FDA unveils FSMA food defense rule, will revise 2 others

The Food and Drug Administration (FDA) today unveiled a proposed rule that would require large food businesses to take measured steps to prevent intentional contamination of their products, as required by the Food Safety Modernization Act (FSMA).

And in another FSMA-related move, the FDA announced yesterday that it would step back and spend several months revising its proposed rules on produce safety and preventive controls as they affect farmers, in response to concerns voiced by farmers and others since the rules were released in January.

First regulatory effort to stop food sabotage

The proposed food defense rule marks the first time the FDA has proposed a regulation to prevent intentional food contamination. As noted in its announcement, in the wake of the 2001 terrorist attacks the agency developed a number of guidance documents and other voluntary tools to help the food industry prevent such sabotage.

"The FDA is unaware of an event where the food supply was adulterated with the goal of inflicting massive public health harm," the agency said. "While such events are unlikely to occur, mitigating strategies proposed in the rule can continue to ensure the safety of the food supply. The proposed rule is intended as a preventive measure, and the FDA seeks public comment on the proposed approach."

The proposed rule is the sixth one issued under FSMA, which was enacted early in 2011.

"The goal is to protect the food supply from those who may attempt to cause large-scale public health harm," said Michael R. Taylor, the FDA's deputy commissioner for foods and veterinary medicine.

The agency said it is proposing a targeted approach focused on certain processes that are most likely to be vulnerable to attack. Under the rule, a food facility would be required to have a written food defense plan addressing vulnerabilities in its production process. Facilities also would have to identify and adopt strategies to address the vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working, ensure that affected personnel receive appropriate training, and maintain certain records.

The rule would not apply to most farms or to facilities that produce animal feed or pet food. Dairy farms, however, would be subject to the regulation, because "fluid milk loading and storage appear to pose a significant vulnerability," says the FDA's Federal Register notice detailing the proposal.

Also exempt would be "very small businesses," defined as those that have less than $10 million in annual sales or have less than $500,000 in sales and meet certain other conditions, the notice says.

The FDA estimates the food industry's cost to comply with the rule at about $370 million. About half of that cost would be incurred by foreign food producers that are currently required to register with the FDA, the notice states.

The agency set a deadline of Mar 31, 2014, for commenting on the proposal.

Revisions on the way for other rules

In announcing plans to revise the FSMA produce-safety and preventive-controls rules, Taylor said the changes will target provisions on water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities (such as farms that have processing operations), and procedures for withdrawing the qualified exemption for certain farms.

He said the changes are needed to accommodate the many kinds of produce farms and ensure that the rules are practical, commenting, "We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers."

The decision to revise the rules follows extensive FDA efforts to get the food industry's feedback on them, as well as a campaign by farmers, lawmakers, and others who said they would be too onerous. That included a November letter from 75 members of the House and Senate, who said the rules would be "severely detrimental" to American agriculture.

Taylor said FDA officials participated in 150 meetings and visited farms across the nation in their effort to gather input on the rules. The comment period for them was extended three times.

Plans now call for publishing the revisions by early summer of 2014, Taylor said. The agency then will accept comments on them.

See also:

Dec 20 FDA press release on proposed food defense rule

Advance copy of Dec 24 Federal Register notice on food defense rule

Dec 19 statement by Michael Taylor on revision of two FSMA rules

Related Dec 19 Michael Taylor blog post

Nov 27 CIDRAP News item on push for rewrite of FSMA rules

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