Tribal Governments (E.O. 13175) The Department of the Interior and BOEM strive to strengthen their government-to-government relationships with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. BOEM has evaluated this rule under the Department of the Interior’s consultation policy, under Departmental Manual part 512 chapters 4 and 5, and under the criteria in E.O. 13175 and determined that this rule has no substantial direct effects on federally recognized Indian Tribes or Alaska Native Claims Settlement Act (ANCSA) Corporations and that consultation under the Department of the Interior’s and BOEM’s Tribal and ANCSA consultation policies is not required. 6. Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (E.O. 13211) This rule is not a significant energy action under the definition in E.O. 13211. Therefore, a statement of energy effects is not required. This action by the Principal Deputy Assistant Secretary is taken herein pursuant to an existing delegation of authority. jspears on DSK121TN23PROD with RULES1 List of Subjects 30 CFR Part 550 Administrative practice and procedure, Continental shelf, Environmental impact statements, Environmental protection, Federal lands, Government contracts, Investigations, Mineral resources, Oil and gas exploration, Outer continental shelf, Penalties, Pipelines, Reporting and recordkeeping requirements, Rightsof-way, Sulfur. 30 CFR Part 553 Administrative practice and procedure, Continental shelf, Financial VerDate Sep<11>2014 15:55 Mar 17, 2022 Jkt 256001 responsibility, Liability, Limit of liability, Oil and gas exploration, Oil pollution, Outer continental shelf, Penalties, Pipelines, Reporting and recordkeeping requirements, Rights-ofway, Surety bonds, Treasury securities. Laura Daniel-Davis, Principal Deputy Assistant Secretary, Land and Minerals Management. For the reasons stated in the preamble, BOEM amends 30 CFR parts 550 and 553 as follows: PART 550—OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF 1. The authority citation for part 550 continues to read as follows: ■ Authority: 30 U.S.C. 1751; 31 U.S.C. 9701; 43 U.S.C. 1334. 2. Revise § 550.1403 to read as follows: ■ § 550.1403 penalty? What is the maximum civil The maximum civil penalty is $48,862 per day per violation. PART 553—OIL SPILL FINANCIAL RESPONSIBILITY FOR OFFSHORE FACILITIES 3. The authority citation for part 553 is revised to read as follows: ■ Authority: 33 U.S.C. 2704, 2716, as amended. 4. Revise § 553.51(a) to read as follows: ■ § 553.51 What are the penalties for not complying with this part? (a) If you fail to comply with the financial responsibility requirements of OPA at 33 U.S.C. 2716 or with the requirements of this part, then you may be liable for a civil penalty of up to $51,796 per COF per day of violation (that is, each day a COF is operated without acceptable evidence of OSFR). * * * * * 15335 This regulation establishes tolerances for residues of bicyclopyrone in or on banana; broccoli; hop, dried cones; horseradish; onion, bulb; onion, green; papaya; strawberry; sweet potato, tuber; timothy, forage; timothy, hay and watermelon. Syngenta Crop Protection, LLC., requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective March 18, 2022. Objections and requests for hearings must be received on or before May 17, 2022 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–2020–0375, 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 open to visitors by appointment only. For the latest status information on EPA/DC services and access, visit https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: [FR Doc. 2022–05633 Filed 3–17–22; 8:45 am] I. General Information BILLING CODE 4310–MR–P 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). ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2020–0375; FRL–9472–01– OCSPP] Bicyclopyrone; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\FR\FM\18MRR1.SGM 18MRR1 15336 Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Rules and Regulations • 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 Office of the Federal Register’s e-CFR site at https://www.ecfr.gov/ current/title-40. jspears on DSK121TN23PROD with RULES1 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–2020–0375 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 May 17, 2022. 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– 2020–0375, 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 VerDate Sep<11>2014 15:55 Mar 17, 2022 Jkt 256001 dockets generally, is available at https:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of February 25, 2021 (86 FR 11488) (FRL–10020–47), 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 0F8853) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419– 8300. