At a public meeting on September 25, 2024, FDA discussed its proposed process for post-market assessment of chemicals in food.
Deputy Commissioner Jim Jones opened the meeting to emphasize that food chemical safety is a top priority for the new Human Foods Program. While FDA has been conducting some post-market safety reviews, these reviews have been ad hoc and limited by resources and the lack of a statutory mandate to do them. Consequently, many states have stepped in to fill the void, but Deputy Commissioner Jones stressed that a state-by-state approach is not the answer. Instead, FDA has established an office dedicated to chemical safety and will be creating a systematic process at the federal level for the targeted post-market assessment of food additives, substances that are generally recognized as safety (GRAS), color additives, food contact substances, and unintentional contaminants (eg, environmental contaminants). Deputy Commissioner Jones cautioned, however, that there is no increase in budget for these reviews, so limited resources will constrain its activities in this area.
The meeting followed the release for comment of the agency’s Discussion Paper Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food. This paper outlines a general approach for such a systematic process that would allow the FDA to proactively identify and target chemicals currently in the food supply for post-market assessment in a structured manner based on risk. The process would start with a review of information that includes (1) identifying new information through monitoring of multiple sources (eg, new submissions, international and US regulatory activities, adverse event reports, media); (2) a preliminary assessment of the information to determine if a post-market assessment is needed; and (3) a decision whether to conduct a “focused” or “comprehensive” assessment based upon the likely complexity of the assessment needed.
Focused assessments would be limited in scope, would be conducted by the agency without external engagement (unless required by law), and should be completed in 4–12 months. In a focused assessment, FDA will define the chemical(s) at issue, conduct a scientific risk and safety assessment, determine whether action is needed to protect public health (or whether additional research or a comprehensive assessment is needed), and communicate the agency’s conclusions and take appropriate risk management actions.
In contrast, comprehensive assessments would be more complex and resource intensive and may take years to complete. While they would involve many of the same steps as a focused assessment (although in more depth), comprehensive assessments would also involve public input in several stages, including in defining the scope of review and in developing a draft scientific risk and safety assessment. Unlike focused assessments, which are done at the program level within FDA, comprehensive assessments require concurrence with the FDA Human Foods Program Leadership, including on recommendations for risk management actions.
The Discussion Paper also outlines the factors FDA will consider to ensure its assessment is “fit for purpose” (ie, whether it should be a focused or comprehensive assessment), as well as a tentative list of factors it will use to prioritize chemicals for review.
The agency specifically seeks input on the following questions:
- When and how should the FDA engage the public on post-market assessments?
- Is the frequency and mechanisms of the envisioned public engagement described in Section V of this document appropriate? If not, please provide alternative areas for engagement/communication, additional information that you believe should be shared publicly, and rationale for the change.
- Should the FDA integrate an advisory committee review into our post-market assessment process? If yes, at what stage, and what should the committee’s role be?
- Are the Fit for Purpose Decision Tree questions in Section III of this document appropriate? If not, what questions would you add or how would you modify the questions to be more appropriate to the task?
- Is the Prioritization of Risks scheme the FDA outlines in Section IV of this document appropriate for ranking food chemicals, (including contaminants, food ingredients, and those substances used in contact with food) for post-market assessments? If not, please explain why and how you would modify the Prioritization of Risks scheme. Please provide supporting rationale for the changes.
- Is the FDA’s two-pronged approach of Focused Assessments and Comprehensive Assessments appropriate to assess public health risks of chemicals in food? If not, please explain why and provide an alternative process, including rationale for such alternative(s).
Comments on the proposal set out in the discussion paper should be submitted to Regulations.gov by December 6, 2024.
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