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6 F[NDING: EPA requires that its scientific research products undergo peer review. However, the Agency does not have a uniform process to ensure a minimum level of quality assurance and peer review for all the science developed in support of Agency decisionmaking. RECOMMENDATION: Quality assurance and peer review should be applied to the planning and results of all scientific and technical efforts to obtain data used for guidance and decisions at EPA, induding such efforts in the program and regional offices. Such a requirement is essential if EPA is to be perceived as a credible, unbiased source of environmental and health information, both in the United States and throughout the world. 7 FINDING: A number of outstanding externally recognized scientists work at EPA. However, the Agency lacks the critical mass of externally recognized scientists needed to make EPA science generally credible to the wider scientific community. ,' RECOMMENDATION: EPA should recruit four to six research scientists or engineers with world-dass reputations and provide them with a significant, long-term commitment of support. These individuals should be national and international leaders in scientific areas vital to the Agency's long-term strategy and direction. They would serve as mentors for developing scientists and provide access to networks of world-dass scientists. 86VEMV09 Executive Summary 7

MAJOR FINDINGS _ AND RECOMMENDATIONS (COrTrIIVUED) 8 FINDING: For EPA to establish a reputation for having high-quality science to support its decisionmaking, its science activities must become more widely known. Academia, Congress, other federal agencies, industry, and the public generally are unfamiliar with the work of EPA scientists. RECOMMENDATION: The Agency should undertake a communications, outreach, and education effort to publicize the activities and accomplishments of EPA scientists. 3' FINDING: EPA often does not evaluate the impact of its regulations. Implementa- tion of an environmental policy or regulation provides a unique opportunity to study the environmental response to changes brought about by regulations, such as changes in the type and amount of pollutants. RECOMMENDATION: The Agency should scientifically evaluate the environ- mental improvements brought about by the major regulations it promulgates. This will help EPA better understand the effectiveness of its regulatory strategies and how those strategies affect environmental processes. s099CM9

09a9999t0Z 10 FINDING: EPA science could benefit substantially from increased scientific contact and openness with other organizations. RECOMMENDATION: The Agency should encourage increased participation of its scientists in the activities of the scientific community. It should enhance relationships with other federal agencies and appropriate industrial and academic research organizations and promote the participation of EPA scientists in the technical activities of professional societies. I 11 i FINDING: EPA has not consistently enlisted the nation's best scientists to provide the research and technical information needed for decisionmaking. Problems in the Agency's approach to academic grants and centers have discouraged many university-based experts from working with EPA. In addition, the program and regional offices and ORD laboratories often rely on contractual mechanisms that prevent EPA from obtaining the best outside scientists to work on EPA issues. ,r . RECOMMENDATION: EPA should move quicldy to bolster its grants and centers program. The Agency also should implement a long-term plan to replace contractual mechanisms that may be detrimental to obtaining the best possible scientific information. Executive Summary 9

The Expert Panel EPA's 1991 statement of strategic direction (Appendix A) calls for sound science to serve as the foundation for the Agency's policy and program decisions. In May 1991, EPA Administrator William K. Reilly established the Expert Panel on the Role of Science at EPA as an independent advisory committee to the Agency under the Federal Advisory Committee Act. The Panel, consisting of Drs. Raymond C. Loehr (Chair), Bernard D. Goldstein, Anil Nerode, and Paul G. Risser, was charged with developing recommendations to help the Agency achieve the following goals: • Identify how best to provide the Administrator with up-to-date, objective scientific information in keeping with the Agency's new strategic direction. • Ensure that the knowledge base necessary to achieve the new vision is available through proper planning, adequate resources, and necessary leadership. • Ensure that the research and scientific information needs of the programs and regions are adequately met and their views incorporated in the scientific advice provided to the Administrator. • Enhance the stature of science within EPA and among the many constituencies with which the Agency interacts. , The Administrator asked the Panel to work with the Assistant Administrator for Research and Development and other EPA offices to accomplish this task and asked the program Assistant Administrators to cooperate fully in this endeavor. Additional details about the charge to the Panel and the affiliations of Panel members are included in Appendix B.

