Transcript Barry Hooberman 'The Role of the RAC in the Peer Review of

The Role of the RAC in
the Peer Review of CVM’s
Risk Assessments
Barry Hooberman, Ph.D., MPH
Center for Veterinary Medicine
Office of New Animal Drug Evaluation
Rockville, MD 20855
September 30, 2003
Risk Assessments at CVM
Antimicrobial Resistance
Human Food Safety
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Drug Residues
Animal Feeds
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BSE
Contaminants (e.g., Dioxin)
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CVM’s Needs for Peer Review
Common to all Risk Assessments
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Independent Review
Reviewers relationship with Agency
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Access to sufficient data/information
Assess scientific reliability of data
Transparency/Openness
Much in common with CFSAN and FSIS
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CVM’s Needs for Peer Review
Distinct from CFSAN and FSIS
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Organization
Size
Structure
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Mission
New Drug Approvals
Past Drug Approvals
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Subject Matter
Antimicrobial Resistance Risk Assessment (ARRA)
vs. Microbial Risk Assessment (MRA)
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Organization of RA Activities
CFSAN:
CVM:
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Risk Analysis Team
In the process of defining the boundaries between the assessors,
managers, and communicators
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Risk Assessments and CVM’s
Mission
New drug approvals
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Guidance 152
Review of past drug approvals
Confidentiality restrictions may limit
external peer review
ARRA rely on publicly available
information
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ARRA: Different from Microbial
Risk Assessment
Microbial and Antimicrobial Resistance Risk
Assessments for food safety overlap extensively in terms
of
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Microbiological properties of the hazard
Exposure pathways – follow the movement of bacteria in the
food chain
Consequences – e.g., human infections
Key differences:
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The hazardous agents are resistance determinants
Exposure – follow the movement of resistance determinants
Two separate pathways – direct and indirect
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Consequences - generally requires a human intervention to
translate into adverse health risks.
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Effects on RA Peer Review
Relatively limited resources
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Efficient Allocation of resources for RA review
Regulatory considerations
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Use and availability of data for external review
Use of risk assessment in the Center
Different complexity of risk problem
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Less publicly available information on risk
models
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Options for Peer Review
Internal review
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Not independent
Sufficient access to data
Skills available to assess scientific reliability
Not transparent
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Options for Peer Review
Inter-Agency review
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The Interagency Risk Assessment
Consortium (RAC)
Semi-independent
Potential for sufficient access to
data/information
Able to assess scientific reliability
Not transparent, but has potential for
transparency (Food Risk Clearinghouse)
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Options for Peer Review
Public Meetings/Drafts of RA
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Independent
Sufficient access to data/information
Range of skills in assessing scientific
reliability of data
Transparent
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Options for Peer Review
Outside Experts
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Range of independence
Used in planning, execution, and review of RAs
Used solely for review
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Sufficient access to data/information
Able to assess scientific reliability of data
Range of transparency
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Options for Peer Review
Other
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The Courts
Independent
Sufficient access to data/information
Varying skills to assess scientific reliability of data
Transparent
The problem of dueling experts!
Resource intensive
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CVM’s Experiences with Peer
Review
Internal Review
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Limited capabilities
Inter-Agency Review
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RAC a very useful tool in the planning and execution
of RAs
RAC participation in CVM Public Meetings
RAC project: Practice of Microbiological Risk
Assessment by U.S. Government Agencies
EPA/OW funded
Incorporates Agency experience that will be useful to RA
peer reviewers of future microbial risk assessments
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CVM’s Experiences with Peer
Review
Public Meetings/Drafts
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Extensively used
Wide range of comments on all aspects of risk
assessment and beyond
Consultants/Outside experts
Consultants/Outside experts
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Used in all phases in risk assessments
Resource-driven
Provide independent viewpoint
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CVM’s Experiences with Peer
Review
Lessons Learned
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Peer review is an important process that
should be ongoing throughout the risk
assessment
A contentious risk assessment is independent
of good peer review procedures
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Observations/Questions
Resource allocation
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The consumption of peer review resources is
inversely proportional to the level of risk (chasing zero
risk).
If the risk assessment finds the risk is from zero to verynearly-zero, should we limit/control/attenuate scarce risk
management resources on extensive peer reviews?
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The consumption of peer review resources is
proportional to the uncertainty in the estimate of risk
A highly uncertain, high risk estimate report consumes fewer
peer review resources than an equivalently uncertain low risk
estimate report
If contentiousness and length of reviews are driven by
uncertainty, then these extremes in reported risk estimates
should get the same level of peer review resources
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Observations/Questions
Boundaries for determining level of Peer
Review
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Based on magnitude (significance) of health
effects, costs/benefits of risk management
actions?
Use of outside experts in RA and peer
review
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Questions of independence
Relationship to Agency and regulated industry
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Acknowledgements
H. Gregg Claycamp
Mary Bartholomew
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