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III Organizalional Arrangements for Risk Assessment The different structures, procedures, and histories of the agencies responsible for regulating toxic substances have produced diversity in their approaches to risk assessment, but common patterns can be discerned, and they permit some broad generalizations about agency organizational arrangements. first, most agencies have exerted little effort to maintain a sharp organizational separation between employees engaged in assessing the risks associated with substances and those responsible for identifying and evaluating regulatory responses. This is not to suggest that the same persons perform both functions; generally, they do not, for agency organizations reflect consider- able specialization, recognizing the distinctive training and capabilities of staff members. However, the two func- tions are often housed in one organizational unit that is responsible for preparing integrated analyses that incor- porate assessments both of risk and of recommended regule- tory responses. Sometimes, risk assessment stat f are employed in an office that is separate from the office of those who formulate and analyze regulatory options, but, with she notable exceptions, this organizational struck ture does not lead to a rigid separation of the two staffs. Second, with the exception of a few experiments in interagency r, sk assessment during the late 1970s and continuing informal exchanges of information, each agency has performed its own assessments of the risks posed by substances that are candidates for regulation. This operational autonomy does not reflect willful ignorance of the activities of sister agencies or indifference to the desirability of consistency in the evaluation of common candidate substances. Rather, it is a product of 86

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87 several factors, including the lack of obvious mechanisms for formalized interagency collaboration, the desire of agency po}'cy-makers to reserve authority for policy dis- cretion in reaching conclusions based on risk assessment, the perception that the diversity of types of exposure for which each agency is responsible makes collaborative r isk assessment impractical, and differences in regu~a- tory priorities and schedules. Third, although the four agencies have viewed them-- sei ves as ultimately response b, e for the risk assessments that support their actions, they often extend their own staff resources available for performing risk assessment by relying on consultants and contractors who are closely supervised by agency personnel. Some agencies--notably the Occupational Safety and Health Administration (OSEA) and the National Institute for Occupational Safety and Health (NIOSE) - whose staffs are small or lack needed expertise rely very heavily on nongovernment contractors and outside scientists in the academic community and government research institutions for performance of risk assessments or specific tasks related to risk assessment (such as literature reviews). In addition, outside scientists are often called on to review assessments produced by agency staff. Such consul- tations sometimes take place informally, but of ten through special advisory committees. These committees can be per- manent, such as the Environmental Protection Agency (EPA) Clean Air Science Advisory Committee, or can be created to review particular risk assessments, as is done for many of the Food and Drug Administration (FDA) Bureau of Foods assessments. Some are established by statute, with requirements that they review agency assessments befor e regulations are proposed. Others are created voluntarily by an agency itself. The members of all federal advisory co~t~ees are appointed by the agencies, perhaps with the approval of higher executive-branch authority. Can- d~dates for committee membership usually are identified by agency staff, although some agencies seek nominees from professional organizations and other interested parties. Nominations for some statutorily mandated committees are supplied by an external body, such as the National Academy of Sciences or the National Science Foundation. Advisory panels generally exercise considerable influence and, although legally they are only advisory, share to some extent the agencies' authority to reach conclusions about risk.

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89 TYPES OF ORGANTZATIO~ AWNS The prominent proposals for reforms in organizational structures and procedures for risk assessment have featured three interrel ated principles: . Risk assessment activities should be strictly separated from the analysis of risk management options and selection of regulatory strategies. Risk assessment act ivities should be centralized in a single body that serves all regulatory agencies. Expert panels composed of nonagency scientists should be used either to perform risk assessments for an agency or to review assessments developed by agency staff. The Committee outlined four idealized models that reflect various combinations of these three principles. The models are integration, intra-agency separation (with or without centralization), extra-agency separation (with or without centralization), and use of scientific review panels. Examples of agency organizations that roughly approximate each model are identified below and in Table III-I. Most of the exiles chosen have many distinctive characteristics that obscure or at least outweigh the three organizational principles. In addition, they are not the only examples of a particular model; others could have been reviewed.* INT~:GRATION In this type of arrangement, a single organizational unit both performs risk assessments and develops regulations. In general, this arrangement is the most common for Begun latory programs. For example, for the assessment of chron' c hazards involved with chemicals f rom consumer products, the Consumer Product Safety Commission (cpsc) *The Committee considered the possible merits of reviewing risk assessment procedures used by other countries as well and decided not to pursue this line of investigation, because of the great differences in political and institu- tional structures between this country and other coun tries. Such differences would make it very difficult, if not impossible, to extrapolate findings on institutional structures used in other countries to the United States.

