Bacillus Thuringensis Cry1B.868 and Cry1Da_7 Proteins; Exemption From the Requirement of a Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 174</CFR> <DEPDOC>[EPA-HQ-OPP-2020-0546; FRL-11674-01-OCSPP]</DEPDOC> <SUBJECT>Bacillus Thuringensis Cry1B.868 and Cry1Da_7 Proteins; 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 thuringensis</E> Cry1B.868 and Cry1Da_7 proteins (hereafter Cry1B.868 and Cry1Da_7) when used as a Plant-Incorporated Protectant (PIP) in or on the food and feed commodities of corn: corn, field; corn, sweet, and corn, pop. Bayer U.S.—Crop Science 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 Cry1B.868 and Cry1Da_7 proteins. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective May 17, 2024. Objections and requests for hearings must be received on or before July 16, 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-2020-0546, is available at <E T="03">https://www.regulations.gov.</E> 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 (7511M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 564-5754; 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 EPA, you must identify docket ID number EPA-HQ-OPP-2020-0546 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 July 16, 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-2020-0546, 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.</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 December 23, 2020 (85 FR 83880) (FRL-10017-71), 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 0F8839) by Bayer Crop Science 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 Cry1B.868 and Cry1Da_7 proteins derived from <E T="03">Bacillus thuringienisis</E> when used as a PIP in or on the following food and feed commodities: corn, field; corn, sweet; and corn, pop. That document referenced a summary of the petition prepared by the petitioner Bayer U.S.—Crop Science, which is available in the docket at <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 Cry1B.868 and Cry1Da_7 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 “Review of the Application for a FIFRA Section 3 Seed Increase Registration of MON 95379 Corn Expressing Transgenic Insecticidal Plant-Incorporated Protectants <E T="03">Bacillus thuringiensis</E> Cry1B.868 and Cry1Da_7 Proteins and associated FFDCA Petition to Establish a Permanent Exemption from the Requirement of a Tolerance for Residues of Cry1B.868 and Cry1Da_7 Proteins when used as Plant-Incorporated Protectants in Food and Feed Commodities of 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-2020-0546. Cry1Da_7 and Cry1B.868 are modified proteins derived from the bacterium <E T="03">Bacillus thuringiensis</E> ( <E T="03">Bt</E> ) and are active against lepidopteran pests of corn. Available data demonstrated that, with regard to humans, Cry1B.868 and Cry1Da_7 proteins are not toxic or allergenic via any route of exposure. The most likely route of exposure is dietary, via products produced from corn expressing the Cry1B.868 and Cry1Da_7 proteins. Oral exposure from ingestion of drinking water is unlikely because the Cry1Da_7 and Cry1B.868 proteins are present at very low levels within the plant cells and the amounts likely to enter the water column from leaves, pollen or plant detritus are low. Further, if Cry1Da_7 and Cry1B.868 proteins do enter the water column, they are expected to degrade rapidly through natural processes. Although there may be dietary exposure to residues of Cry1B.868 and Cry1Da_7 proteins, such exposure presents no concern for adverse effects. Submitted data show that the Cry1B.868 and Cry1Da_7 proteins are not toxic via the oral route of exposure. Likewise, the potential for allergenicity is low because: (1) bioinformatic analysis indicates little similar ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 18k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━