New Headaches For Distillers Grains Producers

Manufacturers of distillers grains are already regulated by an alphabet soup of statutes, implementing agencies and industry certifications, including the U.S. EPA, U.S. Food and Drug Administration (FDA), Toxic Substances Control Act, Generally Recognized as Safe and the Association of American Feed Control Officials, to name just a few. Now, add the Food Safety Modernization Act (FSMA) to the list. On Oct. 25, the FDA released its proposed rule on current good manufacturing practice (cGMP) and hazard analysis and risk-based preventative controls for animal feed. This proposed rule is one of the last rules to be released implementing FSMA, signed into law in January 2011.

This proposed rule would apply to animal facilities required to register under the Federal Food, Drug and Cosmetic Act (FFDCA) that manufacture, process, pack or hold ingredients and finished products that are intended to be fed to animals, including livestock, pets and other animals. The FDA has previously required all facilities that produce animal feed, including ethanol facilities that produce distillers grains, to register under the FFDCA. Further, the FDA has specifically stated that the proposed rule applies to “biofuel manufacturers that supply distillers grains for animal food.”

The proposed rule would establish regulations regarding the manufacturing, processing, packing or holding of food for animals by creating new cGMP regulations that specifically address those areas. This proposed rule marks the first time cGMPs will be required for animal food. The proposed cGMPs would establish procedures in areas such as buildings and facilities, design and layout, cleaning and maintenance, pest control, and personnel hygiene.

It would establish new preventive control provisions that would include requirements to maintain a food safety plan, perform a hazard analysis and implement preventive controls to minimize or prevent those hazards. Facilities would have to monitor their controls, verify effectiveness, take any appropriate corrective actions and maintain records that document these actions. Although similar to the Hazard Analysis and Critical Control Points systems currently used by some in the food industry, the FSMA rule may require preventative controls at points other than critical control points, and critical limits may not be required for all preventative controls.

A written food safety plan would be required to detail the facility’s hazard analysis and risk-based preventative controls, as well as the facility’s monitoring, corrective actions, verification activities, and recordkeeping requirements.  

The FDA has proposed that the rule become effective 60 days after the final rule is published, and has suggested a sliding scale of compliance dates. Very small businesses would have three  years to comply. The agency is soliciting comments on whether very small businesses should mean businesses with less than $500,000, $1 million or $2.5 million in total annual sales of animal food. Small businesses would have two years to comply. The FDA has proposed that a small business employs fewer than 500 employees. Other businesses, which don’t fit into the definition of very small, small or qualify for other exeptions, would have one year to comply. 

As of now, the comment period is set to close Feb. 26, although the animal feed industry will likely ask the FDA to allow additional time to provide comments. We cannot emphasize enough that manufacturers of distillers grains should review the proposed rule, consider how it would impact their operations, and then provide substantive comments to FDA. The agency has increased inspection and enforcement authority, so now is the time to understand how to comply with FSMA’s mandate.  Facility operators should consider meeting with legal counsel to ensure readiness to comply with FSMA and properly manage FDA inspections.

Besides the most recent FSMA rule, FDA continues to be active on ethanol industry issues. In March, a citizen petition was filed with the FDA seeking to ban the use of antibiotics in ethanol production, so that distillers grains with solubles fed to livestock will not contribute to the levels of antibiotics found in the U.S. meat products. If FDA does not ban the use of antibiotics entirely, the petition requests that FDA develop regulations that require antibiotics sold to ethanol producers be registered as a new animal drug under the FFDCA. Although this issue has been simmering for years, do not expect it to go away anytime soon. We are likely only at the cusp of FDA’s oversight of feed coproducts from the ethanol industry.

Authors:  Leah H. Ziemba
Attorney, Michael Best & Friedrich LLP
608-283-4420
[email protected]

Contributor: Seth A. Mailhot
Attorney, Michael Best & Friedrich LLP