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so Directorate for Health Sciences is the responsible unit. Before 1977, the Directorate for Health Sciences had few people involved in the risk assessment process, and risk assessments as such were not generally used. Since then, the Directorate has acquired the expertise needed to per- f orm r isk assessments itself . The r isle assessment Is performed within the Directorate, which is distinct from the Commission's politically appointed policy decisions makers. Two different examples of this model examined by the Committee are the OSBA Directorate of Health Standards Programs and the FDA Bureau of Foods (Table III-1). In the former example, risk assessors and those responsible for formulating and recommmending regulatory strategies are in the same organizational unit. FDA's Bureau of Foods has a separate office that performs risk assessment, but this separation stems from a functional division of scientific disciplines; it is not intended to and does not result In formal separation.of the risk assessment staff from the regulatory staff. INTRA-AGENCY SEPARATION In this model, risk assessment is performed by a group that is ostensibly separate from and independent of the office responsible for regulation in the same agency. An into e-agency risk assessment unit could be programs specific or agency-wide. There are examples of program specific, organizationally separate risk assessment units (notably the Environmental Criteria and Assessment Offices In EPA), but the Committee did not examine them; instead, it reviewed activities of the EPA Carcinogen Assessment Group as an example of an internally separate, agency- wide body. EXTRA-AGENCY SEPARATION l In this model, an agency's risk assessment Is developed outside the agency. The examples reviewed demonstrate the wide variety of arrangements included in this model. Full organizational separation can be achieved by having one institution perform risk assessment and a separate institution regulate exposure to hazardous substances. The relation between NIOSE and OSLO was studied as an example of a permanent, statutory arrangement of this kind. A regulatory agency's use of expert panels to

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91 perform risk assessments can also result in extra-agency separation of risk assessment and regulation. Committees of the National Research Council and several groups of panels used by FDA to review the safety and effectiveness of drugs provide varied examples of such arrangements. The National Toxicology Program Panel on Formaldehyde is an example of an ad hoc assessment group that consisted of government scientists, was organizationally separate from the regulatory agencies (although not without agency members), and served all four agencies (i.e., it was centralized). Because the Interagency Regulatory Liaison Group did not perform r isk assessments, it has not been examined as an example of an extra-agency assessment body. USE OF SCIENTIFIC REVIEW PANELS . Agencies may use independent scientific panels to perform risk assessments or to review assessments prepared by the agencies. This distinction has been used by the Committee to facilitate separate discussion of panels that perform assessments as examples of full organizational separation (see preceding discussion) and panels that review agency assessments as examples of independent review panels. However, the dichotomy is somewhat artificial, in that there may be difficulty in classifying a particular panel. For example, if a panel responsible for performing risk assessments comes to rely heavily on preliminary analyses prepared by agency staff, it can be thought of as acting in a review capacity. Conversely, panels assembled solely for the purpose of reviewing agency assessments have often displayed remarkable independence, sometimes preparing long critiques of agency documents and suggesting sub- stitute Findings and reasons. In such cases, to specify which group had performed and which had reviewed the agency's final assessment of risk is difficult. The extent to which agencies have used independent scientific panels has varied considerably. For example, OSKA has available two types of advisory committees: standing bodies, such as the National Advisory Committee on Occupational Safety and Health, and ad hoc committees that provide advice on specific standards. Members of both types of committee are expected to be knowledgeable about occupational safety and health and may include persons mainly interested in law or regulatory policies. In addition to their professional expertise, however, members of OSHA committees are intended to be represen-

