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EPA/1 OO/R-10/004 | December 2010
www.epa.gov/osa
United States
Environmental Protection
Agency
Integrating Ecological Assessment and
Decision-Making at EPA: A Path Forward
Results of a Colloquium in Response to
Science Advisory Board and National
Research Council Recommendations
Office of the Science Advisor
Risk Assessment Forum
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EPA/100/R-10/004
December 2010
Integrating Ecological Assessment and
Decision-Making at EPA: A Path Forward
Results of a Colloquium in Response to
Science Advisory Board and National
Research Council Recommendations
Risk Assessment Forum
U.S. Environmental Protection Agency
Washington, DC 20460
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NOTICE
This report has been subjected to the Agency's peer and administrative review and has
been approved for publication as an EPA document. Mention of trade names or commercial
products does not constitute endorsement or recommendation for use.
ABSTRACT
An Intra-Agency Colloquium, convened by a Technical Panel of the U.S. EPA's Risk
Assessment Forum, reviewed the state of ecological risk assessment, responded to
recommendations by the Science Advisory Board, and recommended actions to improve
ecological risk assessment practices in the Agency. The panel and participants recommended an
integrated framework that included all types of environmental assessments and focused on
solving environmental problems. They reviewed existing guidance and found that, while it is
abundant, it is not systematic or readily available. The response to comments found that most of
the recommendations were being carried out in some components of the Agency, but practices
are not consistent. The panel and participants made policy recommendations including greater
attention to Agency-wide ecological protection goals, better communication of ecological issues,
and a systems approach to assessment and management including better integration of
assessment into the decision making process. They also made technical recommendations for
improving assessment practice including the development of guidance on linkage of assessment
endpoints to ecosystem services, weighing multiple types of evidence in assessments, and quality
assurance for assessments. Finally, the participants strongly recommended that mechanisms and
venues be provided for communication, problem sharing, training and mentoring in the
community of ecological assessors.
Preferred Citation:
U.S. EPA (Environmental Protection Agency). (2010) Integrating Ecological Assessment and
Decision-Making at EPA: A Path Forward. Results of a Colloquium in Response to Science
Advisory Board and National Research Council Recommendations. Risk Assessment Forum.
Washington, DC. EPA/100/R-10/004
11
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TABLE OF CONTENTS
Page
LIST OF TABLES v
LIST OF FIGURES vi
LIST OF ABBREVIATIONS vii
PREFACE viii
AUTHORS, CONTRIBUTORS, AND REVIEWERS ix
EXECUTIVE SUMMARY xii
1. INTRODUCTION AND OBJECTIVES 1-1
2. COLLOQUIUM APPROACH TO EVALUATING EPA ECOLOGICAL
ASSESSMENTS AND THE SAB AND NRC RECOMMENDATIONS 2-1
3. THE INTEGRATED FRAMEWORK FOR ENVIRONMENTAL ASSESSMENT 3-1
4. CATEGORIZING EXISTING AGENCY PRACTICE AND GUIDANCE WITHIN
THE INTEGRATED ASSESSMENT FRAMEWORK 4-1
5. EXISTING GUIDANCE FOR ECOLOGICAL ASSESSMENTS AT EPA 5-1
5.1. A CONCEPTUAL AND HISTORICAL RE VIEW 5-2
5.2. A COMPILATION AND ORGANIZATION OF EXISTING GUIDANCE 5-13
6. RESPONSE TO THE SAB AND NRC RECOMMENDATIONS 6-1
6.1. ASSESSMENT PROCESSES 6-2
6.2. ENVIRONMENTAL GOALS 6-3
6.3. ADAPTIVE MANAGEMENT 6-4
6.4. PLANNING, SCOPING, AND PROBLEM FORMULATION 6-5
6.5. WEIGHT OF EVIDENCE 6-8
6.6. CUMULATIVE AND INDIRECT EFFECTS 6-9
6.7. OTHER SOURCES OF GUIDANCE 6-10
6.8. BENEFITS AND VALUATION 6-11
6.9. SCALES OF ASSESSMENT 6-14
6.10. METHODS AND TOOLS 6-16
6.ll.POSTDECISION AUDITING AND MONITORING 6-18
6.12. MANAGEMENT, RESOURCES, AND TRAINING 6-19
7. TECHNICAL PANEL RECOMMENDATIONS FOR AGENCY CONSIDERATION 7-1
7.1. GENERAL RECOMMENDATIONS 7-1
7.1.1. Strength Policies to Achieve Ecological Protection Goals 7-1
7.1.2. Enhance Communication of Ecological Assessment Issues and Results 7-2
7.1.3. Strengthen the Risk Assessor-Risk Manager Dialogue 7-2
7.1.4. Enhance Problem Formulation 7-3
7.1.5. Increase Training 7-3
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TABLE OF CONTENTS (continued)
7.1.6. Apply Systems Approaches to Ecological Assessments 7-3
7.1.7. Integrate Different Types of Assessments to Solve Environmental
Problems 7-4
7.1.8. Create Forums for Communication 7-4
7.2. SPECIFIC RECOMMENDATIONS 7-5
REFERENCES R-l
APPENDIX A: COLLOQUIUM PARTICIPANTS AND TECFlNICAL PANEL
MEMBERS A-l
APPENDIX B: INTERVIEWS OF ECOLOGICAL ASSESSORS B-l
APPENDIX C: TABLE OF GUIDANCE C-l
APPENDIX D: SUPPORTING MATERIAL FOR SECTION 6. RESPONSE TO SAB
AND NRC COMMENTS D-l
APPENDIX E: WORKGROUP RECOMMENDATIONS E-l
APPENDIX F: NOTES FROM THE CLOSING SESSION F-l
IV
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LIST OF TABLES
Page
Table 4-1. Composite summary of interviews and EPA Web site review 4-5
Table 5-1. EPA-wide risk assessment polices, principles, and guidance 5-13
Table 5-2. General ecological risk assessment polices, principles, and guidance 5-14
Table 5-3. General probabilistic risk assessment polices, principles, and guidance 5-14
Table 5-4. Superfund program-specific guidance 5-15
Table 5-5. Guidance on stressors, responses, endpoints, and benchmarks 5-15
Table 6-1. NRC broad science policy recommendations 6-20
Table 6-2. SAB recommendations concerning environmental goals 6-20
Table 6-3. SAB recommendations on adaptive management 6-21
Table 6-4. Recommendations on problem formulation 6-22
Table 6-5. Recommendations on weight of evidence and lines of evidence 6-23
Table 6-6. Recommendations on cumulative and indirect effects 6-23
Table 6-7. Recommendations on other sources of guidance 6-23
Table 6-8. Recommendations on valuation and benefits 6-23
Table 6-9. Recommendations on spatial temporal and biological scale 6-24
Table 6-10. Recommendations on assessment methods and tools 6-25
Table 6-11. Recommendations on postdecision auditing and monitoring 6-26
Table 6-12. Recommendations on science management, resources, and training 6-26
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LIST OF FIGURES
Page
Figure 3 -1. A common process for performing environmental assessments 3-6
Figure 3-2. Identification of the planning, analysis, and synthesis activities as depicted in the
Ecological Risk Assessment Framework 3-7
Figure 3-3. Comparison of conventional risk assessment and criterion assessments 3-7
Figure 3-4. The acute (blue) and chronic (red) species sensitivity distributions are examples of
exposure-response models 3-8
Figure 3-5. Identification of the planning, analysis, and synthesis activities as depicted in the
Stressor Identification Framework from www.epa.gov/caddis 3-9
Figure 3-6. The basic structure of an integrated framework for environmental assessment.... 3-10
Figure 3-7. Specific assessment types within the integrated framework showing the shared
common assessment process 3-10
Figure 4-1. Superfund process and integrated assessment 4-6
Figure 4-2. Process for listing impaired waters and determining total maximum daily loads ... 4-7
Figure 6-1. Process for implementing an expanded and integrated approach to ecological
valuation 6-27
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LIST OF ABBREVIATIONS
CADDIS Causal Analysis/Diagnosis Decision Information System
CERCLA Comprehensive Environmental Response, Compensation, and Liability Act
DDT dichlorodiphenyltrichloroethane
DQO data quality objective
EO Executive Order
EPA Environmental Protection Agency
ERA Ecological Risk Assessment
ESRP Ecosystem Services Research Program
FIFRA Federal Insecticide, Fungicide and Rodenticide Act
GEAE Generic Ecological Assessment Endpoint
LCA life-cycle assessment
NAAQS National Ambient Air Quality Standards
NOX nitrogen oxides
NPL National Priority List
NRC National Research Council
OAQPS Office of Air Quality Protection and Standards
OECD Organization for Economic Cooperation and Development
OPP Office of Pesticide Programs
OPPTS Office of Prevention, Pesticides and Toxic Substances
ORD Office of Research and Development
PCB polychlorinated biphenyl
PRO Pesticide Reevaluation Division
RAF Risk Assessment Forum
RCRA Resource Conservation and Recovery Act
ROE Report on the Environment
SAB Science Advisory Board
SOX sulfur oxides
T&E threatened and endangered
TMDL total maximum daily load
TSCA Toxic Substances Control Act
USGCRP U.S. Global Change Research Program
WQC water quality criteria
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PREFACE
This report was prepared by a Technical Panel of the U.S. EPA's Risk Assessment Forum
to document an Intra-Agency Colloquium of ecological assessors. The impetus for the
colloquium was a report of the Ecological Process and Effects Committee of the Science
Advisory Board (SAB). That report presented the Committee's view of the state of practice of
ecological risk assessment in the Agency and made recommendations for improvement. The
Forum determined that the best way to respond to the recommendations was to convene
ecological assessors from across the Agency to consider the Agency's ecological assessment
practices in light of the recommendations. While the colloquium was being planned, the
National Academy of Sciences published a report titled Science and Decisions Advancing Risk
Assessment that contained recommendations concerning environmental risk assessment that were
also relevant. Those recommendations were extracted, organized and added to the SAB's
recommendations for consideration during the colloquium.
The report was prepared in three stages. First, the Technical Panel reviewed the
recommendations, identified topics to be considered during the colloquium and developed white
papers to serve as starting materials. Research for those white papers included interviews with
ecological assessors in the various programs and regions. One outcome of the Technical Panel's
work was a decision to broaden the topic from ecological risk assessment to include all types of
ecological assessments performed by the Agency. Second, during the colloquium, working
groups considered each of the topics identified by the Technical Panel, edited and added to the
white papers, and developed recommendations. In plenary sessions, the recommendations were
discussed and expanded. Third, following the colloquium, the Technical Panel reviewed the
products of the colloquium and their notes and used them to write this report.
These results of the colloquium are already being used to guide the development of new
projects of the Ecological Oversight Committee of the Risk Assessment Forum. The members of
the Technical Panel hope that the report will be widely read and that its recommendations will be
broadly implemented.
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AUTHORS, CONTRIBUTORS, AND REVIEWERS
Anthony Maciorowski (Co-Chairman and Editor)
U.S. EPA,
Science Advisory Board Staff Office,
Washington, DC 20460
Glenn Suter (Co-Chairman and Editor)
U.S. EPA, Office of Research and Development,
National Center for Environmental Assessment,
Cincinnati, OH 45268
Susan Cormier (Group Chairman)
U.S. EPA, Office of Research and Development
National Center for Environmental Assessment
Cincinnati, OH 45268
Kathryn Gallagher (Group Chairman)
U.S. EPA, Office of Science Advisor
Risk Assessment Forum
Washington, DC 20460
Tala Henry (Group Chairman)
U.S. EPA, Office of Chemical Safety and Pollution Prevention
Office of Pollution Prevention and Toxics
Washington, DC 20460
Marc Sprenger (Group Chairman)
U.S. EPA, Office of Solid Waste and Emergency Response
Office of Superfund Remediation and Technology Innovation
Edison, NJ 08837
Mace Barren
U.S. EPA, Office of Research and Development
National Health and Environmental Effects Research Laboratory
Gulf Breeze, FL 32561
Charles Delos
U.S. EPA, Office of Water
Office of Science and Technology
Washington, DC 20460
Kristen Keteles
U.S. EPA, Office of Chemical Safety and Pollution Prevention
Washington, DC 20460
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Charles Maurice
U.S. EPA, Office of Research and Development,
Office of Science Policy, Region 5 Superfund Division
Chicago, Illinois 60604
Wayne Munns
U.S. EPA, Office of Research and Development
National Health and Environmental Effects Research Laboratory
Narragansett, RI 02882
Matt Nicholson
US EPA, Region 3
Environmental Assessment & Innovation Division
Philadelphia, PA 19103
Edward Odenkirchen
U.S. EPA, Office of Chemical Safety and Pollution Prevention
Washington, DC 20460
Vicki Sandiford
U.S. EPA, Office of Air Quality Planning and Standards
Washington, DC 20460
Denice Shaw
U.S. EPA, Office of Research and Development
National Center for Environmental Assessment
Washington, DC 20460
Patti TenBrook
U.S. EPA, Region 10
San Francisco, CA
Dana A. Thomas
U.S. EPA, Office of Water
Office of Science and Technology
Washington, DC 20460
Steve Wharton (retired)
U.S. EPA, Region 8
Denver, CO
Risk Assessment Forum Staff
Lawrence Martin
U.S. EPA, Office of Science Advisor
Risk Assessment Forum
Washington, DC 20460
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Meghan Radtke (Until 3/30/10)
U.S. EPA, Office of Science Advisor
American Association for the Advancement of Science Fellow
Washington, DC 20460
Seema Schappelle (Until 2/28/10)
U.S. EPA, Office of Science Advisor
Risk Assessment Forum
Washington, DC 20460
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EXECUTIVE SUMMARY
BACKGROUND
Both within and beyond the U.S. Environmental Protection Agency (hereafter referred to
as EPA, or the Agency), issues have been raised concerning ecological risk assessment practices
including interpretation of existing guidance, incorporation of recent science, and the
relationship of science and policy (U.S. EPA, 2004a; Tannebaum, 2005; Dearfield et al., 2005;
DeMott et al., 2005; Bridgen, 2005; Stahl et al., 2005). More recently, the Science Advisory
Board (U.S. EPA, 2008e) offered advice to EPA on improving the application of ecological
assessment in environmental decision-making. Shortly thereafter, the National Research Council
(NRC) of the National Academy of Sciences (NRC, 2009) provided advice on advancing risk
assessment science in EPA environmental decisions. Because the collective advice applied to a
number of EPA programs and regions, the development of an appropriate response required
broad Agency representation. Therefore, a Technical Panel of the Risk Assessment Forum's
Ecological Oversight Committee was formed with scientists from various EPA Program Offices
and Regions. The Technical Panel convened an Intra-Agency Colloquium that included over
50 scientists from across the Agency (see Section 2).
AN INTEGRATIVE FRAMEWORK
An integrated framework for environmental assessment (Cormier and Suter, 2008) was
used as a major organizing principle for the Colloquium (see Section 2). Because ecological
assessments are conceptually and methodologically diverse, Colloquium participants used that
framework to organize agency assessment into one of four kinds:
1. Condition assessments to determine whether the environment is impaired or trends that will
lead to impairment.
2. Causal assessments to determine the causes of impairments and the sources of causal agents.
3. Predictive assessments to determine the risks and other considerations associated with
alternative management actions.
4. Outcome assessments to determine whether management actions have adequately resolved
the environmental issues.
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The Technical Panel found that the integrated assessment framework provides a simple
conceptual approach for describing, categorizing, integrating, and harmonizing all EPA
assessment types. Condition, causal, predictive, and outcome assessments each have utility for
specific objectives. However, each assessment type is limited to answering one type of
management question, and no one assessment type can provide the scientific support needed to
meet Agency goals. In contrast, the integrated assessment framework delineates the specific
objectives of the four assessment types, shows how they can be used sequentially, and offers the
option of designing a priori integrated assessments.
Although the integrated framework assessment typology has not been used widely within
EPA, the Technical Panel found that it was compatible with current Agency practice and
regulatory authorities. This was demonstrated through case examples from the Superfund and
total maximum daily load (TMDL) programs and telephone interviews with Agency ecological
assessors (see Section 4). In addition, two innovative assessment case examples in the pesticide
and air programs (atrazine and nitrogen oxides-sulfur oxides [NOX-SOX] National Ambient Air
Quality Criteria and Standards) were also compatible with the integrated framework (see
Section B.2). The Technical Panel believes that implementation of the integrated framework at
EPA would aid communication among assessors, managers, and the general public concerning
the scope of a particular assessment or set of integrated assessments. It could also be used to
clarify how the different assessment types can be combined and integrated to inform
environmental decisions. The integrated framework was developed for ecological assessments
but could be used with human health, economic, and engineering assessments.
EXISTING ECOLOGICAL ASSESSMENT GUIDANCE
Cataloging existing Agency science policy and technical guidance (see Section 5)
pertinent to ecological assessment was necessary for understanding the status of current Agency
practices, and prerequisite for addressing Science Advisory Board (SAB) and NRC advice and
recommendations. EPA science policy guidance provides broad principles for conducting risk
and other kinds of assessments. Technical guidance, on the other hand, focuses on specific
scientific methodologies and procedures to be used during the analytical phase of an assessment.
Collectively, Colloquium participants reviewed and evaluated over 90 Agency guidance
documents. The Technical Panel also conducted a preliminary review of Agency-wide science
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policy documents (U.S. EPA, 1997a, 1998a, 2002a, 2003a,b,c, 2004a). This review
demonstrated that EPA general risk assessment science policies are well developed (see Section
5.1) and have been heavily influenced by National Research Council reports (NRC, 1983, 1993,
1994, 1996, 2009). The Technical Panel concluded that existing science policy documents
provide well-developed guidance on risk assessor-risk manager interactions, roles, and
responsibilities; planning and scoping; problem formulation; conceptual model development;
specific inputs to analytical phases of risk assessment; and risk characterization. However, the
Technical Panel also found that implementation of the foregoing general science policy guidance
was highly variable across the Agency. Awareness and implementation by ecological assessors
of Agency-wide science policy guidance is inhibited by the fact that the guidance is human
health-centric. Therefore, despite its general applicability to ecological assessments, this
guidance is not well known in the ecological community within or beyond EPA.
The Guidelines for Ecological Risk Assessment (U.S. EPA, 1998a) have remained the
primary focus of ecological assessors who are often unaware of Agency-wide science policy
guidance. Concomitantly, because human health issues typically dominate Agency-wide science
policy development and implementation, many human health assessors and senior
decision-makers are unfamiliar with the diversity and scope of ecological assessment approaches
and methods. The Technical Panel concluded that these factors have hindered the development
of and the fullest application of Agency-wide science policies and their regarding protection of
ecological attributes.
The SAB and the Technical Panel agreed that the Guidelines for Ecological Risk
Assessment (U.S. EPA, 1998a) have improved the state of practice. However, ecological risk
assessment has become almost synonymous with estimating acute and chronic toxic risk of
chemicals to plants, fish, invertebrates, and wildlife. Although the guidelines were designed to
cover a wide variety of assessment scenarios, field-based ecologists working on descriptive and
causal assessments do not view their work within the ecological risk assessment paradigm. The
Technical Panel concluded that additional frameworks (e.g., causal assessment) were necessary,
and the integrated assessment framework (Cormier and Suter, 2008) provided an approach for
explaining and documenting alternative frameworks and assessment types, whether conducted
individually, sequentially, or in an integrated manner.
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Cataloging existing Agency guidance for ecological assessment (see Section 5.2,
Appendix C) was challenging because it spans nearly two and a half decades. However, within
the large and heterogeneous set of documents, a set of core documents was identified that
provides general ecological risk assessment policies, principles, and guidance at EPA (U.S. EPA,
1992a, 1997b, 1998a, 2003b, 2004b).
To evaluate the utility of the integrated assessment framework, Colloquium participants
categorized existing ecological assessment guidance as condition, causal, predictive, or
outcome-based (see Section 5.2, Appendix C). All four assessment types were identified in this
exercise, and integration of the four types was evident in selected Agency applications (e.g.,
Superfund, TMDL, Pesticide, and Air Programs). Generally, laboratory toxicity-based
predictive assessments for estimating direct acute and chronic risk of individual chemicals are
the most commonly employed assessment type at EPA. However, condition and causal
assessments are also conducted by field-based ecologists. Outcome assessments that
demonstrate the efficacy of risk management actions are conducted by EPA, but are the least
common assessment type currently conducted by the Agency. The Technical Panel believes that
outcome assessments are underutilized at EPA, and that linking them with other assessment
types would enhance environmental assessment and decision-making.
The categorization of guidance (see Section 5.2, Appendix C) revealed several issues.
General guidance for major steps in the ecological risk assessment process (planning and
scoping, conceptual model development, assessment endpoints, measurement endpoints, effects
assessment, exposure assessment, risk characterization) was found to be well developed.
However, technical guidance was found to be inconsistent. Although not often explicitly stated,
elements of newer guidance and practice supersede older guidance and practice. Guidance
documents reflect the state of science and science policy at the time they were written. Guidance
did not develop in a sequential or coordinated way for the Agency as a whole but reflects
individual historical programmatic or regional needs and mandates with little consideration of
other EPA programmatic or regional practice. In fact, an underlying rationale for the
development of the Guidelines for Ecological Risk Assessment (U.S. EPA, 1998a) and later
general risk characterization guidance (e.g., U.S. EPA, 2003b) was to promote more consistent
terminology and practices at EPA.
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Second, the guidance is not available in any organized manner. The guidance needed for
a particular issue can be found in various documents in various locations. It might be in an
Agency-wide, programmatic or regional document, and the title may not be a good or complete
guide to the contents.
Third, the guidance might not be in a useful form. Rather than a traditional report,
guidance may be more useful if it takes the form of examples, responses to frequently asked
questions, short state-of-practice white papers, exemplary case studies, expert systems, decision
support systems, or other forms.
Finally, some important topics still have not been adequately addressed. For example,
many Agency assessments weigh multiple lines of evidence to derive a value, categorize a
chemical, or even derive a final conclusion concerning conditions, causes, or risks. However, no
guidance has been provided for that inferential process. Similarly, general guidance for
important but peripheral issues such as stakeholder involvement, risk communication, and risk
management is less well developed.
Technical guidance, on the other hand, is often program specific and old. Based on the
number of documents identified (>90), one Colloquium participant observed—"we are drowning
in guidance that is neither easily obtained nor interpreted."
The Technical Panel agreed that a single compendium of available guidance needs to be
developed. This proposed compendium would be most useful as a publicly available web-based
resource. The Risk Portal and the Risk Assessment Forum (RAF) Web sites were suggested as
possible platforms for a compendium.
RESPONSE TO SAB AND NRC COMMENTS
The SAB and NRC comments were summarized, yielding 46 discrete recommendations
(see Section 6). The recommendations included issues directed to the Agency as a whole and to
specific program offices. They included broad suggestions to transform thinking about
ecological assessment and decision-making, as well as suggestions for incremental process and
technical improvements. Each SAB and NRC recommendation was discussed at the
Colloquium, grouped into categories, and ranked as being: (a) investigatory; (b) in initial
implementation in one or more program offices or regions; or (c) fully implemented in one or
more programs or regions. These determinations were made by comparing the recommendations
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with existing science policy and technical guidance (see Section 5) and the collective experience
of Agency scientists at the Colloquium. The accompanying text (see Section 6) demonstrates
that there are relatively few gaps between Agency practice and the SAB and NRC advice.
However, practices are in different stages of development and highly variable among programs
and regions. Many recommendations were found to be investigatory, in initial application
stages, or already implemented in one or more program offices. None of the recommendations
were considered to be fully implemented Agency-wide.
The Technical Panel and Colloquium participants focused on developing general
responses to the transformative issues (e.g., spatial, temporal, and biological scales; global
change; ecosystem services and benefits, adaptive management). The Technical Panel believed
that advancing ecological concepts and incorporating them into Agency science policies has the
greatest potential benefit for future Agency practice and ecological protection. They also believe
that incorporating transformative scientific principles into Agency practice will help to resolve
the apparent confusion surrounding variable Agency practice and the risk assessment-risk
management interface. The Technical Panel strongly recommends that these issues be more
fully considered by the EPA Science and Technology Policy Council.
Colloquium participants and the Technical Panel concurred with the SAB observation
that clear Agency-wide science policies concerning what ecological attributes the Agency strives
to protect have not been established. Some 15 years ago, a report by the Office of Policy,
Planning, and Evaluation (Troyer and Brody, 1994) stated that more than three fourths of EPA
programs interviewed expressed the need for ecology policy guidance within EPA. That report
surveyed Agency legislative authorities, and specific ecological endpoints that EPA Program
Office and Regions had used in risk management decisions. These results were updated in an
appendix to Generic Ecological Assessment Endpoints for Ecological Risk Assessment (U.S.
EPA, 2003b). Although the science and Agency precedents for using ecological attributes in
decision-making have improved, no science policy "bright lines" akin to 1 x 10~6 for cancer risk
exists for ecological risk. The variety of endpoints that the Agency uses in ecological
assessments is a contributing factor to the frustration over perceived inconsistencies in practice,
variable interpretation of existing guidance, the need to incorporate more recent science into
ecological risk assessment, and the intermingling of science and policy (U.S. EPA, 2004a;
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Tannebaum, 2005; Dearfield et al, 2005; DeMott et al, 2005; Bridgen, 2005; Stahl et al, 2005;
U.S. EPA, 2008e)
RECOMMENDATIONS
The Colloquium was the first Agency-wide gathering of ecological assessors since
finalization of the Guidelines for Ecological Risk Assessment in 1998. Accordingly, the
Colloquium participants took the opportunity to develop recommendations for improving
ecological assessment (see Section 7). Five overarching recommendations were identified.
Additionally, the Technical Panel identified a number of specific recommendations to enhance
ecological assessment at EPA.
Summary of Overarching Recommendations
The Technical Panel believes that the quality, scope, and application of ecological
assessments in environmental decisions would be improved by the development and
implementation of Agency-wide science policies in five potentially transformative areas and
recommends that the Science Policy Council undertake their development.
Develop Science Policies that Promote Agency-Wide Ecological Protection Goals
Colloquium participants repeatedly expressed concern that many Agency decision and
policymakers are less familiar with and are less focused on ecological issues and associated
environmental protection goals than human health protection-related goals and issues. The
Technical Panel acknowledged that human health issues remain critical in overall Agency
decisions. However, many emerging environmental issues facing the Agency cannot be
addressed within conventional human health or ecological risk assessment paradigms. Broader
science policies are necessary for categorizing and contextualizing existing ecological
assessments, as well the design and conduct of complex large-scale assessments currently facing
EPA (e.g., global change, sustainability, estuarine and coastal hypoxia, integrated nitrogen
control, bio fuels, hydraulic fracturing of deep geologic formations for methane extraction,
mountain top mining, deep sea oil spills, etc.).
The Technical Panel also noted that that senior science advisor positions in the program
offices, regions, and Agency-wide science policy coordinating bodies are almost exclusively
filled by human health risk assessors. This disciplinary and structural imbalance has had the
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unintended effect of weighting Agency-wide science policy priorities toward the many human
health risk assessment issues facing EPA. If the Agency is to successfully incorporate important
and well-developed ecological science principles (e.g., systems analysis, landscape ecology,
ecosystem services and benefits, adaptive management) into its science policy framework, it
must consider ways to elevate representation and influence of ecological scientists as senior
science advisors in its programs, regions, and Intra-Agency science policy development and
coordinating bodies.
Apply Systems Approaches to Ecological Assessments
Ecological assessors, particularly those in the regions, are concerned that the focus on
medium-specific and chemical-specific assessments have inhibited ecological protection by not
adequately recognizing that pollutants move among media, that multiple sources cause combined
exposures, that multiple pollutants affect multiple receptors, and that effects on one ecological
receptor have consequences for other ecological receptors and for humans. The Technical Panel
recommends that the Agency begin to employ system approaches in ecological assessments.
This is particularly important for broad scale environmental assessment issues discussed above.
Enhance Communication of Ecological Assessment Issues and Results
The strongest and most consistent recommendation of the Colloquium participants was
that methods be developed for better communication with decision-makers and stakeholders.
This applies to communicating both ecological assessment issues during planning of assessments
and results at the conclusion. In part, this is a matter of inability of assessors to communicate the
significance of the loss of species, changes in community structure, and other endpoints. In
addition, it involves the lack of standard bright lines for acceptability like those in human health
assessment, the plethora of assessment methods employed, and difficulties in conveying
variability and uncertainty. Currently there is no guidance for communicating ecological risks.
Consider Ecosystem Services and Benefits in Assessment Scenarios as Methods and Tools
Become Available
Quantification of ecosystem services and benefits is in its infancy but represents a
significant research program at EPA. This program is potentially transformational for
environmental sciences and decision-making. Ecosystem services can be used to describe
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quantitative outcomes for ecological assessments that can be more effectively communicated to
decision-makers and the public.
Explore Adaptive Management as a Formal Science Policy for EPA
Adaptive management is a process that determines the outcome of actions and uses that
information to improve assessments that inform decisions and improves the efficacy of those
decisions. Adaptive management has not been adopted as a science policy at EPA. However it
is conceptually well developed and has been widely adopted in numerous federal and state
agencies charged with ecological, fisheries, and wildlife management. The Technical Panel
recommends that the Science and Technology Policy Council and the Risk Assessment Forum
explore the use of adaptive management for testing and revising risk management actions.
Integrate Different Types of Assessments to Solve Broad Environmental Problems
The Colloquium participants found a need for the Agency to move beyond conventional
risk assessment and to consider additional frameworks and assessment types to better inform
decisions and the efficacy of risk management decisions. The Technical Panel also believes that
conventional risk assessments, systems approaches, and adaptive management are inherent to the
integrated assessment framework (Cormier and Suter, 2008). Additionally, in certain
applications, the Agency is already conducting integrated assessments.
The Technical Panel believes that working toward Agency-wide science policies in the
preceding five transformative areas will benefit ecological assessment at EPA in several ways.
Most notably, it has the potential for applying new and innovative science and assessment
approaches across the range of the Agency's existing authorizing legislation to better inform
management decisions. The process of transforming ecological assessment science policy and
practice would also assist in resolving the perceived confusion concerning ecological
assessment which has been expressed by U.S. EPA (2004a) external observers (Tannebaum,
2005; Dearfield et al, 2005; DeMott et al, 2005; Bridgen, 2005; Stahl et al, 2005) advisory
bodies (U.S. EPA, 2008e; NRC, 2009), and Colloquium participants in the following ways.
» Communication, dialogue, and understanding among risk assessors and risk managers
and the public concerning conditions, causes, predictions, and outcomes would be
enhanced.
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Planning and scoping between risk assessors and risk managers would be improved.
Problem formulation, including conceptual model development and the analytical plan
would be improved for each assessment type whether they are conducted independently,
sequentially, or in an integrated manner.
Communication with risk managers and stakeholders during assessment planning and the
presentation of assessment results would be improved by clear a priori documentation of
the type, scope, and scale of ecological assessments.
Specific Issues and Recommendations
Although Colloquium participants emphasized broad transformative science policy needs
for ecological assessment, the Technical Panel understands that its foregoing recommendations
are visionary and will require significant time and effort to accomplish. The call for
transformative thinking regarding ecological assessment is not intended to diminish the need for
incremental improvements in specific ecological assessment applications. As such, a number of
specific recommendations for improving technical practices also surfaced. Many of the issues
are of longstanding concern in ecological assessment and would benefit from additional
development. The following list is long and ambitious and requires prioritization and flexibility.
The Technical Panel recommends that the following list be referred to the Risk Assessment
Forum Ecological Oversight Committee for further discussion and action.
Increase Training and Awareness for Ecological Assessment—Colloquium participants,
particularly newer staff, stated that not enough training was available for them or the managers
and stakeholders with whom they interact.
Quality assurance and data quality objectives (DQOs)for ecological assessment—The
available quality assurance and DQO guidance for assessments emphasizes human health issues
and techniques. For example, the DQO guidance presumes that risk characterization is
performed by determining the probability of exceeding a bright line. Few ecological assessments
have a priori bright lines, and risk characterization often involves multiple lines of evidence.
Weight of evidence—Although ecological assessments often involve multiple lines of
evidence, there is no guidance on how to weigh those lines of evidence to make inferences.
Multiple stressors—The existing guidance documents for assessing the effects of
mixtures is based on the types of data that are available for human health assessments and are
limited to chemicals.
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Receptor-specific guidance—While assessment methods are well developed for some
taxa and assemblages such as fish and benthic invertebrates, few data and no assessment
guidance are available for others such as amphibians, reptiles, and mollusks.
Stressor-specific guidance—Some stressors, such as nanomaterials, are not well
addressed by current assessment guidance.
Life-cycle analysis for product safety evaluations—A life-cycle approach to the
assessment of new chemicals and other products could improve the completeness and quality of
assessments and decisions.
Uncertainty characterization and communication—The analysis of uncertainty, other
than Monte Carlo analysis of transport and exposure models, has not been addressed by Agency
guidance. Uncertainties in ecological assessments are particularly ill defined. It should be
emphasized that condition, causal, predictive, and outcome assessments represent different
modes of investigation and will require different uncertainty characterization procedures.
State-of-science or best practices reports—Rather than developing guidance, per se, the
RAF might develop reports based on workshops or Technical Panels that summarize the best
practices with respect to an assessment problem.
Case studies—Case studies of good assessment practices are a useful adjunct to training.
They could include large scale assessments, assessments that reach no-effect conclusions in a
defensible manner, or assessments that use new types of data or methods of data analysis.
Success stories—Create a document showing how actions based on ecological risks have
resulted in improvements in the environment. This would encourage both assessors and
managers. Also because ecological successes are more apparent, they can help to justify the
Agency's actions. For example, by banning DDT, the Agency saved bird species and may have
headed off effects on humans.
Cumulative assessment—The RAF should continue developing Agency guidelines on
cumulative assessment, including a discussion of consideration of ecosystem services and
benefits.
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1. INTRODUCTION AND OBJECTIVES
Every technical practice must periodically step back, evaluate itself, and determine its
path forward. For ecological assessors in the U.S. Environmental Protection Agency (EPA or
the Agency) the impetus for reevaluation was the 10th anniversary of the Guidelines for
Ecological Risk Assessment (U.S. EPA, 1998a), an EPA Science Advisory Board (SAB) review
of ecological risk assessment practices, and a National Research Council (NRC) report on
science and decisions in the EPA. This report presents the results of that reevaluation, including
an evaluation of current practices and guidance, a path forward for improving ecological
assessment, and a rationale for the path forward based on responses to the SAB and NRC
recommendations.
The primary source of this document is an Intra-Agency Colloquium to evaluate
ecological risk and related environmental assessments at EPA, which was organized by the Risk
Assessment Forum (RAF), under the auspices of an Ecological Oversight Committee Technical
Panel. The Colloquium afforded an opportunity to catalog the types of ecological risk and
related environmental assessment approaches used by EPA and to consolidate existing guidance
and technical practices employed at EPA under an integrated framework for environmental
assessment (Cormier and Suter, 2008), and provided EPA ecological risk assessors and
ecologists a structured forum to offer recommendations on how to improve the application of
ecological assessments in Agency decision-making. The program allowed an evaluation of
where the Agency has implemented, or is in the process of implementing, SAB and NRC
recommendations, as well as gaps between Agency practice and the external science advice.
Participants recommended priority science and science policy actions to fill gaps between current
Agency practice and the SAB and NRC recommendations.
There has been little deliberate conceptual review of the field of ecological risk
assessment as a whole, or of Agency practices, since the Guidelines for Ecological Risk
Assessment (U.S. EPA, 1998a) were finalized. The guidelines were a milestone in the continuing
evolution of ecological risk assessment. Beginning in the late 1980s and early 1990s, a
conceptual shift began in environmental decision-making from biological assessment and
ecological hazard evaluation to ecological risk assessment. The shift was prompted by increased
attention to human health risk assessment processes in the federal government (NRC, 1983,
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1993, 1994), scientific advances in ecological risk assessment (Barnthouse et al., 1986;
Fava et al., 1987; Suter, 1990, 1993; Calabrese and Baldwin, 1993), and greater focus on
risk-based approaches to environmental regulation (Ruckleshaus, 1983; Thomas, 1987;
U.S. EPA, 1989a,b, 1990a,b,c,d). Recognizing the need for a process that coupled scientific
analysis to decision-making, the Agency undertook a 9-year effort, resulting in an ecological risk
assessment framework and guidelines (U.S. EPA, 1991a, 1992a,b,c, 1993, 1994a,b,h, 1996a,b,
1998a). The EPA guidelines have been evaluated by several federal agencies (CENR, 1999) and
have been found to be useful for related environmental assessments (e.g., agricultural
ecosystems, threatened and endangered species, and ecosystem management).
In 2004, the Agency compiled risk assessment principles and practices (U.S. EPA,
2004a), with the purpose of beginning a dialogue with the scientific community to enhance risk
assessment practices. It formed the basis of a debate and commentary on ecological risk
assessment in the inaugural issue of Integrated Environmental Assessment and Management
(Tannebaum, 2005; Dearfield et al., 2005; DeMott et al., 2005; Bridgen, 2005; Stahl et al., 2005).
