Developing epa s peer review program
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Developing EPA’s Peer Review Program. Joint JIFSAN/SRA/RAC Symposium Dorothy E. Patton, Ph.D., J.D. September 30, 2003. Overview: Parallel Positions. EPA in 1992 External recommendations – from SAB, GAO Mixed Policies and Practices All Federal Agencies in 2003

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Developing EPA’s Peer Review Program

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Developing epa s peer review program

Developing EPA’s Peer Review Program

Joint JIFSAN/SRA/RAC Symposium

Dorothy E. Patton, Ph.D., J.D.

September 30, 2003


Overview parallel positions

Overview: Parallel Positions

  • EPA in 1992

    • External recommendations – from SAB, GAO

    • Mixed Policies and Practices

  • All Federal Agencies in 2003

    • External Recommendations – from OMB

    • Assumption: Mixed Policies and Practices


Agenda

Agenda

  • Brief History: Pre-1990 Policy and Practice

  • 1992 Science Advisory Board Report

  • Implementation Themes and Tasks

    • Re-education

    • Regularity

    • Rigor

  • Recommendations

  • Addendum


Epa s peer review history

EPA’s Peer Review History

  • Peer Review Practices 1970-1992

    • Statutory Mandates

    • Academic Model

    • Evolution and expansion

  • Initiatives for change 1992-2000

    • 1992 Science Advisory Board Report

    • 1993 Reilly Administration Policy

    • GAO Report

    • 1994 Browner Administration Policy


1992 starting point

1992 Starting Point . . .

  • “Requir[e] credible, independent peer review of all scientific and technical efforts of ORD and the program and regional offices (including model development and use, data collection and evaluation, monitoring plans, research, technical studies, scoping studies, and assessments.)”

  • EPA Science Advisory Board


Message

. . . Message

  • General Concerns

    • Lack of Review

    • Non-conforming reviews

  • Specific Concerns

    • Credible and independent reviews

    • All scientific and technical efforts

    • ORD, program offices, regional offices


Implementation program

Implementation Program

  • First Generation – learning and testing

    • Generic template

    • Office-specific approaches

    • Models and examples

  • Second Generation – Peer Review Handbook

    • Multi-office teams

    • First Edition – initial statement of principles, methods

    • Second Edition – reflects Agency experience


Implementation tasks

Implementation Tasks

  • Rigor – as to criteria and standards

  • Regularity – as to internal process

  • Re-education – to assure agency-wide implementation


Rigor criteria standards

Rigor: Criteria & Standards

  • Readiness of Product for Peer Review

    • Consultation vs. peer review

  • Charge to Peer Reviewers

    • Specific issues and general invitation

  • Form of Peer Review

    • Matching form and product

  • Identification of Peer Reviewers

  • Measures of Success


Regularity process decisions

Regularity: Process Decisions

  • Coverage

    • products requiring peer review

    • Offices conducting peer review

  • Form

    • Letter reviews

    • Panel reviews

  • Reviewers

    • Peer Reviewer independence

    • Peer Reviewer expertise


Regularity resources

Regularity: Resources

  • Threshold Considerations

    • Time allocation

    • Budget allocation

    • Staff allocation

  • Staffing Considerations

    • Value of a “Champion”

    • “Top down” and“bottom up

    • Investment in training

    • Investment in models


Re education

Re-education

  • Goals

    • Scientific and regulatory credibility

    • Enhanced agency product

  • Important Distinctions

    • Peer review as intermediate vs. end product

    • Scientific reliability vs. policy preferences

    • Inquiry vs. endorsement


Recommendations tangible considerations

Recommendations: TangibleConsiderations

  • Early attention to resource issues

  • Consensus on criteria and standards

  • Focus on Using peer review comments

  • Draw on EPA Handbook, asappropriate

  • Offer models of sound peer review

  • Establish reasonable implementation timelines


Recommendations intangible considerations

Recommendations: Intangible Considerations

  • Identify a “champion”

  • Educate and engage managers

  • Tailor to program-specific factors

  • Staff participation and team building

  • Recognize “Change-the-culture” issues

  • Aim for scientific quality


Summary three rs

Summary: Three “Rs”

  • Rigor – See the Handbook

  • Regularity – See the Handbook

  • Re-education – iterative combination of “top-down” and “bottom-up” approaches


Additional information

Additional Information

  • EPA’s Peer Review Handbook

    • www.epa.gov

    • EPA 100-B-00-001, December 2000

  • Neutral Science Panels (Federal Judicial Center, 2001)

  • NAS “blue book”


Addendum post epa notes

Addendum: Post-EPA notes

  • Risk Assessment as a multi-disciplinary technical analysis

    • Reliance on many different studies

    • Weight-of-evidence conclusions

    • Policy choices

  • Regulatory Decision

    • Risk assessment or other technical analysis

    • Non-technical considerations


Addendum con t

Addendum (con’t.)

  • OMB guidance

    • “scientific and technical Products”

    • “scientifically rigorous review”

    • “the science that underlies federal regulation”

  • “study”

  • “Studies that have already been subjected to adequate independent review”

  • “regulatory information . . . any scientific or technical study . . . relevant to regulatory policy”


Addendum con t1

Addendum (con’t.)

  • Economics and Social Sciences

  • Submissions from industry, public interest groups, other agencies, academics


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