The role of science in EPA decision making Better information is needed on ways to manage research, develop criteria and set standards, analyze risks, and further distinguish between science issues and policy issues
Richard M. Dowd Environmental Research & Technology Washington, D.C. 20006 Terry F. Yosie Environmental Protection Agency Washington, D.C. 20460
The US. Environmental Protection Agency administers various statutes, all of which require the agency to collect and evaluate scientific data for eventual use in developing and implementing regulations. Each law, however, imposes a distinctive set of data management requirements and a unique information burden upon EPA program offices. The Toxic Substances Control Act (TSCA), for example, requires the use of quantitative risk assessments in evaluating the potential health hazards of new chemicals and provides for consideration of economic factors in determining whether identifiable risks are unreasonable risks. The Clean Air Act, on the other hand, does not allow economics to play any role in setting National Ambient Air Quality Standards (NAAQS) and in fact requires that the standards be based on an adequate margin of safety. This interpretation assumes that there will be no residual risk to populations at air pollution concentrations below the standard. Regulations, and the scientific and technical information supporting them, are developed to carry out statutory mandates, which may be divided into two classes: pollution abatement regulations that reduce or eliminate existing environmental problems, such as toxic and conventional water pollutants, and prospective regulations 0013-936X/81/0915-1137$01.25/0
that identify and control anticipated or potential hazards to the environment and public health or that control new and possibly hazardous uses of existing practices. Examples of prospective regulations are the Premanufacturing Notification Program and Significant New Use Rules developed under TSCA, the Clean Air Act requirements for the New Source Performance Standards, and sections of the Resource Conservation and Recovery Act which relate to the generation, transport, and disposal of hazardous wastes. Implementation of these regulations results in various kinds of decisions. These include the control of individual pollution sources or classes of pollution sources, issuance of permits, regional environmental quality management, and administrative policy decisions that extrapolate from scientific data
@ 1981 American Chemical Society
and lead to multipollutant or multimedia strategies for pollution abatement and control. To a degree, each decision is based upon scientific and technical data. This paper will discuss the role of scientific information in four areas related to EPA's mandate to protect public health and environmental quality. These areas are research management, distinctions between science issues and policy issues, criteria development and standard setting, and risk analysis. Finally, the authors recommend ways to improve the process by which scientific data is evaluated by EPA and the public and incorporated into standard-setting actions by agency decision makers. Perils of research management Numerous procedures have evolve0 and, to a degree, been implemented to Volume 15. Number IO,October 1981
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Issues characterized by “murky” distinctions between science issues
ensure that high-quality data are available for decision making. Quality assurance programs, protocols for conducting scientific studies, and peer review-of research results are examples of such procedures. Evaluation of scientific and technical information provides the basis for making policy choices within certain boundaries. The following are two examples of health studies that are performed to determine scientific boundaries: Blood level measurements of carboxyhemoglobin as a function of exposure to carbon monoxide are used to identify the range of reported health effects that an NAAQS for carbon monoxide must protect against; c a n m risk assessments for chloroform in drinking water are used to calculate risk estimates for various levels of control. Ideally, the boundaries of policy choice provided by scientific data are well defined and policy decisions represent the final sequence in a continuum of scientific evaluation. 1%many cases, however, there exists considerable uncertainty in the establishment of these scientific boundaries. To reduce uncertainty, Congress has directed and funded EPA to sponsor research to aid the development of regulations. Research as conducted by a regulatory agency is an extremely fragile undertaking. Congressional appropriation cycles for research impose time frames that often do not coincide with the research community’s capacity to generate needed information. In addition, the tendency of regulatory agencies and congressional committees to exhibit a “pollutant-of-the-year” syndrome results in a continual~redefinition of research priorities and the reprogramming of research budgets. Such redefinition deters planning and thc integration into regulatorv decision makingof longer-term bas6 research in such areas as atmospheric chemistry, modeling, and mechanisms of pollutant toxicity. The congressional appropriation process and the pollutant-of-the-year syndrome affect the time span during which research must be completed and often cause emphasis to be placed on short-term results. Within EPA, for example, I3 research committees, 1138
