U1-AGTX-Ta1b-QA Protein; Exemption From the Requirement of a Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2021-0781; FRL-11563-01-OCSPP]</DEPDOC> <SUBJECT>U1-AGTX-Ta1b-QA Protein; Exemption From the Requirement of a Tolerance</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This regulation establishes an exemption from the requirement of a tolerance for residues of the U1-AGTX-Ta1b-QA protein in or on all food commodities when used in accordance with label directions and good agricultural practices. Vestaron Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance for residues of the U1-AGTX-Ta1b-QA protein in and on all food commodities. This regulation eliminates the need to establish a maximum permissible level for residues of U1-AGTX-Ta1b-QA protein under FFDCA when used in accordance with this exemption. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective February 12, 2024. Objections and requests for hearings must be received on or before April 12, 2024, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the <E T="02">SUPPLEMENTARY INFORMATION</E> ). </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2021-0781, is available at <E T="03">https://www.regulations.gov.</E> Please review the visitor instructions and additional information about the docket available at <E T="03">https://www.epa.gov/dockets.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Madison Le, Biopesticides and Pollution Prevention Division (7511M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1400; email address: <E T="03">BPPDFRNotices@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. General Information</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: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). <HD SOURCE="HD2">B. How can I get electronic access to other related information?</HD> You may access a frequently updated electronic version of 40 CFR part 180 through the Federal Register Office's e-CFR site at <E T="03">https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.</E> <HD SOURCE="HD2">C. How can I file an objection or hearing request?</HD> 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-2021-0781 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 April 12, 2024. 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-2021-0781, by one of the following methods: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> 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. • <E T="03">Mail:</E> OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. • <E T="03">Hand Delivery:</E> To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at <E T="03">https://www.epa.gov/dockets/where-send-comments-epa-dockets.</E> 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> <HD SOURCE="HD1">II. Background and Statutory Findings</HD> In the <E T="04">Federal Register</E> of March 22, 2022 (87 FR 16133) (FRL-9410-11-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 1F8923) by Vestaron Corporation, 600 Park Offices Dr., Suite 117, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of U1-AGTX-Ta1b-QA protein. That document referenced a summary of the petition prepared by the petitioner Vestaron Corporation, which is available in the docket, <E T="03">https://www.regulations.gov.</E> EPA received one comment on the notice of filing. EPA's response to this comment is discussed in Unit VII.C. <HD SOURCE="HD1">III. Final Rule</HD> <HD SOURCE="HD2">A. EPA's Safety Determination</HD> Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require 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. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.” EPA evaluated the available toxicological and exposure data on U1-AGTX-Ta1b-QA protein and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Human Health Risk Assessment in Support of the Registration of `Basin' End Use Product Containing the New Active Ingredient U1-AGTX-Ta1b-QA (8.5%) and Associated Petition to Establish a Permanent Tolerance Exemption” (Human Health Risk Assessment). This document, as well as other relevant information, is available in the docket for this action as described under <E T="02">ADDRESSES</E> . Available data have demonstrated that, with regard to humans, U1-AGTX-Ta1b-QA protein is not anticipated to be toxic or allergenic via any reasonably foreseeable route of exposure. U1-AGTX-Ta1b-QA protein is a modified form of agatoxin protein derived from the venom of the hobo spider ( <E T="03">Eratigena agrestis</E> ) that is intended for control of insects and mites. In insects, the reported mode-of-action of U1-AGTX-Ta1b-QA is allosteric inhibition of a non-desensitizing nicotinic acetylcholine receptor, a neural receptor responsible for signal transduction and function. The U1-AGTX-Ta1b-QA protein binds to a non-signaling portion of the target (allosteric) site, altering the three-dimensional structure of the neural receptor. According to the Center of Disease Control ( <E T="03">https://www.cdc.gov/niosh/topics/spiders/types.html</E> ), the venom, from which the active ingredient is derived, is not recognized as toxic to humans. Products formulated with U1AGTX-Ta1b-QA will be used for foliar applications to plants or as a dip/immersion for roots or cuttings. Toxicological data provided by the petitioner indicate that U1-AGTX-Ta1b-QA has low acute toxicity via the oral, dermal, inhalation, route and it is not a dermal or eye irritant. This conclusion is further supported by the results of the 90-day oral toxicity study, prenatal development toxicity studies, and the absence of genotoxicity in a bacterial reverse mutation test. In addition, the protein sequence of U1-AGTX-Ta1b-QA does not show significant homology to known allergens and thus there is no indication of allergenic cross-reactivity. Dietary exposure could occur ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 18k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━