Regulation Clarification for Ethanol Producers

There are two relatively new FDA regulations — one being the Food Safety Modernization Act and the other being Veterinary Feed Directives and with the ethanol industry using antimicrobials additives to ensure there is no contamination in the fermentation system there has been some confusion as to what impact the new regulations have on their plants and the distillers grains by-products they produce that are used for animal feed.

Phibro Animal Health Senior Vice President for scientific and regulatory affairs Richard Coulter explains

Coulter: "They are very distinct initiatives and a number of ethanol producers have misconstrued the Veterinary Drug initiative as applying to them. One of the things the Veterinary t Drug initiative requires that no antimicrobials can be used after the end of 2016 in food animals without the specific authorization of a veterinarian. A number of ethanol producers have thought since they are producing ethanol and they are making distiller's grain and distiller's grain is an animal feed that they would need potentially a veterinary to write them a prescription or a vet feed directive to allow them to use anti-microbial product in ethanol. That is not true. The two initiatives are totally separate. The Guidance 209 — which is the FDA's guidance relating to Veterinary Drugs is for vet drugs only. It does not relate to ethanol at all. The Food Safety Modernization Act catches the ethanol industry because the ethanol industry is also an animal feed production plant because of its distiller's grain production."