Environmental Science d Technology
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composed of representatives from the Office of Research and Development (ORD) and regulatory offices, plan and carry out research to support regulation development. This joint planning process is in response to the congressional mandate that EPA generate research that is related to its regulatory programs. In general, program offices have been able to direct the research agenda of these committees by demonstrating a need for short-term studies to support a particular standard-setting action. At times, conflict between ORD and program offices over research priorkieshas resulted in reductions of ORD’s budget and personnel ceilings after the priorities were ranked in the budgetary process. If the research committees’ focus is solely on shortterm results, however, development of a scientific data base for standard setting may be inhibited in such fundamental areas as atmospheric chemistry, chronic exposure to pollutants, and population studies. Research within the agency is also subject to various unpredictable changes in both EPA and congressional budget processes. In the budget cycle, research is viewed as a series of
isolated events rather than as a sequence of results, each building upon the other. Consequently, research projects are often closed down after completion of a specific set of results for a particular regulatory activity, and both dollars and personnel are reassigned to other activities, such as abatement or enforcement. The infrastructure for maintaining a highquality research staff is extremely sensitive to these constantly changing decisions on research priorities and budgets (I). One approach to mitigate these and other difficulties which impede research planningand theestablishment of scientifically supportable standards is a research partnership between the federal government and the private sector. An example of such a partnership is the Health Effects Institute, created by EPA and the automobile companies to plan, sponsor, and review research related to mobile-source pollution. This concept, which includes protocols to ensure quality control of data and independent review of research results, could be expanded to include cooperative research ventures between EPA and the chemical industry, the synthetic fuels industry, and steel companies, to name just a few. These endeavorswould result in the following benefits: The adversarial relationship between EPA and regulated industries would be reduced by a demonstration of their common commitment to research in the public interest. There would be protection from upswings and downswings in the budgetary cycle, which would ensure continuity in research planning and results. Funding of new research areas would generate leadership positions and intellectual capital for both the federal government and the private sector (2). Science issues 81 policy issues Scientists and policymakers mutually strive to obtain high-quality scientific data for use in regulation development. At the same time, each group pursues distinctive paths toward the generation and ultimate use of such information. The scientific community
Documents EPA should h a v e beforernakina a final decisioRa
I
A “criteria document“ ti identifiesand interorets the effectr ~~~~. 1 a pollutant report& in the scientlnc literature relies upon a series of hypotheses, group of scientists recently proposed A “scientific issues staff papw” concepts, laboratory practices, and five guidelines for determining bawd upon the criteria document ti criteria and protocols for study develwhether data from a population-based identifies and interprets the “kc opment and peer review. The product study is scientifically acceptable for studies which serve as the of this scientific method is the puhlisetting ambient air quality stanbasis fw astandard a n d h t cation of results in the open scientific dards: the irnplicatlons of these s literature, which helps to ensure that The study has been reported in protecting the public health and e data is carefully produced and that the open literature. even limited information is of high Concentrations of the pollutant quality. under study were reported. Policymakers, on the other hand, Major confounding factors were employ a different set of criteria for controlled, particularly temperature in evaluating scientific data. While critstudies of acute exposure, and smokically concerned with quality, they are ing, race, and socioeconomicstatus in equally concerned with the utility of eve of protection offered. studies of chronic exposure. data for standard setting. Not all sciThe findings pertain to concenentific data are of equal value for the tration levels in the range under cona Both witerk docurn& and %le development of regulations. For exstaff papers should be pubikh. reviewed. sideration for standard setting. ample, many studies concerned with The data collection, analysis, and criteria air pollutants were carried out interpretation were free of error or at concentration levels that greatly determination of which sensitive pop- potential bias which could substanexceeded population exposure condi- ulations or species to protect, evalua- tially affect