Risk Assessment in the Federal Government Managing the Process (1983) / Chapter Skim
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3 Organizational Arrangements for Risk Assessment
3 Organizational Arrangements for Risk Assessment
Pages 86-149
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From page 86... ...
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.
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From page 87... ...
. In addition, outside scientists are often called on to review assessments produced by agency staff.
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From page 88... ...
88 o to A: A: a: o N A: as o o ~2 o a: Sit o o Q
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From page 89... ...
· 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.
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From page 90... ...
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.
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From page 91... ...
USE OF SCIENTIFIC REVIEW PANELS . Agencies may use independent scientific panels to perform risk assessments or to review assessments prepared by the agencies.
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From page 92... ...
. EDA has often used independent scientific panels both -^ perform and to review agency assessments.
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From page 93... ...
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.
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From page 94... ...
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)
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From page 95... ...
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From page 96... ...
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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From page 97... ...
Sow ilarly, although for many years OSEA did not perform quantitative risk estimates for use in setting standards for carcinogens, it now intends to do so where appropriate. This change results from policy decisions of senior agency officials, based, at least in part, on their interpretation of the Supreme Court's decision on benzene.
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From page 98... ...
In the Co~mittee's opinion, this Olin an nn~lic Proceedings to strengthen and refine I.—_ _~ & ~~ ^_ =~ it J— —— ___ A _ _ _ the scientific basis for the agency's regulatory actions has not been an adequate substitute for independent peer review. In addition, reliance on public proceedings surely precipitated some of the criticism or agency actions and may have jeopardized the scientific integrity and procedural legitimacy of the agency's risk assessments.
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From page 99... ...
data; planned retrospective or cyclic review of approved compounds, supporting data on which the Bureau generally must take as it finds them; and review of inadvertent contaminants in food, supporting data on which are derived from many sources, including open scientific literature, monographs, reports, manufacturers' data, and agency-generated data. In 1981, the Bureau of Foods evaluated 65 food additives, two color additives, and approximately 45 an~maldrug petitions.
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From page 100... ...
Too o c' c)
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From page 101... ...
The Bureau's procedures for reviewing food additives, color additives, and residues of animal drugs are more routine than those for evaluating food contaminants, whose occurrence is largely unpredictable. On receipt in the Division of Food and Color Additives, a ~ood-additive petition is evaluated to determine whether it is acceptable for filing.
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From page 102... ...
Methods and Use of Guidelines Although the Bureau's approach to the evaluation of acute toxicants has remained stable over a long period, its methods for evaluating potential carcinogens have undergone substantial change since the early 1970s. In 1918, the Bureau Director formed a Cancer Assessment Committee in the Office of Toxicological Sciences to evaluate the carcinogen~city of substances being considered for
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From page 103... ...
assessments are not always performed. For some substances, such as contaminants, the magnitude of the risk is relevant, and scientists from the various divisions collaborate with staff responsible for gathering information on human en sure to perform risk characterizations.
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From page 104... ...
After the Board's finding that the evidence was inconclus~ve and before the Bureau's conclusion that the additive was unlikely to be a human carcinogen, Bureau staff performed a risk characterization to estimate the potential risks if this conclusion were in error. The decision to consult an outside panel for review of risk assessments for potential carcinogens is made by the Chairman of the Cancer Assessment Committee.
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From page 105... ...
Thus, the organizational arrangement that places CAG In the Office of Research and Development does have the initial effect of freeing risk assessment personnel from specific policy issues that arise when risk management options are considered. Bowever, when a scientific review committee exam ines documents produced by this office later in -he process, interest groups are able to express their views and CAG personnel are no longer isolated from such influences.
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From page 107... ...
The length and scope of the documents produced vary with the data available, with their purpose, and with the needs of the requesting office. They can range from brief and preliminary literature reviews relevant to hazard identification or tentative estimates of risk as a function of dose to complete and thorough literature reviews leading to a comprehensive risk characterization.
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From page 108... ...
also, the changes made in the guidelines have not, in many cases, been formally acknowledged; i.e., the current guidelines do not exist in a single publicly accessible written document. CAG's use of guidelines, especially for hazard identif ication, has been regarded by some EPA review panels- - notably, the Subcommittee on Airborne Carcinogens -- as too inflexible, possibly misleading, and interfering with critical analysis of underlying data.
