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

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,
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              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.

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              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.
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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
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