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92 tative of groups interested in occupational health and safety. Several committees have reviewed risk assess- ments prepared by OSLO or NIOSE. Bowever, because men bers were intended to be representatives of interest groups, reviews were usually forums for policy debates, not scientific evaluations of risk assessments. In its initial years, OSHA routinely appointed an advisory committee for each regulatory proceeding. CPSC has had the least experience with expert panels. Before 1981, the Commission was not required to have any assessment of carcinogenic hazard reviewed by an outside panel, although it did make occasional use of such panels (most notably CPSC's request for the National Toxicology Program to form a panel on formaldehyde?. CPSC's ~eautho~ rization in 1961 included a pro:. A ~~---~ regulatory action could be proposed on a substance poten tially presenting a carcinogenic, teratogenic, or muta- genic hazard, a chronic hazard advisory panel (CHAP) must be established, with the cooperation of the National Academy of Sciences, to review the toxicity of the sub- stance. The first CHAP has recently been convened to review the toxicity of asbestos. Thus, CPSC relies on two methods of peer review for any proposed action. First, independent peer review by outside experts, as well as by a scientific review panel, is performed before - Second, the Commission relies on a public rule-mak~ng proceeding in accordance with the Administrative Procedure Act during which comment is invited through a Federal Resister notice on all aspects of the proposed action. Extensive written comments have been received in the past by this procedure, from industry, consumer groups, mothers of the academic ~ __ _ __~^ ~ nab_ OTON t~IlV a notice of proposed rule-mak~ng as issues. and scientific communities, and others. Add~tzona~'y, open, informal public hearings may be held in which inter- ested groups present their views orally; in the past, several such hearings were held during the consideration of a single substance (formaldehyde). EDA has often used independent scientific panels both -^ perform and to review agency assessments. The Bureau of Drugs has used standing committees to review and eval- - ~ or~~ uate data on the safety and effectiveness of drug products and to make appropriate recommendations to the Co"~ls- sioner (see preceding discussion). The use of indecent dent panels by the Bureau of Foods, however, has been on an ad hoc basis, usually at the agency's discretion. However, there are exceptions; for example, the Food, Drug, and Cosmetic Act requires that carcinogenicity

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93 issues related to color additives be referred to a come settee of experts selected by the National Academy of Sciences. EPA, in contrast, has had less choice in its relations with its advisory committees. Several statutes require I: PA to consult such committees for scientific review of agency risk assessments or regulations. Examples of mandated advisory committees with a primarily scientific role include the Agency-wide Science Advisory Board; the Clean Air Scientific Advisory Committee, a part of this Board, which reviews criteria documents for air-qual~ty standards; and the Scientific Advisory Panel, which focuses on scientific issues in the Agency Office of Pesticide Programs. The Committee has examined this pane' and a subcommittee of the Science Advisory Board as examples of scientific review panels. Agency actions, including risk assessments, have been reviewed in the Executive Office of the President; how- ever, because these reviews have, with a few notable exceptions, focused primarily on risk management con- cerns, the Committee has not examined them. LEVIS OF Al PROS FOR USE AS=SS~ This section describes the practices used for risk assessment in each of the organizational examples reviewed by the Committee. The descriptions that follow reveal some strengths and weaknesses of particular approaches and permit some tentative generalizations to be made. Such generalizations, augmented by the experi- ence and judgment of Committee members, lead in turn to recommendations applicable to organizational arrangements for the performance of risk assessment. The Committee's necessarily retrospective review of agency performance has focused on events and practices of the 1970s, which triggered the current proposals for reform. Changes have been implemented, or at least are contemplated, in the procedures of several of the agen- cies studied, and the Committee recognized that such changes could alter the performance of risk assessment. Some of the descriptions of agency practices presented here may be dated. However, our purpose is not to des- cribe the current organizational structure of agencies, but rather to discern in the historical record any gent eral relationships between organizational design and procedures and the quality of risk assessments. The