Issues raised in the commentaries included inconsistencies in practice, the variable interpretation
of existing guidance, the need to incorporate more recent science into ecological risk assessment,
and the intermingling of science and policy.
Prompted in part by Risk Assessment Principles and Practices, the SAB convened a
workshop on the application of ecological risk assessment in environmental decision-making.
The workshop results were summarized in a special section of Integrated Environmental
Assessment and Management (Dale et al., 2008; Suter, 2008; Kapustka, 2008; Barnthouse,
2008). Widespread acceptance and success of the EPA ecological risk assessment framework
and guidelines process were acknowledged. However, frustration was also expressed with the
application of the Guidelines for Ecological Risk Assessment, the lack of Agency-wide policy or
guidance defining which ecological attributes to protect (Dale, 2008), and the method of
applying ecological risk assessment in risk management decisions.
The SAB used the workshop proceedings as a starting point for further deliberations,
resulting in an advisory report to the EPA Administrator (U.S. EPA, 2008e). Nearly
concurrently, the NRC released Science and Decisions: Advancing Risk Assessment (NRC,
2009). The primary focus of the latter report was to improve human health risk assessment; but,
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its recommendations have implications for ecological risk assessment, and some were similar to
those made in the SAB Advisory.
Taken collectively, the foregoing literature highlights a need for better understanding and
transparency of risk assessment in decision-making and policy within and beyond the Agency.
Although true for all risk assessment, the need is particularly acute for ecological risk and related
environmental assessments, which are conceptually and methodologically diverse. The
Colloquium was organized to assess the evolution of ecological assessment thinking and
experience in the Agency since 1998, and to address key recommendations found in the
2008 SAB Advisory and NRC Report. The Colloquium approach is described in Section 2, with
the following sections addressing an integrative framework for understanding ecological
assessment, the diversity in ecological risk practices and its development, and finally, the
participants' responses to the SAB and NRC recommendations.
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2. COLLOQUIUM APPROACH TO EVALUATING EPA ECOLOGICAL
ASSESSMENTS AND THE SAB AND NRC RECOMMENDATIONS
The Colloquium was organized to conduct a thorough review of the Agency's ecological
risk assessment practices and guidance in the service of preparing proposals to address the SAB
and NRC recommendations. The EPA Science Policy Council was briefed on the proposed
Colloquium to solicit comment and cross-Agency representation, and the meeting was approved
by the Risk Assessment Forum. A Technical Panel composed of representative scientists from
EPA's Office of Research and Development, Program Offices, and Regions was established to
organize the Colloquium (see Appendix A).
Preliminary evaluation of the SAB and NRC recommendation revealed that the
recommendations were multifaceted, interrelated, and ranged from very general to highly
targeted items directed to particular program offices and regulatory applications. Prior to the
Colloquium, the Technical Panel advised that the report recommendations should be
summarized, with care taken to not introduce bias. Several attempts were made to sort the
bulleted text into discrete categories, but many recommendations were inter-related,
complicating the task. The recommendations were then clustered, and redundant entries were
removed. The final summary yielded 46 recommendations (see Section 6).
Most recommendations focused on broad science policy issues and suggested future risk
assessment directions for EPA. The need for greater clarity, understanding, and communication
of the design and application of ecological assessments at EPA seemed paramount. This was
evidenced by the call for clearer a priori science policies, environmental protection goals, and
guidance, particularly at the risk assessment-risk management interface. Several longstanding
issues were also raised, including weight of evidence, cumulative risk, uncertainty analysis, and
hypothesis development in risk assessment. Finally, SAB and NRC recommended increasing
science resources, management, and training in support of risk assessment. A third of the
recommendations called for the development of additional EPA guidance. Colloquium
participants reviewed the summarized recommendations and ranked their degree of
implementation at EPA as (a) investigatory; (b) initial stages of implementation', or
(c) implemented based on current Agency practice. These responses were grouped, and
Colloquium participants offered additional comments on the recommendations in the individual
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breakout groups. The collective comments from Colloquium participants were collated into the
responses provided in Section 6.
The Agency has published a significant number of science policy and technical guidance
documents for risk assessment, in general, and ecological risk assessment, in particular.
However, these guidance documents have been developed by different EPA offices, are
dispersed, and are not available in a single comprehensive source. Although ecological risk is
often addressed in Agency-wide guidance, these documents often remain little known in the
ecological community at large. Therefore, the Technical Panel viewed consolidation of existing
guidance for use by Colloquium participants as a necessary next step after summarizing the SAB
and NRC recommendations.
The Technical Panel believed that responding to the SAB and NRC recommendations
necessitated a review of the available guidance for the various types of ecological assessments
conducted by the Agency. Over 90 documents covering science policy, technical methods and
tools, and ecological risk and related assessment applications for different decision-making
contexts were identified. Many of these documents were reviewed at the Colloquium to
determine if they provided Agency-wide or program-specific guidance. They were also
evaluated to determine if they addressed problem formulation elements (conceptual model
development, assessment endpoints, measurement endpoints); analysis elements (effects
assessment, exposure assessment); corollary issues (stakeholder involvement, risk
communication, risk management, ecosystem benefits or services, uncertainty; risk integration);
or issues of scale (biological and spatial). They were also sorted by type of assessment
(condition, causal, predictive or outcome).
The integrated framework for environmental assessment (Cormier and Suter, 2008) was
selected as a mechanism to clarify the relationship between the ecological risk assessment
framework and guidelines, and the diversity of approaches to ecological assessments applications
at EPA. The integrated framework was effectively used to categorize and differentiate the
diverse ecological assessments used at EPA. Colloquium participants were introduced to the
integrated framework by applying it to several EPA assessment scenarios, and discussing EPA
frameworks, guidance, and practice relative to the four assessment types identified in the
integrated framework (condition, causation, prediction and outcome).
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Colloquium participants (see Appendix A) were assigned to breakout groups to discuss
« Existing EPA science policy guidance for planning and scoping, problem formulation,
and risk assessor-risk manager interactions;
• The utility of the integrated framework for environmental assessments for cataloging
EPA ecological assessment types;
* EPA ecological assessment approaches - by comparing existing technical guidance and
practice with the integrated framework for environmental assessment; and
« The summarized SAB and NRC recommendations - to evaluate where the Agency has
fully or partially implemented them and to identify gaps between the recommendations
and Agency practice.
Composition of the breakout groups (see Appendix A) was fluid, collaboration between
workgroups was encouraged, and many participants contributed to more than one group.
Preliminary materials developed by the Technical Panel were expanded during breakout group
and plenary sessions to develop the Colloquium proceedings. Unstructured discussions occurred
during the Colloquium and particularly during the closing plenary session, which expanded the
scope of the Colloquium beyond the agenda. The conclusions from the breakout groups and
from those plenary discussions are summarized in Appendices E and F.
The enthusiasm of the discussions showed that the Colloquium was having an unplanned
benefit. The strong cross-Agency collaborative networks established throughout the 1990s
during the guidelines development have not been maintained, and ecological risk assessors have
been increasingly compartmentalized within specific EPA program office and research
applications. The Colloquium reinvigorated communication and clarified the need for
collaboration across a broad range of Agency ecological and environmental activities.
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3. THE INTEGRATED FRAMEWORK FOR ENVIRONMENTAL ASSESSMENT
Although the ecological risk assessment framework and guidelines were designed to meet
all ecological assessment needs, their limitations soon became apparent. Risk assessment
estimates the likelihood of undesired effects from alternative actions, but the Agency's decisions
require a variety of input implying other types of assessments. As a result, frameworks for
implementing the Total Maximum Daily Load provisions of the Clean Water Act, the
development of criteria, the Superfund process, and other programs often bear little relationship
to the Ecological Risk Assessment (ERA) framework. This disconnect has resulted in some
frustration among practitioners, and resentment of the implication that they were not performing
assessments correctly if they did not follow the ERA framework. These issues were expressed
by some participants in the Colloquium. This concern is reinforced by the NAS's 2008 Science
and Decisions report. It emphasizes that assessments should be designed to meet the needs of
decision-makers rather than following a standard process. While the ERA framework was
intended to be flexible, it has not been flexible enough to meet all of the Agency's needs for
ecological assessment.
Until the Colloquium, the question of how the existing ERA framework corresponds to
different environmental statutes and environmental decision-making contexts remained largely
unarticulated. The integrated framework for environmental assessment (Cormier and Suter,
2008) was employed by the Colloquium Technical Panel to bring organization to the ecological
risk assessment universe, and it became an overarching organizing principle during the
Colloquium. The integrated framework offered a compelling conceptual model for clarifying,
categorizing, integrating, and potentially harmonizing ecological assessment approaches and
terminology across the Agency. The integrated framework set the stage for subsequent
Colloquium discussions.
Regardless of scope, scale, objective, type, or methodology, virtually all EPA
assessments can be described using a simple lowest common denominator process (see
Figure 3-1). An assessment is typically initiated to address a regulatory or policy need to
provide information for an environmental decision or action. The process proceeds through
three steps: planning that determines the assessment scope and objectives; analysis that analyzes
data and information on underlying causal relationships (e.g., an exposure-response relationship
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and an exposure estimate); and synthesis that evaluates analytical evidence, considers
uncertainties, identifies implications of the analysis, and interprets the assembled information to
develop conclusions or recommendations. Assessment results may lead to additional
assessment, or to a management decision or action. This generic process is a useful model for
showing relationships between different assessment types, and for illustrating how the ecological
risk assessment framework has been adapted for different assessment purposes (Cormier and
Suter, 2008).
A comparison of the generic assessment process with the ecological risk assessment
framework and guidelines process (see Figure 3-2) demonstrates that the latter incorporates and
expands upon the planning, analysis, and synthesis steps. Planning is divided into planning and
problem formulation steps.
Similarly, analysis is defined further as a characterization of exposure and effects—a
cause and effect relationship that can be modeled empirically, experimentally, or by using
existing knowledge. Synthesis becomes risk characterization, where the probability of a defined
effect occurring at the characterized exposure is calculated.
Many EPA program offices and regions routinely employ the ecological risk assessment
framework and guidelines to assess the toxic risk of chemicals. This specific application is so
commonplace, that, in some quarters, "conventional ecological risk assessment" is synonymous
with estimation of direct acute and chronic risk of chemicals to organisms and populations. This
narrow view is unfortunate and clearly limits the original intent and design of the framework and
guidelines. Yet, it also reflects the reality that many ecologically oriented assessors often judge
their work to lie outside of what they see as a toxicology-oriented paradigm, more akin to human
health risk assessment than ecology. Two case examples illustrate the conceptual and practical
difficulties in characterizing certain Agency assessments as "conventional ecological risk
assessment."
Assessments to derive criteria, standards, or other benchmark values can be
conceptualized as a variant of risk assessment that does not fit the standard framework (see
Figure 3-3). Both conventional ecological risk and criterion assessments incorporate the
planning, analysis, and synthesis steps of the basic assessment process. However, there are
important differences in their underlying conceptual bases. Unlike conventional risk assessment,
which estimates the risk of an ecological effect due to an exposure, criterion assessments
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estimate a level of exposure associated with a type and level of effect that will achieve an
environmental goal (Suter and Cormier, 2008). The operational distinction between
conventional risk assessment and criterion assessment can be understood by considering the role
of the exposure-response relationship in the two assessment types. For conventional risk
assessment, an exposure-response relationship is solved for the predicted exposure level to
estimate risk (red [chronic] and blue [acute] arrows in Figure 3-4). For criterion assessment, the
exposure-response relationship is used to estimate a protective environmental concentration
(acceptable exposure level) based on prescribed effects (dashed orange arrow in Figure 3-4).
Another assessment scenario difficult to place within the conventional risk assessment
view is The Causal Analysis/Diagnosis Decision Information System or CADDIS
(http://www.epa.gov/caddis/). Originally developed in a guidance document (U.S. EPA, 2000b)
and updated in a Web-based application (http://www.epa.gov/caddis) the CADDIS Stressor
Identification framework (see Figure 3-5) was specifically designed for causal assessments. This
causal assessment framework differs from conventional risk assessment in that effects have been
found to have occurred, but the causative agent or agents are unknown. Causal assessments
begin with an observed effect and proceed to the identification of a cause or source and are,
therefore, epidemiological investigations. Note that in causal assessments, the initiator is a
condition assessment, and the decision is to perform predictive assessments to determine how to
remediate the identified cause.
These examples demonstrate that while some ecological risk and related ecological
assessments fit the conventional ecological risk assessment framework, others do not because
they are not intended to predict the environmental effects of an agent or action. Some
assessments represent modifications of the ecological risk assessment framework. Others require
new investigative frameworks to meet emerging or programmatic needs. The essential point is
that regardless of the assessment form or framework, key components of ecological assessments
at EPA remain planning, analysis, and synthesis directed toward environmental problem
resolution.
Conventional ecological risk assessment of chemicals and contaminants is deeply
embedded in EPA's mission and authorizing legislation (e.g., Toxic Substances Control Act
[TSCA], Federal Insecticide, Fungicide and Rodenticide Act [FIFRA], Comprehensive
Environmental Response, Compensation, and Liability Act [CERCLA], Resource Conservation
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and Recovery Act [RCRA], Clean Air Act, etc.) and will remain an important aspect of EPA's
work for the foreseeable future. However, the last decade has also witnessed increased calls for
integrated multidisciplinary environmental research, as well as more formal scientific integration
of all the issues that go into environmental decision-making (U.S. EPA, 2008e; NRC, 2008).
The underlying basis for integration resides in the fact that many environmental issues
(e.g., estuarine and oceanic hypoxia, global warming, reactive nitrogen, fossil fuel extraction,
biofuels development, sustainability, ecosystem services, etc.) are not resolvable by sole reliance
on conventional risk assessment of pollutants.
The value of an integrated framework is that it allows conceptualization and
categorization of different assessment types, it builds on current EPA practice and experience,
and it can be sufficiently flexible to address emerging and future environmental issues. The
framework by Cormier and Suter (2008) appears to offer all these advantages. It appears that all
assessment types conducted by EPA can be conceptualized within a 2 x 2 matrix consisting of
condition, causal, predictive, and outcome assessments (see Figure 3-6). The assessment types
may be integrated in different ways, depending on programmatic needs and objectives. In the
left column, environmental problems are detected by condition assessments that monitor the
biological, chemical, or physical conditions of a site or system, or by outcome assessments that
evaluate the adequacy of a former management action. In the right column, problems may be
solved by causal assessments that identify impairment causes and sources, and by predictive
assessments, such as conventional ecological risk assessment. Any individual assessment type
may lead to any of the other three to investigate and resolve a particular environmental problem.
Therefore, the top row (condition and causal assessments) identifies causes, while the bottom
row (outcome and predictive assessments) manages causes. In any event, the four assessment
types share a common process and can be linked within the integrated framework (see
Figure 3-7).
Condition assessments are performed by analyzing environmental monitoring results (see
Figure 3-7). These assessments determine whether the physical, chemical, or biological
conditions constitute an impairment that should be addressed. A simple condition assessment
would compare ambient chemical concentrations to ambient water quality criteria to determine
whether the criteria are exceeded. If no criteria are exceeded, no further action is necessary until
the next monitoring period. Otherwise, exceeding criteria would lead to a causal assessment.
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Causal assessments determine the probable cause of the impairment and the source of the
causal agent (see Figure 3-7). For example, if a stream is biologically impaired based on a state
bio-criterion, the causal assessment might determine that the cause is ammonia toxicity. A
subsequent source assessment might apportion the nitrogen loading among publicly owned
treatment works, confined animal feeding operations, etc. If the cause is natural or outside the
Agency's authority, no further action is taken by the Agency. Otherwise, the causal assessment
results would lead to a predictive assessment.
Predictive assessments estimate risks and predict the effects of alternative management
actions (see Figure 3-7). They include conventional risk assessments, as well as management
assessments that may integrate ecological risks, health risks, feasibility, costs, policies, and other
considerations. Predictive assessments are intended to inform an environmental management
decision concerning remediation, permitting, or other actions. They may be prompted by prior
assessments that have determined the cause of an observed impairment. More often, they are
performed de novo, as in assessments of new pesticides and industrial chemicals. Predictive
assessments end with a decision to take an action that may resolve the problem.
Following a predictive assessment, an outcome assessment may be used to determine if
the action taken successfully resolved the environmental problem (see Figure 3-7). For example,
outcome assessments are performed at Superfund sites to ensure that the contaminants are
removed or destroyed. Similarly, grants for nonpoint-source remediation awarded by the Office
of Wetlands, Oceans, and Watersheds require outcome assessments. Outcome assessments may
demonstrate problem resolution or may prompt additional risk and management assessments to
identify additional actions.
Within the integrated framework (see Figure 3-7), any of the four assessment types may
serve as a starting point. However, the process typically begins with either a condition or a
predictive assessment. Shortcuts through the process can also occur. In extreme cases, a simple
condition assessment may be sufficient. For example, a causal assessment is not needed when a
major oil spill is detected, and rather than performing a risk assessment, a response plan can be
implemented.
For this report, the integrated assessment framework provides a simple conceptual
approach for describing, categorizing, integrating, and harmonizing all EPA assessment types.
Condition, causal, predictive, and outcome assessments were each found to have utility for
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specific objectives. However, the increasingly complex environmental assessment questions
facing EPA suggest that their characterization and resolution can be enhanced by integrating
different assessment types. The integrated framework is also an aid to communication among
risk assessors, risk managers, and the general public concerning the scope of a particular
assessment or set of integrated assessments. It can be used to clarify how the different
assessment types may be combined and integrated to inform environmental decisions. During
the Colloquium, the integrated framework provided a basis for understanding common
assessment problems and needs across programs. Finally, it can be used to inform how the
four assessment types might be designed to optimize integrated assessments for environmental
decision-making. For example, an assessment may begin with a condition assessment to define a
problem, followed by problem-solving causal or predictive assessments, and culminate with an
outcome assessment.
Planning
^K^
Analysis
^K^H
Synthesis
Decision/
Action
Figure 3-1. A common process for performing environmental assessments
(Cormier and Suter, 2008).
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Framework for
Ecological Risk Assessment
PROBLEM FORMULATION
Planning
^K^
Analysis
^K^H
Synthesis
Characterization
of Ecological
Effects
Characterization
of Exposure
RISK CHARACTERIZATION
Decision/
Action
COMMUNICATE RESULTS TO
RISK MANAGER
RISK MANAGEMENT
Figure 3-2. Identification of the planning, analysis, and synthesis activities as
depicted in the Ecological Risk Assessment Framework.
Environmental Risk Assessment
Conventional Risk Assessment
Planning
Stressor and assessment endpoints
Analysis
Current or anticipated
exposures
Exposure-response
relationship
Synthesis
Type and probability of
effects at that exposure
Planning
Stressor of concern and environmental goal
Criterion Assessment
Analysis
Effects that match
environmental goal
Exposure-response
relationship
,J L,
\/ Synthesis
Level of exposure
that will achieve the goal
Figure 3-3. Comparison of conventional risk assessment and criterion
assessments (Suter and Cormier, 2008).
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1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
0.01 J.I
100 1000 10000
Environmental Concentration (p,g/L)
Figure 3-4. The acute (blue) and chronic (red) species sensitivity
distributions are examples of exposure-response models. In conventional risk
assessment, the red and blue arrows from the concentration axis (exposure) to the
potentially affected fraction (PAF) axis (effects) provide estimates of risks, j^^
is, at an exposure value of 500 (J-g/L, an estimated 39% of species would
experience acute lethality, and 83% would exceed their chronic effects levels. In
criterion assessments, the dashed orange arrow from effects to exposure
determines that the concentration that is below the chronic effects value for 95%
of species is 0.04 (J,g/L (Suter and Cormier, 2008).
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CADDIS Stressor Identification
Process
Common Assessment Process
Detect or Suspect Biological Impairment
Define the Case
^m^H
List Candidate Causes
Planning
Analysis
Evaluate Data from the Case
Evaluate Data from Elsewhere
Synthesis
Identify Probable Cause
Decision/
Action
Identify and Apportion Sources
Management Action:
Eliminate or Control Sources, Monitor Results
Problem
Resolution
Biological Condition Restored or Protected
Figure 3-5. Identification of the planning, analysis, and synthesis activities as
depicted in the Stressor Identification Framework from www.epa.gov/caddis.
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Analysis from Effect to Cause
Problem
Detection
Condition
Assessment
Problem
Solving
Causal Pathway
Assessments
Problem
Resolution
^
Outcome
Assessment
Predictive
Assessments
Analysis from Cause to Effect
Figure 3-6. The basic structure of an integrated framework for
environmental assessment (Cormier and Suter, 2008).
Problem
Detection
Problem
Solving
Causal Assessment
Figure 3-7. Specific assessment types within the integrated framework
showing the shared common assessment process (Cormier and Suter, 2008).
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4. CATEGORIZING EXISTING AGENCY PRACTICE AND GUIDANCE WITHIN THE
INTEGRATED ASSESSMENT FRAMEWORK
The foregoing conceptual overview of the integrated framework asserts that all Agency
assessments include common planning, analysis, and synthesis components, and can be
categorized as condition, causal, predictive, or outcome assessments. While it may not be
readily apparent, EPA already conducts integrated assessments. Two examples are the
Superfund and total maximum daily load (TMDL) programs (Cormier and Suter, 2008).
CERCLA, commonly known as Superfund, was passed in 1980. Following its passage,
federal agencies developed assessment and management processes to address different
provisions of the Act. EPA and state regulatory agencies perform a condition assessment to
determine if the site has been sufficiently contaminated to occur on the National Priority List
(NPL). If a contaminated site is listed, the agency and state prepare two risk assessments: a
baseline risk assessment during the remedial investigation to estimate risks from no action; and a
feasibility study to estimate risks from alternative remedial actions (U.S. EPA, 1998b). The
record of decision presents the results of a management assessment that selects the remedial
action (see Figure 4-1). An outcome assessment is a component of the Operation and
Maintenance Plan that re-evaluates the site after 5 years and may lead to the deletion of the site
from the NPL.
The TMDL process is another example of a program that integrates multiple types of
assessments. Every year, EPA files a Report to Congress listing all water bodies that states have
identified as impaired, the 303(d) List of Impaired Waters. The Clean Water Act requires that
steps be taken to restore 303(d)-listed bodies of water to acceptable, useful conditions. To
accomplish restoration, the Agency mandates that states determine the TMDL of the pollutant
that can be safely discharged, while maintaining "acceptable use" of the body of water. The
TMDL rule also requires states to develop a restoration implementation plan. Figure 4-2 depicts
the sequence of assessments involved with 303(d) listing and the TMDL determination.
Although different in form, the diagram contains all the components of the integrated
environmental assessment framework in a similar sequence. The corresponding components of
the assessment and management framework are indicated in grey oblongs: condition assessment
(listing process), causal assessment (problem/pollutant identification), risk assessment of effects
from exposure (target analysis), source assessment, risk assessment of sources (linkage of
4-1
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sources and target), management assessment (allocation to sources), and outcome assessment
(update next listing cycle).
The CERCLA and TMDL examples demonstrate that the integrated assessment
framework is already implicit in at least two Agency processes. However, the Technical Panel
and participants were interested in further evaluating the applicability of the integrated
assessment framework concepts to existing EPA processes. The evaluation was conducted in
two stages. First, interviews with Agency ecological assessors were preformed prior to the
Colloquium, and they were supplemented by review of frameworks and guidance processes
publicly available on the EPA Web site (see Appendix B). Second, at the Colloquium, a matrix
was developed that compared the integrated framework assessment types with the existing
Agency guidance documents (see Appendix C).
The first stage was initiated by interviewing practitioners in representative program
offices and regions to identify different assessment frameworks or processes used at EPA.
References obtained from interviewees, supplemented with publicly available information from
the EPA Web site were evaluated to determine what assessment types were currently being used
(see Appendix B). If one of the four assessment types was not performed, the U.S. Code for the
pertinent environmental law was consulted to determine if the salient act implied intent or
authorized or required the assessment. Table 4-1 presents a summary of the results.
The composite results indicate that the Guidelines for Ecological Risk Assessment
(U.S. EPA, 1998a) are widely used throughout EPA. Additionally, ecological epidemiology
assessments sometimes use the Stressor Identification (CADDIS) framework. The Superfund,
Air, Water, and Pesticide Programs integrate all four assessment types in certain applications.
Threatened and endangered (T&E) species assessments are also integrated, but Agency
responsibility is limited to risk assessment for pollutant exposures. Still other programs depend
on other groups to initiate or complete a sequence of assessments. For example, the Office of
Water sets water quality criteria (WQC) that are used by states, tribes, and territories to assess
the condition of surface waters. Some programs depend on the regulated entities to supply the
information and even perform the assessments upon which they will be regulated. In rare cases,
ecological assessments are initiated by citizen complaints or suits.
Although preliminary, the evaluation revealed some notable trends. Programs that
involve remediation rather than prevention are more likely to routinely use an integrating
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framework or process with different assessment types. In particular, programs that estimate
chemical and product safety do not routinely conduct outcome reviews, even where they seem to
be allowed under existing legislative authority. The relative rarity of outcome assessments is
scientifically problematic. Without them, the efficacy of risk management actions cannot be
demonstrated; and without monitoring, ecological perturbations from an environmental insult
will not be identified. Without timely detection and action, ecological damage and concomitant
remediation costs are increased. If impacts are severe, remediation may become impossible.
Three overarching assessment issues were identified by the interviews. First, overlapping
authorities were viewed as problematic for the Agency's overall mission of protecting the
environment. Independent decisions in one part of the Agency may impact the ability of other
programs, regions, or states to realize their mission. Overlapping authorities seem to create
two kinds of constraints: (1) no individual program may see a particular issue as being within its
area of responsibility; and (2) different expectations and assumptions embedded in different
frameworks, processes, or technical methods may lead to conflicting assessment results or
decisions. A common integrated framework for assessment and decision-making could provide
the conceptual basis for linking across programs and regions. Second, all interviewees
recognized the importance of involving stakeholders in assessment processes. Regional
scientists, in particular, recounted various situations where success or failure was determined by
stakeholder engagement and involvement. The current ecological risk assessment framework
(U.S. EPA, 1998a) suggests stakeholder involvement before and after the assessment process.
However, regions and states often engage stakeholders throughout the assessment process.
Third, all interviewees voiced a preference for transparent processes and assessments. They
suggested that stakeholder involvement could be strengthened by documenting and publishing
assessment and decision-making processes.
Additional challenges were noted by multiple participants in the interviews and
Colloquium. Certain assessments could be made more transparent if their non-sensitive aspects
could be released while still protecting confidential business and proprietary information. The
recognition by EPA assessors of the importance of stakeholders and transparency is consistent
with the recommendations of review panels (NRC, 2009).
At first glance, frameworks and guidance for ecological risk assessment among different
EPA programs often appear to be dramatically different. However, it was found through the
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interviews and Colloquium that the assessment needs are similar, and virtually all Agency
assessments can be categorized as condition, causal, predictive, or outcome assessments. More
importantly, the four assessment types can be used individually or integrated for different
applications. Clearly, a common framework and terminology for ecological risk assessment has
fostered communication among risk assessors. Similarly, broader Agency adoption of the
integrated assessment framework and its terminology could improve communication and
understanding among risk assessors, risk managers, and stakeholders. Improved communication
could also assist the development of Agency-wide best practices between risk assessors and risk
managers and help teams understand the respective roles of each contributor. Finally, adoption
of the integrated assessment framework and terminology would promote deliberate thinking
about the strengths and limitations of the four assessment types, assist in promoting integrated
assessments for complex assessment scenarios, and, ultimately, provide an iterative feedback
loop between scientists and decision-makers, resulting in better environmental decisions.
Importantly, integrated assessments are already practiced in some EPA programs
(e.g., Water, Air, and Superfund) for certain issues. More importantly, they have demonstrated
that integrated assessments can effectively resolve environmental problems under their purview.
However, the differences among the four types of assessments may remain unrecognized by both
practitioners and decision-makers. Broad Agency adoption of the integrated assessment
framework would provide more opportunities to refine and integrate assessments; more frequent
application of outcome assessments; and improve knowledge concerning the environmental
performance of risk management actions. Directly coupling technical assessments with outcome
assessments through feedback loops would also promote wider application of adaptive
management (i.e., a structured process for implementing policy decisions as an ongoing activity
that requires monitoring and adjustment) into environmental problem-solving and
decision-making.
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Table 4-1. Composite summary of interviews and EPA Web site review to
survey available guidance for each type of environmental assessment.
Program
OSRTI
R6 CERCLA,
RCRA
OAR/OAQPS
OPPTS/OPPT
OPPTS/OPPE
Reg PPCP
Reg TMDL,
NPDES
Reg Landscape
RoE
OW-T&E
OWWQC
OW Drinking
Framework or
Guidance
P
P,Rg,St
A
P
P
A
BPJ
R
BPJ
A
A
A
Condition
Cn
Cn
Cn
Cn
Cn
Cn
Cn
Causal
C,S
C,S
C,S
C,S
s
s
Predictive
R,B,M
R,B,M
R,B,M
R,B,M
R,B,M
R,B
R,B,
R,B
B
M
Outcome
O
O
O
O
6-yr
review
Letter with grey-fill is performed by the program.
Letter with white-fill is performed by others.
Grey-fill alone is part of regulatory authority, but not usually performed.
White-filled alone is not performed and not part of the regulatory authorities for the mission of this program.
programmatic (P), regional (Rg), state (St), agency (A), best professional judgment (BPJ) condition (Cn), cause (C),
source (S), risk (R), benchmark/criteria (B), management (M), outcome (O).
OAQPS = Office of Air Quality Protection and Standards; OAR = Office of Air and Radiation; OPPT = Office of
Pollution Prevention and Toxics; OPPTS = Office of Prevention, Pesticides and Toxic Substances; OSRTI = Office
of Superfund Remediation and Technology Innovation; OW = Office of Water; PPCP = pharmaceuticals and
personal care products; RoE = Report on the Environment.
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Site Assessment Phase
Site
Discovery
i
Preliminary
"" Assessment (PA)
\^ Condition ]
r
Remedial
Investigation (RI)
Feasibility Study
(FS)
Site Assessment
_> (SI)
Expanded Site
Inspection (ESI)
Hazard Ranking
System (MRS)
Caus
Pathv
Remedial Phase
Record of
Decision (ROD)
/ i
Remedial Design
— > (RD) Remedial
Action (RA)
Operati
(O&
— r
,al 1_
/ay )
an and
nance
M)
i—
-
National Priorities
List (NPL)
i i
— I
NPL
Deletion
Risk
Outcome
Figure 4-1. Superfund process and integrated assessment (U.S. EPA, 1998b).
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Priority ranking
Identify impaired and
threatened waters
needing TMDLs
Develop
schedule
f
Listing Process of
Integrated Monitoring and
Assessment Report
Identify \NQS attainment
status of all waters
Sufaml
303(dHistw(th30S:bi
as part of Integrated Report
\
State develops listing
methodology
303(d)list
approved?
YES
Intiale TMDL development
according to schedule.
EPA establishes
or approves TMDL?
Problem/pollutant
identification
\
TMDL submittal
TMDL
Establishment
Process
Monitoring schedule
Target analysis
(amount by which pollutant must
be reduced to meet WQS)
Source
assessment
\
Alocabon to
sources or categories
of sources
Linkage of
sources and target
Figure 4-2. Process for listing impaired waters and determining total
maximum daily loads (U.S. EPA, 2002b).
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5. EXISTING GUIDANCE FOR ECOLOGICAL ASSESSMENTS AT EPA
The large body of guidance for ecological risk assessment and environmental risk
assessment in general is not as helpful as it might be. Several factors may account for this
problem. First, the guidance spans nearly two and a half decades. Although not often explicitly
stated, elements of newer guidance and practice typically supersede older guidance and practice.
Additionally, individual guidance documents reflect the state-of-science policy and science at the
time they were written. Early guidance did not develop in a sequential or coordinated way by the
Agency as a whole but reflects individual historical programmatic or regional needs and
mandates with little consideration of other EPA programmatic or regional practice. In fact, an
underlying rationale for the development of the Ecological Risk Assessment Guidelines
(U.S. EPA, 1998a) and later general risk characterization guidance (e.g., U.S. EPA, 2003b) was
to promote more consistent use of terminology and practice at EPA.
Second, the guidance is not available in any organized manner. The guidance needed for
a particular issue may be found in any one of various documents in various locations. It may be
in an Agency-wide, programmatic, or regional document, and the title may not be a good or
complete guide to the contents.
Third, the guidance may not be in a useful form. Rather than a traditional report,
guidance may be more useful if it takes the form of examples, responses to frequently asked
questions, short state-of-practice white papers, exemplary case studies, expert systems, decision
support systems, or other forms.
Finally, some important topics still have not been adequately addressed. For example,
many Agency assessments weigh multiple lines of evidence to derive a value, categorize a
chemical, or even derive a final conclusion concerning conditions, causes, or risks. However, no
guidance has been provided for that inferential process. Similarly, there is no guidance for
communicating ecological issues when interacting with decision-makers or stakeholders.
This section begins to address these issues. First, a conceptual and historical review of
relevant guidance is presented. Second, relevant guidance is listed and organized in terms of
properties that are indicative of its utility.
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5.1. A CONCEPTUAL AND HISTORICAL REVIEW
The collective body of guidance can be viewed from various perspectives (e.g., technical
issues, objectives, authorizing legislation and regulatory applications, research applications, etc.).
Documents like the Ecological Risk Assessment Guidelines (U.S. EPA, 1998a), Risk
Characterization Handbook (U.S. EPA, 2000d), the Framework for Cumulative Risk Assessment
(U.S. EPA, 2003a), and Risk Assessment Principles and Practices (U.S. EPA, 2004a) are
considered science policy guidance rather than technical guidance. Typically, science policy
guidance provides broad EPA-wide concepts and principles for conducting risk and other kinds
of assessments. Technical guidance, on the other hand, focuses on specific scientific
methodologies and procedures to be used during the analytical phase of an assessment.
The development of science policies, techniques, and applications is a dynamic, often
little known, processes. The distinction between science policy and technical guidance is
important for understanding how ecological risk practices have evolved differently across the
Agency. Generally, EPA programs and regions must meet different legislative mandates and
legal requirements under their respective purviews. In practice, this means that programs and
regions have developed targeted regulatory policies, science policies, and technical guidance
independently and in keeping with their individual regulatory missions.
In cases where science policies or technical practices of one program office significantly
impact that of another program office, Agency coordination vehicles come into play. An
example is the collaboration between the Office of Pesticides and the Office of Water to share
data and harmonize ecological risk assessment approaches for registration of pesticides and the
development of pesticide ambient water quality criteria for the protection of aquatic life. Several
major Agency science coordinating bodies exist. The Science Policy and Technology Council
develops, reviews, and approves Agency-wide science and science policy guidance, whereas the
RAF initiates the development of primarily Agency-wide technical, scientific guidance. Science
coordination and review for rulemaking may also occur through the Office of Policy or the
Office of Research and Development's Office of Science Policy.
The following highlights of developments in science policy for ecological assessments
dispel the perception by some that the variability of ecological risk assessments across the
Agency is disorderly. Biological and ecological assessments are longstanding in pollution
impact studies (e.g., Cairns et al., 1972) and predate the hazard evaluation process (e.g., Cairns et
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al., 1978), which, in turn, predates the ecological risk assessment process. Ecological risk
assessment at EPA arose and coevolved with human health risk assessment in a diverse
regulatory decision-making context (Suter, 2008).
Several NRC reports (NRC, 1983, 1993, 1994, 1996, 2008) have heavily influenced the
development of Agency-wide risk assessment science policy guidance at EPA (U.S. EPA, 1997a,
1998a, 2001a,b, 2002a, 2003a,b). With the exception of the Guidelines for Ecological Risk
Assessment (U.S. EPA, 1998a) and related documents, the primary focus of the NRC and EPA
documents is on human health risk. As a result, the former documents may not be as well known
in the ecological risk and broader ecological assessment communities. Nevertheless, they
provide the necessary background for understanding risk assessment science and science policy
at EPA.
From its inception, risk assessment has been recognized as a scientific process that
informs risk management decisions. Risk Assessment in the Federal Government: Managing the
Process or the Red Book (NRC, 1983) recommended that regulatory agencies
take steps to establish and maintain a clear conceptual distinction between risk
assessments and consideration of risk management alternatives; that is, the
scientific findings and policy judgments embodied in risk assessments should be
explicitly distinguished from the political, economic and technical consideration
that influence the choice of regulatory strategies.
Some 10 years later, Issues in Risk Assessment or the Blue Book (NRC, 1993) proposed a
paradigm for environmental risk assessment. It recognized the need for two-way communication
between risk assessors and risk managers, and the utility of involving the public while preparing
risk assessments to ensure effective communication. The Blue Book recommended
communication between modelers, risk assessors, and managers should be
mutual, iterative, timely and flexible. Risk assessment will be valuable as support
to the risk management process only if the assessments address the right problem
and if the managers who are the users of the products of risk assessment
understand them.
