Deliberative Draft Proposal for Initial Review and Comment The U. S. EPA Science Advisory Board (SAB) Ecological Processes and Effects Committee (EPEC) Ecological Risk Assessment: An Evaluation of the State-of-the-Practice Project Overview The SAB Ecological Processes and Effects Committee (EPEC) will hold two workshops to evaluate the state-of-the-practice for ecological risk assessment. The workshops will be held approximately one year apart in 2005 and 2006. The first workshop will focus on scientific aspects of ecological risk assessment, while the second workshop will examine their application in environmental decision-making. The workshop results will be evaluated by EPEC to develop advice and recommendations to assist the Agency on emerging and cross-cutting science and science policy aspects of ecological risk assessment. Background Although ecological assessment has a longstanding history in pollution investigations, ecological risk assessment is a relatively new concept that largely emerged in response to environmental legislation. Specific laws that authorized some type of ecological assessment included the: Clean Water Act; National Environmental Policy Act; Marine Research Protection and Sanctuaries Act; Federal Insecticide, Fungicide and Rodenticide Act; Toxic Substances Control Act; Resource Conservation and Recovery Act; Comprehensive Environmental Response Compensation and Liability Act; and the Superfund Amendment and Reauthorization Act. Collectively, these laws prompted a dramatic rise in the development and standardization of ecological and toxicological methods from the mid 1960s through the 1970s. By the late 1970s, questions began to arise regarding the ecological relevance of toxicity test results and interpretation in environmental decision-making (Sprague, 1976; Mount, 1977a, b; Doudoroff, 1977; Krenkel, 1979; Grey, 1980; NRC, 1981). A common conclusion was that toxicity test methods had advanced beyond an ability to interpret ecological significance of the results. It had become clear that a consistent process for integrating toxicological, ecological, chemical, and physical data with environmental exposure was necessary for regulatory decision- making. Two workshops, entitled Estimating the Hazard of Chemical Substances to Aquatic Life and Analyzing the Hazard Evaluation Process (Cairns et al., 1978; Dickson et al., 1979; Cairns and Maki, 1979; Cairns, 1980), were pivotal in defining ecological hazard evaluation (data collection) and hazard assessment (data synthesis and interpretation) process. Although the approach was presented as a scientific exercise, the need for a pragmatic process with an identifiable end for regulatory applications was recognized (Maki, 1979). 1 ------- Deliberative Draft Proposal for Initial Review and Comment The move away from ecological hazard evaluation and assessment and toward ecological risk assessment was aided, in part, by developments in human health risk assessment. In 1983, human health risk assessment practices and processes in the federal government were evaluated by the National Research Council (NRC, 1983). This report recognized that regulatory actions were based on two distinct elements: risk assessment (defined as the use of a factual base to define health effects of exposure of individuals or populations to hazardous materials or situations) and risk management (defined as a process for weighing policy alternatives and selecting the most appropriate regulatory action). The NRC report provided impetus for human health risk-based approaches at EPA and also influenced the need for a parallel process for ecological risk (Thomas, 1987; Fava et al,,1987; U.S. EPA 1989a,b; U.S. EPA Science Advisory Board, 1990a,b,c,d; NRC, 1993). Under the auspices of the U.S. EPA Risk Forum, the Agency developed an ecological risk assessment framework (US. EPA, 1991; 1992a,b), a strategic development plan (U.S. EPA, 1992c), a series of agency ecological assessment case studies from a risk assessment perspective (U.S. EPA, 1993a,b; 1994a), issue papers (U.S. EPA ,1994b), draft (U.S. EPA, 1996) and final (U.S. EPA,1998) ecological