Draft Methodological Approach for Designating High-Risk Foods — Comment Period Extended

The Food and Drug Administration (FDA) has published notice of a 45-day extension, until May 22, 2014, of the comment period on its Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of FSMA.  79 Fed. Reg. 16,800 (Mar. 26, 2014).  Notice of the draft guidance document originally was published in the Federal Register on February 4, 2014.

FDA is required under section 204(d)(2) of the Food Safety Modernization Act (FSMA) to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary in order rapidly and effectively to track and trace such foods during a foodborne illness outbreak or another event.  See generally Questions & Answers on Product Tracing.  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 methodological 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, FDA anticipates 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 soliciting comments include:

•         Alternative approaches for identifying high-risk foods;
•         Whether the criteria should be weighted equally;
•         Changes in the scoring system; and
•         How foods should be categorized.

The comment period was extended in response to requests expressing concern that the 60-day comment period did not allow sufficient time to develop a meaningful and thoughtful response to the original notice.