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94 paucity of experience with recent organizational changes and the tendency of any new administration to disclaim the approaches of predecessors while proclaiming the effectiveness of reforms make very recent history less germane to the Committee Is purpose. OSLO ~ S DI=C=~= OF ~= STEMS PR=~ (DESP) OSEA's health standards were expected by Congress to be based on criteria and recommended standards provided by NIOSE. Bowever, improvements in OSLO s scientific copay bility and a court directive that OSHA itself review all studies included in the risk assessment supporting a proposed standard prompted Me agency to rely less heavily on NIOSE and to begin performing its own risk assessments. Until 1976, OSHA had only a few personnel in the health sciences; however, DESP has since become an organization staffed primarily by health professionals, including industrialhygienists, responsible for performing risk assessments and for preparing standards, relying on economic and technical analyses supplied by the Office of Regulatory Analysis In a separate directorate (Figure III-1). In addition, the Directorate normally has used a number of consultants who assist with risk assessment or other aspects of standard development, contributing considerable specialized expertise to the organization. OSHA tried to achieve organizational separation of risk assessment from the preparation of standards in the case of carcinogens. One office in DSSP was supposed to do risk assessment, another to draft standards. In prac- t~ce, however, such separation was not achieved, largely because personnel shortages required that individual staff mothers perform both functions. Agenda and Procedures DH5P's regulatory and risk assessment agenda has been determined largely by two external forces: petitions by labor unions for action on particular hazards and dr='n=tic discoveries of previously unidentified workplace hazards. Court remands of several OSLO standards, such as the bend zene standard, provided new work for Oslo, but none of the mandated re~examinations has led to a final standard. Criteria documents prepared by NIOSE also contributed to O=A's agenda, in Mat DESP staff always read these docks

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96 meets when they were received and normally published a Federal Resister notice soliciting further information. DESP's risk assessments usually began with a NIOSH criteria document or other NIOSE input, whatever informal tion was submitted with a labor petition if there was one, the data available from any precipitating discovery, and assessments performed by others, such as the National Academy of Sciences. A literature search and review were conducted by DHSP personnel, often with the help of con- sultants and NIOSE personnel; and sometimes environmental data on the workplace were solicited or obtained by contractors to contribute to the exposure assessment. DESP has not prepared special assessment documents before issuing notices of proposed rule making. Thus, the first indication provided to the public of the results of an OSHA risk assessment and of the conclusions it intended to draw therefrom was In the Federal Resister preamble to its proposed standard. Public comment was invited on all aspects of the proposed standard, includ- ing the risk assessment. Extensive written c ~ rents were usually received from industry, labor, and others, such as members of the academic scientific community. Cus- tomarily a hearing was held at which oral presentations were made and at which questioning of witnesses by OSlIA personnel and other witnesses was permitted. The preamble to the final rule, if one were issued, included OSEA's f inal risk assessment, which incorporated a literature review and 05EA's conclusions on the available scientific data. In 10 years, OSLO produced permanent health standards for 23 substances or processes, 14 of which were regu- lated together In a single rule-making. OKRA has also proposed standards for eight substances for which final standards have never been issued, and assessments were conducted for several substances for which new or updated standards are now being considered (Table III-2). Methods and Use of Guidelines For most of its history, OSHA has not had formal guides lines for carcinogenic risk assessment. Instead, agency staff have conducted their assessments by choosing options for the components of risk assessment on a case-by-case basis. However, the generic guidelines for identified tion and classification of carcinogens proposed in 1977 and revised and promulgated in 1980 were intended to

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139 notice of proposed rule~malcing and any f inal rule. Appar- ently, the agency is not bound by a panel's determination of carcinogenicity or its estimation of the risk associ- ated with exposure. Although it appears that each panel is to perform its own risk assessment, the statute is silent on The role to be played }by agency staff and on the weight that a panel might legitimately accora to analyses prepared by the agency ~ tself. These panels are exempted from the Federal Advisory Committee Act; the exemption pres'?Tnahly means that they are not required to provide advance notice of their meetings or to deliberate in public. A panel may seek information from third parties, but only through CPSC. CRITICISM OF PROPOS=S FOR S=~T7ON ~ ~~I=TION The Four f ederal regulatory agencies have responded skew tically to proposals to separate and centralize the func; talon of assessing the risks of chemicals that are cane didates for regulation (U. S. Congress, 19815) . Other cheers have also found f laws in the proposals. A central crit~ci=. made by those who argue against full organizational separation between risk assessment and regulatory policy-m~king is that simply separating risk assessment from the regulatory agencies would not separate science from policy. , _ _ This argument is based on the fact that the risk assessment process requires analytic choices to be made that rest, at least in part, on the policy con- sideration of whether to be more or less conservative when determining possible publ~c-health risks. A second point is that, although extra-agency separation of risk assess- ment may help to minimize the influence of risk management considerations on this process, the agency responsible for deciding what exposure to permit or what costs to impose must make what is ultimately a political judgment based on the extent of risk determined in the risk assessment and often on the benefits and costs of regulatory action and its feasibility and political acceptability. For its decision to be politically acceptable and the decisions maker accountable, the agency must have responsibility for each or these components of regulatory decisions making. A third argument against institutional senar a- Lion as related to the internal process by which agencies It is claimed that this process is unavoidably an iterative one. Different specialists are called on repeatedly for analysis and advice as an agency reach decisions.

