FDA Unveils a Tool for Prioritizing Food Chemicals for Post-Market Assessment

In an accompanying Constituent Update, the FDA characterized the method as providing a transparent, systematic, and science-based approach to the issue. This initiative is part of the FDA’s broader effort to enhance transparency and ensure that its resources are focused on chemicals that may pose the greatest potential public health risks (including those affecting sensitive populations) and are of high public concern.

The comment period will end on July 18, after which the method itself and public comments will undergo external scientific review. As part of its announcement, the FDA has presented a set of 14 specific questions that it encourages the public to address during the 30-day comment period.

Description of the Prioritization Tool

The FDA’s Tool for the Prioritization of Food Chemicals for Post-Market Assessment is designed to provide a reproducible, data-driven process for identifying and ranking food chemicals - both intentionally added (such as food additives and color additives) and unintentional contaminants - for further safety review. The tool uses a Multi-Criteria Decision Analysis framework, which assigns scores to chemicals based on a set of defined criteria. The higher the score, the higher the priority for post-market assessment. The method is similar to one developed by the US Environmental Protection Agency for prioritizing chemicals, but takes into account factors specific to exposure from food.

Key Criteria Used in the Tool

1. Public Health Criteria

• Toxicity: This is assessed using a rubric that considers various types of toxicity data (e.g., acute, carcinogenicity, developmental, neurotoxicity, immunotoxicity, bioaccumulation). The highest toxicity score for any single toxicity data type among these categories becomes the overall toxicity score used in the tool.
• Change in Exposure: This evaluates whether exposure to the chemical has increased or decreased since the last assessment, considering factors like levels in food, consumption patterns, and production volumes.
• Susceptible Subpopulations: This considers whether the chemical is present in foods consumed by vulnerable groups (e.g., infants).
• New Scientific Information and Potential Impact: This assesses whether data acquired since the previous assessment could significantly impact the latter’s safety conclusions and the potential impact of any change.

2. Other Decisional Criteria

• External Stakeholder Activity/Attention: This measures the level of concern or attention from, e.g., US Congress, media, advocacy groups, and industry.
• Other Government Decisions: This considers actions taken by other governmental bodies (e.g., new federal or state laws or regulations).
• Public Confidence: This evaluates the potential impact on public trust in the food supply if the chemical is not assessed.

Each public health criterion is scored, and the scores are combined — currently with equal weighting — to produce a Total Public Health Criteria Score. The same process is applied to each Other Decisional Criterion to give a Total Other Decisional Criteria Score. The weighted Total Scores are then combined to give an overall Post-market Assessment Prioritization Score for a given chemical.

Process and Implementation

The FDA will first develop an inventory of chemicals to be prioritized. Next, subject matter experts from the FDA’s Human Foods Program will score each criterion for each chemical in the inventory according to their areas of expertise, and from those scores a total risk score and rank will be derived for each chemical. Risk managers will then use the ranked list to identify chemicals for priority assessment.

Implications for the Food Industry

• Increased Transparency and Predictability: The tool is designed to provide a clear, structured process for how the FDA will prioritize chemicals for review; this can help industry stakeholders anticipate regulatory focus areas.
• Focus on Public Health and Public Perception: Chemicals that present higher potential health risks, are subject to increased exposure, or are of significant public concern are more likely to be prioritized for review.
• Stakeholder Engagement: The FDA is actively seeking input from industry and the public, signaling opportunities for stakeholders to influence the development and refinement of the tool.
• Potential for Regulatory Action: Chemicals identified as high priority may be subject to further safety assessments and, depending on the outcome, possible regulatory actions affecting their use in food.

The FDA views this initiative as a significant step in its efforts to modernize and strengthen its oversight of food chemical safety, with direct implications for compliance, risk management, and public relations within the food industry.