Bacillus thuringiensis Cry1A.2 and Cry1B.2 Proteins; Exemptions From the Requirement of a Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 174</CFR> <DEPDOC>[EPA-HQ-OPP-2024-0293; FRL-12818-01-OCSPP]</DEPDOC> <SUBJECT>Bacillus thuringiensis Cry1A.2 and Cry1B.2 Proteins; Exemptions 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 exemptions from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry1A.2 and Cry1B.2 proteins (hereafter Cry1A.2 and Cry1B.2 proteins) in or on the food and feed commodities of soybean when used as plant-incorporated protectants (PIP) in soybean. Bayer CropScience LP submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting these exemptions. This regulation eliminates the need to establish a maximum permissible level for residues of these pesticides when used in accordance with the terms of the exemption. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective on August 6, 2025. Objections and requests for hearings must be received on or before October 6, 2025, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of this document). </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2024-0293, is available at <E T="03">http://www.regulations.gov.</E> Additional information about dockets generally, along with instructions for visiting the docket in person, is available at <E T="03">https://www.epa.gov/dockets.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Shannon Borges, 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. Executive Summary</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: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <HD SOURCE="HD2">B. What is EPA's authority for taking this action?</HD> EPA is issuing this rulemaking under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(c)(2)(A)(i) 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.” FFDCA section 408(c)(2)(A)(ii) 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, among other things, “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.” <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. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. 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-2024-0293 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 6, 2025. 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 EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, 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/EABALJupload.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 at <E T="03">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. If you wish to include CBI in your request, please follow the applicable instructions at <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets#rules</E> and clearly mark the information that you claim to be CBI. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. <HD SOURCE="HD1">II. Petitioned for Exemption</HD> In the <E T="04">Federal Register</E> of August 8, 2024 (89 FR 64842) (FRL-11682-06-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 3F9096) by Bayer CropScience LP, 800 N Lindbergh Blvd., St. Louis, Missouri 63167. The petition requested that 40 CFR part 174 be amended by establishing an exemption from the requirement of a tolerance for residues of the plant-incorporated protectants (PIPs) <E T="03">Bacillus thuringienisis</E> Cry1A.2 and <E T="03">Bacillus thuringienisis</E> Cry1B.2 in or on soybean. That document referenced a summary of the petition prepared by the petitioner Bayer Crop Science LP, which is available in the docket. There was one comment received in response to the notice of filing. EPA's response to this comment is discussed in Unit III.C. <HD SOURCE="HD1">III. Final Tolerance Actions</HD> <HD SOURCE="HD2">A. EPA's Safety Determination</HD> EPA evaluated the available toxicity and exposure data on Cry1A.2 and Cry1B.2 proteins and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. A summary of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Product Characterization Review and Human Health Risk Assessment of the Insecticidal Plant-Incorporated Protectant Active Ingredients, Cry1A.2 and Cry1B.2, and the Genetic Material Necessary (PV-GMIR527237) for their Production in Event MON 94637 Soybean (OECD Unique Identifier: MON 94637-8), and Establishment of a Permanent Tolerance Exemption for Residues of these Proteins When Used as a Plant Incorporated Protectant in Soybean. Data Were Provided in Support of a FIFRA Section 3 Seed Increase Registration” (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> . Cry1A.2 is a modified protein derived from the bacterium <E T="03">Bacillus thuringiensis</E> ( <E T="03">Bt</E> ) and is active against certain lepidopteran pests of soybean. As discussed in the Human Health Risk Assessment, available data demonstrated that, with regard to humans, the Cry1A.2 protein does not pose a toxic risk to humans and has a low risk of allergenicity. Cry proteins, such as Cry1A.2, have specific activity limited to certain insect orders due to the alkaline environment found in the insect midgut and the presence of specific receptors in ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 27k characters. 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