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140 identifies and considers new control options in attempting to reach a decision. Although this description may over- state the f luidity of internal agency deliberations, captures something of their ad hoc character. Closely coupled with this argument is Me necessity for agencies to retain scientific capability so that they can under- stand what a risk assessment means and how to use it in developing risk management strategies. Thus, even if risk assessment were performed outside the agency, a scientific staff representing many different disciplines would still be required, to ensure that an assessment would be interpreted and used correctly. Other criticisms of proposals for risk assessment by a centralized panel stress the logistic difficulties of meshing independent risk assessment activities with the internal workings of different agencies. Experience suggests that it will be difficult for any risk assess- ment body to meet even generous time limits. Thus, agency decisions will probably be delayed by ~ requirement to consult, or refer issues to, such a body. A central pane, also might become overburdened and cause additional delays. Critics of I.. 638 and the AIEC proposal chal- lenge the ass, - .tion that the regulatory agencies }rave reached inconsistent conclusions in evaluating various chemicals. The recent differences in Me regulation of formaldehyde constitute a rare example of disparate treatment of the same chemical, and even this disparity may not betray basic disagreement over the interpretation of scientific data, as distinct from the degree of risk that justifies regulation. In the past, the agencies have often selected different control options or imposed different exposure limits for a given chemical, but these disparities have typically reflected differences in expose sure (and thus in risk characterization) or differences in regulatory policy or statutory or administrative requirements; none of the current proposals addresses such differences. CONCLUSIONS The Committee was asked by the Congress to consider tithe merits of an Institutional separation of scientific func- tions of developing objective risk assessment from the regulatory process of making public and social policy decisions and the feasibility of unifying risk assessment functions. " In this chapter, the Committee has addressed

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141 these two issues and a third, related issue: the value of independent scientific review of agency risk assessments. In i ts review, the Committee was sensitive to a number of considerations, including the scientific quality and regulatory relevance of the assessments performed. It also tried to ascertain how scientific and policy consid- erations were handled in the performance of risk assess- ment. To reach its conclusions, in the absence of accepted criteria for evaluating agency practices and proposals for change and in view of the sparseness of relevant empirical data, the Committee has relied on discussions with other persons knowledgeable and experi- enced in risk assessment activities, the limited avail- able literature, and especially its own knowledge and experience in regulatory-agency risk assessments, as well as its review and analysis of past agency practices. VALUE OF INSTI'lu$ION~L SEPARATION 1. Although organizational separation mat help to ensure that risk management considerations do not influence the conduct of risk assessment, the degree of organi- zational separation that is optimal for individual agencies cannot be determined on the basis of the Committee' s review. Regulatory programs differ substantially In their degree of organizational separation. In the cases of NIOSE assessments that in the early 1970s were adopted by OSEA and NRC assessments relied on by agencies, the assessment function has been outside the regulatory agencies. At EPA, the risk assessment units in the Office of Health and Environmental Assessment of the Office of Research and Development prepare assessments for regulatory program offices that are organizationally under different assistant administrators. Bowever, ache Office of Toxic Substances does its own assessments, and several other program offices are responsible for their own exposure assessments. The risk assessments for the FDA'S Bureau of Foods are produced within the Bureau, but by an office distinct from offices responsible for fo~mu- lating regulations and enforcement; since 1976, the D~rec- torate of Health Standards Programs in OSLO has both performed risk assessments and formulated all early risk management options. Different agencies also have success-