risk assessment guidelines, and generic ecological assessment endpoints for ecological assessment (U.S. EPA, 2003). Additionally, the risk assessment framework has been applied to diverse situations in the United States and abroad by the Agency, states and tribes, the private sector, and non-governmental organizations. Accordingly, a wealth of ecological risk assessment ;uid decision-making experience has accumulated since the initial framework first appeared in 1992. Most recently, EPA has prepared a perspective of Agency risk assessment principles and practices that is intended to open a dialogue regarding how the risk assessment community might be engaged to enhance ecological risk assessments (U.S. EPA, 2004). Project Goals The ongoing growth of ecological risk assessment, coupled with the Agency's call for an open dialogue to enhance risk assessment practices, prompted EPEC to undertake the present project. The primary goal of this project is to develop information on the current state of the practice of ecological risk assessment, with a view ttnvard developing advice and recommendations for EPA regarding ways to enhance the conduct and application of ecological risk assessment in environmental decision-making. EPEC proposed holding two public workshops to develop information. The first workshop will be held in late fall 2005 or early winter of 2006, and will focus solely on technical themes and issues regarding ecological risk assessment. Specific themes and issues for the first workshop follow. • Are current technological and data resources sufficient to conduct effective ecological risk assessments? ------- Deliberative Draft Proposal for Initial Review and Comment • How effectively are ecological knowledge and principles included in various ecological risk assessment approaches? • In what situations are probabilistic risk assessment most useful? * Are mechanistic, organismic, population and community attributes adequately addressed in ecological risk assessments? * Is endpoint extrapolation adequate in ecological risk assessment? • Are effectiveness and uncertainty involved in translating effect measures across ecological levels handled adequately in ecological risk assessment? • How effectively has the approach performed when regional scales were important to the decision maker? • Does the current process allow one to address regional, hemispheric to global consequences adequately? » What new technologies can be used more effectively to enhance the ecological risk assessment process? • Have new technologies such as embedded sensor networks and molecular genetics been applied effectively? • Do current techniques and approaches allow one to optimally define possible causal pathways and decide which is most likely? • Is interpolating to toxicity reference value (TRY) from test species to species of concern effective in ecological risk assessment? • When and what does one do in going from a screening to comprehensive ERA? • How effectively has the approach performed when regional scales were important to the decision maker? Following completion of the first Ecological Risk Assessment Workshop, a second workshop focused on Ecological Risk Management and Decision-Making will be conducted. A set of discussion issues will be developed and sent to individuals identified by the SAB EPEC to contribute to the workshops. The workshop participants will address these issues by drawing on their experiences and relevant examples or case studies. EPEC will then summarize the workshop finding and use the collected information to develop advice to the Agency. ------- Deliberative Draft Proposal for Initial Review and Comment Tentative Project Schedule and Milestones 21 APR 2005 31 MAY 2005 30 JUN 2005 30 JUL 2005 30 JAN 2006 31 MAR 2006 30 MAY 2006 30 JAN 2007 31 MAR 2007 Finalize proposal for review and approval by EPEC. Establish a steering committee to develop questions that will identify scientific strengths and weaknesses of ecological risk assessments. The questions will identify the type and scope of the risk assessment; its scientific strengths and weaknesses; what went well and what we