UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF THE ADMINISTRATOR
SCIENCE ADVISORY BOARD
October 17, 2007
EPA-SAB-08-002
Honorable Stephen L. Johnson
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, D.C. 20460
Subject: Advice to EPA on Advancing the Science and Application of Ecological Risk
Assessment in Environmental Decision Making: A Report of the U.S. EPA
Science Advisory Board
Dear Administrator Johnson:
The Environmental Protection Agency (EPA) conducts ecological risk assessments to
implement programs required by a number of key environmental statutes. EPA published
a. Framework for Ecological Risk Assessment (1992) and Guidelines for Ecological Risk
Assessment (1998) that greatly improved the state of the practice of ecological risk
assessment, not only in the United States but around the world, by establishing a phased
multidisciplinary approach that has withstood the test of time. The Science Advisory
Board's (SAB) Ecological Processes and Effects Committee (EPEC) has conducted a
self-initiated study to enhance the Agency's risk assessment guidelines (Guidelines) and
advance the state of the practice. The study was initiated to draw upon recent advances
in ecological risk assessment science in three decision-making contexts: 1) product health
and safety, 2) management of contaminated sites, and 3) natural resources protection. To
gather information for the study, EPEC convened a public workshop attended by
ecological risk assessors representing academia, government, industry, and various
environmental organizations.
Overall, the SAB commends the Agency's previous efforts to advance ecological risk
assessment science and encourages further integration of ecological risk assessment into
environmental management decision processes. Generally, the SAB finds that a strength
of ecological risk assessment is its value as a process to formulate problems, to use
analytical tools to evaluate diverse types of environmental data, and to characterize risks.
Moreover, ecological risk assessments have been most effective when clear management
-------
goals were included in the problem formulation, translated into information needs, and
developed in collaboration with decision makers, assessors, scientists, and stakeholders.
Many of the SAB's specific recommendations focus on steps that can be taken to
improve problem formulation.
The enclosed report provides the SAB's specific findings and recommendations. The
report is based on, but not limited to, information received by EPEC at the public
workshop. The SAB notes that implementing many of the recommendations in the report
would make the process of ecological risk assessment more efficient. Some of the
recommendations can be implemented in a relatively short period of time (less than three
years), while others will require the development of extensive guidance or completion of
research over a longer period of time. The executive summary of the report identifies
recommended actions as short or long term efforts.
• The SAB finds that the Agency can advance the practice of ecological risk
assessment by developing methods and tools that assist risk assessors in designing
analyses that appropriately consider the physical, biological, and socio-economic
contexts of decisions. In particular, the SAB believes there is value in advancing
methods and tools to aid the proper consideration of temporal and spatial scale,
biological complexity, and the environmental influences that amplify or detract from
the level of risk associated with any single or multiple stressors in play.
• Developing risk management goals involves making informed normative judgments
on behalf of the public, not just scientists. EPA is therefore urged to encourage, if not
require, problem formulation dialogue between ecological risk managers, risk
assessors, and stakeholders (including both ecologists and the lay public). Managers,
assessors, and stakeholders should be engaged early and iteratively throughout the
risk assessment process.
• Local and regional regulatory processes are conditioned by community values and
economic objectives as well as by ecological conditions. Therefore, aligning the
decision and the supporting risk and economic analyses with "what matters to people"
is essential to achieve acceptable risk solutions that can be easily and effectively
communicated to the public. To achieve such alignment, EPA should increase its
understanding of and capacity to utilize ecosystem valuation methods in conjunction
with such decisions.
• There is a need to bring more specificity to problem formulation in ecological risk
assessments. To accomplish this, the SAB recommends that 1) specific management
alternatives be directly considered during problem formulation, 2) specific testable
hypotheses and questions be tied to management information needs and data
collection and analysis, and 3) uncertainty be addressed in a manner that allows trade-
offs in risk management alternatives to be evaluated and communicated to the public.
• For large, complex ecological risk assessments, EPA is strongly urged to conduct
scientific peer review of proposed risk assessment study designs at the problem
11
-------
formulation stage to assure that studies can provide the information needed by risk
managers.
• Because ecological risk assessments often fail to identify and prioritize uncertainties
that may affect the quality of risk management decisions, uncertainties that
profoundly affect the results and outcome of risk assessments should be identified and
acknowledged during problem formulation. Furthermore, the use of adaptive
management with iterative triggers for action offers promise as a way of dealing with
uncertainties in ecological risk assessments.
• The SAB recommends that EPA initiate post-decision audit programs to evaluate the
environmental outcomes of risk-based decisions. EPA should also use monitoring
data to reduce uncertainties in future ecological risk assessments.
In summary, the SAB has identified opportunities to improve the application of
ecological risk assessment in environmental decision making and encourages EPA to
provide the resources and research support needed to make these improvements. The
SAB notes that EPA's budget for ecological research has decreased by approximately
40% since fiscal year 2003. The Agency has eliminated research in monitoring
programs to assess the status and health of ecological resources. The declining trend in
the EPA budget for ecological research must be reversed in order to address many of the
complex issues discussed in this report. Additional resources are also needed to provide
an interface between risk assessment and monitoring programs so that monitoring data
can be used to improve future risk assessments. We look forward to receiving your
response.
Sincerely,
/Signed/ /Signed/
Dr. Virginia Dale, Former Chair Dr. Judith Meyer, Chair
Ecological Processes and Ecological Processes and
Effects Committee Effects Committee
EPA Science Advisory Board EPA Science Advisory Board
/Signed/
Dr. M. Granger Morgan, Chair
Science Advisory Board
in
-------
NOTICE
This report has been written as part of the activities of the EPA Science Advisory
Board, a public advisory group providing extramural scientific information and
advice to the Administrator and other officials of the Environmental Protection
Agency. The Board is structured to provide balanced, expert assessment of scientific
matters related to the problems facing the Agency. This report has not been reviewed
for approval by the Agency and, hence, the contents of this report do not necessarily
represent the views and policies of the Environmental Protection Agency, nor of other
agencies in the Executive Branch of the Federal government, nor does mention of
trade names or commercial products constitute a recommendation for use. Reports of
the EPA Science Advisory Board are posted on the EPA website at
http://www.epa.gov/sab.
IV
-------
U.S. Environmental Protection Agency
Science Advisory Board
Ecological Processes and Effects Committee
CHAIR
Dr. Virginia Dale*, Corporate Fellow, Environmental Sciences Division, Oak Ridge
National Laboratory, Oak Ridge, TN
Dr. Judith L. Meyer, Distinguished Research Professor Emeritus, Institute of Ecology,
University of Georgia, Athens, GA
MEMBERS
Dr. Richelle Allen-King, Associate Professor of Geology, University at Buffalo,
Buffalo, NY
Dr. Fred Benfield, Professor of Ecology, Department of Biological Sciences, Virginia
Polytechnic Institute and State University, Blacksburg, VA,
Dr. G. Allen Burton, Professor and Chair, Department of Earth and Environmental
Sciences, Wright State University, Dayton, OH
Dr. Peter Chapman, Principal and Senior Environmental Scientist, Environmental
Sciences Group, Golder Associates Ltd, North Vancouver, BC, Canada
Dr. Loveday Conquest, Professor and Associate Director, School of Aquatic and
Fishery Sciences, University of Washington, Seattle, WA
Dr. Ivan J. Fernandez**, Professor, Department of Plant, Soil and Environmental
Sciences, University of Maine, Orono, ME
Dr. Wayne Landis, Professor and Director, Institute of Environmental Toxicology,
Western Washington University, Bellingham, WA, USA
Dr. Lawrence L. Master", Chief Zoologist, NatureServe, Boston, MA
Dr. William Mitsch, Professor, Olentangy River Wetland Research Park, The Ohio State
University, Columbus, OH
Dr. Thomas C. Mueller", Professor, Department of Plant Sciences, University of
Tennessee, Knoxville, TN
Dr. Michael C. Newman", Professor of Marine Science, School of Marine Sciences,
Virginia Institute of Marine Science, College of William & Mary, Gloucester Point, VA
-------
Dr. James Oris, Professor, Department of Zoology, Miami University, Oxford, OH
Dr. Charles Rabeni, Leader, Missouri Cooperative Fish and Wildlife Research Unit,
U.S. Geological Survey, Columbia, MO
Dr. Amanda Rodewald, Associate Professor of Wildlife Ecology, School of
Environment and Natural Resources, The Ohio State University, Columbus, OH
Dr. James Sanders, Director, Skidaway Institute of Oceanography, Savannah, GA
Mr. Timothy Thompson, Senior Environmental Scientist, Science, Engineering, and the
Environment, LLC, Seattle, WA
Dr. Ivor van Heerden, Associate Professor and Director, Department of Civil and
Environment Engineering, LSU Hurricane Public Health Research Center, Louisiana
State University, Baton Rouge, LA, USA
OTHER SCIENCE ADVISORY BOARD MEMBERS
Dr. Gregory Biddinger, Environmental Programs Coordinator, ExxonMobil Biomedical
Sciences, Inc., Houston, TX
SCIENCE ADVISORY BOARD STAFF
Dr. Thomas Armitage, Designated Federal Officer, Washington, DC,
* Former Chair, Ecological Processes and Effects Committee
** Former Member, Ecological Processes and Effects Committee
VI
-------
U.S. Environmental Protection Agency
Science Advisory Board
CHAIR
Dr. M. Granger Morgan, Head and Professor, Department of Engineering and Public
Policy, Carnegie Mellon University, Pittsburgh, PA
SAB MEMBERS
Dr. Gregory Biddinger, Coordinator, Natural Land Management Programs, Toxicology
and Environmental Sciences, ExxonMobil Biomedical Sciences, Inc, Houston, TX
Dr. James Bus, Director of External Technology, Toxicology and Environmental
Research and Consulting, The Dow Chemical Company, Midland, MI
Dr. Trudy Ann Cameron, Raymond F. Mikesell Professor of Environmental and
Resource Economics, Department of Economics, University of Oregon, Eugene, OR
Dr. Deborah Cory-Slechta, Director, Environmental and Occupational Health Sciences
Institute, Robert Wood Johnson Medical School, University of Medicine and Dentistry of
New Jersey and Rutgers University, Piscataway, NJ
Dr. Maureen L. Cropper, Professor, Department of Economics, University of
Maryland, College Park, MD
Dr. Virginia Dale, Corporate Fellow, Environmental Sciences Division, Oak Ridge
National Laboratory, Oak Ridge, TN
Dr. Kenneth Dickson, Professor, Institute of Applied Sciences, University of North
Texas, Denton, TX
Dr. Baruch Fischhoff, Howard Heinz University Professor, Department of Social and
Decision Sciences, Department of Engineering and Public Policy, Carnegie Mellon
University, Pittsburgh, PA
Dr. James Galloway, Professor, Department of Environmental Sciences, University of
Virginia, Charlottesville, VA
Dr. Lawrence Goulder, Shuzo Nishihara Professor of Environmental and Resource
Economics, Department of Economics, Stanford University, Stanford, CA
Dr. James K. Hammitt, Professor of Economics and Decision Sciences, Harvard Center
for Risk Analysis, Harvard University, Boston, MA
vn
-------
Dr. Rogene Henderson, Scientist Emeritus, Lovelace Respiratory Research Institute,
Albuquerque, NM
Dr. James H. Johnson, Professor and Dean, College of Engineering, Architecture &
Computer Sciences, Howard University, Washington, DC
Dr. Agnes Kane, Professor and Chair, Department of Pathology and Laboratory
Medicine, Brown University, Providence, RI
Dr. Meryl Karol, Professor Emerita, Graduate School of Public Health, University of
Pittsburgh, Pittsburgh, PA
Dr. Catherine Kling, Professor, Department of Economics, Iowa State University,
Ames, IA
Dr. George Lambert, Associate Professor of Pediatrics, Director, Center for Childhood
Neurotoxicology, Robert Wood Johnson Medical School-UMDNJ, Belle Mead, NJ
Dr. Jill Lipoti, Director, Division of Environmental Safety and Health, New Jersey
Department of Environmental Protection, Trenton, NJ
Dr. Michael J. McFarland, Associate Professor, Department of Civil and
Environmental Engineering, Utah State University, Logan, UT
Dr. Judith L. Meyer, Distinguished Research Professor Emeritus, Institute of Ecology,
University of Georgia, Athens, GA
Dr. Jana Milford, Associate Professor, Department of Mechanical Engineering,
University of Colorado, Boulder, CO
Dr. Rebecca Parkin, Professor and Associate Dean, Environmental and Occupational
Health, School of Public Health and Health Services, The George Washington University
Medical Center, Washington, DC
Mr. David Rejeski, Director, Foresight and Governance Project, Woodrow Wilson
International Center for Scholars, Washington, DC
Dr. Stephen M. Roberts, Professor, Department of Physiological Sciences, Director,
Center for Environmental and Human Toxicology, University of Florida, Gainesville, FL
Dr. Joan B. Rose, Professor and Homer Nowlin Chair for Water Research, Department
of Fisheries and Wildlife, Michigan State University, East Lansing, MI
Vlll
-------
Dr. Jerald Schnoor, Allen S. Henry Chair Professor, Department of Civil and
Environmental Engineering, Co-Director, Center for Global and Regional Environmental
Research, University of Iowa, Iowa City, IA
Dr. Kathleen Segerson, Professor, Department of Economics, University of
Connecticut, Storrs, CT
Dr. Kristin Shrader-Frechette, O'Neil Professor of Philosophy, Department of
Biological Sciences and Philosophy Department, University of Notre Dame, Notre Dame,
IN
Dr. Philip Singer, Professor, Department of Environmental Sciences and Engineering,
School of Public Health, University of North Carolina, Chapel Hill, NC
Dr. Robert Stavins, Albert Pratt Professor of Business and Government, Environment
and Natural Resources Program, John F. Kennedy School of Government, Harvard
University, Cambridge, MA
Dr. Deborah Swackhamer, Interim Director and Professor, Institute on the
Environment, University of Minnesota, Minneapolis, MN
Dr. Thomas L. Theis, Director, Institute for Environmental Science and Policy,
University of Illinois at Chicago, Chicago, IL
Dr. Valerie Thomas, Anderson Interface Associate Professor, School of Industrial and
Systems Engineering, Georgia Institute of Technology, Atlanta, GA
Dr. Barton H. (Buzz) Thompson, Jr., Robert E. Paradise Professor of Natural
Resources Law, Stanford Law School, and Director, Woods Institute for the
Environment, Stanford University, Stanford, CA
Dr. Robert Twiss, Professor and Emeritus, University of California-Berkeley, Ross, CA
Dr. Terry F. Young, Consultant, Environmental Defense, Oakland, CA
Dr. Lauren Zeise, Chief, Reproductive and Cancer Hazard Assessment Branch, Office
of Environmental Health Hazard Assessment, California Environmental Protection
Agency, Oakland, CA
SCIENCE ADVISORY BOARD STAFF
Mr. Thomas Miller, Designated Federal Officer, U.S. Environmental Protection Agency
IX
-------
Table of Contents
1.0 EXECUTIVE SUMMARY xi
2.0 INTRODUCTION 1
3.0 BACKGROUND 1
4.0 FINDINGS AND RECOMMENDATIONS 2
4.1 EPA's Ecological Risk Assessment Framework and Guidelines 2
4.2 Risk Assessor and Risk Manager Dialogue in Planning and Problem Formulation 3
4.3 Decision Making in the Presence of Uncertainty 6
4.4 Linking Natural and Social Science in Environmental Decision-making 9
4.5 Spatial, Temporal and Biological Scales 11
4.6 Comparison Other Protocols for Conducting Ecological Risk Assessments 12
5.0 IMPROVING ECOLOGICAL RISK ASSESSMENT IN SPECIFIC
DECISION-MAKING CONTEXTS 14
5.1 Ecological Risk Assessments for Product Health and Safety Evaluation 14
5.2 Ecological Risk Assessments for Contaminated Site Management 15
5.3 Ecological Risk Assessments for Natural Resource Protection 17
6.0 CONCLUSION 20
7.0 REFERENCES 22
ATTACHMENT-Ecological Risk Assessment in Environmental Decision Making,
an Evaluation of the State of the Practice: A Summary of the EPA Science
Advisory Board Ecological Processes and Effects Committee Workshop 25
-------
ADVICE TO EPA ON ADVANCING THE SCIENCE AND APPLICATION OF
ECOLOGICAL RISK ASSESSMENT IN ENVIRONMENTAL DECISION
MAKING: A REPORT OF THE U.S. EPA SCIENCE ADVISORY BOARD
1.0 EXECUTIVE SUMMARY
This report presents results from an original study of the Environmental Protection
Agency (EPA) Science Advisory Board (SAB) Ecological Processes and Effects
Committee (EPEC) and provides advice to EPA on advancing the science and application
of ecological risk assessment in environmental decision making. The following specific
findings and recommendations are provided to guide the development of EPA policies
and to strengthen the Agency's program-specific ecological risk assessment guidance.
Cross-cutting recommendations are presented first. These are followed by
recommendations pertaining to ecological risk assessments in three decision-making
contexts: product health and safety, contaminated site management, and natural resources
protection. Implementing many of the recommendations would make the process of
ecological risk assessment more streamlined and efficient. EPEC notes that some of the
recommendations, identified within each of the headings below as "short term," can be
implemented in a relatively short period of time (less than three years). Other
recommendations identified as "long term" will require the development of extensive
guidance or completion of research over a longer period of time.
EPA's Ecological Risk Assessment Framework and Guidelines
EP A's Framework for Ecological Risk Assessment (Framework) and Guidelines for
Ecological Risk Assessment (Guidelines) have improved the practice of ecological risk
assessment by establishing a phased, multidisciplinary risk assessment approach. The
strength of ecological risk assessment for use in decision making is its value as a process.
It provides a consistent approach for integrating laboratory and field data, analytical
tools, and assessment methods as well as a consistent format for reporting risks and
uncertainties. The Framework and Guidelines provide a robust and useful foundation
upon which to build the information needed to support EPA decision making. Yet, the
range of applications has made it difficult to develop Agency-wide policy and guidance
that define what ecological attributes the EPA is striving to protect and how to apply risk
assessment findings to decisions. Such guidance would enhance the consistency of the
risk assessment process. EPEC finds that ecological risk assessments have been most
effective when clear management goals were included in the problem formulation,
translated into information needs, articulated using data quality objectives (DQOs), and
developed in collaboration with decision makers, assessors, scientists, and stakeholders.
Short term recommendations
• Guidance should be developed to better define what ecological attributes EPA is
striving to protect and how to apply risk assessment findings to decisions. In the
short term, EPA could make progress toward incorporating such guidance into
decision-making processes. Non chemical stressors alone and in combination with
XI
-------
chemical stressors should be considered in developing ecological risk assessment
guidance, models, and endpoints. Endpoints should reflect elements of ecological
condition such as ecological processes and various levels of biological organization
including landscape composition and pattern.
• Ecological risk assessment methodologies are not the exclusive purview of the U.S.
EPA. Alternative methodologies have been developed and are being used by other
countries (e.g., Canada, Australia, New Zealand, the European Union) and at least
one other U.S. government agency (the National Oceanographic and Atmospheric
Administration [NOAA]) (Table 1). EPA should be cognizant of these approaches
and incorporate valuable aspects of them into the Agency's risk assessment guidance.
Risk Assessor and Risk Manager Dialogue in Planning and Problem Formulation
Risk assessor and risk manager dialogue is necessary during problem formulation to
integrate ecological risk assessment into the environmental management decision
process. Furthermore, there is a need to engage risk managers and risk assessors in
bringing greater specificity to problem formulation and "risk question" or hypothesis
formulation in ecological risk assessments. EPEC finds that the EPA Science Advisory
Board's Framework for Assessing and Reporting on Ecological Condition may provide a
useful reference checklist for ensuring that appropriate levels of temporal and spatial
scale and biological organization are specifically considered in ecological risk
assessments.
Short term recommendations
• EPEC recognizes that EPA's Framework for Ecological Risk Assessment provides for
interaction between risk managers and risk assessors and recommends that EPA
further encourage and promote, if not require, problem formulation dialogue between
risk assessors and risk managers.
• EPEC recommends that, during problem formulation, explicit connections be
established between risk measures, data quality needs, data collection activities, and
risk management decisions. The gap between risk management and risk assessment
can be bridged by developing guidelines and examples to: 1) connect risk
management with risk questions or testable hypotheses and 2) address scientific and
technical issues such as the appropriate scale of the risk assessment and
communication of uncertainty.
• For large complex risk assessments, peer review at the problem formulation stage and
again at risk assessment completion would help assure that the assessment study
design and implementation are appropriate for the risk management goals. EPEC
recommends that for high priority assessments, problem formulation and study design
be reviewed through an independent scientific peer review process prior to study
implementation. For smaller risk assessments, checklists could be used to ensure that
xn
-------
management goals are considered in problem formulation and translated into
information needs using DQOs.
• To promote a dialogue between risk assessors and risk managers and improve
problem formulation, EPEC recommends that EPA compile and develop ecological
risk assessment case studies that can provide information for developing standards of
practice.
Decision Making in the Presence of Uncertainty
EPEC finds that ecological risk assessments often fail to identify and prioritize
uncertainties that may affect the quality of risk management decisions. The problem
formulation process in ecological risk assessment could be improved by identifying
uncertainties that profoundly affect the results and outcomes of risk assessments and
information needed to reduce uncertainties.
Probabilistic ecological risk assessment is a useful tool for considering uncertainty;
however, that approach can be difficult to explain to non scientific managers. EPEC
finds that the results of probabilistic risk assessments could be more effectively
communicated if during problem formulation 1) a summary of the sources and sizes of
major uncertainties were provided and 2) risk assessors described how probabilistic
approaches would be applied to understand the implications of uncertainty. EPEC finds
that problem formulation could be improved by exploring the use of such methods as
Bayesian analysis and causal argumentation to develop hypotheses or risk questions
focused on causal relationships and weight of evidence. EPEC also finds that it would be
beneficial for EPA to initiate post-decision audit programs to evaluate the environmental
outcomes of risk management decisions relative to those effects predicted and used to
formulate the management decisions.
In addition, EPEC finds that uncertainty in ecological risk assessments could be
reduced by addressing the critical need to develop either a consistent approach to
interpreting lines of evidence and weight of the evidence in complex ecological risk
assessments or a process for evaluating competing technical assessments in
environmental decision making.
Short term recommendations
• EPEC recommends that EPA explore how adaptive management with iterative
triggers for action can be applied in the context of ecological risk assessment and risk
management as a way to deal with uncertainties.
• EPEC recommends that EPA more fully describe the beneficial ecological
consequences resulting from risk management decisions in terms that the public can
understand and then follow the risk management decisions with post-decision audit
programs. Post decision audit programs can be implemented in the short term, but a
longer period of time would be required to complete and document such audits.
Xlll
-------
Long term recommendations
• EPEC recommends that EPA develop case studies and/or standards of practice for
interpreting lines of evidence, with an emphasis on application in decision making.
• EPEC recommends that EPA explore the use of such methods as Bayesian analysis
and causal argumentation to develop hypotheses or risk questions focused on causal
relationships and weight of evidence.
Linking Natural and Social Sciences in Environmental Decision Making
EPA risk management decisions focus on the application of ecological risk science
within a legal and regulatory context; however, Agency decisions are conditioned by
community values and economic objectives as well as ecological conditions. Therefore,
EPEC finds that ecosystem valuation methods must be further developed in order to
formulate and evaluate risk management alternatives at multiple scales and to
communicate them to different stakeholder groups. EPA's Ecological Benefits
Assessment Strategic Plan (U.S. Environmental Protection Agency, 2006a) highlights the
importance of linking natural and social sciences in problem formulation in order to
improve decision making. EPEC also notes that product life cycle analysis is not
typically used in ecological risk assessment but it could be used to understand the
environmental impacts associated with various industrial products, processes, and
activities. EPEC therefore finds that additional guidance on the application of life cycle
analysis would be helpful to risk assessment practitioners.
Long term recommendations
• EPEC advises EPA to maintain a long-term focus on research to develop methods for
valuation of ecosystem services.
• EPEC recommends that EPA develop guidance for risk assessment practitioners on
the application of life cycle analysis.
Spatial, Temporal, and Biological Scales
EPEC finds that methods and tools should be further developed and applied to aid the
proper consideration of spatial, temporal, and biological scales in ecological risk
assessments. A substantial research effort is needed to address the complex issues of
evaluating spatial, temporal, and biological scales and their interrelationships
Short term recommendations
• EPEC recommends that during the problem formulation phase of ecological risk
assessments, EPA explicitly define the extent and resolution of the pertinent spatial
xiv
-------
and temporal scales and levels or scales of biological organization (e.g., cellular,
organismal, population, and ecosystem).
Long term recommendations
• It would be useful to develop standard techniques for assessing risks at pertinent
spatial, temporal, and biological scales. The SAB Framework for Assessing and
Reporting on Ecological Condition could be used to guide the choice of scale.
• EPEC recommends that EPA promote the evaluation and use of statistical and
geospatial data analysis tools (such as time series and spatial data analysis methods)
in identifying the appropriate spatial and temporal scales to be considered in
ecological risk assessments.
Improving Ecological Risk Assessments for Product Health and Safety
EPEC provides the following short and long term recommendations to improve
ecological risk assessments for product health and safety.
In the short term EPA could.
• Use currently available tools for rapid screening level assessments, such as EPA's
Estimation Programs Interface (EPI) Suite, to assist in determining whether chemicals
are biodegradable, toxic, or bioaccumulative. The limitations of such tools must be
taken into consideration. For example, the EPI Suite tools are generally applicable
only to nonpolar organic compounds of relatively low molecular weight. Inorganic
compounds, metallo-organic compounds, polar organic compounds, polymers, and
surfactants cannot be addressed by most of the EPI Suite tools.
• Move away from generic problem formulation that is focused on levels of concern
and risk quotients toward broader consideration of the appropriate spatial, temporal,
and biological scales in the context of the decisions being made.
In the long term EPA could:
• Develop tools for cumulative risk assessments. Contaminants are often released into
stressed environments and risk assessments should consider the combined effects of
stressors.
• Continue to investigate how biomarker and mechanistic data might best be used in
exposure and risk assessments.
• Conduct multigenerational analysis or other retrospective ground-truthing analyses
for prospective risk estimates and re-evaluate and validate levels of concern with
monitoring studies.
xv
-------
Improving Ecological Risk Assessments for Contaminated Site Management
EPEC provides the following short and long term recommendations to improve
ecological risk assessments for contaminated site management.
In the short term EPA could:
• Increase efficiency by developing "programmatic-level" assessments for
contaminants, such as polychlorinated biphenyls, commonly found at many
contaminated sites. Such assessments would be similar to programmatic
environmental impact statements, which are described in the National Environmental
Policy Act and are typically prepared with the intention of describing the impacts of
actions that are repeated over time. This approach would decrease the number of
redundant risk assessments for contaminants commonly found at contaminated sites.
• Take stronger leadership in training Agency personnel and those of state regulators on
the appropriate use of ecological risk assessment methods and data and explicitly
make regulators aware of how such methods and data can be misused. The Agency
should consider how to effectively integrate and weight the importance of modeled
estimates of risk in the presence of ecological observations from the field which are
assessing ecological integrity or biological performance
In the long term EPA could:
• Determine how large scale spatial, temporal, or population-level effects (and the
cumulative effects of several sites within a small area) could be investigated in light
of legal and regulatory requirements that may limit the spatial and temporal scale of
contaminated site assessments
• Develop guidance on the application of adaptive management of ecological resources
in contaminated site decision making.
• Take the initiative to develop guidance on the appropriate and acceptable use of such
screening tools as hazard quotients (HQs), hazard indices ( His), and similar
environmental benchmarks, especially with regard to their utility in setting actionable
environmental protection goals. As EPA addresses recommendations related to
appropriate use of screening tools such as HQ's and the need to reduce uncertainty,
the Agency will need to explore a range of risk calculation methods which represent
better and more certain approaches to estimating risk.
• EPEC also finds that advancing net environmental benefit tools may be a useful
check to fit a specific process such as the remediation of chemically contaminated
sites. These approaches may also be useful to other types of applications (such as
natural resource management).
xvi
-------
Improving Ecological Risk Assessment for Natural Resources Protection
EPEC provides the following short and long term recommendations to improve
ecological risk assessments for natural resources protection
In the short term EPA could:
• Explicitly identify, in the problem formulation phase of the risk assessment, specific
ecological resources to be protected and options for their protection.
• Implement an independent, scientific peer review process for large scale risk
assessments to evaluate endpoints, scale, levels of biological organization,
uncertainties, and study design outcomes of problem formulation prior to initiating
the analysis phase of the risk assessment.
• Consider ongoing change processes (e.g., global climate change) and indirect effects,
that are often revealed at different levels or scales of biological organization, as part
of the risk assessment. Such processes and indirect effects can be particularly
important in ecological risk assessments for natural resources protection.
• Identify, during problem formulation, those spatial and temporal scales and levels of
biological organization of concern that are large enough to capture emerging patterns
across a landscape such as effects on local watersheds or migratory pathways.
• Categorize uncertainties in the ecological risk assessment according to their sources
and sizes, and in the final assessment identify and acknowledge uncertainties that
profoundly affect results and outcomes such as the weight-of-evidence decision-
making process.
In the long term EPA could:
• Develop standard techniques for assessing risks at specific scales and levels of
biological organization and better define associated uncertainties.
• Explore ways to focus hypothesis development on causal relationships and weight of
evidence instead of traditional hypothesis testing with null models.
• Develop guidance for improved weight-of-evidence decision making that decreases
"best professional judgment" and increases statistically-based quantification.
Guidance should contain examples of typical sites covering major ecoregions,
hydrologic types, and stressors (chemical and non-chemical).
• Develop a process to provide an interface between risk assessment and monitoring
programs so that monitoring data can be used to improve future risk assessments.
xvn
-------
EPEC notes that these and other changes discussed in this report would advance the
evolving practice of ecological risk assessment. They would also enable more effective
use of the Framework for Ecological Risk Assessment to address the challenges of
dealing with uncertainties and high variability, linking assessment endpoints to realistic
temporal and spatial scales, and addressing legal and regulatory requirements of policy
precedence. EPEC finds that a substantial research effort is needed to develop the
methodology required to address many of the complex issues discussed in this report.
However, EPA's budget for ecological research has decreased by approximately 40%
since fiscal year 2003. The Agency has eliminated research in monitoring programs to
assess the status and health of ecological resources. The declining trend in the EPA
budget for ecological research must be reversed in order to address many of the complex
issues discussed in this report. Additional resources are also needed to provide an
interface between risk assessment and monitoring programs so that monitoring data can
be used to improve future risk assessments.
xvin
-------
2.0 INTRODUCTION
This report was prepared by the Science Advisory Board (SAB) Ecological Processes
and Effects Committee (EPEC). The report resulted from a study conducted by the
Committee to provide advice to the U.S. Environmental Protection Agency (EPA) on
advancing the science and application of ecological risk assessment in environmental
decision making. In conducting the study and developing this report, EPEC considered
the advantages and potential shortcomings of EPA's current ecological risk assessment
approach, drawing on the wealth of risk assessment experience within the academic,
regulatory, and regulated communities. EPEC considered the effectiveness of EPA's
ecological risk assessment approach and its application in various decision-making
contexts. In this regard, the following key cross-cutting ecological risk assessment issues
were considered: the effects of spatial and temporal scale, assessing risks at different
levels or scales of biological organization, problem formulation and the adequacy of
testable hypotheses, and decision making in the presence of uncertainty. The findings
and recommendations in this report are provided to guide the development of EPA-wide
policies and strengthen the Agency's program-specific risk assessment guidance. Key
findings and recommendations in the report are italicized.
To gather information for this advisory report, EPEC convened a public workshop on
the role and conduct of ecological risk assessments for environmental decision making.
Titled Ecological Risk Assessment - An Evaluation of the State of the Practice, the
workshop was held on February 7-8, 2006 in Washington, D.C. The workshop brought
together more than 120 ecological risk assessors from academia, government, industry,
trade associations, and environmental organizations. The invited speakers, panelists,
subject matter experts and participants discussed their experience and suggested steps for
improving ecological risk assessment in three decision-making contexts: product health
and safety, management of contaminated sites, and natural resource protection. The
primary objective of the workshop was to provide information for EPEC by initiating a
broad dialogue on the current state of the practice of ecological risk assessment as applied
in environmental risk management and decision making. A workshop summary
document describing key points discussed is provided as an attachment to this advisory
report. The workshop summary document and supporting material is also available at:
http://www.epa.gov/sab/sab_epec_wkshp_eco_risk_02_7-9_2006.htm.
3.0 BACKGROUND ON EPA'S ECOLOGICAL RISK ASSESSMENT
FRAMEWORK AND GUIDELINES
EPA's Framework for Ecological Risk Assessment (Framework) and Guidelines for
Ecological Risk Assessment (Guidelines) (U.S. Environmental Protection Agency, 1992,
1998) have greatly improved the state of the practice by stressing the importance of
conducting assessments using a phased approach in a multidisciplinary setting. A key
aspect of the Framework is the problem formulation phase. Early interaction and
discussion among risk assessors, risk managers, and stakeholders helps ensure relevance
of risk assessment results to risk management questions. The development of conceptual
-------
models and assessment endpoints during the problem formulation phase of a risk
assessment is critical to guiding the establishment of a valid analysis plan.
The strengths of ecological risk assessment for use in decision making include its
value as a process, not just a technique. In this regard, ecological risk assessment
provides a consistent approach for using diverse types of laboratory and field data, a
source of analytical tools applicable to address a wide array of environmental problems,
a means to integrate assessment methods (e.g., species sensitivity distributions, and
weight-of-evidence approaches), and a consistent format for reporting risks and
uncertainties.
Both scientific and non-scientific limitations occur in implementing ecological risk
assessment. Scientific and technical challenges in the risk assessment process include
characterizing and incorporating uncertainties associated with the stochastic nature of
ecological systems and the effects of multiple stressors, linking assessment endpoints to
realistic time and space scales, establishing ecological baselines, predicting exposure to
toxic contaminants or other stressors (e.g., variability in dietary exposure to
contaminants), and dealing with variations in toxicological profiles for different taxa.
Non-scientific limitations to the use of ecological risk assessment in decision-making
processes include legal and regulatory requirements. For example, potential liability can
promote avoidance of risk assessment, and requirements to assess individual rather than
cumulative risks may limit the utility of a risk assessment. Furthermore, policies and
precedents may require specific components to be part of risk assessment or establish
inappropriate endpoints. This is exemplified in questions that often arise about: 1) the
validity of policy or precedent-based point estimates of effects used in risk assessments
(e.g., "No Observed Effects Concentrations" [NOECs] that have been used in some risk
assessments are not statistically defensible), 2) the quality of data obtained from peer
reviewed literature (e.g., poor study design and reporting standards), 3) common failures
to connect risk assessments to management issues, and 4) exclusion of some key
stakeholders from the ecological risk assessment process. Social challenges include the
need to engage stakeholders, risk assessors, and risk managers early and often in the
process in order to understand communities' positions on potential management
decisions.
4.0 FINDINGS AND RECOMMENDATIONS
4.1 EPA's Ecological Risk Assessment Framework and Guidelines
EPEC finds that EPA 's Ecological Risk Assessment Framework and Guidelines (U.S.
EPA, 1992, 1998), used to conduct assessments for nearly 20 years, have been and
continue to be a robust and useful foundation upon which to build the information needed
to support decision making for ecological resources. Participants at the EPEC ecological
risk assessment workshop described the Framework as "standing the test of time." The
value of the Framework is further evidenced by its incorporation into many federal and
state guidelines and a large body of references in the scientific literature. The
Framework's underlying ecological risk assessment paradigm has been emulated in
-------
Canada, the European Union, and other countries, and this further attests to the utility of
the Framework.
Risk assessment and risk management are closely linked by design, necessity and law.
The National Research Council has stated that the role of risk assessments is to provide
the information to distinguish between important and trivial threats and, when coupled
with political, social, economic and engineering considerations, to enable decisions about
the need and methods for risk reduction (National Research Council, 1994). EPEC finds
that ecological risk assessments have been most effective when clear management goals
were included in the problem formulation, translated into information needs, articulated
using data quality objectives (DQOs) and, most importantly, developed in collaboration
with the decision makers, assessors, scientists, and stakeholders. EPEC notes that EPA
has developed guidance on use of the DQO process to establish performance criteria for
designing a data collection plan to support study goals (U.S. Environmental Protection
Agency, 2000a,b,c, 2006c). This guidance should be consulted during the problem
formulation phase of ecological risk assessments.
Many participants at the EPEC ecological risk assessment workshop stated that EPA's
Framework for Ecological Risk Assessment has utility, but they noted major differences
in ecological risk assessments conducted by various EPA Program and Regional Offices.
Furthermore, the application of ecological risk assessments in decision making has been
inconsistent. Most EPA offices have, or are in the process of, updating program specific
ecological risk assessment guidance to reflect the principles established in the Framework
and Guidelines. Although the sheer range of applications of the Framework and
Guidelines has made it difficult to develop recognizable Agency-wide policy or guidance
that defines what ecological attributes the Agency is striving to protect and how to apply
those findings in risk decisions, EPEC finds that such guidance would bring consistency
to the overall risk assessment process. EPEC also finds that models and endpoints to be
used in ecological risk assessments should include consideration of non-chemical
stressors as well as mixtures of chemical and non-chemical stressors. In addition,
outcomes of assessments should consistently report risks and uncertainties. If the
Framework and Guidelines are carefully followed, risk assessment results will be used
more frequently in EPA risk management decisions.
4.2 Risk Assessor and Risk Manager Dialogue in Planning and Problem
Formulation
While recognizing the considerable utility of the Framework and Guidelines, EPEC
finds that there are scientific and technical challenges to be addressed in using ecological
risk assessment for decision making. Foremost is to foster increased awareness and use
of ecological risk assessment in the management decision process. While recognizing
that EPA 's Framework for Ecological risk Assessment provides for interaction between
risk managers and risk assessors, EPEC finds that the integration of ecological risk
assessment into the environmental management decision process should be further
promoted.
-------
EPEC finds that there is a need to bring more specificity to problem formulation in
ecological risk assessment. There is also is a need for guidelines and examples
describing how to bridge the gap between risk management and risk assessment. While
no single clear consensus on how to best bridge this gap resulted from the EPEC
ecological risk assessment workshop, patterns of ideas emerged on how to address risk
and risk management for different objectives, on the need to consider the role of spatial
and temporal scales, and on appropriate tools for considering and communicating
uncertainty in risk assessments during the problem formulation step. Broadly, these ideas
can be grouped into four central themes:
1. Managers, assessors, and stakeholders should be engaged early and iteratively
throughout the risk assessment process.
2. Specificity and direct consideration of management alternatives are needed during
problem formulation.
3. Incorporation of specific testable hypotheses, questions, or site assumptions should be
tied directly to management information needs and data collection and analysis.
4. Uncertainty should be addressed in a manner that allows trade-offs in risk
management alternatives to be evaluated using approaches that can be communicated
and understood by the public.
