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Choices In Risk Agse_ssment Regulatory Impact.AnaIysis Project. Inc. The Role of Science PoLicy ha the Environmental Risk Management Process Sandia Nanonal Laboratories Sponsored by The U.S. Department of Energy OffiCe of Environmental Management and OffiCe of Environment. SaintS" and Health " : lab - 000040 TIBR 0019481

REGULATORY IMPACT ANALYSIS PROJECT, INC. CHOICES IN RISK ASSESSMENT TIlE ROLE OF SCIENCE POLICY ENVIRONMENTAL RISK MANAGEMENT PROCESS Prepared for Sandia National Laboratories Sponsored by The U.S. Department of Energy Office of Environmental Management and Office of Environment, Safety and Health TIBR 0019482

Copyright o 1994 by Regulatory Impact Analysis Project, Inc., Washington, D.C. All rights rese~ced except that U.S. Govemmem employees and employees of Sandia National Laboratories may copy any or all pal~.s of this book for oi~cial use. Library of Congress Catalog Number 94-69099 International Standard Book Number 0-9643747-1-4 TIBR 0019483

FOREWORD This report is a product of the Science Policy Impact Analysis Project sponsored by the Office of Environmental Management (EM) in coordination with the Office of Environment, Safety and Health (EH) of the U.S. Department of Energy (DOE). The project was initiated to assist EM and EH's Offiea of Environmental Guidance in gaining insight into the use of "science policy" in the environmental risk assessment and management processes, and the development of environmental regulation. In particular, EM's mission is to use cost-effective and technically sound approaches: To ensure that risks to the environment and human health and safety posed by active, inactive, and surplus facilities and sites are reduced to prescribed and acceptable levels; and To minimize, handle, treat, store, transport, and dispose of DOE waste safely. Rational risk management is essential to accomplish EM.'s mission, especially given the current resource constraints and projected grow~ of its program. The report is intended to describe science policy issues and decisions, and how they have been addressed and used in risk-bas~ environmental regulatory decision making. For the purposes of this proje~ "science policy issue" is defined as a gap or uncertainty in scientific knowledge or data arising in the risk assessment process, and "science policy decision" is defined as the policy decision made to bridge the gap or uncertainty in scientific knowledge and data. Science policy decisions are frequently the driving foroe in the environmental risk assessment and management processes. DOE's need for information relating to the use of science policy developed as a result of a number of efforts, including those: To revise environmental directives and promulgate radiation rules for protection of the public and the environment and to develop supporting guidance documents; • To develop and integrate risk and environmental management strategies for site remediation; and • To improve and develop more consistent environmental risk assessment methodology and decision-making processes through coordination with other government agencies and organizations via intetagency working groups. Knowledge of the existence of science policy issues and how science policy decisions are made may be important to DOE in the development or implementation of many programs and directives. For example, EH's Office of the Environment is in the TIBR 0019484

ii CHOICES IN RISK AS.~ESSMENT process of promulgating the DOE rule concerning radiation protection of the public and environment (to be codified at I0 CFR Part 834) and revising DOE's principal environmental protection directive (DOE 5400.1). The foundation of the environmental and public radiation protection system in the proposed rule is the _as _low _as _reasonably ~hievable (ALARA) process. The ALARA process employs a systems-type approach to ensure that protective and cost-effective controls are implemented in public and environmental protection matters. It requires consideration of and comparisons between radiation doses and health effects to the public and workers, environmental impa~ts, .costs, and natural and cultural resoumes. Similarly, in the development of DOE 5400.1, DOE is considering applying a systems approach to environmental management of DOE facilities. This systems approa-'h will require that the development of site-spo~ific environmental protection strategies consider all media, pathways, impa~ts, and risks in a manner that, on balance, results in the most effective, protecti~/e, and practical approach.. As with the ALARA process, this approach requires that benefits and costs of different health and environmental endpoints be compared and assessed equitably. Hence, a clear understanding of science policy issues and decisions, and their possible impa~ts to the de~ision-making process may be an impormm consideration in the implementation and development of these environmental protection requirements. In the development of DOE environmental risk management strategies relating to cleanup and remediation programs, it is necessary to assess and characterize as rigorously as possible the impa~ts and risks to human health, the envirnnment, and cultural, natural, and other resourges associated with sites and fagilities operations. The fair comparison of these varied impagts and benefits requires a clear understanding of the assessments. Toward this end, and consistent with recommendations from the National A~ademy of Sciences, it is desirable to distinguish the objective, science-based elements from the policy-based elements of environmental risk assessment and management decisions. Additionally, to characterize impacts or risks, it is necessary. to have an understanding of the effects of policy-based decisions on the assessments and management decisions. The Sandia National Laboratories (SNL), a DOE national laboratory, was tasked to conduct the Science Policy impact Analysis Project. As part of the project, the Regulatory lmpa~t Analysis Project, Inc. (RIAP), a nonprofit research organization, was tasked to prepare this report. In developing this report. RIAP sought and received input from a large number of individuals and organizations with expertise and experience in regulatory risk assessment and risk management. Contacts included scientists and risk assessors in government, ~c-a_emia, and industry and nonscientist risk managers, policy makers, and regulatory experts (see Appendix 1 for a list of project information sources). We express our deep appreciation to these individuals and organizations. RIAP collected more than 1,500 studies, reports, documents, and analyses concerning environmental, safety, and health regulatory actions involving risk assessment. Despite