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From page 109... ...
Reviews of CAG assessments by EPA panels have been mixed, with some panels, such as the Scientific Advisory Panel, often approving the assessments and etchers finding numerous shortcomings related to both substance and format (e.g., the Subcommittees on Arsenic as a Possible Bazardous Air Pollutant and on Airborne Carcinogens of the Agency's Science Advisory Board)
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From page 110... ...
In the early 1970s, OSEA relied heavily on NIOSE for evaluation of health effects; later, OSHA developed its own staff of health scientists and, with considerable help from consultants and contractors, performed its own risk assessments to support agency standar~setting activities. Because OS" conducts its own assessments of risk, as well as setting standards, and NIOSH does risk assessments and recommends standards, the relation of NIOSE and OS" as it has existed since 1976 represents, in some sense, duplication, rather than true extra~agency separate tion.
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From page 111... ...
NIOSE's failure to develop risk assessment guidelines has helped to obscure the distinction between scientific and policy judgments in Abe risk assessment process. Although the rationale for separating NIOSE from OSEA has been to allow an independent scientific evaluation without the consideration of economic implzcations that is necessary in OSElA rule~making activities, the effectiveness of this institutional separation in eliminating the effects of such risk management considerations on the conduct of risk assessment by NIOSE is dif f icult to determine.
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From page 112... ...
112 TABIE lII-5 NIOSE Criteria Documents Sent to OSEA by May 1982 Substance or Sub Sect Acetylene Ac rylamide Acrylonitrile Alkanes Allyl chloride Ammonia Antimony Arsenic, inorganic Asbestos Asphalt f Ames Benzene Benzoyl peroxide Benzyl chloride Berylli,~Boron tr if luor ide Cadmium Carbaryl Carbon black Carbon dioxide Carbon disulfide Carbon monoxide Carbon tetrachloride Chlorine Chloroform Chlorophene Chromic acid Chromi''= the ) Coal - Gasification plants Coal-liquefaction (Vole.
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From page 113... ...
113 TABLE I7I-5 (Cons' nued) Substance or Subject Transmitted to OSEA Hydrogen fluoride Hydrogen sulf ide Bydroquinone Identif ication system for occupationally hazardous mater ials Isopropyl alcohol Kepones Ketones Iliad, inorganic 1,ogging -- from felling to first haul Malathion Mercury, inorganic Methyl alcohol Methylene chloride Methyl parathion Nickel, inorganic and ca~ounas Nitric acid Nitriles Nitrogen oxides N i trog lycer ire me thylene glycol dinitrate No ise Organotin Funds Parathion Pesticide mar~ufacturing and formation Phenol Phosgene Polychlorinated biphenyls Refined petroleum solvent S ilica, crystalline Sodium hydroxide Sulfur dioxide Sulfuric acid 1,1,2 ,2-Tetsachloroett2ane Tetrachloroethylene Th ills: n-alkane mono~, cyclohexane, and benzene Toluene Toluene diisocyanate Toluidine 1, 1, l-Tr ichloroethane Tungsten and cemented tungsten carbide Ol tra~riolet radiation Vanadium Vinyl acetate Vinyl chloride Vinyl halides Waste anesthetic gases and vapors Xylene Z inc oxide 1976 197J 1978 1974 1976 1976 1978 1973, 1977 1976 1976 1973 t976 1976 1976 1977 1976 1978 1976 1978 1972 1976 1976 1978 1976 1916 1977 1977 1974 197S 1974, ~ 977 1974 1976 1976 1978 1973 1973, 197 8 }978 1976 1977 1972 1977 1978 1974 1978 1917 1975 1975
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From page 114... ...
After these various reviews were complete and changes were made as deemed appropriate by division staff, the document was forwarded to the Director of NIOSH. Several shortcomings of NIOSH criteria documents were cited In a recent review of the program funded by the agency: the lack of field experience of criteria document managers, the lack of critical analysis of data, and the alleged disregard of reviewers' comments.
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From page 115... ...