The Administrator asked that the Panel report back with its recommendations in four to six months. Given this short time frame, the Panel decided to rely primarily on interviews with key science and policy leaders, both within and outside EPA, to identify areas of concern and generate ideas for solutions. The Panel did not conduct any other independent evaluation of science at EPA; it did not review current research programs, visit EPA laboratories, or examine reports and data generated by the program and regional offices. Over a period of four months, the Panel held three public meetings to discuss the role of science at EPA. It also interviewed more than 30 individuals from EPA, other government agencies, industry, environmental groups, and other organi- zations. These discussions took place in dosed fact-finding sessions to ensure an open expression of views. Because the time available for interviews was limited, the Panel also requested written comments. More than 25 individuals, mostly from the EPA regional offices, sent written comments to the Panel. Appendix C lists the individuals interviewed by the Expert Panel and Appendix D lists those who attended the public meetings or provided written comments. The Panel completed its fact-finding in September 1991. The Panel thanks everyone who attended the public meetings, participated in discussions, and submitted comments for their candid and helpful input, The Panel apologizes to the many people it was unable to interview in person. During the meetings and discussions, the Panel focused its attention on five topics crucial to the acquisition and use of sound science in support of decision- making at EPA: • The mission and direction of EPA science. • The quality of science at EPA. • The quality of scientists at EPA. • How the budget process affects science at EPA. • How EPA uses science in decisionmaking. zo~szESV~z~ The Expert Panel 11

12 The Expert Panel In this report, the Panel uses the term "science" in its broadest sense: it encom- passes a range of activities, including research and development, technical and regulatory support, monitoring and data collection, review and interpretation of technical studies, and assessments of health and environmental risks. By using this definition, the Panel intentionally includes the scientific activities conducted by EPA program, policy, and regional offices; these activities are part of the science EPA uses in its decisionmaking. The Panel also includes the quantitative social sciences, such as economics, as well as the biological, chemical, and physical sciences. A number of consistent concepts and views emerged during the Panel's fact- finding process. Everyone who spoke with the Panel agreed that EPA needs its own strong science base to carry out its mission effectively. At the same time, all i?kpressed concerns about the quality of EPA science and encouraged improve- ments in the way EPA uses science in decisionmaking. The following pages detail the Panel's findings concerning science at EPA and recommendations for addressing those concerns. These findings and recommendations represent the Panel's synthesis and evaluation of the ideas provided in the interviews, public meetings, and written comments.

Background T he basic mission of EPA is to preserve and improve the quality of the environ- ment, protect human health, and safeguard the productivity of natural resources on which all human activity depends. In carrying out this mission, EPA must implement the programs mandated by law as its first priority. However, it has responsibilities beyond the activities mandated by legislation. It also must provide leadership on the scientific and policy issues involved in environmental protection. In addition, EPA must develop, evaluate, and use risk reduction strategies, including those that go beyond the conventional command-and- control regulatory approach, in varying political, cultural, and social contexts. Frevious advisory reports stressed that EPA needs a strong scientific base for its decisions. Future Risk: Research Strategies for the 1990s (1988, SAB-EC-88-040) and Reducing Risk: Setting Priorities and Strategies for Environmental Protection (1990, SAB-EC-90-021) made many recommendations about science at EPA. Fu- ture Risk, for example, recommended that EPA plan and implement a long-term research program in specific core research areas, improve its capability to anticipate environmental problems, and expand its efforts to understand how and to what extent people are exposed to environmental pollutants. Reducing Risk argued that, to take advantage of the best opportunities to reduce risk, EPA must improve the data and analytical methodologies that support the assessment, comparison, and reduction of different environmental risks. Many changes are under way in ORD, the program offices, and the regional offices to bring about needed changes in EPA science. This report builds on previous advisory reports to EPA, current activities within EPA, and the knowledge of individuals in other government agencies and the private sector who have faced similar problems in providing high-quality science for decision making. The report focuses on structural changes to ensure that EPA science can help the Agency realize its new vision for environmental protection. These findings and recommendations are another building block in EPA's efforts to safeguard human health and the environment. tQ~998 9V09" Backgmtmd 13

