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).
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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?
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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.
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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
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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
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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
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Grey, J. S., 1980. Why Do Ecological Monitoring? Marine Pollution Bulletin 11:62.
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Deliberative Draft Proposal for Initial Review and Comment
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Deliberative Draft Proposal for Initial Review and Comment
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