APPENDIX
1

Interim Report of the Committee on Research Opportunities and Priorities for EPA

INTRODUCTION

Although the Environmental Protection Agency (EPA) has always been involved in research and development on a range of environmental and ecological issues, the Agency's action agenda historically has been driven primarily by legislation passed in response to public concerns and occasionally by court orders or threatened litigation. This has often resulted in short-term fixes and piecemeal, media-specific approaches aimed at remedying the crisis of the moment.

EPA's Office of Research and Development (ORD), with a 1995 budget of $550 million and approximately 1,900 employees, has primary responsibility for providing scientific input for the agency's decision making. Addressing the often disparate needs of EPA's regulatory and research functions has been a source of tension within ORD. There is an immediate demand for the scientific data necessary to develop environmental standards and regulations. Yet these standards and regulations must be underpinned by a long-term, comprehensive research effort that can place environmental science and engineering on a firmer footing, permit a deeper understanding of the effects over time of various regulatory approaches, develop new control strategies and technologies, and help guide EPA's priorities. Despite its experienced scientific staff, ORD has received criticism over the years regarding both how it conducts research and what kinds of research it undertakes.

Recently, the Agency has increasingly recognized the complexity of many different environmental problems that interact with each other and simultaneously affect air, water, land, plants, animals, and humans. In an era of constrained government spending, there has also been a growing need to identify and focus on the largest environmental risks. This has resulted in a re-examination of how EPA, and particularly its research arm, is organized and how it detects and addresses environmental problems.



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Building a Foundation for Sound Environmental Decisions APPENDIX 1 Interim Report of the Committee on Research Opportunities and Priorities for EPA INTRODUCTION Although the Environmental Protection Agency (EPA) has always been involved in research and development on a range of environmental and ecological issues, the Agency's action agenda historically has been driven primarily by legislation passed in response to public concerns and occasionally by court orders or threatened litigation. This has often resulted in short-term fixes and piecemeal, media-specific approaches aimed at remedying the crisis of the moment. EPA's Office of Research and Development (ORD), with a 1995 budget of $550 million and approximately 1,900 employees, has primary responsibility for providing scientific input for the agency's decision making. Addressing the often disparate needs of EPA's regulatory and research functions has been a source of tension within ORD. There is an immediate demand for the scientific data necessary to develop environmental standards and regulations. Yet these standards and regulations must be underpinned by a long-term, comprehensive research effort that can place environmental science and engineering on a firmer footing, permit a deeper understanding of the effects over time of various regulatory approaches, develop new control strategies and technologies, and help guide EPA's priorities. Despite its experienced scientific staff, ORD has received criticism over the years regarding both how it conducts research and what kinds of research it undertakes. Recently, the Agency has increasingly recognized the complexity of many different environmental problems that interact with each other and simultaneously affect air, water, land, plants, animals, and humans. In an era of constrained government spending, there has also been a growing need to identify and focus on the largest environmental risks. This has resulted in a re-examination of how EPA, and particularly its research arm, is organized and how it detects and addresses environmental problems.

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Building a Foundation for Sound Environmental Decisions In 1994, an EPA report, Research, Development, and Technical Services at EPA: A New Beginning (referred to hereafter as A New Beginning), launched major changes in ORD's program. The implementation of these changes is ongoing, and a new document, the draft Strategic Plan for the Office of Research and Development (EPA, 1995), provides specifics of the mission and goals of the "new" ORD. (ORD's history, the history of external criticism of EPA's research program, and the recent changes are more fully described in a recent NRC review of ORD [NRC, 1995a]). ROLE OF THE NATIONAL RESEARCH COUNCIL As one input to the reorganization process, EPA's Assistant Administrator for Research and Development, Dr. Robert Huggett, requested that the National Research Council examine the proposed changes in ORD and offer advice in two separate but related areas: research management and research content. Accordingly, the NRC established two expert committees with a small overlap in membership to ensure coordination. The first committee, launched in late 1994, is assessing EPA's research and development structure, peer review procedures, laboratory site review procedures, and career development and performance evaluation for research staff. It issued an interim report in 1995 (NRC, 1995a) that was supportive of the changes proposed in A New Beginning (EPA, 1994) and it is scheduled to complete its more comprehensive review by the spring of 1997. This committee, established in December 1995, has been asked to think creatively about ORD's research areas themselves, identifying high-priority topics that will help solve some of the nation's most pressing current and future environmental problems. Experience suggests that pursuit of these research areas may spark entirely new approaches to environmental regulation and management, although many may require relatively long time frames to yield results. SCOPE OF INTERIM REPORT In light of a rapidly changing budgetary and programmatic climate, ORD requested quick feedback on its recently released draft Strategic Plan (EPA, 1995) in the form of this interim report. Because this committee has met only once, and has examined a limited amount of information, the findings described here are necessarily preliminary, based in large part on the expertise and extensive experience of committee members. FUTURE GOALS FOR THIS STUDY The final report of this study, to be issued in the spring of 1997, will explore several broad and difficult questions. What are the most critical environmental

