Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of the FSMA
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 the first 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.
Section 204(d)(2) of the FDA Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (“FDA” or “we”) to designate high-risk foods (HRFs) for which additional recordkeeping requirements are appropriate and necessary to protect the public health. These additional recordkeeping requirements will make it easier to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak. 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.
- Download the Full Draft Approach Document (PDF:184KB)
- Federal Register Notice
- Questions & Answers on Product Tracing
- Information on the Comment Period Extension
- Docket Folder on Regulations.gov (includes submitted comments)