Risk assessor and risk manager dialogue is necessary during the planning and problem
formulation phase of a risk assessment to develop focused risk assessment questions or
hypotheses that inform specific risk management options. Problem formulation is
currently receiving greater attention than in the past and involves EPA and stakeholders
earlier in the process. Some participants at the EPEC ecological risk assessment
workshop noted that it is difficult to get the Agency risk managers to engage in a
dialogue. A consistent approach for encouraging such a dialogue is needed, and EPEC
recommends that EPA take steps to encourage and promote, if not require, problem
formulation dialogue.
EPEC notes that the EcoUpdate Bulletin published by EPA's Office of Solid Waste
and Emergency Response remains an excellent means of communicating important
aspects of the ecological risk assessment process both within and outside of the Agency.
While the most recent edition of EcoUpdate Bulletin is June 2001, EPEC encourages
EPA to consider using the EcoUpdate Bulletin and developing similar publications so
that EPA program offices can address the issue of problem formulation dialogue, as well
as communicate elements and recommendations included in this advisory report.
As noted above, EPEC finds that there is a need to explore how to bring more
specificity into problem formulation and "risk question " or hypothesis setting. While the
ecological risk assessment paradigm does provide that risk management questions should
be addressed in the problem formulation phase, often the "testable hypotheses" or "risk
questions" are too generic (e.g., "protection of avian populations" or "no adverse effects
-------
to benthic macroinvertebrates"). Generalized questions are difficult to interpret, do not
result in measurable endpoints, and are not explicitly linked to risk management
decisions. Broad questions (e.g., risks to avian populations) must be broken down into
smaller ones (e.g., testing for a 10% decrease in the abundance of a particular species of
bird in a specified period of time). At the same time, answering a well-defined question
is not useful if it does not lead to improvements in managing resources. Testable
hypotheses are not useful unless they are very closely tied to management goals, and
correct problem formulation will drive decisions to collect field data that are meaningful
to decision making. Explicit connections between risk measures, data quality needs, data
collection, and risk management decisions are therefore needed during problem
formulation. However, such connections have not been consistently achieved.
Additional guidance or examples of how to formulate and scientifically test such
connections would be helpful. Furthermore, formulation of specific problems
incorporating testable hypotheses or risk questions has not been effective or consistent in
ecological risk assessments across EPA. EPEC therefore recommends that EPA develop
examples and/or guidance to help connect risk management with risk questions or
testable hypotheses.
EPEC finds that EPA should focus more attention on ensuring that selected measures
of risk for which data will be collected are appropriate for their intended use in decision
making. Often a large amount of field data are collected for risk assessments without first
focusing on how those data will be used in the risk management context. It is
recommended that EPA explicitly tie data collection to risk management questions
through the DQO process. As noted above, often EPA does not clearly identify the
ecological attributes or resources the Agency is striving to protect. EPEC notes that the
EPA Science Advisory Board's Framework for Assessing and Reporting on Ecological
Condition (U.S. EPA Science Advisory Board, 2002) may provide a useful reference
checklist for ensuring that appropriate levels of temporal and spatial scale and biological
organization are considered in ecological risk assessments.
EPEC finds that, for large, complex risk assessments, peer review at the problem
formulation phase and again at risk assessment completion would help assure that the
assessment study design and implementation are appropriate for the risk management
goals. EPEC recommends that for high priority (i.e., high risk, high cost) assessments,
problem formulation and study design be reviewed through an independent scientific
peer review process prior to study implementation. Peer review early in the process will
strengthen ecological risk assessments even if there are no conflicts associated with the
study design. The identification of assessments requiring early peer review could be
based on a recommendation or predetermined criterion or based on evaluation of prior
risk assessments. EPEC notes that the composition of a panel convened for problem
formulation review may be different from the composition of a panel formed for a study
design review.
Recognizing that a peer review process could be unnecessarily cumbersome for
smaller risk assessments, EPEC notes that checklists could be developed to assist risk
assessors and risk managers in planning and problem formulation. These checklists
-------
could identify key points to be addressed when developing specific risk questions and
considering management alternatives. The goal of providing such checklists would be to
ensure that various important points (e.g., adequacy of problem formulation,
consideration of possible management strategies in problem formulation, connections
between assessment and measurement endpoints, and consideration of data quality
objectives) are adequately addressed at all sites. Checklists could be adopted from
existing EPA documents such as Chapter 9 of the Risk Assessment Guidance for
Superfomd, Part A (U.S. Environmental Protection Agency, 1989).
An additional means of assisting the dialogue between risk assessors and managers
and improving the problem formulation process is to compile and present case studies
that evaluate how ecological data have been used in decision making. Case studies
presented at the EPEC ecological risk assessment workshop highlighted the strengths and
weaknesses of various risk assessments. As further discussed below, EPEC recommends
that EPA compile and develop such ecological risk assessment case studies. The case
studies would provide useful information for developing standards of practice to
determine ecological condition. They would also be useful to risk assessors considering
how to address issues of spatial and temporal scale, levels of biological organization, and
cumulative risk.
4.3 Decision Making in the Presence of Uncertainty
EPEC notes that it is important to consider uncertainty and probability in ecological
risk assessment. Ecological risk assessments often fail to identify and prioritize
uncertainties that could affect the quality of remedy decisions, and additional information
that would be needed to reduce the uncertainty of the assessment. This gap leads to an
over reliance on conservative point value estimates of risk. EPEC finds that the problem
formulation process in ecological risk assessment could be improved by explicitly
identifying uncertainties, the consequences of those uncertainties, and the additional
information needed to reduce those uncertainties. For example, Borsuk (2006), in
seeking to define a relationship between oxygen conditions and fish kills in the Neuse
River estuary, uses expert opinion from people with good knowledge of local conditions
(where no good database is available) to construct an influence diagram. Monte Carlo
simulation is then used to generate predictions offish health and fish kills in the estuary
under current and improved oxygen conditions. Here, the model for ecological risk must
account for both knowledge uncertainty and natural variability.
Decision making in the presence of uncertainty is constrained by statutory and
regulatory requirements. Where uncertainty exists, EPA decision makers often select the
most conservative (protective) risk management measures. Although some statutes
require consideration of risks and benefits, ecological risk can be relegated to a
"nonfactor" in decision making where there is great uncertainty in identifying risks. This
absence compromises the decision-making process.
For decision making in the face of uncertainty, there are three options that should be
explored during the problem formulation phase:
-------
Defer making a decision until more study is conducted to reduce uncertainty;
Making a decision with an understanding of the existing uncertainties; or
- Making a decision with monitoring and triggers for further action, if needed.
Additional study data may reduce the uncertainty associated with a decision.
However, there is a financial tradeoff between study costs and a management decision
under consideration. For example, in a system where the main impacts are expected to be
risks associated with bioaccumulated contaminants in fish and the consumers of those
fish, spending additional funds to reduce uncertainty associated with risks to benthic
macroinvertebrates may not be justified because a decision could be made on the basis of
risks to piscivores. Further study of risks to benthic macroinvertebrates would not reduce
uncertainty associated with the management decision
Adaptive management is an option for dealing with uncertainties. Adaptive
management allows a decision to be implemented and requires long-term monitoring
with clear performance triggers to account for uncertainty in the management decision.
An adaptive management approach would address a concern raised by some
representatives of both industry and the environmental and conservation community who
attended the EPEC ecological risk assessment workshop. These individuals viewed the
ecological risk assessment process as too long, too expensive, and at times encumbered
with extensive and unnecessary investigations that do little to protect the exposed
ecological resources. EPEC notes that EPA currently has no guidance on planning for, or
application of, adaptive management in ecological risk assessment. Adaptive
management with iterative triggers for action should be planned as part of the problem
formulation step. EPEC therefore suggests that EPA explore how adaptive management
can be applied in the context of ecological risk assessment and risk management.
At the EPEC ecological risk assessment workshop, there was considerable discussion,
but no consensus, on the use of rigorous "hypothesis-testing" versus "risk questions" in
problem formulation. Some participants expressed the opinion that it is difficult to link
hypothesis statements in ecological risk assessments to explicitly stated process goals.
They noted that when such hypothesis statements are used in ecological risk assessments,
risk managers may not have the information needed to make decisions. Others thought
that well-defined statistically testable exploratory hypotheses with defined Type I and II
error rates were necessary in ecological risk assessments. EPEC finds that problem
formulation could be improved by exploring the use of methods, such as Bayesian
analysis and causal argumentation, to develop hypotheses or "risk questions "focused on
causal relationships and weight of evidence. Likelihood statements or estimation
methods rather than binary (yes/no) statements could be incorporated into problem
formulation. EPEC notes a number of benefits associated with the use of Bayesian
approaches. The use of Bayesian approaches would allow risk assessors to obtain a
"posterior likelihood" for a parameter, along with the uncertainty associated with the
parameter estimate. Posterior likelihoods can be presented to the public in an informative
and understandable manner. Bayesian results provide a clearer, more direct
interpretation, particularly for nonstatistical scientist. This is because it is easier to grasp
-------
the Bayesian notion of "the probability of an event happening, given the data that we
have observed," rather than the frequentist's interpretation of "the probability of seeing
the observed data, or anything more extreme, given that conditions under an event hold"
(the much used, and much abused, P value).
Probabilistic ecological risk assessment is another means for understanding
uncertainties and implications regarding the degree of protectiveness of various
management options. However, EPEC notes that probabilistic assessments can be
difficult to explain and communicate to non-scientific risk managers and the general
public. It is often easier but less precise to communicate a deterministic hazard quotient
used in a risk assessment than a probabilistically derived hazard quotient. EPEC finds
that the results of probabilistic risk assessments could be communicated more effectively
by articulating, during the problem formulation phase, a summary of the sources and
sizes of major uncertainties and how probabilistic approaches would be applied to
understand the implications of uncertainty to the degree of protectiveness of the
management decisions. Uncertainties must be clearly identified during problem
formulation so that risk managers can evaluate the need for conservative or risk tolerant
decisions.
A considerable amount of work has been done on the mechanics of conducting
quantitative uncertainty analyses. However, good examples are not available to
demonstrate how such information could be used in risk management decisions. In this
advisory report, EPEC has noted that one way to reduce the uncertainty in future risk
assessments is to understand what past risk assessments revealed. EPEC therefore
recommends that EPA develop a national compendium, inventory, and/or database
containing information from past ecological risk assessments that can be used to improve
the certainty of future risk assessments. Case examples developed for such a
compendium should illustrate how ecological data have been used in decision making.
Such case examples would provide useful information on the strengths and weaknesses of
various risk assessment approaches, aid in the development of standards of practice for
future risk assessments, and assist EPA in maintaining consistent use of risk assessment
procedures among various Agency offices. Numerous illustrative examples are available
for such a compendium. In one example, Crane et al. (2000) show how the process of
ecological risk assessment could be used to assess the effects of a (hypothetical)
hazardous substance on fish. Their primary purpose is to illustrate a variety of statistical
methods used in ecological risk assessment. However, they also illustrate how to
combine estimates of exposure and effects to calculate risk by making specific
probability statements about fish mortality given various environmental contaminant
concentrations. In another example, Williams et al. (2006) test the assumptions regarding
the bioconcentration factor (BCF) for arsenic bioaccumulation. The traditional
assumption for bioaccumulation is that it is a linear function of exposure concentration.
The authors identify 12 studies (4 laboratory and 8 field investigations, one of which is a
study conducted by EPA's Environmental Monitoring and Assessment Program) of
arsenic bioaccumulation in freshwater fishes in order to explore differences in laboratory-
generated BCFs and field-generated bioaccumulation factors (BAFs), and to assess their
relationship to arsenic concentrations in water. Their analysis indicates that arsenic
-------
concentrations in tissue and arsenic BAFs may be power functions of arsenic
concentration in water. Thus, the assumption of a linear function may be faulty. To
reduce uncertainty in future risk assessments, EPEC also believes it is critically
important that EPA initiate post-decision audit programs to evaluate the environmental
outcomes of risk management decisions relative to those effects predicted and used to
formulate the management decisions. Specifically, EPEC recommends that EPA more
fully describe the beneficial ecological consequences resulting from risk management
decisions in terms that the public can understand, and then follow the risk management
decisions with post-decision audit programs. This process may be equally applied to
contaminated site, natural resource and product health and safety decisions. This
recommendation is consistent with findings in the recent SAB Advisory on EPA's
Superfund Benefits Analysis (U.S. EPA Science Advisory Board, 2006).
EPEC also finds that uncertainty in ecological risk assessments could be reduced by
undertaking critically needed work to develop a consistent approach to interpreting lines
of evidence and weight of evidence in complex ecological risk assessments, or a process
for evaluating competing technical assessments in environmental decision making.
Weight-of-evidence approaches enable ecologists to evaluate multiple types of evidence
and multiple lines of evidence within a type. While many risk assessment practitioners
prefer to consider all available relevant evidence, some consider the process of weighing
evidence to be too subjective. EPEC, therefore, recommends that EPA develop case
studies and/or standards of practice for interpreting lines of evidence and weight of
evidence with an emphasis on application in decision making.
4.4 Linking Natural and Social Science in Environmental Decision Making
EPA's Framework and Guidelines for Ecological Risk Assessment focus on the
application of ecological risk science within a legal and or regulatory decision-making
context. In reality, however, Agency decisions occur within a broader context that is
conditioned by a community's values and economic objectives, as well as ecological
conditions. In order for ecological risk assessment applications to be optimized in the
broad context, they need to be aligned with the social-economic conditions in which
decisions are to be made. To accomplish such alignment, EPA must identify what
ecological services delivered by the environment being protected matter to relevant
community stakeholders. The involvement of stakeholders early and iteratively with the
technical experts and decision makers is needed to identify the valued ecological services
that are at risk. Once those service flows have been identified, they can inform the
selection of relevant assessment endpoints and associated data. Such a coupling will
result in a risk assessment that is linked to quantifiable services and will allow testing of
alternative management strategies to maximize social net benefits (benefits minus costs)
of any EPA decision.
EPEC recognizes that EPA, through its draft Ecological Benefit Assessment Strategic
Plan (U.S. Environmental Protection Agency, 2006a), is wrestling with the integration of
ecological risk assessment and economic benefit analysis. However, EPEC finds that
there has been little elaboration of how ecological risk estimates might be considered or
-------
weighed in these broader decision-making contexts. So from EPEC's perspective, the
path to identifying how social attributes of an ecosystem are translated into assessment
endpoints that meet decision makers' needs represents uncharted waters, and additional
guidance is needed. EPEC strongly encourages the Agency to test these waters through
field demonstrations and then develop guidance as needed.
EPEC finds that benefit-cost and valuation methods need to be further developed in
order to provide mechanisms for conducting risk assessments in the context of policy
decisions regarding risk reduction. Because policy decisions might consider costs and
benefits (or more generally the values that people attach to specific risk changes), it is
important that risk assessments be designed to provide information for estimating costs
and/or benefits or the associated values. Net benefit analysis may be a useful cross-
cutting approach for linking uncertainty analysis and risk management decisions. In this
regard, EPEC notes that some type of net benefit analysis would be beneficial, but it
should not be used to avoid risk assessment. EPA's draft Ecological Benefit Assessment
Strategic Plan is based on an application of benefit-cost analysis to ecological benefits,
following the guidelines for cost benefit analysis contained in U.S. Office of
Management and Budget Circular A-4 (U.S. Office of Management and Budget, 2003).
EPA's work in this area is summarized in the recent review of the Ecological Benefit
Assessment Strategic Plan conducted by the SAB Committee on Valuing the Protection
of Ecological Systems and Services (CVPESS) (U.S. EPA Science Advisory Board,
2005). The CVPESS report states that methods are needed for valuation of ecological
resources and attributes. EPEC encourages EPA to continue developing these holistic
ecosystem valuation methods. However, EPEC notes that during the problem
formulation phase of ecological risk assessments, screening can be conducted by simple
comparisons of costs to benefits such as reduction in area-weighted average
concentrations of contaminants, reduction in hazard quotients or other measures of risk to
identified receptors, or even probability distributions of risk. While these types of
benefit-cost comparisons are clearly in the domain of the risk managers, identifying the
data needs for articulating not only the baseline risk, but also the mechanisms and
measures for incremental risk reduction to ecological resources, should be addressed in
the problem formulation and risk assessment. EPEC advises EPA to develop guidance
for application of risk-reduction metrics such as those mentioned above, while also
maintaining a long-term focus on research to develop methods for valuation of ecosystem
services. Such valuation methods can be applied in the problem formulation phase of a
risk assessment to develop a better understanding of appropriate risk questions. This
approach will provide the knowledge needed for comprehensive benefit assessments.
Product life cycle analysis (LCA), while not typically used for ecological risk
assessments, was viewed by participants at the EPEC ecological risk assessment
workshop as potentially providing useful information for future-oriented investigative
questions and emerging areas (e.g., nanotechnology). Issues such as inputs required for
production and maintenance activities, product use and reuse options, and disposal and
recycling alternatives can be considered in a systems approach. EPEC finds that
additional guidance on application of LCA would be helpful to risk assessment
practitioners.
10
-------
4.5 Spatial, Temporal and Biological Scales
As noted previously, pertinent spatial and temporal scales and levels of biological
organization are not often explicitly considered in the problem formulation phase of
ecological risk assessments, even though they should be. Risk assessments may range
from local to global applications, from immediate to long-term effects, and across a
number of levels of biological organization. As stated in EPA's Framework for
Ecological Risk Assessment, the purpose for conducting a risk assessment determines
whether it is national, regional, or local in scope. For example, the EPA Office of
Pesticide Programs may conduct ecological risk assessments over a range of spatial
scales depending upon uses, fate, transport, and effects of pesticides. The spatial scales
of risk assessments conducted by EPA's Office of Solid Waste and Emergency Remedial
Response may depend upon the boundaries of contaminated sites. Any such exercise
necessarily involves numerous trade-offs of site-specificity and accuracy versus general
applicability to diverse facilities and locations.
It is critical that both the decision makers and the risk assessors be cognizant of
the extent and resolution of scales being considered in addressing any particular
issues. Therefore EPEC recommends explicit definition of the extent and resolution
of the pertinent spatial and temporal scales and levels of biological organization of
concern at the problem formulation phase of a risk assessment.
Scales must be appropriate to each problem in order to identify emerging patterns
across space, time, and levels of biological organization. The appropriate scale of an
ecological risk assessment depends upon such factors as the stressors and media being
evaluated, episodic events considered, specific ecological receptors, and the recovery
time of systems. For example, climate change events of varying scales such as El Nino
cycles, the Eastern Pacific Decadal Oscillation, and anthropogenic warming can
significantly affect ecosystems and should be considered in ecological risk assessments.
The SAB Framework for Assessing and Reporting on Ecological Condition (U.S. EPA
Science Advisory Board, 2002) can be used to guide choice of scale.
EPEC notes that it would be useful to develop standard techniques for assessing risks
at specific levels of biological organization (e.g., based on common definitions of habitat
types and communities). Indirect ecological effects are often revealed at levels of
biological organization above populations, and there is a need for techniques for
assessing risks at all levels of biological organization (i.e., community, habitat, and
landscape scales). Guidance is also needed on the use of population models in ecological
effects assessments.
Multi-generational analyses or estimates of past conditions are rarely used for
prospective risk estimates but should be considered when the time of concern precedes
current information. These tools may include analysis of archaeological structures,
witness tree data, historical journals, and other place-based information.
11
-------
In addition, tools such as geographic information systems, continuous monitors,
habitat and other models, and species life history information may be used to incorporate
spatial and temporal scales in ecological risk assessments. Therefore, EPEC recommends
that EPA promote the evaluation and use of statistical, geospatial, and other tools for
data collection and analysis (e.g., time series and spatial analyses).
4.6 Comparison of Other Protocols for Conducting Ecological Risk Assessments
Ecological risk assessment methodologies are not the exclusive purview of the U.S.
EPA. Alternative methodologies have been developed and are being used by other
countries (e.g., Canada, Australia, New Zealand, the European Union) and at least one
other U.S. government agency (the National Oceanographic and Atmospheric
Administration [NOAA]) (Table 1). EPA should be cognizant of these approaches and
incorporate valuable aspects of them into the Agency's risk assessment guidance. For
example, Environment Canada uses a three-tier approach ranging from (Tier 1) relatively
small areas of contamination to (Tier 3) complex, large scale areas of contamination
(Canadian Council of Ministers of the Environment, 2007). The British Columbia
Ministry of Environment (Canada) has specific guidance for Tier 1 sites including
intended land use post remediation (British Columbia Ministry of the Environment,
2007a,b). Incorporation of planned land use is also a feature of Australian guidance,
which is focused on natural resource protection (Australia Natural Environmental
Protection Council, 2007). New Zealand's guidance is an amalgam of both the
Australian and U.S. models, including tiering similar to the Canadian approach (Landcare
Research, 2007a,b). The European Union approach is based on comparing predicted
environmental concentrations (PECs) to predicted no effects concentrations (PNEC)
(European Commission on Health and Consumer Protection Directorate-General, 2003).
NOAA's guidance for aquaculture uses a model similar to EPA's but includes non-
chemical stressors (Nash et al., 2005). Thus, different approaches to ecological risk
assessment exist both outside and within the U.S. Commonalities include an initial data
summary (problem formulation, hazard assessment) phase, a conceptual model,
considerations of exposure and effects, and a risk calculation process.
Table 1. Links to Various Approaches to Ecological Risk Assessment
Government
Unit
Canadian
Council of
Ministers of the
Environment
(CCME)
Title and/or URL
www.ccme.ca
Short Description
This site contains the Canadian guidance for
ecological risk assessment as well as a wide
variety of relevant guideline documents.
12
-------
BC Ministry of
Environment
(Canada)
Recommended Guidance and
Checklist for Tier 1
Ecological Risk Assessment
of Contaminated Sites in
British Columbia.
http://www.env.gov.bc.ca/ep
d/epdpa/contam_sites/policy
_procedure_protocol/protoco
Is/tier I/index.html
This is the guidance and checklist for smaller
scale sites for the province of British Columbia
(BC). The approach is based on the Canadian
definition of Tiers and the Contaminated Site
regulations for BC. Land use is an important
and explicit consideration in the risk assessment
process.
BC Ministry of
Environment
(Canada)
Tier 1 Ecological Risk
Assessment Policy Decision
Summary
http://www.env.gov.bc.ca/ep
d/epdpa/contam sites/standar
ds_criteria/standards/tierlpol
icy, html
In addition to the guidance document a record of
decision making was produced to justify the use
of 20% effects concentrations (EC20s), site
visits and other features of the above guidance
document.
Australia
Australian Schedule B (5)
Guideline on Ecological Risk
Assessment
http ://www. ephc. gov.au/pdf/
cs/cs_05_era.pdf Additional
documents describing the
risk assessment process for
contaminated sites can be
found at:
http ://www. ephc. gov.au/nep
ms/cs/con sites.html.
Contaminated site risk assessment is the
jurisdiction of the National Environment
Protection Council that is in turn a part of the
Environment Protection and Heritage Council
(EPHC). Part of the mandate of EPHC is the
preservation of natural resources. Land use is an
important and explicit consideration in the
guidance, similar to that of British Columbia.
New Zealand Risk Assessment for
Contaminated Sites in New
Zealand.
http://contamsites.landcarere
search.co.nz/index.htm
New Zealand has an extensive set of risk
assessment documents for contaminated sites.
Many of the tools are based upon Australian and
United States approaches. New Zealand has a
tiered system of risk assessments similar to
Canada.
European Union
Final Report on the
Ecological Risk Assessment
of Chemicals Adopted by the
Scientific Steering
Committee at its Meeting of
6-7 March 2003.
The European Union (EU) document appears
significantly different from Canadian or
Australian approaches. The risk assessment
process is chemical-based, comparing predicted
environmental concentrations and predicted no-
effect concentrations.
13
-------
http ://ec. europa. eu/food/fs/sc
/ssc/out326 en.pdf
NOAA Guidelines for Ecological These guidelines provide information for the
Risk Assessment of Marine evaluation of non-chemical stressors with an
Fish Aquaculture. approach derived from U.S. EPA but used for a
http://www.nwfsc.noaa.gov/a different purpose. Non-chemical stressors
ssets/25/6450_01302006_15 included in the assessment include: transmission
5445_NashFAOFinalTM71 .p of disease organisms; interactions between
df escaped organisms and wild populations; and
physical interactions with marine habitat and
wildlife.
5.0 IMPROVING ECOLOGICAL RISK ASSESSMENT IN SPECIFIC
DECISION-MAKING CONTEXTS
Participants at the EPEC ecological risk assessment workshop discussed opportunities
for advancing ecological risk assessment in three decision-making contexts: product
health and safety, management of contaminated sites, and natural resource protection.
EPEC provides the following specific findings and recommendations to improve
ecological risk assessment in these specific decision-making contexts.
5.1 Ecological Risk Assessments for Product Health and Safety Evaluation
Ecological risk assessments for product health and safety evaluation are conducted to
meet varying requirements of different statutes (e.g., Federal Insecticide, Fungicide, and
Rodenticide Act, Toxic Substances Control Act). EPEC finds that in product health and
safety risk assessments, levels of concern and risk quotients often drive the problem
formulation phase of the risk assessment, but these measurement endpoints may not
provide realistic ecosystem protection goals. Such generic problem formulation does not
focus on why particular risk assessments are being conducted or what ecological
resources should be protected. To improve ecological risk assessments for product health
and safety evaluations EPEC provides the following specific recommendations. These
recommendations focus on actions that can be taken to facilitate consideration of relevant
contaminant release pathways, fate and transport of contaminants, sensitivity of
receptors, and optimization of appropriate assessment and measurement endpoints during
problem formulation.
1. Explicitly consider, during problem formulation, the appropriate spatial and
temporal scales and level of biological organization to be taken into account in
the risk assessment in the context of decisions to be made. This approach will
require broader consideration of receptors and stressors. Again, the Framework
for Assessing and Reporting on Ecological Condition (U.S. EPA Science Advisory
Board, 2002) may be useful in this regard.
14
-------
2. Develop tools for cumulative risk assessment because contaminants are often
released into stressed environments.
3. Continue to conduct research to determine how biomarker and mechanistic data
might best be used in exposure and risk assessments.
4. Conduct multigenerational analyses or other retrospective ground-truthing
analyses for prospective risk estimates and re-evaluate and validate levels of
concern with monitoring studies.
5. Use currently available tools for rapid screening level assessments, such as the
Agency's Estimation Programs Interface (EPI) Suite (U.S. Environmental
Protection Agency, 2004), to assist in determining whether chemicals are
biodegradable, toxic, or bioaccumulative.
5.2 Ecological Risk Assessments for Contaminated Site Management
While there is sufficient flexibility built into EPA's Framework and Guidelines to
evaluate large scale spatial, temporal, or even population-level effects at contaminated
sites, many of these sites are relatively small (e.g., 2 to 10 acres). Under the requirements
of the Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA), a contaminated site remedy must be protective of human health and the
environment within the site boundaries. CERCLA requires that the site investigation,
including the ecological risk assessment and the remedy, focus on the site. An
investigation with broader focus may not be a legal expenditure of resources under the
law. This situation can preclude considering effects that would occur beyond the
boundaries of a site. While acknowledging the regulatory constraints imposed, EPEC
encourages EPA to further evaluate how large scale spatial, temporal, or population-
level effects (and the cumulative effects of several sites within a small area) could be
investigated in the context of legal and regulatory requirements that may limit the focus
of assessments.
Contaminated site management decisions are often made using a weight-of-evidence
approach but, as noted above, the ecological risk assessment process lacks a common
understanding of what is meant by weight of evidence. The result is inconsistency in
contaminated site decision making. This problem is not unique to contaminated sites or
even to ecological risk assessment in general. The National Research Council recently
advocated the use of weight of evidence (National Research Council, 1996) without
providing context for what that means. As discussed above, EPEC recommends that
EPA, or alternatively the EPA Science Advisory Board, develop a common definition
and application methodology addressing what constitutes weight of evidence.
The issue of uncertainly in the decision process encumbers the ecological risk
assessment process with many lengthy and costly studies. Additional studies often are
unable to resolve those uncertainties, and during the time taken to conduct the studies,
ecological resources continue to be exposed. As noted previously, in the face of those
15
-------
uncertainties EPA resource managers often choose to make the most conservative
(protective) decisions, or more often make site decisions based on human health
concerns, rendering the ecological risk assessment moot.
EPEC finds that guidance is needed in the area of risk calculation and application.
Too often ecological risk assessments are designed and executed solely with a
comparison of measured exposure concentrations to toxicological reference values; the
"hazard quotient." Although the area of risk characterization was explored during the
EPEC ecological risk assessment workshop, actual discussions around risk calculation
and application methods were limited. Much of the workshop discussion in this area
focused on the need to better understand the appropriate use of hazard quotients (HQs) to
assess and subsequently manage risk, the issues of uncertainty in calculating risk, and the
need for full exploration and disclosure of uncertainty. Therefore, in the following
discussion and associated recommendations there is an absence of explicit
recommendations related to risk calculation methods other than those related to HQs,
which some might suggest are not risk calculation methods at all. The Agency and other
readers should not take this as a suggestion that the capacity to do better risk calculations
could not be improved. Our expectation and hope is that as EPA seeks to address the
recommendations related to appropriate use of HQs and the need to understand and
reduce uncertainty, the Agency will need to explore a range of risk calculation methods
which represent better and more certain approaches to estimating risk.
EPA is most likely aware that there are some scientists (Tannenbaum, 2003, 2005)
who challenge the veracity of ecological risk assessment as a tool for effectively
informing environmental decisions makers. Although such positions are not widely held,
the Agency should not summarily dismiss issues raised by these contrarians. For
example, some raise the issue that HQs do not provide estimates of risk (Tannenbaum et
al., 2003) and that the use of HQs to set preliminary remediation goals at contaminated
sites is mathematically inaccurate. EPEC recommends that EPA take the initiative on
this point and develop guidance on the appropriate and acceptable use of such screening
tools such as HQs, hazard indices (His), and other environmental benchmarks, especially
with regard to their utility in setting actionable environmental protection goals.
To some degree the concerns raised about ecological risk assessment as a tool for
decision making may be more related to how the ecological risk assessment process and
its output are utilized in a given management context. For example, in ecological risk
assessments of contaminated lands, project managers with limited scientific
understanding may give greater weight to modeled estimates of risk than to field
observations indicating that no harm is apparent. To address this point EPA is advised to
take stronger leadership in training its personnel, and those of state regulators, on the
appropriate use of ecological risk assessment methods and data, and to explicitly make
regulators aware of how such data and methods can be misused. EPA should also
consider how to effectively integrate and weight the importance of modeled estimates of
risk in the presence of ecological observations from the field which provide assessments
of ecological integrity or biological performance. This latter recommendation relates to
the stated need for guidance on weight of evidence procedures discussed in section 4.4 of
16
-------
this advisory. Although these recommendations are presented in the context of
contaminated site decision making, EPEC notes that the need for the training and
education identified above is a cross-cutting issue that pertaining to ecological risk
assessment.
To apply ecological risk assessment in an appropriate decision making context some
have suggested the need to balance the risks from contamination with the risks and
expected benefits from removal of contaminated media. Advancing net environmental
benefit tools (Efroymson et al, 2004) may be a useful check to fit a specific process such
as the remediation of chemically contaminated sites.
To increase efficiency in the process of assessing contaminated sites and to help address
the uncertainty issue, EPEC recommends that EPA develop:
1. Programmatic-level risk assessments for contaminants such as polychlorinated
biphenyls commonly found at many contaminated sites. Such assessments would
be similar to programmatic environmental impact statements which are described
in the National Environmental Policy Act and are typically prepared with the
intention of describing the impacts of actions that are repeated over time. This
would decrease the number of redundant risk assessments for contaminants
commonly found at contaminated sites.
2. An evaluation of post-remedial monitoring of ecological resources as compared
to risks identified as part of remedial decisions.
3. Guidance on the application of adaptive management of ecological resources in
contaminated site decision making.
4. Guidance on the appropriate and acceptable use of such screening tools as
hazard quotients, hazard indices, and other environmental benchmarks,
especially with regard to their utility in setting actionable environmental
protection goals.
5. Training for Agency personnel and state regulators on the appropriate use of
ecological risk assessment methods and data and how such data and tools can be
misused.
6. Research on tools that balance the risks from contamination with the risks and
expected benefits from removal of contaminated media.
5.3 Ecological Risk Assessments for Natural Resource Protection
In general, risk assessments for natural resource protection are more closely tied to
an ecological attributes "values" perspective rather than the stressor perspective that is
typical of chemical specific risk assessments. When viewed from an economic
perspective, such assessments must take into consideration the use and nonuse values
17
-------
people may place on natural resources and healthy ecosystems. Because these types of
risk assessments typically focus on the ecological attributes to be protected, rather than
responses to specific stressors, the discrete ecological resources to be protected and
options for their protection should be explicitly identified in the problem formulation
phase.
Ecological risk assessments for natural resource protection can be large and complex.
Therefore EPEC finds that early scientific peer review of the risk assessment study
designs may be needed for many of these risk assessments. This review should occur
between problem formulation and analysis stages of risk assessments. Peer review of
study designs prior to initiating work plans will enhance the quality and efficiency of
such risk assessments and will help assure that the assessment study design and
implementation are appropriate for the risk management goals.
EPEC finds that natural change processes should be considered as part of ecological
risk assessments for natural resource protection. Protecting natural resources requires
consideration of natural, ongoing, and global process change (e.g., global climate change)
and how such change influences anthropogenic changes in the system under study.
EPEC finds that it is particularly important to identify the scale of concern during the
problem formulation phase of a risk assessment for natural resource protection. It is
important to look at broad scales but also to answer specific questions on local to global
scales. Decisions can be made at very small scales, but they should be considered in the
context of a broader scale. For natural resource protection, spatial scales should be large
enough to identify emerging patterns across a landscape. If additional spatial resolution
is needed to describe species abundance and distribution, this need should be considered
in the uncertainty analysis. In addition, spatial and temporal scale analysis may help later
integration of a risk assessment into a meta-analysis or larger scale analysis. Such
analyses may assist development of a larger body of knowledge for assessment projects.
Although tools are available for spatial and temporal analyses in risk assessment, it is
unclear whether there are enough risk assessment practitioners with specialized expertise
to meet the current need. Standards of practice are needed for ecological risk assessors
and risk managers. These standards of practice should address methods to assure that
spatial and temporal scale issues are appropriately addressed. EPEC notes that such
standards of practice could be broadly applicable to ecological risk assessments in most
decision-making contexts, not just natural resource protection. To resolve this need, it
may be useful to build from the Framework for Assessing and Reporting on Ecological
Condition (U.S. EPA Science Advisory Board, 2002).
EPEC notes that indirect effects can be particularly important in risk assessments for
natural resource protection and such effects are often revealed at specific levels of
biological organization. Risk assessors should consider effects at the individual, species,
community, and ecosystem scales. For example, chemical stress predisposing trees to
disease may be revealed at the community level through an assessment of forest
condition. EPEC finds that it would be useful to develop standard techniques for
assessing risks at specific levels of biological organization. The utility of community
18
-------
level information in assessing ecological risk is demonstrated by the sediment quality
triad of benthic community measures, sediment toxicity tests, and sediment chemistry
(Chapman, 2000).
As in risk assessments conducted and applied in other decision-making contexts,
elements of uncertainty should be identified and incorporated into problem formulation
and built into the design of a risk assessment for natural resources protection.
Uncertainties in ecological risk assessment should be categorized, and those that
profoundly affect results and outcomes should be identified and acknowledged in the final
assessment. As noted previously, systematic collection, organization and cataloging of
data from past risk assessments could provide information to reduce the uncertainty of
future risk assessments. Such efforts could provide better metadata and a centralized
repository for ecological risk assessment data, endangered species information, program
specific risk assessment information, and peer reviewed literature.
To improve ecological risk assessments for natural resource protection, EPEC
recommends that ecological risk assessors rethink how hypotheses are formulated and
consider how to move away from traditional hypothesis testing with null models. Such
hypothesis testing can result in null models that are developed without considering how
to balance Type I and Type II errors. Hypotheses should focus on causal relationships
and weights of evidence.
EPEC also recommends that EPA develop a better interface between risk assessment
and environmental monitoring programs so that monitoring data can be used to improve
risk assessments. Specific monitoring projects could be designed to provide data to
reduce uncertainty in future risk assessments. Monitoring programs need better direction
and redesign to provide information useful for testing hypotheses and reducing
uncertainty in risk assessments. Data collection and analysis procedures developed by
monitoring programs can also be useful to risk assessors. For example, EPA's
Environmental Monitoring and Assessment Program (EMAP) has been in operation for
more than fifteen years and has addressed scale issues (level of biological organization as
well as spatial and temporal scale) in the development of sampling and data analysis
procedures (e.g., the General Randomized Tessellation Sampling Program has been used
in EMAP to generate estimates of salmon abundance in Oregon Streams, taking into
account spatial and temporal correlation, and the fact that sites are sampled at different
frequencies).
In addition, EPEC recommends that EPA integrate work in different disciplines (e.g.,
biology, chemistry, toxicology, ecology) to prevent fragmentary risk analyses. In this
regard, expert systems could be developed to enable the integration of specific chemical
and biological endpoints and identify classes of chemicals and nonchemical stressors to
be assessed.
To improve ecological risk assessments for natural resource protection, EPEC
recommends that EPA:
19
-------
1. Explicitly identify, in the problem formulation phase, discrete ecological
resources to be protected and options for their protection.
2. Implement an independent, scientific peer review process to evaluate endpoints,
scale, levels of biological organization, uncertainties, and study design outcomes
of problem formulation prior to initiating the analysis phase.
3. Consider the development of standards of practice for risk assessors and
managers.
4. Explore ways to focus hypothesis development on causal relationships and
weights of evidence instead of traditional hypothesis testing on null models.
5. Develop a process to interface risk assessment and monitoring programs.
6. Systematically collect, organize and catalog data from past risk assessments that
could reduce the uncertainty of future risk assessments. Such an effort could
provide better metadata and a centralized repository for ecological risk
assessment data, endangered species information, program specific risk
assessment information, and peer reviewed literature.
6.0 CONCLUSION
In developing this report, EPEC considered the current state of the practice of
ecological risk assessment and opportunities to connect the early roots of this approach in
comparative toxicology with recent advances in ecology. The Framework for Ecological
Risk Assessment and Guidelines for Ecological Risk Assessment (U.S. Environmental
Protection Agency, 1992, 1998) have improved the state of the practice of ecological risk
assessment and provided a robust and useful foundation upon which to build. A number
of specific opportunities for advancing the risk assessment process have emerged.
Ecological risk assessments have been most effective when clear management goals were
included in the problem formulation and developed in collaboration with decision
makers, assessors, scientists, and stakeholders. EPA is therefore urged to encourage, if
not require, problem formulation dialogue between ecological risk managers, risk
assessors, and stakeholders (including both ecologists and the lay public). Moreover,
communication between risk managers and assessors should be a part of all aspects of the
process. The practice of ecological risk assessment can also be advanced by developing
methods and tools that assist risk assessors in designing analysis that appropriately
consider the physical, biological, and socio-economic contexts of decisions. Many risk
assessments could be enhanced by the creation of more innovative techniques for framing
and testing risk hypotheses and use of multiple lines of evidence to assess risk at higher
levels of biological organization (population, community, and landscape scales). EPA
should increase its understanding of and capacity to utilize ecosystem valuation methods
in conjunction with risk management decisions. Peer review of proposed risk
assessments before execution would likely improve many large and complex
assessments. More systematic, post-assessment monitoring would enhance the risk
20
-------
assessment process in the long run. A national compendium of past ecological risk
assessment and remediation projects would provide a foundation for enhancing future
assessments and would allow the benefits and weaknesses of the various risk assessment,
management and remediation approaches to be more readily identified. The risk
assessment framework should be viewed in an adaptive management context whereby, as
new understanding is attained, it is incorporated into the analysis process.
