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

One of the foundations of rigorous scientific programs is rigorous critical reviews of scientific reports and analyses. This is particularly important for risk assessments where the need to make assumptions and to make decisions about the suitability of data has the potential for unintentional biases.

CFSAN’s current process includes the following activities:

• Announce intention in the Federal Register and request submission of data.
  
• Hold public meetings to describe the key assumptions, data, and modeling approaches. This is likely to include submission of the materials to one or more FDA advisory committees.
  
• Seek input from stakeholders, scientific experts and advisory committees.
  
• Conduct an initial extensive review of report/ model by government employees, including special governments employees who serve in an advisory capacity.
  
• Issue draft of the risk assessments to the public for review.
  
• Issue revised final risk assessment.

CFSAN’s intention is to formalize this peer review process to assure that CFSAN’s risk assessments meet all of the requirement of FDA’s newly adopted principles for the conduct of risk assessments that support regulatory programs. These reviews will focus on improving both the science underlying these complex risk assessments and the acceptance of the risk assessments by our stakeholders. Requirements for this process are likely to include: (1) a description of the process (activities) by which the peer review is to be conducted; (2) a description of the qualification of reviewers; (3) the specific elements that a reviewer should consider in evaluating food safety risk assessment; (4) an evaluation of benefits/ limitations of the peer review elements, and (5) pragmatic constraints that may limit the alternatives recommended by peer reviewers.