Science and Decisions Advancing Risk Assessment (2009) / Chapter Skim
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2 Evolution and Use of Risk Assessment in the Environmental Protection Agency: Current Practice and Future Prospects
2 Evolution and Use of Risk Assessment in the Environmental Protection Agency: Current Practice and Future Prospects
Pages 26-64
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From page 26... ...
This chapter first describes the diverse statutory requirements that have led to a broad array of agency programs with correspondingly varied approaches to risk assessment; it then highlights current concepts and practices, outlines EPA's multifaceted institutional arrangements for managing the process, and identifies extramural influences. The record shows that EPA continually updates the process with new scientific information and policies, often in response to new laws or advice from advisory bodies as to general principles or individual assessments.
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From page 27... ...
For example, Clean Air Act provisions related to four air-pollution topics use different terms for what is essentially the same statutory finding: • Clean Air Act provisions related to pollutants regulated as national ambient air quality standards are designed to "protect the public health with an adequate margin of safety" (CAA § 109, emphasis added)
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From page 28... ...
Despite differences in statutory language, environmental media, and pollutants, several factors common to the major statutes continue to shape EPA's regulatory structure and function and its perspectives on risk assessment: • The emphasis in each statute on protecting human health and the environment provides the basis of EPA's purported conservative approach to risk assessment. Examples range from generic "adequate margin of safety" language in the Clean Air Act (CAA)
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From page 29... ...
The Pivotal Role of the Red Book The 1983 National Research Council Report During the 1970s, the scientific assessment practices of EPA and other federal agencies faced with similar responsibilities -- the Occupational Safety and Health Administration, the Food and Drug Administration (FDA) , and the Consumer Products Safety Commis ection S 109 of the CAA of 1970 is the most often cited example; note, however, that the statute expressly provides for consideration of costs, feasibility, and other factors in state implementation plans (§ 110)
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From page 30... ...
directed that FDA support a National Research Council study of the "merits of an institutional separation of the scientific functions of developing objective risk assessments from the regulatory process of making public and social policy decisions and the feasibility of unifying risk assessment functions." The National Research Council organized the Committee on the Institutional Means for Assessment of Risks to Public Health in October 1981, and the committee's report, the Red Book, was issued on March 1, 1983. In his letter transmitting the report to the commissioner of FDA, the chairman of the National Research Council, Frank Press, stated, The Congress made provision for this study to strengthen the reliability and objectivity of scientific assessment that forms the basis for federal regulatory policies applicable to car cinogens and other public health hazards.
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From page 31... ...
The Red Book nowhere calls for any other type of "separation" of the two activities. Second, the phrase "policy judgments embodied in risk assessment" (which are said to be different in kind from those involved in risk management)
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From page 32... ...
The development and consistent use of technical guidelines for risk assessment, with the specification of all the necessary defaults, were seen by the Red Book committee as necessary to avoid the institutional separation of scientific assessment from policy development and implementation while minimizing inappropriate and sometimes invisible policy influences on the risk-assessment process. As noted later in this chapter, some critics of the Red Book have raised the concern that the committee's commendable effort to avoid "inappropriate influences" can readily be taken to mean "no influence" from risk managers and other stakeholders.
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From page 33... ...
Draft guidelines are peer-reviewed in open public meetings and published for comment in the Federal Register. In general, each guideline follows the 1983 Red Book paradigm, providing guidance on the use and interpretation of information in each field of analysis, including the role of defaults and assumptions and approaches to uncertain ties and risk characterization.
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From page 34... ...
6) : The analytic-deliberative process leading to a risk characterization should include early and explicit attention to problem formulation; representation of the spectrum of interested and INTEGRATED RISK ASSESSMENT STAKEHOLDER PARTICIPATION Problem Formulation With Hazard Identification RISK MANAGEMENT Analysis Characterization Characterization Dose Exposure of of Response Assessment Exposure Effects Assessment Risk Characterization FIGURE 2-2 The World Health Organization's framework for integrated health and ecologic risk as Figure 2-2.eps sessment.
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From page 35... ...
The 1994 National Research Council report Science and Judgment in Risk Assessment evaluated EPA's risk-assessment practices as they apply to hazardous air pollutants from sources subject to Section 112 of the CAA amendments of 1990. That report did not alter the principles for risk assessment set forth by the Red Book but rather examined EPA guidelines and practices and then recommended ways in which various technical improvements in the conduct of risk assessments and in the presentation of risk characterizations might be accomplished.
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From page 36... ...
The implementation table in Appendix D isolates and highlights National Research Council recommendations on selected risk-assessment topics with relevant EPA responses as documented in a recent EPA Staff Paper (EPA 2004a) , guideline documents, and other EPA sources; it also draws on a Government Accountability Office (GAO)
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From page 37... ...
Documents arrayed here represent major risk assessment reports presented in Tables C-1 and D-1 (see Appendixes C and D)
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. Table D-1 shows a long-standing emphasis on "risk characterization" in both National Research Council recommendations and EPA guidance memoranda, formal guidelines, and other documents (see Box 2-3)
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For example, GAO's survey reports broad-based approval in EPA of the program for developing risk-assessment guidelines in line with 1983 Red Book recommendations for inference guidelines (Table D-1)
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From page 40... ...
follow some of or all of the principles enunciated in the guidelines. Similarly, even with the strong emphasis on identifying uncertainties, explaining defaults, and justifying science-policy choices as critical features of risk characterization in EPA guidance documents (see Table D-1 and Box 2-3)
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. In sum, Table D-1 identifies both EPA guidance responding to National Research Council recommendations and an impressive set of practices undertaken to improve agency risk assessments.
