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FDA Seeks Input on Identification of High-Risk Foods Requiring Additional Records

Tuesday, February 04, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is soliciting through April 7 public comments and scientific data and information that will help it refine its draft approach to identifying high-risk foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health, as required by the Food Safety Modernization Act. This draft, which describes the process and methodology the FDA is considering using for designating high-risk foods, is available here. The FDA anticipates further revising this approach, as necessary, following its consideration of comments received and review by scientific experts.

FSMA requires the designation of high-risk foods to be based on the following factors: (1) the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to it; (2) the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce it; (3) the point in the manufacturing process of the food where contamination is most likely to occur; (4) the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination; (5) the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and (6) the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

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