Bacillus Thuringiensis Cry1Da2 Protein; Exemption From the Requirement of a Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 174</CFR> <DEPDOC>[EPA-HQ-OPP-2023-0022; FRL-12380-01-OCSPP]</DEPDOC> <SUBJECT>Bacillus Thuringiensis Cry1Da2 Protein; 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 the <E T="03">Bacillus thuringiensis</E> Cry1Da2 protein in or on the food and feed commodities of corn: corn, field; corn, sweet; and corn, pop, when used as a plant-incorporated protectant (PIP). Pioneer Hi-Bred International, Inc., (Pioneer) submitted a petition to 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 Cry1Da2 protein. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective December 13, 2024. Objections and requests for hearings must be received on or before February 11, 2025, 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-2023-0022, 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 for 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> Madison Le, Biopesticides and Pollution Prevention Division (7511P), 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 174 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-2023-0022, 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 February 11, 2025. 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-2023-0022, 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 and Statutory Findings</HD> In the <E T="04">Federal Register</E> of February 23, 2023 (88 FR 11401) (FRL-10579-01), 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 0F9003) by Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, P.O. Box 1000, Johnston, Iowa 50131. The petition requested that 40 CFR part 174 be amended by establishing an exemption from the requirement of a tolerance for residues of Cry1Da2 protein. That document referenced a summary of the petition prepared by the petitioner Pioneer Hi-Bred International, Inc., 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. <HD SOURCE="HD1">III. Final Rule</HD> <HD SOURCE="HD2">A. EPA's Safety Determination</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 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 “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.” EPA evaluated the available toxicity and exposure data on Cry1Da2 protein and considered its 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 Ingredient, <E T="03">Bacillus thuringiensis</E> Cry1Da2 and Plant-Incorporated Inert Ingredient DGT-28 EPSPS, and the Genetic Material Necessary (PHP88492) for their Production in Event DAS-1131-3 Maize, and Establishment of a Permanent Tolerance Exemption for Residues of these Proteins when used as a plant-incorporated protectant in corn” (hereafter Human Health Risk Assessment). This document, as well as other relevant information, is available in the docket for this action EPA-HQ-OPP-2023-0022. The gene for the insecticidal protein Cry1Da2 was derived from the bacterium <E T="03">Bacillus thuringiensis</E> (Bt) and contains sequences from Bt crystal toxins, Cry1Ab and Cry1D. The Cry1Da2 protein is intended to provide protection from certain lepidopteran pests of corn. In assessing the safety of the protein, the Agency used a “weight of evidence” approach and determined that, Cry1Da2 is not expected to pose any risk of toxicity to humans and the likelihood of the protein to be a food allergen is minimal. Submitted data show that the Cry1Da2 protein is not toxic via the oral route of exposure and a bioinformatics analysis did not indicate any homology to known toxins. Likewise, the potential for allergenicity is low because: (1) The bacterium source of Cry1Da2 protein, <E T="03">Bacillus thuringiensis,</E> has a long history of safe use and is not considered to be a source of allergenic proteins ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 20k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━