1,4-Bis[[3-[2-(2-hydroxyethoxy)ethoxy]propyl]amino]-9,10-anthracenedione in Pesticide Formulations; Tolerance Exemption

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2022-0595; FRL-11726-01-OCSPP]</DEPDOC> <SUBJECT>1,4-Bis[[3-[2-(2-hydroxyethoxy)ethoxy]propyl]amino]-9,10-anthracenedione in Pesticide Formulations; Tolerance Exemption</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 1,4-bis[[3-[2-(2-hydroxyethoxy)ethoxy]propyl]amino]-9,10-anthracenedione, when used as an inert ingredient (colorant/dye) on growing crops and raw agricultural commodities pre- and post-harvest in/on animals, limited to a maximum concentration of 0.5% in a pesticide formulation, and in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils not to exceed 300 ppm in the end-use concentration. Spring Regulatory Sciences on behalf of Colorants Solutions (new name Heubach Colorants USA LLC) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 1,4-bis[[3-[2-(2-hydroxyethoxy)ethoxy]propyl]amino]-9,10-anthracenedione, when used in accordance with the terms of those exemptions. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective March 1, 2024. Objections and requests for hearings must be received on or before April 30, 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-2022-0595, 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> Charles Smith, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1030; email address: <E T="03">RDFRNotices@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 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(g), 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-2022-0595 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 30, 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-2022-0595, 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#express</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. Petition for Exemption</HD> In the <E T="04">Federal Register</E> of August 30, 2022 (87 FR 52868, FRL-9410-04), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11698) by Spring Regulatory Sciences, 6620 Cypresswood Dr., Suite 250, Spring, TX 77379 on behalf of Heubach Colorants USA LLC, 4000 Monroe Road, Charlotte, NC 28205. The petition requested that 40 CFR be amended by establishing an exemption from the requirement of a tolerance for residues of 1,4-bis[[3-[2-(2-hydroxyethoxy)ethoxy]propyl]amino]-9,10-anthracenedione (CAS Reg. No. 123944-63-8) when used as an inert ingredient (colorant/dye) in pesticide formulations applied to growing crops or raw agricultural commodities pre- and post-harvest under 40 CFR 180.910, in/on animals under 40 CFR 180.930, and in food contact sanitizing solutions under 40 CFR 180.940(a). That document referenced a summary of the petition prepared by Spring Regulatory Sciences on behalf of Heubach Colorants USA LLC, the petitioner, which is available in the docket, <E T="03">https://www.regulations.gov</E> . There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is modifying the petitioner's request to limit the maximum concentration to no more than 0.5% of 1,4-bis[[3-[2-(2-hydroxyethoxy)ethoxy]propyl]amino]-9,10-anthracenedione under 40 CFR 180.910, and 40 CFR 180.930, and not to exceed 300 ppm in the end-use concentration under 40 CFR 180.940(a). This limitation is based on the Agency's risk assessment which can be found at <E T="03">https://www.regulations.gov</E> in document IN-11698; 1,4-Bis[[3-[2-(2-hydroxyethoxy)ethoxy]propyl]amino]-9,10-anthracenedione. Human Health Risk Assessment and Ecological Effects Assessment to Support Inert Ingredient Approval for use in Pesticide Formulations in docket ID number EPA-HQ-OPP-2022-0595. <HD SOURCE="HD1">III. Inert Ingredient Definition</HD> Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. <HD SOURCE="HD1">IV. Aggregate Risk Assessment and 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 tolerance 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. When making a safety determination for an exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B) directs EPA to consider the considerations in section 408(b)(2)(C) and (D). Section 408(b)(2)(C) of FFDCA requires EPA to giv ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 39k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━