FSMA food defense rule proposed

RibEyeSteak_wPotatoes_blogToday the U.S. Food and Drug Administration (FDA) announced a new rule aimed at protecting the U.S. food supply from intentional contamination.

Under the rule, domestic and foreign food facilities will be required to evaluate vulnerabilities in their processes in order to prevent acts that could cause public harm. This kind of adulteration can take many forms, whether it’s from disgruntled employees, competitors or the like contaminating the food supply, economic adulteration with the goal of gaining an economic advantage or terrorism. Although FDA notes that intentional adulteration of food with “the intent to cause public harm” may not be likely, should it occur, its effects could be devastating, including illness, death, economic impacts and shaken confidence in the U.S. food supply. The food defense rule is the sixth to come from the Food Safety Modernization Act (FSMA).

FDA also has listed four main areas of food production that may be susceptible to this kind of adulteration – liquid handling and storage, bulk liquid receiving and loading, mixing, and secondary ingredient handling. Facilities will be required to evaluate these processes, if present, and develop “actionable” steps to reduce the chance of adulteration.

Facilities covered under the rule also will be required to have a food defense plan, which has a range of components including (the full list is here) actionable process steps, mitigation strategies, monitoring, corrective actions, verification, training and recordkeeping.

Businesses will be required to implement these plans 60 days after the publication of the final rule. However, FDA has staggered compliance dates for smaller businesses. Very small businesses (less than $10 million a year in annual food sales) must comply within three years of the final rule’s publication, small businesses (less than 500 employees) will have two years to comply.

The comment period on the rule is open until March 31, 2014. To comment, go to www.regulations.gov. FDA also has a meeting on the rule planned on Feb. 20, 2014 in College Park, MD.

The full rule is available here.

In other FSMA news, FDA plans to publish revised versions of the preventive controls for human food rule and the produce rule during the summer of 2014 following extensive feedback from farmers and other stakeholders, according to a statement from FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor. Once they are published for comment, FDA will only accept comments on the revised sections.

“Based on our discussions with farmers, the research community and other input we have received, we have learned a great deal, and our thinking has evolved. Everyone shares the goal of ensuring produce safety, but, as we said at the beginning of the process, the new safety standards must be flexible enough to accommodate reasonably the great diversity of the produce sector, and they must be practical to implement,” Taylor said in the statement. “To achieve this goal, we believe that significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers. These provisions include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms. 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.”

For more on FSMA from Neogen blog, click here.

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