The US Food and Drug Administration announced its draft methodological approach to identifying high-risk foods (HRF) under section 204(d)(2)(A). The designation of high risk foods will be important as FSMA develops. A HRF designation will require a facility keep additional records, including certifications for imported HRF, enhanced traceability, and increased inspections.
The approach would use the following factors.
Factors to Be Considered
Under section 204(d)(2)(A) of FSMA, FDA’s designation of HRFs must be based on the following factors:
i. 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 (CDC);
ii. 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 such food;
iii. the point in the manufacturing process of the food where contamination is most likely to occur;
iv. the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
v. the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and
vi. the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.
It would also utilize the following procedures.
Procedure for Designating HRFs
The draft approach to designate HRFs would include the following steps:
1) Using the statutory factors to be considered, define criteria and scoring
2) To the extent applicable, develop a comprehensive list of food-hazard pairs representativeof FDA regulated foods or food categories
3) Collect data relevant to the scoring criteria for the food-hazard pairs identified
4) Execute the draft risk model to determine risk scores for the food-hazard pairs
5) Determine the total risk score for a food or food category in which multiple hazards occur
6) Validate risk ranking results from the draft semi-quantitative risk model by using FDAiRISK® (available at http://foodrisk.org/exclusives/fda-irisk-a-comparative-riskassessment-tool/), where necessary
7) Using the total risk score for foods or food categories, create a preliminary list of highriskfoods. This is not anticipated to be a food hazard list but rather a food list.
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