The U.S. Food and Drug Administration (FDA) announced on June 18, 2025, the release of its proposed method for ranking chemicals in the food supply. According to the document, the systematic post-market assessment of food chemicals consists of the following steps: signal detection, triage, prioritization, scoping, scientific assessment (safety, risk, and/or hazard), risk management review, and risk management action. FDA states that it will publish a full description of the process later in 2025 that will describe each of these steps within the context of the systematic post-market assessment process. The document focuses on FDA's proposed method of prioritizing chemicals identified for post-market assessment using existing information about the food chemical. The method uses Multi-Criteria Decision Analysis (MCDA) to determine a score for each chemical based on evaluating the information about a chemical against a pre-determined set of criteria. FDA notes that the method is similar in approach and criteria to one that the U.S. Environmental Protection Agency (EPA) uses for prioritizing chemicals, but FDA's method takes into account factors specific to exposure from food and uses a scoring method similar to the FDA's Risk Ranking Model for Traceability. In FDA's MCDA method, the higher the total score, the higher the priority of that chemical for post-market assessment. For Public Health criteria, a chemical that would receive the highest score is one for which:
- The chemical 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.
For Other Decisional criteria, a chemical that would receive the highest score is one for which:
- 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.
| 1. The purpose of the Post-market Assessment
Prioritization Tool is to assist in making decisions about which
chemicals, including both intentionally added substances and
unintentional contaminants in food, are a priority to review. Is
the modeling approach FDA proposed appropriate for this
purpose? |
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| 2. The draft Post-market Assessment Prioritization
Tool currently includes four Public Health criteria and three Other
Decisional criteria. |
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| a. Are the four Public Health criteria appropriate for the
purpose of the tool? |
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| b. Are the three Other Decisional criteria appropriate for the
purpose of the tool? |
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| c. Are there additional criteria that should be
considered? |
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| 3. FDA developed the draft scoring definitions for
all criteria to consider the expected variability in the types and
extent of data available for the wide variety of food chemicals
that may be considered for review. |
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| a. Given this context, are the scoring definitions for the
Public Health criteria appropriate for the purpose of the
tool? |
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| b. Are the scoring definitions for the Other Decisional
criteria appropriate for the purpose of the tool? |
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| 4. The prioritization methodology includes
weighting factors. |
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| a. FDA is considering equal weighting among the Public Health
criteria and, separately, among the Other Decisional criteria for
the Post-market Assessment Prioritization Tool. Should different
weights be applied to the Public Health or Other Decisional
criteria when determining the Total Public Health Criteria
Score? |
|
| b. FDA is considering equal weighting among the Total Public
Health Criteria Score and the Total Other Decisional Criteria Score
to determine the overall Post-market Assessment Prioritization
Score. Should different weights be applied when determining the
overall Post-market Assessment Prioritization Score? |
|
| 5. The draft toxicity rubric uses traditional
toxicity data (in vivo, as well as limited in vitro such as for
genotoxicity), human health outcomes (e.g., adverse event reports),
and epidemiological data for determination of the toxicity
criterion score within the Public Health criteria. Considering that
the prioritization process is not a comprehensive review, please
address the following questions. |
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| a. How might FDA incorporate information from new approach
methodologies (NAM) into the toxicity rubric? |
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| b. Threshold of Toxicological Concern (TTC) approaches can be used to assess the toxicity of chemicals that lack sufficient safety data and have low dietary exposures. Although the Cramer classification scheme has historically been used in TTC approaches, FDA has recently developed the Expanded Decision Tree (EDT) that assigns chemicals to one of six EDT classes. How might such tools or the information they provide be incorporated into the toxicity rubric? | |
The document includes the following questions for public comment:
Comments are due July 18, 2025. After the public comment period closes, FDA states that it will submit the method and public comments for further evaluation by external scientific experts in line with the requirements of the Information Quality Act (IQA).
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