FDA releases details of FSMA rule, extends compliance deadlines

Meeting a court directed deadline, the U.S. Food and Drug Administration submitted the final rule for the Food Safety Modernization Act for publication at the end of August, releasing information on its website on Sept. 10.  Official publication in the Federal Register is scheduled for Sept. 17.

Signed into law in early 2011, FSMA reforms food safety laws, shifting the focus from responding to contamination to preventing it. The rule introduces new rules for feed manufacturers, which will include the ethanol industry’s coproducts bound for domestic livestock feeding.

The rule requires animal food facilities to have a written food safety plan that includes a hazard analysis and preventive controls, which will need to be reanalyzed at least once every three years. The FDA says it has finalized Current Good Manufacturing Practices for feed producers which are to be implemented first, and which the agency says “take into consideration the unique aspects of the animal food industry and provide flexibility for the wide diversity in types of animal food facilities.”

Richard Sellers, senior vice president of legislative and regulatory affairs for the American Feed Industry Association, released a statement following his initial review of the rule. “AFIA is pleased FDA followed through with our request for a phase-in approach to implementation, giving all animal food manufacturing facilities additional time to execute CGMPs [Current Good Manufacturing Practices] first, followed by the hazard analysis and preventive controls,” he said.

Large business will have one year to comply with CGMP requirements and two years for preventive control requirements. Small businesses, defined as employing fewer than 500 full-time equivalent employees, will have two years for CGMP and three years for preventive control compliance. Very small businesses, with less than $2.5 million in average annual feed sales, will have three years for CGMP and four years for preventive controls.

"AFIA is also pleased FDA recognized animal food is different from human food in revising the CGMPs to be more applicable to animal food facilities and addressing the hazards in our industry,” Sellers said.

The final rule will take effect Sept. 17, when it is scheduled to be published in the Federal Register. In the interim, the PDF of the 666-page rule is available here.

The FDA has scheduled three webinars regarding the rule, and will be posting the slides and recordings to its website. The webinar planned for Sept. 17 will cover significant provisions of the rule regarding preventive controls for animal feed.

Ethanol Producer Magazine has scheduled a webinar for 2 p.m. CDT, Tuesday, Oct. 6, to address FSMA’s impact on the ethanol industry. Speakers will include David Fairfield, vice president, National Grain & Feed Association; Kelly Davis, director of regulatory affairs, Renewable Fuels Association; and Charles Hurburgh, Iowa Grain Quality Initiative, Iowa State University. All three are part of an FDA alliance which has been working on a training program to be offered in the months ahead.   

“RFA collaborates with the FDA’s Food Safety Preventive Controls Alliance,” Davis said, “helping to establish training and technical assistance programs for the FSMA regulations. We are committed to help educating our industry members on the new rules and look forward to working with the industry to help them understand how to comply with these new regulations.”