the results (4). tions to be controlled in the ambient tion of where the line of uncertainty in Alternatives developed for other air. scientific data is to be drawn and how kinds of scientific studies provide In addition, policymakers must ex- conservative an interpretation to adopt guidelines to assess such factors as setrapolate beyond scientific data into an for scientific data, whether to protect lection of organisms for bioassays area of uncertainty in order to protect against any identifiable health or en- based upon their ecological signifipublic health and welfare. This “pre- vironmental effect or only adverse ef- cance in the environment; measureventive” approach to regulation, re- fects, legal requirements such as ment of environmental parameters quired by law and mandated by the court-imposed deadlines for rendering such as salinity, temperature, hardcourts,is evidenced in the process EPA a decision, and procedural aspects of ness, pH, and dissolved oxygen; and used to develop controls for airborne decision making, such as public par- intercomparison and interconversion carcinogens and criteria for toxic water ticipation. of results from studies using different pollutants. Many times, the conceptual dis- protocols. In evaluating reported effects levels tinctions between science issues and Such guidelines are useful for evalresulting from pollutant concentra- policy issues are either limited or uating the quality of particular studies, tions, decision makers must also de- nonexistent. This conceptual vacuum but given the diversity of conditions termine the most resource-efficient impedes both scientists and policy- under which studies are designed and methods for implementing a research makers in making explicit the basis for the responses which they measure, no or control strategy. This factor partly scientific or value judgments. It also set can be all-encompassing nor should explains the tendency to rely upon a blurs the important distinction be- it be applied dogmatically. Otherwise, representativesurrogate for a pollutant tween evaluation of scientific infor- very few studies would qualify as adclass, rather than testing every species, mation and estimation of risks (a sci- equate for use in standard setting. and the selection of certain population entific determination), and the acEPA, because of legal requirements subgroups for measuring effects pro- ceptability of given levels of risk (a and administrative decisions, has made duced by exposure to pollutants. social/policy decision) (3). To render extensive use of scientific guidelines to Some of the major factors that in- more explicit the scientific basis for support its standard-setting activities. fluence policymakers as they judge the policy choices the EPA administrator Such guidelines, and the studies to value of scientific data are identifica- should have the benefit of at least three which they apply, have been compiled tion of areas where knowledge is defi- kinds of documents (see box above). in “criteria” documents that identify cient, definition of areas of disagreepublic health and environmental efment among experts, examination of Development of criteria &standards fects reported in the scientific literaa composite of scientific data rather The scientific and technical data ture and that furnish thescientific and than isolated portions, and evaluation used by EPA in the development of technical basis from which decision of “key” studies that shape a policy standards and policy statements should options are generated. Examples of choice. be consistent and of high quality. EPA criteria documents include: In addition, policymakers must be Thene is, however, an unavoidable air quality criteria documents, concerned with a number of trans- degree of judgment and subjectivity which EPA is legally required to prescientific or nonscientific issues during involved in determining what factors pare before proposing a National the decision-making process, including constitute a good scientific study. One Ambient Air Quality Standard ~
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The advantages of risk analysis.
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and value judgments explicit.
health assessment, exposure assessment, and cancer risk assessment documents developed to assess scientific studies prior to a decision on whether or not to list an air pollutant as hazardous under Section 112 of the Clean Air Act pollution control guidance documents that will contain scientific and technological assessments that EPA will use as the basis for developing technology-based standards for synthetic fuel plants water quality criteria for the protection of aquatic life and human health developed to provide the scientific and technical basis for water quality standards to control toxic water pollutants. The content and quality of EPA criteria documents vary widely. There is a tendency for some to become encyclopedic literature surveys rather than critical and interpretive assessments. Also, as one examines their development within various offices of the agency, it becomes obvious that there is no internally consistent methodology for the review of scientific data contained within these documents. The lack of consistency impedes thepublic’s ability to review the role of scientific data in the standard-setting process for various pollutants.