The committees of N~C have been included in our survey as examples of ad hoc risk assessment groups that are entirely separate from government regulators. Table I7I-6 is a partial list of N~C reports (published since 1977)
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From page 116... ...
1 -- Anticholinesterases and Ant~cholinergics APSE CLS CLS CLS CPS~ CDS CPS~ CBS CONS CLS CPS~ CLS CLS CLS CLS CLS CLS CLS CLS CONS CLS CLS 1977 lg77 1977 1977 1978 1918 ~ 979 1980 1980 1980 1980 1981 1981 1981 1981 1981 1982 1982 1982 1982 1982 1982 LAPSER = Commission on Physical Sciences, Mathematics, and Resources; CDS = Commission on Life Sciences.
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From page 117... ...
A subject of much discussion over the last several years has been the value of including quantitative assessments (in our terms, dose-response assessments or, if exposure data are incorporated, risk characterizations) in reports.
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From page 118... ...
In its efforts to ensure the safety and effectiveness of drugs in these three classes, FDA has relied heavily on advisory panels composed primarily of scientists from academic medicine. Two major programs illustrate the important role of such independent expert panels in agency assessments of human
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From page 119... ...
The two reviews differed in a number of respects that may shed some light on optimal structures and procedures for scientific panels. NBC Review The 1962 Refauver-Earris Amendments to the Federal Food, Drug, and Cosmetic Act required that all new drugs be proved effective, as well as safe, and obliged FDA, after a 2-year grace period, to require proof of efficacy of all pre-1962 drugs.
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From page 120... ...
In practice' FDA has accorded substantial weight to the assessments provided by the NRC panels, usually accepting the rating provided and initiating appropriate regulatory action. A rating of less than ~effective.
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From page 121... ...
m e central function of these review panels was to report and explain their assessments of the safety and effectiveness of the ingredients used in over-the-counter drugs. These reports were to set forth not only the panels' judgments rating each ingredient (as generally recognized as safe and effective, as unsafe or ineffective, or as requiring additional study)
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From page 122... ...
· . ~ _ _ _ NA~TO~ TOXICOLOGY Phi The National Toxicology Program (=P)
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From page 123... ...
NTP thus serves as a vehicle for cooperation among the four regulatory agencies -- FDA, ~PA, OSBA, and CPSC -- especially in recommending candidate substances for testing. At least one agency has also called on NTP to review risk assessments: the FDA has on two occasions asked another NTP advisory group-he Board of Scientific Counselors-to review the carcinogenicity data and the agency's analysis of those data on two color additives being considered for agency approval.
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From page 124... ...
In early 1982, CPSC banned further use of urearformaldehyde foam insulation, in part on the basis of the Panel's report, as well as the agency own risk assessments of formaldehyde's acute and chronic effects. In contrast, EPA has declined to initiate regulation of formaldehyde in response to the Pane1's assessment.
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From page 125... ...
EPA'S USE OF SCIENTIFIC KE:VIEW PANELS The EPA has had considerable experience with independent scientific panels, but they have served the Agency differently from the risk assessment panels discussed in the preceding section. EPA's panels typically have reviewed the work of Agency scientists and analysts, rather than perform their own risk assessments.
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From page 126... ...
Broadly speaking, the Panel reviews risk assessments prepared by EPA's Office of Pesticide Programs to support content plated regulatory actions against hazardous pesticides. It also reviews the proposed and final Corms of such actions.
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From page 127... ...
Informal Review of Draft Proposed Pesticide Registration Guidelines, Subpart I, Exposure Data Requirements: Reentry Protection 8. Review of Proposed Pesticide Registration Guidelines, Subpart 6, Labeling of Pesticide Products 9.
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From page 128... ...
Equally important in the consideration of nonscientific issues has been Cow gress's decision not to restrict the Panel to a strictly scientific review of the Agency's risk assessments. (The Panel's mandated review responsibilities extend to contemr plated EPA actions that combine both risk assessment and regulatory policy elements.)
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From page 129... ...
The Subcommittee reviewed six pairs of draft documents that included hazard identification and dose~response assessments produced by the Carcinogen Assessment Group and exposure assessments produced by private contractors for EPA's Office of Air Quality Planning and Standards. The chemicals evaluated in those documents were trichloroethylene, perchloroethylene, methylene chloride, methyl chloroform, acrylonitrile, and toluene.
