FDA finalizes first two Food Safety Modernization Act regulations

FDA finalizes first two Food Safety Modernization Act regulations

FDA Food Safety Modernization Act reaches fruition with final release of first two of seven major rules

The Food and Drug Administration on Thursday published the first two of seven major rules of the Food Safety and Modernization Act in the Federal Register, moving forward on a process to update food safety rules that has taken more than five years.

Related: FDA clarifies FSMA regs for farmers' direct-to-consumer food sales

The two rules released – one for Preventive Controls for Human Food and the other for Preventive Controls for Animal Food – will put greater emphasis on preventing foodborne illnesses, rather than controlling them.

Food Safety Modernization Act reaches fruition with final release of first two of seven major rules

The rules focus on implementing modern food manufacturing processes for both human and animal foods and require greater collaboration between FDA and food producers to prevent hazards to customers on the front end, rather than waiting to act until an outbreak has occurred.

FDA says the preventive controls rules require human and animal food facilities to develop and implement written food safety plans detailing possible problems and ways to mitigate or minimize those issues.

Under these rules, FDA says it will be able to assess food production systems to prevent problems, will better be able to respond when food safety problems occur, and better protect the safety of manufactured food.

"We've been working with states, food companies, farmers and consumers to create smart, practical and meaningful rules," said Michael R. Taylor, deputy commissioner for foods and veterinary medicine, FDA. "And we have made a firm commitment to provide guidance, technical assistance and training to advance a food safety culture that puts prevention first."

Human, animal food specifics >>

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Safer human food
The Preventive Controls for Human Food rule, first released in January 2013, was revised due to input received during the comment period and feedback during hearings, meetings, webinars and other public outreach.

FDA then issued a supplemental notice of proposed rulemaking in September 2014. The proposed revisions were designed to make the originally proposed rule more "practical, flexible, and effective for industry, while still advancing the FDA’s food safety goals," the agency said.

The final rule released Thursday has elements of both the original and supplemental rules, in addition to added flexibility that, for example, governs the definition of a "farm."

Implementation of the rule is staggered according to business size and type.

Safer animal food
First proposed in October 2013, the Preventive Controls for Animal Food rule also was revised following a public comment period. The updated rule appeared in September 2014, and the final rule released Thursday includes elements of both proposals.

Related: FDA's FSMA and Animal Feed

Specifically, the latest rule includes provisions that address regulations for by-products as animal feed and on-farm feed mills.

FDA expects all seven of the FSMA rules to be finalized in 2016.

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