FDA Announces Extension of Comment Period on Draft Methodological Approach for Designating High-Risk Foods

CFSAN Constituent Update

March 25, 2014

FDA is announcing the extension of the comment period on the draft methodological approach to identifying high-risk foods, which was published in the Federal Register on February 4, 2014. FDA has considered requests to extend the comment period and is granting a 45-day extension to May 22, 2014.

FDA 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.

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