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The Blue Book reiterated maintenance of a clear conceptual distinction between risk
assessment and risk management alternatives. However, a year later, Science and Judgment in
Risk Assessment (NRC, 1994) seemed to reverse that recommendation by stating
A more subtle and less widely recognized impediment to good decision-making
on risk arises from a rigid adherence to the principle of separating risk assessment
from risk management.. .The purpose of separation, however, was not to prevent
any exercise of policy judgment at all when evaluating science or to prevent risk
managers from influencing the type of information that assessors would collect,
analyze, or present. Indeed the Red Book made it clear that judgment (also
referred to as risk assessment policy or science policy) would be required even
during the phase of risk assessment. The present committee concludes further
that the science-policy judgments that EPA makes in the course of risk assessment
would be improved if they were more clearly informed by the Agency's goals and
priorities in risk management.
The NRC publications demonstrate movement away from the distinct separation of risk
assessment as a stand-alone scientific exercise to one that seeks information from risk managers
prior to beginning analyses. More importantly, they differentiate between science and science
policy. Neither science nor science policy represent environmental decisions per se; rather, they
represent the assumptions, objectives, data, estimates, data interpretation, and judgments
concerning the risk that may occur for the defined conditions specified in a particular risk
assessment design.
The ecological risk assessment framework and guidelines represent a significant
developmental effort at EPA. In 1990, the EPA RAF initiated a program to develop ecological
risk assessment guidelines to support environmental statutes. The effort began with a series of
workshops that were intended to build upon information from the broader scientific community
(U.S. EPA, 1991a, 1992a,b,c). The workshops resulted in broad scientific endorsement for an
ecological risk assessment framework that envisioned (1) planning discussions between risk
assessors and risk managers prior to problem formulation and additional discussions following
completion of risk characterization and (2) an assessment process consisting of problem
formulation, analysis, and risk characterization.
The framework provided a consensus foundation for further development of the
Guidelines for Ecological Risk Assessment. Also, over several years, the framework was
increasingly accepted by the scientific community, federal agencies, and international
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organizations. The framework was followed by the development of case studies (U.S. EPA,
1993, 1994h) and issue papers (U.S. EPA, 1994b,c) that examined the utility of the framework in
various EPA program office and regional applications. The case studies were evaluated to
determine if they (1) effectively addressed general components of the ecological risk assessment
framework (problem formulation, analysis, risk characterization); (2) addressed some but not all
of the components; or (3) provided an alternative approach to assessing ecological effects. The
case studies were subsequently used with the framework report to provide a foundation for the
draft (U.S. EPA, 1996a,b) and final (U.S. EPA, 1998a) Guidelines for Ecological Risk
Assessment. Case studies were also evaluated to demonstrate the utility of the guidelines to a
range of applications across several federal agencies (CENR, 1999) that included regulatory
applications for chemicals (e.g., TSCA, FIFRA, CERCLA), and ecological evaluation of non-
indigenous species, agricultural ecosystems, endangered and threatened species, and ecological
assessments in ecosystem management.
Conceptually, there is widespread agreement that risk assessors, who develop scientific
information and analyses for use in decision-making, and risk managers, who use such
information in the decision-making process, both need to be involved in planning ecological risk
assessments. This issue is clearly addressed in the Guidelines for Ecological Risk Assessment
(U.S. EPA, 1998a), which state
Both risk managers and risk and risk assessors should be involved in planning
activities for ecological risk assessment. Risk managers charged with protecting
the environment can identify information they need to develop their decision, risk
assessors can ensure that science is effectively used to address ecological
concerns, and together they can evaluate whether a risk assessment can address
identified problems. However this planning process is distinct from the scientific
conduct of the risk assessment. This distinction helps ensure that political and
social issues, while helping to define the objectives for the risk assessment, do not
introduce undue bias.
In practice, however, roles of risk managers and risk assessors in the planning, problem
formulation, conduct of a risk assessment, and risk communication remain ambiguous. Various
authors have attempted to characterize ecological risk assessor and risk manager relationships
(Maki and Slimak, 1990; U.S. EPA, 1994d, 1995b, 2001a; De Pyster and Day, 1998;
Barbour et al, 2004; Swindoll et al, 2000; Stahl et al, 2001). However, the existing literature
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typically provides an ecological risk assessor's perspective of risk management and addresses
environmental decision-making in specific applications.
At EPA, risk assessment (evaluation of science) and risk management (decision-making,
setting of policy) are distinct but not separate. EPA's Risk Characterization Handbook
(U.S. EPA, 2000d) describes in detail the roles of the risk assessor and risk manager in the risk
assessment process. The NRC report Understanding Risk (NRC, 1996) supports the concept that
risk assessment is conducted for the purpose of supporting risk management, and risk
management consideration shapes what is addressed in the risk assessment. Suter (2008)
credited the framework's primary innovation as the identification of planning and problem
formulation steps. Barnthouse (2008) stated that the problem formulation phase was a key
innovation that recognized that the scope and content of an ERA depended on the problem at
hand and needed to be discussed with the risk manager and stakeholders before initiation of the
assessment. The NRC (2008) recently conducted a detailed review of its earlier
recommendations (NRC, 1983, 1993, 1994, 1996) as well as existing EPA guidance concerning
science policy and the risk assessment and risk management interface (U.S. EPA, 1997a,b,
1998a, 200Ib, 2002a, 2003a,b, 2004a). They recommended EPA "focus greater attention" on
planning and scoping and problem formulation as described in ecological and cumulative risk
assessment guidance. In keeping with EPA guidance, the NRC (2008) discusses planning and
scoping (U.S. EPA, 2003a, 2004a) and problem formulation (U.S. EPA, 1998a, 2003a, 2004a) as
discrete aspects of risk assessment design. It further states that both planning and scoping stages
are necessary to ensure that the form and content of a risk assessment are determined by the
nature of the decision to be determined. The NRC (2008) concisely defined planning and
scoping as a deliberative process that assists decision-makers in defining a risk-related problem,
and problem formulation as a technically-oriented process that assists assessors in operationally
structuring the assessment The NRC also acknowledged that incorporation of these stages in
the risk assessment process is inconsistent.
The Agency document Guidance on Cumulative Risk Assessment. Part 1. Planning and
Scoping (U.S. EPA, 1997a), although devoted to human health, is applicable to all assessments
conducted by EPA. The document defines planning and scoping as follows:
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During planning and scoping, risk assessors, such other technical experts as
ecologists, toxicologists, economists and engineers, and risk managers work
together as a team, informed by stakeholder input, to develop the rationale and
scope for the risk assessment and characterization, specifically to determine the
following:
• purpose and general scope of the risk assessment;
* products needed by management for risk decision-making;
• approaches, including a review of the risk dimensions and technical elements
that may be evaluated in the assessment;
* relationships among potential assessment end points and risk management
options;
• an analysis plan and a conceptual model;
* resources (for example, data or models) required or available;
• identity of those involved and their roles (for example, technical, legal, or
stakeholder advisors); and
• schedule to be followed (including provision for timely and adequate
internal, and independent, external peer review).
The Guidelines for Ecological Risk Assessment (U.S. EPA, 1998a) were specifically
designed to improve the quality and consistency in ecological risk assessments among the many
and varied Agency program office and regions. They do not provide detailed guidance, nor are
they prescriptive. They provide a flexible process to organize and analyze data, information,
assumptions, and uncertainties to evaluate the likelihood of adverse ecological effects. The
guidelines make an explicit distinction between planning and problem formulation. Planning is
identified as a phase that precedes the development of the risk assessment and is described as the
stage in the risk assessment process where agreements are made about the management goals,
the purpose for the risk assessment, and the resources available to conduct the work. These
guidelines identify problem formulation as the first phase in the risk assessment process proper.
The document notes that during problem formulation
The purpose for the assessment is articulated, the problem is defined, and a plan
for analyzing and characterizing risk is determined. Initial work in problem
formulation includes the integration of available information on sources, stressors,
effects, and ecosystem and receptor characteristics. From this information two
products are generated: assessment endpoints and conceptual models. Either
product may be generated first (the order depends on the type of risk assessment),
but both are needed to complete an analysis plan, the final product of problem
formulation.
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EPA's Risk Characterization Handbook (U.S. EPA, 2000d) also provides in-depth
discussion of planning and scoping and was intended for all scientific assessments at EPA.
Specifically, it recommends that during the planning and scoping phase of the risk assessment
process, risk assessors and risk managers should engage in dialogue to identify and characterize
the following issues
» Motivating need for the risk assessment (e.g., regulatory requirements, public concern,
scientific findings, other factors
* Management goals, issues, and policies needing to be addressed
» Context of the risk
» Scope and coverage of the effort
• Current knowledge
» What and where are the available data
» An agreement about how to conduct the assessment including identification of
o resources available to do the assessment
o participants in the process
o plans for coordinating across offices, other agencies, and with stakeholders
o schedules (e.g., milestones and time frame)
» Plans for how the results will be communicated to senior managers and the public
* Information and data needs for other member of the "team" to conduct their analyses
(e.g., economic, social, or legal analyses).
The Risk Characterization Handbook also includes several important insights concerning
planning and scoping effort. Foremost, planning and scoping discussions should focus on the
needs for the assessment effort, not the assessment results. Products that can emerge from
planning and scoping process are the conceptual model and its associated narrative and the
analysis plan.
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The Agency also released Lessons Learned on Planning and Scoping for Environmental
Risk Assessments (U.S. EPA, 2002a), which was meant to be a catalyst for encouraging agency
managers to adopt formal planning and scoping as part of EPA's culture, especially when
conducting significant or unique environmental assessments. The document provided lessons
learned from case studies after release of Guidance on Cumulative Risk Assessment. Part 1.
Planning and Scoping (U.S. EPA, 1997a). The Lessons Learned document identified the
following key lessons learned from the case studies
1. Early and extensive involvement of the risk manager (decision maker) helped
focus the process toward a tangible product.
2. Purporting that planning and scoping will be quick and easy is likely to be
counterproductive; it is a lot more work than people assume. However, it
ultimately saves time by helping to organize everyone's thinking and should
result in a better quality assessment.
3. Stakeholder engagement is essential at the beginning, because their patience is
directly proportional to their sense of influence in the process. They have been
helpful in identifying important public health endpoints that were not initially
considered by EPA in the process of developing a conceptual model.
4. Conceptual models are helpful in demonstrating how one program relates to other
regulatory activities as well as the relationships between stressors and effects
beyond traditional regulatory paradigms.
5. Debate over terminology and brainstorming sessions was necessary to reach a
consensus in the practice. A clear set of definitions would aid this process.
6. The planning and scoping process cannot be prescriptive, because the context of
each situation is different. Planning and scoping is particularly valuable when the
assessment will be complex, controversial, or precedential. At this time, planning
and scoping should precede cumulative risk assessments.
7. Clear objectives, resource commitments, and estimated schedules from
management will drive the approach and level of detail that can be considered.
8. Explaining uncertainty to stakeholders is critical despite a hesitancy to reveal all
that is known and not known about chemicals risks. While revealing these
uncertainties may lead to criticism and political ramifications, it can also develop
a sense of trust, credibility, and support for the decision making process.
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The Framework for Cumulative Risk Assessment (U.S. EPA, 2003 a) further discussed
planning, scoping, and problem formulation. A key point made in this document is that...
During planning and scoping, risk experts (including those involved in assessing
risk, such as ecologists, toxicologists, chemists, and other technical experts such
as economists and engineers), and decision makers work together as a team,
informed by stakeholder input, to develop the rationale and scope for the risk
assessment and characterization.
Several of the EPA guidance documents that describe planning, scoping, and problem
formulation make the point that although steps are frequently described as a sequence, each step
may go through several iterations as additional information is gathered.
In summary, EPA general guidance for risk assessment (see Table 5-1) has evolved over
a period of years. Interestingly, planning and scoping and problem formulation were introduced
in guidance for specific applications (i.e., ecological risk assessment, cumulative risk, aggregate
exposure) prior to inclusion in more general assessment guidance. Nevertheless, guidance for
risk assessor and risk manager roles and responsibilities; stakeholder involvement in planning,
scoping, and problem formulation; and general risk characterization principles are well
developed and relevant to all assessments conducted throughout EPA. In addition to
Agency-wide guidance, several other documents address risk assessor-risk manager interactions.
The Office of Prevention, Pesticides, and Toxic Substances published Ecological Risk: A Primer
for Risk Managers (U.S. EPA, 1995b). Ecological Risk Assessment and Risk Management
Principles for Superfund Sites (U.S. EPA, 1999a) and Role of the Ecological Risk Assessment in
the Baseline Risk Assessment (U.S. EPA, 1994d) specifically address risk management within
the Superfund Program.
A set of six guidance documents provide the basis for the ecological risk assessment
process and practice at EPA (see Table 5-2). These documents are in conceptual harmony and
provide a general paradigm for ecological risk assessments within EPA, approaches toward
specific ecological risk assessment applications (e.g., cumulative and probabilistic risk),
development of ecological assessment endpoints, and EPA program-specific ecological risk
assessment guidance (Superfund, pesticides, and air programs). The latter documents contain
information and guidance to promote the application and use of ecological risk assessment in risk
management decision-making, risk assessor and risk management interactions, problem
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formulation, and specific inputs to the components phases of ecological risk assessment
(e.g., hazard or toxicity assessment). The general documents mentioned above are often
supplemented with additional program office-specific guidance and guidelines.
Although the concept of risk implies uncertainty concerning outcomes and uncertainty is
quantified as probability, there is little Agency guidance on probabilistic risk assessment (see
Table 5-3). However, this is an active area for the RAF.
The Superfund program has a number of program-specific guidance documents that
address process and data needs (see Table 5-4). Guidance documents for the analysis phase
address data to be used in ecological risk assessments, as well as the evaluation of data quality
within data quality objectives, and the use of "qualified" analytical data.
While not risk assessment methods per se, the Office of Prevention, Pesticides and Toxic
Substances (OPPTS) harmonized test guideline library provides numerous study guidelines used
to generate data on pesticides and industrial chemicals. The harmonized test guidelines specify
methods that EPA recommends be used to generate data that are submitted to EPA to support the
registration of a pesticide under the FIFRA (7 U.S.C. 136), or the decision-making process for an
industrial chemical under the TSCA (15 U.S.C. 2601). Data submitted to EPA using the
harmonized guidelines are used by the Agency to perform risk assessments and to make
regulatory decisions. The test guidelines are arranged in topical series, including product
properties (Series 830), fate transport and transformation (Series 835), ecological effects
(Series 850), microbial pesticides (Series 885) and endocrine disrupters (Series 890). These test
guidelines are available at http://www.epa.gov/oppts/pubs/frs/home/guidelin.htm.
Another set of guidance addresses methodologies for assessing particular ecological
responses to stressors (see Table 5-5). General guidance for stressor identification, assessment
endpoint identification, watershed assessments, and population assessments has been developed
by the Office of Research and Development or the RAF. Additionally, stressor specific guidance
has also been developed.
Guidance for developing chemical and physical (e.g., dissolved oxygen, salinity, etc.)
criteria to protect aquatic life (U.S. EPA, 1985) appeared about 25 years ago and has been used
to develop over 120 water quality criteria. However, distinctly different approaches and
guidance has also been established for nutrient criteria, biological criteria, coastal dissolved
oxygen, and suspended and bedded sediments (U.S. EPA, 1996c, 2000c, 2000f, 2006b).
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Approximately 30 technical and policy documents have been developed for nutrients
(nitrogen and phosphorus) in rivers, streams, lakes, reservoirs, wetlands, and estuaries in
different ecoregions of the United States (http://www.epa.gov/waterscience/criteria/nutrient).
The ecoregional nutrient criteria represent surface water conditions associated with minimal
impacts caused by human activities and may be used as baselines identify problem areas, provide
the basis water quality criteria, and assist in evaluating eutrophication reduction programs.
Twenty-seven documents have been developed on biological assessment and biocriteria
(http://www.epa.gov/bioindicators/html/publications.html). These documents describe
bioassessment methods for studying the structural and functional integrity of aquatic
communities (fish, insects, algae, plants, and other organisms) within aquatic ecosystems.
Biocriteria are the qualities of the biological communities necessary for a desired condition, and
they represent a benchmark against which assessment results are compared. Current documents
cover field and laboratory methods for streams and rivers, coral reefs, lakes, wetlands, and
estuaries.
The Agency has also developed a framework for suspended and bedded sediments, and
procedures and guidelines for deriving equilibrium partitioning sediment benchmarks for
nonionic organics, several pesticides, and metal and PAH mixtures (available at
http://www.epa.gov/waterscience/criteria/sediment/). Additionally, the Agency has developed
frameworks for assessing metals and polychlorinated biphenyls (PCBs), biphenyls and furans,
and specific guidance for soil-screening levels (see Table 5-5).
The foregoing discussion demonstrates that existing Agency guidance is fairly extensive
and addresses all phases of the Ecological Risk Assessment process (problem formulation,
analysis, and risk characterization). More recent guidance and guidance in development tend to
focus upon specific technical issue or approaches, rather than core ecological risk assessment
elements. However, some broad issues have been neglected such as ecological risk
communication, uncertainty, weighing evidence, and assessment types other than risk
assessments.
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5.2. A COMPILATION AND ORGANIZATION OF EXISTING GUIDANCE
Agency documents covering science policy, technical methods and tools, and ecological
assessment applications were identified and reviewed to ascertain their defining attributes. A
table of guidance documents was prepared (see Appendix C) characterizing the type of
assessment considered (condition, causal, predictive, outcome), whether they provided
Agency-wide or program-specific guidance, and if they addressed problem-formulation elements
(conceptual model development, assessment endpoints, measurement endpoints); analysis
elements (hazard assessment, exposure assessment); corollary issues (stakeholder involvement,
risk communication, risk management, ecosystem benefits or services, uncertainty, risk
integration); or scale elements (biological and spatial). The table illustrates that Agency
guidance for risk assessment, in general, and ecological assessment, in particular, is extensive
and needs to be better organized and presented so as to be useful to assessors, decision-makers,
and stakeholders.
One of the goals of the effort that generated the table was to categorize the existing
guidance so that the quality and quantity of guidance on topic areas could be evaluated. It was
successful in doing that, and this resulted in two important findings: (1) that the Agency
guidance does already conform to the integrated framework adopted by the Colloquium; and
(2) that ecological risk communication guidance is missing.
Table 5-1. EPA-wide risk assessment polices, principles, and guidance
Guidance on Cumulative Risk Assessment. Part 1. Planning and Scoping (U.S. EPA,
1997a)
EPA Risk Characterization Program Memorandum (U.S. EPA, 1995a)
Guidelines for Ecological Risk Assessment (U.S. EPA, 1998a)
Risk Characterization Handbook (U.S. EPA, 2000d)
Lessons Learned on Planning and Scoping for Environmental Risk Assessments (U. S
2002a)
EPA,
Framework for Cumulative Risk Assessment (U.S. EPA, 2003a)
Risk Assessment Principles and Practices (U.S. EPA, 2004a)
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Table 5-2. General ecological risk assessment polices, principles, and
guidance
Framework for Ecological Risk Assessment (U.S. EPA, 1992a)
Ecological Risk Assessment Guidance for Superfund: Process for Designing and Conducting
Ecological Risk Assessments, Interim Final (U.S. EPA, 1997b)
Guidelines for Ecological Risk Assessment (U.S. EPA, 1998a)
Generic Ecological Assessment Endpoints (GEAEs) for Ecological Risk Assessment (U.S. EPA,
2003b)
Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs
(U.S. EPA, 2004b)a
Air Toxics Risk Assessment Reference Library, Chapter 26: Ecological Risk Characterization
(U.S. EPA, 2004c)
ahttp ://www. epa.gov/espp/consultation/ecorisk-overview.pdf.
Table 5-3. General probabilistic risk assessment polices, principles, and
guidance
Guiding Principles for Monte Carlo Analysis (U.S. EPA, 1997c)
Risk Assessment Guidance for Superfund: Volume III—Part A, Process for Conducting
Probabilistic Risk Assessment (U.S. EPA, 200 la)
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Table 5-4. Superfund program-specific guidance
Risk Assessment Guidance for Superfund, Volume I, Human Health Evaluation Manual,
Parts A-Fa (U.S. EPA, 1989c, 1991b,c, 2001c, 2004d, 2009c)
Guidance for Data Useability in Risk Assessment (Parts A and B) Final (U.S. EPA, 1992e,f)
Eco Update Supplements to Ecological Risk Assessment Guidance for Superfund (U.S. EPA,
1997d) including: Using Toxicity Tests in Ecological Risk Assessments (U.S. EPA, 1994e);
Catalogue of Standard Toxicity Tests for Ecological Risk Assessment (U.S. EPA, 1994f); and
Field Studies for Ecological Risk Assessment (U.S. EPA, 1994g)
Screening Level Ecological Risk Assessment Protocol for Hazardous Waste Combustion
Facilities, Peer Review Draft (U.S. EPA, 1999b)
Interim-Final Guidance for RCRA Corrective Action Environmental Indicators (U.S. EPA, 1999c)
OSWER Directive: Revised Interim Soil Lead Guidance for CERCLA Sites and RCRA Corrective
Action Facilities (U.S. EPA, 19941)
A Summary of General Assessment Factors for Evaluating the Quality of Scientific and
Technical Information (U.S. EPA, 2003c)
a A series document available at http://www.epa.gov/oswer/riskassessment/ragsa/index.htm.
OSWER = Office of Solid Waste and Emergency Response
Table 5-5. Guidance on stressors, responses, endpoints, and benchmarks
Watershed Ecological Risk Assessment (U.S. EPA, 2000a, 2008c)
Stressor Identification Guidance Document (U.S. EPA, 2000b)
Generic Ecological Assessment Endpoints for Ecological Risk Assessment (U.S. EPA, 2003b)
Risk Assessment Forum Technical Workshop on Population-level Ecological Risk Assessment
(U.S. EPA, 2009a)
Guidelines for Deriving Numerical National Water Quality Criteria for Protection of Aquatic
Organisms and Their Uses (U.S. EPA, 1985)
Nutrient Criteria Documents3
Biological Assessment and Biocriteria Documents3
Framework for Developing Suspended and Bedded Sediments (SABS) Water Quality Criteria
(U.S. EPA, 2006b)
Sediment Benchmark Documents3
Framework for Application of the Toxicity Equivalence Methodology for Poly chlorinated
Dioxins, Furans, and Biphenyls in Ecological Risk Assessments (U.S. EPA, 2008c)
Framework for Metals Risk Assessment (U.S. EPA, 2007c)
Guidance for Developing Ecological Soil Screening Levels (U.S. EPA, 2005)
aA series of documents only briefly discussed here. Web site addresses are provided in the text.
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6. RESPONSE TO THE SAB AND NRC RECOMMENDATIONS
The SAB and NRC called for clearer science policies and processes, environmental
protection goals, and guidance, particularly concerning the risk assessment-risk management
interface (NRC, 2009; U.S. EPA, 2008e). Several long-standing risk assessment issues were
raised including clarification of lines of evidence, weight-of-evidence, cumulative risk,
uncertainty analyses, and hypothesis development in risk assessment. A number of
recommendations also call for EPA to address broader spatial, temporal, and biological scales;
global change; and adaptive management including post-decision auditing and monitoring in its
assessments. Finally, recommendations concerning resources, management, and training were
offered. These categories of recommendations are presented in tables and responses are
discussed in this section.
The recommendations were generally directed to the Agency as a whole. However, as
noted earlier, assessments conducted by different program offices or regions can vary
significantly. Some of the recommendations are in initial stages of implementation, or are
partially or fully implemented within specific program offices or regions. Others are being
investigated by EPA research and development programs. As new science develops through
research, it moves into programmatic and regional operations as needed, depending upon
programmatic mission, objectives, and necessity.
These circumstances make a point-by-point response to each recommendation difficult.
Therefore, the Technical Panel and Colloquium participants focused on developing general
responses to the substantive cross-cutting recommendations. This approach was based on an
understanding that significant science advancements at EPA often occur through shifts in
thought, rather than continuous incremental improvements of existing processes. The nature of
the recommendations suggested that transformative thinking was more important for advancing
the application of ecological assessments in environmental decision-making than incremental
process and technical improvements.
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6.1. ASSESSMENT PROCESSES
Although the first six NRC recommendations (see Table 6-1) have implications for
ecological assessment, they were specifically directed to improving processes for human health
risk assessment. Recommendations 2, 4, and 5 relate to the design of risk assessment processes.
The Technical Panel was gratified by the NRC recommendation to draw upon ecological risk
approaches for human health assessments and to use a framework more in line with the ERA
framework to improve risk management decisions. We believe that we are somewhat ahead in
recognizing that a decision-focused assessment process requires types of technical assessments
other than risk assessments (see Section 3).
All Agency programs and regions strive to use the most relevant data for all of their
assessments (Recommendation 1). For emerging issues, filling data needs may start out as
investigatory (e.g., endocrine disrupters [U.S. EPA, 1997e], cumulative risk [U.S. EPA, 2003a],
nanotechnology [U.S. EPA, 2007a]), move into initial applications, and, ultimately, become
operational. In practice, the Agency often relies on existing literature and data or data
submissions from the regulated community in it assessment activities. The Agency's authorities,
abilities, and resources to generate data de novo for specific applications remain highly variable.
Certain programs have broad authority to require data (e.g., new pesticide registration), whereas
others rely on existing scientific literature. In many cases, assessments are updated periodically
(e.g., ambient chemical criteria for aquatic life) or at predetermined intervals (e.g., national
ambient air quality criteria and standards).
Default assumptions (Recommendation 3) are rare in ecological assessments. Because
nonhuman organisms and ecosystems are much more diverse than humans and their societies,
default assumptions are difficult to apply in ecological assessments. However, where they occur,
they should be justified, as the NRC recommends.
Stakeholder involvement in ecological risk assessment (Recommendation 6) is less
common than suggested by the framework and guidelines (US EPA 1998a). The Technical
Panel concurs that EPA should establish a process for stakeholder involvement to balance
participation of stakeholders, including impacted communities and less advantaged stakeholders.
This is particularly true for complex environmental issues that primarily involve ecological
effects such as mountain top mining, Gulf of Mexico hypoxia, integrated nitrogen control,
biofuels, greenhouse gases, carbon sequestration, and hydraulic fracturing of shale for methane
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extraction. Ecological assessors need to develop their own set of approaches for engaging
stakeholders. This is particularly important because the most vocal stakeholders for these issues
are typically the responsible parties such as miners and farmers. It has been widely recognized
that scientists need to appropriately translate technical information to stakeholders and decision-
makers, (see Appendix D.I).
Conclusion—Ecological assessors should continue to innovate in the development of
assessment practices that focus on informing decisions. They need to develop strategies for
productively engaging stakeholders and decision-makers in ecological issues.
6.2. ENVIRONMENTAL GOALS
The SAB called for greater delineation of Agency science policies concerning
environmental protection goals. Specifically, the SAB recommended better definition of what
ecological resources EPA is striving to protect and of assessment endpoints for these resources
(see Table 6-2). The need for better understanding of Agency-wide ecological concerns was
initially broached nearly 15 years ago in Managing Ecological Risks at EPA: Issues and
Recommendations for Progress (U.S. EPA, 1994c). That document was prepared during the
development of the Guidelines for Ecological Risk Assessment, and it inventoried environmental
laws and policy support for ecological assessment endpoints used across the Agency, and offered
eight recommendations for improving ecological considerations at EPA.
The legal and policy support for ecological assessment was reviewed in Generic
Ecological Assessment Endpoints (GEAEs) for Ecological Risk Assessment (U.S. EPA, 2003b).
Each assessment endpoint consists of an ecological entity and valued attribute. A detailed
summary of the GEAE document is beyond the scope of the present effort. However, the
document articulates several discrete categories of environmental values that may be used by
EPA including consumptive values, informational values, functional values, recreational values,
educational values, option (i.e., future environmental use) values, and existence values. The
fifteen GEAEs include attributes of organism, population, community, and ecosystem levels of
organization; critical habitats; and special places.
More recently, the Agency developed its Report on the Environment or ROE (U.S. EPA,
2008a). The ROE is organized around 23 priority questions that EPA considers important and
relevant to its mission and believes should be answered. Although specifically developed as
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indicators to evaluate environmental trends, the priority questions offer another set of policy
relevant science questions that articulate what the Agency values. Refer to Appendix D.2 for a
list of the 14 ROE questions that include an ecological element. Although quite broad, the ROE
questions provide another way to categorize broad ecological attributes valued by EPA. More
importantly, the ROE questions have the potential to define ecological attributes EPA considers
important for media-specific and ecological condition assessments.
Policy-relevant science questions and ecological protection values and goals have been
articulated in the foregoing documents, as well as in Agency and program-specific guidance (see
Appendix C). Yet, science policy-relevant questions for ecological assessments remain poorly
understood This may be partially explained by the different ecological assessment objectives
and decision-making contexts used by EPA. EPA's mission is to protect human health and
safeguard the environment (air water, land) upon which life depends (U.S. EPA, 2004a). EPA
fulfills this obligation by, among other things, developing and enforcing regulations that
implement environmental laws enacted by Congress. See Appendix D.3 for ecological entities
specifically targeted by environmental laws. This does not suggest that there are no Agency-
wide ecological or natural resource protection goals. However, the goals are often couched in
terms of managing risk by eliminating, reducing, or mitigating sources of exposure to protect
natural resources rather than direct management of resources.
Conclusion—The Agency has published extensive guidance on ecological assessment
endpoints, but individual assessments should include a clearer presentation of endpoint entities
and attributes.
6.3. ADAPTIVE MANAGEMENT
Because adaptive management is common practice in fisheries, wildlife, and other
ecological and environmental management applications, it is not surprising that the SAB
recommended that EPA explore its application in risk assessment and risk management (see
Table 6-3).
The SAB has recommended that the Agency use adaptive management to address
uncertainties in decision-making (U.S. EPA, 2008e). The NRC (2004) identified six elements of
adaptive management that are directly relevant to goal setting and research needs: (1) resources
of concern are clearly defined; (2) conceptual models are developed during planning and
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assessment; (3) management questions are formulated as testable hypotheses; (4) management
actions are treated like experiments that test hypotheses to answer questions and provide future
management guidance; (5) ongoing monitoring and evaluation are necessary to improve
accuracy and completeness of knowledge; and (6) management actions are revised with new
cycles of learning. The EPA (2008e) identified the following NRC (2004) statement as perhaps
the most important take home lesson of their work.
Adaptive management does not postpone actions until "enough" is know about a
managed ecosystem (Lee, 1999), but rather is designed to support action in the
face of limitations of scientific knowledge and the complexities and stochastic
behavior of large ecosystems (Holling, 1978). Adaptive management aims to
enhance scientific knowledge and thereby reduce uncertainties. Such
uncertainties may stem from natural variability and stochastic behavior of
ecosystems and interpretation of incomplete data (Parma et al., 1998; Regan et al.,
2002), as well as, social and economic changes and events (e.g., demographic
shifts, changes in prices and consumer demands) that affect natural resource
systems.
While adaptive management is not an explicitly recognized policy at EPA, its basic
elements can be identified in the ecological risk assessment framework and guidelines
(U.S. EPA, 1998a). Additionally, integrated assessments currently performed in some EPA
programs (e.g., Water, Air, Superfund, Pesticides) implicitly contain elements of adaptive
management (as discussed in Section 3, above). As such, the Technical Panel judged that
adaptive management is both investigatory and in initial application stages at EPA programs.
The Technical Panel also believes that directly coupling technical assessments with outcome
assessments through feedback loops will promote wider application of adaptive management at
EPA.
Conclusion—Adaptive management is potentially a highly useful strategy, but its
implementation would require changes in fundamental Agency science policies and practices.
6.4. PLANNING, SCOPING, AND PROBLEM FORMULATION
The NRC recommended the adoption of a framework for risk-based decision-making that
included planning, scoping, and problem formulation (Recommendation 5, Table 6-1). The SAB
provided eight additional recommendations concerning problem formulation for ecological
assessments (see Table 6-4). The specific problem formulation issues raised by the SAB include
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the need for better definition of risk management goals, risk assessor-risk manager roles,
hypothesis development, peer review, scale (spatial, temporal, and biological), uncertainty, and
review of case studies to develop standards of practice (see Table 6-4). The Agency has
published more guidance on design, planning, scoping, and problem formulation than is
suggested by these comments. Planning and scoping for risk assessment are addressed in
13 separate EPA guidance documents, while elements of problem formulation (conceptual model
development, assessment endpoints, measurement endpoints, hazard/toxicity assessment) are
addressed in 37 separate EPA guidance documents (see Appendix C).
The Technical Panel considered planning, scoping, and problem formulation to be widely
implemented across EPA but also recognized that its documentation and external transparency
are widely variable. Problem formulation for screening or routine assessments is sometimes
assumed to be embedded in program-specific technical guidance. In these cases, risk
assessor-risk manager interactions, the various problem formulation elements (conceptual model
development, assessments endpoints, measurement endpoints), and the analysis phase elements
(hazard, exposure, effects analyses, risk characterization) may be more or less informal.
However, as complexity and visibility of an assessment increase, so too does formal and
deliberate characterization and documentation of the problem formulation and analytical plan,
stakeholder involvement, and peer review.
The SAB recommends obtaining peer review of problem formulation of large risk
assessments and use of checklists cataloguing best practices in problem formulation for smaller
scale assessments (Recommendation 12 and 13). The Technical Panel supports this approach to
enhancing formalization and review of problem formulations as appropriate in Agency risk
assessments. Current Agency peer-review policy requires independent peer review for "highly
influential scientific assessments." Peer review of problem formulation prior to implementation
is rare and may be difficult for some programs due to regulatory constraints. However, iterative
peer review of complex assessments has been conducted by some program offices.
An example of iterative assessment and review steps in a program office is provided by
pesticide registration. Office of Pesticide Programs has a mandate to review the registration of
all conventional pesticide active ingredients every 15 years under the Registration Review
program. The problem formulation for each active ingredient is requested by the responsible
management division (Pesticide Reevaluation Division or PRD) according to a predefined
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schedule. The Environmental Fate and Effects Division drafts a problem formulation, which is
subjected to peer review within the division and then is peer reviewed by PRD. The problem
formulation is taken as far as the analysis plan stage, and the data call-in needed to complete the
risk assessment is drafted and justified. The final Problem Formulation becomes part of a
preliminary work plan, which is published in the Federal Register for public comment and peer
review. The problem formulation is modified according to the public comments, if necessary,
and becomes part of the final work plan for the Registration Review.
Detailed descriptions of iterative external peer reviews associated with specific regulatory
assessments are beyond the scope of this document. However, notable examples include the
Office of Pesticides Programs assessment of atrazine and the Office of Air Quality Protection
and Standards assessment for the secondary national ambient air quality standards for nitrogen
oxides (NOX) and sulfur oxides (SOX). The atrazine assessment included consideration of general
ecological effects, specific developmental effects on amphibians, and ecological watershed
monitoring studies
(http://www.epa.gov/pesticides/reregistration/atrazine/atrazine_update.htm#ewmp). TheNOx
and SOX assessment is iterative and has been iteratively reviewed by the Clean Air Scientific
Advisory Council since 2007 and includes planning documents, integrated science assessments,
risk and exposure assessments, and policy assessments
(http://www.epa.gov/ttn/naaqs/standards/no2so2sec/index.html). It is discussed at greater length
in Appendix D.4.
The SAB recommended more dialogue between assessors and managers and more
emphasis on supporting the decision (Recommendation 14, 15, and 16). The two preceding
examples represent assessments where linkages were made between risk measures, data quality
needs, data collection activities, and risk management decisions. They also provide examples
where risk assessment questions are directly linked to risk management questions and watershed
and landscape scales, and uncertainties are addressed. Both are complex, high priority,
data-intense cases; they are certainly not typical. Nevertheless, they demonstrate that the
Agency has linked peer review, problem formulation, uncertainty, and risk management
questions in ecological assessment.
The SAB recommended moving away from generic problem formulations in the near
term (Recommendation 18). However, for certain Agency applications such as routine
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assessments of industrial chemicals or site screening, the panel concluded that generic problem
formulation is useful and should not be abandoned. The panel suggests that such assessment
applications are limited in scope and could be documented using a checklist approach.
Five of the eight recommendations on problem formulation (see Table 6-4) mention
spatial, temporal, and biological scale. The Technical Panel agrees that the scale of the
assessment must be defined and justified during the problem formulation, as discussed in the
Guidelines for Ecological Risk Assessment. In addition to these recommendations concerning
the consideration of scale in planning and problem formulation, the SAB addressed the analysis
of spatial, temporal, and biological scale as a separate issue (see Table 6-9). These
recommendations broadly overlap and represent longstanding issues in ecological assessments.
Conclusion—Planning, scoping, and problem formulation are well characterized in the
Guidelines for Ecological Risk Assessment, but individual programs should examine their
assessment practices and consider whether additional specific guidance is needed.
6.5. WEIGHT OF EVIDENCE
Two SAB recommendations (see Table 6-5) address the need for guidance, case studies,
and standards of practice for weighing multiple lines of evidence to support decision-making.
