ASFBIOF01-02 Polypeptide; Exemption From the Requirement of a Pesticide Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2021-0157; FRL-13031-01-OCSPP]</DEPDOC> <SUBJECT>ASFBIOF01-02 Polypeptide; Exemption From the Requirement of a Pesticide 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 ASFBIOF01-02 polypeptide in or on all food and feed commodities if used according to the label and good agricultural practices. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Biotalys NV submitted a petition to EPA requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of this pesticide when used in accordance with the terms of the exemption. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective October 30, 2025. Objections and requests for hearings must be received on or before December 29, 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-2021-0157, 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) 566-1200; 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. 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. 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 the docket ID number EPA-HQ-OPP-2021-0157 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 December 29, 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/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 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 March 22, 2021 (86 FR 15162) (FRL-10021-44), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 1F8895) by Biotalys NV (Technologiepark 94, 9052 Ghent, Belgium, c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of ASFBIOF01-02 polypeptide in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner Biotalys NV, which is available in the docket. There were no comments received in response to the notice of filing. <HD SOURCE="HD1">III. Final Tolerance Actions</HD> <HD SOURCE="HD2">A. EPA's Safety Determination</HD> EPA evaluated the available toxicological and exposure data on ASFBIOF01-02 polypeptide (hereafter ASFBIOF01-02) 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 “Product Characterization and Human Health Risk Assessment for a FIFRA Section 3 Registration Request for the New Active Ingredient ASFBIOF01-02, the Manufacturing Use Product `ASFBIOF01-02 AGROBODY biofungicide,' and the End Use Product `EVOCA,' as well as an Associated Petition to Exempt Residues of ASFBIOF01-02 from the Requirement of a Tolerance per FFDCA Section 408” (Human Health Risk Assessment). This document, as well as other relevant information, are available in docket number EPA-HQ-OPP-2021-0157. Products formulated with ASFBIOF01-02 are intended for use as fungicides to control or suppress pre-harvest and post-harvest crop diseases on food and non-food crops. The active ingredient ASFBIOF01-02 is an antigen binding fragment of an antibody ( <E T="03">i.e.,</E> protein) that recognizes specific components in the fungal cell membrane. Binding of sufficient amounts of ASFBIOF01-02 to the cell membrane of the growing fungus results in the disruption of the cell integrity, leading to lysis and fungal death. Dietary exposure to ASFBIOF01-02 may result from the consumption of treated crops, although such exposure is likely to be limited by the expected lability of the protein in the environment. The sole end-use product currently proposed for registration is a broad-spectrum sprayable fungicide proposed for the control/suppression of pre-harvest plant and post-harvest crop diseases on both food and non-food crops. ASFBIOF01-02 is a protein, which is a biological substance that is subject to the processes of biodegradation and decay through mechanisms such as photodegradation, hydrolysis, and active degradation through microbial activity in the environment. As such, ASFBIOF01-02 is not expected to accumu ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 19k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━