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
Comment on the Approach Document
The comment period opened February 4, 2014 and has been extended to May 22, 2014.
FDA is requesting comments and scientific data/information. 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.
You may comment electronically on http://www.regulations.gov. Comment Now!
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.