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Building a Foundation for Sound Environmental Decisions issues facing the nation today and likely to face it in the future? What do we need to know to avoid or mitigate unwanted consequences of human actions? What significant environmental research questions need attention? Are there promising new research tools and techniques that might help answer these questions? Are we in need of new approaches to environmental research to meet current and future needs? The committee will also look more specifically at the role ORD can and should play in addressing these questions. What kind of research is most appropriate for ORD's laboratories and staff? Should other capabilities be developed within the labs? What other institutions are conducting, or are able to conduct, the kinds of research identified as most critical? How should ORD monitor and interact with them? This study will not critique past research efforts at EPA or elsewhere, or look at the kinds of research management issues being considered by its companion committee. Its gaze will stay fixed on the future, attempting to anticipate the needs of the approaching new millennium. ASSESSMENT OF ORD'S ''NEW BEGINNING" AND STRATEGIC PLAN ORD's draft Strategic Plan demonstrates a refreshing willingness to tackle the problems identified in numerous previous internal and external evaluations (e.g., EPA/SAB 1990, 1992; MITRE, 1994; NAPA, 1995; NRC, 1993, 1995a, b). Taken together with the New Beginning document discussed above (EPA, 1994), several promising themes emerge. Although long-term planning is extremely difficult in the face of uncertain, inadequate, and fluctuating budgets, it is nonetheless important to undertake the effort. A strategic plan allows limited resources to be used most effectively, and clarifies to others how they will be used. In keeping with this committee's charge, this report only comments on those aspects of the plan that directly influence the selection of research topics. The related NRC Committee on Research and Peer Review at EPA is examining the research management and implementation aspects of the plan. Balance Between Long-term and Short-term Research An important aspect of ORD's new direction is the increased emphasis on long-term, fundamental research. This shift will add to the knowledge base necessary to achieve scientifically sound, cost-effective decision making in the future. Increasing the percentage of projects with a long-term focus is also an important step towards enhancing EPA's credibility as a scientific organization and achieving ORD's goal of providing national and international leadership in environmental science and risk assessment.

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Building a Foundation for Sound Environmental Decisions Working With Others ORD's very appropriate sense of itself as a key participant in a larger arena of environmental research is evident throughout the strategic plan. Obviously, ORD alone can not do it all. Cooperation with outside scientists and others is explicitly, and appropriately, embraced, and the option is left open to implement research priorities through in-house efforts, external grants, interagency and cooperative agreements, or contracts. Other federal agencies, such as the Department of the Interior, the National Oceanographic and Atmospheric Administration, the Department of Energy, the National Institute for Environmental Health Standards, and the National Science Foundation, and scores of outside research institutes and universities, have valuable experience and capabilities in environmental research—ORD should treat them as essential partners. By building on the expertise found in other institutions, ORD can leverage its own limited resources and achieve greater environmental benefits. (The broader question of an appropriate balance between intramural and extramural research is addressed briefly in the interim report of the NRC Committee on Research and Peer Review [NRC, 1995a].) As one visible way of emphasizing the importance of partnerships, it would be appropriate for the first element of ORD's proposed Mission Statement (EPA, 1995, p.7) to be changed from "Perform research and development…" to "Perform, coordinate, integrate, and support research and development.…" The Risk Paradigm The strategic plan's adoption of risk assessment and risk management as a unifying framework is a positive step and should result in a research program that addresses issues of greatest environmental concern first. By requiring a systematic assessment of the magnitude and severity of an environmental problem relative to the many others that may exist, this approach allows for more rational decisions to be made about resource expenditures. The risk approach is also useful in highlighting the relevance of ORD's work to practical aspects of EPA's regulatory mission. Nevertheless, there are challenges in trying to fit every issue or research topic into this framework. EPA may have to refine the risk framework or explore different analytical approaches to incorporate some of the most challenging and complex emerging environmental issues into its agenda. Risk Assessment Methodology The process and application of risk assessment is continually evolving. If risk assessment is to be a cornerstone of ORD's program, research is needed to improve the quality of risk assessments, as well as to analyze the strengths and

