James D. SchaubDirectorOffice of Risk Assessment and Cost-Benefit Analysis U.S. Department of AgricultureSeptember 30, 2003Federal Review of Risk Assessments

Overview Background on ORACBA Expectations Experience

Origin

Organization & staffing Functions RelationshipsBackground on ORACBA

Requires Risk Assessment and Cost-Benefit AnalysisDefines scopePrimary purposehuman health, human safety, the environmentMajor($100 million annual impact)Requires analysis with as much specificity as practicableThe risk . . . risks to persons disproportionately exposedComparison of risksThe benefits including expected risk reductionRequires evaluation whether the regulation Will reduce riskWill be cost effectiveKey Provisions of ORACBA Statute (PL 103-354)

Ensure that any regulatory analysis . . . Is performed consistently and uses reasonably obtainable and sound scientific, technical, economic and other data. Like many statutes, it is left to the Agency to fill in the details.ORACBA Statute and Quality

The publicconsumers, industry and others Executive branch, Congress and the Courts

International

Are these expectations useful for establishing peer review systems?Expectations Regarding Quality

PublicScienceAccessibility, e.g., public meetings and websiteAccountability and good decisionsExecutive BranchE.O. 12866OMB Bulletin on Peer Review & Information QualityOMB Circular A-4 Regulatory AnalysisDepartment and agency guidance, e.g., USDA Departmental Regulation 1512

Communicating Expectations for Quality

CongressInformation Quality Act (P.L. 106-554)ORACBA Statute (P.L. 103-354)FIFRA, FQPACourtsArgentine citrus caseBenzene caseInternationalWTO Agreement on the Application of Sanitary & Phytosanitary MeasuresCodexInternational Plant Protection ConventionOffice International des Epizooties (OIE)Communicating Expectations for Quality

Clearance Sheet

ORACBA ReviewsORACBA staffOther Federal employeesNon-Federal reviewerStandards (partial list)Correct use of scienceBasis for assumptionsGood dataRecognize uncertainty & variabilityTransparentDocumentationClarityJust as risk assessors should be free to follow the facts,so too for peer reviewers.Experience

StrengthsNo financial conflict of interestIndependent clearance by ORACBARelatively low costPool of reviewers, but is it large enough?Correct incentives exist for Federal reviewersCan deal with CBI and Classified materialAccessible to the publicAgencies accept responsibility for obtaining peer review

Experience

WeaknessesPublic distrusts governmentAgencies have lost in courtTime pressures may influence depth of reviews.Reviewers must remain at arms length during development of assessment. This deprives agencies of benefits of consultation.CBI and classified material limits the pool of reviewers.Risk assessment is a team effort but peer review is by individuals. Public access to risk assessments does not ensure sound review.Some officials view risk assessment requirement and peer review as impediments.Experience

Expectations for sound regulatory analyses are high.

Agencies are responding to expectations.Building analytical capacityEmbracing peer review.

An independent review and clearance office is valuable.

Conclusions