Antimicrobials Used in the Fermentation of Fuel Ethanol – Clarification of Jurisdiction

Fuel ethanol is typically produced by a process of fermentation of organic material. During the fermentation process antimicrobial products are often used to prevent the growth of unwanted microorganisms. Because the Environmental Protection Agency has regulatory authority over certain antimicrobial products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Food and Drug Administration (FDA) has regulatory authority over other antimicrobials under the Federal Food, Drug, and Cosmetic Act (FFDCA), companies involved in the fermentation of fuel ethanol have sought clarification of the jurisdiction over antimicrobial use in such facilities.

Guidance

EPA has determined that antimicrobials applied to processed food or feed during fermentation are outside the scope of EPA’s regulatory authority under FIFRA if a by-product of the fermentation process could reasonably be expected to be used as a food or animal feed ingredient. EPA’s definition of “pest” at 40 CFR §152.5(d) excludes microorganisms on or in processed food or processed animal feed.

After consultation with the FDA, EPA considers the contents of the fermentation tank to be processed food or feed if one or more outputs of the fermentation process (e.g., distillers’ grains) could reasonably be used as a processed food or feed. If the microorganisms in the fermentation tank are in a processed food or feed, they are not “pests” under EPA’s regulation, and antimicrobials used to control them are not pesticides subject to FIFRA. However, FIFRA does apply to antimicrobials used in fermentation processes where the antimicrobials are applied to something other than processed food or feed, or where no product could reasonably be expected to be used as a food or feed ingredient.

Contacts

Persons considering marketing an antimicrobial product for use in a fermentation process where the antimicrobial is applied to processed food or feed, or where a by-product of the fermentation process could reasonably be expected to be utilized as a food or feed ingredient, should contact Linda Benjamin, Ph.D., Division of Animal Feed, Center for Veterinary Medicine, Food and Drug Administration, (Linda Benjamin, phone number: 240-453-6855).

Persons considering marketing an antimicrobial for use in a fermentation process where the antimicrobial is applied to something other than processed food or feed, or where no product could reasonably be expected to be used as a food or feed ingredient, should contact the antimicrobials ombudsman (opp_ad_ombudsman@epa.gov).