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Summary SETTING This report explores the intricate relations between science and policy in a field that is the subject of much debate--the assessment of the risk of cancer and other adverse health effects associated with exposure of humans to toxic substances. It is a report of a search for the institutional mechanisms that best foster a constructive partnership between science and government, mechanisms to ensure that government regulation rests on the best avail- able scientific knowledge and to preserve the integrity of scientific data and judgments in the unavoidable col- lision of the contending interests that accompany most important regulatory decisions. Many decisions of Federal agencies in regulating chronic health hazards have been bitterly controversial. The roots of the controversy }ie in Improvements in scientific and technologic capability to detect poten- tially hazardous chemicals, in changes in public expec- tations and concerns about health protection, and in the fact that the costs and benefits of regulatory policies Fall unequally on different groups within American society. me decade of the 197Os was a period of heightened public concern about the effects of technology on the environment. Individuals and groups urged strict gov- ernment regulation as scientific evidence emerged that various chemical substances may induce cancers or other chronic health effects in humans, and new government mrmn~=mc care -~ahlished to control potential hazards. The evidence of health effects of a few chemicals, such as asbestos, has been clear; in many more cases the evidence is meager and indirect. To aid decision-making , 3r ~ ~ ~~ 1
2 agencies have developed procedures for identifying chronic health hazards and estimating the risks to human health posed by products and activities. However, rather than alleviating the controversy attending regulatory deci- sions, the procedures themselves have become a focus of criticism by scientists, industry representatives, and publi~interest groups. STUDY OBJECTIVES AND SCOPE The Committee on Tr~stitutional Means for Assessment of Risks to Public Health was formed, in response to a congressional directive, to fulfill three primary objectives: . To assess the merits of separating the analytic f unctions of developing r isk assessments f rom the regulatory functions of making policy decisions. · To consider the feasibility of designating a single organization to do risk assessments for all regulatory agencies. To consider the feasibility of developing uniform . risk assessment guidelines for use by all regulatory agencies. The Committee considered the current practice of risk assessment and its relation to the process of regulation of hazards to human health, past efforts to develop and use risk assessment guidelines, the experience of gov- ernment regulatory agencies with different administrative arrangements for risk assessment, and various proposals to modify risk assessment procedures. Our study was directed primarily, although not exclusively, to the issue of increased risk of cancer resulting from exposure to chemicals in the environment, an issue that has aroused areas Public concern in recent years, as illustrated by _ the controversies involving the control of saccharin. asbestos, and formaldehyde. Despite this emphasis, however, our conclusions and recommendations are appli- cable in some degree across the broad field of environs mental health. Criticisms of risk assessment have ranged broadly from details of the process to administrative management to statutory authority. The mandate to this Committee did not include examination of the scientific issues involved in risk assessment or the broad social policy questions
3 that have been raised. m e Committee's more limited purpose was to examine whether altered institutional arrangements or Procedures can improve regulatory performance. THE NATURE OF RI SO ASSESSMENT . Regulatory actions are based on two distinct elements, risk assessment, the subject of this study, and risk management. Risk assessment is the use of the factual base to define the health effects of exposure of indi- viduals or populations to hazardous materials and situ- ations. Risk management is the process of weighing pot icy alternatives and selecting the most appropriate regulatory action, integrating the results of risk assessment with engineering data and with social, economic, and political concerns to reach a decision. Risk assessments contain some or all of the following four steps: Hazard zdentif location: me determination of whether a particular chemical is or is not causally linked to particular health effects. . Dose-resuonse assessment: The determination of the relation between the magnitude of exposure and the probability of occurrence of the health effects in question. · Exposure assessment: Me determination of the extent of human exposure before or after application of regulatory controls. · Risk characterization: m e description of the nature and often the magnitude of human risk, including attendant uncertainty. In each step, a number of decision points (components) occur where risk to human health can only be inferred from the available evidence. Both scientif lo judgments and policy choices may be involved in selecting from among possible inferential bridges, and we have used the term risk assessment Pol ICY to differentiate those judg- ments and choices from the broader social and economic policy issues that are inherent in risk management deci- sions. At least some of the controversy surrounding regulatory actions has resulted from a blurring of the distinction between risk assessment policy and risk management policy.
