Bacillus Paralicheniformis Strain CH0273; Exemption From the Requirement of a Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2022-0323; FRL-10389-01-OCSPP]</DEPDOC> <SUBJECT>Bacillus Paralicheniformis Strain CH0273; 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 <E T="03">Bacillus paralicheniformis</E> strain CH0273 in or on all food commodities when used in accordance with label directions and good agricultural practices. Chr. Hansen, Inc., submitted a petition to the EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of <E T="03">Bacillus paralicheniformis</E> strain CH0273 under FFDCA when used in accordance with this exemption. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective August 12, 2024. Objections and requests for hearings must be received on or before October 11, 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-2022-0323, 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 20004. 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 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> Madison H. 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 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 the EPA, you must identify docket ID number EPA-HQ-OPP-2022-0323, 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 October 11, 2024. The EPA's Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. <E T="03">See</E> “Revised Order Urging Electronic Filing and Service,” dated June 22, 2023, which can be found at <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> Although the EPA's regulations require submission via U.S. Mail or hand delivery, the EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, the EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at <E T="03">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.</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 the EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2022-0323, 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</HD> In the <E T="04">Federal Register</E> of April 28, 2022 (87 FR 25178) (FRL-9410-12), the EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance exemption petition (PP 1F8943) by Chr. Hansen, Inc., 9015 W Maple St., Milwaukee, WI 53214. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of fungicide and nematicide <E T="03">Bacillus paralicheniformis</E> strain CH0273. That notice referenced a summary of the petition prepared by the petitioner Chr. Hansen, Inc., and available in the docket via <E T="03">https://www.regulations.gov.</E> The EPA received a comment on the notice of filing. The EPA's response to this comment is discussed in Unit III.C. <HD SOURCE="HD1">III. Final Rule</HD> <HD SOURCE="HD2">A. The EPA's Safety Determination</HD> Section 408(c)(2)(A)(i) of FFDCA allows the 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 the 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, the EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption 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 EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.” The EPA evaluated the available toxicological and exposure data on <E T="03">Bacillus paralicheniformis</E> strain CH0273 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 the EPA relied and its risk assessment based on those data can be found within the document entitled “Human Health Risk Assessment of <E T="03">Bacillus paralicheniformis</E> strain CH0273 and <E T="03">Bacillus subtilis</E> strain CH4000, two New Active Ingredients, in the Manufacturing-use Products (MUPs) CH0273 (2375-U) and CH4000 (2375-A), and End-use Products (EPs) Kansas 3 SC (2375-L) and Kansas 3 WP (2375-T) Proposed for Registration and two Associated Petitions Requesting Tolerance Exemptions.” This document, as well as other relevant information, is available in the docket for this action as described under <E T="02">ADDRESSES</E> . The available data demonstrated that, with regard to humans, <E T="03">Bacillus paralichen ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 18k characters. 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