CFSANs Peer Review for Risk Assessments

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CFSANs Peer Review for Risk Assessments

• Robert L. Buchanan, Sherri Dennis, and Marianne
  Miliotis

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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

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CFSAN Risk Analysis Working Group Recommendations

• 1. Formalize a peer review process that will
  encourage critical review and evaluation of
  CFSANs risk assessments by government and
  non-government experts in a manner that improves
  the science and acceptance of complex risk
  assessments

CFSANs Risk Assessment Framework Report, March
2002
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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

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Peer Review Requirements for FDA

• FDAs Data Quality Guidelines
• Solicit advice and opinions of advisory
  committees as well as peer review from experts
  within and outside of the agency

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CFSANs 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

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CFSANs 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

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CFSANs 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

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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

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Peer Review Elements

• Elements of the review should include a means to
  evaluate
• Data (used, not used, weighting)
• Assumptions
• Modeling techniques

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Peer Review Elements

• Examples
• Completeness
• Accuracy
• Transparency
• 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

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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

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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

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Picking the Right People

• CFSAN believes strongly in seeking public comment
• True test of transparency

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Responding to Peer Reviews

• Need to establish how to respond to peer reviews
  ahead of time
• Criteria for conflicting recommendations
• Publish reviews