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

ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2023-0208; FRL-11678-01-OCSPP]</DEPDOC> <RIN>RIN 2070-ZA16</RIN> <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> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> EPA is proposing to exempt residues of the antimicrobial pesticide ingredient Tetraacetylethylenediamine (TAED), including its metabolites and degradates, from the requirement of a tolerance when used on or applied to food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils. This rulemaking is proposed 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 these chemicals 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> Comments must be received on or before May 7, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by docket identification (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 Confidential Business Information (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> <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> </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. What should I consider as I prepare my comments for EPA?</HD> 1. <E T="03">Submitting CBI.</E> Do not submit this information to EPA through <E T="03">regulations.gov</E> or email. Clearly mark the part or all of the information that you claim to be CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. 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="HD1">II. Background</HD> <HD SOURCE="HD2">A. What action is the Agency taking?</HD> EPA is proposing to establish an exemption from the requirement of a tolerance for residues of the antimicrobial pesticide tetraacetylethylenediamine (TAED) and its metabolites and degradates on food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils. EPA is proposing this tolerance action to implement the tolerance changes identified as necessary during the registration review processes to cover these pesticide chemical residues when used in antimicrobial formulations consistent with current label use directions. Registration review documents, such as the draft risk assessment, typically identify certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings that may be necessary or appropriate to cover pesticide chemical residues or reflect current EPA policy. For the pesticide chemicals at issue in this rulemaking, EPA issued the <E T="03">TAED Interim Registration Review Decision</E> (TAED ID) in April 2020. Electronic copies of the TAED ID and other documents are available in EPA docket number EPA-HQ-OPP-2013-0608, which can be found on <E T="03">https://www.regulations.gov.</E> EPA's risk assessment for TAED contains the Agency's assessment of the potential risk associated with current product uses, and based on the findings of that risk assessment, the TAED ID identified the need to establish exemptions from the requirement of a tolerance for residues of tetraacetylethylenediamine (TAED) when used on or applied to food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils. <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD> Section 408(e) of the FFDCA authorizes EPA to establish exemptions from the requirement of a tolerance. 21 U.S.C. 346a(e)(1)(B). Before issuing the final exemption, EPA is required to issue a proposed rulemaking and provide a comment period of “not less than 60 days”. <E T="03">Id.</E> at 346a(e)(2). A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, authorizes the establishment, modification, and revocation of tolerances and exemptions from the requirement of a tolerance for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Residues of pesticides in or on food that are not covered by a tolerance or exemption are deemed unsafe, 21 U.S.C. 408(a), and any food containing unsafe residues is considered “adulterated” under FFDCA section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce, 21 U.S.C. 331(a). For a food-use pesticide to be sold and distributed in the United States, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA, 7 U.S.C. 136 <E T="03">et seq.</E> Moreover, residues of food-use pesticides not registered in the United States must also be covered by a U.S. tolerance or exemption in order for commodities treated with those pesticides to be imported into the United States. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement of 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(c)(2)(A)(ii) of 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(c)(2)(A)(ii). This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(c)(2)(B) of the FFDCA requires EPA, when making a safety determination concerning an exemption, to take into account, among other relevant considerations, the considerations listed in section 408(b)(2)(C) and (D) of the FFDCA. Section 408(b)(2)(C) of the 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. . . .” Section 408(b)(2)(D) identifies various factors, including available information on aggregate and cumulative exposure, for EPA consideration in making a safety determination. <HD SOURCE="HD2">C. When do these actions become effective?</HD> EPA is proposing that these tolerance actions become effective on the date of publication of the final rule in the <E T="04">Federal Register</E> . <HD SOURCE="HD1">III. Proposed Rule</HD> EPA is proposing this rule to implement the tolerance actions identified in the TAED ID. EPA, on its own initiative, is proposing to establish the necessary exemption under 40 CFR 180.940(a), which would cover all food-contact uses of tetraacetylethylenediamine (TAED), from the requirement of a tolerance when used on or applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils. In order to establish tolerances or exemptions from the requirement of a tolerance, EPA is required to determine that each tolerance or exemption meets the safety standard of FFDCA. In its risk assessment supporting the TAED ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 23k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━