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Building a Foundation for Sound Environmental Decisions weaknesses of the underlying framework and assumptions. In addition, risk assessment models and priority setting criteria must be re-examined periodically. ORD should be active in this area of study. Some of the research questions to be pursued come to light by considering aspects of risk assessment not adequately addressed in the current draft strategic plan. One is the question of multiple risks/multiple stressors: what are all of the stressors to which a given population or ecosystem is exposed and how do the stressors interact? Cumulative risks must be considered to get a true picture of the severity of a problem. Similarly, it can be misleading to calculate the risk resulting from a particular stressor without considering the context of that stress, and the different settings in which it might occur. A third missing element is the explicit assessment of alternatives. The creative consideration of potential alternatives to being exposed to a particular risk needs to be included in any risk assessment. If these alternatives are not explored up front, risk managers can find themselves unnecessarily backed into a reactive mode. The three elements mentioned above should be included in the strategic plan, particularly in Figure 1 or 2 of the plan. Near-Term Research Priorities The six highest-priority, near-term research issues presented by ORD in its draft strategic plan—drinking water disinfection, human health protection, ecosystem protection, particulate matter, endocrine disrupters, and pollution prevention and new technologies—are intended to be implemented by ORD's laboratories. All of these topics are worthy of investigation, but the combination of topics that are very specific (e.g., "endocrine disrupters") with those that are very broad (e.g., "human health protection" and "ecosystem protection") suggests that ORD's priority-setting process continues to need refinement. The tasks described in the plan under "endocrine disrupters'' are mostly exploratory exercises to determine whether these substances pose significant risks, while the latter two topics include almost everything that EPA does. It is possible that this first round of priority setting may have been influenced more by pragmatic considerations than by a strict application of the risk analysis. ORD should continue the process of gathering input on research themes, rethinking and refining the prioritization process, and more clearly explaining the logic behind its selection of research themes in subsequent drafts of the strategic plan. The peer-review process may be particularly valuable in this regard (NRC, 1995a). ORD should also continue to design and implement research evaluation mechanisms as a part of its ongoing priority-setting process. This is necessary to assess whether individual projects are appropriately aligned to address important emerging problems, as well as whether ORD has achieved its overall goal of promoting long-term research.

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Building a Foundation for Sound Environmental Decisions Emerging Issues Although the plan refers more than once to the importance of anticipating emerging issues, it does not include an approach for identifying such issues. In the absence of such an approach, these issues will not be identified early on when they may be most tractable. Although ORD's Environmental Monitoring and Assessment Program (EMAP) is one example of a program that might be helpful in providing such early warning signals, the program has proven extremely difficult to implement soundly (NRC, 1995b). Specific criteria for identifying emerging issues were laid out in the recent report, Beyond the Horizon (EPA/SAB, 1995). This report calls for issues to be assessed according to their timing, novelty, scope, severity, visibility, and probability. The report's recommendations should be reviewed and ORD should identify criteria and procedures for identifying emerging issues of relevance to EPA in future drafts of the strategic plan. Remaining Questions A preliminary assessment such as this one necessarily leaves many questions unanswered. This committee has only begun to identify and prioritize critical research areas to be addressed by ORD and others. In addition, questions concerning ORD's strategic plan were raised, but not resolved, in the process of writing this report. These questions will continue to be addressed along with many others as this study continues. CONCLUSION ORD has taken important steps towards improving the conduct and content of its research program. The New Beginning (EPA, 1994) and ORD's draft Strategic Plan (EPA, 1995) indicate an awareness of the importance of long-term fundamental research in understanding and ameliorating complex environmental problems. ORD's emphasis on cooperation with other institutions is also very important. By taking advantage of the nation's most capable scientists, wherever they may be working, and encouraging new generations of researchers, ORD can leverage its own resources enormously. ORD's adoption of risk assessment as a unifying framework for evaluating problems and setting priorities holds promise for producing a more consistent, rational, relevant, and defensible research program. However, if risk assessment is to be the cornerstone of ORD's program, an ongoing research program should be undertaken to continuously refine, improve, and evaluate the risk assessment methodology and to identify situations where it should be supplemented with other approaches.

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Building a Foundation for Sound Environmental Decisions In order to devote limited resources to the most important problems, ORD should continue to refine its priority setting process so that it can clearly explain its choice of short- and long-term focus areas. A system for identifying potentially important emerging issues should also be developed and implemented. This committee's final report will attempt to identify and prioritize critical research issues and will discuss the roles to be played by ORD and others in addressing them. REFERENCES EPA. 1994. Research, Development, and Technical Services at EPA: A New Beginning. EPA/600/R-94/122. EPA. 1995. Strategic Plan for the Office of Research and Development. November 1995, External Review Draft. EPA/600/R-95/162. EPA/SAB. 1990. Reducing Risk: Setting Priorities and Strategies for Environmental Protection. EPA-SAB-EC-90-021. EPA/SAB. 1992. Safeguarding the Future: Credible Science, Credible Decisions. EPA-SAB-EC-92-005. EPA/SAB. 1995. Beyond the Horizon: Using Foresight to Protect the Environmental Future. EPA-SAB-EC-95-007. MITRE. 1994. Assessment of Scientific and Technical Laboratories and Facilities of the U.S. Environmental Protection Agency. McLean, Virginia. MTR 94W0000082V1. NAPA. 1995. Setting Priorities, Getting Results: A New Direction for EPA. National Academy of Public Administration. Washington, D.C. NRC. 1993. Research to Protect, Restore, and Manage the Environment. National Academy Press. Washington, D.C. NRC. 1995a. Interim Report of the Committee on Research and Peer Review in EPA. National Academy Press. Washington, D.C. NRC. 1995b. Review of EPA's Environmental Monitoring and Assessment Program: An Overall Evaluation. National Academy Press. Washington, D.C.

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