The Role of the RAC in The Role of the RAC in the Peer Review of CVM’s the Peer Review of CVM’s

Risk AssessmentsRisk AssessmentsBarry Hooberman, Ph.D., MPHBarry Hooberman, Ph.D., MPH

Center for Veterinary MedicineCenter for Veterinary MedicineOffice of New Animal Drug EvaluationOffice of New Animal Drug Evaluation

Rockville, MD 20855Rockville, MD 20855

September 30, 2003September 30, 2003

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Risk Assessments at CVMRisk Assessments at CVM

Antimicrobial Resistance Antimicrobial Resistance Human Food SafetyHuman Food Safety Drug ResiduesDrug Residues

Animal FeedsAnimal Feeds BSEBSE Contaminants (e.g., Dioxin)Contaminants (e.g., Dioxin)

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CVM’s Needs for Peer ReviewCVM’s Needs for Peer Review

Common to all Risk AssessmentsCommon to all Risk Assessments Independent ReviewIndependent Review

Reviewers relationship with AgencyReviewers relationship with Agency Access to sufficient data/informationAccess to sufficient data/information Assess scientific reliability of dataAssess scientific reliability of data Transparency/OpennessTransparency/Openness

Much in common with CFSAN and FSISMuch in common with CFSAN and FSIS

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CVM’s Needs for Peer ReviewCVM’s Needs for Peer Review

Distinct from CFSAN and FSISDistinct from CFSAN and FSIS OrganizationOrganization

SizeSizeStructureStructure

MissionMissionNew Drug ApprovalsNew Drug ApprovalsPast Drug ApprovalsPast Drug Approvals

Subject MatterSubject MatterAntimicrobial Resistance Risk Assessment (ARRA) Antimicrobial Resistance Risk Assessment (ARRA) vs. Microbial Risk Assessment (MRA)vs. Microbial Risk Assessment (MRA)

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Organization of RA ActivitiesOrganization of RA ActivitiesCFSAN:CFSAN:

CVM:CVM: Risk Analysis TeamRisk Analysis Team In the process of defining the boundaries between the assessors, In the process of defining the boundaries between the assessors,

managers, and communicatorsmanagers, and communicators

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Risk Assessments and CVM’s Risk Assessments and CVM’s MissionMission

New drug approvalsNew drug approvals Guidance 152Guidance 152

Review of past drug approvalsReview of past drug approvalsConfidentiality restrictions may limit Confidentiality restrictions may limit external peer reviewexternal peer review

ARRA rely on publicly available ARRA rely on publicly available informationinformation

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ARRA: Different from Microbial ARRA: Different from Microbial Risk AssessmentRisk Assessment

Microbial and Antimicrobial Resistance Risk Microbial and Antimicrobial Resistance Risk Assessments for food safety overlap extensively in terms Assessments for food safety overlap extensively in terms of of

Microbiological properties of the hazardMicrobiological properties of the hazard Exposure pathways – follow the movement of bacteria in the Exposure pathways – follow the movement of bacteria in the

food chainfood chain Consequences – e.g., human infectionsConsequences – e.g., human infections

Key differences:Key differences: The hazardous agents are resistance determinantsThe hazardous agents are resistance determinants Exposure – follow the movement of resistance determinantsExposure – follow the movement of resistance determinants

Two separate pathways – direct and indirectTwo separate pathways – direct and indirect Consequences - generally requires a human intervention to Consequences - generally requires a human intervention to

translate into adverse health risks.translate into adverse health risks.

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Effects on RA Peer ReviewEffects on RA Peer Review

Relatively limited resourcesRelatively limited resources Efficient Allocation of resources for RA reviewEfficient Allocation of resources for RA review

Regulatory considerationsRegulatory considerations Use and availability of data for external reviewUse and availability of data for external review Use of risk assessment in the CenterUse of risk assessment in the Center

Different complexity of risk problemDifferent complexity of risk problem Less publicly available information on risk Less publicly available information on risk

modelsmodels

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Options for Peer ReviewOptions for Peer Review

Internal reviewInternal review Not independentNot independent Sufficient access to dataSufficient access to data Skills available to assess scientific reliabilitySkills available to assess scientific reliability Not transparent Not transparent

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Options for Peer ReviewOptions for Peer Review

Inter-Agency reviewInter-Agency review The Interagency Risk Assessment The Interagency Risk Assessment

Consortium (RAC)Consortium (RAC) Semi-independentSemi-independent Potential for sufficient access to Potential for sufficient access to

data/informationdata/information Able to assess scientific reliabilityAble to assess scientific reliability Not transparent, but has potential for Not transparent, but has potential for

transparency (Food Risk Clearinghouse)transparency (Food Risk Clearinghouse)