need to keep doing; what didn't go well and what we need to change; potential barriers to change; and solutions to removing barriers to change that would improve the science. The steering committee will also identify speakers and case studies from EPA, States and Tribes, the Private Sector, and non- governmental organizations to address the questions posed above. Set place and time for the Ecological Risk Assessment Workshop in the late fall 2005 or early winter 2006. Contact speakers, and prepare materials for the public workshop. Finalize planning and logistics for first workshop Hold Ecological Risk Assessment Workshop to discuss questions, case studies, strengths weaknesses, barriers to change, and solutions to barriers to change. EPEC meeting to finalize draft workshop report and recommendation and develop scope and agenda for second workshop. Finalize first workshop proceedings and EPEC report and submit to SAB Quality Review Board. Set place and time for the Ecological Risk Assessment Workshop in the late fall early/winter time frame, contact speakers, and prepare materials for the Ecological Risk Management and Decision-Making Workshop Hold Ecological Risk Management and Decision-Making workshop to discuss questionnaires, case studies, strengths weaknesses, barriers to change, and solutions to barriers to change. EPEC meeting to finalize draft Ecological Risk Management and 4 ------- Deliberative Draft Proposal for Initial Review and Comment Decision-Making Workshop report and recommendations. 30 MAY 2007 Finalize Ecological Risk Management and Decision-Making Workshop proceedings and EPEC report and submit to SAB Quality Review Board. References Cairns, J., Jr., 1980. Estimating hazard. Bioscience 30(2):101-107. Cairns, J., Jr., K. L. Dickson, and A. W. Maki, 1978. Estimating the Hazard of Chemical Substances to Aquatic Life. ASTM STP 657, Philadelphia, PA, American Society for Testing and Material. Cairns, J., Jr., and A. W. Maki, 1979. Hazard Evaluation In Toxic Materials Evaluation. Journal of the Water Pollution Control Federation 51:666. Dickson, K. D., A. W. Maki, and J. Cairns, Jr. (eds.), 1979. Analyzing the Hazard Evaluation Process. Washington, DC, Water Quality Section, American Fisheries Society. Doudoroff, P., 1977. Reflections on Pickle-Jar Ecology In Biological Monitoring of Water and Effluent Quality (J. Cairns, K. Dickson, and G. Westlake, eds.). ASTM STP 607, Philadelphia, PA, American Society for Testing and Materials. Fava, J. A, W.A. Adams, R.L. Larson, G.W. Dickson, K. L. Dickson, W.E. Bishop (Eds.). 1987. Research Priorities in Environmental Risk Assessment. Pensacola, FL, Society of Environmental Toxicology and Chemistry. Grey, J. S., 1980. Why Do Ecological Monitoring? Marine Pollution Bulletin 11:62. Krenkel, P. A., 1979. Problems In The Establishment Of Water Quality Criteria. Journal of the Water Pollution Control Federation 51:2168-2188. Maki, A. W., 1979. An Analysis of Decision Criteria In Environmental Hazard Evaluation Programs In Analyzing the Hazard Evaluation Process (K. L. Dickson, J. Cairns, Jr., and A. W. Maki, eds.). Washington, DC, Water Quality Section, American Fisheries Society. Mount, D. I., 1977a. Biotic monitoring In Biological Monitoring of Water and Effluent Quality (J. Cairns, Jr., K. L. Dickson, and G. F. Westlake, eds.). ASTM STP 607, Philadelphia, PA, American Society for Testing and Materials. Mount, D. I., 1977b. Present Approaches to Toxicity Testing, A Perspective, In Aquatic Toxicology and Hazard Evaluation (F. L. Mayer and J. L. Hamelink, eds.). ASTM STP 634, 5 ------- Deliberative Draft Proposal for Initial Review and Comment Philadelphia, PA, American Society for Testing and Materials. National Research Council, Environmental Study Board, 1981. Testing for Effects of Chemicals on Ecosystems. Washington, DC: National Academy Press. National Research Council. 1983. Risk Assessment in the Federal Government. Washington DC: National Academy Press. 191 p. National Research Council. 1993. Issues in Risk Assessment Washington, DC, National Academy Press. 