On June 18, FDA published a proposed method for ranking chemicals in the food supply to prioritize post-market assessments. The method to rank the chemicals would focus on those that may present the greatest potential public health risk and are of high public concern. FDA has released the proposal for public comment, but allowed only 30 days, with comments due by July 18, 2025.
The method uses multi-criteria decision analysis (MCDA) to determine a score for each chemical (whether added intentionally or not), evaluating the information about a chemical against a pre-determined set of criteria. The method is similar to one used by the EPA but includes factors specific to exposure from food and uses a scoring method similar to the FDA’s Risk Ranking Model for Traceability. It is intended to work in association with FDA’s surveillance and signal detection tools, with FDA stating that it will be refined in response to public comment.
As detailed in the draft FDA Tool for the Prioritization of Food Chemicals for Post-Market Assessment, the method applies the prioritization tool to score specific criteria for each chemical of concern; the higher the score, the higher the priority of that chemical for post-market assessment. Following are the two areas of decisional criteria included in the scoring:
Public Health. A chemical receives the highest score if:
- It may produce severe health effects (e.g., cancer, cardiovascular toxicity);
- Dietary exposure to the chemical has increased;
- The chemical is found in or could potentially be present in food intended for vulnerable subpopulations (e.g., infants); and
- Newly available information, data, or science indicates a potentially high impact on the conclusions of the previous assessment of the chemical.
Other Decisional. A chemical receives the highest score if:
- There is high attention (e.g., Congressional and/or national news media coverage) on this chemical, multiple organizations monitoring it, and/or multiple stakeholder groups active in setting standards;
- Multiple other governmental agencies are making decisions or taking action on this chemical; and
- Not assessing this chemical could result in the public losing confidence in the safety of the U.S. food supply.
The tool document details specific scoring rubrics associated with each of the above. While the public health scores are fairly straightforward (i.e., toxicity level, rate of change of exposure, new scientific information impact), the scoring for the other decisional criteria is more subjective and potentially debatable. For example, attention on the chemical is given the highest score of 9 if there is “high attention raising concerns” (e.g., Congress, GAO, HHS Secretary, FDA Commissioner call for action; national news/social media coverage); multiple organizations watching this; stakeholder groups active in setting standards and establishing best practices. It is given a 5 if that attention is moderate. Where this could be of concern is whether the particulars and examples are rated as ands or ors. That is:
- Does high national news/social media coverage warrant a 9 – regardless of the accuracy of the coverage? Or is that only if there is also Congressional or agency action?
- Do “one or two active groups” collecting data on a chemical or individual industry members raising a concern give the chemical a 5? Or does there need to be a combination of moderate attention?
- With potential impact on public confidence in the safety of the U.S. food supply scored as 9 for high impact, 5 for medium, and 1 for low, it would seem that public outreach with science-based facts on the chemicals would be of greater value than scoring current public perception – which is subject to multitudes of misinformation and disinformation.
The document includes a number of questions on which FDA would like feedback in public comments including whether the modeling approach is appropriate; whether the public health and other decisional criteria, and their scoring definitions, are appropriate, and if equal or different weighting should be considered for these; and questions on the toxicity rubric.
With chemicals in foods continuing to garner federal, state, media, and association attention, it behooves the industry to carefully review the FDA publication and submit comments within the short 30-day comment period.
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