R hI I THE ROLE OF ~ecording to EPA's 1991 statement of strategic direction (Appendix A), EPA is SCIENCE AT EPA .[ lcommitted to ensuring that national efforts to reduce environmental risk are based on the best available scientific information communicated clearly to the public. EPA should be a credible source of science information for all parties within and outside EPA. To achieve this goal, the Agency must acquire scientific information from its own programs as well as from industry, academic institutions, other government agencies, private organizations, and other nations. A key role of science at EPA is to reduce uncertainties in environmental decision- making. While scientists have made significant progress in measuring and com- paring risks to human health and the environment, many uncertainties remain. For example, most of our current knowledge concerning how humans respond to environmental pollutants comes from research with laboratory animals under conditions very different from those that humans actually experience. Many uncertainties, therefore, are involved in deducing how the information gained through this laboratory research applies to people. Other areas of uncertainty include the impact of chemical mixtures and other general stressors on the environment. People and ecosystems are exposed not simply to single chemicals, but to mixtures of different chemicals. The environment is also affected by complex, diffuse factors such as temperature changes, habitat loss, and ozone depletion. EPA historically has focused on chemical-specific impacts and has not developed methods to assess or control the effects of chemical mixtures and general stressors on humans and ecosystems. Science is especially necessary to characterize today's subtle and complex environmental problems that cut across all environmental media (air, water, and land) and transcend national boundaries, such as loss of species diversity, acid deposition, and stratospheric ozone depletion. Science, in fact, is inherently cross-media and international in nature and can be the catalyst for focusing greater attention on cross-media environmental issues. Science is also key to determining which environmental problems pose the greatest risks to human health, ecosystems, and the economy. In the absence of sound scientific information, it is likely that high-profile but low-risk problems will be targeted, while more significant threats are ignored. When science and q 0 ~g 9 G9V 101 9 I,. 1 1 R,..Lnrnijnd

data are uncertain, regulations and policies are often developed to protect every person or every ecosystem uniformly against hazards that few will actually experience. This can impose a heavy burden on the economy and society without providing better protection for most of the population or the nation's ecosystems. The technical support programs maintained by EPA and other agencies are essen- tial to developing the scientific information needed to accurately gauge the costs and benefits of proposed regulations and nonregulatory strategies. In addition, science is critical for developing cost-effective strategies to reduce environmental risks. It provides a foundation for the Agency's efforts to make greater use of alternatives to traditional approaches to risk reduction, to develop and improve pollution control technologies, and to identify changes that all sectors of society can make to prevent or reduce pollution. Finally, science is needed to help anticipate future environmental problems. For example, carefully structured monitoring programs combined with rigorous analysis can paint an accurate picture of present conditions, describe what is happening to an individual or an ecosystem over time, and help predict the environmental consequences of future actions. If scientists can identify emerging environmental trends and their consequences, EPA and the nation can take steps now to reduce the risks posed by these trends, rather than pay the much larger costs to address problems that have evolved to maturity. r In short, science is one of the soundest investments the nation can make for the future. Strong science provides the foundation for credible environmental decisionmaking. With a better understanding of environmental risks to people and ecosystems, EPA can target the hazards that pose the greatest risks, anti- cipate environmental problems before they reach a critical level, and develop strategies that use the nation's, and the world's, environmental protection dollars wisely. Backgmund 15 I

The Mission and Direction of EPA Science EPA's environmental protection strategies are undergoing important shifts--for example, toward setting risk-based priorities, a greater emphasis on pollution prevention, and increased attention to reducing ecological risks. To support and help define tl=~ ; changes, the mission and direction of EPA science must evolve as well. In addition, because limited resources prevent EPA from being equally strong in all areas, the Agency must clearly define the mission and direction of its science activities. Other organizations (such as other government agencies, academic institutions, and industry) have strong programs in scientific and technical areas perhnent to the interests of EPA; information from those programs should be available and used for EPA guidance and decisionmaking. Therefore, it is impor- tant to identify the scientific areas in which EPA should maintain its own strength. The Panel addressed the following questions regarding the mission and direction of EPA science: • In which scientific areas should EPA be a leader, and in which should it be primarily a catalyst for and a user of information? • How can the Agency be aware of and acquire information from the broader scientific community? • How is the Agency's strategic planning process shaping the mission and direction of EPA science? • To what extent is EPA's desire to base decisions on the best scientific information recognized outside EPA? • What is the perception of EPA science in the broader scientific community and among decisionmakers who draw upon scientific and technical knowledge? 1 h Mis4inn and Nrrctir.n