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142 fully used different organizational arrangements for risk assessment. FDA, for example, has often called on NRC and NTP for assessments, but in other cases relied on its own staff. The Committee's review of different agency structures and procedures did not demonstrate that one particular structure produced risk assessments of superior quality and integrity. In addition, the Committee notes that, even if there were a clear finding that a particular arrangement works For a given agency or program, it would be extremely difficult (given the diversity in agency and program mandates, personnel needs, and histories) to justify a suggestion that that arrangement would best serve all agencies or programs. 2. Organizational separation has several important drawbacks that are likely to be intensified with increasing degrees of separation. There are severa} arguments against organizational separation. Separation of the risk assessment function from an agency's regulatory activities is likely to inhibit the interaction between assessors and regulators that is necessary for the proper interpretation of risk estimates and the evaluation of risk management options. Separation cat" lead to disjunction between assessment and regulatory agendas and cause delays In regulatory proceed- ings. Common sense suggests that increased separation would aggravate these drawbacks. In its review, the Com- mittee observed these disadvantages when assessors and regulators were in different organizations (e.g., NIOSE and N~C). Another perceived drawback in extra-agency separation that was neither detected nor likely to --merge in the Committee's review is the erosion of scientific competence within agency staffs if risk assessments are routinely performed outside the agency. Also, any major organizational change may have a disruptive effect on agency performance; thus, such organizational changes are especially questionable when the benefits, if any, are unclear. 3. Organizational arrangements that separate risk assessment from risk management decisionrmakinq will , not necessarily ensure that the Policy basis of - choices made in the risk assessment Process is clearly distinguished from the scientific basis of such choices. _

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143 If risk assessment as practiced by the regulatory agencies were pure science, perhaps an organizational separation could effectively sharpen the distinction between science and policy in risk assessment and regu- latory decision-making. However, many of the analytic choices made throughout the risk assessment process require individual judgments that are based on both scien- t,fic and policy considerations. The policy cons~dera- tions In risk assessment are of a different character from those involved in specific risk management decisions and are generally common to all assessments for similar health effects. Thus, even when one has drawn the rela- t~vely obvious distinction between risk assessment and risk management, there remains the more difficult task of distinguishing between the science and policy dimensions of risk assessment itself. We believe that the latter distinction cannot be ensured or maintained through organ- izational arrangements. Given the inherent mixture of science and policy in risk assessment, organizational separation would simply move risk assessment policy into a different organization that would then have to become politically accountable. The Committee believes that other approaches are more likely to maintain the distinc- tion between science and policy in risk assessment, most notably the development of and adherence to guidelines. VALUE OF CENTRALI ZATION 4. Common risk assessments performed primarily by scienr fists from all interested agencies on an ad hoc basis - mav capture the major advantanes of centralization without the drawbacks that accomoanv Permanent, extraragencv centralization. An argument often advanced for centralization is that it might expedite and perhaps reduce the administrative costs of decisionrmaking when two or more agencies contem- plate regulation of the same substance. And if two or more agencies are going to regulate the some substance, there is much to be said for developing a system that facilitates production of a single, common risk assess- ment. This was one rationale for CPSC's decision to empanel a group of scientists to evaluate the carcinoge- nicity data on formaldehyde, and it argues in support of the central panels suggested in E.R. 638 and the American Industrial Health Counczl's proposal. Although the Come

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144 Settee endorses government-wide consistency in risk assessment, it is less sanguine concerning the prospects of a permanent arrangement for such centralized risk assessment as contemplated by these proposals, in which the idea of centralized assessment is inextricably linked to extraragency separation. The Committee concluded that extra~agency separation would have disadvantages that would offset any advantages. The Committee did find, however, that agency scientists could collaborate to perform joint risk assessments on an ad hoc basis. Because agency scientists would perform an assessment, such an arrangement would avoid most of the drawbacks of extra-agency separation. The Committee looked at the Panel on Formaldehyde as an example of a centralized assessment group. In the Committee's view, the Panel functioned well and produced an assessment that has been accepted by the scientific community. The Panel's assessment has not produced parallel regulatory action among the agencies, and the Committee observed that similar r isk assessments should not necessarily lead to similar regulatory decisions, which reflect consid- erations that often justify different risk` management responses. USE OF SCIENTIFIC KEVTsW PANELS l 5. Independent scientific review o~ - assessments improves the scientific ~ual i=.,r of the assessments and strengthens them against later challenge Agencies and programs with mandated peer review panels, such as EPA's Office of Pesticide Programs, which is required to submit to a Scientific Advisory Panel propose sals to cancel or restrict pesticide use, produce final risk assessments in support of regulatory decisions that are generally of high scientific quality and are accepted by the pu}:'lic and the regulated parties. In contrast, the Committee found several cases in which mechanisms for peer review could be markedly improved: OSLO, which uses public comments to ref ine its risk assessments, rather than formal peer review; NIOSH, which has not had a mech- an~sm to ensure that reviewers' comments are given appro- priate consideration; and FDA's Bureau of Foods, which uses ad hoc panels to review its assessments (a procedure that unfortunately can be circumvented).

