Risk assessment activity at the Center for Veterinary Medicine (CVM) is characterized by a number of factors that result in a set of distinct needs for peer review compared to those at the Center for Food Safety and Analysis, or at the Food Safety and Inspection Service. Organizationally, CVM is limited in size and resources, which restricts the opportunities for internal peer review. Functionally, most of the risk assessment activity at CVM is focused on new or past drug approvals, which can present unique data confidentiality and regulatory issues in performing and reviewing risk assessments. From a subject matter viewpoint, much of the risk assessment activity at CVM relates to antimicrobial resistance in foodborne pathogens, which has important distinctions from microbial risk assessments.
CVM has employed a number of methods for peer review of its risk assessments, including open public meetings, solicitation of public comments in docket form, and the use of outside experts in the planning, execution, and review of its risk assessments. In particular, CVM has successfully used members of the Interagency Risk Assessment Consortium (RAC) as an important and valuable resource in conducting its risk assessments.
This presentation will discuss CVM’s “lessons learned” in its risk assessment activities, the importance of peer review during and after the risk assessment, and the importance of the RAC as a mechanism for peer review.