Suter (1993) noted that separate lines of evidence must be evaluated, organized in some coherent
fashion, and explained to risk managers so that the decision can be based on the weight of all
relevant evidence. Hall and Giddings (2000) illustrated the value and importance of a
weight-of-evidence approach using multiple lines of evidence from field and laboratory data to
assess the occurrence or absence of ecological impairment in aquatic environments. The Stressor
Identification guidance and the CADDIS Web site for determining the causes of biological
impairments use a weight-of-evidence approach (U.S. EPA, 2000b). Lines of evidence have
been discussed in the Air Toxics Risk Assessment Reference Library (U.S. EPA, 2004c). The
latter document states that lines of evidence provide a process and framework for reaching a
conclusion regarding confidence in a risk estimate. There are three principal categories of
factors to consider when evaluating lines of evidence: data adequacy and quality, relative
uncertainty, and relationship to the risk hypothesis.
The Technical Panel agrees, in principle, that case studies or standards of practice may be
helpful in weighing multiple lines of evidence for decision-making. In the interim, the Technical
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Panel believes that the weighing of evidence should be considered during each problem
formulation, and a method for weighing evidence should be included, as appropriate, in the
analysis plan. The chosen method for weighing evidence should be used during data analysis
and interpretation and fully documented during the risk characterization.
Conclusion—Multiple pieces of evidence are often weighed in ecological assessments
without a formal method. Guidance on formalizing inference by weighing evidence could make
these assessments more defensible.
6.6. CUMULATIVE AND INDIRECT EFFECTS
The SAB offered two recommendations on cumulative and indirect effects (see
Table 6-6). Cumulative risk rose to prominence in EPA risk assessments with the passage of the
Food Quality Protection Act in 1996, which required EPA to consider all aggregate risk from
exposure to a pesticide from multiple sources when assessing pesticide food tolerances; and
cumulative exposure to pesticides that have common mechanisms of toxicity. This definition is
widely used by EPA human health risk assessors, but ecologists typically view cumulative risk
more broadly as the sum total of chemical, physical, and biological stressors that may impact a
site, watershed, or other ecosystem.
The EPA Risk Assessment Forum is currently developing a cumulative risk assessment
framework and guidelines using a sequential process like that used for the ecological risk
assessment framework and guidelines (U.S. EPA, 1998a). The Framework for Cumulative Risk
Assessment (U.S. EPA, 2003a) is an information document that identifies terminology, key
issues, and basic elements of cumulative risk as the analysis, characterization, and possible
quantification of the combined risks to human health or the environment from multiple agents or
stressors. As Agency-wide guidance, the framework describes a flexible process without
prescribing fixed protocols or procedures. The second phase of development is nearing
completion, and a draft document entitled A Compendium of Illustrative Examples for
Cumulative Risk Assessment is currently in review. This draft document explores key framework
issues illustrated by case studies. Development of cumulative risk guidelines, the third stage of
the process, began in late 2010.
The SAB recommended that EPA could consider change processes (e.g., climate change)
and indirect effects as considerations in risk assessment (see Table 6-6). EPA's Global Change
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and Ecosystem Services Research Programs are presently looking at these important
environmental issues. The Global Change Research Program
(http://www.epa.gov/ord/npd/globalresearch-intro.htm) is a stakeholder-oriented research and
assessment program in EPA's Office of Research and Development. The program is designed to
address the potential consequences of global change, particularly climate variability and change,
on air and water quality, aquatic ecosystems, human health, and socioeconomic systems in the
United States. The Global Change Research Program emphasizes place-based approaches to
investigate change issues particular to given areas. Using this approach, partnerships with
locally-based decision-makers are being established to ensure programs are responsive to local
scientific information needs and the socioeconomic realities. EPA is 1 of 13 federal agencies
and departments that comprise the U.S. Global Change Research Program (USGCRP), which
coordinates and integrates scientific research on global change across the federal government
(http://www.globalchange.gov/). EPA's research program supports the production of synthesis
and assessment products called for in the USGCRP Strategic Plan
(http://www.globalchange.gov/about/strategic-plan-2003/2003-strategic-plan) and emphasizes
air quality, water quality/aquatic ecosystems, and human health impacts from global change.
Conclusion—Ecological assessors should continue to support and participate in the
RAF's efforts in cumulative risk assessment.
6.7. OTHER SOURCES OF GUIDANCE
The SAB also suggested that the Agency evaluate alternative risk assessment
methodologies used by other countries and federal agencies and incorporate their valuable
aspects in risk assessment guidance (see Table 6-7). Program offices are generally aware of
available scientific methods and approaches used by other Agencies and countries and have
extensive interactions with them. The OPPTS has been actively involved with the Organization
for Economic Cooperation and Development (OECD) for decades to harmonize data
requirements, test methods, and data integration methods for pesticide and toxic substances.
OPPTS also has working relationships concerning risk assessments approaches with Canada and
Mexico under the North American Free Trade Agreement, and other federal agencies including
the Department of Interior, Department of Commerce, and FDA. Similarly, the Regions and
Programs offices have multiple partnerships with international, other federal, state, and tribal
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governments and Agencies to address environmental issues of mutual interest and concern.
Detailed discussion of Agency international, other federal, and state and tribal partnerships on
science and management are too extensive to discuss here. Representative examples with Web
site addresses are identified in Appendix D.6.
The Technical Panel believes that the Office of Research and Development, and
Agency's programs and regions are fully aware of scientific approaches to ecological risk and
environmental assessment used by other countries and federal agencies. Although there are no
barriers to employing appropriate scientific approaches used by other countries or federal
agencies by EPA, incorporating science and regulatory policies from other countries or agencies
is a different matter. Typically, countries and agencies agree that they should use the same
scientific data and information to assess the effects of chemicals and other stressors on the
environment. However, how the assessments are used and applied in decision-making may
differ because of different legal requirements and policy frameworks between countries and
agencies. As an example, pesticide and toxic substances test guidelines are harmonized with all
OECD member countries. Countries have agreed to harmonize methods because it allows them
to share data and information generated by pesticide and chemical companies, which are often
global corporate entities. In contrast, water and air quality standards and criteria are specifically
developed to protect U.S. territorial water and air. Intergovernmental collaboration certainly
occurs for trans-boundary pollution, but collaboration takes the form of bi-lateral or multilateral
agreements. EPA's Office of International Affairs is the primary EPA coordinating body for
such agreements (http://www.epa.gov/international/about/index.html).
Conclusion—The Technical Panel sees no need for specific actions to increase
awareness of assessment methods employed by other agencies and countries.
6.8. BENEFITS AND VALUATION
The SAB's call for a focus on valuation of ecosystem services (see Table 6-8) is being
met by research and guidance development on economic valuation and research on quantification
of ecosystem services. The principal source of Agency guidance is the Guidelines for Preparing
Economic Analyses (U.S. EPA, 2000e, 2008b). These guidelines complement ecological risk
assessment with a focus on economic analyses in support of policy decisions and meet
requirements described by related statutes, Executive Orders (EOs), and regulations. EO 12866
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and its recent amendment EO 13422 direct federal agencies to perform a benefit-cost analysis for
all economically significant rules (those with an economic impact to society of $100 million or
more). The economic analyses guidelines focus on regulatory and non-regulatory management
strategies. They describe economic concepts and techniques to address benefits and social costs
of policy alternatives. They also describe procedures and analyses for clearly identifying the
environmental problem to be addressed and for justifying federal corrective interventions. The
guidance recommends that a clear statement of need for policy action should be included in
economic analyses of environmental policy prepared for economically significant rules. These
considerations include both human health and welfare effects,1 and are similar to ecological risk
assessment planning and problem-formulation activities.
Ecosystem services represent a major research area for the Office of Research and
Development. The Ecosystem Services Research Program is designed to improve knowledge for
the protection and restoration of nature's services, with an eye toward changing how the type,
quality, and magnitude of ecological goods and services can be considered in environmental
management decisions. The research is providing the data, methods, models, and tools needed
by states, communities, and tribes to understand the cost and benefits of using ecosystem
services. The Ecosystem Services Research Program includes major research areas focused on
nitrogen, wetlands, coral reefs, and place-based studies (Willamette River Basin, Tampa Bay,
Coastal Carolinas, and the Midwest and Southwest Ecosystem Services projects). Further
discussion of the use of ecosystem services can be found in Appendix D.7. Details of ongoing
research projects may be found at http://www.epa.gov/ecology/index.htm.
SAB also recommended that EPA expand work in support of assessing the net
environmental benefits of proposed actions. Although net ecosystem benefits analysis
(Efroymson et al., 2004) is largely investigatory at EPA, the Agency has developed the
Ecological Benefits Assessment Strategic Plan (U.S. EPA, 2006a). This document
acknowledges that a new approach is needed to improve the Agency's ability to perform
ecological benefits assessments and emphasizes interdisciplinary participation by natural and
social scientists. Because ecological risk assessments are designed to address different questions
than those of ecological benefits assessments, the immediate value and application of risk
:A regulatory term defined by the Clean Air Act in developing National Ambient Air Quality Standards. Welfare
effects include, but are not limited to, effects on soils, water, wildlife, vegetation, visibility, weather, climate, as well
as effects on materials, economic values, and well being.
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assessment results to benefits assessments is often limited. EPA benefits assessments have
historically been the purview of economists with limited input from natural scientists. This
strategic plan emphasizes that increased collaboration between EPA natural and social scientists
will improve ecological benefits assessments at the Agency. Such improvements include
identifying appropriate ecological endpoints; collecting the necessary data; and developing and
applying the appropriate methods to quantify and value changes in those endpoints.
The Ecological Benefits Assessment Strategic Plan recommends a collaborative
framework that both builds on the conceptual foundations of ecological risk assessment
framework (U.S. EPA, 1998a) and borrows from its terminology. The assessment approach
emphasizes collaborative interaction among Agency decision-makers, social scientists, natural
scientists, and analysts throughout the process. Such collaboration should begin at the earliest
stages of the process, with identification of the need to evaluate alternative policy options for a
decision. The options under consideration may be defined partly by the statutory and legal
context under which EPA operates, information from existing risk assessments, and
technological and socioeconomic considerations. The best science available would then be
applied to understand how each policy option would change the environmental stressors they are
intended to control, to forecast changes in the affected ecosystems and the services they provide,
and to estimate the economic value of the change in those services.
In its review of the Ecological Benefits Assessment Strategic Plan, the Science Advisory
Board (EPA, 2009b) endorsed the general approach in the strategic plan but suggested an
alternative (see Figure 6-1). Although the SAB approach is depicted sequentially, they
emphasize that numerous feedbacks should occur with interactions and iterations across steps.
Accordingly, the valuation process should always be based on an explicit conceptual model that
can be updated or revised. In practice, information about the value of a change in ecosystem
services that would result from a given policy option might cause a reformulation of the problem
or identification of alternative policy options that could be considered. Also, a predicted
ecological effect might suggest social values that were not initially considered.
The SAB framework for ecological valuation process (see Figure 6-1) complements the
ecological risk assessment framework and guidance (U.S. EPA, 1992a, 1998a). Although
similar, ecological valuation necessarily goes beyond ecological risk assessment. Typically, risk
assessments focus on estimating the magnitude and likelihoods of potential adverse effects on
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ecological entities (species, populations, communities, sites, etc.) but lack information about
societal values of the effects. In contrast, ecological valuation characterizes monetary and
nonmonetary societal values of the predicted ecological effects, ecological improvements, or
ecological losses from environmental degradation. Because of the focus on societal values,
ecological valuation more closely resembles risk characterization than risk assessment.
Accordingly, the risk characterization principles offered by the NRC (1996) and Agency risk
characterization guidance (U.S. EPA, 2000d, 2003a) are pertinent for ecological valuation.
Ideally, both are rigorous and transparent analytical processes that integrate scientific
information with transparent policy options that reflect societal values.
Conclusion—As methods for quantifying ecosystem services and benefits are developed
into reliable assessment tools, they should be integrated into existing ecological assessment
guidance.
6.9. SCALES OF ASSESSMENT
The SAB offered several recommendations regarding the consideration of scale and level
of biological organization in ecological assessments (see Table 6-9). Spatial scale was discussed
in the Guidelines for Ecological Risk Assessment (U.S. EPA, 1998a) under management goals
that differentiate between national scale (e.g., water quality criteria) and cases where laws and
regulations are specifically applied to places or sites. Scale was also addressed within the
context of planning and establishing assessment objectives to determine if an assessment is
national, regional, or local in scope.
Examples of the consideration of scale are noted briefly here, and elaborated upon in
Appendix D.8. The Office of Pesticide Programs conducts ecological risk assessments over a
range of spatial scales depending upon uses, fate, transport, and effects of pesticides. These may
include the region within which a crop is grown or the range of a potentially-exposed species of
concern. The Office of Water develops national ambient water quality criteria as science-based
recommendations that EPA considers protective of the aquatic life use, but allows for
place-based modifications to account for variation in water chemistry and biology. The Office of
Solid Waste and Emergency Response considers scope, boundaries, and scale to be important
elements during the development of conceptual site models for ecological risk assessments.
Superfund legislation defines the site as the extent of contamination. When the extent of
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contamination is determined by the remedial investigation, adaptive site management can
provide flexibility in the site boundaries as the extent of contamination is characterized.
In EPA regions, risk assessments are generally tied to discrete geographic locations
(i.e., place-based assessment) and specific time intervals. In contrast, EPA program office risk
assessments are frequently generalized in space and time and, therefore, employ generic
assumptions. This dichotomy often results in different approaches and practices. The spatial
context profoundly impacts planning and problem formulation of regional ecological risk
assessments. Such impacts are illustrated by a case example in northwest Indiana included in
Appendix D.8.
The choice of levels of biological organization to be evaluated in regulatory risk
assessments is also challenging. The enabling legislation for some EPA programs does not
clearly identify a level of organization, using only vague terms such as "the environment" or
"aquatic life." Others explicitly or implicitly identify protection of ecological populations as
management goals. In either case, conventional ecological risk assessments for chemicals have
focused on organismal attributes of assessment populations as assessment endpoints
(e.g., survival, growth, or reproduction in a fish population) (U.S. EPA, 2003b; Suter et al.,
2005). Organismal attributes are practical and expedient because they can be estimated by
toxicity tests. It is often assumed that protection of organismal attributes will protect populations
and population-level attributes (e.g., abundance, fecundity, etc.). Additionally, methods and
practice are well established for organism-level assessments. In contrast, there are few
consensus methods for population-level ecological risk assessment. Consequently, risk to
populations has only been occasionally evaluated directly by EPA (e.g., trout populations of
Adirondack lakes in the National Acid Precipitation Assessment). This situation results from
several factors affecting assessment planning, including the perceived relationships between
assessment endpoints and environmental management goals, historical precedence, and
importantly, the lack of recognized consensus and guidance about how such assessments should
be performed. Examples of the treatment of different levels of organization by the Agency are
described in Appendix D.9.
As mentioned earlier in this section, cumulative risk, global change, and ecosystem
services, and spatial, temporal, and biological scales are conceptually linked and reflect systems
thinking in contemporary ecology and the environmental sciences. As illustrated by the
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preceding discussion for the SAB recommendations listed in Tables 6-4 and 6-6, current
implementation of cumulative risk, global change, ecosystem services, and spatial, temporal and
biological scales ranges from investigatory, to initial applications, to implementation in selected
program offices. It should be emphasized that integration of these system attributes is far from
routine and is not typically encountered in conventional ecological risk assessments of
chemicals. However, they are beginning to move into program office applications.
The Office of Air Quality Protection and Standards (OAQPS) has undertaken a complex
ecological risk assessment that incorporates elements of cumulative risk, global change,
economic benefits, ecosystem services, and broad spatial, temporal biological scale.
Importantly, planning and scoping, problem formulation, analysis, and characterization were
followed, documented, and conducted in accordance with the Guidelines for Ecological Risk
Assessment (U.S. EPA, 1998a). OAQPS is conducting a joint review of the existing secondary
(welfare-based) National Ambient Air Quality Standards (NAAQS) for NOX and SOX. A joint
secondary review of these pollutants was necessary because the atmospheric chemistry and
environmental effects of NOX, SOX, and their associated transformation products are linked, and
because the NRC has recommended that EPA consider multiple pollutants, as appropriate, in
forming the scientific basis for the NAAQS. Notably, this assessment is also the first time since
the NAAQS were established in 1971, that a joint review of NOX, SOX, as well as of total reactive
nitrogen, has been considered. A summary of this innovative assessment follows in
Appendix D.4.
Conclusion—Scale and level of organization are difficult and controversial issues that
are difficult to address Agency-wide. However, the Agency should continue to develop
assessment tools and guidance for conducting assessments for larger scales and higher levels of
organization. During problem formulations, assessors should be clear about their chosen scales
and levels of organization and the rationales for their choices.
6.10. METHODS AND TOOLS
The SAB provided seven recommendations for the development of particular assessment
methods and tools (see Table 6-10). Topics included uncertainty, assessment hypotheses,
life-cycle assessment, screening, and generic assessments of common pollutants.
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The treatment of uncertainty has been a major topic of discussion and consideration
among assessors and is frequently addressed by advisory bodies (NRC, 2009). However,
quantitative uncertainty analysis is controversial and is inconsistently employed in the Agency.
Currently, guidance is limited to Monte Carlo analysis for exposure models (U.S. EPA, 1997c).
However, a review of probabilistic risk assessment practices in the Agency is currently in
preparation. The SAB recommends an option of categorizing uncertainties and identifying those
that are most important to the conclusions (Recommendation 31). This qualitative uncertainty
analysis is consistent with common practices in the Agency's ecological assessments.
SAB Recommendations 32 and 33 address the development of assessment hypotheses.
These are hypotheses about how sources, pollutants, or actions may cause effects and how those
causal relationships might be manipulated to prevent or remediate effects. Hence, conventional
statistical hypothesis testing is inappropriate, and other techniques such as estimation of
conditional probabilities or logical analysis of the weight of evidence are more appropriate. This
issue is largely underappreciated in the Agency.
Product life-cycle assessment (LCA) is distinct from risk assessment in that it is intended
to aid in product design by estimating relative environmental impact rather than estimating the
acceptability of a product. However, the SAB's comment suggests that ecological risk
assessment should adopt some aspects of LCA (Recommendation 34). The Agency has
collaborated with industry through the Design for the Environment program to perform some
LCAs for products such as solders (http://www.epa.gov/dfe/pubs/solder/lca/index.htm).
Although the Agency is not developing guidance on LCA, it has participated in the development
of the international consensus system USEtox (http://www.usetox.org/).
Hazard Quotients and Hazard Indices are the primary techniques for risk characterization
for both health and ecological risk assessments in the Agency. The SAB recommended that
guidance be developed for their appropriate use (Recommendation 35). Individual programs
have described their use in general ecological risk assessment guidance such as The Ecological
Risk Assessment Guidance for Superfund (U.S. EPA, 1997b). Although the interpretation of
these simple calculations can be controversial, the Technical Panel does not perceive a demand
for Agency-wide guidance.
The SAB endorses the EPI suite (Recommendation 36), which is a set of
structure-activity relationships to estimate fate and transport properties of chemicals reviewed by
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the Office of Pollution Prevention and Toxics
(http://www.epa.gov/oppt/exposure/pubs/episuite.htm). The Technical Panel agrees that the
range of applicability of these tools could be expanded. However, the data requirements of the
European REACH regulations and proposed legislative updates of the Toxic Substance Control
Act may reduce the need for such models.
The SAB suggested that the Agency develop generic ecological risk assessments for
common pollutants such as PCBs (Recommendation 37). This recommendation is similar to the
recurrent calls for an Eco IRIS. However, IRIS is a large effort that has difficulty keeping up
with expectations, and it deals with only one species, humans. Currently, precedents (i.e., prior
regional or program office assessments) are used in place of generic assessments. They include
prior assessments at Superfund sites, water quality criteria documents, and priority air pollutant
scientific assessments.
Conclusion—The development of Agency-wide guidance for assessment methods and
approaches is a major mandate of the RAF. The Forum must set priorities for the development
of such guidance.
6.11. POST-DECISION AUDITING AND MONITORING
The SAB recommended (see Table 6-11) that post-decision monitoring be conducted to
determine whether the expected benefits occurred and to provide bases for improving future
assessments. The integrated framework (see Section 3) contains this activity as Outcome
Assessments. The Technical Panel wishes to emphasize that the point is to perform an
assessment of the outcome of a decision, and monitoring is simply a means of gathering data to
support the assessment. A well-conducted outcome assessment can provide the basis for
adaptive management (see Section 6.3). That is, if the expected benefits of the decision are not
realized, the information generated by the outcome assessment can be used to perform new
predictive assessments and to make a new, more effective decision.
Monitoring and outcome assessments are seldom performed after the Agency's
environmental management decisions. In some cases, as in the Superfund 5-year reviews,
monitoring may be performed to determine whether pollutant concentrations have been reduced,
but monitoring and assessments are not performed to determine whether environmental benefits
have been realized.
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Conclusion—The Technical Panel agrees that post-decision monitoring and assessment
could be highly valuable. However, it would take a change in policy to make them a part of the
Agency's conventional regulatory practices.
6.12. MANAGEMENT, RESOURCES, AND TRAINING
The NRC made several recommendations concerning increasing staffing and training (see
Table 6-12). The Office of Research and Development will add staff in new areas, as in the
creation of the Center for Computational Toxicology. However, as the NRC wrote, targeted
staffing is also needed in programs and regions to employ new assessment science.
In general, training is more important and practical than increased staffing. Training in
new assessment science has been irregular. The RAF did a good job of training for the
1992 Framework and 1998 Guidelines for Ecological Risk Assessment. Similarly, the Office of
Water and Office of Research and Development conducted training of state and regional
personnel on biological assessment and stressor identification. However, many guidance
documents have no associated training.
Conclusion—Programs to develop new guidance should include plans for training and, if
necessary, recommendations for acquiring new expertise.
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Table 6-1. NRC broad science policy recommendations
1. (NRC)—Administrator should direct Agency offices to more proactively identify the data
most relevant to the current risk assessment needs (related to Recommendations 7, 8, 17,
and 18).
2. (NRC)—EPA should pay Increased attention to the design of risk assessment in its formative
stages (related to Recommendations 7, 15, 16, 17, 18, 28, and 29).
3. (NRC)—EPA should continue and expand use of the best, most current science to support
and revise default assumptions (related to Recommendation 30).
4. (NRC)—EPA should draw on other approaches, including those from ecologic risk
assessment and social epidemiology, to incorporate interactions between chemical and
nonchemical stressors in assessments; increase the role of biomonitoring, epidemiologic, and
surveillance data in cumulative risk assessments; and develop guidelines and methods for
simpler analytical tools to support cumulative risk assessment and to provide for greater
involvement of stakeholders (related to Recommendations 7, 23, and 36).
(NRC)—To make risk assessments most useful for risk management decisions, the
committee recommends that EPA adopt a framework for risk-based decision-making that
embeds the Red Book risk assessment paradigm into a process with initial problem
formulation and scoping, up front identification of risk-management options, and use of risk
assessment to discriminate among these options.
6. (NRC)—EPA should establish a formal process for stakeholder involvement in the
framework for risk-based decision-making with time limits to ensure that decision-making
schedules are met and with incentives to allow for balanced participation of stakeholders,
including impacted communities and less advantaged stakeholders.
Table 6-2. SAB recommendations concerning environmental goals
7. (SAB)—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. Nonchemical stressors alone, and in combination with chemical stressors, should
be considered in developing ecological risk assessment guidance, models, and endpoints.
Endpoints should reflect elements of ecological conditions such as ecological processes and
various levels of biological organization including landscape composition and pattern
(related to Recommendation 8).
8. (SAB)—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 (related to Recommendations 7, 17, and 28).
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Table 6-3. SAB recommendations on adaptive management
9. (SAB)—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 (related to Recommendation 31).
10. (SAB)—In the long term, EPA could develop guidance on the application of adaptive
management of ecological resources in contaminated site decision-making.
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Table 6-4. Recommendations on problem formulation
11. (SAB)—In the short term, EPA could 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 (related to Recommendations 17, 18, 21, 26, 28, and 29).
12. (SAB)—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 management goals are considered in
problem formulation and translated into information needs using data quality objectives
(DQOs) (related to Recommendation 13).
13. (SAB)—In the short term, EPA could 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 (related to Recommendation 12).
14. (SAB)—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.
15. (SAB)—To promote a dialogue between 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.
16. (SAB)—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.
17. (SAB)—EPEC recommends that during the problem formulation phase of ecological risk
assessments, EPA explicitly define the extent and resolution of the pertinent spatial and
temporal scales and levels of biological organization (related to Recommendations 8, 11, 18,
22, 26, and 30).
18. (SAB)—In the short term, EPA could 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
(related to Recommendations 11, 16, 17, 22, 26, 28, 29, 30, and 35).
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Table 6-5. Recommendations on weight of evidence and lines of evidence
19. (SAB)—In the long term, EPA could 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
eco-regions, hydrologic types, and chemical and nonchemical stressors (related to
Recommendations 12 and 32).
20. (SAB)—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 (related to
Recommendations 19 and 32).
Table 6-6. Recommendations on cumulative and indirect effects
21. (SAB)—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 (related to Recommendations 11, 22, and 26).
22. (SAB)—In the short term, EPA could 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
(related to Recommendations 17, 18, 21, 28, and 29).
Table 6-7. Recommendations on other sources of guidance
23. (SAB)—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).
EPA should be cognizant of these approaches and incorporate valuable aspects of them into
the Agency's risk assessment guidance.
Table 6-8. Recommendations on valuation and benefits
24. (SAB)—EPEC advises EPA to maintain a long-term focus on research to develop methods
for valuation of ecosystem services.
25. (SAB)—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).
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Table 6-9. Recommendations on spatial temporal and biological scale
26. (SAB)—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 (related to Recommendations 11, 16, 17, 18,
21,28,29, and 30).
27. (SAB)—In the long term, EPA could continue to investigate how biomarker and
mechanistic data might best be used in exposure and risk assessments.
28. (SAB)—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 (related to
Recommendations 8, 11, 18, 22, 26, and 30).
29. (SAB)—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 (related to Recommendations 11, 18, 22, 26, and 30).
30. (SAB)—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
(related to Recommendations 17, 28, 29, 18, and 26).
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Table 6-10. Recommendations on assessment methods and tools
31. (SAB)—In the short term, EPA could 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 (related to Recommendations 9, 20, and 32).
32. (SAB)—EPEC recommends that EPA explore the use of such methods as Bayesian
analysis and causal augmentation to develop hypotheses or risk questions focused on
causal relationships and weight of evidence (related to Recommendations 20, 31, and 33).
33. (SAB)—In the long term, EPA could explore ways to focus hypothesis development on
causal relationships and weight of evidence instead of traditional hypothesis testing with
null models (related to Recommendation 32).
34. (SAB)—EPEC recommends that EPA develop guidance for risk assessment
practitioners on the application of life-cycle analysis.
35. (SAB)—In the long-term, EPA could 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 HQs and the need
to reduce uncertainty, the Agency will need to explore a range of risk calculation
methods that represent better and more certain approaches to estimating risk (related to
Recommendation 18).
36. (SAB)—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.
37. (SAB)—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.
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Table 6-11. Recommendations on postdecision auditing and monitoring
38. (SAB)—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 postdecision audit programs
can be implemented in the short term, but a longer period of time would be required to
complete and document such audits (related to Recommendations 39 and 40).
39. (SAB)—In the long term, EPA could 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 (related to Recommendations 38 and 40)
40. Recommendation S-F5: In the long term, EPA could conduct multigenerational analysis or
other retrospective ground-truthing analyses for prospective risk estimates and re-evaluate
and validate levels of concern with monitoring studies (related to Recommendations 32
and 39).
Table 6-12. Recommendations on science management, resources, and
training
41. (NRC)—Additional staff will be needed in fields that are now lightly staffed, and new staff
in fields that are generally understaffed.
42. (SAB)—In the short term, EPA could 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.
43. (NRC)—Agency leaders should give high priority to establishing and maintaining
risk-assessment and decision-making training programs for scientists, managers responsible
for risk-assessment activities, and other participants in the process.
44. (NRC)—Revitalize and expand interoffice and interagency collaboration through existing
structures and by joining scientists from other agencies (related to SAB
Recommendations 15 and 23).
45. (NRC)—Administrator should give special attention to expanding the scientific and
decision-making core in the regional offices to ensure that they have the capacity to use
improved risk-assessment methods and to meet their obligations for interaction with
stakeholders, local agencies, and tribes.
46. (NRC)—EPA should initiate a senior-level strategic re-examination of its risk-related
structures and processes to ensure that it has the institutional capacity to implement the
committee's recommendations for improving the conduct and utility of risk assessment for
meeting the 21st century environmental challenges.
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Social, Behavioral, Economic, and Ecological Sciences
±
(2) Identification of
potential ecological
responses to options
(3) Identification of
socially important
assessment endpoints
(4) Prediction of ecosystem
and ecosystem responses in
biophysical terms
(6) Communication
of valuation results
and integration with
other analyses and
inputs needed for
decision
(5) Characterization,
representation, or
measurement of the value
of changes in monetary
and nonmonetary terms
Figure 6-1. Process for implementing an expanded and integrated approach
to ecological valuation (U.S. EPA, 2009b).
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7. TECHNICAL PANEL RECOMMENDATIONS FOR AGENCY CONSIDERATION
This section presents the Technical Panel's summary compilation of the
recommendations of the participants in the Colloquium for advancing ecological assessment.
Although they were informed and inspired by the SAB's and NAS's recommendations, the
participants also brought other issues to the meeting. Ten years after the publication of the
Guidelines for Ecological Risk Assessment, the concerns and recommendations of the Agency's
ecological assessors involve issues of policy and practice more than with technical methods. In
general, they feel that the science of ecological assessment is stronger than the policies and
practices that turn their scientific findings into Agency actions. Hence, many of the general
recommendations are addressed most directly to policy makers. The relevance of those
recommendations to the Office of Research and Development (ORD), Science and Technology
Policy Council (STPC), regional offices and program offices is identified. The specific
recommendations are more amenable to conventional technical guidance.
7.1. GENERAL RECOMMENDATIONS
7.1.1. Strengthen Policies to Achieve Ecological Protection Goals
Colloquium participants repeatedly expressed concern that many Agency decision and
policymakers are less familiar with and are less focused on ecological issues and associated
environmental protection goals than human health protection-related goals and issues. Some
colloquium participants believe that some in leadership positions operate with the belief that by
protecting human health, they also protect the environment. It would seem that they believe that
humans are not affected by the loss of biodiversity or ecosystem processes. Ecological scientists
at the Colloquium disputed the scientific foundation for these beliefs.
ORD—The Ecosystem Services Research Program (ESRP) is providing one basis for
correcting the misunderstandings.
STPC—This body should include more representatives with expertise in
ecological/environmental science and should devote more attention to environmental
as well as human health protection.
Programs and Regions—These organizations should rededicate themselves to ecological
protection goals.
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7.1.2. Enhance Communication of Ecological Assessment Issues and Results
The strongest and most consistent recommendation of the Colloquium participants was
that methods be developed for better communication with decision-makers and stakeholders.
This applies to communicating both ecological assessment issues during planning of assessments
and results at the conclusion. In part, this is a matter of inability of assessors to communicate the
significance of the loss of species, changes in community structure, and other endpoints. In
addition, it involves the lack of standard bright lines for acceptability like those in human health
assessment, the plethora of assessment methods employed, and difficulties in conveying
variability and uncertainty.
ORD—Conduct research on communicating ecological risks and benefits, possibly in the
ESRP.
RAF—Review ecological communication practices in the Agency and identify best practices.
Programs—Develop specific guidance or procedures for communication of ecological issues
and assessment results
7.1.3. Strengthen the Risk Assessor-Risk Manager Dialogue
Many participants asserted that they do not receive adequate input from decision-makers
when performing ecological assessments. For complex assessments, such as Superfund remedial
investigations, this could require days of participation in a data quality objectives (DQO)
process, while more routine cases, such as TSCA new chemical reviews, may use standard
decision requirements that should be reviewed periodically.
Programs and Regions—These organizations should encourage decision-makers to be more
engaged in assessment and to clearly communicate their information needs.
STPC—An Agency-wide policy might require that the decision-maker's information needs
be identified in every assessment.
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7.1.4. Enhance Problem Formulation
Many participants believe that inadequate attention is paid to problem formulation in
their assessments.
RAF—Although problem formulation is addressed at length in RAF documents, specific
needs for guidance may be identified by programs and regions. A new framework for
assessment and decision-making might be developed in conjunction with human
health assessors, as recommended by the NAS. Problem formulation could be
enhanced if it is not just "an ecological thing."
Programs and Regions—These organizations should develop specific policies and practices
to enhance problem formulation, possibly including checklists of necessary
components and peer reviews in some difficult or high profile cases.
7.1.5. Increase Training
Colloquium participants, particularly newer staff, asserted that there is not enough
training available for them or for the managers and stakeholders with whom they interact. While
formal courses were recommended by some, others recommended online training, training by
case studies, or informal methods.
RAF—The forum might develop new training or revive old training materials and courses for
Agency-wide assessment methods and processes.
Programs and Regions—These organizations should devote more time and resources to
training at all levels.
7.1.6. Apply Systems Approaches to Ecological Assessments
Ecological assessors, particularly those in the regions, are concerned that the medium-by-
medium program design of the Agency has inhibited environmental protection by not adequately
recognizing that pollutants move among media, that multiple sources cause combined exposures,
that multiple pollutants affect receptors, and that effects on one ecological receptor have
consequences for other ecological receptors and for humans. While there have been some efforts
to bridge gaps, the participants assert that the Agency needs a more systems-based approach to
environmental protection.
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RAF—The Forum is already developing guidance on cumulative risk assessment, which is a
potentially important contributor to solving this problem.
STPC—The major need is for policies that mandate the protection of ecosystems and people
as a system.
Programs and Regions—These organizations should extend existing efforts to bridge the
gaps between laws and programs to systematically protect the environment.
7.1.7. Integrate Different Types of Assessments to Solve Environmental Problems
The participants found it useful to go beyond risk assessment and consider all of the types
of assessments that inform decisions. They include condition assessments that determine
whether and in what way the environment is impaired, causal assessments that determine the
causes of impairments and their sources, predictive assessments such as risk assessments and
management assessments that determine the expected results of alternative actions, and outcome
assessments that determine whether the chosen action was effective.
RAF—The forum should develop a document describing the fully integrated assessment
framework and explaining how linking different types of assessments can improve
decision-making.
Programs and Regions—These organizations should recognize and strengthen the role of
assessments other than risk assessments.
7.1.8. Create Forums for Communication
Many ecological risk assessors feel isolated, and assessment concepts and tools are
seldom shared among programs and regions.
RAF—The Forum should look beyond this Colloquium and its products to find ways to make
communication among ecological assessors more regular and effective. They might
include topical interest groups, regular meetings of ecological assessors, and Web
sites.
Programs and Regions—These organizations should afford opportunities to their staff to
participate in meetings, colloquia, workshops, and details.
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7.2. SPECIFIC RECOMMENDATIONS
Although the Colloquium participants emphasized broad policy-related issues, some
specific needs for technical guidance were identified in Groups 2, 3, and 4 or were expressed by
an individual during plenary discussions.
Quality assurance and DQOs for ecological assessments
The available quality assurance and DQO guidance for assessments emphasizes human
health issues and techniques. For example, the DQO guidance presumes that risk
characterization is performed by determining the probability of exceeding a bright line.
Few ecological assessments have a priori bright lines, and risk characterization often
involves multiple lines of evidence.
Weight of evidence
Although ecological assessments often involve multiple lines of evidence, there is no
guidance on how to weigh those lines of evidence to make inferences.
Multiple stressors
The existing guidance documents for assessing the effects of mixtures is based on the
types of data that are available for human health assessments and are limited to
chemicals.
Receptor-specific guidance
While assessment methods are well developed for some taxa and assemblages such as
fish and benthic invertebrates, there are little data and no assessment guidance for others
such as amphibians, reptiles, and mollusks.
Stressor-specific guidance
Some stressors such as nanomaterials are not well addressed by current assessment
guidance.
Adaptive management
Adaptive management is a process that determines the outcome of actions and uses that
information to improve the assessments that inform subsequent decisions and the efficacy
of those decisions. It is particularly useful when uncertainties are large.
Beneficial ecological consequences from risk management decisions
Guidance should be provided on estimating the expected benefits of actions.
Life-cycle analysis for product safety evaluations
A life-cycle approach to the assessment of new chemicals and other products could
improve the completeness and quality of assessments and decisions.
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Uncertainty characterization and communication
The analysis of uncertainty, other than Monte Carlo analysis of transport and exposure
models, has not been the subject of Agency guidance. Uncertainties in ecological
assessments are particularly ill-defined.
State-of-science or best practices reports
Rather than developing guidance, the RAF might develop reports based on workshops
that summarize the best practices with respect to an assessment problem.
Case studies
Case studies of good assessment practices are a useful adjunct to training. They could
include large scale assessments, assessments that reach no-effect conclusions in a
defensible manner, assessments that use new types of data or methods of data analysis,
etc.
Success stories
Create a document showing how actions based on ecological risks have resulted in
improvements in the environment. This would encourage both assessors and managers.
Also, since ecological successes are more apparent, they can help to justify the Agency's
actions. For example, by banning DDT, we saved bird species and may have headed off
effects on humans.