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145 ~~ d~B . mechanisms to maintain the independence of their members appear to be the most useful review bodies. Continuity and independence of review panels help to ensure that such panels are sensitive to regulatory needs while retaining the necessary scientific objectivity. Examples of standing committees, such as the Scientific Advisory Panel in EPA, support this perception. Con- versely, the Committee observed that short-lived or ad hoc groups, such as the Subcommittee on Airborne Carcinoma gens, often do not have sufficient tome to develop a working relationship among panel mashers and that much of the time allotted to review is actually spent in clar~fy- ing individual versus panel viewpoints and understandings. Similarly, an ad hoc panel may not clearly understand its role in relation to the regulatory process. Thus, stand- ~ng panels appear to be of greater value to the agency than ad hoc committees. Furthermore, the existence of a standing panel might encourage an agency to seek its advice more frequently. Because it is important for review committees to be free to express their scientific judgments without concern for regulatory implications, panels that are formed in a manner that neither compromises nor appears to compromise their independence are more likely to improve ultimate risk assessments. The Committee observed that several review panels used by EPA already have a nomination process Mat places the responsibility for developing a slate of possible panel members outside the agency. Although the EPA Administrator maces the final selections of panel members, Me fact that nominations come from outside the agency emphasizes the intent that EPA panels be independent and as free of agency influence as possible. A related point is that membership on EPA panels, and in fact on most review panels used by the regulatory agencies, rotates; members are usually selected for staggered, f iced terms "generally 3-4 years) . This rotation itself reduces the likelihood that members will develop an institutional b' as. Review Panels are best Qualified to Dive scien- t~fic advice when they are composed of scientists who are highly knowledgeable in the aPpronr iate disciplines. For carc~nogen~city r Ask assessments, for exhale, some relevant disciplines would be toxicology, pathology, biostatistics, chemistry, and epidemiology. The Com

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146 mittee believes that professional or organizational affiliation should not be used as a primacy criterion in the determination of the makeup of a particular panel. That is, in contrast with the advisory panels used by 05aa, which are constituted to reflect balance among different aff il iations and presumed biases, the Committee believes that scientific competence must be the primary factor determining panel membership If review panels are to be asked to give their advice on the scientific aspects of an agency's risk assessments. }however, the Committee notes that panel meters who understand the policy in~pli- cations of their scientific judgments are more likely to be helpful to an agency's assessment process and that an attest to balance viewpoints of scientif ically qualif fed panel members may increase a panel's credibility. Review unreels will be ~,3= the _ announcement of the agenc~r's intended regulatory actions, except in cases of emergenev. The Committee believes that review panels serving regulatory agencies should serve in an advisory capacity. That is, the judgments of a panel should not be binding on the agency. Nevertheless, the Committee also believes that the authority of agency review panels should be such that agencies must demonstrate that adequate consideration has been given to reviewers' judgments, and prior consul- tation with review panels helps to ensure this. Because announcements of intended actions or proposed regulations must be thoroughly developed and substantiated, review at the time of announcement or later is likely to be too late to influence an agency; although the regulation is only proposed, the decision of whether to act has, for all practical purposes, already been made. In the Comm~- tee's judgment, exceptions to this idea of prior review are appropriate in the case of emergency actions, such as suspension of pesticide registration. Risk assessments supporting such actions could be reviewed after the announced action. . Independent panels with authority to review risk assessments for all agency regulatory decisions, including decisions not _ =~ ~rounds. Panels with the authority to request the review of any agency risk assessment supporting a particular regulatory