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide bicyclopyrone, 4-hydroxy3-{2-[(2-methoxyethoxy)methyl}-6(trifluoromethyl)-3pyridylcarbonyl}bicyclo[3.2.1]oct-3-en2-one, in or on banana at 0.01 parts per million (ppm); broccoli at 0.01 ppm; garlic, bulb at 0.02 ppm, hops, dried cones at 0.04 ppm; horseradish at 0.015 ppm; onion, bulb at 0.02 ppm; onion, green at 0.05 ppm; papaya at 0.01 ppm; plantains at 0.01 ppm; strawberry at 0.01 ppm; sweet potato, roots at 0.02 ppm; timothy, forage at 0.9 ppm; timothy, hay at 1.5 ppm; and watermelon at 0.01 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC., 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 requested by the petitioner, is not establishing several petitioned for tolerances, and adjusted several commodity definitions. The reasons for these changes are explained 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 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 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 bicyclopyrone including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with bicyclopyrone follows. In an effort to streamline its publications in the Federal Register, EPA is not reprinting sections of the rule that repeat what has been previously published in tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking and republishing the same sections is unnecessary and duplicative. 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 bicyclopyrone, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to bicyclopyrone 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. A. Toxicological Profile For a discussion of the Toxicological Profile of bicyclopyrone, see Unit III.A. of the December 23, 2021, rulemaking (86–FR–72846) (FRL–9199–01–OCSPP). B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. The PODs and levels of concern have not changed from the previous rulemaking and EPA incorporates the background information in the December 23, 2021, rulemaking. A summary of the E:\FR\FM\18MRR1.SGM 18MRR1 Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Rules and Regulations toxicological endpoints for bicyclopyrone used for human risk assessment can be found in the document titled ‘‘Bicyclopyrone: Human Health Risk Assessment for the Establishment of Permanent Tolerances for Residues in/on Bananas, Broccoli, Dry Bulb Onions, Green Onion, Hops, Horseradish, Papaya, Strawberry, Sweet Potatoes, Timothy Forage, Timothy Hay, and Watermelon’’ (hereinafter ‘‘Bicyclopyrone Human Health Risk Assessment’’) in docket ID number EPA–HQ–OPP–2020–0375 in regulations.gov. jspears on DSK121TN23PROD with RULES1 C. Exposure Assessment Much of the exposure assessment remains the same although updates have occurred to accommodate exposures from the petitioned-for tolerance. These updates are discussed in this section; for a description of the rest of the EPA approach to and assumptions for the exposure assessment, please reference Unit III.C. of the December 23, 2021, rulemaking. EPA’s dietary exposure assessments have been updated to include the additional exposure from the new uses of bicyclopyrone on banana; broccoli; hop, dried cones; horseradish; onion, bulb; onion, green; papaya; strawberry; sweet potato, tuber; timothy, forage; timothy, hay; and watermelon (see Unit IV. C for an explanation of the differences between this list and the petitioned for tolerances). The assessment used the same assumptions as the December 23, 2021, final rule concerning average field trial residues for registered crops, tolerance levels for the proposed crops and recently added crops, average empirical processing factors for registered crops, anticipated residues for livestock commodities, and percent crop treated (PCT) for registered crops commodities. D. Anticipated Residue and Percent Crop Treated (PCT) Information Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than VerDate Sep<11>2014 15:55 Mar 17, 2022 Jkt 256001 5 years from the date of issuance of these tolerances. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: • Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue. • Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group. • Condition c: Data are available on pesticide use and food consumption in a particular area, and the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The chronic dietary assessment incorporated the following average PCT estimates: Barley, 1%; field corn, 10%; sweet corn, 5%; pop corn, 10% (used the higher of the corn PCT); and wheat, 5% (used spring wheat PCT which was higher than winter wheat PCTs). An estimate of 100% crop treated was used for all other commodities. The PCT for livestock commodities is based on the PCT value for the livestock feed item used in the dietary burden with the highest percent crop treated (field corn, 10%). In most cases, EPA uses available data from the United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 15337 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT. The Agency believes that the three conditions discussed in Unit III.C.1. iv have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA’s computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA’s risk assessment process ensures that EPA’s exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which bicyclopyrone may be applied in a particular area. Dietary exposure from drinking water. EPA has revised the bicyclopyrone Drinking Water Assessment (DWA) since the December 