Cumulative assessment
The RAF should continue developing Agency guidelines on cumulative assessment,
including a discussion of consideration of ecosystem services.
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http ://www. epa.gov/osw/hazar d/correctiveaction/eis/ei_guida.pdf.
U.S. EPA (Environmental Protection Agency). (2000a) Workshop report on characterizing ecological risk at the
watershed scale. Office of Research and Development, National Center for Environmental Assessment,
Washington, DC; EPA/600/R-99/111. Available online at
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=23760.
U.S. EPA (Environmental Protection Agency). (2000b) Stressor identification guidance document. Office of Water,
Washington, DC; EPA/822/B-00/025. Available online at
http://www.epa.gov/waterscience/biocriteria/stressors/stressorid.pdf.
U.S. EPA (Environmental Protection Agency). (2000c) Ambient aquatic life water quality criteria for dissolved
oxygen (saltwater): Cape Cod to Cape Hatteras. Office of Water, Washington, DC; EPA/822/R-00/012. Available
online at http://www.epa.gov/waterscience/criteria/dissolved/docriteria.pdf.
U.S. EPA (Environmental Protection Agency). (2000d) Risk characterization handbook. Science Policy Council.
Office of Science Policy, Washingtion, DC; EPA/100/B-00/002. Available online athttp://itp-
pfoa.ce.cmu.edu/docs/RChandbk_excerpts_re_exposure.pdf.
U.S. EPA (Environmental Protection Agency). (2000e) Guidelines for preparing economic analyses. Office of the
Administrator, Washington, DC; EPA/240/R-00/003. Available online at
http://yosemite.epa.gov/ee/epa/eed.nsf/webpages/Guidelines.html/$file/Guidelines.pdf.
R-6
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U.S. EPA (Environmental Protection Agency). (2000f) Nutrient criteria technical guidance manual, lakes and
reservoirs. Office of Water, Washington, DC; EPA-/822-BOO-001. Available online at
http://water. epa.gov/scitech/swguidance/waterquality/standards/criteria/aqlife/pollutants/nutrient/lakes_index.cfm
U.S. EPA (Environmental Protection Agency). (2001a) Risk assessment guidance for superfund: volume III - part
A, process for conducting probabilistic risk assessment. Office of Emergency and Remedial Response, Washington,
DC; EPA/540/R-02/002. Available online at
http://www.epa.gov/oswer/riskassessment/rags3adt/pdf/rags3adt_complete.pdf.
U.S. EPA (Environmental Protection Agency). (200Ib) Planning for ecological risk assessment: developing
management objectives (external review draft). Risk Assessment Forum, Washington, DC; EPA/630/R-01/001A.
Available online at http://cfpub.epa.gov/ncea/raf/pdfs/eco_objectives-sab_6-01.pdf.
U.S. EPA (Environmental Protection Agency). (2001c) Risk assessment guidance for Superfund Volume I —
Human health evaluation manual (Part D, Standardized planning, reporting and review of Superfund risk
assessments, Final). Publication 9285.7-47. Office of Emergency and Remedial Response, Washington, DC.
Available online at http://www.epa.gov/oswer/riskassessment/ragsd/index.htm.
U.S. EPA (Environmental Protection Agency). (2002a) Lessons learned on planning and scoping for environmental
risk assessments. Planning and Scoping Workgroup of the Science Policy Council, Washington DC. Available
online at http://www.epa.gov/spc/pdfs/handbook.pdf.
U.S. EPA (Environmental Protection Agency). (2002b) The twenty needs report: how research can improve the
TMDL program. U.S. Environmental Protection Agency, Office of Wetlands, Oceans and Watersheds, Washington,
DC; EPA/841/B-02/002. Available online at http://www.epa.gov/owow/tmdl/20needsreport_8-02.pdf.
U.S. EPA (Environmental Protection Agency). (2003a) Framework for cumulative risk assessment. Risk
Assessment Forum, Washington DC; EPA/600/P-02/001F, 109pp. Available online at
http://www.epa.gov/raf/publications/pdfs/frmwrk_cum_risk_assmnt.pdf.
U.S. EPA (Environmental Protection Agency). (2003b) Generic ecological assessment endpoints (GEAE) for
ecological risk assessment. Risk Assessment Forum, Washington, DC; EPA/630/P-02/004F. Available online at
http ://www. epa. gov/raf/publications/pdfs/GENERIC_ENDPOINT S_2004 .PDF.
U.S. EPA (Environmental Protection Agency). (2003c) A summary of general assessment factors for evaluating the
quality of scientific and technical information. Science Policy Council, Washington, DC; EPA/100/B-003/001.
Available online at http://www.epa.gov/spc/pdfs/assess2.pdf.
U. S. EPA (Environmental Protection Agency). (2004a) An examination of EPA Risk assessment principles and
practices: staff paper. Office of the Science Advisor, Washington, DC; EPA/100/B-04/001. Available online at
http ://www. epa. go v/osa/pdfs/ratf-final.pdf.
U.S. EPA. (Environmental Protection Agency). (2004b) Overview of the ecological risk assessment process in the
Office of Pesticide Programs, U.S. Environmental Protection Agency. Office of Prevention, Pesticides and Toxic
Substances. Washington, DC. Available online at http://www.epa.gov/espp/consultation/ecorisk-overview.pdf.
U.S. EPA (Environmental Protection Agency). (2004c) Air toxics risk assessment reference library. Volume 1
technical resource manual. Office of Air Quality Planning and Standards, Research Triangle Park, NC;
EPA/453/K-04/001A. Available online at http://www.epa.gov/ttn/fera/risk_atra_voll.html.
U.S. EPA (Environmental Protection Agency). (2004d) Risk assessment guidance for Superfund Volume I —
Human health evaluation manual (Part E, Supplemental guidance for dermal risk assessment, Final). EPA/540/R-
99/005. OSWER 9285.7-02EP. PB99-963312. Office of Superfund Remediation and Technology Innovation,
Washington, DC. Available online at http://www.epa.gov/oswer/riskassessment/ragse/index.htm.
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U.S. EPA (Environmental Protection Agency). (2005) Guidance for developing ecological soil screening levels.
November 2003, revised February 2005. Office of Solid Waste and Emergency Response. Washington, DC.
OSWER Directive 9285.7-55. Available online at
http://www.epa. gov/ecotox/ecossl/pdf/ecossl_guidance_chapters.pdf.
U.S. EPA (Environmental Protection Agency). (2006a) Ecological benefits assessment strategic plan. Office of
Policy, Economics and Innovation, National Center for Environment Economics, Washington, DC;
EPA/240/R-06/001.
U.S. EPA (Environmental Protection Agency). (2006b) Framework for developing suspended and bedded sediments
water quality criteria. Office of Water, Washington, DC; EPA/822/R-06/001. Available online at
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=l 64423.
U.S. EPA (Environmental Protection Agency). (2007a) Nanotechnology white paper. Science Policy Council,
Office of the Science Advisor, Washington DC; EPA 100/B-07/001. Available online at
http://www.epa.gov/osa/pdfs/nanotech/epa-nanotechnology-whitepaper-0207.pdf.
U.S. EPA (Environmental Protection Agency). (2007b) Hypoxia in the Northern Gulf of Mexico: an update by the
Science Advisory Board. Washington DC; EPA SAB-08-004. Available online at
http://yosemite.epa.gov/sab/sabproduct.nsf/C3D2F27094E03F90852573B800601D93/$File/EPA-SAB-08-
003complete.unsigned.pdf.
U.S. EPA (Environmental Protection Agency). (2007c) Framework for metals risk assessment. Risk Assessment
Forum, Office of the Science Advisor, Washington DC; EPA 100/B-07/001. Available online at
http://www.epa.gov/raf/metalsframework/pdfs/metals-risk-assessment-final.pdf
U.S. EPA (Environmental Protection Agency). (2008a) EPA's 2008 report on the environment. National Center for
Environmental Assessment, Washington, DC; EPA/600/R-07/045F. Available online at
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=l 90806.
U.S. EPA (Environmental Protection Agency). (2008b) Guidelines for preparing economic analyses. External
review draft, September 12, 2008. National Center for Environmental Economics, Washington, DC. Available
online at http://yosemite.epa.gov/ee/epa/eerm.nsf/vwAN/EE-0516-01 .pdf/$file/EE-0516-01 .pdf.
U.S. EPA (Environmental Protection Agency). (2008c) Framework for application of the toxicity equivalence
methodology for polychlorinated dioxins, furans, and biphenyls in ecological risk assessment. Risk Assessment
Forum, Washington DC; EPA/100/R-08/004. Available online at http://www.epa.gov/raf/tefframework/pdfs/tefs-
draft-052808.pdf.
U.S. EPA (Environmental Protection Agency). (2008d) Integrated science assessment (ISA) for oxides of nitrogen
and sulfur-ecological criteria. Office of Research and Development, Research Triangle Park, NC;
EPA/600/R-08/082F. Available online athttp://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=201485.
U.S. EPA (Environmental Protection Agency). (2008e) Advice to EPA on the science and application of ecological
risk assessment in environmental decision making: a report of the U.S. EPA Science Advisory Board. Science
Advisory Board, Washington, DC: EPA-SAB-08-002. Available online at
http://yosemite.epa.gov/sab/sabproduct.nsf/7140DCOE56EB148A8525737900043063/$File/sab-08-002.pdf.
U.S. EPA (Environmental Protection Agency). (2009a) Summary report: risk assessment forum technical workshop
on population-level ecological risk assessment. Risk Assessment Forum, Washington, DC, EPA/100/R-09/006.
Available online at http://www.epa.gov/raf files/population_level_era_report_supp_materials.pdf.
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U.S. EPA (Environmental Protection Agency). (2009b) Valuing the protection of ecological systems and services: a
report of the U.S. EPA Science Advisory Board. Science Advisory Board, Washington, DC; EPA-SAB-09-012.
Available online at http://yosemite.epa.gov/sab/sabproduct.nsf WebBOARD/ValProtEcolSys&Serv?
OpenDocument.
U.S. EPA (Environmental Protection Agency). (2009c) Risk assessment guidance for Superfund Volume I —
Human health evaluation manual (Part F, Supplemental guidance for inhalation risk assessment, Final). EPA/540/R-
070/002. OSWER 9285.7-82. Office of Superfund Remediation and Technology Innovation, Washington, DC.
Available online at http://www.epa.gov/oswer/riskassessment/ragsf/index.htm.
White, ML; Maurice, CG; Mysz, A; et al. (2008) The critical ecosystem assessment model (CrEAM) - identifying
healthy ecosystems for environmental protection planning. In: Campbell, JC; Jones, KB; Smith, H; et al; eds. North
America Land Cover Summit, Chapter 12. Washington, DC: Association of American Geographers; pp. 181-213.
Available online at http://www.aag.org/galleries/nalcs/CH12.pdf.
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APPENDIX A
COLLOQUIUM PARTICIPANTS
A-l
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PARTICIPANTS
Hunter Anderson, U.S. EPA, Office of Research and Development, National Center for
Environmental Assessment, BRAB, Postdoctoral Research Ecotoxicologist,
anderson.hunter@epa. gov
Joan Aron, U.S. EPA, Office of Research and Development, Office of the Science Advisor,
American Association for the Advancement of Science-Science and Technology Policy
Fellow, aron.joan@epa.gov
Mace Barren, U.S. EPA, Office of Research and Development, National Health and
Environmental Effects Research Laboratory, Gulf Ecology Division, Branch Chief,
barron.mace@epa.gov
Joe Beaman, U.S. EPA, Office of Science and Technology, Ecological Risk Assessment Branch,
Branch Chief, beaman.joe@epa.gov
Michael Broder, U.S. EPA, Office of Science and Technology, Biologist,
broader.michael@epa. gov
Arden Calvert, Office of the Chief Financial Officer, calvert.arden@epa.gov
David Charters, Office of Superfund Remediation and Technology Innovation,
charters. davidw@epa. gov
Susan Cormier, U.S. EPA, Office of Research and Development, National Center for
Environmental Assessment, Biological Risk Assessment Branch, Senior Scientist,
cormier. susan@epa. gov
Charles Delos, U.S. EPA, Office of Water, Office of Science and Technology, Health and
Ecological Criteria Division, Environmental Scientist, delos.charles@epa.gov
Laura Dobbins, U.S. EPA, Office of Science and Technology, Ecological Risk Assessment
Branch, Physical Scientist, dobbins.laura@epa.gov
William Eckel, U.S. EPA, Office of Chemical Safety and Pollution Prevention,
eckel.william@epa.gov
Herbert Fredrickson, U.S. EPA, Office of Research and Development, National Health and
Environmental Effects Research Laboratory, Immediate Office,
fredrickson.herbert@epa.gov
Jeffrey Gallagher, U.S. EPA, Office of Pollution Prevention and Toxics, NCSAB, Toxicologist,
gallagher.j effrey@epa. gov
Kathryn Gallagher, U.S. EPA, Office of the Science Advisor, Risk Assessment Forum, Acting
Director, gallagher.kathryn@epa.gov
Linda George, U.S. EPA, Region 2, Enforcement and Investigations Branch, Risk Assessor,
george. linda@epa. gov
Iris Goodman, U.S. EPA, Office of Research and Development, National Center for
Environmental Assessment, goodman.iris@epa.gov
Michael Griffith, U.S. EPA, Office of Research and Development, National Center for
Environmental Assessment, griffith.michael@epa.gov
Tala Henry, U.S. EPA, Office of Pollution Prevention and Toxics, Office of Chemical Safety and
Pollution Prevention, henry.tala@epa.gov
Lisa Huff, U.S. EPA, Health and Ecological Criteria Division, Office of Science and
Technology, Toxicologist, huff.lisa@epa.gov
Barbara Karn, U.S. EPA, National Center for Environmental Research, Immediate Office,
Scientist, karn.barbara@epa.gov
A-2
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Amuel Kennedy, U.S. EPA, Office of Pollution Prevention and Toxics, Biologist,
kennedy. amuel@epa. gov
Kristen Keteles, U.S. EPA, Office of Pollution Prevention and Toxics, Toxicologist,
keteles .kristen@ep a. gov
Michael Kravitz, U.S. EPA, Office of Research and Development, National Center for
Environmental Assessment, Environmental Scientist, kravitz.michael@epa.gov
Wade Lehmann, U.S. EPA, Office of Science and Technology, Ecological Risk Assessment
Branch, Aquatic Toxicologist, lehmann.wade@epa.gov
Jason Lynch, U.S. EPA, Office of Atmospheric Programs, CMAD, ACB, Ecologist,
lynch.jason@epa.gov
Anthony Maciorowski, U.S. EPA, Science Advisory Board, Staff Office, Deputy Director, Staff
Office, maciorowski.anthony@epa.gov
Charles Maurice, U.S. EPA, Office of Research and Development, Office of Science Policy,
Region 5 Superfund Division, Superfund and Technology Liason,
maurice.charles@epa.gov
Mike McManus, U.S. EPA, Office of Research and Development, National Center for
Environmental Assessment, Environmental Scientist, Ecologist,
mcmanus .michael@epa. gov
Wayne Munns, Office of Research and Development, National Health and Environmental
Effects Research Laboratory, Atlantic Ecology Division, Associate Director for Science,
munns.wayne@epa.gov
Dan Mazur, U.S. EPA, Office of Solid Waste and Emergency Response, Region 5, Ecologist,
mazur.daniel@epa.gov
Edward Odenkirchen, U.S. EPA, Office of Chemical Safety and Pollution Prevention,
odenkirchen. edward@epa. gov
Edward Ohanian, U.S. EPA, Office of Science and Technology, Health and Ecological Criteria
Division, Office of Water, Director, ohanian.edward@epa.gov
Melissa Panger, U.S. EPA, Office of Pollution Prevention and Toxics, Biologist,
panger.melissa@epa.gov
Bruce Pluta, U.S. EPA, Biological Techinal Assistance Group, Region 3 Coordinator, Hazardous
Site Cleanup Division, pluta.bruce@epa.gov
Sara Pollack, U.S. EPA, Office of Pollution Prevention and Toxics, NCSAB, Environmental
Protection Specialist, pollack.sara@epa.gov
Meghan Radtke, U.S. EPA, Office of Science Advisor, Risk Assessment Forum, American
Association for the Advancement of Science-Science and Technology Policy Fellow,
radtke .meghan@epa. gov
Anne Rea, U.S. EPA, Office of Air Quality Planning and Standards, Environmental Health
Scientist, rea.anne@epa.gov
Susan Roddy, U.S. EPA, Superfund Ecological Risk Assessor, Region 6, roddy.susan@epa.gov
Vicki Sandiford, U.S. EPA, Office of Air Quality Planning and Standards,
sandiford.vicki@epa.gov
Seema Schappelle, U.S. EPA, Office of Science Advisor, Risk Assessment Forum,
schappelle.seema@epa.gov
Anne Sergeant, U.S. EPA, National Center for Environmental Research, Applied Science
Division, Environmental Scientist, sergeant.anne@epa.gov
A-3
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Denice Shaw, U.S. EPA, Office of Research and Development, National Center for
Environmental Assessment, Immediate Office, shaw.denice@epa.gov
Michael Slimak, US. EPA, Office of Research and Development, National Center for
Environmental Assessment, Immediate Office, Associate Director for Ecology,
slimak.michael@epa.gov
Mark Sprenger, U.S. EPA, Office of Superfund Remediation and Technology Innovation,
sprenger.mark@epa.gov
Glenn Suter, US. EPA, Office of Research and Development, National Center for Environmental
Assessment, Cincinnati, Science Advisor, suter.glenn@epa.gov
Patti TenBrook, U.S. EPA, Region 9, Life Scientist, tenbrook.patti@epa.gov
Sharon Thorns, U.S. EPA, Superfund, Ecological Risk Assessor, thoms.sharon@epa.gov
Brett Thomas, U.S. EPA, Superfund Support, Life Scientist, thomas.brett@epa.gov
Philip Turner, U.S. EPA, Technical and Enforcement, Life Scientist/Risk Assessor,
turner.philip@epa.gov
Zig Vaituzis, U.S. EPA, Office of Pesticide Programs, Biopesticides and Pollution Prevention
Division, Senior Scientist, vaituzis.zigfridas@epa.gov
Sara Waterson, U.S. EPA, Air Toxis and Monitoring Branch, Life Scientist,
waterson.sara@epa.gov
Marjorie Wellman, U.S. EPA, Office of Science and Technology, RSTSSB, Ecologist,
wellman.marjorie@epa.gov
Randy Wentsel, U.S. EPA, Office of Research and Development, Immediate Office, National
Program Director, wentsel.randy@epa.gov
Steve Wharton, U.S. EPA, Region 8, Risk Assessor, wharton.steve@epa.gov
Pai-Yei Whung, U.S. EPA, Office of Science Advisory, Immediate Office, Chief Scientist,
whung.pai-yei@epa.gov
Tracy Wright, U.S. EPA, Office of Pollution Prevention and Toxics, Risk Assessment Division,
Biologist, wright.tracy@epa.gov
C. Richard Ziegler, U.S. EPA, Office of Research and Development, National Center for
Environmental Assessment, Physical Scientist, ziegler.rick@epa.gov
Jean Zodrow, U.S. EPA, OEA, Toxicologist, zodrow.jean@epa.gov
BREAK-OUT GROUP PARTICIPANTS
Break-out Group #1
Joseph Beaman Denice Shaw
William Eckel Brett Thomas
Herb Fredrickson Sharon Thorns
Kathryn Gallagher Randy Wentsel
Lisa Huff Steve Wharton
Jason Lynch Rick Zeigler
Tony Maciorowski
Chuck Mauric
Wayne Munns
Anne Rea
Vicki Sandiford
Anne Sergeant
A-4
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Break-out Group #2
Hunter Anderson
Mace Barren
Charles Delos
Laura Dobbins
Linda George
Kristen Keteles
Michael Kravitz
Nan Mazur
Melissa Panger
Bruce Pluta
Philip Turner
Marjorie Wellham
Mark Sprenger
Break-out Group #3
Mace Barren
Michael Broder
Arden Calvert
Susan Cormier
Jeffrey Gallagher
Michael Griffith
Barbara Karn
Ameul Kennedy
Wade Lehmann
Bruce Pluta
Sara Pollack
Glenn Suter
Zig Vituzis
Sara Waterson
Jean Zodrow
Break-out Group #4
Joan Aron
Joe Beaman
David Charters
Charles Delos
Iris Goodman
Tala Henry
Tony Maciorowski
Mike McManus
Ed Odenkirchen
Ed Ohanian
Meghan Radtke
Susan Roddy
Mike Slimak
Patti TenBrook
Tracy Wright
A-5
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APPENDIX B
INTERVIEWS OF ECOLOGICAL ASSESSORS
B-l
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This appendix presents the results of the 12 interviews of U.S. Environmental Protection
Agency (EPA) ecological assessors that were conducted prior to the Colloquium. The primary
purpose was to explore the diversity of ecological assessment activities in the Agency and
confirm the applicability of the integrated framework (see Section 3) to current assessment
practices in the Agency. Thereby, the technical committee was able to confirm that the
integrated framework is useful for organizing the Colloquium and report. The interviewees were
chosen to represent the Agency's programs and regions. Most of those chosen are relatively
senior, so that the answers would reflect a breadth of experience and depth of knowledge.
The interview began by identifying the interviewee's experience and then the regulatory
role of their organization and available guidance. The interviewer then proceeded to explain the
four types of assessments in the integrated framework and to ask the interviewee about
assessments of that type performed by their organization. Then the interviewee was asked about
the relationship of ecological assessments to decision-making and to achieving the mandates of
their organization. Finally, the interviewer asked about the needs of their organizations with
respect to assessment methods and guidance.
The interviews have been extensively edited to be concise, consistent, and on topic.
B.I. COMPREHENSIVE ENVIRONMENTAL RESPONSE, COMPENSATION, AND
LIABILITY ACT (CERCLA) AND RESOURCE CONSERVATION AND
RECOVERY ACT (RCRA)
Mark Sprenger, PhD
Region 2 Office of Superfund Remediation & Technology Innovation
Professional experience or organizational affiliations relevant to environmental assessment
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 BS in Biology from the State University of New York at Stony Brook, and a MS
and PhD in Environmental Science from Rutgers, the State University of New Jersey. His
doctorate research and postdoctorate work focused on alteration in metals availability resulting
from acid deposition as well as postdoctorate 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 international in scope, with
a focus on ecological risk assessments; contaminant fate and transport, particularly in sediments;
site environmental monitoring; and most recently, on the assessment of innovative remedial
technologies and ecological restoration, from an ecological risk perspective, at Superfund and
brownfield sites.
B-2
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Regulations or programs that are informed by assessments
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA;
Superfund)
Guidance
Although there is ample guidance for the assessment process (Fig. B-l and B-2), it is not always
followed. Relevant policy guidance documents can be found at
http://www.epa.gov/oswer/riskassessment/policy.htm.
RISK INFORMATION ACTIVITIES
IN THE RI/FS PROCESS
Project
scoping
Site
characterization
(RI)
Establishment of
remedial action
objectives (FS)
Development and
screening of
alternatives (FS)
Detailed analysis
of alternatives
(FS)
Review data
collected in
site inspection
Review
sampling/data
collection
plans
Formulate
PROS
Determine
level of effort
for baseline
risk assessment
Conduct
baseline risk
assessment
Refine PRGs
based on risk
assessment
and ARARs
Conduct risk
evaluation of
remedial
alternatives
Figure B-l. A diagram of the assessment processes in a CERCLA remedial
investigation and feasibility study. Figure by Mark Sprenger.
B-3
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Process
Activities
Pre-Remedial Process
-Preliminary Assessment
-Site Investigation Inspection
-Hazard Ranking System Evaluation
-National Priorities List Listing
Preliminary Identification of site hazards and evaluation of the
need for action under Superfund remedial program
Remedial Investigation/Feasibility Study (RI/FS)
—Scoping the RI/FS
—Site Characterization
—Baseline-Risk Assessment
—Treatability Studies
—Development and Screening of Alternatives
—Detailed Analysis of Alternatives
Gather information sufficient to support an informed risk
management decision regarding which remedy appears to be the
most appropriate for a given site
Remedy Selection Process
, ._ . _ _
i
rred Alternative
r
Make initial identification of Preferred Alternative based upon
preliminary balancing of tradeoffs among alternatives using the
nine NCP criteria
Proposed Plan
Present Preferred Alternative
Public Comment
Minimum 30-day public comment period held on the Proposed
Plan, RI/FS, and other contents of the Administrative Record file
Remedy Selection
Make final determination on remedy
Record of Decision (ROD)
Certify that the remedy complies with CERCLA, outline the
technical goals of the remedy, provide background information
on the site, summarize the analysis of alternatives, and explain
the rationale for the remedy selected
Remedy Implementation
-Remedial Design
-Remedial Action
Design and construct remedy using information contained in the
ROD and other relevant documents. Write Explanation of
Significant Differences (ESDs) or ROD Amendments (if
appropriate)
Long-Term Remedy Maintenance
—Operation and Maintenance
-5
Operate and maintain the remedy and ensure protectiveness
through 5-year reviews if contamination remains
O
I
•t'
I
o_
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continues until the parties get the answer they wanted rather than an objective assessment.
Negotiations occur regarding sampling extent and effort that may not meet the data quality
objectives.
Causal Assessments
Causal assessments almost always needed because (1) the biotic communities of the site are
often obviously impaired, (2) usually almost nothing is eliminated in screening-level Ecological
Risk Assessment (ERA), and (3) the causes are often unclear, creating a need for additional
causal assessment. The conventional ecological risk assessment framework has been used to
perform causal assessments (see Box B-l).
Box B-l. Superfund assessors use the RA paradigm for causal assessments.
Two examples were illustrative. On the Hudson across from West Point was a nickel cadmium battery
manufacturer (Marathon Battery at Foundry Cove, Cold Springs, NY). Yellow cadmium sulfide deposits were
highly visible; however, research by Gary Ankley and others at the Duluth laboratory showed that nickel toxicity
was the greater threat. For a list of contaminants and more information of this site, which has been remediated, see
EPA's Web site. Accessed 20090730.
http://cfpub.epa.gov/supercpad/SiteProfiles/index.cfm?fuseaction=second.Contams&id=0201491
In another case, uranium contamination was suspect, but erosion may have been equally deleterious, or both may
have acted together. This is a question of trying to separate out the causative agents. The system was impacted, but
if it was impacted from erosion (loss of habitat only), Superfund could not legally take an action in the stream. If it
is plausible that an impact would exist from the contamination even if the habitat loss did not exist, then Superfund
may take an action. It is a challenge to make those determinations.
At the Palmerton Zinc Pile Site, one area of 2,000 acres was devegetated and was attributed to air and soil
contamination resulting from the historic smelting operations. However, it is also possible that fires ignited by
coal-fired locomotives during the early part of the 20th century caused the initial damage, and that failure to recover
was due to other causes. This is an issue for the Natural Resource Trustees, but it does not mean that the zinc levels
are not a risk but more of an issue on what was the initial cause of the system loss. However, that is not a
Superfund problem. Accessed 20090730 http://www.epa.gov/reg3hwmd/npl/PAD002395887.htm.
Predictive Assessment—Conventional Risk Assessment
CERCLA assessments are largely not typically predictive because the impact has already
happened. However, future effects due to movement of the contaminants must be considered,
and the selection of a remedy implies that effects will continue if not remediated. An example is
described in Box B-2. Similarly, in a Natural Resource Damage Assessment (NRDA), the
damage is assessed for the past loss of the resource (condition assessment) and for future loss of
the resource (predictive assessment). Sources and causes are also identified in the NRDA.
Predictive Assessment—Benchmark Determination
On occasion, it might be worthwhile to refine a criterion concentration if there may be a cost
saving in the remediation. An example is a New York tannery site contaminated by chromium
and other metals. The lowest effect level was 26 ppm; but background was not much lower, and
a more reasonable cleanup level was selected. This is becoming a nationwide issue. Typically,
promulgated state or federal criteria must be accepted, but states are pushing screening criteria as
state standards. Tribes have identified these values as applicable or relevant and appropriate
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requirements (ARARs) for tribal lands in some cases. The issue is that sometimes we do use the
screening values because it is not cost effective for the potential remedy actions to obtain a more
accurate number (a higher cleanup goal). The reasons are strictly engineering in nature; for
example, a bulldozer can not make a finer cut than 6-12 inches, and dredges are no better and
likely a lot worse because you cannot see their work area. If the changes in the "construction"
do not change the effort, then the technically better ERA and conclusions drawn from it are of no
value to the Program.
Box B-2. Hiteman Tannery, NY.
In mid-1996, a Site Investigation (SI) was performed by EPA. Elevated levels (relative to site reference or
regional background levels) of chromium were detected in the surface soil (up to 75,000 mg/kg), subsurface soils
(up to 72,000 mg/kg), and surface water (33 ug/L unfiltered; 5.7 ug/L filtered). Several other contaminants
detected at low levels and primarily in the soil samples were TAL metals, pesticides, semivolatiles, and volatiles.
A structural evaluation determined that most of the buildings and the stack at the site were structurally unsound,
and demolition was recommended. The stability of the north bank of the Unadilla River adjacent to the site was
determined to be subjected to erosion by high water levels (spring runoff), which may slowly undercut the bank.
In November 1996, to stabilize the north bank of the Unadilla River adjacent to the site, 500 linear feet of man-size
Rip Rap was installed along the bank.
As part of the RI, a screening-level ERA was conducted. The results indicated the potential for risk to ecological
receptors from site-related contaminants. EPA concluded that a more thorough assessment of ecological risk
(i.e., a Baseline ERA, or BERA) was warranted. The BERA used a multiple lines-of-evidence approach to
evaluate ecological risks, including food chain modeling, site-specific toxicity testing, and field observations (such
as the lack of amphibians in the wetland). The BERA focused on both the aquatic communities exposed to
contaminants in the Unadilla River and the terrestrial organisms exposed to contaminants in the on-property
wetland sediment and upland surface soil at the site. The BERA identified the potential for ecological risks from
exposure to chemicals detected in the Unadilla River sediment, wetland sediment, and former tannery property
surface soil. Metals drove the risk calculations, showing a high Hazard Quotient (HQ) of 6 attributable to the
metals in these media (U.S. EPA, 2006).
New benchmarks are usually derived from databases or the literature. In some cases, an
effects-based criterion is determined.
When determining protective levels for cleanup, the selection of assessment endpoints are
important because the relevance of tests that are used is not immediately understood by others.
For example, if the assessment uses earthworm toxicity tests, and no other, then the decision to
remediate a site may appear to be a foolish attempt to save earthworms. In Region 1, such a case
arose with respect to a $20 M remediation at a creosote-contaminated site.
Predictive Assessment—Management Assessment
This should be integrated into the assessment endpoints.
There is no value to limiting the number of assessment endpoints.
Use the RA process to evaluate need-for-remedy options (called the Baseline ERA). If a risk is
identified a feasibility study is conducted to evaluate remedy options. The feasibility study uses
the RA process to evaluate remedy options per the "nine criteria." The feasibility study (FS) is
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typically an engineering document, and the assessors should use the RA to guide remedy
selection. They also do so in concluding whether or not remedy options meet the threshold
criteria of protectiveness. The risks associated with the remedy action itself are not as
systematically evaluated. That is where net ecosystem benefits analysis (NEBA) could be used
effectively, ^is is all documented in the Decision of Record.
Baseline risk assessments do not look at remedial options.
Outcome Assessment
Assessments are seldom performed to determine whether ecological goals are achieved. The
remedy must be "protective," but "protective" is not defined. A 5-year review is performed
which could be based on an outcome assessment, but it typically limited to levels of the
contaminants rather than effects.
General comments
A risk assessment is a tool to reach an informed decision. When it is done well, clear lines of
reasoning lead to a decision. Pure science and knowledge are tools that are applied to these
assessments.
The largest dilemma is how to define "protective." For example, protect population or
community? Industry often wants community-level protection, because it takes longer, and the
results are ambiguous.
Problem formulations are often weak because there are poorly defined assessment endpoints and
often no decision criteria. Also, there is a sense that there is just too much paper and information
to manage. In some cases, problem formulation becomes an assessment in itself, but without the
rigor or protocols to guide the process.
There is no exemption if the "cure is worst than the disease." An option is to apply a risk
remedy to monitor natural attenuation processes.
Superfund involves a legal as well as a scientific process. Actions that are required to satisfy the
legal process sometimes make the science appear less rigorous than it is. Similarly, some of the
analysis may confuse nonscientists because they may not understand the complexity, statistics, or
inferences.
The risk assessment community needs to understand that Superfund risk assessment is conducted
within a legal and decision-making process. The ERA is not the goal, nor is publishable work
the goal; the goal is a justifiable and cost-effective decision.
Suggestions for assuring that scientific information informs and improves decision-making
We need a forum for ERAs with negative results. Such cases help to illustrate that these results
do occur and helps to build confidence when others determine similar results.
We also need Eco-Risk training courses for Superfund and hazardous waste sites. The new
generation does not have the hard-learned experience.
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Jon Rauscher, PhD
Region 6
Professional experience or organizational affiliations relevant to environmental assessment
Jon Rauscher is a Toxicologist in the Superfund Division of U.S. EPA, Region 6. Rauscher has
provided technical assistance on human health and ecological risk assessments at over
100 Superfund and Resource Conservation and Recovery Act (RCRA) sites.
Rauscher has been an active work group participant in the development of following risk
assessment guidance: Risk Assessment Guidance for Superfund, Volume 1 - Human Health
Evaluation Manual, Part C, Risk Evaluation of Remedial Alternative', Risk Assessment Guidance
for Superfund, Volume 2 - Environmental Evaluation Manual', Guidance for Data Usability in
Risk Assessment', and Ecological Risk Assessment Guidance for Superfund. Rauscher is the
Region 6 contact for the Integrated Risk Information System (IRIS). Rauscher was a member of
the Reference Dose and Reference Concentration (RfD/RfC) Work Group, which verified
toxicity values for noncarcinogenic health effects.
In addition, Rauscher is an Adjunct Professor at Southern Methodist University and has taught
graduate-level courses entitled "Sources and Nature of Hazardous Waste" and "Risk Assessment
and Toxicology." Rauscher attended the University of Nebraska and Colorado State University.
Regulations or programs that are informed by assessments
Although not an exhaustive list, several programs and regulations that use assessments were
noted: Superfund, total maximum daily load [TMDL], Biocriteria, Nutrient impairment (Causal
Analysis/Diagnosis Decision Information System [CADDIS] used to address), Louisiana
Regional dissolved oxygen.
Guidance
* Primarily rely on the Ecological Risk Assessment Guidance for Superfund (IFERAGS)
Interim Final (1997)
» Several updates ("Eco-updates") not explicit in the IFERAGS were valuable additions
* 2001 Role of Screening Level Assessments
» Clarification chemicals of concern from Office of Solid Waste and Emergency Response
(OSWER)
» 2008 Ground water-surface water pathways from Eco-forum (Marc Greenberg)
» When he was with the Office of Water, helpful guidance was available for TMDLs.
Stressor Identification (CADDIS), and biocriteria
For RCRA, there is not distinct guidance, so states use IFERAGS. Texas has its own Eco-Risk
guidance for RCRA.
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Condition Assessments
Condition assessments are done as part of the Superfund site assessment but sometimes in
conjunction with other programs. For instance, the Houston/Galveston area was listed on the
303(d) list of impaired waters, but when dioxin was found, it was added to NPL. Subsequently,
the source was identified as a paper waste pit, and the responsible party was identified. A causal
assessment was needed to allocate contribution from the pit and from other water sources.
Preliminary site assessments are condition assessments.
An example of integration is the Calcasieu River in Southwest Louisiana in which a holistic
watershed remediation and protection program was implemented. This involved using the
authorities and programs from the Clean Water Act, RCRA, Superfund, and Oil Pollution Act.
Causal Assessments
Sometimes causes are known at a Superfund site but not always. In particular, causal
assessments are necessary to identify the causal agent for recovering natural resource damages
and to identify the potentially responsible party for site remediation. NRDA is the responsibility
of the "services" or trustees, Fish and Wildlife Service, and National Oceanographic and
Atmospheric Administration. However, the Department of Justice has recommended integrated
assessments so that the liabilities based on the NRDA (lost services, fishery closures, etc.) and
the Superfund ROD (preferred remedy and cleanup costs) be presented together. This has led to
sharing of information between the U.S. Fish and Wildlife Service (FWS), National
Oceanographic and Atmospheric Administration (NOAA), and EPA. Coordination between the
NRDA and Remedial Investigation (including the risk assessments) has allowed for a more
efficient collection of information. The cooperative assessments become parallel processes and
may be iterative.
Predictive Assessment—Conventional Risk Assessment
These assessments are part of Superfund activities. Risk assessment is used to identify the media
and the remedial goal to be addressed by the FS. The FS uses the nine criteria in the National
Contingency Plan to screen the list of potential alternatives.
Predictive Assessment—Benchmark Determination
In the remedial investigation, the cleanup levels are determined depending on the potential future
condition. Examples include residential use, industrial use, or ecological habitat. Remedial
action objectives (RAO) are identified. They may use the triad of contaminant, toxicity, and
biological condition to assess that risk level. The developed level is then used to evaluate
remediation alternatives in the FS.
