FDA Finalizes FSMA Preventive Controls Rules For Human, Animal Foods

Four-and-a-half years after the Food Safety Modernization Act (FSMA) was signed into law, the first two major rules have been finalized.

On Aug. 31, U.S. Food and Drug Administration (FDA) officials announced that they had submitted the final rules on preventive controls in human and animal food to the Federal Register as required by the court.

“Documents submitted to the Federal Register can publish several days after they are submitted, with larger documents taking longer to process and display,” FDA said.

It took more than a week before the preventive controls rules were published and made publicly available on Thursday.

“For those of you who have been following this process closely and read about the original proposals and supplemental, there will be a very minimal number of new things,” said Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine, on a call with reporters.

Last fall, FDA released supplemental languagefor the preventive controls rules, as well as the produce safety and Foreign Supplier Verification Programs (FSVP) rules.

Taylor said that there were some refinements and tweaks made to the preventive controls rules in response to public comments, but there are no significant departures from what’s been published before.

Broadly, the rules require registered food facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for dealing with those hazards. Facilities also have to verify and document that their controls are working.

The rule regarding preventive controls for human foods modernizes existing current good manufacturing practices (CGMPs) for manufacturing, processing, packing or holding human food, which were last updated in 1986. The rule for preventive controls for animal food establishes for the first time CGMPs for the manufacturing, processing, packing, and holding of food for animals.

The human food rule also clarifies the definition of “farm,” which is central to whether an entity has to register as a food facility and, thus, become subject to the new requirements for hazard analysis and risk-based preventive controls.

The preventive controls rules draw on industry best practices, which many food producers already apply in their operations, Taylor said, and which have been shaped by public comments and conversations with farmers, consumers, industry and academics.

The flexibility built into the final rules is meant to ensure food safety “across the great diversity of the food system,” Taylor said.

Very small businesses have three years to comply with the rules, small businesses have two years, and the rest have one year.

FDA will conduct three webinars about the two finalized rules next week and hold a public meeting in Chicago on Oct. 20.

The next three rules for produce safety, foreign supplier verification program, and third-party accreditation must be finalized by Oct. 31.

Taylor also said Thursday that implementing these and the other five major FSMA rules “requires adequate resources.”

Full funding of the president’s budget request for fiscal year 2016, which asks for a $109.5-million increase for FDA, is “essential to maintaining momentum toward timely, effective and efficient implementation of FSMA,” Taylor said.

Earlier this summer, the House and Senate Appropriations Committees allocated $41.5-million and $45-millionincreases, respectively, for FDA’s food safety activities.