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FDA Proposes Model for Designating High-Risk Foods Under FSMA

Feb 12, 2014

The Food and Drug Administration recently developed and published a proposed risk-ranking model designed to help the agency identify high-risk foods that would be subject to additional recordkeeping for traceability under the Food Safety Modernization Act. IDFA believes the proposed model could unintentionally group wholesome dairy products with negligible risk into the same category as potentially high-risk foods.

FDA published the model last week in the Federal Register, along with a request for comments and scientific data. IDFA will respond with industry comments by the April 7 deadline.

According to “FDA’s Draft Approach for Designating High-Risk Foods,” FDA is considering classifying foods for the risk ranking based on the 28 categories of food included in the Reportable Food Registry. That means all dairy products would fall into under one category for dairy, and “representative foods” would be selected and used in the model.

The high-risk designation would be based on a comprehensive evaluation of a set of criteria, including outbreak frequency, illness occurrence, severity of illness, the likelihood of microbial or chemical contamination, potential for the food to support pathogen growth, food consumption patterns, the probability of contamination and steps taken during manufacturing to reduce contamination.

“IDFA is opposed to FDA using the broad categories mentioned in the model,” said Clay Detlefsen, IDFA vice president of regulatory affairs and FSMA expert. “We want to see further refinements to FDA’s approach to avoid any negative impact on foods without associated high risks.”

FDA has not yet determined what the additional recordkeeping requirements would be for designated high-risk foods, Detlefsen said.

Members may login below to read more information in a detailed memorandum, “FDA Requests Comments and Data on Designation of High-Risk Foods for Traceability Purposes Under FSMA,” prepared by Hogan Lovells US LLP, IDFA’s outside legal counsel.

Members with questions may contact Detlefsen at

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