Predictive Assessment—Management Assessment
In the FS, the nine criteria are used to screen out alternatives that will not meet the RAO level.
Then the protection of human health and environment and the ARARs (standards and criteria)
and the other seven criteria are used to identify the preferred alternative that is described in a
proposed plan for remediation. Then the proposed plan is made available to the public for
review and to the responsible party. Comments are considered and incorporated into the final
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Record of Decision (ROD). Successful management decisions depend on adequate integration
of all relevant considerations across all appropriate scales (see Box B-3).
Box B-3. Other types of integration.
Risk Assessments must be integrated in several ways, (1) across jurisdictions, (2) across
regulatory authorities and programs, (3) across receptor endpoints, and (4) across remedial
alternatives. An illustrative example is Tar Creek in the lead belt of Kansas, Missouri, and
Oklahoma. The aquatic ecological risk assessment required that the entire affected areas be
included in the assessment if the remedial action was to be effective. The effort involved
three states, two EPA regions, ground and surface water, analyses by contractors (Don
McDonald), U.S. Geological Survey (Chris Ingersoll), and EPA (Region 6, Region 7, and HQ
[Mark Sprenger]), state agencies, and other integrative efforts. The success of this complex
ecological risk assessment was increased by senior leadership's encouragement and
understanding of the scale of the assessment.
Outcome Assessment
Although monitoring and assessment of both performance and effectiveness can be specifically
directed in the ROD, there is heavy reliance on the required 5-year review. For example, in a
Louisiana case in the early 1990s, concerns were raised by the inspector general's office that the
remedy had failed. At the time of the original ROD, guidance was not available for modeling the
pathways between ground and surface water. In a review of the site, additional sampling was
done to enable this analysis. The assessors coordinated the timing of collection of data from
several programs including 303(d) State monitoring, EPA-NRMRL-Ada, and Superfund so that
the data could be used in modeling. The information collected by these programs will be used to
evaluate the remedy effectiveness.
Several examples of periodic monitoring included in the ROD were mentioned. At the Lavaca
Bay site in Texas, mercury (Hg) levels in shellfish tissue were not improving as desired. The
redeveloped marsh may need to be capped to meet the Hg RAO. This determination will be
based on the well-documented food web for the area. Alcoa, the responsible party, has proposed
that this would be a reasonable action to interrupt the transfer of Hg through the food web.
Other processes to attain EPA's mission
"Imminent and substantial endangerment" clauses appear in RCRA, 42 U.S.C. §§ 6972(a)(l)(B),
6973; CERCLA (Section 106), and Safe Drinking Water Act §143 la , 42 U.S.C. 301i(a).
Guidance on "imminent and substantial endangerment" appears in CERCLA Section 106(a)
Unilateral Administrative Orders for Remedial Designs and Remedial Action (OSWER Directive
Number 9833.0-la). Also note that Toxic Substances Control Act (TSCA) has similar language
(Federal Pollution Control Act, 1973). In contrast, the Clean Water Act (CWA) and Clean Air
Act require evidence of imminent harm.
Strongest aspect of existing processes
The strongest and weakest aspects are when integration is practiced. It is essential to work with
the prioritization panel and to convey the importance of ecological risks.
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Another strength is that the guidance for Superfund and human health is 20 years old.
Familiarity with the guidance by practitioners has a great advantage. The strategic filling of gaps
such as probabilistic guidance and inhalation guidance is helpful. The 1997 IFERAGS that
superseded the original RAGS Part B guidance has also helped make the process more
successful.
Suggestions for assuring that scientific information informs and improves decision-making
Early and continuous involvement with the public is essential. Otherwise, the public will not be
supportive. Region 6 relies heavily on open houses on different aspects of the process, such as
site investigation, remedial investigation, etc. Region 6 benefits from input from the community,
and sometimes the community helps them identify pathways of exposure that were not originally
considered. Through this process, the public starts to understand and recognize how toxicity
tests and other measurements fit together to enable predictions of risk to an ecosystem.
Regarding the definition of protective—It is important to be very earful to properly articulate and
describe the assessment endpoint and to choose appropriate measurement endpoints and
hypotheses. The definition of protective is dependent on the acceptable future condition of the
site, e.g., residential use, industrial use, or ecohabitat.
Regarding problem formulation—There is often a time limitation, and the problem formulation
is short changed. It is important for senior management to have a realistic understanding of the
amount of time it takes to do a good problem formulation and that the adage penny-wise,
pound-foolish is most apt in this case. To counteract this problem, one approach is to begin the
problem formulation even before the responsible party is identified, as soon as an actionable
contaminant is identified.
Regarding guidance and project management—Remedial project managers need to value
problem formulation, and this can be accomplished by elevating its visibility at the National
Association of regional program managers (RPM) meetings and headquarter division director
meetings, and then filter to section leads.
Dan Mazur
Region 5
Professional experience or organizational affiliations relevant to environmental assessment
Dan Mazur is an ecologist in the Land and Chemicals Division of EPA, Region 5 and provides
technical support on ecological risk assessment for RCRA Corrective Action projects. He is the
primary contact for the Region 5 RCRA Ecological Screening Levels and has extensive
ecological risk assessment experience with RCRA permits for combustion facilities and wrote a
Regional protocol (Example Work Plan to Perform a Screening Ecological Risk Assessment at a
Hazardous Waste Combustion Facility) to support the permitting process.
Prior to joining EPA, he was a State Program Manager for both lake restoration and nonpoint
source control with the Missouri Department of Natural Resources. Mazur was also involved in
applied limnology research and sediment toxicity testing at the University of Michigan
Biological Station.
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Regulations or programs that are informed by assessments
Hazardous waste site—If there is a release from a RCRA corrective action site, assessments are
used to determine impact and to guide cleanup.
When combustion facilities seek a permit to handle hazardous waste, a risk assessment would be
conducted to determine how to set their permit limits. For example, cement kilns require very
high temperatures; fuel with hazardous organic waste can be converted to a nonhazardous waste.
There might be a situation where they are burning a hazardous waste blender mix for energy
value, and the mixture contains metals that do not break down. Risk assessments evaluate
routine emissions from the cement kiln in addition to fugitive emissions from valves, transport
lines, etc. This is a predictive process, very different from Superfund, in which the
contamination already occurs. For example, one thing that is different, because the facility is not
yet on line, the assessor can require and use trial burns to estimate rate of release when
developing risk projections. The assessors do not duplicate efforts, that is, they use the same
release values to estimate risk to ecological resources and to human health. The assessment of
combustion facilities in Region 5 is guided by an example workplan for combustion facilities
developed by Mazur. However, his responsibilities have shifted, and he is no longer involved in
the permitting process for combustion facilities. The workplan has been shared—but not widely.
Polychlorinated biphenyl (PCB) cleanup activities have been directed to RCRA, so that the
remediation is parallel to the RCRA corrective action. There are a few regulatory differences
with PCBs assessments versus other RCRA activities. Regions 5, 6, and 7 have many RCRA
sites. The responsibility for some of these sites has been delegated to the states.
Guidance
Superfund and RCRA are under the auspices of OSWER, and much of guidance developed by
Superfund is also applicable to RCRA.
* The 1997 Interim Final Ecological Risk Assessment Guidance for Superfund is the
primary source of guidance.
* Eco-updates have been a very practical tool for the people in the regions. These are
focused white papers/guidance documents.
» Workplan for combustion facilities.
Condition Assessments
Background assessments of soils are required to determine the condition of the site in the
absence of contamination. It also provides a limit for cleanup, because the Agency does not
normally cleanup below background.
Causal Assessments
Causal assessments determine the source. Sources are not always sure, because highly
industrialized area may have several potential sources of the same contaminant.
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Predictive Assessment—Conventional Risk Assessment
Described above.
Predictive Assessment—Benchmark Determination
Described above.
Predictive Assessment—Management Assessment
Not as formalized as in a Superfund assessment. Some might do a cleanup until a benchmark is
reached.
Outcome Assessment
Not specifically done. But with ground water plumes, pump and treat operations are monitored.
Spot check attainment of progress and benchmark. It would be nice to determine if project
management's ecological goals were met after the permit was issued.
Strongest aspect of existing processes
Human health goals are not as relevant, e.g., ground water plume into the river, no fishing, no
beaches, no withdrawal for potable water, then the driver is ecological, and the project manager
is very engaged, then the ecological issues are truly addressed.
Aspects of the process that could be strengthened
The biggest weakness is in the front end, the planning, and scoping. Program managers do not
establish their own ecological project goals. They do not go back and look at the contaminants
of concern. They do a broad analysis of contaminants rather than targeting the contaminants of
concern. Time is wasted and lots of issues are settled by negotiations. A checklist of questions
for planning and scoping could be helpful.
Suggestions for assuring that scientific information informs and improves decision-making
We need guidance, communication tools, and decision tools. It would be nice to share them
broadly among regions. Establish guidance on the content of assessments, including a uniform
format to make review easier. Give it to industry to use to develop their reports. Some reports
are an executive summary; everything is in tables, and work is not shown.
B.2. CLEAN AIR ACT
Vicki Sandiford
Office of Air, Office of Air Quality and Planning Standards
Professional experience or organizational affiliations relevant to environmental assessment
Vicki Sandiford is an environmental scientist with EPA's Office of Air and Radiation
(OAR)/Office of Air Quality Planning and Standards. She received her BS in Biology from
Davidson College in Davidson, NC and her Masters of Environmental Management with a focus
on Resource Ecology from Duke University in Durham, NC. Since beginning with EPA in 1990,
she has participated in numerous reviews of the Secondary National Ambient Air Quality
Standards (NAAQS), including those for sulfur dioxide (802), nitrogen dioxide (NO2), Ozone
(Os) and particulate matter (PM). Her primary area of expertise is in Os effects on vegetation
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and ecosystems. In her position, she regularly oversees and/or participates in exposure/risk,
policy, and benefits assessments. She works closely with colleagues in Office of Research and
Development (ORD)'s National Center for Environmental Assessment in identifying the most
policy-relevant research useful in informing the NAAQS reviews. She develops alternative
policy scenarios and briefs upper management on the implications of each. She regularly
participates in public meetings, including those of the Clean Air Scientific Advisory Committee
(CASAC) and reviews and responds to public and CASAC comments on proposed and final
rules.
Regulations or programs that are informed by assessments
The Clean Air Act (CAA), which was last amended in 1990, requires EPA to set NAAQS for
wide-spread pollutants from numerous and diverse sources considered harmful to public health
and the environment. The CAA requires periodic review (every 5 years) of the science upon
which the standards are based and the standards themselves. The NAAQS Program continuously
reviews and recommends standards for lead, ozone, carbon monoxide, sulfur dioxide, nitrogen
dioxide, and particulate matter.
The CAA established two types of national air quality standards.
« Primary standards set limits to protect public health, including the health of "sensitive"
populations such as asthmatics, children, and the elderly.
» Secondary standards set limits to protect public welfare, including protection against
visibility impairment, damage to animals, crops, vegetation, and buildings. Economic
value is considered. Accessed 20090725. http://www.epa.gov/ttn/naaqs/.
The process of review involves a call for information. NCEA-RTP compiles information into an
Integrated Science Assessment (ISA). In recent years, the ISA have been more finely tuned to
the needs of OAR as required for policy making. The ISA reports on new information since the
last assessment and draws attention to what is important for consideration. The documents are
peer reviewed and published in the Federal Register. The CASAC reviews the documents and
provides independent advice to the EPA Administrator on the technical bases for EPA's
NAAQS. Established in 1977 under the CAA Amendments of 1977 [see
42 U.S.C. § 7409(d)(2)], CASAC also addresses research related to air quality, sources of air
pollution, and strategies to attain and maintain air quality standards and to prevent significant
deterioration of air quality.
Guidance
Some of the guidance used by OAR is listed below.
Guidelines used by OAR are listed on Technology Transfer Network Fate, Exposure, and Risk
Analysis (FERA). http://www.epa.gov/ttn/fera/risk_related.html.
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Risk Assessment and Modeling: OAR uses EPA Risk Assessment Policy, Guidelines,
and Related Materials.
Policies, Guidance and Frameworks: Cumulative Risk Assessment, Probabilistic
Analysis, Risk Characterization.
Guidelines: Cancer Risk Assessment Guidelines, Cancer Risk Assessment
Guidelines-Implementation, Chemical Mixtures Risk Assessment Guidelines and
Supplementary Guidance, Developmental Risk Assessment Guidelines, Ecological Risk
Assessment Guidelines, Neurotoxicity Risk Assessment Guidelines, Reproductive
Toxicity Risk Assessment Guidelines.
Methods: Methods for Derivation of RfCs and Application of Inhalation Dosimetry
(U.S. EPA, 1994).
Condition Assessments
The condition assessment asks if there are still effects occurring at current standards and if there
are exceedances of the existing standard. If direct information is not available, then effects are
predicted based on stressor response associations from the literature. (See predictive assessment
below.) For example, current ozone levels could be used to predict expected crop loss and
foliage injury to trees. This diverse information is interpolated geographically as a national
assessment.
Causal Assessments
The cause is predetermined (the six chemicals previously noted); however, confounding effects
such as those of climate change may be evaluated and influence the standard so that it is set
"with an adequate margin of safety."
Predictive Assessment-Conventional Risk Assessment
Risk and exposure assessments (REAs) are used to evaluate effects when and where they are not
measured.
Predictive Assessment-Benchmark Determination
Given the evidence and the REA, a standard is recommended based on 8-hour exposure on
average (3-year period) using the 98th percentile for effects. A proposed rule making is
published in the Federal Register, often indicating a range. Recommended standards may apply
to certain regions (e.g., Adirondack lakes), scenic vistas, and Class 1 areas (e.g., Grand Canyon).
Predictive Assessment—Management Assessment
The purpose of the Economics and Cost Analysis Support site is to make the documents
developed by the Air Benefit and Cost Group (ABCG) available in one place. Tools include the
databases and models that have been developed by ABCG for cost, benefit, and economic impact
analyses. Documents include analytical guidance and reports on conducting analysis of costs,
benefits, and economic impacts of air quality management strategies, programs, and regulations
(http://www.epa. gov/ttn/ecas/).
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Outcome Assessment
As soon as one cycle ends, another begins to evaluate effectiveness of the program.
Other processes to attain EPA's mission
For the primary standard for human welfare, 8 years after the standard is implemented, there are
fines or other repercussions, such as loss of highway funds. There is no penalty for failure to
meet the secondary standard. Rather, the responsible entities are to achieve the standard as
"expeditiously as practicable." This requirement has never been tested in court. It would seem
that the statute is weak and has no stimulus for compliance.
Strongest aspect of existing processes
A new innovation is the combined assessment of NOX and SOX because the combined deposition
is responsible for the effects of acid rain (U.S. EPA, 2008d). Critical loads are back calculated to
air levels
Aspects of the process that could be strengthened
Weaknesses lie in the lack of tools and the standards to assess and define the term "adverse."
For example, how much loss to biomass in tree roots is a significant threat to trees, which need
energy in subsequent years? Also, data and information are dependent on other groups, as in this
case, the Forest Service.
The importance of ecological endpoints is undervalued, and standards are set primarily based on
public health.
Suggestions for assuring that scientific information informs and improves decision-making
The 1998 ERA guidelines are good for site-specific assessments but less satisfactory for national
assessments that have so many assessment endpoints, sources, and geographic variability.
How do we make uncertainties less influential? How do we explain that directionally correct
tightening of a standard may still result in a loss of the resource if the protection is not enough?
The Risk Assessment Forum could address how to apply NAAQS (40 CFR part 50).
Other Divisions in OAR involved with assessments
OAR Condition Assessments and Greenhouse Gases
On April 2, 2007, in Massachusetts v. EPA, 549 U.S. 497 (2007), the Supreme Court found that
greenhouse gases are air pollutants covered by the CAA. The Court held that the Administrator
must determine whether or not emissions of greenhouse gases from new motor vehicles cause or
contribute to air pollution, which may reasonably be anticipated to endanger public health or
welfare, or whether the science is too uncertain to make a reasoned decision. In making these
decisions, the Administrator is required to follow the language of Section 202(a) of the CAA.
The Supreme Court decision resulted from a petition for rulemaking under Section 202(a) filed
by more than a dozen environmental, renewable energy, and other organizations.
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The Administrator signed a proposal with two distinct findings regarding greenhouse gases under
Section 202(a) of the CAA:
The Administrator is proposing to find that the current and projected concentrations of
the mix of six key greenhouse gases—carbon dioxide (CC>2), methane (CH4), nitrous
oxide (N2O), hydrofiuorocarbons (HFCs), perfiuorocarbons, and sulfur hexafluoride—in
the atmosphere threaten the public health and welfare of current and future generations.
This is referred to as the endangerment finding.
The Administrator is further proposing to find that the combined emissions of CC>2, CH4,
N2O, and HFCs from new motor vehicles and motor vehicle engines contribute to the
atmospheric concentrations of these key greenhouse gases and, hence, to the threat of
climate change. This is referred to as the cause or contribute finding. (See
http://www.epa.gov/climatechange/endangerment.html.)
Residual Risk—Risk and Management Assessments
Residual Risk Program for Air Toxics evaluates the residual risk that remains after using best
available technology. These assessments are done by sector-based assessment groups. The Risk
and Technology Review is a combined effort to evaluate both risk and technology as required by
the CAA after the application of maximum achievable control technology (MACT) standards.
Section 112(f) of the CAA requires EPA to complete a Report to Congress that includes a
discussion of methods the EPA would use to evaluate the risks remaining after the application of
MACT standards. These are known as residual risks. EPA published the Residual Risk Report
to Congress in March 1999. Section 112(f)(2) directs EPA to conduct risk assessments on each
source category subject to MACT standards, and to determine if additional standards are needed
to reduce residual risks.
National Air Toxics Assessments—Relative Risk Assessments
The National-Scale Air Toxics Assessment (NATA) is EPA's ongoing comprehensive evaluation
of air toxics in the EPA developed the NATA as a state-of-the-science screening tool for
state/local/tribal agencies to prioritize pollutants, emission sources, and locations of interest for
further study in order to gain a better understanding of risks. The goal is to identify those air
toxics which are of greatest potential concern in terms of contribution to population risk. NATA
assessments do not incorporate refined information about emission sources, but rather, use
general information about sources to develop estimates of risks, which are more likely to
overestimate impacts than underestimate them. NATA provides estimates of the risk of cancer
and other serious health effects from breathing (inhaling) air toxics in order to inform both
national and more localized efforts to identify and prioritize air toxics, emission source types,
and locations that are of greatest potential concern in terms of contributing to population risk.
This, in turn, helps air pollution experts focus limited analytical resources on areas and or
populations where the potential for health risks are highest. Assessments include estimates of
cancer and noncancer health effects based on chronic exposure from outdoor sources, including
assessments of noncancer health effects for Diesel PM. Assessments provide a snapshot of the
outdoor air quality and the risks to human health that would result if air toxic emissions levels
remained unchanged (see http://www.epa.gov/ttn/atw/natamain/).
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B.3. TOXIC SUBSTANCES CONTROL ACT (TSCA) AND FEDERAL INSECTICIDE,
FUNGICIDE AND RODENTICIDE ACT (FIFRA)
Tala Henry, PhD
Office of Chemical Safety and Pollution Prevention, Office of Pollution Prevention and Toxics
Professional experience or organizational affiliations relevant to environmental assessment
Dr. Tala Henry has been with the U.S. Environmental Protection Agency for over 15 years. She
is currently located in the Office of Pollution Prevention and Toxics (OPPT) in Washington, DC
working on cross-cutting issues related to assessment and management of industrial chemicals.
Dr. Henry also represents the United States in international chemical assessment and
management activities, such as the Organization for Economic Cooperation and Development's
Existing Chemicals Task Force and Quantitative Structure Activity Relationship (QSAR)
Management Group and the United Nations Persistent Organic Pollutants Review Committee.
Previously, Dr. Henry worked in EPA's Region 8 office where she conducted risk assessments
for RCRA and Superfund hazardous waste sites, in the Office of Water where she led the team
that develops Ambient Water Quality Criteria, and in the Office of Research and Development
where she conducted research on chemical toxicity and endocrine disruption in aquatic
organisms.
Regulations or programs that are informed by assessments
Under the TSCA, OPPT regulates new and existing industrial chemicals. TSCA has differing
mandates for "existing" chemicals (those already in commerce) and for "new" chemicals
(reviewed by EPA before they are produced or imported).
Guidance
New Chemicals
The process for assessing new chemicals under TSCA is described in general terms at
http://www.epa.gov/oppt/newchems/ and http://www.epa.gov/oppt/pubs/opptl01-032008.pdf.
More specific risk assessment procedures are not collated into a single publicly available
guidance document; however, components of the assessments are described in training materials
OPPTS provides to chemical manufacturers (i.e., those who submit premanufacture notices
[PMNs]) and other interested parties through Sustainable Futures
(http://www.epa. gov/oppt/sf/meetings/train.htm#included).
OPPT has developed many different tools and models both to support its own staff analyses in
implementing OPPT programs and regulations, as well as to help external users assess and
manage chemical risks. Some of these focus on hazard information, estimating the physical or
chemical properties of a substance, its environmental fate, or its toxicity. Others focus on
estimating the potential for human exposure or assessing risk by examining both hazard and
exposure. OPPT's tools and models have extensive guidance and training materials associated
with them (see below for more info on models).
Existing Chemicals
Existing chemicals are the approximately 61,000 chemicals "grandfathered in" when TSCA was
passed in 1976. For priority-setting purposes, OPPT has focused its data-development and
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data-collection efforts on a subset of approximately 15,000 nonpolymeric chemicals reported in
the two most recent IUR cycles as being produced in quantities greater than 10,000 pounds per
year. Currently, OPPT is focusing on a subset of approximately 3,000 high production volume
(HPV) chemicals, which are produced and/or imported in annual volumes of 1 million pounds or
more across all U.S. companies.
A number of technical experts (scientists and engineers) review incoming information on
chemicals to assess hazard, exposure, and risk. Although each program is different, there are
common elements to the review process. For example, for the HPV chemicals, OPPT developed
specific guidance (http://www.epa.gov/chemrtk/pubs/general/guidocs.htm) and was instrumental
in developing similar guidance for the Organization for Economic Cooperation and Development
(OECD) HPV chemical Programme. OPPT currently follows the OECD guidance for assessing
hazards of existing chemicals
(http://www.oecd.org/document/7/0,3343,en_2649_34379_1947463_l_l_l_l,OO.html). In
general, OPPT follows established Agency risk assessment guidance, such as that developed by
the Risk Assessment Forum, in conducting risk assessments of existing chemicals.
Condition Assessments
Condition assessments are not part of OPPT new chemical assessments. For existing chemicals,
TSCA §8 (http://www.epa.gov/oppt/chemtest/pubs/pdfiist8.htm) has a variety of data-gathering
authorities. For example, under TSCA §8(e), EPA must be notified immediately of new
unpublished information on chemicals that reasonably supports a conclusion of substantial risk to
human health or the environment. In addition, TSCA §8(c) provides a mechanism to identify
previously unknown chemical hazards in that it may reveal patterns of adverse effects that may
not be otherwise noticed or detected. Examples of significant adverse reactions include gradual
or sudden changes to animal or plant life in a given geographic area; abnormal numbers of
deaths/changes in behavior or distribution of organisms; and long lasting or irreversible
contamination of the physical environment.
Causal Assessments
See descriptions under Condition Assessments; in some instances, these might include causal
assessments.
Predictive Assessment—Conventional Risk Assessment
This is the predominant type of assessment conducted by OPPT.
New Chemicals
For new chemicals, manufacturers are required to notify EPA of their intent to bring new
chemicals into the U.S. market but are not required to submit data other than that already
available, with their initial notification. A risk-based finding is needed to take regulatory action;
hence, EPA must make decisions often with limited information. OPPT has an established
process and procedures for performing risk assessments for new chemicals. jhe process is
generally described at http://www.epa.gov/oppt/newchems/ and
http://www.epa.gov/oppt/pubs/opptl01-032008.pdf. More specific risk assessment procedures
are not collated into a single publicly available guidance document; however, components of the
assessments are described in training materials OPPTS provides to chemical manufacturers
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(i.e., those who submit PMNs) and other interested parties through Sustainable Futures
(http://www.epa.gov/oppt/sf/meetings/train.htm#included). The goal of the Sustainable Futures
Initiative is to make new chemicals safer and available faster and at lower cost. It works by
giving chemical developers the same risk-screening models that EPA uses to evaluate new
chemicals before they enter the market. For new chemical risk assessments, OPPT relies on data
from the manufacturer regarding the manufacturing process and potential uses, exposure
modeling, and variety of approaches, including structure-activity relationships, nearest analog
analysis, chemical class analogy, chemical categories, mechanisms of toxicity, and professional
judgment, to conduct screening-level risk assessment for industrial chemicals. For the most part,
because these are new chemicals with proprietary and confidential business information
restrictions, only EPA and the manufacturer have access to the results of these assessments. The
results are best viewed as screening level assessments. OPPT conducts screening-level risk
assessments for approximately 1,500-2,000 new chemical, premanufacture notices each year.
Brief descriptions of each of the screening-level models and methods developed by OPPT
for chemical assessment are provided here. Additional information on these models can
be found at http://www.epa.gov/oppt/sf/index.htm. Presentations on these models and
methods from EPA Sustainable Futures training sessions can be found at
http://www.epa.gov/oppt/sf/meetings/train.htm#included.
EPI Suite™ estimates physical/chemical properties (melting point, water solubility,
etc.) and environmental fate properties (breakdown in water or air, etc.), which
can indicate where a chemical will go in the environment and how long it will
stay there.
ECOSAR predicts toxicity of chemicals released into water to aquatic life (fish,
algae, and invertebrates).
PBT Profiler screens chemicals for potential to persist, bioaccumulate, and be toxic.
OncoLogic™ is a computer software program designed to predict the potential
cancer-causing effects of a chemical by applying the rules of structure activity
relationship (SAR) analysis and incorporating knowledge of how chemicals cause
cancer in animals and humans.
NonCancer Screening Protocol is a stepwise process (not a computerized method)
useful for screening untested chemicals for noncancer health effects and is
described in the P2 Framework Manual.
E-FAST estimates chemical releases and dose rates to humans from these releases.
ChemSTEER estimates environmental releases and worker exposures resulting from
chemical manufacture, processing, and/or use in industrial and commercial
workplaces.
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Analog Identification Methodology (AIM) is currently being developed to address
needs identified by participants in the Sustainable Futures Initiative. AIM is
expected to be released to the public by the end of 2009. For chemicals lacking
data, identifying a close analog with measured data is the most challenging step in
using screening models and QSAR methods that predict the toxicity of chemicals
based on their structural similarity to chemicals for which toxicity data are
available. AIM is being developed to identify close analogs that have measured
data, and it points to sources where those data can be found.
Existing Chemicals
A number of technical experts (scientists and engineers) review incoming information on
chemicals to assess hazard, exposure, and risk. Although each program is different, there are
common elements to the review process. In general, OPPT follows established Agency risk
assessment guidance, such as that developed by the Risk Assessment Forum, in conducting risk
assessments of existing chemicals.
Predictive Assessment—Benchmark Determination
OPPT applies a number of policies, many based on specific benchmarks (e.g., levels of exposure,
PBT properties, etc.) to require testing and/or limit production or use of chemicals
(http://www.epa.gov/oppt/newchems/pubs/policies.htm). For example, the PBT policy sets forth
specific criteria for persistence, bioaccumulation, and toxicity, which if met, will result in
specific orders or banning of the chemical pending further testing.
Predictive Assessment—Management Assessment
TSCA Section 6 (for existing chemicals) requires cost-benefit analysis as part of the assessment
for proposed regulatory action.
Outcome Assessment
Provisions of TSCA Section 8 (described above and available at
http://www.epa.gov/oppt/chemtest/pubs/pdfiist8.htm) can serve as 'early warning' system as
well as indicate adverse effects/outcomes resulting from chemical use.
Strongest aspect of existing processes
The limited availability of data is both a strength and a weakness. Because the data are limited,
OPPT has been innovative in developing predictive analytical approaches including SARs,
nearest analog analysis, chemical class analogy, chemical categories, mechanisms of toxicity,
and professional judgment, and has built these approaches into computer-based models and
expert systems. The data limitations have encouraged the development and implementation of
intelligent testing. This has also been necessary because the Office must deal with many
chemicals.
Aspects of the process that could be strengthened
Having few data increases the uncertainty of the assessment. OPPT models do not cover all
relevant toxicological endpoints; in particular, increased availability of predictive tools for
assessing health effects is needed. OPPT models also do not cover all types of chemicals.
Additional development of predictive models for additional chemical classes is needed.
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Suggestions for assuring that scientific information informs and improves decision-making
New chemicals assessment procedures could be published as an integrated document.
Problem formulation could be more explicit.
Greater accessibility or authority to require data would help inform decisions.
William Eckel
Office of Chemical Safety and Pollution Prevention
Professional experience or organizational affiliations relevant to environmental assessment
Dr. Eckel is Senior Science Advisor in Environmental Risk Branch 6, Environmental Fate and
Effects Division, Office of Pesticide Programs, where he is involved in ecological risk
assessment for threatened and endangered species. Previously, he was in ERB 2 for 10 years,
culminating in a 5-month tenure as acting Branch Chief. His PhD in Environmental
Science/Public Policy is from George Mason University. His dissertation focused on the
20th century secondary lead smelting industry in the United States. Eckel published one of the
earliest (1993) papers on pharmaceuticals in groundwater. Currently, he is working on
developing a process for consultation under Section 7 of the Endangered Species Act within the
Pesticide Registration Review program.
Regulations or programs that are informed by assessments
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and Endangered Species Act
(ESA)—The assessments must predict effects on specific species such as the California red
legged frog. So, the question is, does the pesticide pose a risk to these organisms?
Guidance
Guidance is available, and some is publically available. The overall approach is in an overview
document, published in 2004. The Office of Pesticide Programs (OPP) uses the same language
as the ERA framework. Internal guidance is available for problem formulation and formats are
available for different types of risk assessment such as species-specific assessments.
Condition Assessments
Registration review (15-year cycle) each active ingredient and registered use. An example is
carbofuran, which went to a series of scientific panel meetings. The registration was cancelled,
and the company did not agree. The assessment went from an observed effect to the cause.
Cause
Some observed effects have unknown causes that may include pesticides: colony collapse
disorder, intersex, and malformations.
Predictive
These are typical risk assessments that start with the information industry submits. Toxicity test
information is supplied for invertebrates, birds, mammals, fish, and vascular and nonvascular
plants. Exposure is estimated for different media. They are combined to get a risk quotient,
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which is compared to predefined levels of concern, which are different for endangered and
nonlisted species. Risk characterization synthesizes it all. A biological and economic analysis
division considers benefits when asked. This is not routine.
Outcome assessment
The reregistration program looks at all registered active ingredients on a 15-year basis. Make
sure registrations are in keeping with current science and policy.
Sometimes OPP asks for monitoring. Mitigation measures should keep the adverse effects down
to reasonable levels.
Improvements
There is a recognized need for improved incident reporting. For example, there were lots of
incidents of bird kills associated with carbofuran, but reporting requirements changed. Was it
the reporting change or a real change? Outcome assessment would be important for risk
mitigation.
What is the strongest aspect of the assessment processes your organization already has in
place to inform decision-making?
We are able to require submission of data, so we do not need to estimate toxicity. We have a
well laid out procedure and continue improvement of the ERA process. We do all of the work
ourselves, not contractors, except for review. Therefore, expertise and knowledge are retained in
the government.
What is the weakest link in these processes?
We need to continue improving our ability to make the risk assessment more realistic. There is
not enough time to do this and meet requirements to do the risk assessment.
Kristen Keteles, PhD
Region 8
Professional experience or organizational affiliations relevant to environmental assessment
Dr. Kristen Keteles was coordinator of the Coastal Watershed Condition Assessment program
for the National Park Service and prior to working for NFS, a professor with the University of
Central Arkansas where she maintained a research program investigating environmental factors
that influence trace metal availability. She joined EPA Region 8 in 2008.
Keteles has a PhD from Louisiana State University, and her doctoral research examined the fate
and effect of metals and polycyclic aromatic hydrocarbons in a Louisiana Salt Marsh. She did a
postdoctoral fellowship as a visiting scientist at the Federal Bureau of Investigation (FBI)
academy in Quantico Virginia in the Counter Terrorism and Forensic Science Research Unit.
Prior to earning a doctorate, she was a research associate at Dartmouth College in the Superfund
Basic Research Program investigating the fate of metals in aquatic food webs.
At EPA, Keteles primarily provides technical support regarding TSCA and FIFRA, particularly
effects of pesticides and toxics, and manages the R8 Pesticides Water Quality Program. She is
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also presently involved in studies regarding PCBs, mercury, and pharmaceuticals and personal
care products (PPCPs). She is sponsoring a graduate student at Colorado State University to
study the effects of endocrine-active chemicals on fish reproduction and to develop a whole
effluent toxicity-based approach to assess estrogenicity and androgenicity of effluents. Recently,
Keteles has provided technical assistance as a subject matter expert during the Deepwater
Horizon Oil Spill to the NRDA trustees and has been deployed to the Gulf on oceanographic
cruises to collect data on the oil spill.
Regulations or programs that are informed by assessments
TSCA, FIFRA.
Guidance
There are many pesticides for which there are no criteria or benchmarks. The FIFRA process
does not take into account the latest science policy, scientific knowledge, or regulatory
implications across programs. Emergent contaminants of concern lag even further behind.
When criteria are developed, the EPA's Ecological Risk Assessment framework is used.
Condition Assessments
Some states have hired consultants to evaluate PCB contamination using sediment
concentrations, fish tissue levels, and toxic equivalents. These feed into predictive assessments
that set remediation targets for cleanup, and they also continue monitoring to determine
effectiveness.
Sometimes there are discrepancies on how to handle a problem. For example, the authorities of
TSCA and RCRA sometimes overlap, which creates a need for better cooperation.
The National Park Service initiated an Ecological Condition Assessment program in 2003. The
assessment involved 280 parks with different ecoregions as diverse as Alaska and the Virgin
Islands. They developed an indicator-based framework that focused on shared issues such as
physical disturbance, invasive species, and contaminants.
Causal Assessments
The Stressor Identification Guidance is used as the framework for assessing causes of biological
impairment. There are also some regional guidelines for some effects, sources, wastewater
treatment plant (WWTP), and confined animal feeding operations (CAFOs). For example, the
week of July 27, fish will be caged above and below CAFOs and WWTPs in a joint study with
National Exposure Research Laboratory-Cincinnati, and fish will be assayed for vitellogenin.
The hope is that this will lead to strategies for minimizing exposure to and effects of estrogenic
compounds.
In another study, intersex in fish has been reported in Rocky Mountain high country lakes. The
source of the estrogens is unknown. Pregnant elk, atmospheric deposition, natural effects, and
phytoestrogens are considered candidate causes. This proposed work will be submitted to the
Regional Applied Research Effort program to develop a conceptual model of this effect and
candidate causes.
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Causal assessments are routinely undertaken (e.g., presently using stressor identification (ID)
process to evaluate cause of inter sex fish in a pristine environment). They use the stressor ID
document and are working to develop regulatory guidelines for evaluating sources.
Predictive Assessment—Conventional Risk Assessment
Dr. Keteles provided an example of an oil spill in San Francisco Bay in which the concentration
in the sediment and water were used to evaluate cumulative risk to biota calculated from toxic
equivalents rather than benchmarks. She noted that the EPA and Coast Guard cooperated in
developing an oil spill response plan so that differential risks to different resources would be
estimated for the mixture. For example, how would a spill differentially affect coral reefs and
mangroves?
Guidance for cumulative risks for ecological assessment endpoints would be a valuable tool.
Predictive Assessment—Benchmark Determination
Most of the work that the Region does involves comparing concentrations to existing
benchmarks rather than developing them.
Predictive Assessment—Management Assessment
Management assessments would be very useful for evaluating risks and economic costs because
reverse osmosis and activated charcoal filtration is expensive for removing PPCP from a waste
stream. For example, tire crumbs (ground-up tires) are used for children's play grounds and are
being marketed as cover for sides of highways. They contain high amounts of zinc, which is
toxic to aquatic life. PAH toxicity is not well known.
Outcome Assessment
Pesticides of interest to states have been monitored and detected in surface and ground water.
States have proposed management plans to meet environmental objectives.
Other processes to attain EPA's mission
The jurisdictions of TSCA and RCRA need to be clarified.
Our processes should be compared with Canada's and the Park Service's to get ideas and
increase consistency.
Improve communication by providing a list of who is doing what in congruent offices in Regions
because now they all have different nomenclature and structure, and it is hard to find other
experts.
Suggestions for assuring that scientific information informs and improves decision-making
Guidance for cumulative effects in ecological situations that stress mode of action and
appropriate frameworks would be helpful.
EPA Web sites need to be improved so that it will be easier to access and search for information.
Benchmarks are needed for pesticides and PPCP.
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Decision tools need to bridge the perceived disconnect between human health and ecosystem
health.