23, 2021, rule. The 2016 DWA for bicyclopyrone (USEPA, 2016, DP Barcode 428614) recommended moving forward with estimated drinking water concentrations (EDWCs) for a groundwater scenario that occurred in a wheat and barley growing area and move away from the existing EDWCs based on a simulation resulting in the highest groundwater EDWC. The Human Health Risk Assessment (USEPA, 2022, DP Barcode 459563) used the highest groundwater EDWCs from the previous 2016 DWA. The maximum acute and chronic/cancer surface water and groundwater EDWCs associated with bicyclopyrone use were 7.61 parts per billion (ppb) for the maximum acute and 6.66 ppb, for the maximum chronic/cancer. Non-occupational exposure. There are no new residential (non-occupational) exposures associated with the new proposed uses and bicyclopyrone is not registered for any use patterns that would result in residential exposure. Cumulative exposure. For a discussion of the cumulative exposure assessment of bicyclopyrone, see Unit E:\FR\FM\18MRR1.SGM 18MRR1 jspears on DSK121TN23PROD with RULES1 15338 Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Rules and Regulations III.C.4 of the December 23, 2021, rulemaking. Safety factor for infants and children. EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor. See Unit III.D of the December 23, 2021 rulemaking for a discussion of the Agency’s rationale for that determination. Aggregate risks and determination of safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population-adjusted dose (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure exists. An acute dietary exposure assessment was not conducted as toxicological effects attributable to a single dose were not identified. Chronic dietary risks are below the Agency’s level of concern of 100% of the cPAD: The population subgroup with the highest exposure estimate was all infants at 16% of the cPAD. Bicyclopyrone is classified as ‘‘Suggestive Evidence of Carcinogenic Potential’’. However, because the Agency has determined that the chronic reference dose will be protective of any potential cancer risk and there are no chronic risks that exceeds the Agency’s level of concern, EPA concludes that there is not a concern for cancer risk from exposure to bicyclopyrone. There are no registered or new uses of bicyclopyrone that would result in residential exposure, therefore the aggregate risk estimates are equivalent to the chronic dietary (food and water) risk estimates and are not of concern. Based on these risk assessments and the information described above, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to bicyclopyrone residues. More detailed information about the Agency’s analysis can be found in the Bicyclopyrone Human Health Risk Assessment in docket ID number EPA–HQ–OPP–2020– 0373 in regulations.gov at https:// www.regulations.gov. IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit VerDate Sep<11>2014 15:55 Mar 17, 2022 Jkt 256001 IV.A of the December 23, 2021, 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). The Codex has not established a MRL for residues of bicyclopyrone in/on bananas, broccoli, dry bulb onions, timothy forage or hay, green onion, hops, horseradish, papaya, strawberry, sweet potato, or watermelon. C. Revisions to Petitioned-For Tolerances FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a tolerance that varies from that sought by the petition. The petitioner initially requested to include tolerances for both banana and plantain; however, a separate tolerance is not required for plantain per 40 CFR 180.1(g). Therefore, the Agency is only finalizing a tolerance for banana. The petitioner also requested to include tolerances for both garlic and onion, bulb; however, a separate tolerance is not required for garlic per 40 CFR 180.1(g). Therefore, the Agency is only finalizing a tolerance for onion, bulb. The proposed commodity definitions for hops, dried cones; sweet potato, roots; have been modified to hop, dried cones; sweet potato, tuber, respectively, in order be consistent with Agency nomenclature. The petitioner initially requested a tolerance of 0.9 ppm for timothy, forage and 1.5 ppm for timothy, hay. The petitioner appears to have calculated the requested tolerance value using input residue values from the forage and hay decline trials with a longer preharvest intervals (PHI), which would underestimate the resulting residues. The Agency used the residue values from the decline trial that had the shortest PHI. The Agency deems it appropriate to use the more conservative (i.e., results with the highest residue value) approach and as a result produced a recommended tolerance of 1.5 ppm for timothy, forage and 2 ppm for timothy, hay when entered into the OECD calculator. The proposed commodity for horseradish tolerance has also been modified to be set at the respective limit of quantitation (LOQs), as there were no residues detected. PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 V. Conclusion Therefore, tolerances are established for residues of bicyclopyrone, 4hydroxy-3-[[2-[(2methoxyethoxy)methyl]-6(trifluoromethyl)-3pyridinyl]carbonyl]bicyclo[3.2.1]oct-3en-2-one, including its metabolites and degradates in or on banana at 0.01 ppm; broccoli at 0.01 ppm; hop, dried cones at 0.04 ppm; horseradish at 0.02 ppm; onion, bulb at 0.02 ppm; onion, green at 0.05 ppm; papaya at 0.01 ppm; strawberry at 0.01 ppm; sweet potato, tuber at 0.02 ppm; timothy, forage at 1.5 ppm; timothy, hay at 2 ppm; and watermelon at 0.01 ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). 