Topic: Detecting Signals for Chemical Hazards of Concern in CFSAN-Regulated Products.
Charge and Questions
Charge: CFSAN intends to develop a framework or a systematic process to better enable the Center to recognize and evaluate evidence of emerging chemical hazards or newly recognized risks from known chemical hazards in food, dietary supplements, food and color additives, and cosmetics. CFSAN seeks to be more proactive in identifying and monitoring emerging issues rather than reacting to issues after they occur. The task before this Food Advisory Committee is to consider possible sources of information and data on chemical hazards and to provide input on how CFSAN might recognize and take advantage of incoming information and data. Such data can include reports of adverse reactions, both acute and chronic, provided such information can plausibly be linked to a chemical hazard. Specifically, there are several issues for which CFSAN would like a response from the committee:
Question 1: What are the sources of data and information on chemical hazards that might best identify emerging chemical hazards or newly recognized risks from known chemical hazards? Rank these sources of data or information in order of the expected value in identifying new or emerging chemical hazards.
Question 2: Are the signal definition and the categories of signal types clear, well-defined, and inclusive? Are the definition and categories sufficient to detect potential issues related to chemicals in foods, food and color additives, dietary supplements, and cosmetics? Are there other categories that should be included or others that should be deleted?
Question 3: Once a potential signal is identified, CFSAN recognizes the need for considering and weighting various factors in the review and prioritization of a signal, and subsequent action. What factors and weighting are most critical in moving an identified signal from the Signal Manager through the process to review? What factors and weighting are most critical in prioritizing a signal into particular categories (“low” versus “high”)? What factors and weighting are most critical in deciding the follow-up and action on a signal?
Question 4: How should CFSAN conduct ongoing literature searches to capture new and emerging data on chemical hazards in published literature on foods, food and color additives, dietary supplements, and cosmetics as part of this detection system? What key words would be appropriate to search on? What journals are most valuable for this purpose?
Question 5: Are there specific web-based technologies or services which the FAC would recommend for generating effective broad literature searches and monthly reports? How frequently should these searches be done (e.g., monthly or at different frequencies)?
Question 6: Are social media tools available and refined enough to be of use in this area? Should CFSAN take advantage of current contracts with social media or are there other ways to obtain and analyze social media information? Would it be useful for this process?
Question 7: How should the various data for the chemical signal detection process be stored and managed? The current proposed system enables the data to be collected in one focal point, managed by two designated full-time employees, and stored on a designated server. Future plans involve a CFSAN specific data warehouse and analysis network. Is the current proposed system adequate for a pilot and for designing a long- term system? How should this repository be structured, who would have access, and how often should it be updated?
Question 8: What skill set should a signal manager have? Should he or she be an information management specialist, or should he or she have expertise in other scientific disciplines (e.g. chemistry, toxicology, epidemiology)?
Question 9: Does the signal review committee composition make sense? How often should it meet? Should there be any other types of committees considered for decision-making or to facilitate communication? Who should be included as members and what types of scientific disciplines should be included?