Bacillus amyloliquefaciens strain AT-332; Exemption From the Requirement of a Pesticide Tolerance
Final Rule by the Environmental Protection Agency
Effective Date: September 15, 2026
SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus amyloliquefaciens strain AT-332 in or on all food and feed commodities when used in accordance with label directions and good agricultural practices. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Gowan Company, in cooperation with SDS Biotech K.K., c/o Landis International, Inc., 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.
EPA’s Safety Determination
EPA has assessed the individual risks from exposure to the pesticide active ingredients identified and discussed in this rule, taking into consideration all reliable data on toxicity and exposure, including for infants and children, and has included a safety finding under FFDCA section 408(b).
Based upon its evaluation, EPA concludes that, with regards to humans, Bacillus amyloliquefaciens strain AT-332 is not anticipated to be toxic, pathogenic, or infective. Bacillus amyloliquefaciens strain AT-332 is ubiquitous in soil and the rhizosphere. Dietary, drinking water, and residential exposure is expected. However, food crops undergo postharvest washing and municipal water treatment practices would reduce any residues further. Even if dietary or residential exposure to residues were to occur, there are no risks of concern due to the lack of adverse effects from toxicity, pathogenicity, or infectivity of the strain.
EPA determined that no additional margin of safety is necessary to protect infants and children as part of the qualitative assessment conducted, as data and rationale demonstrated that Bacillus amyloliquefaciens strain AT-332 is not toxic, pathogenic, or infective.
Revisions to the Requested Tolerance Exemption
An analytical method is not required for Bacillus amyloliquefaciens strain AT-332 because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation. Furthermore, the Agency removed the descriptor “fungicide” from the tolerance exemption to reduce any unnecessary future regulatory burden and conform with current standard practices.
Therefore, EPA is finalizing the tolerance exemption that was petitioned for by Gowan Company in cooperation with SDS Biotech K.K., c/o Landis International, Inc. for residues of Bacillus amyloliquefaciens strain AT-332 in or on all food commodities when used in accordance with label directions and good agricultural practices.
Objections and Hearing Requests
This rule is effective on September 15, 2026. Objections and requests for hearings must be received on or before November 16, 2026, and must be filed 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-2024-0308 in the subject line on the first page of your submission.
© 2026 Environmental Protection Agency | Pesticide Tolerance Exemption
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