Together, these and other changes discussed in this report would advance the evolving
practice of ecological risk assessment. They would also enable more effective use of the
Framework for Ecological Risk Assessment to address the challenges of dealing with
uncertainties and high variability; linking assessments endpoints to realistic temporal and
spatial scales; and addressing legal and regulatory requirements or policy precedence.
Furthermore an adaptive management approach to ecological risk assessment would
allow consideration of validity of data and its scale of reference, connection to major
management problems, and involvement of stakeholders. The development and
application of the consistent approach of ecological risk assessment has greatly enhanced
the integration of laboratory and field data, analytical tools, and assessment methods and
provided a consistent format for reporting risks and uncertainties. There are clearly big
challenges ahead in applying and using the framework for ecological risk assessment; yet
there are also opportunities to address current limitations and advance the state of the
practice. EPEC finds that a substantial research effort is needed to develop the
methodology required to address many of the complex issues discussed in this report.
21
-------
7.0 REFERENCES
Australia National Environment Protection Council. 2007. Australian Schedule B(5)
Guideline on Ecological Risk Assessment, http://www.ephc.gov.au/pdf/cs/cs_05_era.pdf
[Accessed February 14, 2007]
Borsuk, M. 2006. Predictive assessment offish health and fish kills in the Neuse River
estuary using elicited expert judgment. Human and Ecological Risk Assessment; 10:415-
434.
British Columbia Ministry of the Environment. 2007a. Recommended Guidance and
Checklist for Tier 1 Ecological Risk Assessment of Contaminated Sites in British
Columbia.
http://www.env.gov.be.ca/epd/epdpa/contam_sites/policy_procedure_protocol/protocols/t
ier_l/index.html [Accessed February 14, 2007]
British Columbia Ministry of the Environment. 2007b. Tier 1 Ecological Risk
Assessment Policy Decision Document.
http://www.env.gov.be.ca/epd/epdpa/contam_sites/standards_criteria/standards/tierlpolic
y.html [Accessed February 14, 2007]
Canadian Council of Ministers of the Environment. 2007. Environmental Quality
Guidelines, http://www.ccme.ca [Accessed March 7, 2007]
Chapman, P.M. 2000. The sediment quality triad: then, now, and tomorrow.
InternationalJournal of Environment and Pollution; 13(l/2/3/4/5/6):351-356.
Crane M., A. Grosso, C. Janssen. 2000. Statistical techniques for the
ecological risk assessment of chemicals in freshwaters. In, Statistics in Ecotoxicology, T.
Sparks, Ed., John Wiley and Sons, New York, pp. 247-278.
Efroymson, R., J.P. Nicolette, and G.W. Suter II. 2004. A framework for net
environmental benefit analysis for remediation or restoration of contaminated sites.
Environmental Management; 34(3):315-331.
European Commission Health and Consumer Protection Directorate-General. 2003.
Final Report on the Ecological risk Assessment of Chemicals Adopted by the Scientific
Steering committee at its meeting of 6-7March, 2003.
http://ec.europa.eu/food/fs/sc/ssc/out326_en.pdf. [Accessed February 14, 2007]
Landcare Research. 2007a. Document Resources.
http://contamsites.landcareresearch.co.nz/era_document_resources.htm#framework .
[Accessed February 14, 2007]
22
-------
Landcare Research. 2007b. Summary of Risk Assessment Methodologies.
http://contamsites.landcareresearch.co.nz/review_methodologies.htm . [Accessed
February 14, 2007]
Nash, C.E., P.R. Burbridge, and J.K. Volkman (editors). 2005. Guidelines for Assessing
the Ecological Risks of Marine Fish Aquaculture. U. S. Department of Commerce
NOAA Technical memorandum NMFS-NWFSC-71. U.S. Department of Commerce,
National Oceanic and Atmospheric Administration, National Marine Fisheries Service,
Washington, D.C. Available:
http://www.nwfsc.noaa.gov/assets/25/6450_01302006_155445_NashF AOFinalTM71.pdf
National Research Council. 1994. Science and Judgment in Risk Assessment. National
Academies Press. Washington, D.C.
National Research Council. 1996. Understanding Risk, Informing Decisions in a
Democratic Society. National Academies Press, Washington, D.C.
Tannenbaum, L.V. 2003. Can ecological receptors really be at risk? Human and
Ecological Risk Assessment; 79:5-13.
Tannenbaum, L.V. 2005. A critical assessment of the ecological risk assessment
process: a review of misapplied concepts. Integrated Environmental Assessment and
Management; l(l):66-72.
Tannenbaum, L.V., Johnson, and M. Bazar. 2003. Application of the hazard quotient
method in remedial decisions: a comparison of human and ecological risk assessment.
Human and Ecological Risk Assessment; 9:387-401.
U.S. Office of Management and Budget. 2003. Circular A-4 to the heads of executive
agencies and establishments, http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf
[Accessed: July 22, 2007]
U.S. Environmental Protection Agency. 1989. Risk Assessment Guidance for Superfund,
Part A. EPA/540/1-89/002, Office of Emergency and Remedial Response, U.S.
Environmental Protection Agency, Washington, D.C.
U.S. Environmental Protection Agency. 1992. Framework for Ecological Risk
Assessment. EPA/600/R-92-001, Risk Assessment Forum, Washington, D.C.
U.S. Environmental Protection Agency. 1998. Guidelines for Ecological Risk
Assessment. EPA/630/R095//002F, Risk Assessment Forum, U.S. Environmental
Protection Agency, Washington, D.C.
Available: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid= 12460
U.S. Environmental Protection Agency. 2000a. Data Quality Objectives Process for
Hazardous Waste Site Investigations. EPA QA/G-4HW. Final. EPA/600/R-00/007,
23
-------
January 2000, United States Environmental Protection Agency, Office of Environmental
Information. Washington, D.C Available: http://www.epa.gov/quality/qs-docs/g4hw-
final.pdf
U.S, Environmental Protection Agency. 2000b. Guidance for the Data Quality
Objectives Process (EPA QA/G4). EPA/600/R-96/055, Office of Environmental
Information, U.S. Environmental Protection Agency, Washington, D.C.
U.S. Environmental Protection Agency. 2004. Estimation Program Interface (EPI)
Suite, http://www.epa.gov/opptintr/exposure/pubs/episuite.htm. [Accessed February 14,
2007]
U.S. Environmental Protection Agency. 2006a. Ecological Benefits Assessment
Strategic Plan. EPA-240-R-06-001. United States Environmental Protection Agency,
Washington, D.C.
U.S. Environmental Protection Agency. 2006b. Guidance on Systematic Planning Using
the Data Quality Objectives Process EPA QA/G-4. EPA/240/B-06/001. February 2006.
United States Environmental Protection Agency, Office of Environmental Information
Washington, D.C. Available: http://www.epa.gov/QUALITY/qs-docs/g4-fmal.pdf
U.S. Environmental Protection Agency. 2006c. Guidance on Systematic planning Using
the Data Quality Objectives Process. EPA/240/B-06/001, Office of Environmental
Information, U.S. Environmental Protection Agency, Washington, D.C.
U.S. EPA Science Advisory Board. 2002. A Framework for Assessing and Reporting on
Ecological Condition: An SAB Report. Edited by T.F. Young and S. Sanzone. EPA-
SAB-EPEC-02-009, U.S. Environmental Protection Agency, Washington, D.C.
Available: http://www.epa.gov/sab/pdf/epec02009.pdf
U.S. EPA Science Advisory Board. 2005. Advisory Review of EPA 's Draft Ecological
Benefit Assessment Strategic Plan: An Advisory by the SAB Committee on Valuing the
Protection of Ecological Systems and Services. EPA-SAB-ADV-05-004, U.S.
Environmental Protection Agency, Washington, D.C.
Available: http://www.epa.gov/sab/pdf/c-vpess_sab-adv-05-004.pdf
U.S. EPA Science Advisory Board. 2006. Advisory on EPA 's SuperfundBenefits
Analysis. EPA-SAB-ADV-06-002, U.S Environmental Protection Agency, Washington,
D.C.
Available: http://www.epa.gov/sab/pdf/superfund_sab-adv-06-002.pdf
Williams L., R.A. Schoof, J.W. Yager, and J.W. Goodrich-Mahoney. 2006. Arsenic
bioaccumulation in freshwater fishes. Human and Ecological Risk Assessment; 12:904-
923.
24
-------
ATTACHMENT - Ecological Risk Assessment in Environmental Decision
Making, an Evaluation of the State of the Practice: A
Summary of the EPA Science Advisory Board Ecological
Processes and Effects Committee Workshop
The attached document describes the key points discussed at the EPA Science Advisory
Board Ecological Processes and Effects Committee workshop: Ecological Risk
Assessment in Environmental Decision Making, an Evaluation of the State of the
Practice.
25
-------
Ecological Risk Assessment in Environmental Decision Making
An Evaluation of the State of the Practice
A Summary of the
EPA Science Advisory Board
Ecological Processes and Effects Committee
Workshop
February 7 - 8, 2006
Washington, D.C.
-------
NOTICE
This workshop summary has been written as part of the activities of the U.S.
Environmental Protection Agency's (EPA) Science Advisory Board (SAB) Ecological
Processes and Effects Committee (EPEC). EPEC is a standing committee of the
chartered SAB which provides extramural scientific information and advice to the
Administrator of the EPA. This workshop summary report describes the key points
discussed at a public workshop and represents the diverse opinions of workshop
participants. The workshop summary does not represent the views and policies of the
EPA nor of other agencies in the Executive Branch of the Federal government
11
-------
Table of Contents
1.0 EXECUTIVE SUMMARY v
2.0 WORKSHOP BACKGROUND AND OBJECTIVES 1
3.0 WORKSHOP OVERVIEW AND SUMMARY 1
3.1 Introductory Presentations 1
3.2 EPA Case Examples 4
3.3 Workshop Questions 6
3.4 Breakout Group Panel Discussion Highlights 7
4.0 KEY WORKSHOP DISCUSSION POINTS 8
4.1 General and Cross-Cutting Discussion Points 8
4.2 Product Health and Safety Key Discussion Points 14
4.3 Contaminated Site Management Key Discussion Points 15
4.4 Natural Resources Protection Key Discussion Points 16
5.0 BREAKOUT GROUP SUMMARY REPORTS 19
6.0 CONCLUSION 19
7.0 REFERENCES 21
APPENDIX A - AGENDA A-l
APPENDIX B - ECOLOGICAL RISK MANAGEMENT AND
DECISION MAKING AT EPA B-l
APPENDIX C - ECOLOGICAL RISK ASSESSMENT - OVERVIEW OF
DEVELOPMENT AND APPLICATION OF THE SCIENCE C-l
APPENDIX D - EPA'S ECOLOGICAL RESEARCH STRATEGY AND
MULTI-YEAR PLAN D-l
in
-------
APPENDIX E - STRENGTHS OF THE ECOLOGICAL RISK ASSESSMENT
PROCESS FOR USE IN DECISION-MAKING E-l
APPENDIX F - LIMITATIONS OF THE ECOLOGICAL RISK ASSESSMENT
PROCESS FOR USE IN DECISION-MAKING F-l
APPENDIX G - ECOLOGICAL RISK ASSESSMENT FOR REGULATION
UNDER THE FEDERAL INSECTICIDE, FUNGICIDE, AND
RODENTICIDE ACT G-l
APPENDIX H - APPLICATION OF ECOLOGICAL RISK ASSESSMENT IN
MANAGEMENT OF CONTAMINATED SITES - CASE EXAMPLE,
ECOLOGICAL RISK ASSESSMENT OF THE CLARK FORK RIVER
SUPERFUND SITE H-l
APPENDIX I - APPLICATION OF ECOLOGICAL RISK ASSESSMENT
IN NATURAL RESOURCES PROTECTION - ASSESSING THE EFFECTS
OF SELENIUM ON AQUATIC LIFE 1-1
APPENDIX J - BIOSKETCHES OF INVITED SPEAKERS AND PANELISTS J-l
APPENDIX K - REGISTERED WORKSHOP PARTICIPANTS K-l
APPENDIX L - SUMMARY OF PRODUCT HEALTH AND SAFETY DECISION
MAKING BREAKOUT GROUP PARTICIPANTS, PANEL DISCUSSION, AND
REPORT L-l
APPENDIX M - SUMMARY OF MANAGEMENT OF CONTAMINATED SITES
BREAKOUT GROUP PARTICIPANTS, PANEL DISCUSSION, AND REPORT M-l
APPENDIX N - SUMMARY OF NATURAL RESOURCE PROTECTION
BREAKOUT GROUP PARTICIPANTS, PANEL DISCUSSION, AND REPORT N-l
IV
-------
1.0 EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency (EPA) Science Advisory Board (SAB) Ecological
Processes and Effects Committee (EPEC) is advising the agency on how to advance the science
and application of ecological risk assessment in environmental decision making. As part of this
advisory activity, the SAB EPEC convened a public workshop on the role and conduct of
ecological risk assessments for environmental decision making. The workshop brought together
more than 120 ecological risk assessors from academia, government, industry, trade associations,
and environmental organizations. The invited speakers, panelists, subject matter experts and
participants discussed their experience, and suggested steps for improving ecological risk
assessment in three decision-making contexts; product health and safety; management of
contaminated sites, and natural resource protection. The background and history of the
development of ecological risk assessment were reviewed. A number of opportunities for
advancement of the state of the practice were identified by the workshop participants. Key
workshop discussion points are briefly summarized in this executive summary and presented in
more detail in subsequent sections of this report. There were many points of view represented at
the workshop, and in some cases participants did not agree on points discussed. Consensus
findings or recommendations were not developed at the workshop, and this may be reflected in
the key points presented below. It should be noted that this document is not an SAB advisory
report, but it will be used by the SAB EPEC to develop separate advice to EPA.
Background
• EPA's Ecological Risk Assessment Framework and Guidelines (U. S. Environmental
Protection Agency, 1992a; 1998) have improved the state of the practice by stressing the
importance of:
- Problem formulation;
- Early interaction and discussion among risk assessors and risk managers;
- Relevance of risk assessment results to risk management questions;
- Conceptual models and appropriate assessment endpoints;
- An analysis plan;
- Consideration of non-chemical stressors;
- More frequent use of risk assessment results in EPA risk management decisions; and
- Consistently reporting risks and uncertainties.
• Strengths of ecological risk assessment for use in decision making include:
- Recognition of its value as process rather than technique;
- Its value as a consistent approach for using diverse types of laboratory and field data;
- Its value as a source of analytical tools applicable to a wide array of environmental
problems;
- Opportunities presented for transfer of assessment methods (e.g., species sensitivity
distributions and weight-of-evidence approaches); and
- Its value as a consistent format for reporting risks and uncertainties.
-------
• Challenges to be addressed in using ecological risk assessment for decision making include:
- Uncertainties associated with
• the stochastic nature of ecological systems; and
• the effects of multiple stressors.
- Difficulties associated with
• linking assessment endpoints to realistic time and space scales;
• establishing ecological baselines;
• predicting exposure to toxic contaminants (e.g., variability in dietary
exposure to contaminants); and
• variations in toxicological profiles for different taxa.
- Non-scientific limitations associated with
• legal/regulatory requirements (examples include potential liability that can
promote avoidance of risk assessment, and requirements to assess
individual rather than cumulative risks - such as assessing underground
storage tanks one tank at a time rather than looking at all in an area - that
place limitations on risk assessments); and
• policy and precedent that may establish inappropriate endpoints.
- Questions regarding
• validity of point estimates of effects concentrations used in risk
assessments (e.g., No Observed Adverse Effects Concentration);
• quality of data obtained from peer reviewed literature and used in risk
assessments (e.g., as a result of poor study design or reporting standards);
• failure to connect risk assessments to management problems; and
• exclusion of some key stakeholders from the ecological risk assessment
process.
• Ecological risk assessments for product health and safety are conducted under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act
(TSCA). For ecological risk assessments conducted under these statutes:
- A tiered iterative process is used;
- The information used is dependent on the statutory authority;
- Data requirements are based on hazard quotients (estimated exposure/effects
concentration) for a few species;
- EPA is developing probabilistic risk assessment methods; and
- New screening and testing methods are being developed and validated for endocrine
disrupter s.
• Ecological risk assessments for managing contaminated sites are conducted under the
Resource Conservation and Recovery Act (RCRA) and Comprehensive Environmental
VI
-------
Response Compensation, and Liability Act (CERCLA). For ecological risk assessments
under these statutes:
- EPA has developed useful guidance for risk assessments designed to establish legal
action for site-specific remediation goals;
- Statutes may limit assessments to consideration of chemical releases at sites; and
- Legal requirements may constrain evaluation of larger spatial, temporal or biological
scale effects.
• Ecological risk assessments for natural resource protection are closely tied to a "value"
oriented paradigm focused on ecological attributes to be protected, rather than responses to
specific stressors. Ecological risk assessments for natural resource protection should
consider:
- Natural change processes; and
- The importance of looking at broad scales but answering specific questions on local
or global scales.
Key Workshop Discussion Points
Discussion topics were raised across all areas of application and they are summarized below;
however several cross-cutting themes emerged. An integrating vision of risk assessment
connects its early roots in comparative toxicology with recent advances in quantitative and
landscape ecology. Many of the cross-cutting themes discussed at the workshop address
challenges associated with these complexities.
A number of common key points emerged from the three focus workgroups (product
health and safety, contaminated sites management, and natural resource protection). These
key points can be grouped into five general categories: 1) EPA's Ecological Risk
Assessment Framework and Guidelines; 2) risk assessor and risk manager dialogue in
planning and problem formulation; 3) linking natural and social sciences in environmental
decision making; 4) spatial, temporal and biological scales; and 5) uncertainty in ecological
risk assessment.
EPA 's Ecological Risk Assessment Framework and Guidelines
• EPA's Ecological Risk Assessment Framework and Guidelines are robust and useful for
environmental decision making. They have stood the test of time, as evidenced by a growing
scientific literature, and incorporation into various governmental (international, federal, state,
and tribal) voluntary and regulatory programs.
• Most EPA offices have, or are in the process of, updating program specific ecological risk
assessment guidance to reflect the Framework and Guidelines principles. However, the
sheer range of applications has made it difficult to develop recognizable Agency-wide policy
or guidance that defines what ecological attributes EPA is striving to protect.
vn
-------
Risk Assessor and Risk Manager Dialogue in Planning and Problem Formulation
• Dialogue between risk assessors and risk managers in the planning and problem formulation
step is necessary to develop focused risk assessment questions or hypotheses that support
specific risk management options. Explicit connections between risk measures, data quality
needs, data collection activities, and risk management decisions are needed during the
problem formulation step, but these connections have not been consistently achieved.
Additional guidance or examples demonstrating how such connections might be formulated
and scientifically tested would be helpful.
• Problem formulation for chemical and product risk assessments does not focus on why
particular risk assessments are being conducted or what ecological resource should be
protected. The EPA Science Advisory Board's Framew orkfor Assessing and Reporting on
Ecological Condition (2002) can be used as a reference checklist to ensure that appropriate
levels of organization are considered in ecological risk assessments.
• For large, complex risk assessments, peer review at the problem formulation stage and again
at the completion of the risk assessment would help assure that the assessment study design
and implementation are appropriate for the risk management goals. For smaller assessments,
checklists could be developed to assist risk assessors and risk managers in planning and
problem formulation in order to focus on greater specificity of risk questions and direct
consideration of management alternatives.
• Case studies that demonstrate and evaluate how ecological data were used in decisions could
be useful to help develop standards of practice for determination of ecological condition,
application of appropriate spatial and temporal scales and levels of biological organization,
and assessment of cumulative risk.
Linking Natural and Social Science in Environmental Decision Making
• EPA's Ecological Risk Assessment Framework and Guidelines (U. S. Environmental
Protection Agency, 1992a; 1998) focus on the application of ecological risk science within a
socio-economic, legal and political decision-making arena. However, there has been little
elaboration of how ecological risk estimates might be considered or weighed in these broader
decision-making contexts.
• Benefit-cost and valuation methods are needed to communicate risk management alternatives
at multiple scales to different stakeholder groups. Net benefit analysis may be a useful cross-
cutting approach for linking uncertainty analysis and risk management decisions. Some type
of net benefit analysis would be beneficial, but it should not be used to avoid risk assessment.
• There is no consensus approach for interpreting lines of evidence, or weight-of-the-evidence
in complex ecological risk assessments, or in evaluating competing technical assessments in
environmental decision making.
Vlll
-------
• Product life cycle analysis (LCA), while not typically used for ecological risk assessments,
was viewed as potentially providing useful information for future-oriented investigative
questions and emerging areas (e.g., nanotechnology). Additional guidance on application of
LCA would be helpful.
Spatial, Temporal, and Biological Scales
• Scales are not often explicitly considered in problem formulation, even though risk
assessments may range from local to global applications, from immediate to long-term
effects, and across a number of levels of biological organization.
• Scales must be appropriate to see emerging patterns across space, time, and levels of
biological organization. The appropriate scale of an ecological risk assessment depends upon
such factors as the stressors and media being evaluated, episodic events considered, the
specific ecological receptors, and the recovery time of systems.
• Multi-generational analyses or other retrospective ground-truthing analyses are rarely
conducted for prospective risk estimates, but should be considered.
• Tools such as geographic information systems, continuous monitors, and models, as well as
species life history information, may be used to identify and incorporate appropriate spatial
and temporal scales in ecological risk assessments.
• Indirect ecological effects are often revealed at levels of biological organization above
populations, and there is a need for techniques to assess risks at high levels of biological
organization (i.e., community or ecosystem scales).
• Guidance is needed on the use of models for population level effects assessments,
particularly for terrestrial population assessment.
• It would be useful to develop standard techniques for assessing risks at specific levels of
biological organization (e.g., techniques based on common definitions of habitat types and
communities).
Uncertainty in Ecological Risk Assessment
• There was general agreement on the need for explicit consideration of uncertainty and
probability during problem formulation. This could be accomplished by explicitly
identifying uncertainties, the consequences of the uncertainties, and additional information
needed to reduce the uncertainties.
• Probabilistic ecological risk assessment can provide a useful approach for understanding
uncertainties and implications regarding the degree of protectiveness of various management
options. However, these assessments can be difficult to explain and communicate to non-
scientific risk managers and the general public. Uncertainties must be clearly identified so
that risk managers can evaluate the need for conservative or risk tolerant decisions.
IX
-------
• Decision making in the face of uncertainty is reduced to three options that should be explored
during problem formulation: (1) conduct more study to reduce uncertainty; (2) make a
decision acknowledging the uncertainties, and move on; or (3) make a decision with
monitoring and triggers for further action if needed.
• Adaptive management was identified as an option for dealing with uncertainties. Adaptive
management would allow a decision to be implemented and would require monitoring that
could trigger additional work if appropriate risk reduction is not achieved.
• There was considerable discussion, but no consensus, on the use of rigorous "hypothesis-
testing" versus "risk questions" in problem formulation. Some participants expressed the
opinion that hypothesis statements are not often linked to explicitly stated process goals,
leaving risk managers without the information needed to make decisions. Others thought that
well-defined statistically testable hypotheses with defined Type I and II error rates were
necessary.
• Innovative methods such as Bayesian analysis and causal argumentation could be used to
develop hypotheses or "risk questions" focused on causal relationships and weight-of-
evidence. Likelihood statements or estimation methods could be incorporated into problem
formulation rather than binary (yes/no) statements.
• Reducing uncertainty for future risk assessments could be aided by a better understanding of
past risk assessments. It was suggested that EPA develop a national compendium, inventory,
and/or database of past ecological risk assessments, and/or case examples to characterize the
strengths and weaknesses of various risk assessment approaches. Uncertainty could be
further reduced by developing expanded data on phylogenetic responses to stressors
(comparative toxicology).
• Post risk assessment ground-truthing and validation should be part of problem formulation
for product health and safety decisions, as well as for contaminated site and natural resource
management. A better interface between risk assessment and monitoring programs should be
developed so that monitoring data could be used to improve risk assessments. Specific
monitoring projects could be designed to provide data that could reduce uncertainty in risk
assessments.
• EPA was also encouraged to initiate an audit program to evaluate the effects of risk
management decisions on ecological receptors and to translate risk reduction into beneficial
ecological effects that the public can understand.
The workshop presented an integrating vision of ecological risk assessment that connects its
early roots in comparative toxicology with recent advances in quantitative and landscape
ecology. In this regard, several potential areas for advancing the risk assessment process
emerged from the workshop. Peer review of proposed risk assessments before execution would
likely improve many assessments. Many risk assessments could be enhanced by the creation of
more innovative techniques for framing and testing risk hypotheses, and use of multiple lines of
-------
evidence to assess risk at higher levels of biological organization (population, community, or
ecosystem scales). More systematic, post-assessment monitoring would enhance the process in
the long run. A national compendium of past ecological risk assessment and remediation
projects would provide a foundation for enhancing future assessments, and would allow the
benefits and weaknesses of the various risk assessment, management and remediation
approaches to be more readily identified. Moreover, communication between risk managers and
assessors should be a part of all aspects of the process. The framework for ecological risk
assessment should be viewed in an adaptive management context whereby, as new understanding
is attained, it is incorporated into the analysis process.
Together, these changes would accelerate the evolving practice of ecological risk assessment.
They would also enable more effective use of the ecological risk assessment approach to address
the challenges of dealing with uncertainties and high variability; linking assessments endpoints
to realistic temporal and spatial scales; and addressing legal and regulatory requirements or
policy precedence. Furthermore an adaptive management approach will allow consideration of
validity of data and its scale of reference, connection to major management problems, and
involvement of stakeholders. There are clearly big challenges ahead in applying and using the
ecological risk assessment approach, yet the discussion at the workshop suggested helpful ways
to address current limitations.
XI
-------
2.0 WORKSHOP BACKGROUND AND OBJECTIVES
The U. S. Environmental Protection Agency (EPA or the Agency) Ecological Risk
Assessment Framework and Guidelines have undergone extensive development and review (U.S.
Environmental Protection Agency, 1991; 1992a,b,c; 1993a,b; 1994a,b; 1996a,b, 2004b). The
Framework and Guidelines were specifically designed to establish a flexible process to promote
greater consistency across a wide range of EPA research and regulatory applications. They were
not intended to replace programmatic and regional regulatory risk assessment practices, but to
foster greater commonality and understanding in a rapidly emerging field. Yet flexibility is not
without problems, particularly for regulatory applications where uniformity and standardization
are often the norm. Recently, the Agency compiled risk assessment principles and practices
(U.S. Environmental Protection Agency, 2004a) with a view toward opening dialogue with the
scientific community to enhance the state of the practice. Such dialogue formed the basis of a
debate and commentary section in the inaugural issue of Integrated Environmental Assessment
and Management (Tannenbaum, 2005; Dearfield et al., 2005, DeMott et al., 2005; Bridgen 2005;
Stahl et al., 2005).
The EPA Science Advisory Board (SAB) Ecological Processes and Effects Committee
(EPEC) is advising the Agency on how to advance the science and application of ecological risk
assessment in environmental decision making. As part of this advisory activity, the SAB EPEC
convened a public workshop on ecological risk assessment. The primary objective of the
workshop was to initiate a broad dialogue on the current state-of-the-practice of ecological risk
assessment as applied in environmental risk management and decision making. This document
summarizes the key workshop discussion points, which were used by EPEC as part of its further
deliberations in preparing an advisory report to EPA.
3.0 WORKSHOP OVERVIEW AND SUMMARY
3.1 Introductory Presentations
The workshop (Agenda in Appendix A) was designed to stimulate discussion of the state of
the practice of ecological risk assessment in environmental risk management and decision
making. The introductory presentations offered broad overviews of:
• Ecological Risk Management and Decision Making at EPA - Ms. Deni se Keehner,
Director, Standards and Health Protection Division, Office of Science and Technology,
EPA Office of Water (Presentation in Appendix B);
• Ecological Risk Assessment - Overview of Development and Application of the Science -
Dr. Glenn Suter, Science Advisor, National Center for Environmental Assessment, EPA
Office of Research and Development (Presentation in Appendix C);
• EPA 's Ecological Research Strategy and Multi-Year Plan - Dr. Michael Slimak,
Associate Director for Ecology, National Center for Environmental Assessment, EPA
Office of Research and Development (Presentation in Appendix D);
-------
• Strengths of the Ecological Risk Assessment Process for Use in Decision Making - Dr.
Lawrence Barnthouse, President and Principal Scientist, LWB Environmental Services
(Presentation in Appendix E); and
• Limitations of the Ecological Risk Assessment Process for Use in Decision Making - Dr.
Lawrence Kapustka, Senior Ecotoxicologist, Golder Associates, Ltd. (Presentation in
Appendix F).
The introductory presentations identified important issues regarding ecological risk
assessment in environmental risk management and decision making. Selected presentation
highlights are summarized below.
• EPA's Ecological Risk Assessment Framework and Guidelines (U. S. Environmental
Protection Agency, 1992a; 1998) have provided a structured yet flexible approach to risk
assessment for nearly a decade.
• Numerous EPA program-specific and problem-specific ecological risk assessment
documents have been developed and are being applied across the Agency.
• The Ecological Risk Assessment Framework and Guidelines are widely imitated outside
of the U.S.
• EPA's Ecological Risk Assessment Framework and Guidelines has helped risk managers
and assessors understand the importance of problem formulation for evaluating a range of
chemical, physical and biological stressors in decision making.
• Better methods are needed to quantify and communicate the risks and benefits of
ecological protection and mitigation to ecological risk managers and the public.
• Mechanisms to improve the recognition of ecological concerns in risk management
decisions are needed across the Agency (e.g., heightening managers' awareness of the
importance of such questions as: what will happen to a local stream community if there
are no sensitive fish, or if fish are reduced in size and number, and what problems are
associated with reduced diversity?)
• Ecological research is necessary for improving ecological risk assessment in a number of
areas:
- Status and trends of ecological condition at regional and national scales;
- Causes of degraded and undesirable condition;
- Management practices that protect and restore ecological resources;
- Ecological services important to resource managers; and
-------
- Appropriate spatial and temporal scales for restoring ecological services.
• Ecological risk assessment issues that require additional consideration and development
include:
- Probability, uncertainty and variability;
- Levels of biological organization;
- Ecological epidemiology;
- Weight-of-evidence approaches; and
- Cost-benefit analyses.
• Ecological risk assessment strengths include:
- Its value as a systematic approach to organize scientific information in support of
environmental decision making;
- Its value as a source of analytical tools applicable to a wide array of environmental
problems; and
- Its value as a stimulus for the development of better tools to improve future
environmental decisions.
• Difficulties that affect the utility of ecological risk assessment in decision making
include:
- Differential societal values for the protection of ecological resources;
- Identifying emergent properties in managing populations, communities, and
ecological functions;
- The stochastic nature of ecological systems and concomitant uncertainty associated
with measurement and prediction;
- Using assessment endpoints that reflect realistic spatial, temporal and biological
scales;
- Obtaining sufficient information to be able to define ecological baselines in context of
the issue;
- Addressing the effects of complex and multiple stressors; and
-------
- Regulatory practices that promote prescriptive measures, stifle innovation, and justify
minimalist approaches.
3.2 EPA Case Examples
Following the introductory presentations, EPA officials who work at the interface of
ecological risk assessment and environmental decision making provided case examples in
three environmental risk management and decision-making contexts.
• Ecological Risk Assessment for Regulation Under the Federal Insecticide, Fungicide, and
Rodenticide Act - Dr. Steven Bradbury, Director, Environmental Fate and Effects
Division, EPA Office of Pesticide Programs (Presentation in Appendix G);
• Application of Ecological Risk Assessment in Management of Contaminated Sites - Case
Example, Ecological Risk Assessment of the Clark Fork River Superfund Site - Dr. John
Wardell, Director, Montana Office, U.S. EPA Region 8 (Presentation in Appendix FT); and
• Application of Ecological Risk Assessment in Natural Resources Protection - Assessing
the Effects of Selenium on Aquatic Life - Dr. Edward Ohanian, Director, Health and
Ecological Criteria Division, Office of Science and Technology, EPA Office of Water
(Presentation in Appendix I}.
The case examples did not cover the full range of ecological risk assessment research and
regulatory applications facing EPA. Rather, they offered a window into pragmatic issues
associated with applying science in regulatory decisions. Selected highlights follow.
• Ecological risk assessments under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) are conducted by the Office of Pesticide Programs (OPP) to evaluate new
pesticides and reevaluate existing pesticides on a regular, statutory schedule.
- FIFRA requires a determination that a pesticide will not "cause unreasonable adverse
effects" taking into account the economic benefits of pesticide use on the target
commodity.
- The primary regulatory decision is the development of pesticide labels that define use
sites (i.e., crops), maximum use rates, minimum application rates, allowable
application methods, etc.
- OPP uses a tiered, iterative approach to ecological risk assessment that ranges from
preliminary deterministic screening assessments using generic assumptions, to highly
site-specific probabilistic assessments at the watershed and ecosystem scales.
- Several ecological risk assessment examples were presented including:
• Assessment of vulnerable aquatic sites and effects of copper and metolachlor on
national, regional, and action area scales; and
-------
• Use of geographic information system (GIS) data and spatial modeling to
identify vulnerable watersheds where monitoring was required as a condition of
pesticide re-registration.
Ecological risk assessments under the Resource Conservation Recovery Act (RCRA) and
Superfund Amendments and Reauthorization Act (SARA) are conducted in the EPA
Office of Solid Waste and Emergency Response (OSWER) to identify risks and
remediation options for contaminated sites.
- The case example presented risks and remediation options for mine tailing wastes in
the flood plain of the Clark Fork River (Montana) Superfund Site.
- A conceptual model developed for the Clark Fork Site was used in the problem
formulation phase of the risk assessment. This provided information on the primary
contaminant source, contaminated media, and food chain and ecological receptors
(including a range of aquatic and terrestrial plant, invertebrate, vertebrate, and
community endpoints).
- Risk characterization included a weight-of-the-evidence analysis of predictive, direct
testing, and population studies.
- Fish, riparian vegetation, and wildlife were identified as receptors that were at risk
from exposure to mine waste from overland flow during storm events, mine tailings,
and contaminated soils.
- Eight alternative management options were identified for remediation.
- The final risk management options were selected to remove acute and chronic
releases of toxic materials to aquatic and terrestrial life.
Ecological risk assessments under the Clean Water Act (CWA) are conducted by the
Office of Water (OW) to develop water quality criteria for the protection of aquatic life.
Water quality criteria represent science-based recommendations (i.e., guidance). Criteria
are linked with a designated use by States and Tribes to establish water quality standards
which are legally enforceable.
- Typically, criteria are derived from toxicity data for a range of taxa that are used to
construct a species sensitivity curve, and a water concentration that protects 95% of
the taxa.
- The typical criteria derivation procedures were inappropriate for selenium because:
• selenium exposure occurs through diet, not the water column;
• selenium bioaccumulates but does not biomagnify; and
-------
• water concentrations do not adequately predict toxicity of bioaccumulative
chemicals.
- After considering selenium criteria options expressed as water, sediment or tissue
concentrations, EPA derived a draft criterion as a fish tissue concentration.
- The tissue criterion provided a valid scientific approach for selenium, but also
required the development of new implementation guidance to assist risk managers in
states and tribes who actually establish enforceable water quality standards. In
applying the tissue criterion:
• tissue criteria should be translated into media concentrations; and
• field derived estimates of bioaccumulation or food web models can be used to
derive national or site-specific values.
- EPA is in the process of revising its general methodology for deriving aquatic life
criteria to include tissue criteria for bioaccumulative pollutants.
3.3 Workshop Questions
Following the introductory and case example presentations, the workshop speakers, panelists
(Biosketches in Appendix J), and participants (Registered Workshop Participants in Appendix K)
met in three breakout groups corresponding to the product health and safety, management of
contaminated sites, and natural resource protection case examples. Each of the breakout groups
discussed four cross-cutting ecological risk assessment issues:
1. Effects of spatial and temporal scale;
2. Assessing risks at different biological scales;
3. Problem formulation and adequacy of testable hypotheses; and
4. Decision making in the presence of uncertainty.
The breakout groups were also provided with six suggested questions to initiate discussion of
these cross-cutting issues.
1. How does the issue affect the quality of analysis?
2. How does the issue affect the utility of the output?
3. What opportunities exist to reduce the effect of this issue on ecological risk assessment
performance?
-------
4. Do you have recommendations for data collection, research, and demonstrations that
could mitigate the effect of this issue?
5. How do the cross-cutting issues interact?
6. Can you identify other cross-cutting issues?
The workshop cross-cutting issues and suggested discussion questions were introduced by a
panel of invited experts, discussed by all workshop participants, and summarized in breakout
group reports at the workshop final plenary session (complete breakout group summaries for
product health and safety, management of contaminated sites, and natural resource protection
are found in Appendices L, M, andN, respectively).
3.4 Breakout Group Panel Discussion Highlights
Although the individual breakout group panel discussions specifically focused on product
health and safety (Appendix L), management of contaminated sites (Appendix M), and natural
resource protection (Appendix N), several general issues were identified.
• Most ecological risk assessments conducted or reviewed by EPA are for single chemicals
and are designed to inform risk management decisions by individual program offices.
• Ecological risk assessments are often prospective risk estimates based on laboratory
toxicity studies.
• Problem formulation is often defined by regulations and regulatory guidelines rather than
by deliberate and iterative planning and dialogue between risk assessors and risk
managers.
• The ecological relevance of toxicity-based risk assessments are often questioned by field
ecologists interested in:
- Communities or mixed assemblages of plants and animals;
- Cumulative risk from multiple stressors;
- Longer temporal scales;
- Large spatial scales; and
- Multiple levels of biological organization.
• Scientific consensus has not emerged on how to use weight-of-the-evidence approaches
for integrating information and data for ecological risk assessment.
-------
• Streamlining analytical and decision-making processes is necessary to provide timely
control of the greatest ecological risks.
• Regardless of the specific decision-making context, there is a need for databases that link
ecological risk estimates, risk management decision, and monitoring or ground-truthing
information and data to document the environmental efficacy of risk assessment and
management actions.
• Better tools and guidance are needed for ecological risk assessment planning and problem
formulation between risk assessors and risk managers. Such tools and guidance might
focus on:
- Scientific needs and resolving power for risk management decisions;
- Uncertainty in analyses and decision making;
- Landscape effects; and
- Biological scale effects.
4.0 KEY WORKSHOP DISCUSSION POINTS
The workshop findings represent the collective work of more than 120 ecological risk
assessors from academia, government, industry, environmental organizations, trade associations,
and consulting organizations. General and cross-cutting issues that emerged in the breakout
groups are presented first (Section 4.1), followed by summaries of key discussion points for
product health and safety (Section 4.2), management of contaminated sites (Section 4.3), and
natural resource protection (Section 4.4).
4.1 General and Cross-Cutting Key Discussion Points
General and cross cutting issues emerged in five general categories: 1) EPA's
Ecological Risk Assessment Framework and Guidelines; 2) risk assessor and risk manager
dialogue in planning and problem formulation; 3) linking natural and social sciences in
environmental decision making; 4) spatial, temporal and biological scales; and 5)
uncertainty in ecological risk assessment.
