FDA Seeks Public Comment on High-Risk Foods

WASHINGTONThe Food Safety Modernization Act requires the U.S. Food and Drug Administration (FDA) to designate high-risk foods for recordkeeping purposes in an effort to swiftly trace such foods during an outbreak of foodborne illness.

Although FDA hasn't yet designated high-risk foods, it published a notice last week to present its draft methodological approach to doing so.

FDA said it plans to publish a list of high-risk foods before or at the same time it issues a proposed rule to establish recordkeeping requirements for such foods.

The methodological approach doesn't identify specific foods or hazards. Rather, it is based on an evaluation of chemical and microbial hazards combined with foods using criteria that encompass factors that the Food Safety Modernization Act (FSMA) requires.

FDA specifies that it must base the designation of high-risk foods on the following:

(1) 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;

(2) 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;

(3) point in the manufacturing process of the food where contamination is most likely to occur;

(4) likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;

(5) likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and  

(6) likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

"Inclusion on the high-risk food list would be based on the total risk score for foods or food categories," FDA explained.

FDA is seeking public comment and scientific data on alternative approaches for identifying high-risk foods, whether or not certain criteria should be weighted equally, changes in the scoring system and how the agency should categorize foods. Comments can be submitted through April 7, 2014.

Among some of the other information FDA is requesting: a list of pathogens and chemical contaminants that are likely to be found in food, the levels of contaminants in food, the point at which contaminants are likely be introduced and typical steps and control measures taken in the manufacturing process to reduce the possibility of contamination.