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James D. Schaub Director

Federal Review of Risk Assessments. James D. Schaub Director Office of Risk Assessment and Cost-Benefit Analysis U.S. Department of Agriculture September 30, 2003. Overview. Background on ORACBA Expectations Experience. Background on ORACBA. Origin Organization & staffing Functions

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James D. Schaub Director

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  1. Federal Review ofRisk Assessments James D. Schaub Director Office of Risk Assessment and Cost-Benefit AnalysisU.S. Department of Agriculture September 30, 2003

  2. Overview • Background on ORACBA • Expectations • Experience

  3. Background on ORACBA • Origin • Organization & staffing • Functions • Relationships

  4. Key Provisions of ORACBA Statute(PL 103-354) • Requires Risk Assessment and Cost-Benefit Analysis • Defines scope • Primary purpose—human health, human safety, the environment • Major—($100 million annual impact) • Requires analysis “with as much specificity as practicable” • The risk . . . risks to persons disproportionately exposed • Comparison of risks • The benefits including expected risk reduction • Requires evaluation whether the regulation • Will reduce risk • Will be cost effective

  5. ORACBA Statute and Quality • “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.

  6. Expectations Regarding Quality • The public—consumers, industry and others • Executive branch, Congress and the Courts • International Are these expectations useful for establishing peer review systems?

  7. Communicating Expectations for Quality • Public • Science • Accessibility, e.g., public meetings and website • Accountability and good decisions • Executive Branch • E.O. 12866 • OMB Bulletin on Peer Review & Information Quality • OMB Circular A-4 Regulatory Analysis • Department and agency guidance, e.g., USDA Departmental Regulation 1512

  8. Communicating Expectations for Quality • Congress • Information Quality Act (P.L. 106-554) • ORACBA Statute (P.L. 103-354) • FIFRA, FQPA • Courts • Argentine citrus case • Benzene case • International • WTO Agreement on the Application of Sanitary & Phytosanitary Measures • Codex • International Plant Protection Convention • Office International des Epizooties (OIE)

  9. Clearance Sheet

  10. Experience • ORACBA Reviews • ORACBA staff • Other Federal employees • Non-Federal reviewer • Standards (partial list) • Correct use of science • Basis for assumptions • Good data • Recognize uncertainty & variability • Transparent • Documentation • Clarity Just as risk assessors should be free to follow the facts, so too for peer reviewers.

  11. Experience • Strengths • No financial conflict of interest • Independent clearance by ORACBA • Relatively low cost • Pool of reviewers, but is it large enough? • Correct incentives exist for Federal reviewers • Can deal with CBI and Classified material • Accessible to the public • Agencies accept responsibility for obtaining peer review

  12. Experience • Weaknesses • Public distrusts government • Agencies have lost in court • Time 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.

  13. Conclusions • Expectations for sound regulatory analyses are high. • Agencies are responding to expectations. • Building analytical capacity • Embracing peer review. • An independent review and clearance office is valuable.

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