Information available related to Product Tracing under the FDA Food Safety Modernization Act (FSMA).
- Pilot Projects for Improving Product Tracing along the Food Supply System Final Report
- Draft Methodological Approach to Identifying High-Risk Foods
- Sections of the Law Relating to Product Tracing
- Frequently Asked Questions
- Meetings & Blogs
March 4, 2013 - Final Report Issued; Comments Requested
FDA has released a report on two product tracing pilot projects conducted by the Institute of Food Technologists (IFT) under an existing contract with FDA. FDA announced the pilots on September 7, 2011, indicating that they will enhance the agency's and industry's ability to trace products through the food supply. In conducting these two pilot projects, one for processed foods and one for produce, IFT obtained input from the industry sectors and consulted with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies . The pilots were required under section 204 of the FDA Food Safety Modernization Act, which also requires FDA to establish recordkeeping requirements for high-risk foods to help in tracing products.
The pilot projects were designed to explore and demonstrate methods for rapid and effective tracking and tracing of food, including types of data that are useful for tracing, ways to connect the various points in the supply chain and how quickly data can be made available to FDA. In addition to providing the findings of the pilot projects, the report contains IFT’s recommendations to FDA for improving the tracking and tracing of food. FDA is seeking public comment on this report. We request information that may help us form our own recommendations. We will offer recommendations in our Report to Congress, which also is required by section 204 of FSMA.
After additional data are gathered, FDA will initiate rulemaking on recordkeeping requirements for high-risk foods to facilitate tracing. The FDA must define high-risk foods, considering such factors as the known risks of a food based on foodborne illness data, the likelihood that a particular food has a high potential risk for contamination, and the likely severity of an illness attributed to a particular food. The FDA will hold three public meetings during the comment period on the proposed rule.
FDA is seeking comments on the pilot projects final report. You may submit comments and information, identified by Docket No.FDA-2012-N-1153, by any of the following methods:
- Submit electronic comments (starting March 5, 2013 to July 3, 2013):
- Federal eRulemaking Portal: http://www.regulations.gov.
- Follow the instructions for submitting comments and information.
- Submit written submissions:
- Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
- Instructions: All submissions received must include the Agency name and Docket No. FDA-2012-N-1153 for this notice. All comments and information received may be posted without change to http://www.regulations.gov, including any personal information provided.
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. View the FDA’s Draft Approach for Designating High-Risk Foods as Required by Section 204 of FSMA.
- Stakeholder Teleconference Sponsored by the Food and Drug Administration to Discuss Product Tracing Pilots
September 7, 2011