Risk Assessment in the Federal Government Managing the Process (1983) / Chapter Skim
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2 Inference Guidelines for Risk Assessment
2 Inference Guidelines for Risk Assessment
Pages 51-85
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From page 51... ...
. This terminology is potentially confusing, because Guidelines cat be understood as codified principles addressed to a particular subject matter, risk assessment, or as describing the legal weight of any codified stand cards or principles.
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From page 52... ...
In contrast, the use of guidelines makes more evident the generic choice oF inference options, which we have seen in Chapter 7, is based on both scientific and risk assessment policy considerations. HISTORY OF 'Gil USE OF GUIDErINES ~~F~.~v ~V~1nATION GUIDELINES FOR ~ The development and use of guidelines by a regulatory agency first became of major importance after Congress only those addressed to risk assessment, in legal proceedings.
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From page 53... ...
and adopted by the Joint Food and Agricultural Organization and World Health Organization Expert Committees on Food Additives (1972) add Pesticide Residues (1965)
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From page 54... ...
. The Interagency Regulatory Liaison Group began to develop guidelines for risk assessment of reproductive and teratogenic effects, but the effort ceased with the disbanding of the group in 1981.
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From page 55... ...
The process stopped at hazard Many factors contributed to the later use of doseresponse assessment, exposure assessment, and risk characterization to determine quantitative estimates of risk. One of these may have been the growing perception during the 1960s and 1970s that many kinds of risk could not be eliminated completely without unacceptable social and economic consequences.
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From page 56... ...
The IARC allows the expert committees considerable latitude to evaluate many inference options on a case-by-case basis, although the agency appears to insist on adherence to the few stated guidelines. Food and Drug Administration The 1958 Food Additives Amendment to the Food, Drug, and Cosmetics Act prohibited the use of Food additives found to be carcinogenic.
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From page 57... ...
They address a narrow though complex set of issues encountered in regulating a single class of products, animal drugs. Although they deal to ~ large extent with testing, they were the first to address quantitative risk assessment methods, listing assumptions for dose~response assessment, exposure assessment, and risk characterization.
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From page 58... ...
They are grate general, cover less than a page of Federal Resister text, and address only a few co~ponents of hazard identification, dose-response assessment, exposure assessment, and risk characterization. More detailed guidelines that specify assumptions for the choice of extrapolation models, scaling factors, and other elements of dose~response assessment were published in 3980 by program offices in EPA (ERA, 1980~)
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From page 59... ...
The OSEA rule, written by agency staff, was a detailed scientific and regulatory document that took several hunt dred pages of Federal Register text and addressed almost every component of hazard identification. The final rule did not address exposure assessment and red ected the use of dose~response assessment for any regulatory purpose except priority-setting.
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From page 60... ...
Furthermore, at that tome CPSC had decided to rely on the guidelines of IRLG. Interagency Regulatory Liaison Grout The four agencies represented in IRLG undertook the task or developing guidelines to n ensure that the regulatory agencies evaluate carcinogenic risk consistently.
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From page 61... ...
Almost immediately after its publication, the IRLG report was adopted by the Pres~dent's Regulatory Council and incorporated as the scientific basis of the Council's government-wide statement on regulation of chemical carcinogens. The Council viewed the IRLG guidelines as a major step in reducing inconsistency, duplication of effort, and lack of coordination among agencies in carcinogenic risk assessment (Regulatory Council, 1979)
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From page 62... ...
lances guidelines address only hazard identification; OSTIA's guidelines (1980) dealt mainly win hazard identification, with some ct~scusszon of dose~response assessment and none of exposure assess' ment and risk characterization; and IBI`G's guidelines focused in detail on hazard identification and doseresponse assessment, with some discussion of exposure assessment and risk characterization.
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From page 63... ...
A guideline usllall y prefers one option, although some guidelines permit the selection of more than one or of all the options. The preferred inference opt ion may be viewed as a default option, i.e., Be option chosen on the basis of risk assessment policy that appears to be the best choice in the absence of data to the contrary.
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From page 64... ...
On the issue of benign versus malignant t'',nors, IRLG' s guideline stated: The induction of benign neoplasms would, therefore, h" Considered evidence of carcinogenic activity unless definitive evidence is provided that the test chemical is incapable of inducing malignant neoplasm. The guideline did not attempt to define the type of defier itive evidence that would be needed to demonstrate that a latest chemical is incapable of inducing malignant new plasma..
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From page 65... ...
were adequately examined to search for invasion of the tumor cells into adjacent tissue, and that multiple sections of other organs were adequately examined to search for tumor metastases. By leaving open the type of evidence needed to supe~sede the default option (benign tumors should be considered evidence of carcinogenic activity)
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From page 66... ...
Suppose that an agency decides to adopt, as one of its risk assessment guidelines, the default option that benign tumors should be aggregated with malignant tumors in determining whether a mammalian bioassay demonstrates that an agent causes cancer in the test species. This guideline could be adopted as a regulation, as what we term an established procedure, or simply as a recommendation.