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From page 130... ...
Other criticisms focused on specific issues, including the validity of basing a conclusion of carcinogenic~ty on an increase in mouse liver tumors, the importance of contaminants in the test chemicals, and the wisdom of using a single model for extrapolating from high to low doses. The Subcommittee viewed these issues as primarily scientific, whereas Agency staff considered them, although resting on scientific principles, as resolvable through the choice of Conservative policy options -- a choice embodied in the Agency's guidelines.
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From page 131... ...
If risks are m~sdescribed, it follows that public perception of the risks will be i naccurate . In addition, because agency announc ements of regulatory actions typically stress the ultimate risk management strategy, such as the banning of sack chain, and do not explain why a particular action is be' ng taken, the public is led to infer the degree of risk from the action proposed or from the decision not to act.
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From page 132... ...
This dissatisfaction led to one of the precursors of the current proposals: the idea of a science court for resolving science tif ic issues underlying regulatory decisions. That suggestion and other, more recent proposals for procedural and structural reforms are discussed briefly below.
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From page 133... ...
Even after several years of sometimes heated debate in the scientific and regulatory communities, the overall reactions to the concept can be characterized as at best only lukewarm. Although a genuine science court will probably not be established, the underlying idea of separation of scientific issues from social and political considerations in decision~malcing has since appeared in other proposals.
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From page 134... ...
OSTP Proposal A 1978 report from OSLO gave impetus to emerging proposals for separation and centralization of scientific aspects of risk assessment. The report recommended several steps to ensure consistency in the identification, characteriza~ tion, and assessment of potential human carcinogens.
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From page 135... ...
Both proposals stress the importance of uniform, consistent resolution of the scientific questions underlying regulatory decisions. Both espouse the separation of risk assessment from the design and selection of regulatory responses, and both would use independent scientific experts to perform the assessments.
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From page 136... ...
638 AIEC Proposal Structure: Single continuing panel separate from agencies; centralized Membership: 15 full-time members appointed by chairman of N Sit from NAS nominees; members to be qualified, distinguished scientists scone: Referral by any party of adjudications involving harm to hen health from substances considered by CPSC, FDA, USDA c DEBS,d OSHA, and EPA Functions: Panel could prepare an independent risk assessment; its decision would be binding on the agency Public Participation: Parties to adjudication would be involved Implementation: Legislation Single continuing body with rotating members; in the NASH IS part-time members selected according to NAS procedures; members to represent the best scientists Referral by any party or agency (only latter require mandatory cone sideratiOn) concerning proposed rules or agency adjudications; all agencies with regulatory jurisdiction would be affected Panel could prepare an independent risk assessment; its f indings would be advisory, but would be part of record Federal Register notice of referral would solicit submission of data by pub1 ~ c Legislation ~National Academy of Sciences.
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From page 137... ...
638, the National Science Council would decide scientific questions after conducting a formal shearing on the record,. in which all parties to the agency proceeding could participate.
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From page 138... ...
These proposals for independent scientific panels differ from B.R. 638 in three important ways: they would apply to one agency or program; they contemplate only an advisory role, rather than a resolving function, for the scientific panel; and they would apply to any agency proceeding in which rise; assessments were at issue.
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From page 139... ...
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'?
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From page 140... ...
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 assessment body to meet even generous time limits.
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From page 141... ...
It also tried to ascertain how scientific and policy considerations were handled in the performance of risk assessment. 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 experienced in risk assessment activities, the limited available literature, and especially its own knowledge and experience in regulatory-agency risk assessments, as well as its review and analysis of past agency practices.
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From page 142... ...
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.
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From page 143... ...
We believe that the latter distinction cannot be ensured or maintained through organizational 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.
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From page 144... ...
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.
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From page 145... ...
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.
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From page 146... ...
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 consultation 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.
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From page 147... ...
. Although most requirements of the Federal Advisorv Committee Act are salutary, others mav inhibit agency use of review panels.
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From page 148... ...
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)
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From page 149... ...
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.
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