Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides; Terbacil, et al.

ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2023-0502; FRL-11773-01-OCSPP]</DEPDOC> <SUBJECT>Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides; Terbacil, et al.</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Environmental Protection Agency (EPA or the Agency) is proposing to implement several tolerance actions under the Federal Food, Drug, and Cosmetic Act (FFDCA) that the Agency determined were necessary or appropriate during the registration review conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). During registration review, EPA reviews all aspects of a pesticide case, including existing tolerances, to ensure that the pesticide continues to meet the standard for registration under FIFRA. The tolerance actions and pesticide active ingredients addressed in this rulemaking are identified in Unit I.B. and discussed in detail in Unit III. of this document. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before September 20, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2023-0502, through the Federal eRulemaking Portal at: <E T="03">https://www.regulations.gov.</E> Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at <E T="03">https://www.epa.gov/dockets.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Katherine Atha, Pesticide Re-Evaluation Division (7508M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-1933; email address: <E T="03">atha.katherine@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Does this action apply to me?</HD> 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: <FP SOURCE="FP-1">• Crop production (NAICS code 111).</FP> <FP SOURCE="FP-1">• Animal production (NAICS code 112).</FP> <FP SOURCE="FP-1">• Food manufacturing (NAICS code 311).</FP> <FP SOURCE="FP-1">• Pesticide manufacturing (NAICS code 32532).</FP> <HD SOURCE="HD2">B. What action is the Agency taking?</HD> EPA is proposing several tolerance actions that the Agency previously determined were necessary or appropriate during registration review for the following pesticide active ingredients: terbacil, bromacil, metolachlor and <E T="03">S</E> -metolachlor, etridiazole, triclopyr, deltamethrin, cyfluthrin and isomer beta-cyfluthrin, cyproconazole, fluroxypyr, pyraflufen-ethyl, etoxazole, acequinocyl, pinoxaden, flonicamid, and d-phenothrin. The proposed tolerance actions for each pesticide active ingredient are described in Unit III and may include but are not limited to the following types of actions: <FP SOURCE="FP-1">• Revising tolerance expressions;</FP> <FP SOURCE="FP-1">• Modifying commodity definitions;</FP> <FP SOURCE="FP-1">• Updating crop groups;</FP> <FP SOURCE="FP-1">• Removing expired tolerances;</FP> <FP SOURCE="FP-1">• Revoking tolerances that are no longer needed; and</FP> <FP SOURCE="FP-1">• Harmonizing tolerances with Codex Maximum Residue Levels (MRLs).</FP> Although they may not have been identified in the registration review of a particular pesticide, this rule also includes proposals to reflect the Agency's 2019 adoption of the Organization of Economic Cooperation and Development (OECD) Rounding Class Practice. Where applicable, these adjustments are proposed for specific pesticides as reflected in the proposed regulatory text section. <HD SOURCE="HD2">C. What is the Agency's authority for taking this action?</HD> Pursuant to its authority under the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a, EPA is proposing the tolerance actions in this rulemaking that the Agency previously determined were necessary or appropriate during the registration review conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 <E T="03">et seq.</E> FFDCA section 408(b) authorizes EPA to establish a tolerance, if the Agency determines that a tolerance is safe; FFDCA section 408(c) authorizes EPA to establish an exemption from the requirement of a tolerance if the Agency determines that the exemption is safe. <E T="03">See</E> 21 U.S.C. 346a(b) and (c). If EPA determines that a tolerance or exemption is not safe, EPA must modify or revoke that tolerance or exemption. The 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.” 21 U.S.C. 346a(b)(2)(A)(ii), (c)(2)(A)(ii). This includes exposure through drinking water and in residential settings but does not include occupational exposure. FFDCA section 408(b)(2)(C) requires EPA to give special consideration to the 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[s.]” 21 U.S.C. 346a(b)(2)(C). In addition, FFDCA section 408(b)(2)(D) contains several factors EPA must consider when making determinations about establishing, modifying, or revoking tolerances. 21 U.S.C. 346a(b)(2)(D). FFDCA section 408(c)(2)(B) requires that EPA, when making determinations about exemptions, to take into account, among other things, the considerations set forth in FFDCA section 408(b)(2)(C) and (D). 21 U.S.C. 346a(c)(2)(B). FFDCA section 408(e), 21 U.S.C. 346a(e), authorizes EPA to establish, modify, or revoke tolerances or exemptions from the requirement of a tolerance on its own initiative. Prior to issuing the final regulation, FFDCA section 408(e)(2) requires EPA to issue a notice of proposed rulemaking for a 60-day public comment period, unless the Administrator for good cause finds that it would be in the public interest to have a shorter period and states the reasons in the rulemaking. Furthermore, when establishing tolerances or exemptions from the requirement of a tolerance, FFDCA sections 408(b)(3) and (c)(3) require that there be a practical method for detecting and measuring pesticide chemical residue levels in or on food, unless in the case of exemptions, EPA determines that such method is not needed and states the reasons therefore in the rulemaking. 21 U.S.C. 346a(b) and (c). Under FIFRA section 3(g), 7 U.S.C. 136a(g), EPA is required to periodically review all registered pesticides and determine if those pesticides continue to meet the standard for registration under FIFRA. <E T="03">See also</E> 40 CFR 155.40(a). Consistent with its obligations under FIFRA section 3(g) and FFDCA section 408, EPA has reviewed the available scientific data and other relevant information and determined it is appropriate to take the tolerance actions being proposed in this rulemaking. <HD SOURCE="HD2">D. What can I do if I want the Agency to maintain a tolerance that the Agency proposes to revoke?</HD> This proposed rule provides a 60-day public comment period that allows any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives such a comment within the 60-day period, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the <E T="04">Federal Register</E> under FFDCA section 408(f), if needed. The order would specify data needed and the timeframes for submission of the data and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA. After considering comments that are received in response to this proposed rule, EPA will issue a final rule. At the time of the final rule, you may file an objection or request a hearing on the action taken in the final rule. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. After the filing deadline specified in the final rule, issues resolved in the final rule cannot be raised again in any subsequent proceedings. <HD SOURCE="HD2">E. What should I consider as I prepare my comments for EPA?</HD> <HD SOURCE="HD3">1. Submitting CBI</HD> Do not submit this information to EPA through <E T="03">https://www.regulations.gov</E> or email. If you wish to include CBI in your comment, please follow the applicable instructions at <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets#rules</E> and clearly mark the part or all of the information that you claim to be CBI. 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