Fenoxaprop-Ethyl, Flufenpyr-Ethyl, Imazapyr, Maleic Hydrazide, Pyrazon, Quinclorac, Triflumizole, et al.; Tolerance and Tolerance Exemption Actions

ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2017-0418; FRL-6704-02-OCSPP]</DEPDOC> <RIN>RIN 2070-ZA16</RIN> <SUBJECT>Fenoxaprop-Ethyl, Flufenpyr-Ethyl, Imazapyr, Maleic Hydrazide, Pyrazon, Quinclorac, Triflumizole, et al.; Tolerance and Tolerance Exemption Actions</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Supplemental notice of proposed rulemaking. <SUM> <HD SOURCE="HED">SUMMARY:</HD> On February 5, 2019, the Environmental Protection Agency (EPA or Agency) proposed tolerance and tolerance exemption actions for several pesticides under the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA is issuing this supplemental notice of proposed rulemaking to modify the previously proposed tolerance exemptions for one of those pesticides: maleic hydrazide. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before September 8, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2017-0418, through <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> Robert Little, Pesticide Re-Evaluation Division (7508M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-2219; email address: <E T="03">little.robert@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 might apply to them: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). If you have any questions regarding the applicability of this proposed action to a particular entity, consult the person listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <HD SOURCE="HD2">B. What action is the Agency taking?</HD> EPA is issuing this supplemental notice of proposed rulemaking to modify the exemptions from the requirement of a tolerance for residues of the pesticide maleic hydrazide previously proposed in <E T="03">Fenoxaprop-ethyl, Flufenpyr-ethyl, Imazapyr, Maleic hydrazide, Pyrazon, Quinclorac, Triflumizole, et al.; Proposed Tolerance and Tolerance Exemption Actions</E> (FRL-9970-24; 84 FR 1691, February 5, 2019) (“2019 Proposed Rule”). Specifically, the Agency previously proposed to establish tolerance exemptions for residues of maleic hydrazide when used as a plant growth regulator or herbicide in or on onion, bulb and potato, and when present in or on potato chips as a result of application to the growing potato plant. EPA is now proposing to establish a single tolerance exemption for residues of maleic hydrazide when used as a plant growth regulator or herbicide, without limiting the exemption to specific commodities. Further discussion of this action and the Agency's rationale can be found in Unit III of this rulemaking. <HD SOURCE="HD2">C. What is EPA's authority for taking this action?</HD> Section 408(e) of the Federal Food, Drug and Cosmetic Act (FFDCA), 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. 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. As part of the registration review of a pesticide, EPA also evaluates the existing tolerances for the pesticide. Any tolerance changes identified as necessary or appropriate during registration review are summarized in the registration review decision documents for each pesticide active ingredient or registration review case ( <E T="03">e.g.,</E> in the Proposed Interim Decision (PID), Interim Decision (ID), Proposed Final Decision (PFD), and Final Decision (FD)). Registration review decision documents for maleic hydrazide can be found in the public docket at <E T="03">https://www.regulations.gov/</E> in docket identification (ID) number EPA-HQ-OPP-2017-0418. 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 proposed rulemaking. EPA has determined that such good cause exists here. The Agency previously issued the 2019 Proposed Rule for a 60-day public comment period that closed on April 8, 2019, and did not receive any comments. In the 2019 Proposed Rule, EPA proposed tolerance and tolerance exemption actions that were identified as necessary or appropriate during registration review for several pesticides. This supplemental notice of proposed rulemaking modifies the proposed tolerance exemption for only one of those pesticides, maleic hydrazide; the remainder of the 2019 Proposed Rule is unchanged. EPA finds that it would be in the public interest to have a shorter 30-day public comment period for this supplemental notice to allow the Agency to move forward sooner with issuing a final rule implementing the necessary or appropriate actions that it previously proposed while also providing an adequate opportunity for public comment on the discrete modification described in this supplemental notice. EPA is seeking comment only on the issues discussed in this supplemental notice and is not reopening comment on any other aspects of the 2019 Proposed Rule. After consideration of public comments on this supplemental notice, EPA intends to finalize this action and all applicable actions of the 2019 Proposed Rule in one final rule. <HD SOURCE="HD2">D. What should I consider as I prepare my comments for EPA?</HD> 1. <E T="03">Submitting CBI.</E> Do not submit CBI to EPA through email or <E T="03">https://www.regulations.gov.</E> 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 information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. <E T="03">Tips for preparing your comments.</E> When preparing and submitting your comments, see the commenting tips at <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E> <HD SOURCE="HD2">E. How can I file an objection or hearing request?</HD> This supplemental notice of proposed rulemaking provides a 30-day public comment period. After considering comments that are received in response to this supplemental notice, 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="HD1">II. Background</HD> <HD SOURCE="HD2">A. What is a tolerance?</HD> A “tolerance” represents the maximum level for residues of a pesticide chemical legally allowed in or on food, which includes raw agricultural commodities and processed foods and feed for animals. Under the FFDCA, residues of a pesticide chemical that are not covered by a tolerance or exemption from the requirement of a tolerance are considered unsafe. <E T="03">See</E> 21 U.S.C. 346a(a)(1). Foods containing unsafe residues are deemed adulterated and may not be distributed in interstate commerce. <E T="03">See</E> 21 U.S.C. 331(a) and 342(a)(2)(B). Consequently, for a food-use pesticide ( <E T="03">i.e.,</E> a pesticide use that is likely to result in residues in or on food) to be sold and distributed in the United States, the pesticide must not only have appropriate tolerances or exemptions under the FFDCA, but also must be registered under FIFRA. Food-use pesticides not registered in the United States must have tolerances or exemptions in order for commodities treated with those pesticides to be imported into the United States. For additional information about tolerances, go to <E T="03">https://www.epa.gov/pesticide-tolerances/about-pesticide-tolerances.</E> <HD SOURCE="HD2">B. What is registration review?</HD> 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). The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides can continue to be used without causing unreasonable adverse eff ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 24k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━