EPA 's Ecological Risk Assessment Framework and Guidelines
• EPA's Ecological Risk Assessment Framework and Guidelines (U. S. Environmental
Protection Agency, 1992a; 1998) are robust and useful for environmental decision
making.
-------
• The Framework and Guidelines were designed to establish a flexible process to promote
consistency between EPA programs and Regions and have positively influenced the
conduct of risk assessments.
• They have stood the test of time, as evidenced by a growing scientific literature, and
incorporation into various governmental (international, federal, state, and tribal)
voluntary and regulatory programs.
• Most EPA offices have, or are in the process of, updating program specific ecological
risk assessment guidance to reflect the Framework and Guidelines principles.
• The Framework and Guidelines have been applied across a broad range of ecological
attributes and chemical, physical, and biological stressors.
• However, the sheer range of applications has made it difficult to develop recognizable
Agency wide policy or guidance that defines what ecological attributes the Agency is
striving to protect.
Risk Assessor and Risk Manager Dialogue in Planning and Problem Formulation
• Despite the prominence of a collaborative and iterative planning and problem formulation
phase presented in EPA's Framework and Guidelines, risk assessor and risk manager
interactions are often limited.
• Focused risk assessment questions supporting risk management options are needed. How
they might be formulated and scientifically tested requires exploration.
• Specific, rather than generic, risk questions or hypotheses are needed during problem
formulation because generalized questions may be difficult to interpret in the context of
specific risk management decisions.
• Explicit connections between risk measures, data quality needs, acceptable levels of
uncertainty, data collection, and risk management decisions are needed during problem
formulation.
• For large complex risk assessments, rapid and independent review of the approach at the
problem formulation stage and again at risk assessment completion would help assure that
the assessment study design and implementation are appropriate for the risk management
goals.
• For smaller risk assessments, guidance and checklists are needed to assist risk assessors and
risk managers in planning and problem formulation in order to focus on specific risk
questions and direct consideration of management alternatives.
-------
• Case studies that evaluate how ecological data are used in decisions are needed to develop
standards of practice for determining ecological condition, identifying appropriate spatial and
temporal scales and levels of biological organization, and assessing cumulative risk.
Linking Natural and Social Science in Environmental Decision Making
• The Framework and Guidelines focus on the application of ecological risk science within a
socio-economic, legal and political decision-making arena. However, there is little
elaboration of the how ecological risk estimates might be considered or weighed in these
broader decision-making contexts.
• Environmental decision making has become a multi-faceted process and it increasingly
requires consideration of human health risk, economics, and other social science assessments.
• Benefit-cost and valuation methods are needed to communicate risk management alternatives
at multiple scales to different stakeholder groups. Net benefit analysis may be a useful cross-
cutting approach for linking uncertainty analysis and risk management decisions. Some type
of net benefit analysis would be beneficial, but it should not be used to avoid risk assessment.
• The need for economic valuation of ecosystems and services is clear. The SAB Committee
on Valuing the Protection of Ecological Systems and Services (CVPESS)1 is addressing this
need in its work.
• Decision sciences are increasingly important in environmental decision making. The
interface between social and environmental sciences is relatively new and needs more
development.
• There is no consensus approach for interpreting lines-of-evidence, or weight-of-the-evidence
in complex ecological risk assessments, or in evaluating competing technical assessments in
environmental decision making.
• Adaptive management was identified as an option for dealing with uncertainties in risk
assessment, risk management, and decision making.
- Adaptive management requires an iterative ecological risk assessment process
developed in problem formulation and applied when long-term problems must be
addressed.
- Long-term monitoring with clear performance triggers would be included to account
for uncertainty in the management decision.
- Adaptive management would address the concerns of the environmental and
conservation community that the ecological risk assessment process is too lengthy
CVPESS http://www.epa.gov/sab/panels/vpesspanel.html
10
-------
and encumbered with unnecessary investigations and litigation that do little to protect
ecological resources.
• Product life cycle analysis (LCA), while not typically used for ecological risk assessments,
was viewed as potentially providing useful information to address future-oriented
investigative questions and emerging areas (e.g., nanotechnology). Additional guidance on
application of LCA would be helpful.
Spatial, Temporal and Biological Scales
• Scales are not often explicitly considered in problem formulation, even though risk
assessments may range from local to global applications, from immediate to long-term
effects, and across a number of levels of biological organization.
• Scales should be appropriate to see emerging patterns across space, time, and levels of
biological organization.
• The use of scales that are broad enough to see emergent patterns over landscapes, time, and
systems will provide insight into cumulative effects.
• The appropriate scale of an ecological risk assessment depends upon such factors as the
stressors and media being evaluated, episodic events considered, the specific ecological
receptors, and the recovery time of systems.
• Multi-generational analyses or other retrospective ground-truthing analyses are rarely
conducted for prospective risk estimates, but should be considered.
• Tools such as geographic information systems, continuous monitors, and models, as well as
species life history information, may be used to identify and incorporate appropriate spatial
and temporal scales in ecological risk assessments.
• Indirect ecological effects are often revealed at levels of biological organization above
populations, and there is a need for techniques for assessing risks at high levels of biological
organizations (i.e., community or ecosystem scales).
• The EPA Science Advisory Board's Framework for Assessing and Reporting Ecological
Condition (U.S. EPA Science Advisory Board, 2002) should be used as a reference checklist
to ensure that appropriate levels of organization are considered in assessments.
Uncertainty in Ecological Risk Assessment
• There was general consensus on the need for explicit consideration of uncertainty and
probability during problem formulation. The process of problem formulation should include
explicit identification of uncertainties, the consequences of the uncertainties, and additional
information needed to reduce the uncertainties. Uncertainties should be categorized, and
those that profoundly affect results and outcomes identified and openly acknowledged in the
11
-------
assessment. If data are insufficient to conduct analyses at an appropriate scale, this constraint
should be acknowledged and addressed in the uncertainty analysis.
- Failure to identify and prioritize uncertainties, as well as any additional information
needed to reduce the uncertainties, can affect the quality of a decision. Uncertainties
should be clearly identified so that risk managers can evaluate the need for
conservative or risk tolerant decisions.
- Decision making in the presence of uncertainty is sometimes constrained by statutory
or regulatory practices leading to measures that may be over or under-protective.
- Statutes vary with respect to requirements for consideration of ecological risks and
benefits, but ecological risk can become a "nonfactor" when uncertainty associated
with ecological risk is high.
Probabilistic ecological risk assessment can provide a useful approach for understanding
uncertainties and how they relate to the protectiveness of various management options.
Decision making in the face of uncertainty is reduced to three options that should be explored
during problem formulation:
- Conduct more study to reduce uncertainty;
- Make a decision acknowledging the uncertainties, and move on; or
- Implement adaptive management decisions and require monitoring that would trigger
additional work if appropriate risk reduction is not achieved.
Additional study data can reduce uncertainty, but there are often tradeoffs between study
costs and timeliness of management decisions that need to be made.
Adaptive management was identified as an option for dealing with uncertainties. Adaptive
management would allow a decision to be implemented but would require monitoring that
could trigger additional work if appropriate risk reduction is not achieved.
There was considerable discussion, but no consensus, on the use of rigorous "hypothesis-
testing" versus "risk questions" in problem formulation.
- Some workshop participants noted that often hypothesis statements are not linked to
explicitly stated process goals and this leaves risk managers without the information
needed to make decisions
- Some thought that well-defined statistically testable hypotheses with defined Type I
and II error rates were necessary.
12
-------
- Others favored risk questions because "testable hypotheses" are easy to manipulate,
may not provide information necessary for estimating risk, and hence are
inappropriate for problem formulation.
- It was noted, however, that risk questions are often vague and removing testable
hypotheses from risk assessments might sharpen such criticism.
• In some applications, traditional null hypothesis testing may be appropriate, but various
alternatives were discussed.
- Innovative methods such as Bayesian analysis and causal argumentation could be
used to develop hypotheses or "risk questions" focused on causal relationships and
weight-of-evidence.
- Likelihood statements or estimation methods could be incorporated into problem
formulation rather than binary (yes/no) statements.
• Probabilistic risk assessment (Regan et al., 2003) is an important approach but it can be
difficult to explain and communicate to non-scientific risk managers and the general public.
- Communication should begin during problem formulation by providing a summary of
major uncertainties and by discussing how probabilistic approaches will be applied to
assist in understanding different management options.
- Sensitivity analyses can be conducted to identify sources of uncertainty and
determine where additional information may be useful.
- Risk assessment assumptions, parameters, and the factors driving the uncertainty
should be clearly explained and discussed with risk managers.
• While considerable work has been done on how to conduct quantitative uncertainty analyses,
good examples are not available to demonstrate how uncertainty analysis was or could be
used in making risk management decisions.
• Reducing uncertainty for future risk assessments could be aided by a better understanding of
past risk assessments.
- A national compendium, inventory, and/or database of past ecological risk
assessments would provide very useful information to improving certainty of future
risk assessments.
Such information could be systematically collected, organized, and cataloged.
- Case examples could be developed to characterize the strengths and weaknesses of
various risk assessment approaches.
13
-------
EPA is also encouraged to initiate an audit program to evaluate the effects of risk
management decisions on ecological receptors and to translate risk reduction into beneficial
ecological effects that the public can understand. This is discussed in a recent SAB report
(U.S. EPA Science Advisory Board, 2006).
Post risk assessment ground-truthing and validation should be part of problem formulation
for product health and safety decisions, as well as for contaminated site and natural resource
management. A better interface between risk assessment and monitoring programs should be
developed so that monitoring data could be used to improve risk assessments. Specific
monitoring projects could be designed to provide data that would reduce uncertainty in risk
assessments
4.2 Product Health and Safety Key Discussion Points
Guidance is needed on the use of models for population level effects assessments,
particularly for terrestrial population assessment.
Tools are currently available for rapid, accurate screening-level risk assessments.
- European Union databases can provide ecotoxicology information.
- EPA's Estimation Programs Interface (EPI) Suite tools provide physical and
biological parameters to enable a determination of whether a chemical is
biodegradable, toxic, or bioaccumulative.
Problem formulation for chemical and product risk assessments does not focus on why
particular risk assessments are being conducted or what ecological resource should be
protected.
Often contaminants are released into stressed environments. Therefore, tools for cumulative
risk assessment need to be developed.
Research is needed to determine how biomarker and mechanistic data might best be used in
exposure and risk assessments for product health and safety decision making.
Product life cycle analysis (LCA) is not typically used for ecological risk assessments.
Guidance for the use of LCA in emerging areas (e.g., nanotechnology) is needed.
Scale is often not considered in problem formulation or in ecological risk assessments for
product health and safety decisions.
Multi-generational analyses or other retrospective ground-truthing analyses are rarely
conducted for prospective risk estimates.
14
-------
• Levels of concern and risk quotients often drive problem formulation in product health and
safety risk assessments, but they may not provide realistic protection goals. Measurement
endpoints should be more closely tied to appropriate assessment endpoints.
• In some cases, problem formulation is generic, and therefore not all relevant routes of
exposure (e.g., dermal exposure) or receptors are considered. Relevant release pathways,
fate and transport, and sensitivity should be considered to optimize appropriate assessment
and measurement endpoints. Post risk assessment ground-truthing and validation should be
part of problem formulation for product health and safety decisions and addressed in EPA
guidance documents.
- Frequently, problem formulation does not adequately address spatial, temporal or
biological scales.
- Levels of concern should be re-evaluated and validated with monitoring studies.
4.3 Contaminated Site Management Key Discussion Points
• Spatial and temporal scales and representative data collection issues should be considered
during problem formulation for ecological risk assessments at contaminated sites.
- Spatial scale is important in evaluating exposure routes and will influence sampling
plans.
- Temporal scale is important for determining remediation time frames.
- The appropriate temporal scale for a contaminated site risk assessment depends on the
specific chemical contaminants, media, ecological receptors, episodic events,
potential for contamination reoccurrence, and recovery time of the system.
• Recent advances in technology and tools for the analysis and interpretation of data can
enhance ecological risk assessments. Such tools include: geographic information system
mapping technologies; remote sensing technologies; spatial statistics; population and
exposure models; and access to large databases.
• Central data exchange technology is improving, and a national data repository would benefit
ecological risk assessment by providing information on the strengths and weaknesses of
various risk assessment and management approaches (e.g., EPA Superfund program reviews
provide useful abstracts of risk assessment study results every five years).
• Basic life history information (e.g., home ranges, organism distribution) is needed to enhance
ecological and toxicity information, and to improve exposure and risk assessments for
species at risk near contaminated sites.
• Long-term ecological research is needed for some large-scale contaminated sites.
15
-------
- Post-remediation monitoring is needed to understand how risk assessments might be
enhanced.
- Criteria are needed for assessing successful remediation outcomes at contaminated
sites.
- Such sites provide opportunities for long-term ecological research and evaluation of
the efficacy of adaptive management approaches.
• Benefit-cost and valuation methods are needed to communicate risk management alternatives
at multiple scales to different stakeholder groups.
• EPA could develop a checklist to be used for confirming that the necessary ecological risk
assessment steps have been completed and explained.
• A rigorous framework could be developed for considering remediation options at
contaminated sites early in the process. This would enhance the relevancy and quality of
risk assessments.
• EPA should consider early peer review of problem formulation and study design for complex
contaminated sites. Such reviews could be conducted by external technical experts,
including appropriate social scientists who could help resolve stakeholder issues.
• Long-term monitoring could provide data to reduce uncertainty, improve decisions about
remedy selection, and improve future risk assessments.
• Contaminated sites remediated over the past twenty years should be evaluated to develop
data on remedy efficacy to inform risk assessment uncertainties and remediation decisions at
new sites.
• Probabilistic risk assessments do not always summarize and communicate uncertainty to
CERCLA site managers.
• Net benefit analysis may be a useful cross-cutting approach for linking uncertainty analysis
and risk management decisions. Some type of net benefit analysis would be beneficial but it
should not be used to avoid risk assessment.
4.4 Natural Resources Protection Key Discussion Points
• Risk assessments for natural resource protection are more closely tied to an ecological
attributes "values" perspective than the stressor perspective that is typical of chemical
specific risk assessments.
• The discrete ecological resources to be protected and options for their protection should be
explicitly identified.
16
-------
• Protecting natural resources requires consideration of "natural" and "global" process change
(e.g., global climate change) and how such change influences anthropogenic changes in the
system under study.
• Early peer review of the risk assessment study designs is needed.
- Early peer review should occur between the problem formulation and analysis stages
of risk assessments.
- Peer review of study designs prior to initiating work plans will enhance the quality
and efficiency of risk assessments.
- Early peer review will help assure that the assessment study design and
implementation are appropriate for the risk management goals.
• In risk assessments for natural resource protection, assessors may look at broad scales, but
specific questions addressed by a study can be local or global.
- The scale of concern should be identified during the problem formulation stage of the
risk assessment.
- Decisions can be made at very small scales but should be considered in the context of
broader scales.
- Chemicals are not the only stressors to be evaluated in ecological risk assessments for
natural resource protection.
• For natural resource protection, spatial scales should be large enough to identify emerging
patterns across a landscape such as the declining condition of small streams and the effects of
myriad small point sources (e.g., leaking underground storage tanks).
• Spatial and temporal scale analysis may provide information for later integration of a risk
assessment into a meta-analysis or larger scale analysis. Such analyses may assist in the
development of a larger body of knowledge for assessment projects.
• Although tools are available for spatial and temporal analyses in risk assessment, it is not
clear whether there are enough risk assessment practitioners with specialized expertise in the
use of these tools to meet the current need.
- Tools that can be used for spatial and temporal analysis include geographic
information systems, continuous monitors, models, and species life history
information.
- If additional spatial resolution is needed to describe species abundance and
distribution, this should be considered in the uncertainty analysis.
17
-------
• Some workshop participants argued that an interagency effort be undertaken to develop an
ecological version of the Integrated Risk Information System (IRIS) that would provide
information needed for risk assessments.
• Indirect effects can be important in risk assessments and are often revealed at specific levels
of biological organization. Risk assessors should consider effects at the individual, species,
community, habitat, and landscape scales (e.g., chemical stress predisposing trees to disease).
• It would be useful to develop standard techniques for assessing risks at specific levels of
biological organization (e.g., common definitions of habitat types and communities). The
utility of community level information is demonstrated by the sediment quality triad of
benthic community measures, sediment toxicity tests, and sediment chemistry.
• Standards of practice are needed for ecological risk assessors and risk managers. These
standards of practice should address methods to assure that spatial and temporal scale issues
are appropriately addressed.
• Ecological risk assessors should rethink testable hypotheses and how to move away from
traditional hypothesis testing with null models.
- Such hypotheses can be easy to manipulate and difficult to formulate.
- In risk assessment, hypothesis testing can result in null models that are developed
without considering how to balance Type I and Type II errors.
- Innovative methods such as Bayesian analysis and causal argumentation are available
for use in risk assessments.
- Hypotheses should focus on causal relationships and weights of evidence.
• A better interface between risk assessment and monitoring programs should be developed so
that monitoring data could be used to improve risk assessments.
- Specific monitoring projects could be designed to provide data to reduce uncertainty
in risk future assessments.
- Monitoring programs need better direction and redesign to provide information useful
for testing hypotheses and reducing uncertainly in risk assessments.
- Risk assessors working with existing data can influence how new monitoring data are
collected.
• Better integration of work in different disciplines (e.g., biology, chemistry, toxicology,
ecology) is needed to prevent fragmentary risk analyses.
18
-------
- EPA's separate development of biological and chemical water quality criteria is an
example of fragmentary risk analysis.
- Expert systems could be developed to enable the integration of specific chemical and
biological endpoints and identify classes of chemicals to be assessed.
• Elements of uncertainty should be identified and incorporated into problem formulation and
built into the design of a risk assessment.
- Uncertainties in an ecological risk assessment should be categorized, and those that
profoundly affect results and outcomes should be identified and acknowledged in the
final assessment (transparency).
- A rich literature exists on disaggregating analytical variability, stochastic variability,
and model variability. It would be useful to consider the available tools for use in
problem formulation.
Systematic data collection, organization and cataloging from past risk assessments could provide
information that could reduce the uncertainty of future risk assessments. Such efforts could
provide better metadata and a centralized data repository for ecological risk assessment data,
endangered species information, program specific risk assessment information, and peer
reviewed literature.
5.0 BREAKOUT GROUP SUMMARY REPORTS
Summaries of the panel discussions and reports of the product health and safety, contaminated
site management, and natural resource protection breakout groups are included in Appendices L,
M, and N, respectively.
6.0 CONCLUSION
This workshop presented an integrating vision of ecological risk assessment that connects its
early roots in comparative toxicology with recent advances in quantitative and landscape
ecology. In this regard, several potential opportunities for advancing the risk assessment process
emerged from the workshop. Peer review of proposed risk assessments before execution would
likely improve many assessments. Many risk assessments could be enhanced by the creation of
more innovative techniques for framing and testing risk hypotheses, and use of multiple lines of
evidence to assess risk at higher levels of biological organization (population, community, an
landscape scales). More systematic, post-assessment monitoring would enhance the process in
the long run. A national compendium of past ecological risk assessment and remediation
projects would provide a foundation for enhancing future assessments, and would allow the
benefits and weaknesses of the various risk assessment, management and remediation
approaches to be more readily identified. Moreover, communication between risk managers and
assessors should be a part of all aspects of the process. The risk assessment framework should be
viewed in an adaptive management context whereby, as new understanding is attained, it is
incorporated into the analysis process.
19
-------
Together, these changes would accelerate the evolving practice of ecological risk assessment.
They would also enable more effective use of the ecological risk assessment approach to address
the challenges of dealing with uncertainties and high variability; linking assessments endpoints
to realistic temporal and spatial scales; and addressing legal and regulatory requirements or
policy precedence. Furthermore, an adaptive management approach will allow consideration of
validity of data and its scale of reference, connection to major management problems, and
involvement of stakeholders. The development and application of the consistent approach of
ecological risk assessment has greatly enhanced the integration of laboratory and field data,
analytical tools, and assessment methods and provided a consistent format for reporting risks and
uncertainties. There are clearly big challenges ahead in applying and using the ecological risk
assessment approach, yet the discussion at the workshop suggested helpful ways to address
current limitations. The Ecological Processes and Effects Committee of the EPA Science
Advisory Board will use the information gathered at the workshop to develop an advisory report
to the Agency.
20
-------
7.0 REFERENCES
Bridgen, P. 2005. Protecting Native Americans through the Risk Assessment Process: A
Commentary on an Examination of U.S. EPA Risk Assessment Practices and Principles.
Integrated Environmental Assessment and Management 1:73-76.
Dear-field, K.D., E.S. Bender, M. Kravitz, R. Wentsel, M.W. Slimak, W. H. Farland, and P.
Oilman. 2005. Ecological Risk Assessment Issues Identified During the U.S. Environmental
Protection Agency's Examination of Risk Assessment Practices. Integrated Environmental
Assessment and Management 1:73-76.
DeMott, R.P., A. Balarman, and M.T. Sorensen. 2005. The Future Direction of Ecological Risk
Assessment in the United States: Reflecting on the U.S. Environmental Protection Agency's
Examination of Risk Assessment Practices and Principles. Integrated Environmental Assessment
and Management 1:77-82.
Regan, H.M., H. Resit Akcakaya, S. Person, K. V. Root, S. Carroll, and L.R. Ginzburg. 2003.
Treatments of Uncertainty and Variability in Ecological Risk Assessment of Single-Species
Populations. Human and Ecological Risk Assessment 9(4):889-906.
Stahl, R.S., A. Giuiseppi-Elie, and T.S. Bingman. 2005. The U.S. Environmental Protection
Agency's Examination of its Risk Practices: A Brief Perspective From the Regulated
Community. Integrated Environmental Assessment and Management 1:86-92.
U. S. Environmental Protection Agency. 1992a. Framework for Ecological Risk Assessment.
EPA/600/R-92/001, Risk Assessment Forum, Washington, D.C.
U. S. Environmental Protection Agency. 1992b. Peer Review Workshop Report on a Framework
for Ecological Risk Assessment. EPA/625/3-91/022 (NTIS PB922131198),
Risk Assessment Forum, Washington, D.C.
U. S. Environmental Protection Agency. 1992c. Report on the Ecological Risk Assessment
Guidelines Strategic Planning Workshop. EPA/630/R-92/002 (NTIS PB93102200), Risk
Assessment Forum, Washington, D.C,
U. S. Environmental Protection Agency. 1993a. A Review of Ecological Assessment Case
Studies from a Risk Assessment Perspective. Risk Assessment Forum, Washington, D.C.
EPA/630/R-92/005.
U. S. Environmental Protection Agency. 1993b. A Review of Ecological Assessment Case
Studies from a Risk Assessment Perspective-Vol. II. EPA/630/R-94/003, Risk Assessment
Forum, U.S. Environmental Protection Agency, Washington, D.C.
U. S. Environmental Protection Agency. 1994a. Peer Review Workshop on Ecological Risk
Assessment Issue Papers. EPA/630/R-94/008 (NTIS PB5252490), Risk Assessment Forum,
Washington, D.C.
21
-------
U. S. Environmental Protection Agency. 1994b. Ecological Risk Assessment Issue Papers.
EPA/63O/R-94/009 (NTIS PB95224192), Risk Assessment Forum, Washington, D.C.
U .S. Environmental Protection Agency. 1996a. Proposed Guidelines for Ecological Risk
Assessment. Federal Register 61(175):47552-47631.
U. S. Environmental Protection Agency. 1996b. Proposed Guidelines for Ecological Risk
Assessment. Federal Register 61(175):47552-47631.
U. S. Environmental Protection Agency. 1996c. Peer Review Workshop Report on Draft
Proposed Guidelines for Ecological Risk Assessment. EPA/63 O/R-96/002, Ri sk Assessment
Forum, Washington, D.C.
U. S. Environmental Protection Agency. 1998. Guidelines for Ecological Risk Assessment.
EPA/630/R-095/002F, Risk Assessment Forum, Washington, D.C.
U. S. Environmental Protection Agency. 2002. Risk Characterization Handbook. EPA-100-B-
00-002, Science Policy Council, Washington, D.C.
U. S. Environmental Protection Agency. 2004a. An Examination of EPA Risk Assessment
Principles and Practices: Staff Paper. EPA/100/B-04/001, Office of the Science Advisor,
Washington, D.C.,
U. S. Environmental Protection Agency. 2004b. Generic Ecological Assessment Endpoints
(GEAEs)for Ecological Risk Assessment. EPA/630/P-02/004F, Risk Assessment Forum,
Washington, D.C.,
U.S. EPA Science Advisory Board. 2002. A Framework for Assessing and Reporting on
Ecological Condition: An SAB Report. Edited by T.F. Young and S. Sanzone. EPA-SAB-EPEC-
02-009, U.S. Environmental Protection Agency, Washington, D.C.
(http//www. epa.gov/sab/pdf/epec02009.pdf)
U.S. EPA Science Advisory Board. 2006. Science Advisory BoardSuperfundBenefits Analysis
Advisory Panel Report. January 29, 2006. (http ://www. epa. gov/sab/pdf/superfund sab-adv-06-
002.pdf)
22
-------
APPENDIX A - AGENDA
U.S. Environmental Protection Agency
Science Advisory Board
Ecological Processes and Effects Committee Workshop (Public)
Ecological Risk Assessment - An Evaluation of the State-of-the-Practice
February 7- 8, 2006
The Westin Embassy Row Hotel
2100 Massachusetts Avenue, N.W.
Washington, D.C.
Agenda
Day 1 - Tuesday, February 7
Plenary Session
8:30 a.m. Welcoming Remarks and Workshop Introduction — Dr. Virginia Dale, Oak
Ridge National Research Laboratory and Chair, EPA Science Advisory Board
(SAB) Ecological Processes and Effects Committee (EPEC)
8:40 a.m. Ecological Risk Management and Decision Making at EPA —
Ms. Denise Keehner, Director, Standards and Health Protection Division, EPA
Office of Water
9:10 a.m. Ecological Risk Assessment - Overview of Development and Application of
the Science — Dr. Glenn Suter, National Center for Environmental Assessment,
EPA Office of Research and Development
9:40 a.m. EPA's Ecological Research Strategy and Multi-Year Plan - Dr. Michael
Slimak — National Center for Environmental Assessment, EPA Office of Research
and Development
10:10 a.m. BREAK
10:30 a.m. Strengths of Ecological Risk Assessment Process for Use in Decision Making
~ Dr. Lawrence Barnthouse, LWB Environmental Services
11:00 a.m. Limitations of Ecological Risk Assessment Process for Use in Decision
Making — Dr. Lawrence Kapustka, Colder Associates, Ltd.
A-l
-------
11:30 am Application of Ecological Risk Assessment in Product Health and Safety
Decision Making - Ecological Risk Assessment for Regulation Under the
Federal Insecticide, Fungicide, and Rodenticide Act — Dr. Steven Bradbury,
Director, Environmental Fate and Effects Division, EPA Office of Pesticide
Programs
12:15 p.m. LUNCH
1:30 p.m. Application of Ecological Risk Assessment in Management of Contaminated
Sites - Case Example, Ecological Risk Assessment of the Clark Fork River
Superfund Site —Dr. John War dell, Director, Montana Office, U.S. EPA Region
2:15 p.m. Application of Ecological Risk Assessment in Natural Resources Protection -
Assessing the Effects of Selenium on Aquatic Life ~ Dr. Edward Ohanian,
Director, Health and Ecological Criteria Division, Office of Science and
Technology, EPA Office of Water
3:00 p.m. Goals and Objectives for Breakout Sessions —Dr. Virginia Dale, Chair, SAB
Ecological Processes and Effects Committee
3:15 p.m. BREAK
3:30 p.m. Overview of Breakout Session Discussion Questions - There will be three
overview breakout groups organized by ecological risk assessment type: Group 1-
Product Health and Safety Decision Making; Group 2 - Management of
Contaminated Sites; and Group 3 - Natural Resource Protection. The breakout
groups will begin with a panel discussion to give an overview of the following
cross-cutting issues.
1) Effects of spatial and temporal scale;
2) Assessing risks at different biological scales (e.g., organism,
population, and community;
3) Problem formulation and adequacy of testable hypotheses;
4) Decision making in the presence of uncertainty.
The breakout group facilitators will also introduce suggested discussion questions
for the workshop participants.
Group 1 — Product Health and Safety Decision Making
(Will meet in the Whitehall Room)
Facilitator: Dr. Gregory Biddinger, Exxon Mobil Biomedical Sciences
A-2
-------
Rapporteur: Dr. Charles Pittinger, BB&L Sciences
Panelists: Dr. Peter DeFur, Environmental Stewardship
Mr. Max Feken, Florida Department of Agriculture
Dr. David Fischer, Bayer Crop Science
Dr. Leslie Touart, U.S. EPA
Group 2 — Management of Contaminated Sites
(Will meet in the Terrace Court Room)
Facilitator: Dr. Michael Newman, Virginia Institute of Marine Science,
College of William and Mary
Rapporteur: Mr. Timothy Thompson, Science Engineering and the
Environment
Panelists: Ms. Vickie Meredith, Wyoming Dept. of Environmental
Quality
Dr. Michael Fry, American Bird Conservancy
Dr. MarkSprenger, U.S. EPA
Dr. Ralph Stahl, DuPont
Group 3 — Natural Resource Protection
(Will meet in the Balcony Room)
Facilitator: Dr. Kenneth Dickson, University of North Texas
Rapporteur: Dr. James Oris, Miami University
Panelists: Dr. Bruce Hope, Oregon Dept. of Environmental Quality
Dr. EugeniaMcNaughton, U.S. EPA
Dr. Jennifer Shaw, Syngenta
Dr. Terry Young, Environmental Defense
4:45 p.m. Adjourn for the Day
Day 2 - Wednesday, February 8
8:30 a.m. Breakout Group Discussions - There will be six breakout groups. The breakout
groups should consider how the cross-cutting issues might be better defined and
incorporated into the design and performance of ecological risk assessments used
in decision making. To facilitate the discussion, the following questions are
suggested for each issue.
1. How the issue affects the quality of the analysis
A-3
-------
2. How the issue affects the utility of the output
3. What opportunities exist to reduce the effect of this issue on
ecological risk assessment performance
4. Recommendations for data collection, research, and demonstrations that could
mitigate the effect of this issue
5. How cross cutting issues interact
6. Identification of other important cross cutting issues
Group #la Ecological Risk Assessment in Product Health and Safety
Decision Making - Facilitator, Dr. Gregory Biddinger, Exxon Mobil Biomedical
Sciences
(Will meet in the Churchill Room)
Effects of Spatial and Temporal Scale
Assessing Risks at Different Biological Scales (e.g., organism, population,
community)
Group #lb Ecological Risk Assessment in Product Health and Safety
Decision Making - Facilitator, Dr. Charles Pittinger, BBL Sciences
(Will meet in the Consulate Room)
Problem Formulation and Adequacy of Testable Hypotheses
Decision Making in the Presence of Uncertainty
Group #2a Ecological Risk Assessment in Management of Contaminated
Sites - Facilitator, Dr. Michael Newman, Virginia Institute of Marine Science,
College of William and Mary
(Will meet in the Ambassador Room)
Effects of Spatial and Temporal Scale
Assessing Risks at Different Biological Scales (e.g., organism, population,
community)
Group #2b Ecological Risk Assessment in Management of Contaminated
Sites - Facilitator, Mr. Timothy Thompson, Science Engineering and the
Environment
(Will meet in the Whitehall Room)
Problem Formulation and Adequacy of Testable Hypotheses
Decision Making in the Presence of Uncertainty
Group #3a Ecological Risk Assessment in Natural Resources Protection -
Facilitator, Dr. Kenneth Dickson, University of North Texas
(Will meet in the Balcony Room)
Effects of Spatial and Temporal Scale
A-4
-------
- Assessing Risks at Different Biological Scales (e.g., organism, population,
community)
Group #3b Ecological Risk Assessment in Natural Resources Protection -
Facilitator, Dr. James Oris, Miami University
(Will meet in the Terrace Court Room)
- Problem Formulation and Adequacy of Testable Hypotheses
Decision Making in the Presence of Uncertainty
12:00 p.m. LUNCH
1:00 p.m. Breakout Group Discussions (Continued)
2:30 p.m. Breakout Group Reports
(Plenary Session — Will meet in Ballroom)
4:00 p.m. Summary and Next Steps — Dr. Virginia Dale, Chair, SAB Ecological
Processes and Effects Committee
4:30 p.m. Adjourn Workshop
A-5
-------
APPENDIX B - ECOLOGICAL RISK MANAGEMENT AND DECISION
MAKING AT EPA
Ecological Risk Management and Decision Making at EPA — Ms. Denise Keehner, Director,
Standards and Health Protection Division, Office of Science and Technology, EPA Office of
Water
From her perspective as a manager in EPA's Office of Pesticide Programs and Office of
Water, Ms. Keehner discussed how ecological risk assessment is used in risk management and
decision making at EPA. She also discussed needed improvements in ecological risk assessment
to support Agency decisions.
Ecological Risk Assessment Approaches Used by EPA
A study completed by the Agency in 1994 indicated that, although decisions in different EPA
programs were driven by different statutory requirements, there were common ecological risk
assessment approaches used across programs.
• Acute mortality to fish and wildlife was the most frequent and widely used ecological effect of
concern in EPA program decisions, although chronic and subchronic effects were also used by
some key programs.
• Most EPA programs relied on laboratory test data and results to define ecological risk levels for
decision making.
• Agency programs generally focused on effects on animals rather than plants in making decisions.
• With the exception of endangered species, the Agency was not focused on the protection of
individual organisms. However, EPA had not established "bright lines" defining the magnitude
of ecological effects considered to be significant.
• In its ecological risk assessments, EPA was generally not considering dynamic parameters
(such as birth, death, and migration), interaction among species (such as predator/prey
relationships), and interaction among animal and plant communities.
• In 1994, most EPA programs were considering ecological risks in a fairly simplistic manner.
Therefore, risk assessments did not provide risk managers information needed to make
decisions in cases where economic effects on society were expected to be large.
Since 1994, there have been marked improvements in ecological risk assessment at EPA.
Agency programs have been uniformly applying EPA's Guidelines for Ecological Risk
Assessment. The Ecological Risk Assessment Guidelines stressed the importance of problem
formulation in conducting risk assessments, and implementation of the Guidelines has resulted in
early interaction and discussion among risk assessors and risk managers. This interaction has
increased the relevance of risk assessment results to risk management questions. Some EPA
programs have invested significant resources and effort into developing probabilistic risk
B-l
-------
assessment methods. These methods have provided information on the magnitude and extent of
effects of environmental stressors (such as changes in mortality and growth rates and fecundity).
As EPA has moved beyond simplistic ecological risk assessment, the results of risk assessments
have been more frequently used in the Agency's risk management decisions.
Remaining Challenges
A number of challenges remain. EPA should further develop ecological risk assessment
methods to answer the "real questions" of risk managers in a timely manner at a reasonable cost.
Risk managers need answers to questions such as:
• What will happen to a local population of organisms if the predicted concentration of a
chemical exceeds the LC50, LC10, or LC20 of a test organism?
• What are the "trip points" across frequency and magnitude of exceedence of an LC50 value
for a sensitive species where the local population will not recover and will disappear?
• What will happen to a local stream community if there are no sensitive fish, or if fish are
reduced in size and number? What problems are associated with reduced diversity?
• What will happen to wildlife if there are no sensitive fish in a local stream community?
• How sure can we be of effects?
Risk managers need to know enough about the biological, spatial, and temporal effects of
stressors to argue persuasively in the political arena for regulatory action that may be needed.
Risk managers need to know how confident scientists are in risk assessment conclusions and
what ecological improvements can be expected from various risk management options.
As we look to the future, there are a number of actions that should be taken to enhance the
consideration of ecological risk in EPA decisions.
• We need to continue using the Agency's Ecological Risk Assessment Guidelines and
continue emphasizing the importance of early engagement of risk managers and risk
assessors in the problem formulation stage of risk assessment.
• We need to continue investing in improving risk assessment methodologies that will provide
better answers to the "so what" question (i.e., probability and magnitude of effects and
spatial and temporal implications of effects)
• We need to ensure that resources are available to use methods that provide answers to the "so
what" questions.
• We need to ensure continued investment in data collection to support new methodology
enhancements.
B-2
-------
• We need to keep records of ecologically-based risk management decisions and encourage
more sharing of information across EPA on an ongoing basis. Mechanisms for such sharing
of information do not exist.
• We need to invest in methods to quantify the benefits of ecological protection and mitigation
of ecological risk. We are good at estimating economic effects but not as good at estimating
the benefits of ecological improvements.
• We need to improve the communication of ecological risk to risk managers and the public.
In summary, risk managers need ecological risk assessments that more fully answer their
most important questions, quantify what is being lost ecologically, and address what can be done
to mitigate the loss. Better communication to risk managers and the public of what the science is
telling us is also needed. It is hard to overestimate how much non scientists don't understand
about ecological risk
Slides of Ms. Keehner 's presentation are available at:
http://www.epa.gov/sab/pdf/ecorisk workshop summaryS appendix g.pdf
B-3
-------
APPENDIX C - ECOLOGICAL RISK ASSESSMENT - OVERVIEW OF
DEVELOPMENT AND APPLICATION OF THE SCIENCE
Ecological Risk Assessment - Overview of Development and Application of the Science -
Dr. Glenn Suter, Science Advisor, National Center for Environmental Assessment, EPA Office of
Research and Development
Dr. Suter discussed the history of ecological risk assessment. Assessments that were
conducted in the late 1960's to meet requirements of the National Environmental Policy Act
were largely descriptive and compliance oriented. In the 1970's and 1980's, hazard assessment
and tiered testing approaches were developed by EPA to compare exposure to pesticides and
toxic substances with organism responses. The Clean Water Act also provided a strong mandate
to EPA for protection of ecosystems. Although implementation of the Clean Water Act was not
risk oriented, EPA's Office of Water developed ambient water quality criteria, effluent toxicity
testing methods, bioassessment methods, and biocriteria.
Development of Ecological Risk Assessment Framework and Guidance
In the 1980's, EPA's Synfuels Program funded development of the first ecological risk
assessment methods and methods manuals. Those methods and the first framework for
ecological risk assessment were developed by researchers at the Oak Ridge National Research
Laboratory. Since 1990 most of the ecological risk assessment activity associated with EPA has
been in support of the Superfund program. A number of ecological risk assessment methods and
guidance documents have been developed by the Superfund Program. These have included: field
and laboratory methods, the Risk Assessment Guidance for Superfund (RAGS), various
Environmental Response Team guidance documents, and guidance on ecological risk assessment
for contaminated sites.
In 1992, EPA published its Framework for Ecological Risk Assessment. This Framework
established an ecological risk assessment process that included: planning and problem
formulation, development of assessment endpoints, development of conceptual models, an
analysis plan, and inclusion of non-chemical stressors. EPA's Framework for Ecological Risk
Assessment has been adapted for use by other organizations.
EPA's Guidelines for Ecological Risk Assessment1 were published in 1998. In the
guidelines, EPA provided additional guidance for applying the Framework for Ecological Risk
Assessment. The Agency plans to continue developing a "bookshelf of specific ecological risk
assessment guidance documents. One of these documents, guidance on generic assessment
endpoints, has been published.
