The New Sheriff: FDA’s Increased Focus

By Andrew Anderson and Steve Toeniskoetter | November 05, 2012

The U.S. Food and Drug Administration has historically left regulation of animal feed facilities, including ethanol facilities producing feed as coproducts, to the states. But with the passage of the Food Safety Modernization Act and other changes within FDA, the agency is beginning to assert its authority. The FDA is showing a newfound interest in ethanol facilities, including registration requirements, antimicrobial usage and aflatoxin testing.

There are several key points for the industry to remember. First, all facilities producing or storing biofuels coproducts used for animal feed must register with FDA.  Although this has been a requirement since the end of 2003, FDA had no way of enforcing the requirement until the passage of the FSMA in January 2011 gave teeth to the registration requirement by allowing FDA to suspend a facility’s registration. FSMA also prohibits the shipment of any goods from the facility if its registration is suspended or if it is not registered. Under FSMA, facilities are supposed to renew their registration every two years. That renewal period was set to begin in October, but FDA’s website was not yet ready for the renewals. Biofuel facilities that have already registered with FDA should sign up for FDA’s FSMA alert emails and be prepared to register once the website is active again. Facilities that are not yet registered should register immediately at Registration is relatively simple, with just a few questions regarding the facility, its products and the responsible party for the facility.

FDA has also significantly increased its focus on the use of antimicrobials in the ethanol production process over the past few years. FDA has been sampling and testing DDGS and other coproducts. In 2010, it conducted a significant study that showed antimicrobial residues in four of 46 samples tested. Earlier this year a consumer interest group, focused on what it calls sustainable food, farm and trade systems, released a report entitled “Bugs in the System: How the FDA Fails to Regulate Antibiotics in Ethanol Production.” That report spurred some members of Congress to write a letter to FDA seeking FDA action on antimicrobials. With FDA’s increased focus on antibiotic resistance and the subtherapeutic use of antibiotics in food animals, we expect FDA to begin more testing for antimicrobial residues in ethanol coproducts and potentially start issuing warning letters or other enforcement actions when residues are found.

With the severe drought that affected the Midwest and Great Plains this year, aflatoxin levels in corn and wheat feedstock have become a significant concern. FDA’s Compliance Policy Guide 638.100, first issued in 1979, provides action levels— levels at which FDA will consider taking enforcement action—with respect to aflatoxin in animal feed. This CPG applies to ethanol coproducts fed to animals. It generally prohibits companies from mixing grain with high aflatoxin levels with clean grain in order to dilute the amount of aflatoxin in the finished product below the action level. With the significant grain shortages and high aflatoxin levels this year, FDA approved several states’ requests to allow blending. However, that blending must be done under very strict conditions. The blend must be sold for use with appropriate species, must be analyzed for aflatoxin content and be accompanied by certification by the seller, the seller must obtain a certification from the buyer regarding the buyer’s use of the product, and the product must be clearly labeled as for animal feed use only. 

The new reality in the feed and biofuels world is that FDA is here to stay. We believe the actions outlined here are just the beginning of greater FDA involvement in the industry. Ethanol companies are well-advised to get ahead of the curve by understanding FDA’s involvement in the industry and putting in place the necessary FDA compliance systems and other policies to ensure compliance.

Authors: Andrew Anderson
Partner, Faegre Baker Daniels
[email protected]

Steve Toeniskoetter
Associate, Faegre Baker Daniels
[email protected]