FOREWORD iii the large number of documents collected, the project's data collection effort does not and is no.t intended to reflect the total information on environmental risk assessment and risk management in print. Nonetheless, we are confident that sufficient information was collected and analyzed to produce a report that factually and fairly discusses and characterizes, the role of science policy in environmental risk assessment and management. The project was conducted in two stages. In the first stage, RIAP collected information through: (1) interviews with individuals in the public and private sectors who are knowledgeable about regulatory risk assessment and science policy and (2) research into environmental protection and regulatory issues that were raised by project information sources known to R.IAP staff, or developed through project research efforts. From the many regulatory topics and decisions identified through project research efforts, eight were selected as vehicles through which to discuss science policy and its regulatory impacts. Factors considered in selecting these topics for presentation in the final report were: (1) the nature and extent of the science policy issues involved; (2) the nature and extent of the regulatory impacts of the associated regulatory program; (3) familiarity of the regulatory topic among the public; and (4) variety among topics with respect to regulatory programs and agencies. The second stage of the project involved comprehensive research of the selected topics and preparation of the final report. While the examples selected for review may or may not impact DOE, the analyses of science policy issues are pertinent to DOE's efforts to develop environmental protection strategies or requirements, insofar as such development uses environmental risk assessment methodology. This report discusses science policy primarily in the context of cancer risk assessment. Science policy is addressed only briefly in the context of ecological risk assessment and only incidentally in the context of noncancer risk assessment. The lack of attention to ecological and noncancer risk assessment or the assessment of their impacts or benefits should not be viewed either as a shortcoming of the report or a dismissal of such issues as unimportant or uninteresting. As a matter of fact, much of DOE's desire for an improved understanding of science policy issues and decisions is derived from the need to compare and balance competing ecological and resource related impacts to cancer and noncancer health risks in the decision making process. Risk assessment has historically focused on the likelihood of inducing cancer in humans. However, as the recent Environmental Protection Agency reassessment of dioxin risks indicates, noncancer effects may be triggered at very low levels of exposure. Noncancer risk assessment is an emerging area, not nearly as well studied as careinogenicity, that may become a driving force in risk assessments and cleanup decisions in the near future. The focus of the project was science policy, not cancer, noncancer, or ecological risk assessment. Because it is a more seasoned process, cancer risk assessment is a more convenient vehicle through which to discuss science policy. We expect that lessons learned in cancer risk assessment will be applicable to risk assessments for other ecological and health endpoints. TIBR 0019486