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147 decision will have a greater impact on agency decision- making. For example, if a panel can review only assess- ments referred to it by an agency, some agency decisions might not benefit from independent review of their screw: tific basis. This is especially likely if an agency has decided not JO regulate. Such a decision may have con- siderable impact and should receive the same careful review as decisions to regulate. In addition, panels with the authority to request reviews can respond to suggestions for review from the public. . Although most requirements of the Federal Advisorv Committee Act are salutary, others mav inhibit agency use of review panels. The Committee believes that most provisions of the Act are beneficial and endorses such provisions as the requirement that advisory committees meet In public and provide advance notice of their meetings. However, the Act does Impose requirements, some burdensome, for agency- created bodies that meet the definition of advisory committee. Notably, the Act requires that an advisory committee be formally chartered by an agency head and approved by the General Services Administration. This procedure has often proved cumbersome. Some agencies, such as FDA, lack independent chartering authority and thus require approval at the departmental level. In addition, procedures used by the General Services Adminis- tration for screening new committees have often imposed long delays, sometimes inspired by political concerns about committee membership or by resistance to the crea- tion of new government "agencies. These legal require- ments of the Act have caused some agencies to seek other ways of obtaining the views of scientific experts, especially when the issues involve single chemicals or tests. In such cases, regulators often confine their consultations to gov~r~ent scientists, who can be. accessible immediately and, if necessary, for extended per iods. . Written reviews help to ensure agency consideration of scientific criticism. A summary of a panells review that is transmitted in written form and made available to the public will help to avoid confusion and to ensure agency consideration of the panel's comments. As mentioned earlier, in the absence of adequate mechanisms to ensure agency cons~der- ation of reviewers' comments, the comments might be

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148 ignored, or the public might perceive that they are ignored. Putting its summary in writing should also ensure that the panel states its findings clearly and make it more likely that the agency will interpret its comments correctly. O~;R OBSERVATIONS 6. Preparation of fully documented written risk assess- ments that exPl~citlv define the iudq~ents made and attendant uncertatrti~.~.~y~f]d =~ _!~:Y_: dec~s~onrmakinq process and aids the review Process considerably. When a fully documented written risk assessment is not produced before an agency's decision to regulate or not to regulate, it is difficult to understand the process by which an agency made its assessment. The Committee believes that the creation of such a document encourages public understanding of and respect for agency procedures and provides a basis for review by a scientific advisory panel. Furthermore, a detailed risk assessment document that clearly identifies the inference options chosen in the assessment and explains the rationale for those choices will help to maintain a sharper distinction between science and policy in the assessment of risk and will guard against the inappropriate intrusion of risk management considerations. REFERENCES AIEC (American Industrial Health Council). 1979. Recommended Framework for Identifying Carcinogens and Regulating Thorn in Manufacturing Situations. EPA (Enviror~ental Protection Agency). 1976. Health risis and economic impact assessments of suspected carcinogens: interim procedures and guidelines. Fed. Reg. 41(102):21402-21405. EPA (Environmental Protection Agency). }979. Water Quality Criteria, Request for Comments. Fed. Reg. 44(52):15926. EPA (Envi~ormental Protection Agency). 1980. Water Quality Criteria Documents; Availability. Fed. Reg. 4 5 (231): 79350-79353 ~

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149 Food Safety Council. Social and Economic Committee. 1979. Principles and Processes for Making Food Safety Decisions. 54 pp. H~gginson, John. 1982. Report of the Scientif ~ c Workshop on the Critical Evaluation of Proposals by the American Industrial Health Council to Strengthen the Scientific Base For Regulatory Decisions. Rantrowitz, Arthur. 1975. Controlling technology democratically. Am. Sci. 63:505-S09. NRC "National Research Council). 1981. The Bandling of Risk Assessments in ARC Reports. A Report to the Governing Board, National Research Counci}, by the Governing Board Committee on the Assessment of Risk. 19 pp. Office of Science and Technology Policy. 1978. Identification, Characterization, and Control of Potential Human Carcinogens: A Framework for Federal Deciszon-Making. O.S. Congress. 1981a. Omnibus Budget Reconciliation Act. {P.L. 97 - 35, August 13, 1981) 15 U.S.C. 2077. O.S. Congress. 1981b. Bouse of Representatives, Committee on Agriculture, Hearings on the National Science Council Act, B.~. 638. Bearings Before the Subcommittee on Department Operations, Research, and Foreign Agriculture of the Committee on Agriculture, June 23, 1981. U.S. Congress. 1981c. Bouse of Representatives B.R. 638. National Science Council Act 97th Congress, 1st Session, 1981. O.S. Congress. 1981d. Senate. S. 1442. Food Safety Amendments of 1981, 97th Congress, 1st Session, 1981 .