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 E:\FR\FM\18MRR1.SGM 18MRR1 Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Rules and Regulations 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: March 9, 2022. 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: jspears on DSK121TN23PROD with RULES1 ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.682 amend Table 1 to Paragraph (a) (1) by adding in alphabetical order the entries ‘‘Banana’’; ‘‘Broccoli’’; ‘‘Hop, dried cones’’; ‘‘Horseradish’’; ‘‘Onion, bulb’’; ‘‘Onion, ■ VerDate Sep<11>2014 15:55 Mar 17, 2022 Jkt 256001 15339 green’’; ‘‘Papaya’’; ‘‘Strawberry’’; ‘‘Sweet potato, tuber’’; ‘‘Timothy, forage’’; Timothy, hay’’; and ‘‘Watermelon’’ to read as follows: Media Bureau, Audio Division (202) 418–2739, James.Bradshaw@fcc.gov; Christine Goepp, Attorney Advisor, Media Bureau, Audio Division, (202) 418–7834, Christine.Goepp@fcc.gov. § 180.682 Bicyclopyrone; tolerances for SUPPLEMENTARY INFORMATION: This is a residues. summary of the Commission’s Report (a) * * * and Order (R&O), MB Docket No. 21– (1) * * * 263, FCC 22–13, adopted on February 16, 2022, and released on February 17, TABLE 1 TO PARAGRAPH (a)(1) 2022. The full text of the R&O will be available electronically via the FCC’s Parts per Commodity Electronic Document Management million System (EDOCS) website at Banana ....................................... 0.01 www.fcc.gov/edocs or via the FCC’s Electronic Comment Filing System * * * * * (ECFS) website at www.fcc.gov/ecfs. The Broccoli ....................................... 0.01 Commission published the notice of proposed rulemaking (NPRM) at 86 FR * * * * * 43145 on August 6, 2021. Hop, dried cones ........................ 0.04 Synopsis 1. The Federal Communication Commission amends the following rules applicable to broadcast radio stations to * * * * * Onion, bulb ................................. 0.02 better reflect current requirements and Onion, green ............................... 0.05 eliminate redundant, outdated, or Papaya ........................................ 0.01 conflicting technical provisions. 2. Maximum rated transmitter power * * * * * for AM stations. The Commission Strawberry .................................. 0.01 amends 47 CFR 73.1665(b) to remove the maximum rated transmitter power * * * * * limit for AM stations and deletes the Sweet potato, tuber .................... 0.02 Timothy, forage ........................... 1.5 corresponding ‘‘Table 1 to paragraph Timothy, hay ............................... 2 (b).’’ This equipment limitation on potential transmitter power is outdated and unnecessary given the * * * * * Watermelon ................................ 0.01 Commission’s current reliance on actual operating antenna input power as the * * * * * most accurate and effective means of ensuring that AM stations adhere to * * * * * their authorized power limits. The [FR Doc. 2022–05737 Filed 3–17–22; 8:45 am] Commission anticipates that elimination BILLING CODE 6560–50–P of this technical restriction on AM transmitters will allow AM stations of any class to use transmitters of any rated FEDERAL COMMUNICATIONS power, thus benefiting the AM service COMMISSION by broadening the market of transmitters available to stations, enhancing the 47 CFR Parts 73 and 74 secondary market for AM transmitters, and reducing the number of transmitters [MB Docket No. 21–263; FCC 22–13; FR ID that need to be disposed of. 76380] Accordingly, it amends 47 CFR Broadcast Radio Technical Rules 73.1665(b) by removing the maximum rated transmitter power for AM stations, AGENCY: Federal Communications deletes the ‘‘Table 1 to paragraph (b),’’ Commission. and replaces ‘‘power rating limit’’ in the ACTION: Final rule. first sentence with ‘‘manufacturer-rated power limit’’ to indicate that this is a SUMMARY: The Federal Communication technical specification established by Commission (Commission or FCC) the transmitter manufacturer. amends the rules applicable to 3. Noncommercial Educational (NCE) broadcast radio stations to better reflect community of license coverage. The current requirements and eliminate Commission eliminates the redundant, outdated, or conflicting inconsistency between 47 CFR technical provisions. 73.316(c)(2)(ix)(B) and 73.1690(c)(8)(i) DATES: Effective April 18, 2022. and the NCE FM community coverage FOR FURTHER INFORMATION CONTACT: standard set out in 47 CFR 73.515. James Bradshaw, Deputy Division Chief, Specifically, it amends * * * * Horseradish ................................ PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 * 0.02 E:\FR\FM\18MRR1.SGM 18MRR1

