FDA Has No Jurisdiction Here—Or Does It?

By Sarah Brew and Steve Toeniskoetter | March 05, 2012

Pop quiz time—which federal agencies regulate your plant? Did your answer include the Food and Drug Administration? If your plant produces distillers grains, corn oil or similar products for human or animal consumption, your answer should have. Ethanol plants that produce coproducts for food or feed are considered food facilities subject to FDA jurisdiction.

But you are already regulated by the U.S. EPA and your state’s department of agriculture, so why should you care? For years, ethanol producers have mostly flown under FDA’s radar, but times are changing. FDA’s recent focus on antibiotic residues and mycotoxins in DDGSs was just a taste of things to come. A little over a year ago, President Obama signed into law the Food Safety Modernization Act, the first significant update and expansion of FDA’s food and feed safety regulatory powers in almost 70 years. While plants producing feed (including ethanol plants) have had to register with FDA since 2002, FSMA gives that requirement some teeth by allowing FDA to revoke a facility’s registration due to food or feed safety reasons. FSMA also prohibits shipping food or feed into interstate commerce without a current registration, effectively turning your registration into a license to operate. In other words, FDA could effectively shut down your sales, or even order a mandatory recall, if it finds significant food safety violations.

The backbone of FSMA is the requirement that all registered facilities develop and implement a hazard analysis and preventive controls plan. Such a system is likely to be quite similar to the Hazard Analysis and Critical Control Point plan system discussed in the November Business Matters column. We expect FDA to release its proposed rule on preventive control plans for animal feed facilities sometime between March and June. At a minimum, the rule will require feed manufacturers to evaluate known or reasonably foreseeable feed safety hazards, identify and implement preventive controls, monitor those controls, take corrective actions when they are not working, and periodically verify the effectiveness of the overall system. All of this must be in writing and will no doubt be a primary focus of FDA or state department of agriculture inspectors.

While we do not yet know what preventive controls will be required, they will likely include testing both incoming grain and finished product for mycotoxins, testing finished product for antibiotic residues and possible microbial contaminants such as Salmonella or E. coli, pest control programs and implementation of required current good manufacturing practices. A recall plan may also be required, along with controls to ensure unapproved food or feed additives do not make it into the final product. Based upon comments by FDA officials, we believe FDA will likely mandate certain controls but still allow a producer flexibility to implement a different control that achieves the same or better result.

FSMA also requires FDA to perform more frequent inspections of regulated facilities, which for some ethanol plants will be the first. The law requires all facilities be inspected by 2018, and at least once every five years thereafter. Certain high- risk facilities will get inspected more often, though it is highly unlikely FDA will find most ethanol facilities to be high risk.

A key part of any inspection will be a review of a facility’s records. In addition to access to hazard analysis and preventive control plan records (including monitoring and verification records, such as test results), FDA also gets increased records access in Class I-recall situations. Managing records and training employees on how to handle inspections will be essential to avoid receiving FDA warning letters. A Form 483 or Warning Letter will generally note FDA’s concerns with a facility and require they be fixed. Under FSMA, if FDA reinspections are needed, fees starting at $224 an hour per inspector will be paid.

This is just a sampling of FDA’s new powers and possible requirements for ethanol facilities. FDA has its hands full implementing FSMA and, therefore, many of these provisions will not be in effect for months, or even years. Nonetheless, we encourage you to visit with your legal advisor to begin preparing for compliance with this important new law. Sooner or later, FDA will be knocking at your door—will you be ready?

Authors: Sarah Brew
Partner, Food and Agriculture Industry Group
Faegre Baker Daniels
(612) 766-7470

Steve Toeniskoetter
Associate, Food and Agriculture Industry Group
(612) 766-7353