Future Needs
1 U.S. EPA 1998. Guidelines for Ecological Risk Assessment. EPA/30/R-95/002F. U.S.
Environmental Protection Agency, Washington, D.C.
(http://cfpub. epa.gov/ncea/raf/recordisplay. cfm?deid=12460)
C-l
-------
The following issues should be considered to make continued advances in the practice of
ecological risk assessment:
• Probability and Uncertainty. The first ecological risk assessment methods were probabilistic,
but assessments performed by the Agency generally have not been probabilistic. However it
is important to consider uncertainty and variability in risk assessment. Tiered approaches
and models have been developed for conducting probabilistic ecological risk assessment of
pesticides. Ecological risk assessors are ahead of their human health risk assessment
colleagues in the application of joint probability distributions to assess risk.
• Levels of Biological Organization. Regulated parties and many ecologists prefer that
ecological risk assessments be conducted using higher levels of organization. However,
EPA's ecological risk assessments generally use organismal attributes because they are easier
to evaluate with currently available data and methods, methods that address organismal
attributes are scientifically and legally defensible, they are understandable by decision-
makers and the public, and they are protective. When organismal attributes have been used,
EPA has been incorrectly criticized for "protecting individuals."
• Ecological Epidemiology. Ecological epidemiology provides tools for assessing ecological
risks. Bioassessment guidance has been developed by EPA's Office of Water, Superfund
assessments often include observed effects, and pesticide reregistrations include incident
reports. Bioassessment can reveal effects of multiple agents and indirect effects, but effects
may not be clearly revealed and determining causality is often difficult.
• Weight-of-evidence. Weight-of-evidence approaches enable ecologists to evaluate multiple
types of evidence and multiple lines of evidence within a type. Most risk assessment
practitioners prefer to consider all available relevant evidence, but some consider the process
of weighing evidence to be too subjective.
• Cost-benefit Analysis. Ecological risk assessment is aimed at protecting specific ecological
endpoints. These include representative species and ecosystems and sensitive species and
ecosystems. Benefits accounting requires estimating all of the ecological effects that are
welfare effects and surrogates or representatives are not acceptable. The SAB is providing
advice on monetizing benefits, but advice is also needed on how to estimate benefits before
they can be monetized.
• Increasing the Influence of Ecological Concerns. In EPA's risk management decisions,
human health concerns have often carried greater weight than ecological concerns. To
increase the influence of ecological concerns, it will be important to provide decision-makers
with an understanding that human health and welfare are dependent upon ecosystem quality.
Slides of Dr. Suter 's presentation are available at:
http://www.epa.gov/sab/pdf/ecorisk workshop summaryS appendix h.pdf
C-2
-------
APPENDIX D - EPA'S ECOLOGICAL RESEARCH STRATEGY AND
MULTI-YEAR PLAN
EPA's Ecological Research Strategy and Multi-Year Plan-Dr. Michael Slimak, Associate
Director for Ecology, National Center for Environmental Assessment, EPA Office of Research
and Development
Dr. Slimak provided an overview of EPA's Ecological Research Strategy and Multi-Year
Research Plan. He described EPA Office of Research and Development resources that are
focused on ecological research and the planning process used to target areas of research for
funding.
There has been a longstanding relationship between risk managers and risk assessors. The
state of the practice of ecological risk assessment is good. It has evolved and is becoming more
sophisticated. EPA's Framework for Ecological Risk Assessment has helped risk managers and
assessors understand the importance of problem formulation and the importance of evaluating
stressors like habitat loss and invasive species. There is, however, low public awareness of some
actions that EPA takes to manage ecological risks, such as not approving certain proposed uses
of pesticides. These Agency decisions are improving the quality of ecosystems.
Office of Research and Development Multi-Year Ecological Research Plan
EPA's Office of Research and Development (ORD) has developed a number of multi-year
research plans that are linked to the Agency's strategic goals. Both core research and problem
driven research is conducted by ORD, and ecological research is a large component of the
overall ORD research program. The current Ecological Research Multi-Year Plan was written in
2003 and it is being revised to describe research that will be conducted in the 2006-2015 time
frame. Revision of the research plan will be based on examination of the program by the Office
of Management and Budget, an external program review held in March 2005, and the need to
focus research on ecological outcomes.
Long-term Goals
Ecological research is being conducted in support of several long-term goals. The ecological
research program with a budget of $80 million and 300 full time equivalent positions is the
largest ORD research program. The long-term program goals were developed to provide
assessment and management tools needed by national, state, and local decision-makers. Long-
term goal #1 states that national policy makers will have the tools and technologies to develop
scientifically-defensible assessments of the state of our nation's ecosystems and the effectiveness
of existing national programs and policies. To support this goal, research is being conducted to
answer some important questions:
• What statistically valid, scientifically defensible frameworks are needed to measure, assess,
and report on the status and trends of ecosystem condition at regional and national scales?
D-l
-------
• What sensitive and reliable ecological indicators are needed to measure changes in ecosystem
condition over broad regions of the country?
• How can environmental monitoring help evaluate the effectiveness of national efforts to
protect and improve the environment?
Long-term goal #2 states that states and tribes will apply improved tools and methods to protect
and restore their valued ecological resources. Ecological research is being conducted to answer
the following important questions associated with this goal.
• How can states and tribes best assess the condition of their ecological resources?
• What are the causes of degraded and undesirable conditions?
• How will the condition of ecological resources and the causes of degraded conditions change
in the future?
• Which management practices are most successful for the protection and restoration of
ecological resources?
Long-term goal #3 states that decision makers will use tools to make informed proactive
management decisions that consider a range of choices and alternative outcomes, including
effects on ecosystem services. Ecological research is being conducted to answer the following
questions associated with this goal.
• What set of ecosystem services are most important to resource managers?
• What are the ranges of choices managers have to reduce the loss of ecosystems services?
• What are the available approaches to restoring ecosystem services?
• What are appropriate spatial and temporal scales for restoring ecosystem services?
ORD's ecological research program has resulted in numerous publications in the peer
reviewed literature and has involved collaborators in a number of different universities and
federal agencies. Planned new areas of ecological research include the development of
forecasting tools for population, community, and ecosystem assessment, ecological forensics,
research on large river basins (historically ecological research has been at a smaller scale and has
overlooked large basins), ecological services research to identify benefits provided by
ecosystems, and global earth observation system research to take advantage of ground and
ocean-based observing systems as well as satellites.
Slides of Dr. Slimak's presentation are available at:
http://www.epa.gov/sab/pdf/ecorisk workshop summaryS appendix i.pdf
D-2
-------
APPENDIX E - STRENGTHS OF THE ECOLOGICAL RISK
ASSESSMENT PROCESS FOR USE IN DECISION MAKING
Strengths of the Ecological Risk Assessment Process for Use in Decision Making - Dr.
Lawrence Barnthouse, President and Principal Scientist, LWB Environmental Service
Dr. Barnthouse discussed the strengths of ecological risk assessment for use in decision
making. Methods and processes for conducting ecological risk assessments have been developed
in recent time. In 1981 the term ecological risk assessment had not yet been invented and the
process was non-existent. Assessments were performed independently by different organizations
using different principles and methods. Little communication occurred among those
organizations, and there were no opportunities to compare methods, identify common
approaches, and advance the state of the science. Risk management judgments were often
hidden within assessment procedures.
Unified Conceptual Approach to Ecological Risk Assessment
The pioneers of ecological risk assessment developed a unified conceptual approach to
environmental assessment and facilitated the cooperation and collaboration between assessment
related disciplines. They also increased the transparency of risk assessments to users (the
decision makers), provided standardized tools and techniques and generally dispelled the
common perception that "ecological risk assessment was impossible." Presently, ecological risk
assessment is being applied to all levels of decision making. EPA's Ecological Risk Assessment
Framework and Guidelines have been in place for nearly a decade. Numerous EPA program-
specific and problem-specific ecological risk assessment documents have been developed and
are being applied across the Agency. The Ecological Risk Assessment Framework and
Guidelines is also being widely imitated outside of the U.S.
Case Examples Illustrate Strengths of Ecological Risk Assessment
The key to success in the practice of ecological risk assessment has been recognition of the
importance of ecological risk assessment as a process, not a technique. Three case studies
illustrate the application of a common ecological risk assessment framework to diverse
regulatory assessments.
• A baseline ecological risk assessment of the Clinch River provided a site-specific assessment
of remediation requirements at a Superfund site. In the Clinch River baseline ecological risk
assessment, the fish community was the assessment endpoint. Exposure to measured
chemical concentrations in water was determined. Literature-derived toxicity data, site-
specific toxicity tests, and local and regional fish community composition were used to
measure ecological effects, and risk characterization was based on multiple lines of evidence.
• EPA's special review of the herbicide, atrazine provided a regional/continental assessment of
the need for risk reduction. In the special review of atrazine, the aquatic community was the
assessment endpoint. Atrazine exposure was measured and modeled, and literature-derived
toxicity data for various aquatic taxa were used to measures of effects. A probabilistic
E-l
-------
approach was used to characterize the risk or exceeding an effects threshold for 10% of
aquatic taxa.
• Validation of the European Union pharmaceutical ecological risk assessment procedure
provided an evaluation of the standardized hazard classification process. In this ecological
risk assessment, the assessment endpoint was aquatic ecosystem function. Measured and
modeled concentrations of chemical concentrations in water were used to determine
exposure, and a hazard quotient approach was used for risk characterization.
These three case studies demonstrate use of a consistent approach for application of diverse
types of data in ecological risk assessments to be used in decision making. Field and laboratory
data were used in the Clinch River baseline ecological risk assessment, and a species sensitivity
distribution approach was used in the atrazine and pharmaceutical ecological risk assessments.
The case studies also demonstrate effective transfer of assessment methods between risk
assessments. A triad approach was used in the Clinch River baseline ecological risk assessment,
and the species sensitivity approach was used in the atrazine and pharmaceutical ecological risk
assessments. In all of these case examples, a consistent format was used for reporting risks and
uncertainties.
Nonregulatory risk assessments for decision making can be effectively conducted using a
relative risk model. In this model, assessment endpoints may be diverse, as defined by
stakeholders. Quantitative and qualitative information may be used to determine the sources of
stressors affecting assessment endpoints. Quantitative and qualitative information on the effects
of stressors may be used to determine effects, and risk characterization may be based on
multiplication of ranked exposure and effects indices. The Cherry Point Pacific Herring
ecological risk assessment exemplifies this approach. In this case assessment, endpoints were
defined with stakeholder input. The abundance of the spawning run was the assessment
endpoint. A conceptual model was used to clearly relate exposures to effects. Risk
characterization was completed using an integrative model, and the results were linked to
management objectives, in this case management of the Cherry Point Aquatic Preserve.
The strengths of ecological risk assessment exemplified in the case studies discussed are
that it:
• Provides a systematic approach to organizing scientific information to support environmental
decision making;
• Provides a source of analytical tools applicable to a wide array of environmental problems;
• Provides a stimulus for the development of better tools to improve future environmental
decisions.
In order to effectively take advantage of these strengths, risk assessors should ensure that
assessments address management needs. The distinction between management and science must
be maintained. In addition, the best available relevant science should be used, the process should
E-2
-------
be transparent, and methods and results should be comprehensible to decision makers and
stakeholders.
Slides of Dr. Barnthouse 's presentation are available at:
http://www.epa.gov/sab/pdf/ecorisk^workshopsummary 5 appendixJ.pdf
E-3
-------
APPENDIX F - LIMITATIONS OF THE ECOLOGICAL RISK
ASSESSMENT PROCESS FOR USE IN DECISION MAKING
Limitations of the Ecological Risk Assessment Process for Use in Decision Making - Dr.
Lawrence Kapustka, Senior Ecotoxicologist, Golder Associates, Ltd.
Dr. Kapustka identified a number of important limitations of ecological risk assessment as it
is applied in decision making. The use of ecological risk assessment in decision making is
limited by the difficulty of assigning value to ecological resources. Ecological resources are
assigned values differently by different humans based on cultural, ethnic, class, age, and gender
differences. In addition, the emergent properties of ecological systems should be considered if
one is to manage populations, communities, and ecosystem functions. However, problems are
encountered in managing ecological systems because they cannot be restored, they can only be
emulated, change in ecological systems is inevitable, and predictions of future conditions are
tenuous at best.
Inherent and Contrived Limitations of Ecological Risk Assessment
Ecological risk assessment is also limited by uncertainties associated with
• The stochastic nature of ecological systems. Due to the stochastic nature of ecological
systems, uncertainty is certain. Risk statements can therefore be easily interpreted as lacking
understanding.
• Consideration of space and time scales that may be unrealistic. Space and time scales should
be considered in ecological risk assessment. However, it can be difficult to choose
assessment endpoints that reflect realistic scales of time and space.
• Difficulties in establishing ecological baselines. Establishing ecological baselines can be
difficult because ecological processes occur over decades or even centuries. Short-term
trajectories may provide a false indication of a long-term trend. Fortuitous change that
coincides with a hypothesis can also be misleading.
• Toxicological profiles. Variation in toxicity profiles for different taxa can make it difficult to
predict toxicity. At higher taxonomic levels, toxicity profiles are less accurate.
• Exposure conditions. It can be difficult to predict exposure because of variations caused by
dietary preferences, dietary availability, metabolic (caloric) demand, incidental ingestion of
soil and sediment, bioavailable fraction of contaminants, and behavioral dynamics (such as
seasonal patterns and eco-regional patterns).
• The effects of multiple stressors. The effects of multiple stressors introduce uncertainty in to
the ecological risk assessment process because: no organism resides at the optimum position
for all of its niche parameters, acclimation and adaptation are mechanisms that can cause
organisms and populations to adjust to changing environments, and the cumulative effects of
multiple stressors can confound predictive capacity regarding particular stressor effects.
F-l
-------
• Complex stressors. Complex stressors can have different effects under different conditions.
Examples include the effects of essential nutrients, acclimation regimes, co-occurrence of
stressors, and sequences of exposure.
Contrived limitations or obstacles to the use of ecological risk assessment in decision making
processes have also been created. These contrived limitations include:
• Legal/regulatory limitations. Practices specified by law and established regulations may
have unintended consequences. Potential liability can promote avoidance of risk assessment
and prescriptive measures can stifle innovation or provide justification for minimalistic
approaches.
• Policy and precedent. Policy and precedent may establish the use of inappropriate endpoints
or risk characterization approaches.
• Ecotheocracy. Ecotheocracy derived from Clementsian views of grand design, the goodness
of nature, and the evil of humans may lead to the use of measurement endpoints such as
ecosystem health, integrity, stability, the balance of nature, recovery, and restoration that are
not defensible for science-based assessment.
• Use of point estimates. The validity of point estimates such as No Observed Adverse Effects
Concentration (NOAEC), Lowest Observed Adverse Effects Concentration (LOAEC), and
Maximum Allowable Toxic Concentration (MATC) has been widely refuted over the past 20
years. An alternative is to use all of the available data in non-linear regression models to
derive an effects concentration thereby avoiding serious deficiencies of the NOAEC
approach.
• Data quality. Data obtained from the peer reviewed literature can be unusable in an
ecological risk assessment because of poor study design and poor reporting standards. The
taxonomic diversity of terrestrial toxicity test species is highly restrictive and the costs of
toxicity testing make it unlikely that more species will be added. Risk assessors currently
have a limited ability to place species accurately along a species sensitivity gradient relative
to test species. Too much data are reported as point estimates, and conflicts stemming from
animal rights concerns effectively preclude gathering new data.
• Perceived value/cost. Ecological risk assessments are sometimes viewed as "make work"
efforts completed to "check a box." The connection of such risk assessments to management
decisions is often obscure or lacking. Such risk assessments are not seen as identifying key
problems that could be addressed through meaningful management strategies, and commonly
there is a failure to match the level of effort of a risk assessment to the magnitude of the
problems being investigated.
• Trustworthiness. Some of the major stakeholders are sometimes excluded from the
ecological risk assessment process. In such cases there can be a perception that decisions are
made in advance of an ecological risk assessment. Then there is the perception that data are
F-2
-------
manipulated to justify decisions. Finally, there is little focus on follow-up measurements to
monitor, calibrate, and corroborate the risk assessment, which strains the relationship among
stakeholders.
Actions to Improve the Process of Ecological Risk Assessment
Actions can be taken in the near term (less than three years) and the long-term (more than
three years) to improve the process of ecological risk assessment for use in decision making. In
the near term, policies and practices should be aligned with the state-of-the-science.
• Effects concentrations (ECX) should be used for screening and complete response profiles
could be used for higher tiered assessments.
• The use of hazard quotients should be restricted to screening level assessments, and effects
response relationships should be used for higher tiered assessments.
• Contemporary ecological theory and practices should be adopted in defining assessment
endpoints, conducting analysis steps, interpreting consequences, and proposing risk
mitigation/reduction actions.
• Focused follow-up monitoring, calibration, and corroboration activities should be undertaken
to evaluate risk predictions.
• Integration of ecological risk assessment into the environmental management decision
process should be promoted.
• Long range research programs should be initiated. In the long term it will be important to fill
data gaps to improve the process of ecological risk assessment.
• Additional toxicity data are needed to improve species sensitivity analyses.
• The scope of ecological risk assessments should be expanded to explicitly include biological
and physical stressors and put chemical stressors in an ecological context.
• Ecological risk assessments should explicitly focus on functional ecological processes at
population and community levels.
• Necessary regulations and policies should be configured to require landscape-level
assessments that approach meaningful ecological scales. To conduct such assessments,
effects should be aggregated at eco-regional levels, and risk predictions should be evaluated
with analyses contained in state of the environment reports.
Slides of Dr. Kapustka 's presentation are available at:
http://www.epa.sov/sab/pdf/ecorisk workshop summaryS appendix k.pdf
F-3
-------
APPENDIX G - ECOLOGICAL RISK ASSESSMENT FOR
REGULATION UNDER THE FEDERAL INSECTICIDE, FUNGICIDE,
AND RODENTICIDE ACT
Application of Ecological Risk Assessment in Product Health and Safety Decision Making -
Ecological Risk Assessment for Regulation Under the Federal Insecticide and Pesticide Act
-Dr. Steven Bradbury, Director, Environmental Fate and Effects Division, EPA Office of
Pesticide Programs
Dr. Bradbury provided an overview of ecological risk assessment conducted by the U.S. EPA
Office of Pesticide Programs to support pesticide regulation under the Federal Insecticide,
Fungicide, and rodenticide Act (FIFRA). Under FIFRA, the Agency may approve a pesticide if
its use will not "cause unreasonable adverse effects on the environment." The Agency evaluates
ecological risks to wildlife, aquatic life, and their habitat. The statute requires US EPA to weigh
risks against benefits from the use of a pesticide. In addition, US EPA regulatory actions should
be in compliance with the Endangered Species Act. The Program makes over 5,000 regulatory
decisions annually for biopesticides, agricultural chemicals, and antimicrobial products. These
decisions concern requested registrations for new active ingredients, new uses of existing
pesticides, re-registrations for existing products, emergency exemptions, and experimental use
permits.
Currently there are approximately 1,100 active ingredients and 19,000 pesticide products on
the market. Consequently, there are many potential adverse outcomes over space, time, and
levels of biological organization that should be addressed in the context of finite resources and
specified, statutory timeframes. To meet its mission, the Program should determine sufficient,
credible amounts of data needed for assessment and management decisions, as specified by
specific statutes, and analyze these data in a scientifically sound, transparent, and timely manner.
The Program uses the Agency's Ecological Risk Assessment Guidelines to assess potential
risks of pesticides, as summarized at: http://www.epa.gov/espp/consultation/ecorisk-
overview.pdf and http://www.epa.gov/oppefedl/ecorisk/index.htm
While substantial advances in the field of ecological risk assessment have been achieved, the
following significant challenges remain: 1) quantifying exposures and effects at appropriate
biological scales in a spatially, temporally-explicit manner to facilitate evaluations that inform
risk management decisions relevant to public policy and economic considerations and 2)
assessing environmental conditions and identifying causes of impairment to quantify outcomes
of risk management actions and effectively focus future environmental protection activities.
Quantifying Exposures and Effects in an Explicit Manner
A stepwise or tiered approach to risk assessment is intended to incorporate the most efficient
use of resources by facilitating credible decisions at the earliest possible stage, while at the same
time maintaining ample margins of safety so that protection of the environment is ensured. The
tiered approach allows scientific expertise; test laboratory capabilities; test organisms; time
G-l
-------
needed to conduct, interpret, and report tests; and costs to be allocated to the issues of greatest
concern. The challenge is to advance the scientific means to refine and characterize ecological
risk projections at appropriate biological, spatial, and temporal scales that are responsive to the
scales associated with corresponding social and economic considerations in the overall risk
management decision.
The challenge to provide increasingly explicit information to support risk management
decisions can be simply expressed as the extent to which useful answers to the "So what?"
questions can be provided. For example, what can happen to a population offish if the predicted
environmental concentration exceeds an LC50 derived from an acute toxicity test? What are the
potential consequences to a fish population if X% of the fish has Y level of reproductive
impairment at a given exposure level? How long can it take for the population offish to be
affected? Will these population effects happen in certain places? Which places? Some places
more than others?
A number of international organizations are pursuing the means to answer the "So what?"
question on several fronts. For example, the US EPA Office of Pesticide Program's on-going
efforts are focused on the development of probabilistic techniques to estimate the risk of
pesticide exposures to aquatic life and wildlife (see
http://www.epa.gov/oppefedl/ecorisk/index.htm ). Immediate efforts are designed to move risk
estimates of effects at the individual-level beyond single-point deterministic assessment
approaches that relate an estimated environmental concentration to a specific adverse effect (e.g.,
an LC50 or NOAEL). Probabilistic techniques help in answering the "So what?" questions by
estimating the magnitude and extent of mortality rates, growth rates, fecundity, and other effects
for varying exposure scenarios. This approach to characterizing risks more fully employs
available information (e.g., dose-response data when available) and provides risk managers with
a more complete understanding of the potential effects associated with a chemical stressor.
When deterministic or probabilistic techniques are used to characterize risks of mortality or
reproductive fitness at the individual level, additional and significant "so what?" questions
remain. For example, "To what degree do changes in survival or reproductive performance
translate to changes in populations and communities?" and "To what degree are these mortality
or reproductive effects, and for that matter, population and community effects, expected to be
significant at the field, watershed, or regional scale?"
Regulatory decision making for environmental effects may require information at biological,
temporal, and spatial scales that is typically not addressed with current techniques. For example,
environmental management evaluations, especially those that are required to evaluate the costs
and benefits of a decision, operate at spatial scales that can encompass eco-regions, watersheds,
or the habitat range of a species. Clearly, environmental management decisions concerning
potential chemical effects require the means to provide spatially-explicit estimates of chemical
exposure, population responses, and potential risk to aquatic life and wildlife.
Aquatic life and wildlife populations, and the associated community structure and function
that provide habitat for forage and reproduction, are potentially affected by many stressors
related to human activity, including habitat alteration, introduced species, and chemical use,
G-2
-------
among others. The magnitude and extent of population responses and the sustainability of a
population to changes in the landscape is a function of the interactive and cumulative effects of
the associated stressors. Populations and stressors are distributed in a heterogeneous manner
within the landscape. Understanding relationships between spatial and temporal patterns of
stressor exposures and the spatial and temporal distribution of populations is a major facet to
estimating or interpreting the severity of population responses.
Developing spatially-explicit population estimates requires techniques for generating
quantitative chemical exposure-response relationships and habitat-response relationships at the
individual level. The development of such capabilities should be tailored to address applications
that range from general, broad screening-level assessments to realistic and situation-specific
applications. Associated with these developments is the need to improve approaches for
extrapolating toxicological data across species. Models appropriate for these applications should
be established to generate outputs describing population growth rates or other appropriate
population-level endpoints as a function of stressor relationships to fecundity, life-stage specific
survival, and related demographic rates. Finally, if these relationships can be projected in the
context of generic/representative or actual spatial and temporal characterizations of stressors and
populations in a landscape, it may be possible to assess effects from chemical exposure in the
context of habitat modification.
Creating the means to answer these "So what?" questions through GIS will be contingent on
the development of interactive information management systems that link databases for species-
specific toxicity, demographics, life history, and habitat quality requirements. These knowledge
bases, linked to models that can estimate missing values from existing information, may provide
the means for projecting population responses for specified species in defined locations. This
conceptual approach can be broadly applied to a wide range of risk assessment applications. For
applications with limited toxicological data (measured or predicted) and generic representations
of appropriate landscape scenarios, bounding conditions and assumptions can be explored in
problem formulation and simple, but insightful, "What if?" analyses can be employed to help
characterize and communicate potential risks. In cases where the species' toxicological,
population demography, and associated landscape information are increasingly resolved and rich,
more explicit risk assessments are possible. Obviously, all risk assessments will have limited or
missing data in one or more facets of an analysis. Use of this modeling construct may provide
the means to evaluate uncertainties related to missing information and determine the extent to
which generation of additional, specific data can make a material difference in the risk estimate.
Assessing Ecological Condition and Identifying Causes of Impairment
Two different perspectives influence the regulatory pressure for advancing eco-epidemiology
and diagnostics. The first perspective concerns the need to track and document the
environmental outcomes of regulatory decision making to evaluate whether or not environmental
management has improved or maintained ecological condition. The second perspective concerns
the need to identify likely causative agents within impaired ecosystems. Proper diagnosis of the
chemical and/or non-chemical stressors responsible for impairment is essential to forming a cost-
effective and efficient approach to risk mitigation.
G-3
-------
Advancement of eco-epidemiology and diagnostic methods addresses a wide range of
management questions: How has the reduction of non-point source loading of a pesticide in a
watershed changed the status of the fish community? Has the introduction of a new class of
lower risk pesticides maintained or improved the condition of bird populations in the associated
agro-ecosystems? Has reduction in the use of persistent bioaccumulative pesticides resulted in
lower wildlife body burdens and improved fitness? The ability to answer these questions in a
systematic fashion will help risk assessors inform decision makers if previous regulatory actions
need refinement and will help inform priority-setting for future efforts.
The ability to assess the current condition of the environment and to monitor change in
condition over time is needed to quantify environmental outcomes derived through regulatory
decisions. Development of probability-based survey designs are needed to assess ecological
condition at local, state or province, regional, national and continental scales in such a way that
data can be aggregated in a cost-effective manner (see http://www.epa.gov/emap). Through the
use of comprehensive and comparable methods, these designs also provide the means to compare
ecosystem conditions across common spatial scales of regulatory interest The combination of
sound survey designs with the use of ecological and exposure indicators, developed through
rigorous evaluation criteria, provide the means to evaluate trends in environmental condition
with stressors most likely associated with impaired condition. Establishing unbiased estimates
of environmental trends in a scientifically- and statistically-credible manner provides the means
to associate ecological condition with land-use activities and stressors so as to identify those
regulatory actions that are meeting performance goals and to establish priorities for future risk
management activities. Developing sound methods to establish baseline environmental
conditions and trends is a universal need that transcends ecosystem types, classes of stressors,
and regulatory programs.
While techniques to assess ecological condition and to identify impaired ecosystems are
advancing, the need to establish diagnostic capabilities to determine cause-effect relationships
within impaired systems remains a significant challenge. A diagnostic evaluation should provide
a definition of the primary causes of impairment (chemical or non-chemical) and an
apportionment of adverse effects across multiple stressors and their potential interactions. The
development of diagnostic techniques is critical for refining leading causes of impairment in
specific ecosystems or classes of similar ecosystems, for determining the extent to which existing
remediation programs are effective, and for identifying situations where further refinements in
risk management activities are required.
In the context of chemical stressors, research to date has established numerous indicators at
the molecular, biochemical, and organismal level that can establish whether exposure has or is
occurring to specific chemicals or classes of chemicals. What continues to be a major gap in the
science is the lack of effect indicators that establish the extent to which adverse outcomes are
occurring or are likely to occur in the future.
Slides of Dr. Bradbury's presentation are available at:
http://www.epa.gov/sab/pdf/ecorisk workshop summaryS appendix l.pdf
G-4
-------
APPENDIX H - APPLICATION OF ECOLOGICAL RISK ASSESSMENT
IN MANAGEMENT OF CONTAMINATED SITES - CASE EXAMPLE,
ECOLOGICAL RISK ASSESSMENT OF THE CLARK
FORK RIVER SUPERFUND SITE
Application of Ecological Risk Assessment in Management of Contaminated Sites - Case
Example, Ecological Risk Assessment of the Clark Fork River Superfund Site Dr. John
War dell, Director, Montana Office, U.S. EPA Region 8
Dr. Wardell discussed the ecological risk assessment conducted in support of risk
management decisions at the Clark Fork River Superfund site in Montana. At this site, fluvial
deposition of mine wastes over a period of 100 years had resulted in contaminated media (soils,
river bank, and surface water). Challenges in conducting the risk assessment at this site were to
identify the risks, evaluate remedies and communicate the benefits of the remedies to ranch
owners along the river.
Problem Formulation
A number of assessment endpoints were selected for evaluation in the problem formulation
phase of the risk assessment. Site specific toxicity studies provided data to evaluate assessment
endpoints for terrestrial receptors. These endpoints included:
• Survival, growth, diversity and abundance of the riparian vegetation community under
chronic exposure to contaminants and other chemical and physical stressors in the 100 year
flood plain habitats of the Clark Fork River.
• Survival, growth, and reproduction of wildlife populations under chronic exposure to
contaminants and other chemical and physical stressors in the 100 year flood plain habitats of
the Clark Fork River.
Site specific toxicity studies also provided data to evaluate assessment endpoints for aquatic
receptors. A species of special concern in the Clark Fork River was the endangered Bull Trout.
Endpoints for aquatic receptors included
• Survival offish, aquatic invertebrates, and algal populations under acute exposure to
contaminants of concern and other chemical and physical stressors in the Clark Fork River.
• Survival, growth, and reproduction offish, aquatic invertebrates, and algal populations under
chronic exposure to contaminants of concern and other chemical and physical stressors in the
Clark Fork River.
• Survival, growth, and reproduction of Bull Trout under acute and chronic exposure to
contaminants of concern and other chemical and physical stressors in the Clark Fork River.
H-l
-------
During problem formulation, a site conceptual model for ecological exposures was developed
for the Clark Fork River Operable Unit. The conceptual model identified the primary source of
contaminants (historic disposal of mine waste to surface soils, streams, and rivers) and described
exposure pathways from contaminated media (soils, overbank deposits, surface water, and river
sediments) through the food chain to ecological receptors. A weight-of-evidence approach was
developed to characterize risk. Weight-of-evidence conclusions concerning risk were developed
by evaluating exposure pathways and toxicity reference values, field and laboratory site specific
toxicity studies, and field observations of taxa richness and abundance.
Exposure and Risk Characterization
Exposure point concentrations and risks were characterized separately for the aquatic
community as a whole, fish, macroinvertebrates, algae, terrestrial plants, terrestrial vertebrates
and soil organisms. Exposure pathways were identified and hazard quotients were predicted.
Site specific toxicity testing was conducted using water effect ratio tests with rainbow trout,
ceriodaphnia, and fat head minnows. In addition, site-specific receptor population and
demographic data were collected. The weight-of-evidence analysis indicated that
• Copper is imposing an intermittent low-level chronic stress to the aquatic community.
Observed effects on fish populations are most likely the result of acute pulses of high
concentrations of high concentrations of copper. Metals are likely to be altering the
composition of the macroinvertebrate community but not the overall abundance. Dissolved
metals are causing low to minimal stress to algae.
• The weight-of-evidence is strong that mine tailings materials present in the root zone of
riparian area soils are significantly phytotoxic to terrestrial plants.
• Dietary exposure to contaminants is likely to pose risks to small terrestrial vertebrate
insectivores and herbivores. However there are little site-specific data available, and hence
these receptors had the greatest amount of uncertainty.
Alternatives Considered
The common theme developed in the risk characterization process was that mine waste
presents stress to the aquatic environment and, to a lesser extent, to the terrestrial environment.
To address the problem of mine waste and contaminated soils in the floodplain and river banks,
the following alternatives were considered
• No further action.
• In-place reclamation of exposed tailings.
• In-place reclamation of exposed tailings and other impacted soils and vegetation areas.
• In-place reclamation of exposed tailings and other impacted soils and vegetation areas with
stream bank stabilization.
H-2
-------
• Removal of exposed tailings and other impacted soils and vegetation with stream bank
stabilization.
• Total removal unless overlain by woody vegetation.
• Total removal of all exposed and buried tailings areas (i.e., essentially a complete recovery)
• Construction of the entire floodplain of the Clark Fork River.
The anticipated outcomes of the alternatives were evaluated. None of the alternatives
considered, if individually implemented, would completely achieve all of the remedial action
objectives. For example, the State of Montana's water quality standard for copper would not be
met because of continued copper loading from tributary, upstream, and residual contamination
sources left onsite. A remedy was developed to balance long-term and short-term effectiveness
and permanence, reduction of mobility, toxicity, and volume of wastes as well as concerns with
implementation.
Proposed Remedy
The proposed remedy calls for:
• Removal of most "slickens" (fine textured mining wastes that are detrimental to plant
growth) where uncertainty is greater regarding the effectiveness of in-situ treatment. It was
most cost effective to dig up these wastes from which potentially large-scale releases of toxic
materials could occur into the river. The ecological risk assessment identified this type of
contamination problem as an acute risk to aquatic life.
• In-situ treatment where success of this technique was deemed likely to decrease the mobility
of wastes. The ecological risk assessment identified this type of contamination problem as a
chronic risk to aquatic life.
• Stream bank stabilization where appropriate to minimize erosion of contaminated materials
into the river to reduce episodic large-scale releases of toxic materials that the ecological risk
assessment identified as a chronic risk to aquatic life.
• Revegetation of slickens, other areas as appropriate, and stream banks was needed to address
terrestrial risks identified in the ecological risk assessment.
It was determined that this set of remedies could be completed in a reasonable period of time
(approximately 10 years) at a reasonable cost (approximately $100 million) and at a
reasonable impact to current use of land by ranchers and farmers on whose property the
remedy would be carried out.
Slides of Dr. War dell's presentation are available at:
http://www.epa.gov/sab/pdf/ecorisk workshop summaryS appendix m.pdf
H-3
-------
APPENDIX I - APPLICATION OF ECOLOGICAL RISK ASSESSMENT IN
NATURAL RESOURCES PROTECTION - ASSESSING THE EFFECTS
OF SELENIUM ON AQUATIC LIFE
Application of Ecological Risk Assessment in Natural Resources Protection -
Assessing the Effects of Selenium on Aquatic Life - Dr. Edward Ohanian, Director, Health
and Ecological Criteria Division, Office of Science and Technology, EPA Office of Water
Dr. Ohanian discussed EPA's development of a proposed water quality criterion for selenium.
In 2004, EPA proposed a draft criterion for selenium that has been expressed as a fish tissue
concentration. The Agency is now addressing comments received on the criterion and will
determine whether additional studies should be conducted. Section 304(a) of the Clean Water
Act requires EPA to develop and publish, and from time to time to revise, criteria for water
quality accurately reflecting the latest scientific knowledge. Within the context of their Clean
Water Act application, EPA should be able to defend its criteria as being sufficiently protective
but not unnecessarily stringent relative to what is needed for achieving aquatic life use goals.
Within the risk assessment paradigm, the derivation of criteria is an effects assessment.
Exposure assessment comes into play during criteria implementation, when determining whether
criteria are being attained at a site.
Since 1980, EPA has preferred to derive its criteria concentrations following agreed upon
methodologies. The methodology for deriving aquatic life criteria was published in 1985. This
methodology calls for compiling toxicity data for a diverse set of taxa, constructing a Species
Sensitivity Distribution with the toxicity values, and interpolating or extrapolating to the water
concentration needed to protect 95% of taxa. This methodology is still in use, although efforts to
revise it are currently underway.
The 1985 methodology is not particularly well suited to deriving aquatic life criteria for
bioaccumulative pollutants. It was designed for pollutants where aquatic life are exposed
predominantly via water. That is, in ordinary chronic toxicity tests, the organisms are placed in
contaminated water, but are fed an uncontaminated diet.
On the other hand, because algae and aquatic plants bioconcentrate selenium, aquatic animals
in the real world are exposed to selenium primarily through their diet. Nevertheless, in contrast
to the mercury, selenium is not biomagnified in the upper trophic levels.
As a consequence of this bioaccumulative behavior, when aquatic organisms consume food
grown in the contaminated water, effects are seen at far lower concentrations than when fed an
uncontaminated diet in ordinary toxicity tests. Because of this phenomenon, in 1987 when EPA
published its current chronic criterion, 5 |ig/L, EPA did not use such toxicity test data but rather
relied on field data collected at Belews Lake, North Carolina, comparing sunfish health with the
water concentration of selenium in different parts of the lake.
1-1
-------
EPA is currently in an extended process of revising the 1987 selenium criterion to reflect the
considerable amount of additional toxicity data that has since become available. EPA has
examined the new information and prepared a draft revised criterion. After considering the
potential for a selenium criterion expressed as a water, sediment, or tissue concentration, EPA
has derived the draft criterion as a fish tissue criterion. This has allowed use of numerous
laboratory, field, and mesocosm studies where tissue concentrations were measured. This step
also removes site-to-site variations in food chain bioaccumulation from the numeric value of the
criterion.
When the adult life stage of sensitive fish species are exposed to excessive levels of selenium,
the sensitive endpoints are manifested in the early life stages of the offspring, not in the adults
themselves. For this reason, a tissue criterion can be applied with the expectation that adult fish
will be available for sampling even at sites where effects are occurring.
Nevertheless, unlike water, fish tissue is not an exposure medium shared by numerous
species. When compared across the various species that may reside at a site, the same tissue
concentration may have different significance not only because of species differences in their
tolerance of elevated tissue levels, but also because of species differences in their propensity to
bioaccumulate selenium.
As part of its ongoing efforts to revise the general methodology for deriving aquatic life
criteria, EPA is in the process of addressing the issues involved in developing and applying
tissue criteria for bioaccumulative pollutants.
Slides of Dr. Ohanian 's presentation are available at:
http://www.epa.gov/sab/pdf/ecorisk workshop summaryS appendix n.pdf
1-2
-------
APPENDIX J - BIOSKETCHES OF INVITED SPEAKERS AND
PANELISTS
Speakers
Dr. Lawrence Barnthouse is the President and Principal Scientist of LWB Environmental
Services, Inc. Before he became a consultant, he was a research staff member and Group Leader
in the Environmental Sciences Division at Oak Ridge National Laboratory. In 1981 he became
co-principal investigator (with Glenn Suter) on EPA's first research project on ecological risk
assessment. Since that time, he has been active in the development and application of ecological
risk assessment methods for EPA, other federal agencies, state agencies, and private industry.
He has chaired workshops on ecological risk assessment for the National Academy of Sciences
and the Society of Environmental Toxicology and Chemistry, and served on the peer review
panels for the Framework for Ecological Risk Assessment and the Guidelines for Ecological
Risk Assessment. He continues to support the development of improved methods for ecological
risk assessment as the Hazard/Risk Assessment Editor of Environmental Toxicology and
Chemistry and a Founding Editorial Board Member of Integrated Environmental Assessment and
Management.
