The U.S. Food and Drug Administration (FDA) announced today that it is publishing a Federal Register notice to present its draft methodological approach to identifying high-risk foods, as required under section 204(d)(2) of the Food Safety Modernization Act (FSMA). The agency is seeking comments on the draft, as well as relevant scientific data, to help refine its approach.

Under section 204(d)(2) of FSMA, the FDA is required to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary in order to rapidly and effectively track and trace such foods during a foodborne illness outbreak or other event. Agency officials said publishing this draft methodological approach is the first step towards meeting the FSMA requirement.

The FDA plans to publish a list of these high-risk foods either before or at the same time that it issues a proposed rule under section 204(d)(1) of FSMA to establish the recordkeeping requirements for the designated high-risk foods. On the Draft Methodological Approach to Identifying High-Risk Foods web page, the FDA explains that designation of HRFs must be based on the historical public health significance of the food with respect to outbreaks and cases of foodborne disease, as well as a number of food- and processing-related factors.

In a Constituent Update issued by FDA's Center for Food Safety and Nutrition (CFSAN), the agency noted that the draft approach is based on an evaluation of chemical and microbial hazards combined with foods (i.e. food-hazard pairs) using criteria that encompass the factors required under section 204(d)(2)(A) of FSMA. Available data for each criterion are used to determine a total risk score for each food-hazard pair. The draft approach allows each criterion to be weighted where appropriate. No specific foods or hazards are included in the draft methodological approach. Although the analysis would encompass food-hazard pairs, we anticipate that the list would contain foods only, not food-hazard pairs. Where multiple hazards occur for a given food, a total risk score would be determined for that food.

Some of the specific issues on which FDA is inviting comments include: alternative approaches for identifying high-risk foods, whether or not the criteria should be weighted equally, changes in the scoring system, and how foods should be categorized. The comment period for the draft methodological approach opens tomorrow (Feb. 4); comments may be submitted electronically via Regulations.gov or in writing to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

All submissions received must include the agency name and Docket No. FDA-2014-N-0053 for this notice.

For more information on the Draft Methodological Approach to Identifying High-Risk Foods:

• Download the full approach document (PDF:184KB)
• Read the Federal Register notice
• See Questions & Answers on Product Tracing