Pesticide Tolerance Exemption for Microbial Strains
Summary
This regulation establishes exemptions from the requirement of a tolerance for residues of Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y in or on all food commodities when used in accordance with label directions and good agricultural practices. Danisco US Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting exemptions from the requirement of a tolerance. This regulation eliminates the need to establish maximum permissible levels for residues of Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y when used in accordance with this exemption.
Compliance Requirements
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Exemptions from the requirement of tolerances are established for residues of Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y in or on all food commodities when used in accordance with label directions and good agricultural practices.; Objections and requests for hearings must be received on or before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER] and must be filed in accordance with the instructions provided in 40 CFR part 178; 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-2023-0008 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 [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]; 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
Market Impacts
Exemption from tolerance requirements allows unrestricted use of Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y microbial pesticides on all food commodities, eliminating regulatory barriers for market entry and expansion; Removal of maximum residue level requirements enables broader adoption of these microbial pesticides across all food commodity sectors without regulatory restrictions
Validated Company Impacts
Archer-Daniels-Midland Co
ADM operates extensively in food manufacturing (NAICS 311) and agricultural production, directly aligning with the rule's exemption for microbial pesticides used on all food commodities. As a major processor of agricultural commodities, ADM would benefit from reduced regulatory barriers for pesticide use in its supply chain operations. The rule establishes pesticide tolerance exemptions which could marginally reduce regulatory compliance costs for agricultural operations, but the company's primary regulatory risk is biofuel policy uncertainty, not pesticide regulations. There is minimal overlap as the rule addresses microbial pesticide approvals while the company's regulatory concerns focus on energy policy impacts.