Regulatory issues for antimicrobials evolving
With the implementation of the Food Safety Modernization Act, many customers have questions about the proper regulatory position of all products used in their ethanol plants. The uncertainty is well-founded because of the far-reaching impact and complexity of this new regulation.
It is important to note that the U.S. Food and Drug Administration spent several years prior to the implementation of FSMA to define procedures necessary for regulatory compliance for use of any processing additive or antimicrobial in ethanol production. These procedures remain consistent with and will be integrated into the new FSMA program.
These guidelines, which remain consistent with FSMA, state that any additive, including antimicrobials, used in an ethanol plant must meet one of three criteria to be acceptable for use. These criteria are:
1. An AAFCO definition: The product has a definition in the feed ingredient manual approved by the American Association of Feed Control Officials.
2. Approved food additive: The product has an approved food additive petition that is listed in the Federal Registry.
3. Generally recognized as safe (GRAS): The product has been determined to be generally recognized as safe by panel of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food.
If the product in use meets one or more of the above criteria, it is acceptable for use under FDA guidelines and it is compliant with FSMA simultaneously.
Recently there has been further confusion in the industry as to the impact and potential overlap of the recently revised Veterinary Feed Directive guidance on the use of antimicrobials in the fermentation process. U.S. ethanol producers have the responsibility as animal feed suppliers to ensure that their suppliers and fermentation aids and ingredients fully comply with today’s regulations under FSMA. In spite of the fact there are many regulations governing how antimicrobials and processing aids can be used, it is important to remember that each regulation is set in place for specific areas of governance defined by the intended use. Regulations are very clear on this point. The use of antimicrobials/antibiotics in ethanol processing does not require a Veterinary Feed Directive.
Accordingly, recent news regarding the FDA changes to the VFD regulations (21 CFR 558.6) does not apply to the ethanol industry, nor do the VFD regulations apply to the feeding of distillers coproducts to livestock. VFDs are only applicable to the use of certain approved animal drugs.
The FDA’s consideration of the use of antimicrobials by the ethanol industry dates back more than two decades. In June of 1993, Alice O’Connell of SmithKlineBeacham Animal Health (SKB), the company now known as Phibro Animal Health, made a submission for the use of virginiamycin in the fermentation of alcohol. Dr. George Graber of the FDA Center for Veterinary Medicine’s Division of Animal Feeds replied Nov. 22, 1993, with their letter of no objection to the use of virginiamycin to SKB, thus paving the way for use of this important antibiotic to control infections. In more recent years, the FDA has further clarified the methods for any additive, including antimicrobials, to become acceptable for use in ethanol production. The FDA’s guidance has been very clear that the intended use of the component or drug is the basis of the regulatory categorization. Antimicrobials used in the fermentation process to produce ethanol are not regulated as animal drugs but are food additives (as defined in FFDCA 201(s)) or components that are considered to be GRAS.
Most processing aids, antimicrobials, yeasts and other fermentation components currently being sold to the U.S. ethanol industry are predominantly GRAS, but some are also approved food additives (or AAFCO defined ingredients). 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.
In summary, Veterinary Feed Directives are for tracking the use of antibiotic treated feed (medicated feed) intended for the treatment of disease conditions, in accordance with the new animal drug regulations and have no bearing on products used in ethanol production. Ethanol coproducts are not medicated feeds and, therefore, not subject to the VFD requirements for use. All processing aids, including antimicrobials, used in ethanol fermentation must be either food additives or GRAS components intended for use in ethanol production, and are fully compliant with FSMA.
Author: Richard Coulter, BVSc
Senior vice president, scientific and regulatory affairs
Phibro Animal Health
Info requests: Steve.Rust@pahc.com
Contributing author: Kristi Smedley, PhD, principal,
Center for Regulatory Services Inc.