Tuesday, February 04, 2014 by Lee Mannering
Yesterday I mentioned that today I would be sharing some details from PMA’s comments to the U.S. Food and Drug Administration on the agency’s Food Safety Modernization Act (FSMA) proposed rule on third-party audit accreditation. However, that information will be coming either tomorrow or Thursday because in today’s Federal Register, the FDA opened a docket to obtain comments and scientific data and information that will help it implement the section of the FSMA that requires FDA to designate high-risk foods. Per the FSMA, high-risk foods must be based on the:
- known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention;
- 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 such food;
- point in the manufacturing process of the food where contamination is most likely to occur;
- likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
- likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and
- likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.
With the docket, FDA released a tentative draft approach document for the review and evaluation of data to designate high-risk foods. As you’ll see, fresh produce is cited as an example in the approach document; FDA says it is considering using a semi-quantitative risk ranking model similar to the produce risk ranking model.
To learn more about this docket and the draft approach document, visit the What’s New tab in our FSMA Resource Center for this and a variety of other resources on the various FSMA proposed rules.