Dr. Steven Bradbury is Director, Environmental Fate and Effects Division, Office of Pesticide
Programs, U.S. EPA. The Division's ecological risk assessments and drinking water exposure
characterizations support risk management policies and decisions concerning the registration and
re-registration of pesticides. Efforts are integrated with other USEPA Offices and Regions, as
well as other Federal and international agencies, and stakeholder organizations. Before assuming
his current position Dr. Bradbury led and managed EPA Office of Research and Development
(ORD) laboratory facilities in Duluth, MN and Grosse Isle, MI. This Division's programs
advanced ecological monitoring and assessment designs and indicators for the Great Lakes and
Great Rivers; understanding of the effects of stressors on freshwater ecosystems, aquatic like and
wildlife to support ecological risk assessment methods; and computational toxicology
approaches to assess industrial chemicals and pesticides. Dr. Bradbury also led, managed and
undertook research on effects of industrial chemicals and pesticides on aquatic life and wildlife
to support risk assessment methods for TSCA, FIFRA, CERCLA and RCRA. He is a member of
EPA risk assessment forum and contributor to EPA's Ecological Risk Assessment Guidelines.
He is also holds an adjunct appointment in the toxicology degree program in the graduate school
of the University of Minnesota. Dr. Bradbury holds a Ph.D. in Toxicology and Entomology
(Insecticide Toxicology) Iowa State University, an M.S. in Entomology (Insecticide Toxicology)
Iowa State University, and a B.S. in Molecular Biology, University of Wisconsin-Madison. He
has published over 75 peer-reviewed journal articles and book chapters.
Dr. Lawrence A. Kapustka joined Golder Associates in July 2005 as a Senior Ecotoxicologist.
He is focusing on the use of spatially-explicit risk assessments, integrating environmental
assessment practices with environmental management decision processes, and advancing the
emerging methods in the field of ecological valuation. In the previous 15 years, at ecological
planning and toxicology, inc., Corvallis, Oregon he worked in the areas of ecological risk
assessments, plant ecotoxicology, and other aspects of ecological applications. Dr. Kapustka
received his Ph.D. in Botany from the University of Oklahoma, Norman in 1975. He received
J-l
-------
his M.S. (1972) and B.S. Ed. (1970) from the University of Nebraska-Lincoln. Before entering
the private sector, Dr. Kapustka was a Research Ecologist and Team Leader of the Plant
Toxicology and Hazardous Waste Teams with the US EPA, Environmental Research Laboratory,
Corvallis, OR (1988-1990). Dr. Kapustka was on the faculty in the Botany Department, Miami
University, Oxford, OH from 1978-1988 where he was tenured and held the rank of Professor.
From 1975-1978 he was on the staff with the Biology Department and Center for Lake Superior
Environmental Studies, University of Wisconsin-Superior, Superior, WI. Dr. Kapustka is active
in several professional societies including the Ecological Society of America (ESA), the
International Association of Landscape Ecologists (IALE), Society for Environmental
Toxicology and Chemistry (SETAC), and the American Society for Testing and Materials
(ASTM). He is a Certified Senior Ecologist (ESA)
Ms. Denise Keehner is the Director of the Standards and Health Protection Division in the
Office of Water at EPA Headquarters. In this position Ms. Keehner has responsibility for
overseeing the implementation of the Water Quality Standards Program, the Beach Program and
the Fish Advisory Program. Prior to moving to the Office of Water in 2003 Ms. Keehner was the
Director of the Biological and Economic Analysis Division in EPA's Office of Pesticide
Programs (OPP) and also served as the acting Director of the Environmental Fate and Effects
Division in OPP. Ms. Keehner has also held management positions in the EPA Office of Solid
Waste and Emergency Response and in the former EPA Office of Toxic Substances. In her 27
years with EPA she has participated in risk management decision making under the Clean Water
Act, the Resource Conservation and Recovery Act, the Federal Insecticide Fungicide and
Rodenticide Act, the Food Quality Protection Act, and the Toxic Substances Control Act.
Dr. Edward Ohanian is the Director of the Health and Ecological Criteria Division, Office of
Water, United States Environmental Protection Agency (U.S. EPA), in Washington, D.C. The
Division is responsible for conducting human and ecological risk assessments as required under
both the Safe Drinking Water Act and Clean Water Act. Recently, he has been appointed the
Chairman of the U.S. EPA Risk Assessment Forum. He also serves as an Adjunct Associate
Professor with the School of Public Health and Tropical Medicine at Tulane University Medical
Center, and with the School of Public Health and Health Services at George Washington
University Medical Center. Previously, he served as the Acting Director of U.S. EPA Office of
Research and Development's National Center for Environmental Assessment at Cincinnati,
Ohio. Dr. Ohanian received his bachelors in Biological Sciences from Columbia University and
his Masters in Physiology from the New York Medical College. His Doctorate in Biomedical
Sciences was obtained from Mount Sinai School of Medicine. He has contributed over 60
articles and chapters to scientific journals and books.
Dr. Michael Slimak is beginning his 29th year of service at the U.S. EPA. Located in
Washington, D.C., he is currently the Associate Director for Ecology in the National Center for
Environmental Assessment, one of five major research units at EPA. He is responsible for
developing and implementing assessment programs in a number of important areas such as
ecological risk, conservation biology, global climate change, invasive species, and water quality.
During his tenure at EPA he has worked in a variety of programs and has been involved in a
number of critical environmental issues. Dr. Slimak is a recognized authority on ecological risk,
has authored numerous government-sponsored reports, has published in peer-reviewed journals
J-2
-------
and books, and has received numerous EPA awards. He holds a BS in Biology, an MS in
Wildlife Ecology and a Ph.D. in Environmental Science.
Dr. Glenn W. Suter II is currently Science Advisor in the U.S. Environmental Protection
Agency's National Center for Environmental Assessment-Cincinnati, and was formerly a Senior
Research Staff Member in the Environmental Sciences Division, Oak Ridge National
Laboratory, U.S.A. He has a Ph.D. in Ecology from the University of California, Davis, and 29
years of professional experience including 24 years of experience in ecological risk assessment.
He is the principal author of two texts in the field of ecological risk assessment, editor of two
other books and author of more than a hundred open literature publications. He is Associate
Editor for Ecological Risk of "Human and Ecological Risk Assessment," and Reviews Editor for
the Society for Environmental Toxicology and Chemistry (SETAC). He has served on the
International Institute of Applied Systems Analysis Task Force on Risk and Policy Analysis, the
Board of Directors of SETAC, an Expert Panel for the Council on Environmental Quality, and
the editorial boards of "Environmental Toxicology and Chemistry," "Environmental Health
Perspectives," and "Ecological Indicators." He is the recipient of numerous awards and honors;
most notably, he is an Elected Fellow of the American Association for the Advancement of
Science and he received SET AC's Global Founder's Award, their highest award for career
achievement, and the EPA's Level 1 Scientific and Technical Achievement Award. His research
experience includes development and application of methods for ecological risk assessment and
ecological epidemiology, development of soil microcosm and fish toxicity tests, and
environmental monitoring. His work is currently focused on the development of methods for
determining the causes of biological impairments.
Dr. John Wardell is Director of the U.S. EPA Region 8 Montana Office. He served on active
duty and reserves in the U.S. Army and he was Chief of the U.S. EPA Region 8 Superfund
Program. He holds a Ph.D. in Plant Pathology from Michigan State University and an MBA
from Colorado State University.
Panelists
Dr. Peter L. DeFur is an independent consultant and part time faculty member at Virginia
Commonwealth University in Richmond, VA. Most of his work is for government agencies and
citizen organizations regarding environmental cleanups and regulatory programs and activities.
Dr. DeFur's expertise includes ecological and human health risk assessment, endocrine
disrupting chemicals, coastal eutrophication and public participation. He worked for
Environmental Defense for six years and served on the National Research Council (NRC) Board
on Environmental Studies and Toxicology, as well as on a number of NRC study committees.
Dr. DeFur has served on the planning committees for a number of SETAC workshops on
ecological risk topics.
Dr. David L Fischer is currently the Head of Bayer CropScience's Ecotoxicology Section in the
U.S. Dr. Fischer holds a B.S. degree in Zoology from the University of Massachusetts, a M.S.
degree in Zoology from Western Illinois University, and a Ph.D. in Zoology from Brigham
Young University. He has been working in the field of ecotoxicology and risk assessment since
1986 and has supervised the conduct of hundreds of laboratory and field studies of pesticides and
J-3
-------
animal pharmaceuticals, authored dozens of chemical risk assessments, and published more than
20 peer-reviewed scientific papers. Dr. Fischer's expertise is in the area of wildlife toxicology
and risk assessment.
Dr. Michael Fry is an avian toxicologist whose research interests over the past 28 years have
focused on the effects of pollutants and pesticides on ecological systems, with a focus on wild
birds. Before joining American Bird Conservancy, Dr. Fry was Senior Environmental
Toxicologist at Stratus Consulting, a firm specializing in environmental consulting in the public
interest. Prior to 2003, he was a research physiologist in the Department of Avian/Animal
Sciences at the University of California, Davis, for 25 years. Dr. Fry has been a panel member
for the National Academy of Sciences on hormone active chemicals in the environment, and has
participated in toxicology reviews and international symposia for the Organization for Economic
Cooperation and Development (OECD), and for the United Nations University in Japan. He has
been a committee member for EPA and OECD in revising avian toxicity test methods, and was a
member of the EPA Ecological Committee for FIFRA Risk Assessment Methods (ECOFRAM)
(1997-1999), and an EPA Science Advisory Panel (SAP) member for EPA terrestrial risk
assessment in 2004. Dr Fry was a member and Chairman of the Department of Interior, Minerals
Management Service Advisory Board Scientific Committee, from 1989-1966. Dr. Fry reviewed
lead exposure sources and lead toxicity issues of California Condors for the CA Department of
Fish and Game, publishing a comprehensive report in 2003. Dr. Fry received his Ph.D. in
physiology from the University of California, Davis, in 1971, and has had held postdoctoral
research and teaching positions in Australia and at the Cardiovascular Research Institute at
University of California, San Francisco.
Dr. Bruce K. Hope is with the Oregon Department of Environmental Quality (DEQ), where he
currently serves as the senior environmental toxicologist for the Air Quality Division.
Previously, he worked with the Water Quality Division to develop aquatic food web
biomagnification and mass balance models for the Willamette River Mercury Total maximum
Daily Load (TMDL) and in the Land Quality Division, reviewing human health and ecological
risk assessments for specific cleanup sites, developing risk assessment guidance (human health,
ecological, probabilistic) to support implementation of Oregon's cleanup law, and leading the
State's efforts to implement probabilistic human health and population-level ecological risk
assessments. In 2000-01, he was on leave from DEQ as an American Association for the
Advancement of Science (AAAS) risk policy fellow at the U.S. Department of Agriculture in
Washington DC. Prior to joining DEQ in 1995, he was a private sector consultant managing
human health and ecological risk assessment projects for commercial and government clients at
CERCLA, RCRA, and BRAC sites throughout the U.S. and Pacific Rim. Dr. Hope has been an
adjunct faculty member at Oregon Health & Science University (in both the Oregon Graduate
Institute and the School of Nursing), Concordia University (Portland), and Portland State
University. He holds M.S. and Ph.D. degrees in biology (aquatic toxicology) from the
University of Southern California and a B.A. degree from the University of California (Santa
Barbara).
Mr. Max Feken is an environmental toxicologist for the Florida Department of Agriculture
where he performs ecological risk assessments for pesticides registered in Florida. He is also the
Coordinator for the Department's Endangered Species Protection Program.
J-4
-------
Dr. Eugenia McNaughton is currently Chief of the Quality Assurance (QA) Office in U.S. EPA
Region 9. Dr. McNaughton has worked for EPA for 11 years. She started in the QA Office,
moved to the Water Division to work on the U.S.-Mexico Border Team, and came back to QA
this past year. She received her Ph.D. in Biology from the University of California, Santa Cruz
and worked in the private sector on aquatic toxicology projects. Her interest in selenium impacts
on the environment began at that time. She has represented EPA for the past ten years on a multi-
agency team working to reduce selenium load discharge into the San Joaquin River associated
with tile water coming from agricultural fields.
Ms. Vickie Meredith is a graduate of the University of Wyoming and a Wyoming Registered
Professional Geologist. She has worked for the Wyoming Department of Environmental Quality
(WDEQ) for 16 years and has been the project manager on several RCRA Subtitle C and
voluntary cleanup sites in Wyoming - most notably, the former BP Amoco refinery site in
Casper, Wyoming. The former BP Casper site covers over 3000 acres of land and the site
assessments included three different ecological risk assessments which helped her make risk
management and cleanup decisions for several types of land uses and habitats. Ms. Meredith has
worked on and chaired several WDEQ workgroups and been instrumental in the development of
guidance for the state's Voluntary Remediation Program including; human health and ecological
risk assessment, monitored natural attenuation, remedy selection, establishing points of
compliance and technical impracticability determinations. In addition to overseeing two former
refinery cleanups, Vickie is currently developing a Targeted Brownfield Assessment program
and an orphan site cleanup program for the WDEQ.
Dr. Jennifer Shaw is currently head of Syngenta's Stewardship function where she leads
initiatives on environmental stewardship, sustainable agriculture and environmental issues
management. She has a BS degree in Agricultural Science and a Ph.D. in Ecology and
Epidemiology from the Universities of Glasgow and Aberdeen in Scotland. In the past 17 years
with the Crop Protection industry Dr. Shaw has managed large scale environmental field studies,
headed a facility that researched effects of pesticides on aquatic ecosystems, and led
development of ecological risk assessment to inform decision making. For the past decade she
has been involved in data generation and risk assessments for threatened and endangered species.
Since 1990, Dr. Shaw has served in leadership positions in various industry task forces, trade
association committees and expert workgroups including serving as an invited expert on U.S.
EPA's Ecological Committee on FIFRA Risk Assessment Methods (ECOFRAM) and as an
Ecological Risk Editor for the "Environmental Toxicology and Chemistry" journal.
Dr. Mark Sprenger is an environmental scientist with the U. S. Environmental Protection
Agency's - Office of Superfund Remediation and Technology Innovation - Environmental
Response Team. He received a B.S. in Biology from the State University of New York at Stony
Brook, and a M.S. and Ph.D. in Environmental Science from Rutgers, the State University of
New Jersey. His doctorate research and post-doctorate work focused on alteration in metals
availability resulting from acid deposition as well as post-doctorate work on the impacts of DDT
on a salt marsh. He is a coauthor of the national Superfund ecological risk assessment guidance
and has been active in the development of ecological risk assessments both in terms of new
technical applications and national consistency. His current responsibilities are nationwide and
J-5
-------
international in scope, with a focus on ecological risk assessments, contaminant fate and
transport, site environmental monitoring; and most recently on the assessment of innovative
remedial technologies and ecological restoration in the context of Site remediation.
Dr. Ralph Stahl joined the DuPont Company in 1984 and in the intervening years has held both
technical and management positions in the research and internal consulting arenas. His research
over the last 23 years has focused primarily on evaluating the effects of chemical stressors on
aquatic and terrestrial ecosystems. Since 1993 Dr. Stahl has been responsible for leading
DuPont's corporate efforts in ecological risk assessment and natural resource damage
assessments for site remediation. Dr. Stahl received his B.S. in Marine Biology from Texas
A&M University (cum laude) in 1976, his M.S. in Biology from Texas A&M University in
1980, and his Ph.D. in Environmental Science and Toxicology from the University of Texas
School of Public Health in 1982. After receiving his Ph.D., he was a Senior Postdoctoral Fellow
in the Department of Pathology at the University of Washington in Seattle where he investigated
the impact of genetic toxins on biological systems. Dr. Stahl is a member of the US EPA's
Science Advisory Board (Advisory Council on Clean Air Compliance Analysis, Ecological
Effects Subcommittee) and is active in the Society of Environmental Toxicology and Chemistry
(SETAC), serving on the Ecological Risk Assessment Advisory Group. He is board certified in
General Toxicology and is a Diplomate of the American Board of Toxicology. He has authored
over 30 peer reviewed publications on topics in environmental toxicology, ecological risk
assessment, and risk management. He recently edited two books and is currently co-editing a
third book stemming from a SETAC Education Foundation-sponsored workshop on the
valuation of ecological resources.
Dr. Leslie Touart is currently a senior ecotoxicologist with EPA's Office of Science
Coordination and Policy in the Office of Prevention, Pesticides and Toxic Substances. Primary
duties involve the development and validation of ecotoxicity assays for the Endocrine Disrupter
Screening Program. Dr. Touart earned a Ph.D. from George Mason University in Environmental
Biology and Public Policy. He served briefly with EPA's Office of Research and Development,
Gulf Breeze laboratory conducting estuarine organism toxicity tests early in his career. He spent
20 years with the U.S. EPA Office of Pesticide Programs performing ecological risk
assessments. He interacts with the OECD in the development of internationally harmonized test
guidelines and risk assessment practices.
Dr. Terry Young is an independent consultant, and has managed projects for Environmental
Defense for more than twenty years. Her recent work includes the design of a system that uses
economic incentives, including input pricing and tradable discharge permits, to control farm
pollution in California's San Joaquin Valley. Additional work includes the development of
ecological indicators to track management and restoration of ecological systems such as the San
Francisco estuary. She has published on topics of economic incentives for environmental
protection, indicators of ecological integrity, and market solutions for water pollution Dr.
Young received her bachelor's degree in chemistry at Yale University and her Ph.D. in
Agricultural and Environmental Chemistry from the University of California at Berkeley.
J-6
-------
APPENDIX K - REGISTERED WORKSHOP PARTICIPANTS
Richelle Allen-King1
University of Buffalo
Buffalo, NY
Thomas Armitage
Science Advisory Board Staff Office
U.S. Environmental Protection Agency
Washington, DC
Joseph Arvai
Michigan State University
East Lansing, MI
Lawrence Barnthouse
LWB Environmental Services
Hamilton, OH
John J. Bascietto
U.S. Department of Energy
Washington, DC
Steven Bay
Southern California Coastal Water
Research Project
Westminister, CA
Matthew Behum
Integral Consulting
Annapolis, MD
Nancy Bettinger
Massachusetts Department of
Environmental Protection
Boston, MA
Gregory Biddinger2
Exxon Mobil Biomedical Sciences
Houston, TX
1 Member of the EPA Science Advisory Board
Ecological Processes and Effects Committee
2 Member of the Chartered EPA Science
Advisory Board
Pieter Booth
Exponent
Bellevue, WA
William Bowerman
Clemson University
Clemson, SC
Steven Bradbury
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC
Kristin E. Brugger
DuPont Crop Protection
Boothwyn, PA
Allen Burton1
Wright StateUniversity
Dayton, OH
John Carbone
Rohm and Haas Company
Spring House, PA
Patricia Casano
GE Corporate Environmental Programs
Washington, DC
Grant Cope
Office of Senator Barbara Boxer
Washington, DC
Mark Corbin
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC
David Charters
Office of Solid Waste and Emergency
Response
U.S. Environmental Protection Agency
Edison, NJ
K-l
-------
William Creal
Michigan Department of Environmental
Quality
Lansing, MI
Virginia Dale1'2
Oak Ridge National Laboratory
Oak Ridge, TN
Gregory DeCowsky
Delaware Department of Natural
Resources and Environmental Control
(DNREC/DAWM/SIRB)
New Castle, DE
Peter DeFur
Environmental Stewardship Concepts
Richmond, VA
Kenneth Dickson2
University of North Texas
Denton, TX
Clifford Duke,
Ecological Society of America
Washington, DC
Anne Fairbrother
Office of Research and Development
U.S. Environmental Protection Agency
Corvallis, OH
James Fairchild
U.S. Geological Survey
Columbia, MO
Max Feken
Florida Department of Agriculture and
Consumer Services
Tallahassee, FL
David Fischer
Bayer Corporation
Stilwell, KS
Reinhard Fischer
Bayer CropScience
Research Triangle Park, NC
Thomas Forbes
U.S. Environmental Protection Agency
Washington, DC
Barry Forsythe
U.S. Fish and Wildlife Service
Dallas, TX
Robert Frederick
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC
Jeffrey Frithsen
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC
D. Michael Fry
American Bird Conservancy
The Plains, VA
Jeffrey Giddings
Compliance Services International,
Rochester, MA
Carolyn Hammer
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC
Laura Haynes
Office of Air and Radiation
U.S. Environmental Protection Agency
Research Triangle Park, NC
1 Member of the EPA Science Advisory Board
Ecological Processes and Effects Committee
2 Member of the Chartered EPA Science
Advisory Board
K-2
-------
Paul Hendley
Syngenta Crop Protection Incorporated
Greensboro, NC
Miranda Henning
ENVIRON International Corporation
Portland, ME
Tala Henry
Office of Water
U.S. Environmental Protection Agency
Washington, DC
Diane Henshel
Indiana University
Bloomington, IN
Dale Hoff
Region 8
U.S. Environmental Protection Agency
Denver, CO
Bruce Hope
Oregon Department of Environmental
Quality
Portland, OR
Michael Hooper
Texas Tech University
Lubbock, TX
Mike Johns
Windward Environmental
Seattle, WA
Ron Josephson
Science Advisory Board Staff Office
U.S. Environmental Protection Agency
Washington, DC
Chester Joy
U.S. Government Accountability Office
Washington D.C.
Lawrence Kapustka
Golder Associates
Calgary, CANADA
Denise Keehner
Office of Water
U.S. Environmental Protection Agency
Washington, DC
Iain Kelly
Bayer CropScience
Durham, NC
Trevor Knoblich
Risk Policy Report
Washington, DC
Thomas La Point
University of North Texas
Denton, TX
Wayne Landis1
Western Washington University
Bellingham, WA
Danny Lee
U.S. Forest Service
Asheville, NC
Deborah Lester
King County Natural Resources
Seattle, WA
Gregory Leyes
ISK Biosciences Corporation
Concord, OH
Josh Lipton
Stratus Consulting Incorporated
Boulder, CO
Anthony Maciorowski
U.S. Environmental Protection Agency
Washington, DC
1 Member of the EPA Science Advisory Board
Ecological Processes and Effects Committee
K-3
-------
Jeff Margolin
ENVIRON International Corporation
Atlanta, GA
Gregory Masson
U.S. Fish and Wildlife Service
Washington, DC
Lawrence Master1
Nature Serve
Boston, MA
Bernalyn D. McGaughey
Compliance Services International
Lakewood, WA
Eugenia McNaughton
Region 9
U.S. Environmental Protection Agency
San Francisco, CA
Charles Menzie
Menzie-Cura & Associates, Incorporated
Winchester, MA
Vickie Meredith
Wyoming Department of
Environmental Quality
Cheyenne, WY
Joseph Meyer
University of Wyoming
Laramie, WY
Judith Meyer1'2
University of Georgia
Athens, GA
Dwayne R. J. Moore
Cantox Environmental
Ottawa, CANADA
1 Member of the EPA Science Advisory Board
Ecological Processes and Effects Committee
2 Member of the Chartered EPA Science
Advisory Board
Thomas Mueller1
University of Tennessee
Knoxville, TN
Michael Newman1
Virginia Institute of Marine Science
College of William and Mary
Gloucester Point VA
Susan B. Norton
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC
Angela Nugent
Science Advisory Board Staff Office
U.S. Environmental Protection Agency
Washington, DC
Edward Odenkirchen
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC
Edward Ohanian
Office of Water
U.S. Environmental Protection Agency
Washington, DC
James Oris1
Miami University
Oxford, OH
Mary Ann Ottinger
University of Maryland
College Park, MD
Joan Pioli
Menzie-Cura & Associates, Inc.
Winchester, MA
Charles Pittinger
BB & L Sciences
Cincinnati, OH
K-4
-------
Nicholas Poletika
Dow AgroSciences
Indianapolis, IN
Damian Preziosi
Integral Consulting
Berlin, MD
Donna Randall
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC
Anne Rea
Office of Air and Radiation
U.S. Environmental Protection Agency
Research Triangle Park, NC
Kevin Reinert
AMEC Earth &Environmental
Plymouth Meeting, PA
Amanda Rodewald1
Ohio State University
Columbus, OH
Donald Rodier
Office of Pollution Prevention and
Toxics
U.S. Environmental Protection Agency
Washington, DC
Andy Rowe
GHK International
Camden, SC
Lisa Saban
Windward Environmental
Seattle, WA
James Sanders1
Skidaway Institute of Oceanography
Savannah, GA
1 Member of the EPA Science Advisory Board
Ecological Processes and Effects Committee
Stephanie Sanzone
George Mason University
Alexandria, VA
Keith Sappington
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC
John S chaffer
Tetra Tech EC, Incorporated
Morris Plains, NJ
Rita Schoeny
Office of Water
U.S. Environmental Protection Agency
Washington, DC
Jennifer Shaw
Syngenta Crop Protection
Greensboro, NC
Michael Slimak
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC
Sean Smith
U.S. Navy
Washington, DC
Mark Sprenger
Office of Solid Waste and Emergency
Response
U.S. Environmental Protection Agency
Edison, NJ
Dee Ann Staats
Crop Life America
Washington, DC
Holly Stallworth
Science Advisory Board Staff Office
U.S. Environmental Protection Agency
Washington, DC
K-5
-------
Ralph Stahl
DuPont Corporation
Wilmington, DE
Andrea Robin Stewart
U.S. Geological Survey
Menlo Park, CA
Erik Stokstad
American Association for the
Advancement of Science
Washington, DC
Ingrid Sunzenauer
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC
Glenn Suter
Office of Research and Development
U.S. Environmental Protection Agency
Cincinnati, OH
Timothy Thompson1
Science Engineering and the
Environment
Seattle, WA
Kristen Thornton
Delaware Department of Natural
Resources and Environmental Control
DNREC/DAWM/SIRB
New Castle, DE
Leslie Touart
Office of Prevention Pesticides and
Toxic Substances
U.S. Environmental Protection Agency
Washington, DC
1 Member of the EPA Science Advisory Board
Ecological Processes and Effects Committee
2 Member of the Chartered EPA Science
Advisory Board
Vivian Turner
Science Advisory Board Staff Office
U.S. Environmental Protection Agency
Washington, DC
Ivor van Heerden1
Louisiana State University
Baton Rouge, LA
Vanessa Vu
Science Advisory Board Staff Office
U.S. Environmental Protection Agency
Washington, DC
Kristen Wandland
ENSR
Raleigh, NC
John Wardell
Montana Office, Region 8
U.S. Environmental Protection Agency
Helena, MT
Randall Wentsel
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC
Steve Wharton
U.S. Environmental Protection Agency
Region 8
Denver, CO
Kathleen White
Science Advisory Board Staff Office
U.S. Environmental Protection Agency
Washington, DC
Terry Young2
Environmental Defense
Oakland, CA
Rick Ziegler
Office of Research and Development
U.S. Environmental Protection Agency
Washington, D.C.
K-6
-------
APPENDIX L - SUMMARY OF PRODUCT HEALTH AND SAFETY
DECISION MAKING BREAKOUT GROUP PARTICIPANTS,
PANEL DISCUSSION, AND REPORT
Facilitator: Gregory Biddinger, Exxon Biomedical Sciences
Rapporteurs: Wayne Landis, Western Washington University and Charles Pittinger,
BB&L Sciences
Panelists: Peter Defur, Environmental Stewardship
Max Feken, Florida Department of Agriculture
David Fischer, Bayer Crop Science
Leslie Touart, U.S. EPA
Participants: Thomas Armitage, U.S. EPA
Lawrence Barnthouse, LWB Environmental Services
William Bowerman, Clemson
Kristin Brugger, Dupont
MarkCorbin, U.S. EPA
John Carbone, Rohm and Haas
James Fairchild, USGS
Reinhard Fischer, Bayer Crop Science
Jeffrey Frithsen, U.S. EPA
Jeffrey Giddings, Compliance Services International
Paul Hendley, Syngenta Crop Protection
Diane Henshel, Indiana University
Michael Hooper, Texas Tech University
Wayne Landis, Western Washington University
Gregory Leyes, ISK Biosciences
Josh Lipton, Stratus Consulting
Gregory Masson, U. S. FWS
Charles Menzie, Menzie-Cura & Associates
Dwayne Moore, Cantox
Thomas Mueller, University of Tennessee
Susan Norton, U.S. EPA
Edward Odenkirchen, U.S. EPA
Nicholas Poletika, Dow AgroSciences
Donna Randall
Donald Rodier, U.S. EPA
Dee Ann Staats, Croplife America
Holly Stall worth, U.S. EPA
Ingrid Sunzenauer, U.S. EPA
Kristen Thornton, DNREC
L-l
-------
Panel Discussion - Ecological Risk Assessment for Product Health and
Safety Decision Making - Facilitator: Dr. Gregory Biddinger, Exxon Biomedical
Sciences; Rapporteur: Dr. Charles Pittinger, BB& L Sciences; Invited Panelists: Dr.
Peter DeFur, Environmental Stewardship; Mr. Max Feken, Florida Department of
Agriculture; Dr. David Fischer, Bayer Crop Science; Dr. Leslie Touart, U.S. EPA Office
of Pollution Prevention and Toxic Substances (See Panel biosketches in Appendix J)
Dr. Biddinger introduced the members of the panel who presented different
perspectives on needs to advance the practice of ecological risk assessment for product
health and decision making.
Dr. Defur 's Presentation
Dr. Defur discussed issues of concern in the conduct of ecological risk assessments
supporting product health and safety decision making.
• The practice of ecological risk assessment is currently focused on protecting
populations. Therefore, the condition of individual plants or animals is often ignored.
Ecological risk assessment measures are designed to provide information that can be
used to determine whether a population is persisting over time in space (e.g., will a
fish population exist in a particular water body in ten years?). The morbidity offish
is often ignored in a risk assessment and although fish can be terminally ill, their
reproduction is the only measure considered. This risk assessment approach is
unacceptable because it ignores health. A stable population of sick animals or plants
is not an adequate outcome. Ecological risk assessors should consider more than just
gross population levels and measures of biomass. Condition is an extremely
important measure.
• Ecological risk assessors focus on populations and seldom assess communities or
mixed assemblages of plants and animals. This is not because measures for assessing
communities are unavailable. Rather, it is because that knowledge has not been
translated into ecological risk assessment.
• Ecological risk assessment does not currently address cumulative risk (i.e., the
addition of a single stressor upon an already stressed condition). An example of this
is failure to consider cumulative risk in assessment of a forest that has experienced
acid rain for 10 years when another stressor is introduced. These issues have
relevance to product health and safety assessments. Although ecological risk
assessment does not presently consider biological stress (e.g., imposition of an exotic
species), product health and safety assessments increasingly should address genetic or
biological components of products.
• Time and space issues are particularly challenging in making decisions about many
products (e.g., pesticides, plastics, perflourooctanoic acid [PFOA]), yet ecological
risk assessments often do not consider long time scales or multiple levels of
organization. Assessing the risks of lead and mercury on adequate temporal and
L-2
-------
spatial scales would lead to questions concerning the use of these substances in any
product. National Institutes of Health (NIH) has questioned any use of mercury in a
product because either its manufacturing or disposal will result in further releases into
the environment. Gasoline additives, pesticides, PFOA, polybrominated
dibenzodioxin (PBDD), nickel and cadmium are all introduced into the environment
in ways that have not been considered.
It is important that ecological risk assessors think about the kinds of problems that might
not be readily predicted or foreseen. With this consideration, the use of lead in products
could have been recognized as dangerous from the outset.
Mr. Feken 's Presentation
Mr. Feken discussed ecological risk assessment practices supporting decisions
concerning pesticide use in Florida. He stated that to protect Florida's unique
environment, risk assessments should address such issues as double cropping in
agriculture, production of unique crops, environmental conditions such as annual rainfall
of more than 60 inches in Tallahassee, and unique natural communities. To conduct risk
assessments, meteorological data are used to run models that provide predictions for
periods of 30 years.
A worst-case spatial scale is used. The scale varies depending upon the crop of
concern. Different crops are grown throughout Florida; citrus is grown in the central
region of the state and different vegetable crops and field crops produced in other parts of
the state. Several areas are modeled for each crop in order to refine assessments beyond
a worst case scenario. However, there are a number of significant weaknesses in
ecological risk assessment practices.
• It is not possible to model the effect of reducing runoff into nearby surface water
bodies. It is not possible to model the effects of buffers on runoff. It is assumed that
water bodies at risk are adjacent to fields where pesticides are applied, but ecological
risk assessors need to understand how pesticide exposure in water bodies can be
modeled in order to expand the spatial scale of risk assessments. Models are needed
for canal systems and estuarine systems.
• The State of Florida needs additional EPA guidance on models that can be used for
terrestrial ecological risk assessment. Currently, organism-level effects on
vertebrates are evaluated by looking at risk quotients for individual mortality.
Species sensitivity distributions have been used to conduct ecological risk
assessments and the State is considering use of the slope of the LC50 for assessments
of risk to endangered species. However, there is a need for models to conduct
population level effects assessments. Mesocosms and microcosms are currently used
to demonstrate magnitude of effects and potential for recovery of populations.
Prospective risk assessments are conducted and data gaps are filled using information
from simulated runoff studies. Developing testable hypotheses is important for these
L-3
-------
kinds of risk assessments. In conducting these risk assessments, uncertainty is quantified
to the maximum possible extent so that decision making can be as transparent as possible.
Dr. Fischer's Presentation
Dr. Fischer also discussed ecological risk assessment practices to support pesticide use
decisions. He identified a number of opportunities to improve risk assessment practices.
• If ecological risk assessments are to be believable, they should be of high quality and
should focus on the things that can be assessed well. It is impossible to assess
everything.
• There is value in applying standardized scenarios of known spatial and temporal
scale. Greater level of detail in ecological risk scenarios is associated with less
certainty.
• There is value in focusing on individuals, not populations, under the assumption that
if individuals can be protected, populations can also be protected.
• Problem formulation is the most important part of a risk assessment. Risk assessors
often mistakenly start with measurements and determine endpoints. Endpoints should
be selected keeping goals for the landscape in mind.
• Some subjective assumptions are important in the face of uncertainty (e.g., how
different is a risk quotient of 3 from a risk quotient of 0.3 ?)
Dr. Touart 's Presentation
Dr. Touart discussed how ecological risk assessment is conducted under the
requirements of different statutes that address product health and safety. There are many
different statutory authorities that require ecological risk assessment (e.g., Federal
Insecticide, Fungicide and Rodenticide Act [FIFRA], Toxic Substances Control Act
[TSCA], and Clean Water Act [CWA]). Ecological risk assessments conducted under
each of these statutes will be quite different depending upon legal constraints and who is
asking questions. Ecological risk assessment is an iterative process and the information
available for an assessment depends upon the statutory authority. Under FIFRA, industry
should demonstrate that products will not cause harm. Under TSCA, the burden of proof
is upon EPA to prove potential harm. Sometimes states should conduct risk assessments.
There are a number of limitations to the current practice of ecological risk assessment and
opportunities for improvement.
• Data requirements for pesticides and industrial compounds are based on hazard
quotients, so the kinds of studies conducted are limited to a few species.
• New probabilistic approaches are being developed and will advance the practice of
ecological risk assessment.
L-4
-------
• New tools are being developed to assess endocrine disrupters, but demands for
validation of new methodologies will slow the process of developing risk assessment
tools.
• Risk assessment is an iterative process, and assessments are refined until actionable
information is developed. New data should, however, feed back into old ecological
risk assessments.
• Conservatism is built into risk assessments because assessors are striving to deal with
the worst cases.
Discussion of Points Raised by Panelists
After presentations by the panel members, workshop participants raised the following
issues concerning the limitations of ecological risk assessment supporting product health
and safety decisions, and opportunities for improving the practice.
• It is important to note that many tools are currently available to conduct accurate
screening level risk assessments for product health and safety in a short period of
time. There are many sources of information available for conducting these rapid
assessments. European Union databases can provide ecotoxicology information.
EPA's EPI Suite tool can provide physical and biological parameters to enable a
determination of whether a chemical is biodegradable, toxic or bioaccumulative.
• It is important for ecological risk assessors to consider the question of why risk
assessments should be conducted and what should be protected. As currently
described in EPA guidance, the process of problem formulation does not focus on this
important question.
• In considering the appropriate spatial and temporal scales of ecological risk
assessments, it is important to consider differences between predictive risk
assessments of new chemical releases, and assessments of chemicals that have
already been in the environment for long periods of time. If effects are not observed
in the latter case, an assessor should determine whether this is because effects did not
occur, could not be found, or whether compensation had occurred.
• Tiered risk assessment approaches can help risk assessors to foresee the ecological
risks of substances like lead, but there is a need to develop additional tools for
evaluating cumulative risks. Contaminants are being released into environments that
are already stressed, and regulations do not address cumulative stress. Cumulative
risk tools are not available.
• A challenging question that should be answered in considering cumulative risk is,
"what are the conditions of watersheds right now?" This information is needed to
frame the problem and consider the issue of cumulative risk in pesticide re-
L-5
-------
registrations or expanded use registrations. Field data are generated over the lifespan
of a chemical, and these data should be considered.
• Ecological risk assessments for product health and safety decisions are conducted to
allow permitting, and there is pressure to allow permitting. However, it is important
to consider society's goals and consider baseline conditions in ecological risk
assessments.
• In terrestrial systems, accelerated changes are frequently being driven by product
registration requirements of the Food Quality Protection Act. Improved ecosystem
and community-level measures are needed to assess these changes in the field. Old
products were associated with intense short term impacts on ecological systems.
Newer products are associated with less severe impacts that occur over longer periods
of time, and pesticide registration decisions have been made on the basis of human
health protection. Data obtained from land that is under integrated pest management
can be useful for developing measures of ecosystem and community structure.
• There is a tremendous amount of data in the ecology literature that could be tapped to
improve assessments of ecosystems and communities (e.g., production functions).
There are "tens of thousands" of models that could be generalized and adapted to
other contexts.
• Ecological risk assessments should also consider the effects of invasive species,
exotic species, genetically modified organisms, and water transfer.
• It is important to find ways to closely tie risk assessment science to product health
and safety decisions made by organizations. Pesticide re-registration decisions
should be ecosystem-level decisions.
Ecological Risk Assessment for Product Health and Safety Decision
Making Breakout Group Summary Report
Definition of Spatial and Temporal Scale in Risk Assessments for Product Health and
Safety Decision Making
• Defining and incorporating the appropriate spatial and temporal scales in ecological
risk assessments for product health and safety is a major challenge. The broadest
scale of product use is often considered in risk assessments.
• In defining spatial scale, it is important to consider biological processes (ecological
and phylogenetic considerations) as well as management processes. The scale of
management processes may necessarily be the largest.
• Spatial and temporal scales should be explicitly considered in the problem
formulation stage of ecological risk assessments. Appropriate scales will vary with
the context of the risk assessments and the decisions to be made. Broadening the risk
L-6
-------
assessment context (i.e. evaluating landscape scale effects) demands broader
consideration of receptors and other stressors (e.g., cumulative risk).
• A shift is needed in EPA's approach to the application of ecological risk assessment
to move from program driven decisions toward managing and assessing risk at a
place-based or landscape level. Regulations "perform" within a local context (i.e.,
protection risks and politics are local).
Definition and Incorporation of Biological Scale into Ecological Risk Assessments for
Product Health and Safety Decision Making
• EPA needs to incorporate a broader approach to consideration of biological scale,
beyond population levels, into ecological risk assessment.