4 UNIFORM GUIDEI'INES RI SK ASSESSORS An inference guideline is an explicit statement of a pre- determ~ned choice among alternative methods (inference options) that might be used to infer human risk from data that are not fully adequate or are not drawn directly from human experience. For example, a guideline might specify the majestical model to be used to estimate the effects of exposure at low doses on the basis of the effects of exposure at high doses. Over the last 2 decades, most f ederal regulatory agencies and other institutions responsible for risk assessment of toxic chemicals have sought to develop such guidelines. Their efforts have met with varied success. Agencies have cited several reasons for writing guides lines: to provide a systematic way to meet statutory requirements, to inform the public and regulated indus- tries of agency policies, to stimulate public comment on those policies, to avoid arguing generic questions anew In each specific case, and to foster consistency and continuity of approach. Interagency guidelines for carcinogens, although short-lived, were developed by the agencies of the Interagency Regulatory Liaison Group (IRLG) and adopted by the President ' s Regulatory Counci 1 in 1979. me stated objective of that effort was to reduce inconsistency, duplication of effort, and lack of coordination among the federal agencies. The form of guidelines varies widely. Some guidelines are comprehensive and detailed, addressing most of the components of risk assessment and describing underlying scientific concepts; others address only a few broad principles. Guidelines differ greatly In their degree of flexibility, We., the degree to which they permit assessors to consider scientific evidence that may jus- t if y departures f ram Me prescr ibed inference opt ions. And they vary in the legal authority vested in them: some are adopted as formal regulations and others by less formal means. The Committee concludes that guidelines are feasible and, if properly designed, desirable; that clear state- ments of the inferences to be made in each step would be of advantage to the regulatory agencies, to the industries concerned, and to the general public; and that guidelines should be used uniformly by the governmental agenc ies .
INSTITUTIONAL ARRANGEMENTS FOR RISE ASSESSMENT . Dissatisfaction with government regulatory actions has led to proposals to restructure the institutional arrangements for risk assessment by: . Organizational separation of risk assessment from risk management. · Centralization of risk assessment activities in a single organization to serve all the regulatory agencies. Four federal agencies--the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), Occupa- tzonal Safety and Health Administration (OSAKA), and Consumer Product Safety Commission (CPSC) have been given primary authority to regulate activities and substances that pose chronic health risks, and these four agencies ' past actions have inspired many of the proposals for institutional change. The Committee reviewed a number of agency structures and procedures in an attempt to deter- mine the merits of institutional separation and centra}- ization. Examples were selected to illustrate different degrees of separation and centralization in the four agencies. Independent scientific review panels have been used to obtain some of the advantages proposed for organizational separation, and some of their experiences were examined. Cross-agency compar isons are dif ficult, because the regulatory agencies and their various programs differ markedly in structure, procedures, personnel character- istics, administrative history, and statutory direction. In addition, agencies and programs change, and practices adhered to for several years may be altered substantially. These practical limitations to the evaluation of agency structures and practices led the Committee to conclude that predicting the likely effects of organizational rearrangements on agency performance of risk assessment is unavoidably judgmental. However, the available evidence shows no clear advantage of one administrative structure over another. CONCLUSIONS ~ FOR ~CO~=ATIONS Dissatisfaction with the actions of federal regulatory agencies is often expressed as criticism of the conduct and administration of the risk assessment process. The