1111

Options for Peer ReviewOptions for Peer Review

Public Meetings/Drafts of RAPublic Meetings/Drafts of RA IndependentIndependent Sufficient access to data/informationSufficient access to data/information Range of skills in assessing scientific Range of skills in assessing scientific

reliability of datareliability of data TransparentTransparent

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Options for Peer ReviewOptions for Peer Review

Outside ExpertsOutside Experts Range of independenceRange of independence

Used in planning, execution, and review of RAsUsed in planning, execution, and review of RAsUsed solely for reviewUsed solely for review

Sufficient access to data/informationSufficient access to data/information Able to assess scientific reliability of dataAble to assess scientific reliability of data Range of transparencyRange of transparency

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Options for Peer ReviewOptions for Peer Review

OtherOther The CourtsThe Courts

IndependentIndependentSufficient access to data/informationSufficient access to data/informationVarying skills to assess scientific reliability of dataVarying skills to assess scientific reliability of dataTransparentTransparentThe problem of dueling experts!The problem of dueling experts!Resource intensiveResource intensive

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CVM’s Experiences with Peer CVM’s Experiences with Peer ReviewReview

Internal ReviewInternal Review Limited capabilitiesLimited capabilitiesInter-Agency ReviewInter-Agency Review RAC a very useful tool in the planning and execution RAC a very useful tool in the planning and execution

of RAsof RAs RAC participation in CVM Public MeetingsRAC participation in CVM Public Meetings RAC project: Practice of Microbiological Risk RAC project: Practice of Microbiological Risk

Assessment by U.S. Government AgenciesAssessment by U.S. Government AgenciesEPA/OW fundedEPA/OW fundedIncorporates Agency experience that will be useful to RA Incorporates Agency experience that will be useful to RA peer reviewers of future microbial risk assessmentspeer reviewers of future microbial risk assessments

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CVM’s Experiences with Peer CVM’s Experiences with Peer ReviewReview

Public Meetings/DraftsPublic Meetings/Drafts Extensively usedExtensively used Wide range of comments on all aspects of risk Wide range of comments on all aspects of risk

assessment and beyondassessment and beyond Consultants/Outside expertsConsultants/Outside expertsConsultants/Outside expertsConsultants/Outside experts Used in all phases in risk assessmentsUsed in all phases in risk assessments Resource-drivenResource-driven Provide independent viewpointProvide independent viewpoint

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CVM’s Experiences with Peer CVM’s Experiences with Peer ReviewReview

Lessons LearnedLessons Learned Peer review is an important process that Peer review is an important process that

should be ongoing throughout the risk should be ongoing throughout the risk assessmentassessment

A contentious risk assessment is independent A contentious risk assessment is independent of good peer review proceduresof good peer review procedures

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Observations/QuestionsObservations/QuestionsResource allocationResource allocation The consumption of peer review resources is The consumption of peer review resources is

inversely proportional to the level of risk (chasing zero inversely proportional to the level of risk (chasing zero risk).risk).

If the risk assessment finds the risk is from zero to very-If the risk assessment finds the risk is from zero to very-nearly-zero, should we limit/control/attenuate scarce risk nearly-zero, should we limit/control/attenuate scarce risk management resources on extensive peer reviews?management resources on extensive peer reviews?

The consumption of peer review resources is The consumption of peer review resources is proportional to the uncertainty in the estimate of riskproportional to the uncertainty in the estimate of risk

A highly uncertain, high risk estimate report consumes fewer A highly uncertain, high risk estimate report consumes fewer peer review resources than an equivalently uncertain low risk peer review resources than an equivalently uncertain low risk estimate reportestimate reportIf contentiousness and length of reviews are driven by If contentiousness and length of reviews are driven by uncertainty, then these extremes in reported risk estimates uncertainty, then these extremes in reported risk estimates should get the same level of peer review resourcesshould get the same level of peer review resources

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Observations/QuestionsObservations/Questions

Boundaries for determining level of Peer Boundaries for determining level of Peer ReviewReview Based on magnitude (significance) of health Based on magnitude (significance) of health

effects, costs/benefits of risk management effects, costs/benefits of risk management actions?actions?

Use of outside experts in RA and peer Use of outside experts in RA and peer reviewreview Questions of independenceQuestions of independence

Relationship to Agency and regulated industryRelationship to Agency and regulated industry

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AcknowledgementsAcknowledgements

H. Gregg ClaycampH. Gregg ClaycampMary BartholomewMary Bartholomew