Agencies

[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Rules and Regulations]
[Pages 15335-15339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05737]


=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0375; FRL-9472-01-OCSPP]


Bicyclopyrone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
bicyclopyrone in or on banana; broccoli; hop, dried cones; horseradish; 
onion, bulb; onion, green; papaya; strawberry; sweet potato, tuber; 
timothy, forage; timothy, hay and watermelon. Syngenta Crop Protection, 
LLC., requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective March 18, 2022. Objections and 
requests for hearings must be received on or before May 17, 2022 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-2020-0375, 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 open to visitors by 
appointment only. For the latest status information on EPA/DC services 
and access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

[[Page 15336]]

     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 Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2020-0375 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 
May 17, 2022. 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-2020-0375, 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 February 25, 2021 (86 FR 11488) (FRL-
10020-47), 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 
0F8853) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR part 180 be amended 
by establishing tolerances for residues of the herbicide bicyclopyrone, 
4-hydroxy-3-{2-[(2-methoxyethoxy)methyl{time} -6-(trifluoromethyl)-3-
pyridylcarbonyl{time} bicyclo[3.2.1]oct-3-en-2-one, in or on banana at 
0.01 parts per million (ppm); broccoli at 0.01 ppm; garlic, bulb at 
0.02 ppm, hops, dried cones at 0.04 ppm; horseradish at 0.015 ppm; 
onion, bulb at 0.02 ppm; onion, green at 0.05 ppm; papaya at 0.01 ppm; 
plantains at 0.01 ppm; strawberry at 0.01 ppm; sweet potato, roots at 
0.02 ppm; timothy, forage at 0.9 ppm; timothy, hay at 1.5 ppm; and 
watermelon at 0.01 ppm.
    That document referenced a summary of the petition prepared by 
Syngenta Crop Protection, LLC., 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 requested by 
the petitioner, is not establishing several petitioned for tolerances, 
and adjusted several commodity definitions. The reasons for these 
changes are explained 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 bicyclopyrone including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with bicyclopyrone 
follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections of the rule that repeat what 
has been previously published in tolerance rulemakings for the same 
pesticide chemical. Where scientific information concerning a 
particular chemical remains unchanged, the content of those sections 
would not vary between tolerance rulemaking and republishing the same 
sections is unnecessary and duplicative. 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 
bicyclopyrone, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to bicyclopyrone 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.

A. Toxicological Profile

    For a discussion of the Toxicological Profile of bicyclopyrone, see 
Unit III.A. of the December 23, 2021, rulemaking (86-FR-72846) (FRL-
9199-01-OCSPP).

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. The PODs and levels of concern have not changed from the 
previous rulemaking and EPA incorporates the background information in 
the December 23, 2021, rulemaking. A summary of the

[[Page 15337]]

toxicological endpoints for bicyclopyrone used for human risk 
assessment can be found in the document titled ``Bicyclopyrone: Human 
Health Risk Assessment for the Establishment of Permanent Tolerances 
for Residues in/on Bananas, Broccoli, Dry Bulb Onions, Green Onion, 
Hops, Horseradish, Papaya, Strawberry, Sweet Potatoes, Timothy Forage, 
Timothy Hay, and Watermelon'' (hereinafter ``Bicyclopyrone Human Health 
Risk Assessment'') in docket ID number EPA-HQ-OPP-2020-0375 in 
regulations.gov.

