1. CFSAN’s Peer Review for Risk Assessments Robert L. Buchanan, Sherri Dennis, and Marianne Miliotis

2. Background Our mission is to protect public health We must develop and use efficient means to collect, organize, review and share information used in regulatory decisions Risk assessment is an important tool used to guide risk management decisions

3. CFSAN Risk Analysis Working Group: Recommendations 1. “Formalize a peer review process that will encourage critical review and evaluation of CFSAN’s risk assessments by government and non-government experts in a manner that improves the science and acceptance of complex risk assessments” CFSAN’s Risk Assessment Framework Report, March 2002

4. CFSAN Risk Analysis Working Group: Recommendations 2. “Develop criteria to evaluate the quality of data used for risk assessment and specify what information is needed to scientifically evaluate the usefulness of a study or data set used for risk assessment” 3. “Develop guidelines to evaluate risk assessments and supporting data developed by stakeholders and submitted to the Center”

5. Peer Review Requirements for FDA FDA’s Data Quality Guidelines: “Solicit advice and opinions of advisory committees as well as peer review from experts within and outside of the agency”

6. CFSAN’s Current Peer Review Process Specific activities include: Announce intention in the Federal Register and request submission of data Hold public meetings: key assumptions, data, and modeling approaches Seek input from stakeholders, scientific experts and advisory committees Conduct extensive review of report/ model by government employees Issue draft document and model for public comment Publish revised risk assessment

7. CFSAN’s Goal for Peer Review Formalize and implement a comprehensive peer review process that: Encourages critical review and evaluation of the risk assessment in a manner that ultimately leads to improvements in both the science and acceptability of complex risk assessment and models

8. CFSAN’s Peer Review Process For Food Safety Risk Assessments includes: Periodic solicitation of input from scientific experts and our stakeholders throughout the process of conducting the risk assessment Terminal reviews only are too late

9. What Is Needed A description of the process (activities) by which peer review is to be conducted Specific elements that a reviewer should consider in evaluating food safety risk assessment Evaluation of benefits/ limitations of the peer review elements Sufficient numbers of reviewers

10. Peer Review Elements Elements of the review should include a means to evaluate: Data (used, not used, weighting) Assumptions Modeling techniques

11. Peer Review Elements Examples:CompletenessAccuracyTransparency Reviewers should be given a complete description of the goal/scope of the risk assessment including the risk management issue and the risk assessment question. Ideally, the peer reviewer should be asked to respond to specific questions and provide an overall evaluation of the work

12. Characteristics of Peer Reviewers Independent/ objective Can maintain confidentiality Subject-matter expert Understanding of science, research, and policy issues related to food safety problems Has the time to review the document, model or specific portions within the timeframe needed

13. Picking the “Right” People Weigh the timeframes required Avoid only talking to the same old people Go out of your way not to only pick your “friends” Confidentiality of the information

14. Picking the “Right” People CFSAN believes strongly in seeking public comment True test of transparency

15. Responding to Peer Reviews Need to establish how to respond to peer reviews ahead of time Criteria for conflicting recommendations “Publish” reviews