Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis.

However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment.

Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE ON IMPROVING RISK ANALYSIS APPROACHES USED BY THE U.S. ENVIRONMENTAL PROTECTION AGENCY
• BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
• OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
• Preface
• Abbreviations
• Summary
• 1. Introduction
  • BACKGROUND
  • CHALLENGES
  • TRADITIONAL AND EMERGING VIEWS OF THE ROLES OF RISK ASSESSMENT
  • TECHNICAL IMPEDIMENTS TO RISK ASSESSMENT
  • IMPROVING RISK ANALYSIS
  • THE NATIONAL RESEARCH COUNCIL COMMITTEE
  • ORGANIZATION OF THE REPORT
  • REFERENCES
• 2. Evolution and Use of Risk Assessment in the Environmental Protection Agency: Current Practice and Future Prospects
  • OVERVIEW
  • STATUTORY PLAN AND REGULATORY STRUCTURE
  • THE PIVOTAL ROLE OF THE RED BOOK
  • CURRENT CONCEPTS AND PRACTICES
  • INSTITUTIONAL ARRANGEMENTS FOR MANAGING THE PROCESS
  • EXTRAMURAL INFLUENCES AND PARTICIPANTS
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
• 3. The Design of Risk Assessments
  • RISK ASSESSMENT AS A DESIGN CHALLENGE
  • DESIGN CONSIDERATIONS: OBJECTIVES, CONSTRAINTS, AND TRADEOFFS
  • ENVIRONMENTAL PROTECTION AGENCY’S CURRENT GUIDANCE RELATED TO RISK-ASSESSMENT DESIGN
  • INCORPORATING VALUE-OF-INFORMATION PRINCIPLES IN FORMATIVE AND ITERATIVE DESIGN
  • CONCLUSIONS
  • RECOMMENDATIONS
  • REFERENCES
• 4. Uncertainty and Variability: The Recurring and Recalcitrant Elements of Risk Assessment
  • INTRODUCTION TO THE ISSUES AND TERMINOLOGY
  • UNCERTAINTY IN RISK ASSESSMENT
  • VARIABILITY AND VULNERABILITY IN RISK ASSESSMENT
  • UNCERTAINTY AND VARIABILITY IN SPECIFIC COMPONENTS OF RISK ASSESSMENT
  • PRINCIPLES FOR ADDRESSING UNCERTAINTY AND VARIABILITY
  • RECOMMENDATIONS
  • REFERENCES
• 5. Toward a Unified Approach to Dose-Response Assessment
  • THE NEED FOR AN IMPROVED DOSE-RESPONSE FRAMEWORK
  • A UNIFIED FRAMEWORK AND APPROACH FOR DOSE-RESPONSE ASSESSMENT
  • CASE STUDIES AND POSSIBLE MODELING APPROACHES
  • IMPLEMENTATION
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
• 6. Selection and Use of Defaults
  • CURRENT ENVIRONMENTAL PROTECTION AGENCY POLICY ON DEFAULTS
  • THE ENVIRONMENTAL PROTECTION AGENCY’S SYSTEM OF DEFAULTS
  • COMPLICATIONS INTRODUCED BY USE OF DEFAULTS
  • ENHANCEMENTS OF THE ENVIRONMENTAL PROTECTION AGENCY’S DEFAULT APPROACH
  • PERFORMING MULTIPLE RISK CHARACTERIZATIONS FOR ALTERNATIVE MODELS
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
• 7. Implementing Cumulative Risk Assessment
  • INTRODUCTION AND DEFINITIONS
  • HISTORY OF CUMULATIVE RISK ASSESSMENT
  • APPROACHES TO CUMULATIVE RISK ASSESSMENT
  • KEY CONCERNS AND PROPOSED MODIFICATIONS
  • RECOMMENDATIONS
  • REFERENCES
• 8. Improving the Utility of Risk Assessment
  • BEYOND THE RED BOOK
  • A DECISION-MAKING FRAMEWORK THAT MAXIMIZES THE UTILITY OF RISK ASSESSMENT
  • THE FRAMEWORK: AN OVERVIEW
  • ADDITIONAL IMPROVEMENTS OFFERED BY THE FRAMEWORK
  • POTENTIAL CONCERNS RAISED BY THE FRAMEWORK
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
• 9. Toward Improved Risk-Based Decision-Making
  • TRANSITION TO THE FRAMEWORK FOR RISK-BASED DECISION-MAKING
  • INSTITUTIONAL PROCESSES
  • LEADERSHIP AND MANAGEMENT
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
• Appendixes
  • Appendix A Biographic Information on the Committee on Improving Risk Analysis Approaches Used by the Environmental Protection Agency
  • Appendix B Statement of Task of the Committee on Improving Risk Analysis Approaches Used by the Environmental Protection Agency
  • Appendix C Timeline of Selected Environmental Protection Agency Risk-Assessment Activities
  • Appendix D Environmental Protection Agency Response to Recommendations from Selected NRC Reports: Policy, Activity, and Practice
  • Appendix E Environmental Protection Agency Program and Region Responses to Questions from the Committee
  • Appendix F Case Studies of the Framework for Risk-Based Decision-Making

This project was supported by Contract EP-C-06-056 between the National Academy of Sciences and the U.S. Environmental Protection Agency. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.