356 p. Science Advisory Board, U. S. Environmental Protection Agency, 1990a. Reducing Risk: Setting Priorities And Strategies For Environmental Protection. SAB-EC-90-021, Washington, DC, U.S. EPA. Science Advisory Board, U. S. Environmental Protection Agency. 1990b. The Report of the Ecology and Welfare Subcommittee: Relative risk reduction project, reducing risk, Appendix A. EPA SAB-EC-90-021 A, Washington, DC, U.S. EPA. Science Advisory Board, U. S. Environmental Protection Agency. I990c. The Report of the Human Health Subcommittee: Relative risk reduction project, reducing risk, Appendix B. EPA SAB-EC-90-021 B, Washington, DC, U.S. EPA Science Advisory Board, U. S. Environmental Protection Agency. 1990d. The Report of the Strategic Options Subcommittee: Relative risk reduction project, reducing risk, Appendix C. EPA SAB-EC-90-021 C, Washington, DC, U.S. EPA. Sprague, J. B., 1976. Current Status of Sublethal Tests of Pollutants on Aquatic Organisms. Journal of the Fisheries Research Board of Canada 33:1988-1992. Thomas, L. M., 1987. Environmental Decision-Making Today. Environmental Protection Agency Journal 13:2-5. U. S. Environmental Protection Agency. 1989a. Ecological Assessment of Hazardous Waste Sites. EPA 600/3-89/013. Corvallis, OR, U. S. EPA. U. S. Environmental Protection Agency. 1989b. Risk Assessment Guidance for Superrund. Volume II. Environmental evaluation manual. Interim final. Washington, DC, EPA/540/1-89/001. U. S. Environmental Protection Agency. 1991. Summary Report on Issues in Ecological Assessment. Risk Assessment Forum, Washington, DC, EPA/630/R-92/005. ------- Deliberative Draft Proposal for Initial Review and Comment U. S. Environmental Protection Agency, 1992. Framework for Ecological Risk Assessment. Risk Assessment Forum, Washington, DC, EPA/600/R-92/001. U. S. Environmental Protection Agency. 1992. Peer Review Workshop Report on a Framework for Ecological Risk Assessment. Risk Assessment Forum, Washington, DC, EPA/625/3-91/022 (NTISPB922131198). U. S. Environmental Protection Agency. 1992. Report on the Ecological Risk Assessment Guidelines Strategic Planning Workshop. Risk Assessment Forum, Washington, DC, EPA/630/R-92/002 (NTIS PB93102200). U. S. Environmental Protection Agency. 1993. A Review of Ecological Assessment Case Studies from a Risk Assessment Perspective. Risk Assessment Forum,Washington, DC. EPA/630/R-92/005. U. S. Environmental Protection Agency. 1993. A Review of Ecological Assessment Case Studies from a Risk Assessment Perspective-Vol. II. Risk Assessment Forum, U.S. Environmental Protection Agency, Washington, DC, EPA/630/R-94/003. U. S. Environmental Protection Agency. 1994. Peer Review Workshop on Ecological Risk Assessment Issue Papers. Risk Assessment Forum, Washington, DC, EPA/630/R-94/008 (NTIS PB5252490). U. S. Environmental Protection Agency. 1994. Ecological Risk Assessment Issue Papers. Risk Assessment Forum, Washington,DC, EPA/63O/R-94/009 (NTIS PB95224192). U .S. Environmental Protection Agency. 1996. Proposed Guidelines For Ecological Risk Assessment Federal Register 61(175):47552-47631. U. S. Environmental Protection Agency. 1996. Proposed Guidelines For Ecological Risk Assessment. Federal Register 61(175):47552-47631. U. S. Environmental Protection Agency. 1996. Peer Review Workshop Report on Draft Proposed Guidelines for Ecological Risk Assessment. Risk Assessment Forum,Washington, DC, EPA/630/R-96/002. U. S. Environmental Protection Agency. 2001. Planning for Ecological Risk Assessment: Developing Management Objectives (External Review Draft). Risk Assessment Forum, Washington, DC, EPA/630/R-96/002. U. S. Environmental Protection Agency. 2002. Guidelines for Ecological Risk Assessment. Risk Assessment Forum, Washington, DC, EPA/630/R-095/002F. 7 ------- Deliberative Draft Proposal for Initial Review and Comment U. S. Environmental Protection Agency. 2004. Generic Ecological Assessment Endpoints (GEAEs) for Ecological Risk Assessment. Risk Assessment Forum, Washington, DC, EPA/630/P-027004F. U. S. Environmental Protection Agency. 2004. An Examination of EPA Risk Assessment Principles and Practices: Staff Paper. Office of the Science Advisor, Washington, DC, EPA/100/B-04/001. ------- |