Preface

In the 1990 Clean Air Act Amendments, Congress mandated that a Commission on Risk Assessment and Risk Management be formed to:

make a full investigation of the policy implications and appropriate uses of risk assessment and risk management in regulatory programs under various Federal laws to prevent cancer and other chronic human health effects which may result from exposure to hazardous substances.

The Commission was assembled in May 1994. Our members included specialists in public health, occupational and environmental health, medicine, pediatrics, toxicology, epidemiology, engineering, law, and public policy. The members were appointed—six by Congress, three by President Clinton, and one by the president of the National Academy of Sciences—from health and environmental organizations, academia, research institutes, a law firm, and industry. Members also have experience in federal, state, and local governments. We held hearings across the country to obtain input from interested and concerned parties. The information and insights provided by these forums, as well as public comments on our June 1996 Draft Report, provided valuable contributions to our deliberations, findings, and recommendations.

A clear need to modify the traditional approaches used to assess and reduce risks emerged as a major theme from our deliberations. These approaches rely on a chemical-by-chemical, medium-by-medium, risk-by-risk strategy. They tend to focus attention on refining assumption-laden mathematical estimates of the small risks associated with exposures to individual chemicals, rather than on the overall goal of reducing risk and improving health status.

With this volume, which constitutes Volume 1 of our two-volume Final Report, the Commission introduces a unique Risk Management Framework to guide investments of valuable public-sector and private-sector resources in researching, assessing, characterizing, and reducing risk. We set forth principles for making good risk management decisions and for actively engaging stakeholders in the process. Our Framework is intended to catalyze a new generation of risk-based environmental and health protection. Building on current practices, it adds important new dimensions to the risk management process.

The Commission’s Framework defines a clear, six-stage process for risk management that can be scaled to the importance of a public health or environmental problem and that:

In response to public commenters on our June 1996 Draft Report, we decided to issue a two-volume final report. The first volume focuses solely on our Risk Management Framework and its implementation. This publication has been prepared for regulatory authorities and others who may participate in the risk management process as risk managers or stakeholders. We have provided a glossary for those who seek more information and listed resource documents and organizations at the end of this report. Volume 2, to be published in February 1997, addresses many other issues related to health and environmental risk-based decisions, including recommendations for specific federal regulatory programs and agencies. The table of contents for Volume 2 is provided in an appendix to this report.

The Commission gratefully acknowledges the valuable contributions made by the many people who testified during our deliberations or provided written comments on our Draft Report. We also acknowledge and appreciate the time and effort that regulatory agencies devoted to providing us with needed information and resources. Finally, we acknowledge members and staff of the Congress and leaders and staff of the Clinton Administration for the interest they have taken in our findings and recommendations. We look forward to continuing to work with them to implement the recommendations.

Gilbert S. Omenn
Chair

NOTE: The Commission’s June 1996 Draft Report, both volumes of our Final Report, and all supplementary reports (listed in Appendix 6 of Volume 2) can be found on the Commission’s homepage at the Riskworld website: http://www.riskworld.com.