C. Exposure Assessment

    Much of the exposure assessment remains the same although updates 
have occurred to accommodate exposures from the petitioned-for 
tolerance. These updates are discussed in this section; for a 
description of the rest of the EPA approach to and assumptions for the 
exposure assessment, please reference Unit III.C. of the December 23, 
2021, rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposure from the new uses of bicyclopyrone on banana; 
broccoli; hop, dried cones; horseradish; onion, bulb; onion, green; 
papaya; strawberry; sweet potato, tuber; timothy, forage; timothy, hay; 
and watermelon (see Unit IV. C for an explanation of the differences 
between this list and the petitioned for tolerances). The assessment 
used the same assumptions as the December 23, 2021, final rule 
concerning average field trial residues for registered crops, tolerance 
levels for the proposed crops and recently added crops, average 
empirical processing factors for registered crops, anticipated residues 
for livestock commodities, and percent crop treated (PCT) for 
registered crops commodities.

D. Anticipated Residue and Percent Crop Treated (PCT) Information

    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, and the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The chronic dietary assessment incorporated the following average 
PCT estimates: Barley, 1%; field corn, 10%; sweet corn, 5%; pop corn, 
10% (used the higher of the corn PCT); and wheat, 5% (used spring wheat 
PCT which was higher than winter wheat PCTs). An estimate of 100% crop 
treated was used for all other commodities. The PCT for livestock 
commodities is based on the PCT value for the livestock feed item used 
in the dietary burden with the highest percent crop treated (field 
corn, 10%).
    In most cases, EPA uses available data from the United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the California Department 
of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute dietary risk analysis. The average PCT figure for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding to 
the nearest 5%, except for those situations in which the average PCT is 
less than 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit 
III.C.1. iv have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which bicyclopyrone may be applied in a particular area.
    Dietary exposure from drinking water. EPA has revised the 
bicyclopyrone Drinking Water Assessment (DWA) since the December 23, 
2021, rule. The 2016 DWA for bicyclopyrone (USEPA, 2016, DP Barcode 
428614) recommended moving forward with estimated drinking water 
concentrations (EDWCs) for a groundwater scenario that occurred in a 
wheat and barley growing area and move away from the existing EDWCs 
based on a simulation resulting in the highest groundwater EDWC. The 
Human Health Risk Assessment (USEPA, 2022, DP Barcode 459563) used the 
highest groundwater EDWCs from the previous 2016 DWA. The maximum acute 
and chronic/cancer surface water and groundwater EDWCs associated with 
bicyclopyrone use were 7.61 parts per billion (ppb) for the maximum 
acute and 6.66 ppb, for the maximum chronic/cancer.
    Non-occupational exposure. There are no new residential (non-
occupational) exposures associated with the new proposed uses and 
bicyclopyrone is not registered for any use patterns that would result 
in residential exposure.
    Cumulative exposure. For a discussion of the cumulative exposure 
assessment of bicyclopyrone, see Unit

[[Page 15338]]

III.C.4 of the December 23, 2021, rulemaking.
    Safety factor for infants and children. EPA continues to conclude 
that there are reliable data to support the reduction of the Food 
Quality Protection Act (FQPA) safety factor. See Unit III.D of the 
December 23, 2021 rulemaking for a discussion of the Agency's rationale 
for that determination.
    Aggregate risks and determination of safety. EPA determines whether 
acute and chronic dietary pesticide exposures are safe by comparing 
aggregate exposure estimates to the acute population-adjusted dose 
(aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates 
the lifetime probability of acquiring cancer given the estimated 
aggregate exposure. Short-, intermediate-, and chronic-term risks are 
evaluated by comparing the estimated aggregate food, water, and 
residential exposure to the appropriate points of departure to ensure 
that an adequate margin of exposure exists.
    An acute dietary exposure assessment was not conducted as 
toxicological effects attributable to a single dose were not 
identified. Chronic dietary risks are below the Agency's level of 
concern of 100% of the cPAD: The population subgroup with the highest 
exposure estimate was all infants at 16% of the cPAD. Bicyclopyrone is 
classified as ``Suggestive Evidence of Carcinogenic Potential''. 
However, because the Agency has determined that the chronic reference 
dose will be protective of any potential cancer risk and there are no 
chronic risks that exceeds the Agency's level of concern, EPA concludes 
that there is not a concern for cancer risk from exposure to 
bicyclopyrone. There are no registered or new uses of bicyclopyrone 
that would result in residential exposure, therefore the aggregate risk 
estimates are equivalent to the chronic dietary (food and water) risk 
estimates and are not of concern.
    Based on these risk assessments and the information described 
above, EPA concludes that there is a reasonable certainty that no harm 
will result to the general population, or to infants and children from 
aggregate exposure to bicyclopyrone residues. More detailed information 
about the Agency's analysis can be found in the Bicyclopyrone Human 
Health Risk Assessment in docket ID number EPA-HQ-OPP-2020-0373 in 
regulations.gov at https://www.regulations.gov.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A of the December 23, 2021, 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).
    The Codex has not established a MRL for residues of bicyclopyrone 
in/on bananas, broccoli, dry bulb onions, timothy forage or hay, green 
onion, hops, horseradish, papaya, strawberry, sweet potato, or 
watermelon.

