Ethanol Blog

Antimicrobial Use for Ethanol Production Defined in FSMA

Cheryl Anderson
By  Cheryl Anderson , DTN Staff Reporter

Although the Food Safety Modernization Act is complex and will affect ethanol production facilities, guidelines for processing additives and antimicrobials will remain consistent with definitions developed by the U.S. Food and Drug Administration.

According to an article appearing in Ethanol Producer Magazine written by Richard Coulter, senior vice president, scientific and regulatory affairs for Phibro Animal Health (…), many ethanol producers have questions about regulatory issues with products they use and their compliance with new FSMA regulations.

Coulter said FDA has spent a number of years prior to the implementation of FSMA to define procedures and guidelines regarding additives. These guidelines state that all additives and antimicrobials used in ethanol production must meet one of three criteria to be used and to be compliant with FSMA. The product must either have a definition in the feed ingredient manual approved by the American Association of Feed Control Officials, must have an approved food additive petition listed in the Federal Registry, or must have been determined to be generally recognized as safe (GRAS) by a panel of experts.

While there has been some confusion in the industry as to potential overlap of the Veterinary Feed Directive guidance on the use of antimicrobials, Coulter said that regulations are very clear that the use of antimicrobials in ethanol production do not require a Veterinary Feed Directive, and that FDA changes to the VFD regulations do not apply to the ethanol industry.

He added that the FDA has been clear that antimicrobials used in the fermentation process for ethanol production are not regulated as animal drugs, but are food additives or components that are considered to be GRAS. Since ethanol coproducts are not medicated feeds, they are not subject to the VFD requirements for use.

Coulter also stated, "Antimicrobials used for ethanol fermentation are not intended to impact distillers grains in any way. They are simply the most effective, safe, and proven infection-management tools available to the industry to control bacteria in fermentation for over 30 years."

Cheryl Anderson can be reached at



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