We need to take national surveys to the next level including conceptual models that show
relationships among groups and among sources, stressors, and effects.
Patti TenBrook, PhD
Region 9, CED-5
Professional experience or organizational affiliations relevant to environmental assessment
Dr. TenBrook has been a life scientist with EPA Region 9 since 2007. She also has 12 years of
experience with water and wastewater treatment and environmental laboratory work. She has
published several papers on fate, effects, and biotransformation of pesticides in aquatic systems.
Prior to joining EPA, she worked on a project for the State of California to develop a method for
derivation of water quality criteria with limited data sets. Dr. TenBrook does not perform risk
assessments, but she does review OPP assessments with an eye to their adequacy in addressing
potential risks to surface and groundwater quality and whether registered pesticide uses might
lead to noncompliance with the CWA.
Regulations or programs that are informed by assessments
FIFRA and the CWA both require protection of water resources. Currently, effects
characterizations done by the OPP and the Office of Water (OW) are not integrated to provide a
common basis for achieving the water quality protection goals established under the CWA and
FIFRA statutes. The Agency has begun a process to harmonize effects assessments to meet the
goals of both statutes. In addition, OPP exposure assessments often do not adequately consider
direct or indirect pathways to surface water, particularly from indoor and outdoor urban uses.
This has led to CWA compliance challenges for stormwater and municipal wastewater treatment
agencies. CWA agencies cannot regulate pesticides but are responsible for water quality
impairments or National Pollutant Discharge Elimination System compliance due to pesticides.
One approach to address this disconnect would be for CWA compliance to be an assessment
endpoint for FIFRA risk assessments.
Guidance
Most evaluations of the assessments are performed using best professional judgment rather than
guidance.
Condition Assessments
Although not in her purview, she noted that condition assessments are used in Region 9 as part of
the CWA, Superfund, and National Environmental Policy Act reviews.
Causal Assessments
Once a waterbody is identified as impaired due to a pesticide, state, and federal (i.e., EPA
Region 9 Water Division) CWA agencies must develop a TMDL for the specific pesticide for
that waterbody. The TMDL requires a source evaluation, which can only be accomplished with
a thorough understanding of environmental fate pathways. Many FIFRA risk assessments do not
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adequately consider pathways by which pesticides may reach surface water. This is particularly
true for urban pesticide use, which can lead to pesticides reaching municipal stormwater,
wastewater collection, and treatment systems, and, ultimately, surface waters.
Example: Risk assessments for pyrethroid pesticides typically disregard the importance of
potential water column contamination. This is based on the hydrophobicity of pyrethroids and
on their high solid/water partition coefficients. The assumption is made that pyrethroids will
partition into solids in the environment (or in a wastewater treatment plant) and will not be found
at levels of concern in the water column. Pyrethroids are highly toxic to fish and extremely toxic
to aquatic invertebrates. Thus, very low concentrations in water can cause toxicity. In a recent
study of sources of pyrethroids to the Sacramento River Delta, a University of California,
Berkeley researcher found widespread water column toxicity due to pyrethroids downstream of
urban areas, with the largest source of pyrethroids being a municipal wastewater treatment plant
(WWTP). The study was based entirely on water column sampling. The sources, pathways, and
effects found in this study would never have been predicted by the FIFRA risk assessment.
Predictive Assessment—Conventional Risk Assessment
Risk assessment is a key part of OPP's mission in which the consequences of pesticide use are
estimated. The process described on the OPP Web site directly uses the EPA Guidelines for
Ecological Risk Assessment (see Table B-l). The ecotoxicological methods used by OPP (see
Table B-2) differ from the CWA methods for developing safe levels. CWA criteria use more
points (8) to develop their water quality criteria. OPP uses benchmarks based on the most
sensitive species data available; OPP assesses potential hazards to aquatic life based on as few as
three pieces of data. However, inherent in the RA done in conjunction with the registration
process, OPP describes mitigation such as rate of use, application methods, and buffers. The
result of the process is to reject or register the pesticide with prescriptive label requirements.
With new chemicals, there is no public participation because of proprietary or confidential
business information. Although not all information falls into this category, there is no practice
for releasing information that is not confidential. Because only the manufacturer has information
on the proposed pesticide, all information used in the assessment comes from the registrant and
not from the literature. Some exposure pathways, particularly in urban scenarios, are often not
adequately addressed, or are overlooked entirely.
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Table B-l. An outline of the ERA process as implemented by OPP
(http://www.epa.gov/oppefedl/ecorisk_ders/)
Problem Formulation
Analysis—Ecological Effects Characterization
Studies Needed
Ecotoxicity Data Use/DER Templates
Ecotoxicity Categories
Analysis—Exposure Characterization
Pesticide Degradation/Dissipation
Fate and Transport Studies Needed
Fate and Transport Data Use/DER Templates
Approaches for Evaluating Exposure
Risk Characterization
Deterministic Approach
Probabilistic Approach
Table B-2. Criteria for ecotoxicological risk used by OPP a'b
(http://www.epa.gov/oppefedl/ecorisk_ders/)
Presumption of
minimal risk
Presumption of unacceptable risk
Nonendangered species
Endangered species
Acute toxicity
Mammals
Birds
Aquatic
organisms
EECl/2ofLC50
EEC>l/2ofLD50
EEC>l/2ofLC50
EEC>l/2ofLC50
EEC>l/10ofLC50
EEC>l/10ofLD50
EEC>l/10ofLC50
EEC>l/20ofLC50
Chronic Toxicity
EEC < lowest effect
level
EEC > lowest effect
level
EEC > lowest effect
level
a Another criterion for birds and mammals specific to granular products is whether the amount of exposed granules
per square foot of soil surface exceeds 1/2 of the LD50 for nonendangered species or is greater than 1/10 of the LD50
for endangered species.
b EEC= Expected Environmental Concentration
LC50 — Median Lethal Concentration
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Predictive Assessment—Benchmark Determination
OPP uses aquatic life benchmarks to determine whether estimated exposures will pose a risk to
aquatic life. See the OPP Web site
(http://www.epa. gov/oppefed 1 /ecorisk_ders/aquatic_life_benchmark.htm).
Predictive Assessment—Management Assessment
FIFRA is a risk/benefit statute. That is, if there is significant benefit in the use of a pesticide,
that benefit has to be weighed against identified risks. The risk/benefit assessment typically
considers crop or other property losses that might occur if the pesticide were not available. Costs
of CWA compliance are not considered. Agencies that are responsible for CWA compliance
have no control over pesticide use.
The cost of compliance (with statutes other than FIFRA) is never included with the cost-benefit
analysis during registration. Cost analysis is only in terms of crop or property damage. The cost
of noncompliance should be factored into the cost-benefit analysis.
Outcome Assessment
No outcome assessment is required for as long as 15 years after registration. Earlier outcome
assessment can be requested. Adverse outcomes are often detected by parties that had no
opportunity to participate in the registration process (e.g., drinking water/stormwater/wastewater
agencies, health agencies, and farmworker advocates). Once a pesticide is registered, it is very
difficult to eliminate uses that are subsequently found to be causing or contributing to water
quality or other problems. Adding a feedback step (e.g., registrant-required monitoring) within
the first 5 years of registration would improve the pesticide RA process.
Aspects of the process that could be strengthened
OPP can ask for a lot of data, but the process for new chemicals is not open. An open process
would allow for refinement of the amount and kinds of data that would give the best predictive
assessment. Information on new chemicals is not in the open literature and not widely available.
There does not seem to be movement toward testing the boundaries of what can and cannot be
shared during registration of new chemicals. Currently, OPP cannot share registration data for
new chemicals with Regions, which means OPP has to make decisions without Regional
perspectives.
There is no public or 3rd party review of the registration process for new chemicals. Even with
pesticide re-evaluation, the public processes are not equally accessible to all stakeholders.
Proactive outreach is needed to ensure equal participation for those who cannot afford to
maintain a presence in Washington, DC.
Cost analysis considers only crop and property damage. It does not consider socioeconomic
costs or environmental justice issues or costs incurred to comply with statutes other than FIFRA.
Historically, there has been poor coordination between OPP and OW. OPP can approve a
pesticide, which may lead to water quality impairments. OW winds up addressing problems
caused by an activity another office has approved. Recent effort to harmonize risk assessments
between OPP and OW is a huge step in the right direction.
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Suggestions for assuring that scientific information informs and improves decision-making
More transparency—especially for registration of new chemicals—is needed for there to be more
accountability.
OPP and OW need to be harmonized with respect to assessment endpoints and analysis for
determining, with reasonable assurance, pesticide levels that will not cause harm. There needs to
be a way to evaluate if implementation of one statute may cause problems under another statute.
The SOP on submittal of water quality data is likely not achieving what it should. OPP and OW
need to explore the extent to which they can share data, and then OPP needs to actively seek data
pertaining to pesticides that come up for registration review. For example, state water agencies
that have already submitted reports to OW cannot justify expending resources to send that same
data to OPP. If they have "sent it to EPA," that ought to be enough.
Allow the guidance to change on a shorter time frame than 10 years.
B.4. CLEAN WATER ACT
Matt Nicholson, PhD
Region 3
Professional experience or organizational affiliations relevant to environmental assessment
Dr. Nicholson's background and training are in natural resource management, and much of his
research has been in the field of wildlife conservation. He has research experience with the
conservation of avian and mammalian species nationally and internationally. The breadth of
conservation challenges he has been involved with ranges from modeling human risk to Lyme
disease through quantifying the effects of landscape heterogeneity on the spatial distribution of
environmental risks at large scales. A common element of Dr. Nicholson's work over the past
25 years has involved applying the tools of landscape ecology and spatial analysis to questions of
environmental health and risk. He has
organized several symposia on
landscape ecology and risk, has served
as guest editor for two journals, and was
a panelist for special projects involving
the CDC and the Heinz Center.
Regulations or programs that are
informed by assessments
Work at Region 3 on CERCLA is linked
to the CWA through work on
impervious surface, and overall
sustainability associated with state
conservation plans called "Green
Infrastructure" (see Box B-4). The
primary objective of his research has
been to develop statistical models for
predicting the condition of aquatic
Box B-4. Green infrastructure and green communities:
linking landscapes and communities.
Green infrastructure can be defined in many ways. In its
broadest application, green infrastructure encompasses an
"interconnected network of natural areas and other open
spaces that conserves natural ecosystem values and
functions, sustains clean air and water, and provides a wide
array of benefits to people and wildlife."
Green infrastructure is a strategic conservation tool that
can be integrated into a comprehensive, Green Communities
planning process. In fact, Green Infrastructure planning is
compatible with a five-step planning approach as described
below. Key to the success of a Green Infrastructure Strategy
is broad stakeholder involvement. As with any sustainable
planning effort, getting knowledgeable and interested parties
involved at the beginning will ensure a successful process.
See http://www.epa.gov/greenkit/green_infrastructure.htm
[accessed 07/25/2009]).
B-30
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resources by merging probabilistic survey data with broadly available geographic data to
estimate regional stressor patterns.
Dr. Nicholson has also used watershed characteristics as indicators and predictors of aquatic
condition in relation to the coordination of state conservation plans and Superfund activities.
Although there are statewide conservation plans that attempt to manage resources from a
landscape perspective, sometimes other programs are unaware of the plans. For example, key
landscape features or parcels of land may be critical habitat required by wildlife and birds.
Superfund site managers may be unaware of the conflicting objectives for site cleanup as they
relate to habitat preservation. Now, state level plans are readily available to the RCRA or
CERCLA site manager, and there are guidance and educational materials to show how to relate a
waste site to the larger environment.
Guidance
Dr. Nicholson uses Quality Assurance Project Plan guidance. However, there is no guidance
specifically for landscape-level assessment.
Predictive Assessment—Management Assessment
Multicriteria, Integrated Resource Assessment (MIRA) is similar to multicriteria decision
analysis and is being used to allocate resources and prioritize efforts such as in abandoned mine
lands. Region 3 is working with Doug Norton (also Cynthia Stahl, Christine Mazzarella).
Accessed 20090725. (See http://www.epa.gov/reg3esdl/data/pdf/transdisciplinary.pdf.)
Strongest aspect of existing processes
One strength is that the regional scientists are out with the affected parties and involving them in
decision-making, including RPMs, the public, and state personnel.
Aspects of the process that could be strengthened
It is difficult to know how to deal with uncertainty without impeding progress.
Suggestions for assuring that scientific information informs and improves decision-making
There is a need for guidance on ecological systems risk rather than risks to species. This might
include functions, species dependence, and movement of stressor through ecosystems. This
could begin with development of conceptual models and then improving basic scientific
understanding through testing resulting in guidance to inform decision-making using that
information.
Charles Delos
Office of Water, Office of Science and Technology,
Health and Ecological Criteria Division
Professional experience or organizational affiliations relevant to environmental assessment
Charles Delos has many years of experience developing water quality criteria. Most recently he
was instrumental in the reassessment of the ammonia criteria and selenium criteria.
B-31
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Regulations or programs that are informed by assessments
Criteria development is aimed mainly at NPDES permit development
Guidance
There is little guidance for obtaining data but lots of guidance for developing criteria and for
developing permit limits based on criteria.
Condition Assessments
The Clean Water Act requires reporting of chemical, physical, and biological impairments to
Congress in the form of 305b and 303d reports. Condition assessments are necessary and usually
performed by states. The actual report to Congress is assembled and submitted by EPA. Water
quality condition is often used as a surrogate for biological condition.
Causal Assessments
The Total Maximum Daily Load Rule requires that the cause be identified and the amount of
loading be allocated among sources. This regulation is administered by Office of Wetlands,
Oceans and Watersheds and the Regional Offices with the actual assessments performed by the
states.
Predictive Assessment—Conventional Risk Assessment
There are not many types of general guidance left that are needed. This activity does not fit
readily into a regulatory framework.
There is little general guidance that pulls things together, that is, links environmental
concentration to ecological effect. The main problem is not lack of guidance but lack of basic
understanding.
Predictive Assessment—Benchmark Determination
Developing criteria is the primaryjob of the interviewee. The guidance on setting benchmark
concentrations (e.g., water quality criteria) is rather dated (mid-1980s) but still viewed as
serviceable. Technical staff has long had an interest in developing a more rigorous and complex
approach, while management might prefer a simpler, less data-intensive approach. Although
efforts toward a complete revision of the general methodology have been suspended, new
methods are developed and applied as the need arises.
Predictive Assessment—Management Assessment
His office is precluded from doing this sort of assessment. The Use Attainability Analyses
(UAA) process is the closest thing to this because it considers and economic factors and social
preferences.
Outcome Assessment
This is only done with respect to concentration. In a permit context, there is very close
monitoring of concentration but no assessment regarding ecological effects—except in Ohio.
Generally, once the decision is made, move to the next problem.
B-32
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Other processes to attain EPA's mission
Outcome assessments would be very desirable because there is so much uncertainty regarding
cause and effect with respect to criterion concentrations and biological response.
Strongest aspect of existing processes
The process has clear objectives (chemical criteria) and attainment of concentration goals.
However, we must balance simplification against the risk of being incorrect and not protective.
Aspects of the process that could be strengthened
Biocriteria are poorly integrated because of uncertainty regarding cause and effect.
Suggestions for assuring that scientific information informs and improves decision-making
We need basic knowledge about ecology and the causal relationships between stressors and
biological effects.
Dana Thomas, PhD
Office of Water, Ecological and Health Protection Branch,
Professional experience or organizational affiliations relevant to environmental assessment
Dr. Thomas has worked primarily on endangered species, biosolids, nutrient criteria, and
biocriteria. He is now Branch Chief for Ecological and Health Protection Branch, but had more
experience with Endangered Species Act Section 7(a)(2) consultations in the Office of Water.
She approached the interview from a OW ESA perspective.
Regulations or programs that are informed by assessments
Section 304(a)(l) of the CWA requires the Environmental Protection Agency (EPA) to develop,
publish, and, from time to time, revise criteria for water that accurately reflect the latest scientific
knowledge.
The Endangered Species Act, Section 7, requires that all federal agencies that authorize, fund, or
carry out any action that could affect a federally listed threatened or endangered species (T&E
species) must consult with U.S. Fish and Wildlife or NOAA (the Services) to ensure that the
action is not likely to jeopardize the continued existence of any such species or destroy or
adversely modify its habitat.
Aquatic Life Criteria must be protective of T&E species, and criteria may need to be customized
based on modeling of ecological risk and toxicity to those species.
Guidance
Endangered Species Act
Condition Assessments
Listing a species is a condition assessment. Removing a species from the T&E list is also the
result of a condition assessment.
B-33
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Causal Assessments
Causal assessments may be done when the cause is unknown, such as the case with Acroporid
corals. However, this assessment is done by NOAA.
Predictive Assessment—Conventional Risk Assessment
These types of assessments are part of the organization's mission. They evaluate water quality
criteria (WQC) with respect to endangered species. There is no assessment to compare with
standards; rather they perform a theoretical assessment to evaluate whether existing criteria
protect endangered species [per Section 304(a)]. Results of this "Biological Evaluation" are
given to the Services as a finding of "likely to adversely affect" or "not likely to adversely
affect." The Services review EPA's finding and issues a "jeopardy" or "no jeopardy" opinion,
which may result in a change or no change in a national or state criterion.
Predictive Assessment—Benchmark Determination
If the Services determine that a WQC is not protective, then the criterion can be reevaluated. For
example, endangered unionid mussels were found to be more sensitive to ammonia than the
species used to develop the current criteria. A revised criterion for ammonia was developed by
EPA and sent to the Services for comment in 2009.
Predictive Assessment—Management Assessment
Inclusion of costs is precluded by law.
Outcome Assessment
There is a clause in the statute that consultations can be revisited if new data suggest that the
current criteria may not be protective or if a new species is added to the T&E list.
Other processes to attain EPA's mission
In an attempt to develop a framework that was more transparent, the EPA met with the Services
to improve the process. Now the consultation between the EPA and Services is national in scope
rather conducted state by state. Although, the process is in place, it has not yet been exercised.
EPA also tried to establish what information was necessary to make a biological evaluation, but
the Services do not have a process and probably use a different method each time. EPA hopes to
take results from experience and back-engineer what information the Services need to perform
the risk assessment.
Strongest aspect of existing processes
Available data are very extensive. There is an awareness of what the 1985 guidelines for WQC
say regarding what can be screened out, and applicable and not.
Pathways of exposure are fairly well developed and include diet, water, and sediment that are
considered with respect to life stages.
Aspects of the process that could be strengthened
There are many data gaps for many T&E species.
B-34
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The process is too slow; the statute says 90 days, but the last submission was March of 2007 and
no biological opinion from the Services yet.
Suggestions for assuring that scientific information informs and improves decision-making
Rather than developing criteria chemical by chemical for every T&E species, it may be more
realistic to group by family (for the biological endpoint) or by a mode of action (for chemicals).
B.5. REPORT ON THE ENVIRONMENT
Denice Shaw, PhD
ORD, National Center for Environmental Assessment
Professional experience or organizational affiliations relevant to environmental assessment
Dr. Shaw is a scientist with the National Center for Environmental Assessment responsible for
the Report on the Environment (ROE).
Regulations or programs that are informed by assessments
Since the ROE is developed at the discretion of the Administrator, the intent is that the questions
and the information should inform a vision for the Agency and the direction for action.
However, it is unclear if the ROE has influenced or resulted in changes in regulations, execution
of regulations, or programs. However, this is a real need, and refinements to the process for
developing the questions and the form of the ROE could make the ROE more influential and
useful. For example, the efforts of the ROE could be directed to major issues, such as a national
energy policy with directed questions that would lead to the development of assessments within
the Agency and later toward the evaluation of the outcomes of effectiveness of those strategies.
The target audience of the ROE is diffuse and diverse. (Note that Australia has a State of the
Environment Report that is more assessment in nature.) The ROE is more fact and less
assessment-oriented to ensure that the information is scientifically rigorous and that it will not be
delayed due to interpretive uncertainties).
Guidance
There is no guidance for the selection and development of the questions that are addressed by the
ROE. There is no guidance for the processes for selecting indicators or evaluating those
indicators. The ROE has continued to be improved by consultations with the Science Advisory
Board (SAB) and from reviewer comments.
Condition Assessments
When there are established benchmarks or standards, the ROE does indicate if those benchmarks
are being met. However, often there are no consistent benchmarks, or the set of questions that
the ROE addresses has little or no direct influence on decision-making. For example, the
Threatened and Endangered Species Act, involves all agencies, but the determination is by the
Services, NOAA, and FWS. It is not the mission of the EPA to document the condition of T&E
species, but sometimes, these types of questions are inserted into the list to be included in the
ROE. However, it could be relevant if the question was more directed such as, "how well are
granivorous birds, including T&E species, protected by OPPT regulations"?
B-35
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Causal Assessments
Levels of stressors and trends are reported but not whether they are causing harm or the causes of
harm.
Predictive Assessment—Conventional Risk Assessment
SAB has called for assessment rather than a characterization of the environment, but the ROE
authors believe that this would dilute the effort and that the ROE would serve better as a
potential starting point for assessments. For example, the ROE includes human health area data
on asthma and data on particulate matter. However, the two data streams are not interpreted or
synthesized in an assessment.
Outcome Assessment
The ROE was initiated by Administrator Whitman. She wanted the report to help evaluate how
her tenure had influenced environmental outcomes.
Other processes to attain EPA's mission
Within the next 3 months, the questions that will be addressed by the ROE will be selected. The
ROE is framed by a set of questions that are of critical importance to EPA. As work begins on
the development of the 2012 report, the ROE developers are seeking input review and
suggestions for revising the framework questions for relevance and significance.
Aspects of the process that could be strengthened
The scientific content and application is spotless.
Peer review was extensive.
There was extensive involvement of many components of the Agency. NCEA facilitated, but the
leads were usually from the program offices and regions.
The team also repeatedly attempted to connect policy by working with Office of the Chief
Financial Officer (OCFO) and Office of Policy, Economics, and Innovation, but this was not as
successful as was hoped for.
Suggestions for assuring that scientific information informs and improves decision-making
It would be helpful to have a single document describing the roles of different agencies.
It would be helpful if there were a framework or guidance for developing environmental policy
and environmental vision for the Agency.
It would also be helpful to have guidance for determining emerging issues and for identifying
questions that need to be answered as a concerted effort of an Agency rather than separate
activities.
It would be helpful if the Agency had a vision that informs policy development for the longer
term. That seems to be lacking and restricted to a 3-year window. Need a longer-term policy
vision.
B-36
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Canada has issued their yearly report that focuses on particular laws and how well the
government is addressing the intent of those legislative pieces. See pdf at http://www.oag-
bvg.gc.ca/internet/docs/parl_cesd_200905_00_e.pdf (accessed July 22, 2009).
As the ROE has changed since its inception, the original question format was based on the Mines
report. Later it was based on recommendations from the EPEC to include ecological attributes
rather than entities, such as forests. The authors of the ROE believe the next evolutionary step
would be to develop issues that are depicted in a conceptual model that focuses efforts not only
for the Report but for the direction of the Agency to answer or address the identified problems.
We need to open up the OCFO process for problem identification and, ultimately, program and
project direction.
The Agency's position needs to be known as a corporate position so that its credibility remains
polished, and other agencies can better coordinate with us.
B.6. REFERENCES
U.S. EPA (Environmental Protection Agency). (1994) Methods for derivation of inhalation reference concentrations
and application of inhalation dosimetry. Office of Research and Development, Office of Health and Environmental
Assessment, Environmental Criteria and Assessment Office, Washington, DC; EPA/600/8-90/066F. Available
online athttp://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=71993.
U.S. EPA (Environmental Protection Agency). (1997) Ecological risk assessment guidance for superfund: process
for designing and conducting ecological risk assessments - interim final, Office of Solid Waste and Emergency
Response, Washington, DC; EPA/540/R-97/006 http://www.epa.gov/oswer/riskassessment/ecorisk/ecorisk.htm.
U.S. EPA (Environmental Protection Agency). (2005) Contaminated sediment remediation guidance for hazardous
waste sites. Office of Solid Waste and Emergency Response. Washington, DC; EPA/540/R-05/012. Available
online at http://www.epa.gov/superfund/health/conmedia/sediment/pdfs/guidance.pdf.
U.S. EPA (Environmental Protection Agency). (2006) EPA Superfund record of decision: Hiteman Leather EPA ID:
NYD981560915 OU 01 West Winfield, NY, 09/28/2006. EPA/ROD/R2006020001430. Available online at
http://www.epa.gov/superfund/sites/rods/fulltext/r2006020001430.pdf.
B-37
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APPENDIX C
TABLE OF GUIDANCE
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA
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Guidance on
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Assessment Part 1 —
Planning and
Scoping
Framework for
Cumulative Risk
Assessment
A Summary of
General Assessment
Factors for
Evaluating the
Quality of Scientific
and Technical
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Risk
Characterization
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Guidance for Risk
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Probabilistic
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Guidelines for
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Endpoints (GEAEs)
for Ecological Risk
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Framework for
Application of the
Toxicity Equivalence
Factors (TEF)
Methodology for
Polychlorinated
Dioxins, Furans,
andBiphenyls in
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Assessment
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Quality Criteria for
the Protection of
Aquatic Organisms
and their Uses
Framework/or
Developing
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Bedded Sediment
(SABS) Water
Quality Criteria
Modeling
Framework Applied
to Establishing the
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
AQUATOX (Release
3), Modeling
Environmental Fate
and Ecological
Effects in Aquatic
Ecosystems. Volume
2: Technical
Documentation
Best Practices for
Identifying
Reference Condition
in Mid-Atlantic
Streams.
Proof of Concept for
Integrating
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Results from Three
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-------
Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Developing
Biological
Indicators: Lessons
Learned from Mid-
Atlantic Streams
Biological Indicator
Variability and
Stream Monitoring
Program
Integration: A
Maryland Case
Study
Estuarine and
Coastal Marine
Waters:
Bioassessment and
Biocriteria
Technical Guidance.
Nutrient Criteria
Technical Guidance
Manual Wetlands
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Lake and Reservoir
Bioassessment and
Biocriteria,
Technical Guidance
Document
Use of Biological
Information to
Better Define
Des ignated A quatic
Life Uses in State
and Tribal Water
Quality Standards:
Tiered Aquatic Life
Uses. Draft
Consolidated
Assessment and
Listing
Methodology,
Toward a
Compendium of Best
Practices, First
Edition
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Biocriteria and
Biological
Assessment
Guidance
Nutrient Criteria
Guidance
Documents
Interim-Final
Guidance for RCRA
Corrective Action
Environmental
Indicators
Screening Level
Ecological Risk
Assessment Protocol
for Hazardous
Waste Combustion
Facilities, Peer
Review Draft
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-------
Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Ecological Risk
Assessment
Guidance for
Superfimd: Process
for Designing and
Conducting
Ecological Risk
Assessments, Interim
Final
Guidance for
Developing
Ecological Soil
Screening Levels
Guidance for Data
Useability in Risk
Assessment (Part A)
April 1992
Guidance for Data
Usability in Risk
Assessment (Part B)
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Issuance of Final
Guidance:
Ecological Risk
Assessment and Risk
Management
Principles for
Superfund OSWER
Directive 9285.728P
Ecological Risk
Assessment and Risk
Management
Principles for
Superfund Sites
(Issuance of Final
Guidance)
Eco Update The
RoleoftheBTAGs
in Ecological
Assessments
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-------
Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Eco Update
Ecological
Assessment of
Superfund Sites: An
Overview
Eco Update the Role
of Natural
Resources Trustees
in the Superfund
Eco Update
Developing a Work
Scope for Ecological
Assessments
ECO Update
Briefing the BTAG:
Initial Description,
Setting, History and
Ecology of the Site
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
ECO Update Using
Toxicity Tests in
Ecological Risk
Assessments
ECO Update
Catalogue of
Standard Toxicity
Tests for Ecological
Risk Assessments
ECO Update Field
Studies for
Ecological Risk
Assessment
ECO Update
Selecting and Using
Reference
Information in
Superfiind
Ecological Risk
Assessments
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Eco Update Ecotox
Thresholds
ECO Update
Ecological
Significance and
Selection of
Candidate
Assessment
Endpoints
ECO Update the
Role of Screening -
Level Risk
Assessments and
Refining
Contaminants of
Concern in Baseline
Risk Assessments
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Eco Update/
Groundwater Forum
Issue Paper
Evaluating Ground-
Water/Surface-
Water Transition
Zones in Ecological
Risk Assessments
Role of the
Ecological Risk
Assessment in the
Baseline Risk
Assessment
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Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Revised Interim Soil
Lead Guidance for
Comprehensive
Environmental
Response,
Compensation, and
Liability Act Sites
and Resource
Conservation and
Recovery Act
Corrective Action
Facilities
Risk Assessment
Guidance for
Superfund(RAGS):
Volume III - Part A,
Process for
Conducting
Probabilistic Risk
Assessment
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-------
Table C-l. A preliminary table of available guidance for ecological assessments in the EPA (continued)
Document title
Memorandum. EPA
Risk
Characterization
Program.
Overview of the
Ecological Risk
Assessment Process
in the Office of
Pesticide Programs
Population Risk
Assessment
Workshop Summary
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-------
APPENDIX D
SUPPORTING MATERIAL FOR
SECTION 6. RESPONSE TO SAB AND NRC COMMENTS
D-l
-------
D.I. ENHANCE COMMUNICATION OF ECOLOGICAL RISK ASSESSMENT
RESULTS
Methods to improve the communication of the results of an Ecological Risk Assessment
(ERA) to managers and stakeholders have been needed since the Chicago Bears won the
Superbowl. The lack of a bright line in ERA that defines this is good and this is bad to risk
managers is one issue. The variable decision structure for different U.S. Environmental
Protection Agency (EPA) Program Offices and Regions is another issue. Also communication of
risk assessments that include uncertainty and variability discussions can be difficult and can
result in a confusing message to managers and stakeholder.
The Risk Assessment Forum (RAF) needs to take a new look at communication issues by
studying within the various offices of the EPA how ERA results are communicated and to
identify what processes or structures are in place that may inhibit an informed discussion of the
ERA results. Another task could gather case studies on successful communication strategies and
incorporate the thoughts of external experts and managers.
D.2. THE FOLLOWING FOURTEEN ROE QUESTIONS INCLUDE AN ECOLOGICAL
COMPONENT
1. What are the trends in outdoor air quality and their effects on human health and the
environment?
2. What are the trends in extent and condition of fresh surface waters and their effects
on human health and the environment?
3. What are the trends in extent and condition of wetlands and their effects on human
health and the environment?
4. What are the trends in extent and condition of coastal waters and their effects on
human health and the environment?
5. What are the trends in the condition of consumable fish and shellfish their effects on
human health?
6. What are the trends in land cover and their effects on human health and the
environment?
7. What are the trends in wastes and their effects on human health and the environment?
8. What are the trends in chemicals used in land and their effects on human health and
the environment?
D-2
-------
9. What are the trends in contaminated land andtheir effect on human health and the
environment?
10. What are the trends in the extent and distribution of the Nation's ecological systems?
11. What are the trends in the diversity and biological balance of the Nation's ecological
systems?
12. What are the trends in the ecological processes that sustain the Nation's ecological
systems?
13. What are the trends in the critical physical and chemical attributes and processes of
the Nation's ecological systems?
14. What are the trends in the biomarkers of exposure to common environmental
pollutants in plants and animals?
D.3. A SUMMARY OF ECOLOGICAL ENTITIES SPECIFICALLY TARGETED FOR
PROTECTION BY ENVIRONMENTAL LAWS
Ecological
entities
Environment
Natural
resources
Ecosystems
Marine
ecosystems
Biota/living
things
Aquatic or
marine life
Endangered
species
Wildlife
Fish
Birds
Marine
mammals
Shellfish
Federal laws
CAA
y
y
y
y
y
y
CWA
y
y
y
y
y
y
CZMA
y
y
y
CERCLA
y
y
y
y
y
y
ESA
y
y
FIFRA
y
y
y
MMPA
y
y
MPRSA
y
y
y
y
y
y
MBTA
y
NEPA
y
y
RCRA
y
TSCA
y
y
D-3
-------
Ecological
entities
Plankton
Plants
Land
Soil
Water
Coastal waters
Wetlands
Shorelines,
beaches
Estuaries, flood
plains, dunes,
barrier islands,
coral reefs
National parks,
wilderness
areas, and other
special areas
Great Lakes,
Chesapeake
Bay, Lake
Champlain
Federal laws
CAA
'
-f
s
s
'
'
CWA
'
'
'
'
-f
'
'
CZMA
'
-f
'
^
CERCLA
^
^
ESA
FIFRA
'
^
^
^
MMPA
MPRSA
^
^
^
'
MBTA
NEPA
RCRA
'
^
TSCA
^
^
CAA = Clean Air Act; CWA = Clean Water Act; CZMA = Coastal Zone Management Act;
CERCLA = Comprehensive Environmental Response and Liability Act; ESA = Endangered Species Act;
FIFRA = Federal Insecticide, Fungicide and Rodenticide Act; MPRSA = Marine Protection, Research and
Sanctuaries Act; MBTA = Migratory Bird Treaty Act; MMPA = Marine Mammal Protection Act; NEPA = National
Environmental Policy Act; RCRA = Resource Conservation and Recovery Act; TSCA = Toxic Substances Control
Act
D.4. THE USE OF SERVICES OF NATURE IN AN ASSESSMENT OF AIR
POLLUTANTS
Ecosystems differ in biota, climate, geochemistry, and hydrology, and concomitantly
responses to pollutant exposures can also vary greatly between ecosystems. The Final Risk and
Exposure Assessment in the Integrated Science Assessment (ISA) for Oxides of Nitrogen and
Sulfur-Ecological Criteria addresses four main ecosystem effects (U.S. EPA, 2008).
D-4
-------
« Aquatic acidification due to nitrogen and sulfur
« Terrestrial acidification due to nitrogen and sulfur
• Aquatic nitrogen enrichment, including eutrophication
• Terrestrial nitrogen enrichment
Since these ecosystem effects are not evenly distributed across the United States, case
studies were developed for these analyses based on ecosystems identified as sensitive to nitrogen
and/or sulfur deposition effects. This assessment builds upon the scientific information
presented in the ISA, and ecological indicator(s) and case study locations were selected based on
this information. Eight case study areas were identified in recognized sensitive ecosystems
nationwide focusing on each of the targeted effect areas.
For assessing this set of secondary National Ambient Air Quality Standards (NAAQS), in
addition to assessing the degree of scientific impairment of ecological systems relating to inputs
of nitrogen oxides (NOX) and sulfur oxides (SOX), the Final Risk and Exposure Assessment
(U.S. EPA, 2009b) presents an overview of the concept of ecosystem services. The analysis of
the effects on ecosystem services helps to link what is biologically adverse effects with known or
anticipated adverse effects on public welfare. In the assessment, ecosystem services are used to
show the impacts of ecological effects on public welfare and to help explain how these effects
are viewed by the public (U.S. EPA, 2006). The ability to inform decisions on the level of a
secondary NAAQS required the development of clear linkages between biologically adverse
effects and effects that are known or anticipated to be adverse to public welfare. The concept of
adversity to public welfare does not require the use of ecosystem services, yet they were
envisioned as a beneficial tool that may provide more information on the linkages between
changes in ecological effects and known or anticipated adverse public welfare effects.
As described in the EPA's Ecological Benefits Assessment Strategic Plan, it is necessary
to recognize that in the analysis of the environmental responses associated with any particular
policy or environmental management action, some of the ecosystem services likely to be affected
are readily identified, while others will not be quantified (U.S. EPA, 2006). Of those ecosystem
services that are identified, some changes can be quantified, whereas others will remain
unidentified. Within services whose changes are quantified, only a few will likely be monetized,
D-5
-------
and many will remain un-monetized. Similar to health effects, only a portion of the ecosystem
services affected by a policy can be monetized. A conceptual model integrating the role of
ecosystem services in characterizing known or anticipated adverse effects to public welfare is
shown in Figure D-l.
Knowledge of the relationships linking ambient concentrations and ecosystem services
can be used to inform a policy judgment on a known or anticipated adverse public welfare effect.
The conceptual model outlined for aquatic acidification in Figure D-l can be modified for any
targeted effect area where sufficient data and models are available. This information can then be
used to characterize known or anticipated adverse effects to public welfare and to inform a
policy based on welfare effects.
While there will always be inherent variability in ecological data and uncertainties
associated with modeling approaches, there is a high level of confidence from a scientific
perspective that known or anticipated adverse ecological effects are occurring under current
ambient loadings of nitrogen and sulfur in sensitive ecosystems across the United States.
For aquatic and terrestrial acidification effects, a similar conceptual approach was used
(critical loads) to evaluate the impacts of multiple pollutants on an ecological endpoint, whereas
the approaches used for aquatic and terrestrial nutrient enrichment were fundamentally distinct.
Although the ecological indicators for aquatic and terrestrial acidification (i.e., acid neutralizing
capacity [ANC] and base cations: aluminum ratio Bc/Al) are very different, both ecological
indicators are well-correlated with effects such as reduced biodiversity and growth. While
aquatic acidification is clearly the targeted effect area with the highest level of confidence, the
relationship between atmospheric deposition and an ecological indicator is also quite strong for
terrestrial acidification. The main drawback with the understanding of terrestrial acidification is
that the data are based on laboratory responses rather than field measurements. Other stressors
that are present in the field but that are not present in the laboratory may confound this
relationship.