• Data on phylogenetic responses to stressors (comparative toxicity) should be
expanded and applied in ecological risk assessments.
• New biomarker and mechanistic data should be incorporated into ecological risk
assessments. Additional research should be completed to determine whether such
data can be used to indicate exposure or risk.
Problem Formulation and Incorporation of Testable Hypothesis into the Design of
Ecological Risk Assessments for Product Health and Safety Decision Making
• Problem formulation should be an iterative process
• The problem formulation stage of ecological risk assessment may be limited by the
lack of approaches for considering the life cycle of a product. For example, the first
question considered in problem formulation is the decision to be made. Questions
addressed in the decision to register a pesticide are different from "end-of-life"
questions concerning the product.
• Life cycle analysis is not addressed in regulations, and additional guidance is needed
in this area. An example is the regulation of nanotechnology. In the past, product life
cycles were not considered, but the Agency should now look ahead and correct past
mistakes.
• Life cycle issues should be considered with care. "Front-end" issues should be
carefully evaluated in product decisions. Life cycle considerations are "future
oriented." Folding life cycle considerations into ecological risk assessment could be
useful for evaluating future technologies.
• There currently appears to be good guidance available on how to conduct problem
formulation. Often, however, generic problem formulation is conducted and
assessment endpoints do not account for long-term dynamics of populations. This
problem is more a technical issue of what can be measured than a problem of
L-7
-------
ecological risk assessment design. For example, assessment endpoints for pesticides
are very generic, concerned with aquatic and terrestrial animals and plants.
Population density and other technical questions are ignored. Better definitions of
assessment endpoints are needed.
• Scale is often not properly considered in problem formulation and ecological risk
assessment. Assessors are not conducting multi-generational analyses to determine
whether population failures have occurred. There are no legal requirements to
conduct this kind of follow-up analysis. There is currently very little ground truthing
of risk assessments. EPA's pesticide program is, however, working with the
Agency's Environmental Monitoring and Assessment (EMAP) program to establish
baselines to determine whether regulatory decisions are making an impact on the
environment.
• Participants expressed the opinion that problem formulation for product health and
safety risk assessments should be focused on dealing with specific issues of decisions
such as:
- The effectiveness of EPA's decisions to regulate pesticide use.
- Individual pesticide registration and re-registration decisions and constraints
that should be placed on products to maintain safety.
- Manufacturing permits for chemicals or processes.
- Determinations regarding the safety of genetically modified organisms.
- Industry decisions to bring a new product or formulation to the market.
- National Pollution Discharge Elimination System (NPDES) permit decisions
to regulate thermal pollution and other non chemical stressors.
- Regulation of compounds falling under multiple agency jurisdictions (e.g.,
military production).
- Assessing the ecological risks and uncertainties of exotic new technologies for
which there may not be existing regulation (e.g., nanotechnology, regulating
polyhalogenated organics).
- Determination of whether non-indigenous species should be introduced into a
region. It is not clear whether there is sufficient guidance on how to conduct
problem formulation for this kind of risk assessment. For example, is problem
formulation guidance robust enough to conduct problem formulation for
assessing the risks of introducing the Asian oyster into Chesapeake Bay?
How should uncertainty be handled?
L-8
-------
- Determination of how regional considerations should be factored into the use
and application of products (e.g., the use of commodity chemicals like boron
in various ecoregions with different soils and characteristics).
- Decisions accounting for the spatial distribution of product-use patterns (e.g.,
decisions concerning the use of pesticides on 100,000,000 acres are different
from decisions concerning the use of product on 100,000 acres).
- Determining differences between the ecological risks of formulated product
mixtures and constituent ingredients.
- Decisions concerning disposal of products (e.g., should current disposal
techniques for pharmaceuticals be modified to avoid harm to the environment
from wastewater release.
• The following problem formulation issues associated with product health and safety
decisions were identified.
- Pesticide registrants conduct problem formulation to identify assessment
endpoints, measurement endpoints, and a range of conceptual models. A
tiered approach to risk assessment is used. However, the tiered approach may
not capture all effects. Passing a screening level does not mean that there are
no adverse effects associated with the proposed use of a product.
- Levels of concern and risk quotients are used to drive problem formulation in
product health and safety risk assessments, but they may not represent realistic
protection goals. Measurement endpoints should be more closely tied to
appropriate assessment endpoints.
- The problem formulation stage of product health and safety risk assessment
should address all routes of exposure and tiered assessments. However in
some cases problem formulations are generic and therefore all routes of
exposure (e.g., dermal exposure) or receptors are not considered. There is a
need to consider release pathways, fate and transport, and sensitivity to target
the risk assessment and tie measurement endpoints to the appropriate
assessment endpoints.
- Currently, problem formulation in product health and safety risk assessments
is often not oriented toward decision making (e.g., it may not be realistic to
ask whether there is a risk, it may be more appropriate to question the
magnitude of the risk). Available tools and data can drive the direction of
problem formulation (e.g., if dermal exposure models are not available, skin is
not considered as a route of exposure).
- Ground truthing, follow up to risk assessments, and validation should be part
of problem formulation. Frequently, problem formulation does not adequately
L-9
-------
address the complexity of a system in terms of time and space. The need for
monitoring should be addressed in the problem formulation stage of a risk
assessment. Levels of concern should be re-evaluated and validated with
monitoring studies. These concerns should be addressed in EPA's guidance
documents.
• The following issues concerning the use of testable hypotheses in ecological risk
assessments were identified.
- Because testable hypotheses may represent "yes/no" answers, they may not
always be useful in risk assessments. Problem formulation should be
designed to provide an evaluation or quantitative description of magnitude of
risk along a continuum. Hypotheses are embedded in a conceptual model, but
the objective of an ecological risk assessment is to describe the likelihood,
probability, magnitude, and consequences of effects. Therefore, well
formulated risk questions (e.g., what is the probability and magnitude of the
effect of pesticide y on endpoint x?) may be more useful than testable
hypotheses.
- Testable hypotheses can be framed in such terms as statistically significant
effects and quantile endpoints. Such hypotheses may be useful because they
may not represent yes/no answers. However, if desired outcomes are clear to
decision-makers yes/no answers can support management decisions.
- Testable hypotheses may be useful if applied to appropriate tiers of
evaluation. In this regard, questions such as "does exposure exceed a
concentration at time x in a river?" or "does a model provide adequate
protection against releases to the environment?" may be useful. However,
hypotheses should not be confused with regulatory decision criteria.
• In risk assessments for product health and safety decision making, a generic approach
to problem formulation is often followed. Problem formulation is often dictated by
regulatory constructs, especially for screening level risk assessments that are
conducted in the same way for many chemicals. In early tiers of risk assessments,
problem formulation may be defined more by precedent and policy, but problem
formulation becomes more refined in subsequent tiers. Stakeholders can offer criteria
and levels of concern that enable such refinements. A dialogue with risk managers is
a key step in completing an improved problem formulation process. Additional tools
such as software packages could be developed to assist in problem formulation. Risk
assessments conducted for pesticide registration decisions require careful problem
formulation.
• A concern discussed by the group is that risk assessments currently do not provide a
complete understanding of risks posed by cumulative effects, interactions among
communities, and multiple stressors and impacts. To develop this knowledge,
monitoring efforts should be better coordinated within multiple agencies of the
L-10
-------
federal government to support ecological risk assessments. Coordination is needed to
integrate monitoring programs and use resources for multiple purposes.
• Data collection activities can be improved and focused on providing the most
important information by evaluating the current level of confidence in decisions.
Sensitivity analyses can be conducted to parse out sources of uncertainty and
determine what additional information is useful.
• Laws that drive various product health and safety programs articulate protection goals
differently. Therefore explicit cross-cutting ecological protection goals have not been
defined. There is a need to develop consistent definitions of what should be protected
across media.
Health and Product Safety Decision Making in the Face of Uncertainty
• Ecological risk assessments often fail to identify and prioritize additional information
that would be needed to reduce the uncertainty of the assessment. The risk
assessment process could be improved by explicitly identifying uncertainties, the
consequences of those uncertainties, and the additional information that would reduce
those uncertainties. "What if questions could be posed for each uncertainty. A
specific example discussed was the need to develop tools to provide additional
information for conducting improved ecological exposure assessments.
• Although various statutes require consideration of risks and benefits, ecological risk
can be relegated to a "nonfactor" in decision making if there is great uncertainty in
identifying risks. Uncertainties should be clearly identified to risk managers so that
they can evaluate the need for conservative or risk tolerant decisions.
• Decisions in the face of uncertainty will be made using extrapolation factors, and
therefore conservative management decisions may be needed.
• Tools that can be developed and applied to help focus problem formulation, reduce
uncertainty, and refine risk assessments. These include tools for evaluating
geospatial data, and probabilistic risk assessment methods.
• Stakeholders should also provide input on "value" issues. Risk management
decisions should reflect stakeholder values.
• It would be useful to develop a case study to show how uncertainty could be reduced
by assessing cumulative risk for an emerging technology or a new product. This case
study could focus on building a conceptual model, constructing a screening approach,
and completing a risk assessment. Potential case examples discussed included
pressures from invasive species and chemical exposures. It would be difficult to
develop such a case example on a national scale, so a regional scale might be
considered. The Heinz Center report on the State of the Nation might provide
L-ll
-------
knowledge that would be useful in considering responses of ecosystems to multiple
stressors.
• Additional tools are needed to develop more efficient screens for assessing ecological
risk. Additional sources of data and models should be considered, evaluated, and
adapted. It will be important to leverage the efforts underway in a number of different
federal agencies and academia to seek multiple values from data and tools
L-12
-------
APPENDIX M - SUMMARY OF MANAGEMENT OF
CONTAMINATED SITES BREAKOUT GROUP PARTICIPANTS,
PANEL DISCUSSION, AND REPORT
Facilitator: Michael Newman, College of William and Mary
Rapporteurs:
Panelists:
Participants:
Richelle Allen-King, University of Buffalo and Timothy Thompson,
Science, Engineering and the Environment
Vicki Meredith, Wyoming DEQ
Michael Fry, American Bird Conservancy
Mark Sprenger, U.S. EPA
Ralph Stahl, Dupont
John Bascietto, DOE
Matthew Behum, Integral Consulting
Nancy Bettinger, MA DEP
G. Allen Burton, Wright State University
Patricia Casano, General Electric
William Creal, Michigan DEQ
Gregory DeCowsky, DNREC
Anne Fairbrother, U.S. EPA
Thomas Forbes, U.S. EPA
Barry Forsythe, U.S. FWS
Carolyn Hammer, U.S. EPA
Laura Haynes, U.S. EPA
Miranda Henning, ENVIRON Corp.
DaleHoff, U.S. EPA
Michael Johns, Windward Environmental
Ron Josephson, U.S. EPA
Thomas La Point, University of North Texas
Jeff Margolin, Environ
Joseph Meyer, University of Wyoming
AnneRea, U.S. EPA
Kevin Reinert, AMEC Earth and Environmental
Keith Sappington, U.S. EPA
Lisa Saban, Windward Environmental
John Schaffer, Tetra Tech
Sean Smith, US Navy
Glenn Suter, U.S. EPA
Kristen Wandland, ENSR
John Wardell, U.S EPA
Randall Wentsel, U.S. EPA
Kathleen White, U.S. EPA
M-l
-------
Panel Discussion - Ecological Risk Assessment in Management of
Contaminated Sites - Facilitator: Dr. Michael Newman, Virginia Institute of Marine
Science, College of William and Mary; Rapporteur: Mr. Timothy Thompson, Science
Engineering and the Environment; Invited Panelists: Ms. Vickie Meredith, Wyoming
Department of Environmental Quality; Dr. Michael Fry, American Bird Conservancy;
Dr. MarkSprenger, U.S. EPA, Office of SuperfundRemediation and Technology
Innovation; Dr. Ralph Stahl, DuPont Corp. (See Panel biosketches in Appendix J)
Dr. Newman opened the discussion by providing context for the panel discussion and
the breakout group session. He described four cross-cutting issues for the discussion of
ecological risk assessment for remedial decision making at contaminated sites:
1. Evaluating the effects of spatial and temporal scales
2. Assessing risks at different biological scales
3. Problem formulation and testable hypotheses in risk management
4. Decision making in the presence of uncertainty
The panelists provided initial perspectives on these issues from the points of view of a
state decision maker (Vickie Meredith), the environmental and conservation community
(Dr. Michael Fry), an EPA ecological risk assessment practitioner (Dr. Mark Sprenger),
and the regulated industries (Dr. Ralph Stahl).
Ms. Meredith's Presentation
Ms. Meredith is a geologist and contaminated site manager with the Wyoming
Department of Environmental Quality (WDEQ). She noted that her experience as a
geologist and a risk manager makes understanding all of the elements of the overall
ecological risk assessment process a challenge. From a state decision maker's
perspective, Ms. Meredith noted that the ecological risk assessment process is one of
several decision-making tools to (1) diagnose the problem; (2) provide input on how to
remedy the problem; and (3) evaluate whether the remedy itself is going to cause other
problems.
Ms. Meredith discussed the application of the ecological risk assessment as part of a
cleanup determination at a former refinery site in Casper, Wyoming. The refinery was
originally a Resource Conservation and Recovery Act (RCRA) site. As part of a
settlement of a citizen's lawsuit in 1998, the responsible party (BP/Amoco) was required
to conduct corrective action at the site, and oversight of the program was transferred from
the U.S. EPA to the Wyoming Department of Environmental Quality (WDEQ). The site
was a unique challenge because the community of Casper wanted to redevelop the
property, but a decision on cleanup levels and actions to protect both ecological and
human health risk had to be made within three years.
In order to meet this deadline, a collaborative process was established to bring
together all of the stakeholders to develop the assessment and study, and formulate the
M-2
-------
remedial decision. While ultimate decision making rested with the WDEQ, the
stakeholders included the BP/Amoco, EPA, the U.S. Fish and Wildlife Service, Wyoming
Game and Fish, Wyoming Department of Transportation, and the community (city,
county, and citizens groups). Use of the ecological risk assessment paradigm was helpful
because it provided an established process to support decision making. Problem
formulation and articulation of data quality objectives (DQOs) were done in collaboration
among all of the stakeholders, and all decisions were made as transparent and open as
possible.
Risks and remedies for the 3000-acre site included upland receptor risks and risks to
benthic infauna, fish and birds from historic contamination and groundwater discharge to
the North Platte River. The assessment also evaluated risks to fish, birds, and piscivorous
mammals from refinery wastewater and residuals that were pumped into a playa lake in
the central bird flyway. The risks and remedy decisions needed to be made rapidly and
safely. Problem formulation was done very early, followed by the development of DQOs
as initial investigations were conducted at the site. There were no presumptive remedies
going into the process. While ecological receptors at the playa lake and river were
judged to have "moderate risk" using a weight-of-evidence approach, remedies that
removed the sources were chosen in collaboration with BP/Amoco.
From the lessons learned at this site, WDEQ developed its Voluntary Cleanup
Program (VCP) guidance documents (http://deq.state.wy.us/volremedi/index.asp). The
overall VCP risk assessment process is similar to EPA's. Wyoming incorporated initial
screening steps that allow for "off-ramping" the process for smaller sites. For example,
the ecological exclusion assessment allows exclusion of a site from assessment by
answering simple questions, such as, "is there habitat?", and, "are there threatened or
endangered species?" Wyoming's perspective is that an ecological risk assessment
would not be needed for such uses as a parking lot.
Discussion of Points Raised by Ms. Meredith
Group discussion following Ms. Meredith's presentation focused on what constitutes
weight-of-evidence. Workshop participants noted that:
• The ecological risk assessment process lacks a common understanding of what
weight-of-evidence means, and that more clarity would be helpful. It was stated that
there were at least four different definitions, but as yet there is no common consensus
on what weight-of-evidence means.
• The National Research Council1 recently advocated the use of weight-of-evidence,
without providing context for what that means. A general recommendation suggested
by members of the panel and group was that the EPA SAB further investigate the
issue of what constitutes weight-of-evidence.
1 National Research Council. 1996. Understanding risk. Informing decisions in a democratic society.
National Academy Press, Washington, D.C.
M-3
-------
Dr. Fry's Presentation
Dr. Fry stated that from the perspective of the environmental and conservation
community, the ecological risk assessment process is too long and at times is encumbered
with extensive and unnecessary investigations that do little to aid the exposed ecological
resources. After the ecological risk assessments are complete, there may be long and
costly litigation that delays cleanups even further. During these delays, little is done to
aid the ecological resources that are subject to continued exposure over the entire period
of time. A streamlined risk assessment process (e.g., a "programmatic" ecological risk
assessment) that would lead to more rapid cleanups would greatly benefit natural
resources.
Dr. Fry noted that the four focus questions posed to the group for consideration
emphasized the problem formulation stage of risk assessment instead of clean-up and
reducing the immediate risks to ecological receptors. From the perspective of the
environmental community, when a contaminated site is identified or listed EPA has
already made an assessment that the release of a hazardous substance has occurred and
the environment is at risk. With regard to risk assessment for management of
contaminated sites he noted that:
• Focusing on the effects of spatial scale is not relevant in determining whether or not
the site is contaminated.
• Furthermore, focusing on larger populations effects can mask the fact that smaller
highly contaminated sites are causing mortality in individuals. The main emphasis in
ecological risk assessments for contaminated site management should be on how to
clean up the site as opposed to determining whether a site should be cleaned up.
• Dr. Fry asserted that the first question to be answered is how to remove or control the
greatest risks in a timely fashion. The next step is to assess whether there is
additional environmental contamination that should be addressed. Dr. Fry discussed
two contrasting cases where this important question was addressed differently.
• The Exxon Valdez oil spill was a case of a large environmental release that, while
large, was a relatively simple site from the perspective of problem formulation and
cleanup. The problems and risks were identified quickly, cleanup was conducted, and
a long-term monitoring program was put in place to determine if the system was
recovering or additional actions were required.
• By contrast, DDT releases into the southern California Bight involved 20 years of
investigation and an additional 10 years of litigation, during which ecological
resources continued to be exposed to DDT.
Dr. Fry commented on the use of probabilistic risk assessment for management of
contaminated sites and the influence of politics on risk management decisions.
M-4
-------
• He acknowledged that a modeling assessment may be useful in making judgments
about the relative importance and uncertainty of the risks, but probabilistic
assessments are not a substitute for field data. Field data are needed to make remedial
decisions.
• Dr. Fry also expressed the view that the environmental community often perceives
that good science is circumvented by political decisions. EPA's proposal to publish a
tissue-based selenium criterion instead of the well developed water quality criterion
was, in his view, a good example of this. This appeared to be a political decision
based upon relaxing the selenium water quality standard rather than basing the
decision on good science. He stated that when the politics of cleanup undermines
science, it corrupts the system.
Discussion of Points Raised by Dr. Fry
After Dr. Fry's presentation the group discussed the following points.
The group discussed Dr. Fry's observation that ecological risk assessments and
associated investigations have not been focused on whether to clean up, but how much to
clean up. Workshop participants noted that investigations of the nature and extent of
contamination and evaluations of potential risk reduction associated with resources
expended are required elements under contaminated sites statutes. Dr. Fry agreed, but
stated that the paradigm could be shifted to focus first on clear and obvious hot spots or
source removal and then use a long term monitoring program to determine what else
should be done. A workshop participant expressed the opinion that it is important to keep
the science in the ecological risk assessment separate from the political process.
One participant offered the observation that for some contaminated sites, it may not be
necessary to factor ecological risk assessments into cleanup decisions. As an example he
cited the Tannery Bay site in White Lake (near Lake Michigan), where the sediment
clean up criteria were based on the extent of observed color (purple) and the presence of
hides and hair. Even though there were high levels of chromium and mercury found in
the sediments (up to 5,000 ppm), there were no adverse effects observed in toxicity
testing of the sediments. In this case, the site was remediated mainly because the lake
was used as a "landfill", not because of ecological risks.
Dr. Sprenger 's Presentation
Dr. Sprenger is an ecotoxicologist with U.S. EPA's Office of Solid Waste and
Emergency Response (OSWER) and one of the authors of EPA's 1997 ecological risk
assessment guidance for Superfund. Dr. Sprenger stated that his experience is principally
with Superfund contaminated sites. Under the Comprehensive Environmental Response
Compensation, and Liability Act (CERCLA) and the associated National Contingency
Plan (NCP), ecological risk assessments are inherently part of a legal process, bounded
by the laws of that process, and are therefore constrained by the legal process and social
M-5
-------
pressures associated with these sites. Dr. Sprenger described some of the legal/regulatory
requirements and constraints for ecological risk assessment under CERCLA.
• As defined by regulations under CERCLA, the role of the ecological risk assessment
is that it (1) establishes a legal authority for an action, and (2) develops the
information that can be used to set the preliminary remediation goals.
• CERCLA constrains the ecological risk assessment process in that it may only
consider chemical releases, the ecological risks should be evaluated within the
confines of the site, and the protective remedies should address the standard set in the
law.
• Many Superfund sites are relatively small, 2 to 10 acres, and by legislative
requirement a remedy should be protective of human health and the environment
within the site boundaries. By law, the site investigation (including the ecological
risk assessment and the remedy) should focus on the site, or the investigation is not a
legal expenditure of resources under the law. This can preclude looking at larger
spatial, temporal, or even population-level effects that would occur outside the site.
• There is sufficient flexibility written into the ecological risk assessment guidance
documents to consider the issues of scale, time, and populations. However,
application of scales in contaminated site risk assessments is constrained by:
1. Legal requirements under CERCLA;
2. Timing and funding issues associated with conducting the site
investigation; and
3. Uncertainty by site managers as to how the additional information
will assist them in making site management decisions.
Dr. Sprenger described a paradoxical situation arising in the case of point source
releases to a stream. At the local site level, a community level response could be readily
demonstrated. However, relative to a population level view of the entire stream, there
may not be an impact even though a point impact might be observed. Under CERCLA, a
remedy should protect resources at the point release (i.e., "the site"). While the Agency
is open to assessing risks at different scales, practical considerations make this difficult.
There is a need to explore how the Agency could implement spatial, temporal, and
biological scales within the confines of the law.
Dr. Sprenger commented on problem formulation in ecological risk assessments for
CERCLA and decision making in the presence of uncertainty. He observed that:
• Formulation of specific problems incorporating testable hypotheses has not been
effectively conducted across all CERCLA site evaluations. There is a need to explore
how to bring more specificity into the problem formulation and risk question setting,
as this process has not been changed for many years.
M-6
-------
• Decision making in the presence of uncertainty is constrained by the legislative
program regulating the site. Where there is uncertainty, Agency decision-makers
should select the conservative protective remedy.
• Additional data can reduce the uncertainty associated with decision making, but there
is a financial tradeoff between study cost and remediation cost that needs to be
considered.
• There are sites where a remedy will always be the same in terms of scale and cost,
and additional study won't change the risk management decision. For example, in the
case of industrial lagoons a lot of money can be spent on investigations and risk
assessments, but the need for remediation is known and the options and scale of the
remediation are known. Sometimes this is misconstrued as selecting the remedy
beforehand and then constructing an ecological risk assessment to fit the
preconceived notion.
• Under CERCLA, ecological risk assessments are conducted to provide information
for site-specific remedies. There are opportunities at some sites to conduct good
studies that can influence remedy costs in a positive way. The Clark Fork River in
Montana is an example that illustrates how the study and the ecological risk
assessment helped point out opportunities to protect human health and the
environment while not having to undertake the costly removal of all contaminated
soils and sediments.
• The risk assessment community could benefit by having additional examples or case
studies that highlight how the conduct and findings of the ecological risk assessment
did or did not impact the final remedy decision.
Discussion of Points Raised by Dr. Sprenger
The group discussed the following points in response to Dr. Sprenger's observations
on questions related to spatial, temporal scale and population level risk assessments.
• Some participants noted that incorporating spatial considerations into an ecological
risk assessment is a "slippery slope" in the sense that one should determine how far to
go down that path before the site assessment is meaningless.
• Incorporation of temporal scale can be equally "slippery." Temporal scale is
discussed even less than spatial scale. Implicit in remedial decision making for
contaminated sites is that sites should be returned to functionality as soon as possible.
However, it is also important to think of these decisions in terms of ecological
timelines.
• Dr. Sprenger noted that consideration of spatial and temporal scale can be feasibility
study questions that define bounds beyond which no further action or natural
M-7
-------
attenuation can be considered. However, he noted that if temporal and spatial
boundaries are large enough, toxic effects could be lost in the noise.
• A participant pointed out that the problem of assessing effects which are often severe
at a point of maximum exposure versus assessing effects for an entire stream, lake, or
forest (where the effect may be negligible) can be avoided by defining an assessment
population or assessment community using EPA's generic ecological assessment
endpoints1. This problem may be addressed by recognizing that the endpoint attribute
for a population or community may be defined at a lower level of organization2. For
example, if the assessment population is the clapper rails in a marsh treated with
pesticides or sunfish in a stream reach receiving waste leachate from a storm event,
then the attribute may be the proportion killed by a treatment or leaching event (an
organism-level attribute). It is not necessary to apply a population-level attribute
such as changes in the population growth rate.
• A participant pointed out that in ecological risk assessment additional investigations
can be balanced against reduction in remediation costs as well as reduced uncertainty
associated with the nature and extent of contamination and exposure.
Dr. Stahl 's Presentation
Dr. Stahl has been involved with ecological risk assessment for DuPont since 1993.
He noted that DuPont has conducted work at 188 sites in the U.S. and others overseas,
and that about 20 sites are under active consideration at any one time. He stated that risk-
based decisions are being made in Europe as well as Latin America and Asia. Dr. Stahl
expressed the opinion that ecological risk assessment of contaminated sites can be
improved, and he focused his comments on the workshop's cross-cutting issues.
• The problem of addressing spatial scale may be made more tractable by finding areas
with commonalities and parsing out some of the space issues. He noted that
historically there have been many ecological risk assessments conducted at small
sites, but large sites such as the Hudson, Housatonic, or Passaic Rivers are being or
will be assessed in the future and the issue of scale can be better examined. Mining
sites are also examples of large sites.
• Adding temporal scale to risk assessment is difficult because many sites have slow,
chronic releases of contaminants, but there are no available data on original
conditions to assess the ecological effects that may or may not have occurred. It is
difficult to predict what a site will look like after implementing a remedy, and
temporal scale issues may not receive attention because industry does not view
remediation as a long-term business opportunity. Companies are in the business of
U.S. EPA. 2003. Generic Ecological Assessment Endpoints (GEAEs) for Ecological Risk Assessment.
EPA/630/P-02/004B. Risk Assessment Forum, Washington, DC.
2 Suter, G.W. II., S.B. Norton, A. Fairbrother. 2005. Individuals versus Organisms versus Populations in
the Definition of Ecological Assessment Endpoints. Integrated Environ. Assess. &Manage. 1:397-400.
M-8
-------
removing liabilities from their corporate books. Generally, follow-up monitoring is
not done, possibly because risk managers may not want to find out they made the
wrong decisions.
• An approach to risk management decisions in the face of uncertainty might be to
provide a mechanism for making and implementing remedial decisions, and then
requiring long-term monitoring that could trigger additional work if the expected risk
reduction is not achieved.
• Regarding the assessment of risks at different biological scales, Dr. Stahl noted that it
is easier and cheaper to do small-scale individual studies, and then extrapolate those
to populations. While tools are available to conduct population-level studies, it is
important to understand whether the decision is so important that it is necessary spend
the money and time to conduct those kinds of investigations. The Department of the
Interior has started a Natural Resource Damage Assessment and Restoration Advisory
Committee under the Federal Advisory Committee Act to look at similar issues. One
of the objectives of this committee is to determine if there is a way of constraining
investigations and get to an answer in a reasonable amount of time, and these findings
will likely relate to risk assessments.
• The problem formulation stage of risk assessment seems to be receiving greater
attention than it has in the past and is involving EPA and stakeholders earlier in the
process. A difficult part of problem formulation is getting the risk managers to spend
the time to talk through all of the issues. It is important that the risk assessment team
talk through data collection and actions to be taken based on the results. It is
important to identify testable hypotheses, but they need not necessarily be
statistically-testable. Rather, they are a set of conditions that the parties believe may
be occurring and are tested accordingly.
• For decision making in the face of uncertainty, there are really three options:
More study to reduce uncertainty;
Make a decision and move on; or
Make a decision with monitoring and triggers for further action if needed.
Dr. Stahl identified two big issues that require additional attention to improve
ecological risk assessments: 1) assessment of multiple stressors, and 2) watershed level
assessments.
Discussion of Points Raised by Panelists
Workshop participants discussed a number of points following the panel presentations.
• A participant asked whether looking specifically at the ecological conditions at a site
would result in more conflict with local authorities. Ms. Meredith responded that for
her site she brought all the stakeholders together early to articulate their needs, but in
the end the WDEQ made the final decision. Dr. Sprenger pointed out that at the
M-9
-------
Coeur d'Alene Superfund site the remedy was well received in Idaho where there was
support for the mining industry, it was not well received downstream by constituents
in Spokane, Washington. In this case, a watershed approach to the risk assessment
was needed because there were multiple constituencies.
• A commenter observed that the ecological risk assessment guidelines discuss "the
likelihood of adverse effects," but this can mean different things. Most risk
assessments just look at harm and are not predictive. There is not consensus on what
is "harm." Dr. Sprenger stated that this is why problem formulation needs more
attention. Superfund risk assessments might apply environmental epidemiology or
toxicology studies but not probabilistic risk assessment. Dr. Sprenger stated that in
fact, most Superfund ecological risk assessments are more "lexicological risk
assessments" or "hazard assessments" - not necessarily a true "risk assessment."
• A state site manager stated that he wants to know what risks need to be mitigated and
the level of certainty associated with those risks. He stated that assessors and
managers need to sit down together early and, without compromising the integrity of
the science, make sure the assessors understand the kind of information the manager
will need. Furthermore, there is a need to understand not only the cost of the remedy
and the resultant reduction in risk but also to understand the impact to the
environment of implementing the remedy. This analysis is generally not done in the
ecological risk assessments but could be part of problem formulation.
Ecological Risk Assessment in Management of Contaminated Sites
Group Summary Report
Definition of Spatial and Temporal Scale in Ecological Risk Assessments for
Management of Contaminated Sites
• During the problem formulation stage of an ecological risk assessment, it is important
to consider spatial and temporal scale and representative data collection issues.
Spatial scale is important in evaluating exposure routes at contaminated sites. Spatial
components have a major influence on large sites, and sampling plans should match
the scales of sites. Temporal scale should be considered when determining time
frames for remediation of contaminated sites.
• The appropriate temporal scale of a risk assessment will depend on the chemical
contaminants, media, and episodic events to be considered. Other issues to be
considered in determining temporal scale include specific ecological receptors,
possible reoccurrence of contamination, and recovery time of the system. It is
important to reach agreement with stakeholders on scale issues during the problem
formulation stage of the risk assessment.
• It is also very important to understand the hydrology at a contaminated site in order to
address issues of connectivity and deposition, and determine the appropriate spatial
scale of the risk assessment.
M-10
-------
• It will be important for EPA to provide information to states on "lessons learned"
about the effect of spatial and temporal scale issues on the quality of analyses. It is
very difficult to pull this kind of information from existing state and EPA databases.
• During the problem formulation stage of the risk assessment, it is important to match
the scale of exposure sampling with the effects questions being answered (i.e., the
receptors). It is not possible to complete an accurate risk characterization unless
exposure is linked to effects.
• In the problem formulation stage of the risk assessment, it is important to consider
whether neighboring sites within a watershed should be included in the assessment. It
is current practice to sometimes assess risk at contaminated sites without considering
the cumulative risks within a watershed.
• At small sites, a "streamlined" risk assessment process is often used. This approach
can result in insufficient problem formulation and affect the quality of analyses.
During problem formulation, it is particularly important to link the data quality
objectives process to the risk assessment so that representative data can be collected.
The group discussed how spatial and temporal scales can affect the utility of analyses.
The following issues were discussed and recommendations for improvements in the
process were identified.
• The utility of analyses conducted in ecological risk assessments are dependent on the
linkage of spatial and temporal scale with biological organization. It is essential to
match the scale of a risk assessment with the questions that should be answered.
• The scale of a study conducted to assess ecological risks at a contaminated site should
match the scale of the remediation alternatives considered. Remedial alternatives
such as bulldozing and dredging are associated with differing levels of precision and
a risk assessment of one size may not provide appropriate information to support
these activities.
• An iterative ecological risk assessment process should be applied at contaminated
sites where long-term problems should be addressed. This procedure would enable
adaptive approaches to be applied to risk management.
• Peer review should be conducted after the problem formulation stage of a
contaminated site risk assessment and then repeated at points throughout the process.
• The technical sophistication of a contaminated site ecological risk assessment is not
always justified by the utility of the information provided. More resource
requirements and higher costs for the risk assessment do not always equate to higher
quality and utility. It is important to ensure that representative data are collected.
M-ll
-------
• It is important to ensure that sampling plans for ecological risk assessments at
contaminated sites match the scale of the site to be assessed.
• Ecological risk assessments could be enhanced by making the process more iterative
and conducting peer review after problem formulation and throughout the process.
• Risk assessors should take advantage of recent advances in technology and tools for
the analysis and interpretation of data. Application of such tools can enhance
ecological risk assessments. These tools include: geographic information system
mapping technologies, remote sensing technologies, spatial statistics, population and
exposure modeling, and improved access to large databases.
• Risk assessors should focus more attention on data quality relative to
representativeness of the data.
• Ecological risk assessments conducted at sites where the chronic sublethal effects are
of concern could be enhanced by applying population and community models. Such
models are not often used and additional guidance is needed for application of these
kinds of models.
• There is a need for a national database containing information on ecological risk
assessments that have been conducted for management of contaminated sites and
other purposes. Case examples could be included in such a database to provide useful
information on the strengths and weaknesses of various risk assessment approaches.
Central data exchanges are improving. For example, five year EPA Superfund
program reviews provide useful abstracts of risk assessment study results.
• Additional basic life history information, such as home ranges and organism
distribution, is needed for many species to improve assessment of exposure to
contaminants and ecological risk. There is often a mismatch between available
ecological and toxicity information for species at contaminated sites.
• Long-term ecological research is needed for some large scale contaminated sites.
Post remediation monitoring is needed to improve our understanding of how risk
assessments can be enhanced. Criteria should be set for assessing the outcome and
success of contaminated site remediation. Exploratory long-term ecological research
can also be conducted at these sites, and adaptive management approaches can be
demonstrated.
• Ecological risk assessment for management of contaminated sites should be
approached from a watershed perspective, not from only the perspective of operable
units.
Definition and Incorporation of Biological Scale into Ecological Risk Assessments for
Management of Contaminated Sites
M-12
-------
• It is important to initially define what resources are to be protected (answer the "so
what?" question) and identify the appropriate assessment endpoints. The main
concern of ecological risk assessors should be effects on populations. However, risk
assessments are currently often focused on the protection of individuals and therefore
may not be of high quality.
• Species distributions of LCSOs do not relate to protection of communities and
therefore may or may not be protective. There is a high level of uncertainty in the
level of protection associated with the use of species sensitivity distributions.
• Ecological risk assessments are not often focused on assessing indirect effects such as
those associated with habitat loss or competition. Toxicity studies may not reflect the
state of populations in the field.
• Attributes of populations may be incorrectly applied in ecological risk assessments.
For example, concepts such as the protection of functional feeding classes should be
considered. There is a need to communicate why higher level entities such as feeding
classes should be important as receptors and endpoints in a risk assessment.
• It is important to link the nature of contaminants to the appropriate receptors and
develop an understanding of why particular organisms should be studied.
• The question of remediation versus restoration of contaminated sites drives study
designs for ecological risk assessments at contaminated sites. The consequences of
making a mistake also drive the design of the study (e.g., consideration of the effects
of persistent organic pollutants versus consideration of the effects of nutrients).
• In some but not all cases, protecting individuals may protect populations. Focusing
risk assessments on individuals will therefore result in some level of uncertainty in
the assessment of effects on populations. The level of certainty associated with
ecological risk assessments can be increased by using multiple lines of evidence of
biological responses. However, all lines of evidence are not equal in quality, and
rules are needed to define how multiple lines of evidence should be evaluated.
• Evaluating a small number of species a site will lead to uncertainties that can hamper
decision making. The power of various lines of evidence should be assessed during
problem formulation to determine which line of evidence is useful for decision
making.
• The ecological risk assessment process could be enhanced by using population
models. More models could be used early in the risk assessment process and "pre-
surveys" could be used to look at the power of various kinds of analyses. Sensitivity
analyses would be useful in this regard. EPA should consider recommending or
identifying appropriate models for various uses and developing a menu of optimal
tools for use in certain risk assessment scenarios.
M-13
-------
• "Informed consent" during problem formulation is important. Risk assessors should
determine how and when the assessments, and data generated, will be used.
• Data and metrics on rates are needed to make predictions concerning appropriate
levels of biological organization.
• Life history information could be augmented for many species of concern. There is
great need for additional life history information for vertebrates. Information for
more species should be included in EPA's exposure factors handbook. Additional
research is needed to provide more life history information for common or important
species and to link tissue residues and toxicity test results to biological levels of
organization (e.g., to link tissue residues to community effects).
• The quality of ecological risk assessments should be improved so that decisions are
legally defensible.
• Benefit/cost assessments are needed. Ecologists and economists do not communicate
well because typical monetization methods cannot be used for ecological systems.
However, it is important to assess the benefits associated with risk management
alternatives. More information is needed for valuation of resources and assessment of
ecological services and this information should be provided on multiple scales and
from the perspective of multiple stakeholders.
Overarching Recommendations Concerning Spatial and Temporal Scale for Ecological
Risk Assessment at Contaminated Sites
• Methods exist to conduct ecological risk assessment at different scales, but more
relevant data and explicit guidance are needed to do this. It is particularly important
to have more guidance on how to evaluate lines-of-evidence.
• In the problem formulation stage of the risk assessment, it is essential to get clear
"buy in" from stakeholders on the scales to be considered. It is also important that
stakeholders understand that large spatial scales and long temporal scales require
modeling. Outside peer review and stakeholder input is necessary during problem
formulation. Use of an iterative process and adaptive management will also promote
stakeholder buy in to the process. In addition, is important to emphasize the
importance of problem formulation in driving the risk assessment.
• Models should be applied in the problem formulation stage of the risk assessment.
During problem formulation, applicable population, community, and landscape
models should be selected for use. These models should be used to identify
uncertainties and conduct sensitivity analyses.
• A very clear statement of the consequences of remediation should be developed (i.e.,
risk versus remedy versus time scale). Development of such a statement is essential
for risk assessments conducted at large scales.
M-14
-------
• It is important to consolidate lessons learned from previous risk assessments to guide
future risk assessment activities.
• There is a great need for short- to long-term post remediation monitoring activities in
order to conduct improved outcome assessment (e.g., long-term ecological research
model). These activities should be part of original planning for a baseline
comparison.
• Effective communication with stakeholders and relevant professionals is absolutely
essential in conducting risk assessments at critical scales, especially broad scales.
• Tangible action from EPA to address guidance and research needs is essential in
order to realize the full potential of considering spatial and temporal scale issues in
ecological risk assessments.