6 Committee believes that the basic problem in risk assess- ment is the sparseness and uncertainty of the scientific knowledge of the health hazards addressed, and this prob- lem has no ready solution. The field has been developing rapidly, and the greatest improvements in risk assessment result from the acquisition of more and better data, which decreases the need to rely on inference and informed j~dg- ment to bridge gaps in knowledge. Proposals to separate the administrative responsibility for risk assessment From risk management imply that the change would lead to improved risk assessment and hence better risk management decisions. Administrative relocate tion will not, however, improve the knowledge base, and, because risk assessment is only one element in the forms ration of regulatory actions, even considerable improve- ments in r isk assessment cannot be expected to eliminate controversy over those actions. Organizational separation may have the advantage of establishing Firmly the distinction between risk assess- ment and risk management, }'ut it also has some disadvan~ sages. The importance of distinguishing between risk _~--c.~=m~n~ and wick manaa -'rent does not imply that they should be isolated from each other; in practice they interact, and communication in both directions is desir- able and should not be disrupted. Institutional separa- tion would surely reduce the res;,onsi~reness of the risk asses-C.~'ent process to the needs of the regulatory agencies for tamely reports in accord with their priorities. In addition to the operational disadvantages, the disruption of current patterns of activity would be great, and the benefits uncertain. On balance, the Committee believes that transfer of risk assessment functions to an organiza- tion seuar ate from the regulatory agencies is not ,~ ·. ~ ~ _ _ appropriate. mare We believe that rise assessment con "= =~_ a___ surely and more effectively by adopting a program with three major parts: (A) implementation of procedural changes to ensure that individual assessments routinely take full advantage of the available scientif ic knowledge, while preserving the diversified approaches to the admin- istration of risk assessment necessary to accommodate the varied needs of federal regulatory programs; (B) stan- dardization of analytic procedures among federal programs through the development and use of uniform inference guidelines; and (C) creation of a mechanism that will ensure orderly and continuing review and modification of
7 risk assessment procedures as the scientif ic knowledge base expands. (A) We recommend that regulatory agencies take steps to establish and maintain a clear conceptual - distinction between assessment of r~sks and consid- . elation of risk management alternatives; that is, the scientific findings and Policy inditements embodied in risk asses-~.,,ents should be explicitly distinguished from the political, economic, and technical considerations that influence the design and choice of requlatorv strategies. We agree with proponents of such measures as the American Industrial Health Council' s proposed science pane' and B.~. 638 that efforts should be made by regal labors and others to distinguish clearly between the assessment of risk and the choice of regulatory options. We advocate the adoption of specific procedural mee- sures that can be introduced under current arrangements. These measures include timely independent scientific review of major agency risk assessments and, to facili- tate both scientific and public review of risk assess- ments, the routine preparation of written risk assess- ments that explicitly state the basis of choice among inference options. (a) We recommend that uniform inference quide- lines be developed for the use of federal requla- torv agencies in the risk assessment The Committee endorses the development and use of guidelines for risk assessment. These guidelines, which would structure the interpretation of scientific and tech- naval information relevant to the assessment of health risks, should be followed by all federal agencies. They should address all elements of risk assessment, but allow flexibility to consider unique scientific evidence in particular instances. The use of uniform guidelines would promote clarity, completeness, and consistency in risk assessment; would c larify the relative roles of scientific and other factors in risk assessment policy; would help to ensure that assessments reflect the latest scientific understanding; and would enable regulated parties to anticipate govern- ment decisions. In addition, adherence to inference
8 guidelines will aid in maintaining the distinction between risk assessment and risk management. (C) We recommend to the Congress that a Board on Risk Assessment Methods be established to Perform the follow~ti~s: tific basis of risk assessment and to make explicit the underlying assumptions and policy ramifications of the inference options an each component of the risk assessment process. (2) To draft and neriodicallv to revise recommended inf erence guidelines ~ assessment for adoption and use by federal regulatory agencies. (3) To study agency experience with risk assessment and evaluate the usefulness of the Guidelines. _ , . (4) To identify research needs in the risk assessment f ield and in rel event underlvinq . disciplines. The Committee concludes that success in improving the risk assessment process requires the establishment of an independent board of scientific stature. Such a board can serve as a continuing locus of discussion about ways to improve scientific and procedural aspects of risk assessment.