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FSIS’s Needs for Peer Review of Risk Assessments

FSIS’s Needs for Peer Review of Risk Assessments. Carol Maczka, Ph.D. Senior Scientist for Risk Assessment FSIS/USDA September 30, 2003 Presented at JIFSAN/SRA/RAC Symposium On Peer Review of Risk Assessment. FSIS Peer Review Process to date Lessons Learned Needs and Challenges.

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FSIS’s Needs for Peer Review of Risk Assessments

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  1. FSIS’s Needs for Peer Review of Risk Assessments Carol Maczka, Ph.D. Senior Scientist for Risk Assessment FSIS/USDA September 30, 2003 Presented at JIFSAN/SRA/RAC Symposium On Peer Review of Risk Assessment

  2. FSIS Peer Review Process to date • Lessons Learned • Needs and Challenges

  3. Peer Review Mechanisms • Salmonella Enteriditis Risk Assessment in Shell Eggs and Egg Products (1995) • Inter- and Intra-Agency review by specialists • Independent review by select subject area specialists • Publications in peer review literature • E. coli 0157:H7 Risk Assessment in Ground Beef • Inter- and Intra-Agency review by specialists • NACMCF review • Independent review by select subject area specialists • Public comment • External peer review by National Academies of Science

  4. Peer Review Mechanisms (Continued) • Risk of E. coli 0157:H7 in Tenderized versus Non-Tenderized Steaks/Roasts • Inter-Agency review • NACMCF review • Harvard BSE Risk Assessment • Commission risk assessment (Independence) • Inter- and Intra-Agency review • External peer review using independent contractor • Listeria Risk Assessment - Product Contamination from Food Contact Surfaces • Inter- and Intra-Agency review • ORACBA review • Public comment • External peer review using independent contractor • ORACBA/OMB review

  5. Peer Review Mechanisms (Continued) • Other Risk Assessments (Currently in Progress) • Perfringens Risk Assessment in RTE Meat and Poultry Products • Risk Assessment for Salmonella Enteriditis in Shell Eggs and Salmonella spp in Egg Products • Salmonella Risk Assessment in Raw Beef and Poultry Products • Salmonella, E. coli 0157:H7 Risk Assessment in RTEMeat and Poultry Products • External Peer Review using Independent Contractor

  6. FSIS Peer Review Process to Date Independent External Peer Review RA Inter-Agency Review Intra-Agency Review ORACBA ORACBA R R R Public Comment R OMB R = Revised in response to comments

  7. Elements of a “Good” Peer Review Process Lessons Learned • Independent External Peer Review especially for major regulations or influential information • Access to broad range of scientific expertise (modelers, subject area experts) • Timely and cost-effective review • Appropriate staging of peer review and public comment to avoid unnecessary revisions • Reviewers are given a focused charge and are invited to provide general comments. At a minimum, reviewers should be asked to comment on: Overarching logical structure of the model; Validity and appropriateness of the data used, reasonableness of assumptions made, model’s mathematics and equations, whether risks have been appropriately characterized; key sources of variability and uncertainty identified; critical assumptions; data gaps. Computerized models should be audited. • Reviewers are instructed to avoid policy determinations

  8. Elements of a “Good” Peer Review Process Lessons Learned (Continued) • Reviewers are provided with relevant background information on potential sources of controversy • Reviewers are held accountable • Review is balanced • Reviewers do not have a conflict of interest • Procedures for documenting response to comments; comment/response document • Outside firm (entity) supervises the review. Comments are provided to Agency blinded • SOPs for conducting peer reviews

  9. Needs and Challenges • Large pool of external peer reviewers (“expert registry”) • Requirements for Peer Reviewers • Scientific and Technical Expertise/Experience • Multiple areas of expertise (e.g., modelers, epidemiologists, microbiologists) • No real or perceived conflict of interests • No advocated positions (balance) • Have not conducted multiple peer reviews for the Agency in recent years • How can an “expert registry” be created ? • How and When are the pool of potential candidates screened for bias/conflict of interests

  10. Needs and Challenges (Continued) • Appropriate Mechanisms for Peer Review • Contract with Independent Body • National Academies of Science • Outside Firm • NACMCF • Risk Assessment Consortium • Consortium of Universities ? • Pro Bono • Others ? • Need to ensure Timely/Cost Effective/Independent Peer Review Mechanism • Standard Operating Procedures for Conducting Peer Review • Need to ensure consistency with other agencies conducting significant regulatory review

  11. Summary of Major Needs • Pool of External Reviewers from which to select • Mechanisms for accessing peer reviewers • Establish SOPs for external peer review

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