C. Revisions to Petitioned-For Tolerances

    FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a 
tolerance that varies from that sought by the petition. The petitioner 
initially requested to include tolerances for both banana and plantain; 
however, a separate tolerance is not required for plantain per 40 CFR 
180.1(g). Therefore, the Agency is only finalizing a tolerance for 
banana. The petitioner also requested to include tolerances for both 
garlic and onion, bulb; however, a separate tolerance is not required 
for garlic per 40 CFR 180.1(g). Therefore, the Agency is only 
finalizing a tolerance for onion, bulb.
    The proposed commodity definitions for hops, dried cones; sweet 
potato, roots; have been modified to hop, dried cones; sweet potato, 
tuber, respectively, in order be consistent with Agency nomenclature.
    The petitioner initially requested a tolerance of 0.9 ppm for 
timothy, forage and 1.5 ppm for timothy, hay. The petitioner appears to 
have calculated the requested tolerance value using input residue 
values from the forage and hay decline trials with a longer preharvest 
intervals (PHI), which would underestimate the resulting residues. The 
Agency used the residue values from the decline trial that had the 
shortest PHI. The Agency deems it appropriate to use the more 
conservative (i.e., results with the highest residue value) approach 
and as a result produced a recommended tolerance of 1.5 ppm for 
timothy, forage and 2 ppm for timothy, hay when entered into the OECD 
calculator.
    The proposed commodity for horseradish tolerance has also been 
modified to be set at the respective limit of quantitation (LOQs), as 
there were no residues detected.

V. Conclusion

    Therefore, tolerances are established for residues of 
bicyclopyrone, 4-hydroxy-3-[[2-[(2-methoxyethoxy)methyl]-6-
(trifluoromethyl)-3-pyridinyl]carbonyl]bicyclo[3.2.1]oct-3-en-2-one, 
including its metabolites and degradates in or on banana at 0.01 ppm; 
broccoli at 0.01 ppm; hop, dried cones at 0.04 ppm; horseradish at 0.02 
ppm; onion, bulb at 0.02 ppm; onion, green at 0.05 ppm; papaya at 0.01 
ppm; strawberry at 0.01 ppm; sweet potato, tuber at 0.02 ppm; timothy, 
forage at 1.5 ppm; timothy, hay at 2 ppm; and watermelon at 0.01 ppm.

VI. Statutory and Executive Order Reviews

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

[[Page 15339]]

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: March 9, 2022.
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.  180.682 amend Table 1 to Paragraph (a) (1) by adding in 
alphabetical order the entries ``Banana''; ``Broccoli''; ``Hop, dried 
cones''; ``Horseradish''; ``Onion, bulb''; ``Onion, green''; 
``Papaya''; ``Strawberry''; ``Sweet potato, tuber''; ``Timothy, 
forage''; Timothy, hay''; and ``Watermelon'' to read as follows:


Sec.  180.682  Bicyclopyrone; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana......................................................        0.01
 
                                * * * * *
Broccoli....................................................        0.01
 
                                * * * * *
Hop, dried cones............................................        0.04
 
                                * * * * *
Horseradish.................................................        0.02
 
                                * * * * *
Onion, bulb.................................................        0.02
Onion, green................................................        0.05
Papaya......................................................        0.01
 
                                * * * * *
Strawberry..................................................        0.01
 
                                * * * * *
Sweet potato, tuber.........................................        0.02
Timothy, forage.............................................         1.5
Timothy, hay................................................           2
 
                                * * * * *
Watermelon..................................................        0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-05737 Filed 3-17-22; 8:45 am]
BILLING CODE 6560-50-P
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