iv CHOICES IN RISK ASSESSMENT Given that much has been written on environmental risk assessment and risk management over the last twenty or so years, some may wonder what the value of yet another exposition on these issues might be. This report addresses these issues from a unique perspective. We do not intend to be critical or complimentary of the regulatory risk assessment process. Recommendations for improving environmental risk assessment per se or for farther scientific research are not made in this report. Although advances in scientific knowledge and assessment methodology are clearly desirable and are occurring, advances in either area will not come soon enough to assist regulators in addressing the onslaught of genuine and manufactured, known and hypothetical, and significant and insignificant environmental, safety, and health risks and issues currently facing DOE and other federal agencies. We a~cept environmental risk assessment for what it is--a tool to assist regulators in making decisions concerning difficult issues. This tool has its su'engths and its limitations, which are the focus of this report. Wider recognition and better understanding of these s~rengths and limitations will not make regulatory decisions easier but may result in more informed, unbiased, and transparent decisions, We would like to express our deep appreciation to DOE's Office of Environmental Guidance, in particular Mr. Andrew Wallo, III, for input to and oversight of this project, and SNL staff, particularly Dennis Berry, Ph.D.; Charles Massey, Ph.D.; and Ms. Teresa Sype for their valuable assistance. Additionally, we would like to thank the reviewers of this repo~ including William Raub, Ph.D. (Science Advisor to the Adminiswator of the Environmental Protection Agency); Michael Gough, Ph.D. (Manager, Biological Applications Program, Office of Technology Assessment, U.S. Congress); William Mills, Ph.D. (Senior Scientist/Policy Advisor to the Committee on Interagency Radiation Research and Policy Coordination); Bryan Hardin, Ph.D. (Director of the Washing'con, D.C., Office of the National Institute for Occupational Safmy and Health); Ronald Lung, Ph.D. (President, American Indus~'ial Health Council); Ernest S. Rosenberg, Ph.D., J.D. (Director of External Affairs and Compliance Suppo~ Occidental Pem31eum Corp.); and Joe Findaro, Esq. (Bayh, Connaughton, Fensterheim & Malone). Finally, we would like to thank our staff who worked very hard in the preparation of this report: Ms. Martha D. Kaufman and Ms. Hollie Burdt Sheaffer. Steven J. Milloy, Project Manager Pamela S. Aycock, Research Manager Jason E. Johnston, Senior Research Associate Regulatory Impact Analysis Project, Inc. October 1994 TIBR0019487

TABLE OF CONTENTS Chapter Page Foreword i Executive Summary vii What is Science Policy? What are its Impacts? A Hypothetical Example A Ftistorieal Perspective on Science Policy 5 Basic Science Policy Issues and Default Assumptions 25 Alternative Assumptions to the Basic Science Policy Issues 65 Fluoride in Drinking Water 107 Asbestos in Consumer Products 123 Unleaded Gasoline 139 Used Oil 149 Trichloroethylene 165 Workplace Indoor Air Quality 177 Toxics Release Inventory 201 Radon in Drinking Water 221 Conclusions and Recommendations 241 Appendix 1 Project Information Sources249 Appendix 2 Glossar~ of Acronyms and Abbreviations 253 Appendix 3 Glossary of Terms 257 TIBR 0019488

vi CHOICES IN RISK ASSESSMENT T~BR 0019489

EXECUTIVE SUMMARY What Is Science Policy? In the context of this repor~ "science policy issues" are the gaps and uncertainties in scientific knowledge and ~t~ that arise in the assessment of risks to human health and the environment associated with exposure to substances, conditions, activities, and sites. "Science policy decisions" are the policy choices made to bridge such gaps and uncertainties. Science policy decisions are vital to the regulatory risk assessment and management processes. Science policy decisions enable regulators to justify the costs of regulatory programs in terms of estimated health and environmental risk reductions. Default Assumptions Default assumptions are science policy decisions that are applied automatically when certain science policy issues arise. Examples of science policy issues and the corresponding default assumptions are presented in Table ES" I. Default assumptions are perceived--and criticized---by some as being conservative. There are others who criticize them for insufficient protectiveness. The selection of default assumptions generally is driven by the policy decision to avoid underestimating potential risks. Given the frequent use of quantitative risk assessment in health and environmental regulation, for any individual science policy issue, use of a default assumption may be the most practical option for getting the work done. Departures from default assumptions have been rare in the past, but alternate assumptions have been adopted in limited cases. Attempts to depart from default assumptions in future risk assassmen~ may invite increased scrotiny, which could result in a reluctance to consider or adopt alternatives based on new scientific information. Continued reliance on default assumptions can be problematic in two scenarios: 1. Multiple conservative science policy decisions, known as "compounded conservatism," may result in inconsistent or unduly biased decisions; and 2. Whether or not compounded conservatism results, policy m~kers, risk managers, the media, and the public are often unaware of: a. The gaps and uncertainties in scientific knowledge and data used in conducting a risk assessment; b. The policy-based default assumptions that are used to bridge these gaps and uncet~aintias; and c. The extent to which default assumptions may determine the outcome of the risk assessment. TIBR 0019490