Tetraacetylethylenediamine (TAED), and Its Metabolite Diacetylethylenediamine (DAED); Exemption From the Requirement of a Pesticide Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2023-0208; FRL-12187-01-OCSPP]</DEPDOC> <SUBJECT>Tetraacetylethylenediamine (TAED), and Its Metabolite Diacetylethylenediamine (DAED); Exemption From the Requirement of a Pesticide 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 tetraacetylethylenediamine (TAED), including its metabolites and degradates, on or applied to food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils. This tolerance exemption is established on the Agency's own initiative under the Federal Food, Drug, and Cosmetic Act (FFDCA), in order to implement the tolerance actions EPA identified during its review of this chemical as part of the Agency's registration review program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective August 29, 2024. Objections and requests for hearings must be received on or before October 28, 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-2023-0208, is available at <E T="03">https://www.regulations.gov</E> 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 and the OPP docket is (202) 566-1744. 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> Anita Pease, Antimicrobials Division (7510M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-0736; email address: <E T="03">pease.anita@epa.gov</E> or <E T="03">ADFRNotices@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 a 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: • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). • Restaurant kitchen cleaning services (NAICS code 561720). • Milk production, dairy cattle (NAICS code 112120). • Food processing machinery and equipment merchant wholesalers (NAICS code 423830). <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 Office of the Federal Register's e-CFR site at <E T="03">https://www.ecfr.gov/current/title-40.</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-2023-0208 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 in the Office of the Administrative Law Judges on or before October 28, 2024. Notwithstanding the procedural requirements of 40 CFR 178.25(b), the Office of the Administrative Law Judges has issued an order urging parties to file and serve documents with the Tribunal by electronic means only. <E T="03">See Revised Order Urging Electronic Filing and Service</E> (dated June 22, 2023), <E T="03">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.</E> 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-2023-0208, 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.</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</HD> <HD SOURCE="HD2">A. Proposed Rule</HD> In the <E T="04">Federal Register</E> of March 8, 2024 (89 FR 16714) (FRL-11678-01-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of an Agency initiated exemption from the requirement of a tolerance for TAED, and its metabolites and degradates. The action proposed that 40 CFR 180.940(a) be amended by establishing an exemption from the requirement of a tolerance with no limit in end-use solutions eligible for tolerance exemption. The Agency had identified the need for the exemption as part of the registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136a(g), and published a proposed rulemaking under its authority to initiate tolerance rulemakings under the FFDCA section 408(e), 21 U.S.C. 346a(e). As noted in the proposal, the <E T="03">TAED Interim Registration Review Decision</E> (TAED ID), identified the need for this exemption based on existing registered pesticide uses, and the underlying risk assessment concluded that there were no risks of concern associated with these uses. Electronic copies of the TAED ID and other documents are available in EPA docket number EPA-HQ-OPP-2013-0608 at <E T="03">https://www.regulations.gov.</E> There were no comments received in response to the notice of filing. <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD> Under section 408(e) of the FFDCA, EPA can establish an exemption from the requirement of a tolerance for residues of a pesticide chemical after publishing a proposed rule and providing 60-day period for public comment, 21 U.S.C. 346a(e). EPA published the proposed rule on March 8, 2024, and provided 60 days for public comment (until May 7, 2024). <HD SOURCE="HD1">III. Final Rule</HD> <HD SOURCE="HD2">A. Comments</HD> No comments were submitted in response to the proposed rule. <HD SOURCE="HD2">B. Determination of Safety</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 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. . . .” As noted in the proposed rule, EPA reviewed the available scientific data and other relevant information as part of registration review and in support of this action. Based on that review, EPA's proposed rule concluded that the exemptions would be safe. Since no comments were filed, EPA's assessment of the potential for risks from exposure to these pesticide chemicals and conclusions about the safety of this exemption remains unchanged. Therefore, based on the lack of any aggregate risks of concern, EPA concludes that this exemption from the requirement of a tolerance for residues of TAED, and it ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 19k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━