FDA Requests Comments on Draft Methodological Approach for Designating High-Risk Foods Under Section 204 of FSMA

CFSAN Constituent Update

February 3, 2014

FDA is publishing a Federal Register notice to present its draft methodological approach to identifying high-risk foods under section 204(d)(2) of the FDA Food Safety Modernization Act (FSMA) and is seeking comments and scientific data that will help to refine its approach. FDA is required under section 204(d)(2) of FSMA 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. This is an important step towards meeting that requirement. 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.

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. 

Comment on the Approach Document

The comment period opens February 4, 2014.

You may comment electronically on 

Submit written submissions 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.

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