Problem Formulation
• A number of preliminary issues were discussed by the group including:
- The need for clarification during the problem formulation of the natural
resource goals and cleanup management decision that would be made under
CERCLA, RCRA, and state programs. For example, if managers will be
making a decision based on human health concerns, should the problem
formulation reflect this early on?
- What role could, or should, net benefit analysis have in problem formulation?
Net benefit analysis (NBA) compares incremental positive effects as a result
of removing or mitigating a contaminant or pathway, with incremental
negative effects that can occur such as disturbing habitat for threatened and
endangered species. The need for, and tools to conduct NBA should be
considered during the problem formulation.
- What role should cost benefit analyses (CBA) have and what are the tools
available to do that? Participants noted that conducting cost-benefit analyses
would require more work than is usually completed for an ecological risk
assessment. Participants questioned whether cost-benefit issues should be
separated from other science-based questions.
• An "up front" analysis of questions that are critical to decision making can be useful
in deciding what to measure in a risk assessment. For example, if decision makers
knew that their decision might be based on effects on a particular species, they might
not want to invest heavily in certain measures. In this regard, there is tension
between a managers' need for a timely, economical, implementable solution to a
contaminated site problem and the scientists' desire to reach the best possible answer
through research.
M-15
-------
• A participant expressed concern that limited studies do not provide a basis for a
comprehensive cost-benefit analysis for contaminated site remediation. In this
regard, it is important to consider not just the population protected, but how
protection affects interactions with other species. Because risk assessments always
focus on a subset of organisms, assessors do not gather data needed to assess all of
the benefits of remediation.
• Other participants noted that assessors might work with stakeholders to prioritize
risks during problem formulation and decide which are the most important. Concern
was expressed that it might be difficult to do this early in the process and that an
iterative problem formulation approach might be useful.
• EPA's Guidelines for Ecological Risk Assessment should be more widely and
consistently used in problem formulation. A reviewer checklist associated with the
Guidelines should be developed. The goal of the checklist is to ensure that various
important points (e.g., adequacy of problem formulation, consideration of possible
management strategies in problem formulation, connections between assessment and
measurement endpoints, and consideration of data quality objectives) are adequately
addressed at all sites. The implementation of such a checklist would improve the
clarity and consistency of the process for all involved. The checklist could be
evaluated by all parties at the end of problem formulation, or could be the basis for a
peer review.
• A recommendation is that a peer review be conducted at the end of the problem
formulation stage to ensure that the science applied in the risk assessments is
appropriate to the management goals. Currently, scientific review of risk assessments
does not occur until after the data have already been collected and analyses
completed. Independent review at the end of the problem formulation stage of a risk
assessment would insure that assessment endpoints could be linked to goals, and that
the science applied would provide the data needed to answer the risk management
questions. An additional peer review, at the completion of the draft risk assessment,
will continue to be useful.
• The group discussed the stage of the process when peer review occurs, and the extent
to which modifying the timing of peer review could improve the process. For high
priority (i.e., high risk, high cost) sites, problem formulation and study design should
be submitted for peer review by an independent scientific panel prior to
implementation of the study. Such peer review early in the process will strengthen
ecological risk assessments. Peer review would be beneficial at sites where there is
conflict about the study design as well as at sites where there are no conflicts. The
identification of sites where early peer review would be triggered could be based on a
recommendation or predetermined criterion or based on a post remediation audit
evaluation of prior risk assessments. The composition of a panel convened for
problem formulation may be different from the composition of a panel formed for a
study design review.
M-16
-------
• Problem formulation could also be improved by identifying very specific endpoints
such as effects on populations. However it is important to link measurement
endpoints to assessment endpoints. A concern to be considered when quantifying
measurement endpoints in the problem formulation stage is the possibility of
prejudging an assessment. It is important to distinguish between the data quality
objectives process and a determined level of effect that would trigger management
action. These are problems associated with implementing EPA's Guidelines for
Ecological Risk Assessment rather than problems associated with the Guidelines
document itself.
Incorporation of Testable Hypothesis into the Design of Ecological Risk Assessments for
Management of Contaminated Sites
• Participants expressed the opinion that the term "testable hypothesis" does not belong
in the problem formulation step and actually confuses the issue or creates conflict.
Testable hypotheses with well defined error rates may not provide the information
needed to estimate risk. Estimation of risk is the purpose of the risk assessment.
• Regulated parties at contaminated sites frequently criticize contaminated site risk
assessments as being too vague; removing testable hypotheses from the assessment
could make this criticism sharper. However, estimation methods could be substituted
for hypothesis testing. For example, after formulating a risk management decision
that is based on an unacceptable (i.e., remediable) risk or toxic response for a specific
receptor group, an estimator in the form of an expected toxicity testing a dose
response curve should be developed. Participants noted that consideration of testable
hypotheses or estimation methods could be moved from the problem formulation into
the data collection step of an assessment.
• Participants suggested that it might not be necessary to require testable hypotheses.
However, if they are to be applied in risk assessments it will be necessary to provide
improved definition and guidance for their development. It is particularly important
to provide guidance concerning the statistical element of the testable hypothesis (e.g.,
Type I and II error).
• EPA's Framework for Ecological Risk Assessment is very useful and is "standing the
test of time." However there are differences in the practice of ecological risk
assessment from site to site, and additional help or guidance would be useful.
• There is a general lack of understanding of whether remediation of contaminated sites
has resulted in the ecological improvements upon which the requirement for action
was based. This is not a problem associated with the existing ecological risk
assessment framework but with follow-up monitoring and evaluation of remedial
actions. However, it is difficult to measure the success of remediation, and it has not
been sufficient to demonstrate that a limited number of contaminated site
remediations, permits, or other actions have been successful. Two recommendations
M-17
-------
from the discussion were that (1) to the degree practicable the Agency or SAB should
evaluate improvements brought about by site remediation, and that (2) long-term
monitoring should be explicitly considered during the problem formulation, and in the
remedy decision documents. The latter may require development of an appropriate
guidance document.
• It is important to involve risk managers in problem formulation at an early stage of
the risk assessment. A rigorous framework for addressing risk management decisions
at an early stage of the assessment, without compromising the process and precluding
important alternatives, would be useful. Greater attention should be focused on
ensuring that the selected measures of risk for which data will be collected are
appropriate in the context of their intended use in decision making. It may be
beneficial to use a conceptual site model for initial analyses needed to facilitate these
kinds of discussions.
Contaminated Site Decision Making in the Face of Uncertainty
• There are cases in which a probabilistic risk assessment can be useful in conveying
the uncertainty of an ecological risk assessment. However, in many cases a
probabilistic ecological risk assessment that incorporates the variety of uncertainties
associated with ecosystems may not help management decisions. Dealing with
ecological risks is unlike human health risk assessments in which a large amount of
data are available to assess effects on a single species. Therefore, it is important to
have clear exposition of the magnitude of the factors driving the uncertainty of the
ecological risk assessment, the sources of the parameters, and the assumptions used.
In some cases sensitivity analysis can be useful in this regard.
• Risk assessors should be aware that some uncertainties, such as those associated with
interspecies extrapolation, are not easily quantified. Moreover, explaining
probabilistic risk assessments to the public can be difficult, and these kinds of risk
assessments can be difficult to interpret. It is easier to communicate a deterministic
hazard quotient used in a risk assessment than a probabilistically derived hazard
quotient. If probabilistic risk assessments are conducted, risk assessors should ensure
that those who review and use the results know what the results mean and can
distinguish "good" results from "bad." Probabilistic risk assessments can also be
correct but may miss major issues.
• Probabilistic approaches are, however, useful in understanding the implications and
degree of protectiveness of various remediation options.
• A post remediation audit program could reduce decision-making uncertainties at new
contaminated sites. EPA, in conjunction with other agencies, should evaluate the
effects of clean-up on sites remediated 5-20 years ago. Such a retrospective analysis
will build a database that could be used to reduce uncertainty in decision making.
Net Environmental Benefit
M-18
-------
Net environmental benefit analysis is an important tool that could be used to a greater
extent in the practice of ecological risk assessment. Net environmental benefit
analysis can be used to evaluate the risks of a contaminated site remedies to the
ecosystem and answer questions such as "does cleanup cause more harm than good?"
Net environmental benefit analysis can also be used to compare the risks of various
remedy options to the ecosystem. Where appropriate and warranted, net
environmental benefit analysis could be incorporated into a risk identification
feasibility study. This concept has already been incorporated into EPA's Guidelines
for Ecological Risk Assessment; however EPA should develop a process and/or tools
for conducting net environmental benefit analysis at an appropriate spectrum of sites.
M-19
-------
APPENDIX N - SUMMARY OF NATURAL RESOURCE
PROTECTION BREAKOUT GROUP PARTICIPANTS, PANEL
DISCUSSION, AND REPORT
Facilitator Kenneth Dickson, University of North Texas
Rapporteurs Judith Meyer, University of Georgia and James Oris, Miami University
Panelists Bruce Hope, Oregon Dept. of Environmental Quality
Eugenia McNaughton, U.S. EPA
Jennifer Shaw, Syngenta
Terry Young, Environmental Defense
Participants: Steve Bay, SCCWRP
Pietr Booth, Exponent
Grant Cope, Congress
Clifford Duke, Ecological Society of America
Robert Frederick, U.S. EPA
Tala Henry, U.S. EPA
Chester Joy, U.S. Government Accountability Office
Lawrence Kapustka, Golder Associates
Iain Kelly, Bayer Crop Science
Danny Lee, U. S. Forest Service
Deborah Lester, King County Natural Resources
Lawrence Master, NatureServe
Bernalyn McGaughey, Compliance Services International
Angela Nugent, U.S. EPA
Marianne Ottinger, University of Maryland
Judith Meyer, University of Georgia
Joan Pioli, Menzie-Curie and Associates
Damian Preziosi, Integral Consulting
Amanda Rodewald, Ohio State University
Andy Rowe, GHK International
James Sanders, Skidaway Institute of Oceanography
Stephanie Sanzone, George Mason University
Rita Schoeny, U.S. EPA
Michael Slimak, U.S. EPA
Robin Stewart, USGS
Eric Stokstadt, AAAS
Vivian Turner, U.S. EPA
Ivor van Heerdon, Louisiana State University
Steven Wharton, U.S. EPA
Rick Ziegler, US EPA
N-l
-------
Panel Discussion - Ecological Risk Assessment in Natural Resources
Protection — Facilitator: Dr. Kenneth Dickson, University of North Texas;
Rapporteur: Dr. James Oris, Miami University; Invited Panelists: Dr. Bruce Hope,
Oregon Department of Environmental Quality; Dr. Eugenia McNaughton, U.S. EPA
Region IX; Dr. Jennifer Shaw, Syngenta Corporation; Dr. Terry Young, Environmental
Defense (See Panel biosketches in Appendix J).
Dr. Dickson introduced the panelists and stated that the purpose of the session was to
discuss how to advance the state of the practice of ecological risk assessment for natural
resource protection. He commented on how risk assessments for the purpose of natural
resources protection are different from other kinds of risk assessments. He noted that in
these kinds of risk assessments assessors should often be concerned about stressors other
than just chemicals. Such assessments should often be conducted at landscape scales. He
encouraged the panelists and participants to discuss issues, challenges, and make the
recommendations necessary to "take ecological risk assessments for natural resource
protection to a higher level." He also introduced four cross-cutting issues to be discussed
in the session: 1) Effects of spatial and temporal scales; 2) Biological organization; 3)
Problem formulation and testable hypotheses; and 4) Decision making in presence of
uncertainty.
Dr. Young's Presentation
Dr. Young introduced a document developed by the EPA Science Advisory Board
Ecological Processes and Effects Committee, A Framework for Assessing and Reporting
on Ecological Condition15 (SAB Framework Report). Dr. Young discussed the following
points:
• The SAB Framework Report was developed to provide advice and recommendations
to EPA on how to evaluate the ecological condition of systems.
• The SAB Framework Report establishes a hierarchical scheme to describe systems,
and provides endpoints and factors to consider during the problem formulation stage
of an ecological risk assessment.
• The SAB Framework Report is focused on attributes, not stressors. EPA is good at
focusing on stressors, but condition parameters can be used to evaluate multiple
stressors.
• Many attributes are associated with ecological condition. Therefore, a hierarchical
scheme and guiding principles are needed to look at patterns and processes. Dr.
15 U.S. EPA Science Advisory Board. 2002. A Framework for Assessing and Reporting on Ecological
Condition: An SAB Report. Edited by T. F. Young, and S. Sanzone, EPA-SAB-EPEC-02-009. U.S.
Environmental Protection Agency, Washington, D.C. (http://www.epa.gov/sab/pdf/epec02009.pdf)
N-2
-------
Young referred to Table EF-1 in the SAB Framework Report and described how
biotic condition could be described using the hierarchy to explicitly focus on the
species and population level while also looking at communities and ecosystems.
• In conducting ecological risk assessments it is important to ask the question, "are
there landscape effects?" Biological scales are embedded in the hierarchy in the SAB
Framework Report. Processes are also embedded in the hierarchy. Use of the
hierarchy also enables the consideration of time scales. Dr. Young suggested that the
group might talk further about how the might be useful for looking at ecological risk
assessment.
Dr. Shaw 's Presentation
Dr. Shaw commented on the issues proposed for discussion in the workshop breakout
session. She talked about the importance of the following issues and offered suggestions
for improvements to enhance the practice of ecological risk assessment for natural
resources protection.
• Effects of spatial and temporal scale. Consideration of scale is very important to
informed decision making. Species location and distribution will drive the spatial and
temporal scale of an assessment. Spatial and temporal scales need explicit definition
during the problem formulation stage to be most accurate and useful for decision
making. If risk assessors are explicit about this at the beginning of the process, they
can provide information to make management decisions more accurate and reduce the
potential economic impact of actions taken. Dr. Shaw identified the following
opportunities for improvements in consideration of spatial and temporal scale:
- The quality of risk assessments could be improved by having better
information to characterize stressors, species distribution, and land-use
characteristics.
- There is an opportunity to use more standardized methods and tools to form a
working basis for characterizing stressors.
- There is an opportunity to have more consistent development of higher quality
spatial data layers.
- There is an opportunity for improved efficiency through single reviews of
metadata with enhanced updating and managing of data layers.
- There is an opportunity for multiple stakeholders to provide different types of
data and data layers used in risk assessments. More information can also be
made available to stakeholders.
• Consideration of level of biological organization. It is important to be specific about
resources that need to be protected. EPA is implementing regulations, policy, and
N-3
-------
guidance at the programmatic levels that will affect assessment endpoints. To
improve the performance of the risk assessments, there is a need to ensure that risk
assessments can inform decisions that have to be made. Dr. Shaw stated that an
appropriate biological scale should be well defined for effective risk management
decisions. It is important to know how decisions will be made. It is important to
understand what the risk manager is protecting, and this should drive the biological
scale of the risk assessment.
• Problem formulation and adequacy of testable hypotheses. It is important to ensure
that risk assessments will provide the information needed to support risk management
decisions. Problem formulation needs to clearly identify protection goals. Policy
goals should also be established. Dr. Shaw identified the following opportunities for
improved efficiency and effectiveness in problem formulation and use of testable
hypotheses:
- It is important to recognize that improved problem formulation processes
effectively set up the work of risk assessment.
- Toolboxes of conceptual models are needed for use in problem formulation.
It is important that risk assessors have the ability to easily modify such models
for application to particular types of regulatory action.
- Increased consistency in development of testable hypotheses is needed.
Species-specific conceptual models are needed.
- The toolbox should contain a tool that could be used to develop an analysis
plan. This would eliminate redoing work that has already been completed by
others.
• Decision making in presence of uncertainty. The reality of risk management is that
decisions are made with some degree of uncertainty. To decide how much
uncertainty can be accepted, it is necessary to look at the quality and relevance of risk
assessment. It is necessary to consider how much additional work should be done to
reduce uncertainty and how much the assessment is improved by this work.
Additional information can provide an understanding of factors such as exposure
route and can significantly reduce uncertainty. Risk assessments can drive risk
management decisions that result in tradeoffs affecting natural resources. Such
tradeoffs should be carefully considered. For example, risk management decisions
may result in loss of pesticide products needed to manage invasive species. Risk
management decisions may result in loss of agricultural areas. It is necessary to put
risk management decisions into a bigger context and consider the practicality of
implementation. Dr. Shaw identified the following opportunities for improved risk
assessment to enhance decision making in the face of uncertainty:
N-4
-------
- It is important to spend time looking at the practicality of risk assessments
and risk management decisions.
- It is important to make an effort to separate science from policy.
- Risk assessors and risk managers need to ensure that they are using the best
available science.
- Careful consideration of risk communication is needed.
- Statements concerning risk need to be much clearer. Risk assessors need to
identify "things that risk managers can't do anything about."
- Risk assessors need to separate variability from uncertainty in order to
determine where risk assessments are inadequate.
Dr. McNaughton 's Presentation
Dr. McNaughton discussed assessment of ecological risks posed by selenium in the
Central Valley of California. She described the assessment and issues that were
addressed to focus on the protection of natural resources.
• The Central Valley in California is an area where there is alluvial soil and it is
dominated by farming.
• The land in this area is drained for agriculture. The Bureau of Reclamation has been
concerned with how the salt water can be drained and removed from the land. The
Bureau decided to move drained water into vacant land. It was drained into the
Kesterson Wildlife Refuge.
• In draining the soil, selenium was mobilized. It bioaccumulated and was found to be
toxic to birds. The grasslands district is north of this area, and grasslands farmers
also moved water into a different site in certain times of year.
• EPA and other federal agencies have been working with farmers to find solutions to
the selenium problem. Farmers proposed using the drainage water and moving it to
the San Joaquin River. They agreed to reduce the selenium in the drainage water by
using on-farm practices. This has been a very positive step toward finding a solution
to the problem and it has evolved into the first monthly nonpoint source Total
Maximum Daily Load (TMDL) determination in California.
• The area now has a very good monitoring program. Toxicity testing on fish is
conducted once per month. Water quality, sediment quality and biological
monitoring is conducted monthly.
N-5
-------
• The State of California can be proud of accomplishments. The project has met the
TMDLs in seven out of eight years. Levels of selenium going into and out the
grasslands have been reduced. In some areas (e.g., Mud Slough) levels of selenium
have stayed high, but in other areas (e.g., Salt Slough) levels have declined in the
water and in the tissues of monitored species. Biological monitoring has allowed risk
assessors and risk managers to determine how well risk management measures are
working.
• It is important to note that consideration of bioaccumulation has added much
complexity to the ecological risk assessment and there is work yet to be done because
there is still selenium in system.
• In conducting the risk assessment it was necessary to rely on water quality criteria
that had already been developed. Initial objectives were based on those water quality
criteria. However, bioaccumulation occurred, and the ecological system was
impacted.
• Migratory bird species and sturgeon in rivers are now found in lesser numbers.
Initially there was not enough information available to make decisions. However, it
was necessary to make decisions and it is now necessary to keep reviewing these
decisions as more monitoring information becomes available. EPA has been unable
to look at the larger question of whether the environment benefited from the decisions
that have been made.
Dr. Hope's Presentation
Dr. Hope stated that he has been with the Oregon Department of Environmental Quality
for ten years. During that period of time he has been applying science in risk assessments
to support the development of regulations. He commented on the issues to be discussed
in the session from his perspective as a risk assessor in a state regulatory agency.
• Spatial and temporal scale. Dr. Hope pointed out the importance of considering
spatial and temporal scale issues in ecological risk assessments. Spatial and temporal
cale are important issues to consider because of habitat requirements of organisms.
These issues are less important in human health risk assessments. However,
inappropriate legal or other constraints may prevent risk assessors from addressing
ecologically relevant spatial and temporal scales. Scales that are ecologically relevant
may not be manageable on legal scales.
• Biological scale. Dr. Hope pointed out that Oregon is the only state that requires
evaluation of populations of organisms in its regulatory risk assessments. However, it
is problematic to create rules that protect populations. Many say that population
assessments are too data-intensive, and habitat boundaries are too difficult to define,
to conduct risk assessments at these levels of biological organization. However,
moving from science to regulation or from research to operations typically takes from
N-6
-------
five to twenty years. We are really just beginning to understand to how to move from
science to regulation in ecological risk assessment.
• Decision making in presence of uncertainty. Dr. Hope pointed out that regulators are
always looking for "bright line" standards. A "bad" number is often considered to be
better than no number. Oregon is one of two states that have published regulations on
ecological risk assessment. These regulations require more data and competent
practitioners to interpret the data. In many cases there is too much work and few who
can complete the work. Risk assessors and managers have found that going from
good ecological risk assessment research to practical use is difficult.
• Problem formulation. Problem formulation is the most important thing to consider in
the ecological risk assessment. More data, time, and money should be focused on
problem formulation. Unfortunately there is pressure to conduct assessments quickly
and inexpensively, and this has resulted in the development of conservative screening
systems that may be of limited use. The results of analyses conducted using these
screening systems may not provide definitive results. This is a problem because the
public does not like to see regulators changing their minds.
• Needs for application of "cutting edge" risk assessment methods. The State of
Oregon is trying to apply cutting edge methods in ecological risk assessment. But
these require money. It will be necessary to ask whether we value resources enough
to spend the money to conduct cutting edge risk assessments. We may not need a
twenty five year study, but we do need better definition of habitat boundaries. It is
important to understand that:
- Risk assessment work only needs to go "far enough" to be practical.
- It is hard to get people to articulate testable hypotheses but they need to be
spelled out.
- An analysis plan has to answer a question posed by a testable hypothesis.
- Problem formulation can save time in the field and help avoid work that is
not needed.
Discussion of Points Raised by Panelists
Participants discussed the following points in response to panelists' presentations:
• A participant noted that the state of Delaware has taken "a beating" over revision of
the arsenic standard. He stated that there is not enough money to reassess the
standard. The participant stated that perhaps the burden of proof of standards should
be on those who want to exploit public trust resources.
N-7
-------
• A participant questioned how much responsibility scientists have in educating
decision makers about the limits of risk assessment methods and tools. He stated that
clients ask how risk assessments should be conducted, but scientists have a
responsibility to explain the complexity of risk assessments.
• A participant commented that the polluter should pay for ecological protection. He
noted that this issue is built into statues. However, there is a need to better define
goals. A level of problem formulation needs to occur in the societal realm.
• A participant commented that if a goal of risk management is to conserve
populations, the present way of going about risk assessment (i.e., use of single species
tests to assess risks before contaminants are registered) will never accomplish that
goal. The commenter noted that he was not convinced that it is cheaper to use single
species tests in risk assessments.
• A participant commented on the SAB Framework Report presented by Dr. Young.
She noted that there might be some procedural steps that people should go through
during problem formulation (e.g., landscape effects, hydrology, and geomorphology)
that would enhance risk assessment. There may be a need for a professional
checklist. She stated that an example to be considered is the protection of wetlands.
Assessors need to look at landscape level attributes and the hydrology of the area.
Assessors need to look at geomorphology and disturbance regimes. Formulas and a
checklist could be used to develop problem formulation templates
• A participant noted that the language used in the SAB Framework Report is
appropriate, but it is important to plug it into problem formulation. Assessors may
find that regulated industries will need to provide better information. It is also
important to show regulators the benefits of more transparency. The participant also
noted that laws and regulations have not been chiseled in stone. Progress can be
made by influencing laws and regulations.
• A participant noted that the concept of natural system protection is important. For
example, a great value of wetlands protection is reduction of storm surges. The
participant noted that he would like to see the value of a system "beyond the critters"
to be brought into ecological the risk assessments.
Dr. Dickson 's Summary
• Dr. Dickson noted that that a number of topics and ideas for improving risk
assessments had been raised, and that the discussions would continue the following
day.
• He reiterated Dr. Young's idea of assessment of biological condition. He noted that
if condition were understood, it could be communicated to the public. He noted that
there is also a need to understand habitat quality conditions at the beginning of a risk
assessment.
N-8
-------
• He noted that there is a need for more guidance and information on appropriate tools
for ecological risk assessment and how they can be linked together. The inadequacy
of toolboxes might be an area for further discussion.
Ecological Risk Assessment in Natural Resource Protection Breakout
Group Summary Report
• Members of the group commented that the definition of quality and utility of an
ecological risk assessment should reflect the needs of both risk managers and
stakeholders.
• It is important to consider appropriate spatial and temporal scales in the risk
assessment in order to avoid missing underlying processes.
• Early peer review of the risk assessment study designs is needed.
- Peer review should occur between Problem Formulation and Analysis stages
of risk assessments where appropriate (e.g., natural resource protection or
management of contaminated sites)
- Peer review of study designs prior to initiating work plans will enhance the
quality and efficiency of risk assessments.
- Early peer review will help assure that the assessment study design and
implementation are appropriate for the risk management goals.
• Resource constraints may limit the spatial and temporal scales that are applied in a
risk assessment, and this may impact the quality of the risk assessment. Insufficient
analysis may, however, be worse than no analysis.
• It is important to use spatial scales that are large enough to see patterns emerging
across a landscape. This viewpoint will provide insight into the assessment of
cumulative effects. Examples of emerging effects that should be considered at a
broad scale include declining condition of small streams and the effects of a myriad
of small point sources such as leaking underground storage tanks.
• Broad scales bring the interests of more stakeholders into consideration and can also
blur details. However, fine scales may exclude regional and global trends that affect
local conditions. This perspective may leave the process subject to influences of local
politics.
• Spatial and temporal scale analysis may help to integrate a risk assessment into a
meta-analysis or assessment of a larger scale impact. Such an analysis may also
develop a body of knowledge useful for other risk assessment projects.
N-9
-------
• It is important to explicitly incorporate spatial and temporal scale into a conceptual
model, report it out transparently, and incorporate scale into uncertainty analysis.
• Tools are available to bring spatial and temporal considerations into the analysis. It is
not clear whether the number of practitioners with expertise in these areas is
sufficient to meet risk assessment needs. Useful tools include geographic information
system continuous monitors, and models as well as species life history information.
If additional spatial resolution is needed to describe species abundance and
distribution, this perspective should be included in the uncertainty analysis.
• It would be useful to assemble case studies that document the value of incorporating
the appropriate spatial and temporal scales into a risk assessment. These case studies
should be marketed to risk managers.
• Tools for completing common risk assessment activities, such as vulnerability
analysis, should be provided to risk assessors.
• An interagency effort could be undertaken to develop an ecological version of the
Integrated Risk Information System (IRIS) that would provide information needed for
risk assessments.
Levels of Biological Organization in Ecological Risk Assessments for Natural Resource
Protection
• The EPA Science Advisory Board Framework for Assessing and Reporting
Ecological Condition should be used as a reference checklist to ensure that
appropriate levels of organization are considered.
• It is important to be cognizant of the fact that indirect effects are important in risk
assessments and they are revealed at levels of biological organization above
populations. Risk assessors should consider effects at the community, habitat, and
landscape scales (e.g., chemical predisposing trees to disease).
• It would be useful to develop standard techniques for assessing risks at specific levels
of biological organization (e.g., common definitions of habitat types and
communities). The utility of community level information is demonstrated by the
sediment quality triad (this includes information on: benthic community measures,
sediment toxicity tests, and sediment chemistry).
• In determining the biological scale for assessment endpoints, it is useful to identify
the level where the effect is most obvious and then look one level up and one level
down.
• The state of the science of ecology is not the state of the practice of ecological risk
assessment. It is important to facilitate the transfer of science into practical use.
N-10
-------
Ecology is a science and ecological risk assessment is the art of practically applying a
continuum of tools.
• Opportunities for research, data collection and demonstration tools to enhance
ecological risk assessment include:
- Studies (including data mining) to assess the value of and uncertainty associated
with moving from individual to population level assessments.
- Studies to search for emerging patterns for groups of chemicals (e.g., quantitative
structure activity relationships to predict community or landscape-level effects).
- Side-by-side demonstrations of different tools for assessing effects on populations
and communities. Such studies are needed to test the relative efficiency of
methods.
Cross-cutting Issues Concerning Spatial, Temporal and Biological Scale in Ecological
Risk Assessment for Natural Resources Protection
• A website is needed to provide ecological risk assessment information that is
truncated in journal article publications or that is otherwise unavailable to ecological
risk assessment practitioners. It would be useful to investigate how to make data
from work performed under government contracts available to risk assessors.
• Risk communication training is needed for both risk assessors and risk managers.
• Cumulative risk should be rigorously incorporated into risk assessments.
• Findings from reactive risk assessments should be used to inform proactive risk
assessments. Scientists should clearly identify what relationships are testable and
determine which testable alternatives provide the most information for the cost.
• Uncertainty analysis concerning spatial and temporal scale and higher order effects
should be explicitly included in risk assessments.
• Incorporation of appropriate scales and consideration of multiple levels of biological
organization in ecological risk assessments will provide a record and body of
knowledge to improve future risk assessments.
Other Points and Issues Concerning Scale and Level of Biological Organization in
Ecological Risk Assessments for Natural Resources Protection
• Problem formulation is a critical step in ecological risk assessment to adequately
define appropriate scale and biological organization. Peer review of this phase would
help assure that the assessment study design and implementation are appropriate for
the risk management goals.
N-ll
-------
• Standards of practice are needed for ecological risk assessment. These standards
should include a checklist of ecological condition assessments to consider; spatial and
temporal scale and biological levels of organization to consider; standards for
assessing cumulative risk; standards for developing case studies; and standards for
transparency in ecological risk assessment.
• If data are insufficient to conduct analysis at an appropriate scale, this deficiency
should be acknowledged "up front" (transparency) and addressed in the uncertainly
analysis.
• Case studies are needed to demonstrate the use of practical tools for incorporation of
appropriate spatial and temporal scales and levels of biological organization into
ecological risk assessments.
Unique Issues Associated with Ecological Risk Assessment for Natural Resources
Protection
• Risk assessments for natural resources protection differ from other kinds of risk
assessments. Risk assessments for natural resources protection are more closely tied
to a "value" oriented paradigm. Other kinds of risk assessments are conducted from a
stressor perspective. In assessments for natural resources protection, there is a need
to identify the ecological attributes that should be protected and to determine how
they can be protected.
• In protecting natural resources, it is important to consider "natural" change, or
changes driven through global processes (like climate change). There is a need to
know how natural change will influence other changes that might be noted in the
system under study.
• In protection of natural resources it is necessary to consider linkages between
ecological risk assessments and effects assessments. For example, setting water
quality criteria is an effects assessment because when the criteria are developed little
is known about exposure. When a discharge permit is written more information is
provided about exposure that can lead to a risk assessment. There is a continuum of
processes between effects assessment and risk assessment.
• In natural resources protection assessors are looking at broad scales, but the specific
questions addressed by a study can be local or global. This difference in scale should
be clearly addressed in the problem formulation stage of the risk assessment.
Decisions can be made at very small scales but they should be made in the context of
much broader scales. It is also important to consider the point that chemicals are not
the only stressors to be evaluated in ecological risk assessments for natural resources
protection.
Problem Formulation and Testable Hypotheses
N-12
-------
• Both problem formulation and incorporation of testable hypotheses affect the quality
of a risk assessment. Paying proper attention to both concerns leads to higher quality
decisions, but testable hypotheses can be misused and this problem can lead to
degraded decision making.
• Natural resources protection should begin with an examination of critical ecological
attributes. Specific endpoints can then be established on the basis of specific
hypotheses. This process will result in more useful (higher quality) analyses.
• In many risk assessments there has been a lack of problem formulation. Some studies
have been designed with drivers such as a total maximum daily load or a permit in
mind, and these studies may measure the wrong attributes of the system. By initiating
a study with careful problem formulation, these problems can be avoided. At times,
risk assessors also work with available data without identifying data gaps. Decisions
are then made with incomplete information, and conclusions are not supportable.
Higher quality decisions will result if problem formulation, testable hypotheses, and
data collection are designed "up front."
• It is important to change the way we think about hypotheses. It is important to move
away from traditional hypothesis testing with null models that can be easy to
manipulate and difficult to formulate. In risk assessment, hypothesis testing will
result in null models that are developed without considering how to balance Type I
and Type II errors. There is a need to move toward more innovative methods such as
Bayesian analysis and causal argumentation. Hypotheses should focus on causal
relationships and weights of evidence.
• Problem formulation and testable hypotheses narrow the focus of questions to be
asked and allow risk assessors to apply the most appropriate tools.
• In the problem formulation process, it is necessary to first identify sensitive and
realistic measurements. For example, endocrine disrupters do not often kill animals
so it is necessary to look at their potential effects over fifty years, not two years. It is
not always necessary to look at catastrophic effects. Assessors should consider long-
term effects. Linkages should be made between tools that can sensitively measure
impact and actual effects at a more appropriate (e.g., population or landscape) level.
• It is important to build a mechanistic link between toxicity and other stressors and
effects on populations and communities. There is a need to take mechanistic
approaches from the laboratory and apply the appropriate relationship at a population
or community level. This approach will require more work to identify and assess true
links between molecular, cellular, and organismal responses and impacts that can be
noted in populations or communities.
• Ecology should be brought back into the process. There are many innovative
approaches that can be used to look at risk assessment issues from a different
N-13
-------
perspective. Risk assessors should not be caught in the traditional paradigm of using
the endpoints from toxicity tests in risk assessments. Individual mortality may not be
the most sensitive endpoint for assessing risks to a population. Risk assessors should
consider effects on populations or communities and endpoints such as the number of
impaired individuals using resources and not reproducing.
It is important to ensure close and frequent communication between risk managers
and risk assessors. Both groups should be involved in problem formulation and the
development of testable hypotheses.
Most risk assessments are carried out at the local level and often local intellectual
capital is not enough to provide adequate problem formulation. There is a need to
ensure that training and guidance are available for people who are involved in risk
assessment. EPA has developed some good risk assessment documents and these
should be used to train risk assessors.
Monitoring programs need better direction to provide information that can be used to
conduct risk assessments. Monitoring programs should be redesigned so they can
provide information to help test improved hypotheses. Risk assessors who are
working with existing data should influence how new data are collected by
monitoring programs.
To avoid fragmented analyses, there is a need to better integrate work that has been
conducted in different disciplinary areas (e.g., biology, vs. chemistry, toxicology vs.
ecology). For example, EPA has developed biological and chemical water quality
criteria separately. Expert systems could be developed to enable the integration of
specific chemical and biological endpoints and to identify classes of chemicals to be
assessed.
In problem formulation, it is important to look at problems at multiple levels of
organization.
Problem formulation should include the development of site conceptual models that
represent interactions and ecological processes that could be important at a
community landscape level (e.g., habitat fragmentation).
More innovative techniques should be used for hypothesis testing or alternative
analyses. Likelihood statements could be incorporated into problem formulation
rather than binary (yes/no) statements.
Explicit identification of multiple stressors is needed in problem formulation. It is
important to move beyond the single stressor model.
It will be important to consider providing guidance to formalize the development of
specific linkages that indicate how data will actually be used to inform decision-
N-14
-------
makers and lead to appropriate decisions. This step should occur in the problem
formulation stage.
• Hypothesis statements should be linked to explicitly stated process goals. Risk
managers often do not have the information needed to make decisions and may not
know how to get it. Causal arguments should be systematically included in problem
formulation. Confidence intervals should be built into testable hypotheses, and a
process should be followed to determine whether indicators are appropriate for a
purpose.
• Scientific review is another important tool that should be applied. In many cases
scientific review of risk assessments has occurred when data have already been
collected and analysis has been completed. Independent review at the end of the
problem formulation stage of a risk assessment would ensure that assessment
endpoints could be linked to goals.
Natural Resource Decision Making in the Face of Uncertainty
• Uncertainty can drive conclusions that identify risk when, in fact, there may be no
adverse effects. It is therefore important to identify appropriate measures and
assessment endpoints. Uncertainty can be minimized by using appropriate analytic
measures with sufficient power.
• It is important to remember that risk managers and risk assessors address uncertainty
differently. Risk managers should decide what level of uncertainty is acceptable.
Risk assessors should select methods that enable quantification of uncertainty. The
Guidelines for Ecological Risk Assessment identify many different kinds of
uncertainty, and it is important to be able to say which ones affect risk. Risk
managers and risk assessors should therefore communicate effectively, and the most
profound uncertainties should be identified a priori.
• Uncertainty in risk assessments can reduce the utility of an assessment by leading to
paralysis in the decision-making process. Uncertainty also gives more weight to
factors like cost in a risk management decision. In addition, uncertainty affects the
ability of risk assessors to extrapolate results between sites. When there is a large
amount of uncertainty, only site-specific risk assessments are possible.
• There is a need to conduct relative assessments of uncertainties so that risk managers
can "plan around them." It is particularly important for risk managers to articulate
how much uncertainty they can tolerate.
• It is important to recognize the difference between uncertainty and variability.
Variability can be written into assessment endpoints as part of the data quality
objectives process. This allows assessors to avoid mistakes like using analytical
methods with bad detection limits that are higher than effects concentrations.
N-15
-------
• Uncertainty also affects the utility of a risk assessment because the timeline for a
decision and the timeline needed to observe effects in the field may be disconnected.
• Risk assessors should explore the use of alternative methods of analysis such as
likelihood matrices and Bayesian methods. EPA might consider developing guidance
on how to construct likelihood arrays that can be integrated into risk assessments.
• Risk assessors should explore opportunities to use statistical methods that better
inform the risk assessment process such as power analysis and sensitivity analysis.
• Elements of uncertainty should be identified and incorporated into problem
formulation and built into the design of a risk assessment. From a qualitative
perspective, uncertainties should be categorized, and those that profoundly affect
results and outcomes should be identified. There is a rich literature on disaggregating
analytical variability, stochastic variability, and model variability. It would be useful
to consider available tools for use in problem formulation.
• The uncertainty associated with key variables in risk assessments should be assessed
to help reduce overall uncertainty.
• Each ecological risk assessment represents an opportunity to understand uncertainty.
EPA should take advantage of this for future risk assessments. In this regard data
should be mined from EPA Superfund and other documents.
• A better interface with monitoring programs should be developed so that data could
be collected for the purpose of improving risk assessments. Specific monitoring
projects could be designed to provide data that could reduce uncertainty in risk
assessments.
• It was suggested that specific white papers on the following topics could be developed to
reduce uncertainty and provide information for improved ecological risk assessments:
- Methodological guidance to describe multiple outcomes in a likelihood matrix.
- Quantitative inspection of dose-response models to determine slopes, functional
forms, and error rates.
- Determining differential sensitivity of test animals in the field vs. laboratory
responses.
- Guidance on the use of cumulative stress and effects models.
- An approach to address fluctuating variability in exposure models.
- Conceptual and arithmetic flaws associated with the use of hazard quotients.
N-16
-------
- Determining sources of variability in species responses and sensitivity.
- Reviewing how to evaluate and express perturbations.
- Exploring the notion of individual vs. population distinctions (e.g., what the
distinctions are and how they should be described).
An improved interface could be developed for use of current assessment and management
tools available from management agencies.
A key question to be answered is how much uncertainty a risk manager can tolerate. It is
important to dissect types of uncertainty in a qualitative assessment to provide
information that can help answer this question.
There is a need for a systematic data collection and organization effort to catalog and
make available information from past risk assessments in order to reduce the uncertainty
of future risk assessments. This effort should provide better metadata and a centralized
data repository for: ecological risk assessment data, endangered species information,
FIFRA risk assessment information, Superfund risk assessment information, and the peer
reviewed literature.
N-17
------- |