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From page 42... ...
. Despite conformity with the Red Book, approval of peer reviewers (see peer-review history at the front of individual guidelines)
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. In addition to choosing one set of "hard" data over another where necessary, risk assessors identify uncertainties and unknowns at each stage in the process.
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• For carcinogens, a threshold or nonthreshold approach. Exposure assessment can involve an even broader range of uncertainties and related choice points.
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Chapter 6 of the present report provides additional recommendations on developing alternative risk estimates in light of plausible alternatives to defaults. The Red Book points out that "risk characterization, the estimate of the magnitude of the public health problem, involves no additional scientific knowledge or concepts" (NRC 1983, p.
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From page 46... ...
In 1996, Congress set new deadlines for pesticide actions under the FQPA, requiring the agency to reassess the risks of all existing pesticide food tolerances (standards) over a ten year period; that same year Congress enacted a new Safe Drinking Water Act requiring the agency to select five new contaminants each year for decisions on maximum contaminant levels (MCLs)
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From page 47... ...
In addition, the training of scientists, by design, and the embedded cultural traditions, such as requiring p values in tests of significance, instill values of prudence, replication, scientific debate, and peer review as prerequisites of a conclusion characterized as "sound science." This issue is discussed in more detail in Chapter 3. Institutional Arrangements For Managing the Process Consideration of EPA's risk-assessment accomplishments and shortfalls and of the effects of policy and time leads to questions about institutional arrangements for "managing the process," the subtext of the Red Book.
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From page 48... ...
For example, the Office of Water has programs for conducting health risk assessments under the Safe Drinking Water Act (SDWA) and ecologic risk assessments under the Clean Water Act.
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From page 49... ...
The Risk Assessment Forum was chartered in response to recommendations in the 1983 Red Book. Somewhat later, the agency set up a Risk Management Council composed of senior EPA risk managers with oversight 16 n I addition to the ORD laboratories, program and regional offices manage laboratories, such as that in Ann Arbor for the air program, that in Bay St.
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From page 50... ...
In accord with statutory directives, EPA program and regional offices interact with state and local offices on implementation and compliance issues, such as schedules, costs, feasibility, impacts, and enforcement. Regarding regulation development, as indicated earlier, the Red Book emphasis on the "conceptual distinction" between risk assessment and risk management reflects the statutory dichotomy between information used in assessing risk and other kinds of information -- "the public health, economic, social, political consequences of regulatory options" (Figure 21)
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From page 51... ...
The 1990 amendments introduced a two-part scheme -- part technology-based, part risk assessment -- for 189 toxic pollutants regulated under Section 112 of the CAA. The first step directs EPA to identify major emitters of the BOX 2-8 Arsenic in Drinking Water: Uncertainties and Standard-Setting On January 22, 2001, EPA issued a pending standard of 10 μg/L as the maximum contaminant level of arsenic in drinking water.
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From page 52... ...
The CAA takes a different approach in setting national ambient air quality standards for criteria air pollutants (ozone, PM, carbon monoxide, sulfur dioxide, nitrogen oxides, and lead)
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From page 53... ...
to expand the scope of their risk-assessment programs to cover cumulative risks20 and children's risks,21 in combination with related congressional legislation, led to new emphases as to data collection and approaches to risk analysis.22 Furthermore, such provisions as Section 3-301(a) in Executive Order 12898 on environmental justice are highly specific as to the kind of data required: Environmental health research, whenever practicable and appropriate, shall include diverse segments of the population in epidemiological and clinical studies, including segments at high risk from environmental hazards, low income populations, and workers who may be exposed to substantial environmental hazards.
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The present committee did not assess the impact of those and other executive orders on EPA risk assessment. Public Participation EPA relies on information from the public in developing both general principles and risk assessments of individual chemicals.
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From page 55... ...
For example, a subcommittee of EPA's SAB monitored the development of EPA's first guidelines for ecologic risk assessment. Of course, assessments of individual chemicals based on new methods are subject to statutory requirements for peer review, such as the CAA requirement for review of the scientific basis of national ambient air quality standards and the FIFRA requirement for EPA's Scientific Advisory Panel (SAP)
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From page 56... ...
EPA scientists sit on numerous international committees including the IPCS, the International Agency for Research on Cancer (IARC) /WHO, the International Commission on Radiological Protection, and the Intergovernmental Forum on Chemical Safety; participate in the writing of scholarly papers; and conduct risk-assessment training in conjunction with these international organizations.
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. Implementing several of the recommendations in the present report will require additional data and methods related to each of the three analytic fields in the Red Book paradigm.
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This reinforces the Government Accountability Office recommendation that the Administrator of the Environmental Protection Agency "ensure that risk assessors and risk managers have the skills needed to produce quality risk assessments by developing and implementing in-depth training" (GAO 2006, p.
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1986c. Guidelines for Health Risk Assessment of Chemical Mix tures.
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1992c. Guidance on Risk Characterization for Risk Managers and Risk Assessors.
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2003c. Disposition of Comments and Recommendations for Re visions to "Perchlorate Environmental Contamination: Toxicological Review and Risk Characterization, External Review Draft (January16, 2002)
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GAO (U.S. Government Accountability Office)
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2006. Health Risks from Dioxin and Related Compounds/Evaluation of the EPA Reassessment.
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2005. Arsenic in Drinking Water: Regulatory Developments and Issues.
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