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From page 67... ...
an other words, such an established procedure is binding on the agency until formally revoked or changed, and third parties can rely on it and insist that the agency adhere to it.*
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From page 68... ...
any set of guidelines depends as much on the las~guage chosen as on the legal form in which they appear. Suppose that an agency's default option is: Ordinarily benign and malignant tumors shall be equated and their sum used to determine the significance of observed effects, unless (a)
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From page 69... ...
Thus, such guidelines could probably provide the sharpest distinction between risk assessment and risk management. Quality Control Proponents of guidelines argue that their use would ensure the application of selected inference options based on the informed judgment of experts.
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From page 70... ...
In the absence of such guidelines, there are increased opportunities for inconsistency in the choice of inference options available for each risk assessment component and in the conclusions based on those choices. Proponents of guidelines contend it is often difficult even to know whether there is consistency among risk assessments, because of lack of explicit documentation of inference options used.
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From page 71... ...
: The report is a significant step toward the formulation of a national cancer policy. AIEC supports the report's stated objective of ensuring that regulatory agencies evaluate carcinogenic risks consistently.
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From page 72... ...
Guidelines published as established procedures would be the best option, for the regulatory agencies would not change their procedures without formal notice, but the procedures would not be binding on the regulated parties. Evolutionarv Improvement of the Risk Assessment Process Proponents of guidelines argue that their use provides a locus for debate, examination, and revision of the selected inference options generally used in risk assess meet.
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From page 73... ...
Administrative Efficiency Some contend that when risk assessments are performed on a chemical-by-chemical basis without the use of guidelines, too many agency resources are devoted to reargument of the same issues with regulated parties. For example: should animal carcinogenicity data be used to assess human risk?
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From page 74... ...
DISADVANTAGES OF GUIDELINE USE Oversimplification The adoption of guidelines may foster a cookbook approach to risk assessment. The more assessors look at chemicals from a generic point of view, the less they are able to draw distinctions among them on We basis of specific data.
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From page 75... ...
~ Detailed guidelines can reduce the possibility of oversimnlif ~ cation if the intent of detail Is to capture for the assessor the cc$pplex~ty of the issue addressee. For example, a guideline might state the scientific basis for the chosen inference option, Me kinds of evidence that are typically applicable, circumstances in which accept tance of exceptional evidence may be appropriate, and other rationales for choosing a particular inference option.
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From page 76... ...
Consider, for example, the American Industrial Bealth Councilts criticism of the IRVING guidelines (ATTIC, 1980) : When the IREG report speaks of the importance of using conservative methods or assumptions so as not to underestimate human risk, the report is mixing regulatory considerations into the so lent tific function.
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From page 77... ...
Guidelines very different from the kinds described could be designed to be devoid of Disk assessment policy choices. They would state the scientifically plausible inference options for each risk assessment component without attempting to select or even suggest a preferred inference option.
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From page 78... ...
OSLO responded to this criticism by incorporate ng three amendment procedures into its cancer policy: a genera' review of the guidelines every 3 years by the directors of the National Cancer Institute, the National Institute of Environmental Health Sciences, and the National Instztute for Occupational Safety and Bealth; recommendations at any time from the National Cancer Institute, the National Institute of Environmental Bealth Sciences, or the National Institute for Occupational Safety and Health; and petitions from the public. Final amendments would occur only through formal, independent rule making, to ensure that major changes in the guidelines would not be made during the litigation of individual cases.
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From page 79... ...
CPSC's guidelines were not comprehensive and dealt mainly with hazard identification; they had no regulatory status. FDA's proposed sensitivity~of-method guidelines are cow prehensive and detailed for dose-response assessment and exposure assessment; they are regulations.
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From page 80... ...
First, the use of different guidelines by the agencies could undermine the credibility of their risk assessments. Critics of an agency risk assessment might argue persuar sively that another agency estimates risk differently, on the basis of a different set of inference options.
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From page 81... ...
Whereas guidelines for the identification of hazard and for the quantitative estimation of risk in test animals may be commonly applied, no such con basis exists for applying exposure assessment guidelines. 4 Even well-desi~ned guidelines mav be unsuccessful unless: .
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From page 82... ...
ALEC comments on: A Report of the Interagency Regulatory Liaison Group (IRKING) , Work Group on Risk Assessment, entitled Unscientific Basis for Identificar tion of Potential Carcinogens and Estimation of Risks,.
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From page 83... ...
1980a. Mutagenic~ty risk assessments; proposed guidelines.
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From page 84... ...
PL/1965/10, t~IO/Food Add./26.65. Joint Food and Agricultural Organization and world Health Organization Expert Committee on Food Additives.
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From page 85... ...
1982. Identif ication, classif ication and regulation of potential occupational carcinogens.
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