- On June 18, 2025, FDA announced its proposed “method for post-market assessments of chemicals in the food supply.” This “Post-market Assessment Prioritization Tool” will give chemicals an overall score that will be used to rank each post-market chemical assessment in order of priority. We previously reported on FDA’s proposed systematic process for post-market assessment of chemicals in foods, which had its comment period extended to January 21, 2025.
- According to FDA’s proposed method, a chemical’s overall score will be calculated from a Multi-Criteria Decision Analysis (MCDA) which will use four Public Health Criteria and three Other Decisional Criteria. The Public Health Criteria are toxicity, change in exposure, effects on a susceptible subpopulation (e.g., children), and availability of new scientific information. The Other Decisional Criteria are external stakeholder attention, other government decisions, and public confidence in the U.S. food supply.
- The total score of the Public Health Criteria is given equal weight to that of the Other Decision Criteria, as they both get a score of 1-9 and then the two are averaged to calculate the chemical’s overall score. FDA’s press release points to how the Environmental Protection Agency (EPA) similarly prioritizes certain substances for risk evaluation, though notably the EPA criteria are already specified in the Toxic Substances Control Act (TSCA) § 2605(b)(1)(B) and are “without consideration of costs or other nonrisk factors.”
- The proposed prioritization method will be open to public comments until July 18, 2025 under Docket No. FDA-2025-N-1733. In a departure from past practice, there is no Federal Register notice announcing the establishment of this docket for receipt of public comments, only a link in FDA’s announcement to the docket on www.regulations.gov. By way of contrast, see FDA’s August 2024 Federal Register notice announcing a public meeting and soliciting public comment on FDA’s Post-Market Assessment of Chemicals in Food (89 Fed. Reg. 65633, Aug. 12, 2024).
- Keller and Heckman would be happy to prepare comments and we will continue to monitor and relay updates on FDA’s post-market review process.