ments after the basic risk analysis has been esta It ensures that ?--‘ decisions will consi technical and nonte
PAS use of risk
the
Office of Pesticides
Risk analysis & standard setting Through statutory direction and administrative decision, EPA sponsors scientific research and conducts scientific assessments to determine the level of protection for public health and the environment. One set of approaches and methods that has evolved to address these issues is known as risk analysis. Risk analysis has been defined as a “logical procedure used io evaluate the probabilities of specified events occurring, and the consequences of each such occurrence.” It consists of scientific data collection, assessment of the probabilities of risk based upon available scientific data, and the evaluation of risks based upon their probabilities as governed by the risk assessment process and their relative importance as determined by the policymaker ( 5 ) . A comparison of risks within a particular regulatory conttxt may be a useful decision-making tool, but 1140
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comparisonsgoing beyond the context
’ of one statute to several statutes, or
from one risk situation to a different risk situation, is a scientifically questionable practice. Where scientific data are insufficient to assess the risk to public health per unit of chemical, exposure assessments may prove useful in determining the degree of hazard. (Exposure assessments are the total amount of a contaminant that a pop ulation has been exposed to over a given time period.) The use of risk assessment by EPA has had a mixed record. The agency has focused on assessing cancer risks but has tended to neglect the noncancerous effects, which may be equally hazardous to public health. More emphasis also needs to be placed upon
the development of exposure assessments, for exposure data can often prove useful in targeting areas for public health protection when toxicity data for particular pollutants are less definitive. Finally, it is not clear that the agency has utilized risk assessment to identify regulatory priorities. Risk assessment should be considered part of any cost-benefit calculation because good scientific data, properly assessed, is the partner of good economics. What is a supportable standard? The standard-setting process is composed of many links in a decisionmaking continuum that includes both science and policy issues. Many of these links, such as the peer review of research results, are subject to quality controls; others are not so verifiable. A general consensus exists among scientists and policymakers that improving the quality of these links is a precursor to better decision making; but few criteria have been developed by these groups to evaluate the regulations and standards that represent the product of this science/policy continuum. It is highly unlikely that a consensus or resolution of scientific uncertainties will occur in the near future. Given these circumstances, how can the scientific and policy communities determine the scientific adequacy of standards? Two principles are offered as a guide through this dilemma. First, EPA and other regulatory agencies should state the levels of protection a standard is designed to provide and then compare this level to the degree of certainty the scientifc evidence can support. Incorporated within this principle are the use of risk analysis to quantify or qualify the evaluation of scientific and technical data, definition of key studies which support a proposed standard, declaration of both the extrapolation that occurred beyond the data base and the acceptability of a given level of risk as determined by the agency, and identification of the nonscientific policy issues that influenced the setting of the standard. Second, the process f o r arriving at a regulatory decision is inseparable from the decision itsew The contro-
Eliminate the hazard instead of the chemical
...
versy and uncertainty that surround scientific data and their use in standard setting stems in large part from the procedures used by regulatory agencies to evaluate scientific data. Regulatory offices frequently resist public scrutiny of their scientific assessments prior to publication of proposed standards for public comment in the Federal Regisfer. The result of this practice is that the public sees its comments as a pro forma exercise. When public groups comment on agency.documents and decisions, EPA catalogues and responds to the comments; but these groups often perceive that they do not affect the final decision and thus they frequently have little incentive to pronounce either the decision or the review process leading up to the decision as scientifically acceptable. The result of this approach is often a race to the court house. As an alternative process for scientific review, EPA could solicit comments from environmental and industrial groups and request their participation in advisory committee meetings. An EPA advisory committee traditionally reviews scientific data that have been compiled and interpreted by the agency. This concept should be expanded to include the review of ranges of standards prior to their formal proposal in the Federal Reg-
discussions among a wide range of individuals and groups concerning both the scientific evidence and the decision-making process. These discussions would enhance the possibility of a consensus that the agency's interpretation of scientific data was open and acceptable despite numerous scientific uncertainties. References
Servalional Studies."
publication.
p.
6. submitted for
( 5 ) Wilson. Richard: Harrington. Joseph
J.
"Business Roundtable Air Quality Project": Vol. 1.p. I .
The views stated in this paper are the personal views of the authors and do not rep resent officialpolicy of their affiliatedorganizations.
ister.
In addition, steps should be taken to ensure the independence of the agency's scientific advisory committees. Professional societies or other groups such as the National Academy of Sciences could, for example, be invited to nominate a pool of individualsas one source from which the administrator could select committee members. Private citizens should also participate in advisory committee meetings to present new scientific data and offer alternative interpretations of data presented by the agency. Several advantages would result from this approach: It would require EPA to articulate its interpretation of scientific evidence and the relationship between such evidence and the proposed standard; public groups would participate in the process of scientific review prior to the agency's commitment to a standard; and the advisory process itself would facilitate serious
Richard M. Dowd (iefi) i.s nranager, Poiicy Armiysis Division, Encironmentai K r search and Technology. Washington. D.C. He preuiously served as EPA's acting assistant administrator /or research and deueiopment and as the executive director of EPA's Science Advisory Board. His experience in gouernment/sciencedecision making includes nine years at executiveoJfice, congressional, and state levels.
Terry E Yosie (right) is acfingdirectorof EPA's Science Advisory Board. H e is also the executive secretary of the Clean Air Scientific Advisory Committee, a congressionally established advisory committee charged with reviewing rhe scientific basis OJ National Ambient Air Quality Standards.
P 0 k x 1368 lanerv~lle.Wisconsin 53547 A Divsbon of Scimce R r l a l d Matenair Inc
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