The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.

Contents

• [Letter to Arthur Hull Hayes, Jr., M.D.]
• Committee on the Institutional Means for Assessment of Risks to Public Health
• Acknowledgments
• Preface
• Summary
• Introduction
• I. The Nature of Risk Assessment
  • Terminology
  • Scientific and Policy Judgments in Risk Assessment
  • Risk Assessment in Practice
  • Conclusions
  • References
• II. Inference Guidelines for Risk Assessment
  • Introduction and Definitions
  • History Of The Use Of Guidelines Safety Evaluation Guidelines For Effects Other Than Cancer
  • Variation in the Form of Guidelines
  • Arguments for and Against the Use of Guidelines
  • Conclusions
  • References
• III. Organizational Arrangements for Risk Assessment
  • Types of Organizational Arrangements
  • Review of Agency Procedures for Risk Assessment
  • Proposed Changes in Organizational Arrangements for Risk Assessment
  • Conclusions
  • References
• IV. Recommendations
  • Improving Risk Assessment through Procedural Changes
  • Improving Risk Assessment through Uniform Inference Guidelines
  • A Central Board on Risk Assessment Methods
• Appendix A Background Information on Committee Members
• Appendix B Bibliography
• Appendix C Working Papers

The study reported here was supported by Contract 223–81–8251 between the National Academy of Sciences and the Food and Drug Administration, Department of Health and Human Services.

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 competencies and with regard for appropriate balance.

This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

The National Research Council was established by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and of advising the federal government. The Council operates in accordance with general policies determined by the Academy under the authority of its congressional charter of 1863, which establishes the Academy as a private, nonprofit, self-governing membership corporation. The Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in the conduct of their services to the government, the public, and the scientific and engineering communities. It is administered jointly by both Academies and the Institute of Medicine. The National Academy of Engineering and the Institute of Medicine were established in 1964 and 1970, respectively, under the charter of the National Academy of Sciences.