D-6
-------
Ambient Air Quality
Indicator
NOX/SOX
Concentrations
Exposure Pathway
Affected Ecosystem
Atmospheric N & S
^_ Deposition ^_
Aquatic
Ecological Response
(ecological indicator)
Ecological Effect
Acidification
(lake/stream ANC)
Change in Ecosyster
Structure & Processes
(fish species richness)
Ecological Benefit/
Welfare Effect
Policy based on
Welfare Effects
Change ir
Ecosystem Services
(recreational fishing)
Secondary
Standard
Figure D-l. Conceptual model showing the relationships among ambient air
quality indicators and exposure pathways and the resulting impacts on
ecosystems, ecological responses, ecological effects, and finally, on the quality
of a particular activity (e.g., recreational fishing) known to influence public
welfare.
The ecological indicator chosen for aquatic nutrient enrichment, the ASSETS
eutrophication index (El), seems to be inadequate to relate atmospheric deposition to the targeted
ecological effect, likely due to confounding factors. Further, there is far less confidence
associated with the understanding of aquatic nutrient enrichment because of the large
contributions from nonatmospheric sources of nitrogen and the influence of both oxidized and
D-7
-------
reduced forms of nitrogen, particularly in large watersheds and coastal areas. However, a strong
relationship exists between atmospheric deposition of nitrogen and ecological effects in high
alpine lakes in the Rocky Mountains, because atmospheric deposition is the only source of
nitrogen to these systems. There is also a strong weight-of-evidence regarding the relationships
between ecological effects attributable to terrestrial nitrogen nutrient enrichment, but ozone and
climate change may be confounding factors. In addition, the response for other species or
species in other regions of the United States has not been quantified.
A summary of the information presented by this Risk and Exposure Assessment that may
be useful for characterizing known or anticipated adverse effects to public welfare is shown in
Table D-l. This information will be used to aid the Administrator's decision about what levels
of protection might be appropriate to protect public welfare from known or anticipated adverse
ecological effects such as acidification in sensitive ecosystems.
The Final NOX/SOX Secondary NAAQS Risk and Exposure Assessment, as well as
related documents developed as part of the planning and science assessment phases of this
review (e.g., Integrated Review Plan, the ISA), are available at
http://www.epa.gov/ttn/naaqs/standards/no2so2sec/index.html.
D-8
-------
Table D-l. Summary of information assessed in the risk and exposure assessment to aid in informing policy
based on welfare effects (EPA, 2009b).
Exposure pathway
(current deposition levels)
Adirondack Case Study Area:
lOkgN/ha/yr
9 kg S/ha/yr
Shenandoah Case Study Area:
1 1 kg N/ha/yr
1 1 kg S/ha/yr
Kane Experimental Forest
Case Study Area:
14 kg N/ha/yr
2 10 kg S/ha/yr
Hubbard Brook Experimental
Forest Case Study Area:
8 kg N/ha/yr
7 kg S/ha/yr
Potomac River/Potomac
Estuary Case Study Area:
13 kg N/ha/yr
Neuse River/Neuse River
Estuary Case Study Area:
14 Kg N/ha/yr
Coastal Sage Scrub
from 3 to 10 kg N/ha/yr
Mixed Conifer Forest (San
Bernardino Mountains and
Sierra Nevada Range): from 3
to 10 kg N/ha/yr
Affected ecosystem
(case study areas)
Adirondack Mountains,
NY
Blue Ridge Mountains and
Shenandoah National
Park, VA
Kane Experimental Forest
(Allegheny Plateau, PA)
Hubbard Brook
Experimental Forest
(White Mountains, NH)
Potomac River Basin,
Chesapeake Bay
Neuse River Basin,
Pamlico Sound
Southern California
Coastal Sage Scrub
Mixed Conifer Forest (San
Bernardino Mountains and
Sierra Nevada Mountains,
CA)
Ecological
response
(targeted effect)
Acidification in
lakes and streams
Acidification of
forest soils
Nutrient
enrichment in main
stem river of an
estuary
Nutrient
enrichment in
terrestrial
ecosystems
Ecological
indicator
Fish species
richness,
abundance,
composition,
ANC
Tree health
Red spruce,
sugar maple
Bc/Al ratio
ASSETS El
Species
composition
Ecological effect
Species losses offish,
phytoplankton,
zooplankton; changed
community
composition, ecosystem
structure, and function
Decreased tree growth
Increased susceptibility
to stress, episodic
dieback; changed
community
composition, ecosystem
structure, and function
Habitat degradation,
algal blooms, toxicity,
hypoxia, anoxia, fish
kills, decreases in
biodiversity
Species changes,
nutrient enrichment of
soil, changes in fire
regime, changes in
nutrient cycling
Ecosystem service affected
Annual recreational freshwater
fishing in New York State = more
than 1 3 million days
Approximately $66.4 million in
implied value to New York anglers
from a zero-out of nitrogen and
sulfur deposition
Provision of wood products (sugar
maple)
900 million board feet timber
production
Current saltwater
recreational fishing
26.1 million activity days (North
Carolina-Massachusetts)
Annual benefits to California
residents hunting, fishing, and
wildlife viewing = approximately
$4.6 billion; state expenditures for
fire suppression = $300 million
(2008)
o
Note: ANC = acid neutralizing capacity, Bc/Al = Base cation: Aluminum, QA/QC = quality assurance/quality control.
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D.5. RELATEDNESS OF CUMULATIVE AND ECOLOGICAL RISK ASSESSMENT
Various parts of the EPA have been developing cumulative risk assessment (CRA)
approaches and tools for several years. One of the formal EPA efforts to develop CRA began in
1999 when the RAF began its process to develop Agency-wide CRA guidelines. The RAF chose
to follow the same sequential progression that it used to develop its Agency-wide Guidelines for
Ecological Risk Assessment. This multiyear, 3-phase developmental process consists of
sequentially developing (1) a framework; (2) issue papers and case studies; and (3) guidelines.
Phase I was completed in 2003 with release of the Framework for Cumulative Risk
Assessment (EPA/630/P-02/001F). Several objectives were achieved with the CRA Framework.
It is an informational document which is focused on identifying and describing various aspects,
key issues, and basic elements of cumulative risk. The CRA Framework defines cumulative risk
assessment as "an analysis, characterization, and possible quantification of the combined risks to
human health or the environment from multiple agents or stressors." Additionally, common
cumulative risk terms are defined and a flexible structure is provided. As Agency-wide
guidelines, no attempt was made to lay out protocols or set procedures.
Phase II is nearing completion as the corresponding report, Issues and Case Studies in
Cumulative Risk Assessment, is currently undergoing internal peer review. In the Phase II report,
key issues are explored, which were identified in the Framework, and numerous case studies are
described to illustrate the basic CRA elements, as well as various aspects of CRAs. Phase III
will commence during 2010 and will culminate with publication of the Agency-wide CRA
guidelines.
In addition to the common developmental process, CRA and ERA share other
commonalities. Both types of risk assessment tend toward integration of assessment elements
(e.g., considering aggregate exposures to multiple agents or stressors), exploring
interconnections and interrelationships between and among environmental components, rather
than segregating components with a deconstructive approach. Thus, they both can be viewed as
tending toward being holistic approaches.
From this perspective, it is not surprising that the CRA paradigm illustrated in the CRA
Framework is nearly identical to the ERA paradigm as presented in the ERA Framework and
Guidelines. Especially prominent is the emphasis on problem formulation as being a key
component to the success of both risk assessment types. Clear definition and statement of
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(1) questions being asked; (2) objectives being desired; (3) assessment endpoints being
evaluated; (4) measures and indicators being used; (5) conceptual model being envisioned; and
(6) analysis plan being undertaken become increasingly important as the risk assessment
complexity increases due to increasing consideration of interrelationships and interconnectedness
of the risk assessment elements.
D.6. WEB SITES ILLUSTRATING THE EPA'S INTERNATIONAL, FEDERAL,
STATE, AND TRIBAL PARTNERSHIPS ON SCIENCE AND MANAGEMENT
* Information about EPA cooperation with Europe
http://www.epa.gov/international/regions/Europe
• EPA projects to assist in the environmental recovery of the former Soviet Union and
other Central and Eastern European countries
http://www.epa.gov/international/regions/Europe/darkpast.htm (HTML)
• An overview of the international activities related to pesticides
http://www.epa.gov/oppfeadl/international
» Home page for EPA's international air and climate pages
http://www.epa.gov/international/air
» Information about partners in managing marine pollution issues
http://www.epa.gov/international/water/marine/partners.html
» international agreement on global control of mercury pollution
http://www.epa.gov/international/toxics/mercury.html (HTML)
* Information on Agency-wide efforts to strengthen public health and environmental
protection with Native Americans http://www.epa.gov/tribal
* Information on the Mississippi River/Gulf of Mexico Watershed Nutrient Task
http://www.epa.gov/msbasin/members.htm
» Information on the Columbia River Basin landscape, including parts of seven states and
British Columbia... http://yosemite.epa.gov/R10/ECOCOMM.NSF/Columbia/Columbia
* Information about water quality standards and the Endangered Species Act
http://www.epa.gov/waterscience/standards/esa.html
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D.7. INCLUDE ECOSYSTEM SERVICES AS ASSESSMENT ENDPOINTS WHERE
APPROPRIATE
Ecological relevance, susceptibility to the stressor and relevance to management goals are
the key considerations when selecting assessment endpoints responsive to the needs of the
decision-maker (U.S. EPA, 1998). Attention to the first two of these helps to ensure the
scientific credibility of the ERA; attention to the third enhances the significance of assessment
results to decision-makers and the public. As stated in EPA (1998)...
Ultimately, the effectiveness of a risk assessment depends on whether it is used
and improves the quality of management decisions. Risk managers are more
willing to use a risk assessment for making decisions when it is based on
ecological values that people care about. Thus, candidates for assessment
endpoints include endangered species or ecosystems, commercially or
recreationally important species, functional attributes that support food sources or
flood control (e.g., wetland water sequestration), aesthetic values such as clean air
in national parks, or the existence of charismatic species such as eagles or whales.
However, selection of assessment endpoints based on public perceptions alone
could lead to management decisions that do not consider important ecological
information. While responsiveness to the public is important, it does not obviate
the requirement for scientific validity.
Elsewhere in this document we discussed the tendency in the Agency to default to human
health risks as the key drivers in environmental decisions (although instances in which ecological
risks influenced decisions more strongly were described above). The issues surrounding this fact
are both simple and complex—simple in that humans are making the decisions and our
perceptions typically are ones of protecting human health being paramount; complex in that
program policies and the political will of decision-makers interplay in ways that influence how
various types of scientific information are used in the decision-making process. But a substantial
part of EPA's mission is to protect the environment. One means by which ecological risk can be
put on a par with that of human health risk is to couch ecological effects in terms of ecosystem
services, ecological benefits, and social welfare.
We encourage selection of assessment endpoints that can be tied closely to ecosystem
goods and services—the outputs of ecological functions or processes that directly or indirectly
contribute to social welfare or have the potential to do so in the future (U.S. EPA, 2006a). In this
regard, EPA (2004) describes the relationships between the individual generic ecological
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assessment endpoints and several of the environmental values that the public ascribes to
ecological entities and functions. Having this relationship well described is particularly relevant
to the translation questions of concern here, because linking assessment endpoints to public
values can help to identify economic methods appropriate for monetization. Although
monetization is not always required nor desired, quantification of the risks to ecosystem services
in biophysical terms still provides information most easily communicated to and understood by
decision-makers and the public.
Problem formulation of the Agency's risk assessments should included ecosystem
services to the extent that they can help to inform decision-making. Rationale for selecting such
endpoints should include explicit explanation of the linkages existing among the endpoints used
and social welfare. When assessment endpoints are included whose relationships to welfare are
less obvious (e.g., benthic community structure), care should be taken to describe how adverse
effects to those endpoints can manifest to loss of ecosystem services. Identifying appropriately
valued assessment endpoints likely will require involvement of social scientists is some
significant way—either during planning and problem formulation themselves, or in precursor
planning activities that might identify a suite of ecosystem service assessment endpoints as
proposed by Munns et al. (2009). The rationale underlying selection of such endpoints can
become critical components of strategies communicating the assessment approach and results.
D.8. THE TREATMENT OF SCALE IN EPA PROGRAM OFFICES
D.8.1. Office of Pesticide Programs
The Office of Pesticide Programs conducts ecological risk assessments over a range of
spatial scales depending upon uses, fate, transport, and effects of pesticides. National scale
assessments are based on conservative regional scenarios to evaluate the potential risks from
pesticides in the specific locales where they are most likely to be applied to meet regional pest
pressures. Specific regional scenarios are developed for specific crops (e.g., Maine potatoes).
The scenarios incorporate regional climate data (e.g., rainfall, temperature) base don historical
weather data. The exposure estimates for the scenarios are based on modeled exposure data, and
monitoring data where available. Temporal scale of OPP risk assessments is defined by the use
pattern of the active ingredient. For residential and consumer use patterns, use may be at any
time of the year. For agricultural use patterns, the temporal scale is defined by agronomic
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practices such as application timing in relation to plant growth stage. Timing and duration of
exposure may also be assessed through the use of time-series monitoring data. The biological
scale of OPP risk assessments is based on mortality, growth, and reproduction as assessment
endpoints. For endangered species, additional sublethal effects are considered. Effects on higher
levels of biological organization are assessed through probit-slope relationships for acute effects
(percent effect on populations), and by consideration of indirect effects (food supply and
predator-prey relationships). Endangered species assessments require an analysis of effects on
listed critical habitat which may be addressed at the ecosystem-level analysis, depending on the
size of the habitat.
D.8.2. Office of Water
The Office of Water develops national ambient water quality criteria as science based
recommendations that EPA considers protective of the aquatic life use. Criteria are not
regulations, nor are they enforceable. When criteria are linked to a designated use and adopted
into a water quality standard by a state, the standard becomes enforceable. Accordingly, the
Office of Water and states are coregulators that work together to consider and prioritize
pollutants for criteria development. The Office of Water works with EPA Regions and states to
identity and select criteria candidates. Because ambient water quality criteria are developed on a
national scale, pollutants of broad national or multiregional interest are given priority over those
limited to a single region. National criteria are developed according to EPA (1985) and do not
explicitly address exposure spatially. Rather, it is conservatively assumed that aquatic life is
exposed to the pollutant. Temporal scale is typically considered in terms of two categories,
short-term (acute) and long-term (chronic) exposures. If a pollutant is more prevalent during
particular seasons, or if toxicity is affected by seasonal temperature variation, a criteria
recommendation may be proposed with a seasonal temperature component. Additionally,
frequency and duration of exceedences may also be included in a criterion recommendation.
Seasonal DO regimes based on living resources physiologic requirements and seasonal and
hydrologic/bathymetric constraints were considered during the scoping and problem formulation
step for development of dissolved oxygen criteria for the Chesapeake Bay.
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D.8.3. Office of Solid Waste and Emergency Response
The Office of Solid Waste and Emergency Response considers scope, boundaries, and
scale to be important elements during the development of conceptual site models for ecological
risk assessments. Scope, target populations, and boundaries are established using EPA's
Guidance on Systematic Planning Using the Data Quality Objectives Process (U.S. EPA, 2006).
The scope and boundaries of the conceptual site model are developed during problem
formulation and reflect the scope and boundaries of the risk management decision. The
conceptual site models present geographic scales of risk management decisions. EPA's
Guidance for Conducting Remedial Investigations and Feasibility Studies (RI/FS) Under
CERCLA (U.S. EPA, 1988) encourages EPA risk managers to identify options to address
contamination at a site early in the process. EPA risk managers come to EPA risk assessors with
their initial plans for conducting a RI/FS. The schedule and project boundaries and other
requirements are often specified in a consent decree or signed by the potentially responsible
parties. When EPA contractors are preparing the risk assessment documents, the schedule and
requirements are communicated in the Scope of Work. Usually there is also a meeting between
EPA's risk managers, contractors, risk assessors, and contract officers to begin a project.
Superfund legislation defines the site as the extent of contamination. When the extent of
contamination is determined by the remedial investigation, adaptive site management can
provide flexibility in the site boundaries as the extent of contamination is characterized. The
spatial extent of the affected ecological population is not usually considered in the ecological risk
assessment problem formulation. Rather, a locally affected population (or part of the population)
is assumed to be an appropriate assessment spatial scale. The conceptual site model may also
identify where separate decisions for the smallest subpopulation or time period may be of interest
to risk managers. Cleanup decisions requiring a predictive risk assessment are targeted to
potential remedies identified by risk managers in early stages of the RI/FS. Therefore, the
geographic scoping can relate to source areas and specific migration pathways. A larger site may
be subdivided into operable units, solid waste management units, or exposure units to support
decisions targeted to specific sources or pathways. These decisions are made during planning,
before initiation of the risk assessment. Decisions are revisited as new information becomes
available or as management objectives change. The boundaries and scale of the risk evaluation
is designed to reflect the scale of the risk management decision. The risk assessment evaluates
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current and potential future risks. Remedies should achieve protectiveness within a reasonable
time frame. The definition of "reasonable" will depend on the severity of impacts and magnitude
of effect within an ecosystem. Outcome assessments are evaluated in five year review cycles
which may also include trend analyses. The exposure profile considers temporal aspects of
exposures and ecosystem responses, such as seasonal use or pulsed exposures. The exposure
profile is used to guide development of biological studies, the selection of toxicity reference
values, and monitoring. The technical support document for the development of the ecological
soil screening values (U.S. EPA, 2005) specifies survival, growth, and reproduction of organisms
as the biological scale. Office of Solid Waste and Emergency Response risk assessments also
consider protection of populations and communities. The biological scale can depend on the
spatial scale of the site or of the spatial scale of the decision unit in the case of a larger site.
D.8.4. A Case of Assessment Scaling
The case example includes three sequential assessments that moved through Broad
Regional, watershed, and site-specific concerns involving the Grand Calumet River and a
Northern Indiana Public Service Company (NIPSCO) facility. EPA Regions have developed is a
geographic information system based ecological assessment tool called the Critical Ecosystem
Assessment Model or CrEAM (White et al., 2008). CrEAM has been used to evaluate the
undeveloped areas of the six EPA Region 5 states (Illinois, Indiana, Michigan, Minnesota, Ohio,
and Wisconsin). The CrEAM assessment was requested by the Region 5 managers who were
interested in identifying and protecting ecologically important regional landscapes. The planning
and problem formulation for CrEAM included: (1) interactions with senior managers to define
management goals; (2) establishing a multidisciplinary, cross-program team; (3) obtaining
stakeholder input from tribal, federal, state, and local governments; (4) developing a conceptual
model; and (5) developing an analysis plan that incorporated ecological assessment endpoints
and measures of exposures and effects. This effort identified that Grand Calumet River was
subject to pollution from multiple sources.
The Grand Calumet River was also identified as one of 27 American, 12 Canadian, and
3 bi-national areas of concern in the Great Lakes region. The areas of concern were established
by the Great Lakes Water Quality Agreement (GLWQA) between Canada and the United States
to mutually address gross water pollution. The GLWQA emphasizes an ecosystem approach to
the management of the Great Lakes, and identifies 14 potential Beneficial Use Impairments
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(BUIs). The Grand Calumet River is located in the northwestern corner of Indiana, originating
in the east end of Gary. It winds for 13 miles through the heavily industrialized cities of Gary,
East Chicago, and Hammond, discharging about 1 billion gallons per day into Lake Michigan.
Approximately 50 Superfund (CERCLA) and 420 hazardous waste (Resource Conservation and
Recovery Act or RCRA) sites are in close proximity to the river. Additionally, the river contains
5 to 10 million cubic yards of contaminated sediment (PAHs, PCBs, heavy metals, oil, and
grease) that is 20 feet deep in some places. Natural areas that contain globally rare or state
significant community types, plants, and birds are intermingled with contaminated sites.
Numerous assessments of environmental conditions, contamination, and environmental impacts
have been conducted by federal and state agencies and nongovernmental organizations within
this large, complex area. Collectively, these studies were tied together into an ecosystem area of
concern tied together by the area of concern problems defined by the BUIs. Delisting targets
associated with measurable indicators that can be applied to the entire area of concern are being
developed. The delisting targets are management objectives for the Grand Calumet River area of
concern (AOC). One aspect of delisting target development is determining the appropriate
spatial scale in which to evaluate metrics. The NIPSCO facility is a northwest Indiana RCRA
Corrective Action site located adjacent to the Indiana Dunes National Lake Shore of Lake
Michigan. Having the smallest assessment area, it completes the 3-part spatial sequence
illustration. The NIPSCO is a coal-fired power generating plant which potentially has associated
hazardous waste releases to the National Lake Shore and Lake Michigan. The scope and
objectives of the ecological risk assessment are stipulated in the corresponding Administrative
Order of Consent. For this site-specific spatial context, the problem formulation is much more
discrete and defined than for those of the CrEAM or the Grand Calumet River AOC assessments.
D.8.5. Office of Air
In EPA's Office of Air, ecological risk assessments are often national in scale to support
National Ambient Air Quality Standards (NAAQS). Spatial resolution is described by
distribution of sources, distribution of receptors, and enabling legislative authorities. The
distribution of ambient air sources affects the distribution of sensitive receptors which ultimately
defines the spatial scale of the assessment. In addition, atmospheric mixing processes and
residence times will also impact the spatial scale of the ecological effect being addressed. For
example, sulfur dioxide emitted from power plants and motor vehicles is mixed and transported
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within an airshed (up to hundreds of miles) resulting in a cumulative impact from many sources
on a given ecological receptor. Enabling legislative authorities define the spatial scale of an
ecological risk assessment as in the 1990 Clean Air Act (CAA) Amendments. For example, air
toxics are regulated under the Hazardous Air Pollutant (HAP) program (Section 112 of the CAA)
which focuses on major releases (more than 10 tons per year from a single HAP or 25 tons per
year from multiple HAPs) from source categories of air pollutants (i.e., industrial boilers,
halogenated solvent cleaners, or hazardous waste incineration). Title IV of the CAA regulates
sulfur emissions from the power sector nationally, although the trading sector only encompasses
the east coast. The National Ambient Air Quality Standards (NAAQS) for welfare effects
addressed in Section 108 of the CAA must be national in scope. Under these authorities,
ecological risk assessments can be focused on one site (sole source of an air toxic), multiple
sources within a region (power generation), or national scale from all ambient sources (criteria
pollutants).
D.8.6. Interagency Assessment Scales
The spatial scale examples discussed above emphasize program office activities; the
Agency is also working with other federal agencies on the Global Earth Observation System of
Systems (GEOSS). As a part of that activity, the Agency has established the EPA Group on
Earth Observations (EPA GEO) to facilitate and coordinate responses and contributions to the
development of GEOSS. The goal of GEOSS is to provide decision-makers with scientific
information that can address societal benefit areas including human health, ecosystems, climate
change, and air and water quality. EPA GEO is currently in the investigatory phase. One of its
principal activities is guiding Office of Research and Development (ORD)'s Advanced
Monitoring Initiative (AMI) pilot projects for improving environmental health decision-making.
In 2010 EPA GEO is offering Decision-Making Engagement Workshops in several EPA
programs and regions to demonstrate AMI tools to decision-makers so that they may be
incorporated into decision-making by EPA, EPA's partners and the public. EPA representatives
also coordinate EPA's GEOSS role with United States Group on Earth Observations—a standing
subcommittee reporting to the White House's National Science and Technology Council's
Committee on Environment and Natural Resources (CENR). This CENR subcommittee
coordinates all U.S. Government agencies within the international GEOSS mechanism known as
GEO (Group on Earth Observations). The scope of U.S. EPA's role in GEOSS is indicated by
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the current version of the Strategic Plan for the U.S. Integrated Earth Observation System (see
www.epa.gov/geoss/ or http://usgeo.gov). GEO is a voluntary partnership of governments and
international organizations that provides a framework for collaboration for exploiting the
growing potential of Earth observations to support decision-making in an increasingly complex
and environmentally-stressed world.
D.9. THE TREATMENT OF LEVELS OF BIOLOGICAL ORGANIZATION IN THE
EPA
Generally, ecological risk assessments can be conducted at any level of biological
organization. The level or levels to be addressed may be affected by enabling legislation and
regulations, risk management questions, and assessment objectives. It is not uncommon for
multiple levels of the biological hierarchy to be included in a single assessment. Endocrine
disruption and a commensurate feminization of fish is a case in which multiple levels of
biological organization may be needed for an assessment. If observed fish feminization is
suspected to be caused by pharmaceutical products being released into a stream, the planning and
problem formulation for the corresponding ecological risk assessment could specify analysis of
in situ fish metabolic pathways, hormone levels, and tissues. Additionally, fish population
surveys could be specified to evaluate sex and age distributions of the various fish species
inhabiting the river reach under investigation. Assessments involving potential harm to
individuals of a particular species are required when a threatened or endangered species is
involved. EPA (2003) identifies a range of organisms, populations, communities, and
ecosystems for which policy or precedents exist for ecological assessment endpoints.
Numerous scientific arguments have been made about the need to focus on population
and higher-level ecological attributes. A central question is whether population-level assessment
endpoints would improve the quality of the risk assessment for the specific decisions they are
intended to inform. Wentsel et al. (2004) noted that population-level assessment endpoints may
be inappropriate for certain decision contexts.
1. Certain environmental laws and regulations may preclude a population endpoint
in some ecological risk assessments.
2. The species evaluated might be endangered or otherwise highly valued and the
individual organisms might be considered the appropriate assessment entity.
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3. For some assessments, population-level endpoints may not be relevant. Examples
include situations where tumors or other abnormalities in fish and amphibians are
primary concerns of the public.
4. A resource such as air quality, as it relates to visibility in a park, may bear no
relation to populations.
5. Population endpoints may be impractical as measurement endpoints using an
empirical approach. The guidance for conducting risk assessments at Superfund
sites (U.S. EPA, 1997) points out that even in the absence of the stressors
examined in an assessment, populations of at least some kinds of organisms
fluctuate so greatly that it is impractical to quantify the effect of a stressor. The
authors mention populations of small mammals and fish as especially variable.
Given the variability inherent in some populations, it might take several years of
data from reference sites to establish reliable bounds of reference populations. So
although maintenance of population size may be a relevant assessment endpoint,
it may be necessary to use individual-level measures of performance
(e.g., survival, reproductive output) as measurement endpoints.
6. The quality of the habitat may be considered by the assessor as the resource to
protect. For example, when setting sediment quality criteria, the purpose may be
to protect aquatic life in general, and there is no local population to assess.
7. Cost is also a consideration, and a population assessment might be considered too
expensive in particular circumstances.
Similar considerations are relevant when considering community and ecosystem level
assessments.
The choice of biological scale to be evaluated in regulatory ERAs can be challenging.
The enabling legislation of many of EPA's programs either explicitly or implicitly identifies
protection of ecological populations as management goals. Most ERAs conducted for chemicals
by EPA, and indeed by most organizations worldwide, focus on organism-level attributes
(e.g., survival, growth or reproduction) but population-level entities (e.g., a rainbow trout
population) (Suter et al., 2005). These endpoints are practical because they often can be
estimated through toxicological testing and other means, and are expedient because they are
commonly presumed to provide protection of population-level attributes (e.g., abundance and
persistence). Further, methods and practice are well established for assessing risk to
organism-level attributes, but documentation of consensus methods for estimating risks to
population-level attributes is lacking. Consequently, risk to populations has only occasionally
been evaluated directly by EPA (e.g., extirpation of trout populations in Adirondack lakes in the
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National Acid Precipitation Assessment). This situation results from several factors affecting
assessment planning, including the perceived relationships between assessment endpoints and
environmental management goals, historical precedence, the assumption that protection of the
organism-level attributes of a population will result in protection of its population-level
attributes, and importantly, the lack of recognized consensus and guidance about methods. In
addition, assessment of population-level attributes maybe inappropriate in some contexts (see
Section D.9).
Many of the Agency's assessments evaluate the condition of communities (collections of
interacting populations), and some metrics intended to reflect the condition of those communities
(e.g., indices of biotic integrity) are being used to inform certain environmental protection
decisions. Yet, methods for assessing risks to communities, and even less so for risk to
ecosystem functions, are poorly developed at present (although some ecosystem models are
available to evaluate higher order effects). We recommend that additional guidance be
developed concerning the issues and considerations cogent to selecting assessment endpoints at
the community and ecosystem levels of organization.
The EPA Risk Assessment Forum has started to develop best practice guidelines for
population-level assessment endpoints (U.S. EPA, 2009a). Initial efforts have focused on the
state of the science and practice for population assessment techniques, and identifying key
activities that might lead to the development of best practices. These efforts will likely continue
over the next few years, with supplemental guidelines for population-level ecological risk
assessment, including for planning, scoping, and problem formulation, being one outcome.
Many Agency assessments evaluate the condition of communities, and metrics intended to
reflect the community condition (e.g., indices of biotic integrity) have been used to inform
certain environmental protection decisions. However, methods for evaluating communities are
primarily descriptive rather than causative or predictive. Risks method for ecosystem functions
are poorly developed at present, although some ecosystem models are available to evaluate
higher order effects.
D.10. TRIBAL ISSUES
Current risk assessment methodology does not explicitly address tribal culture, values,
and/or lifeways. The impact to tribes when tribal resources are contaminated extends beyond
impacts to human health and the overall ecosystem to these larger issues. The processes fail to
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adequately account for or include a holistic approach for assessing the social, cultural, and
spiritual values, beliefs, and practices that link tribal people to their environment.
Tribal traditional lifeways encompass the unique cultural, spiritual, economic, and
language practices pursued by tribal communities. Tribal Science Council (TSC) representatives
have identified traditional tribal lifeways as the overarching issue under which all of the tribal
science priorities fall. The importance of each science priority is directly related to the way in
which the issue impacts not only tribal health and the environment, but also the way in which it
directly impacts the ability of tribal communities to pursue their traditional tribal ways of life—
with direct implications for cultural, spiritual, economic, and language practices of tribal
communities.
The TSC recognizes that EPA currently utilizes the risk assessment paradigm as the basis
for environmental decision-making and seeks to improve the policies and practices to incorporate
tribal traditional lifeways. In addition, the TSC recognizes that the fundamental assumptions and
approach of EPA's risk assessment paradigm cannot fully address tribal issues and perspectives
and seeks a longer-term goal of developing a new environmental decision-making paradigm for
EPA consideration—one focusing on human and ecological health well-being
(http://www.epa. gov/osp/tribes/key/html).
There is a need for a broadened perspective regarding temporal and spatial aspects of
ecological risk assessment, and this is particularly evident in the context of assessments
involving Native American tribes, Alaska Native communities, and similar indigenous peoples.
Tribal perspectives on risk assessment emphasize the need to include traditional ecological
knowledge in assessments, such as observational data on ecosystems and other natural resources
collected over multiple human generations. In addition, while the Agency is largely media
focused, tribes are most focused on context-specific issues that stress the interdependence of
various risk factors, many of which require analysis at lengthy temporal and/or expansive spatial
scales to discern effects. Finally, tribes possess a culture-based knowledge of ecosystems, often
linked to their original creation stories, which may be an integral part of their tribal
decision-making processes regarding protection of the natural environment.
At the Tribal Science Council Risk Assessment/Health and Well-being Workshop,
February 19 and 20, 2003, the TSC identified as the top science priority the need for the
integration of tribal concerns into EPA's risk assessment and management process. TSC
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representatives stressed that they are seeking policy-level changes as well as methodological
improvements. An EPA representative noted that one of the big hurdles to getting such policy
moved through the Agency lies in being able to quantify the benefits of policy decisions to the
Office of Management and Budget (OMB), noting that OMB holds great sway over policy
implementation at the Agency. She added that only if it can be proven to the managers that the
proposed policy change is workable and viable will it move forward within the Agency
(http://www.epa. gov/osp/tribes/pdf/rah&w.pdf).
Executive Order 12898: Federal Actions to Address EnvironmentalJustice in Minority
Populations and Low-Income Populations. "Developing and conducting EPA's programs,
policies, and activities that substantially affect human health and the environment to ensure the
fair treatment of all people including minority and/or low-income populations." This Executive
Order is particularly relevant not only to ecological risk assessments involving Tribes and their
deep interconnectedness with ecosystems, but also to ecological risk assessments conducted in
areas with limited opportunities for human interactions with the natural environment, due to the
scarcity of unimpacted ecosystems. The adequate assessment, remediation, and protection of
these areas results in benefits to not only the ecological receptors within the systems, but also to
the human inhabitants utilizing those environments for consumptive and nonconsumptive uses
(http ://www. epa. gov/compliance/resources/policies/ej'/index .html).
D.ll. REFERENCES
Munns, WR, Jr; Helm, RC; Adams, WJ; et al. (2009) Translating ecological risk to ecosystem service loss. Integr
Environ Assess Manag 5(4):500-514.
Suter, GW, II; Norton, SB; Fairbrother, A. (2005) Individuals versus organisms versus populations in the definition
of ecological assessment endpoints. Integr Environ Assess Manag. 1(4):397-400.
U.S. EPA (Environmental Protection Agency). (1985) Guidelines for deriving numerical National Water Quality
Criteria for the protection of aquatic organisms and their uses. PB85-227049. Office of Research and Development,
Environmental Research Laboratories, Duluth, MN, Narragansett, RI, Corvallis, OR. Available online at
http://www.epa.gov/waterscience/criteria/library/85guidelines.pdf.
U.S. EPA (Environmental Protection Agency). (1988) Guidance for conducting remedial investigations and
feasibility studies under CERCLA (Interim Final). PE89-184626. EPA/540/G-89/004. OSWER Directive 9355.3-
01. Office of Emergency and Remedial Response, Washington, DC.
U.S. EPA (U.S. Environmental Protection Agency). (1997) Ecological risk assessment guidance for superfund:
process for designing and conducting ecological risk assessments, Interim final. Office of Solid Waste and
Emergency Response, Washington, DC; June 1997, EPA/540/R-97/006. Available online at
http://www.epa.gov/oswer/riskassessment/ecorisk/pdf/intro.pdf.
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U.S. EPA (Environmental Protection Agency). (1998) Guidelines for ecological risk assessment. Risk Assessment
Forum, Washington DC; EPA/630/R-95/002F. Available online at
http://www.epa.gov/raf/publications/pdfs/ECOTXTBX.PDF.
U.S. EPA (Environmental Protection Agency). (2003) Generic ecological assessment endpoints (GEAE) for
ecological risk assessment. Risk Assessment Forum, Washington, DC; EPA/630/P-02/004F. Available online at
http://www.epa.gov/raf/publications/pdfs/GENERIC_ENDPOINTS_2004.PDF.
U.S. EPA (Environmental Protection Agency). (2005) Guidance for developing ecological soil screening levels.
November 2003, revised February 2005. Office of Solid Waste and Emergency Response. Washington, DC.
OSWER Directive 9285.7-55. Available online at
http://www.epa. gov/ecotox/ecossl/pdf/ecossl_guidance_chapters.pdf.
U.S. EPA (Environmental Protection Agency). (2006) Guidance on Systematic Planning Using the Data Quality
Objectives Process. Office of Environmental Information, Washington, DC; EPA QA/G-4. Available online at
http://www.epa.gov/quality/qs-docs/g4-final.pdf
U.S. EPA (Environmental Protection Agency). (2006) Ecological benefits assessment strategic plan. Office of
Policy, Economics and Innovation, National Center for Environment Economics, Washington, DC;
EPA/240/R-06/001.
U.S. EPA (Environmental Protection Agency). (2008) Integrated science assessment (ISA) for oxides of nitrogen
and sulfur-ecological criteria. Office of Research and Development, Research Triangle Park, NC;
EPA/600/R-08/082F. Available online athttp://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=201485.
U.S. EPA (Environmental Protection Agency). (2009a) Summary report: risk assessment forum technical workshop
on population-level ecological risk assessment. Risk Assessment Forum, Washington, DC, EPA/100/R-09/006.
Available online at http://www.epa.gov/raf files/population_level_era_report_supp_materials.pdf.
US EPA (United States Environmental Protection Agency). (2009b). Risk and Exposure Assessment for Review of
the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Sulfur. Final. U.S.
Environmental Protection Agency, Office of Research and Development, National Center for Environmental
Assessment, Research Triangle Park, NC.
Wentsel, R., N. Beyer, V. Forbes, S. Maud, and R. Pastorok. (2007) A framework to apply population-level
methods to ecological risk assessment. Chapter 10. In: Population-Level Ecological Risk Assessment. Eds.
Barnthouse, Munns, and Sorensen. Taylor & Francis, New York, NY.
White, ML; Maurice, CG; Mysz, A; et al. (2008) The critical ecosystem assessment model (CrEAM) - identifying
healthy ecosystems for environmental protection planning. In: Campbell, JC; Jones, KB; Smith, H; et al; eds. North
America Land Cover Summit, Chapter 12. Washington, DC: Association of American Geographers; pp. 181-213.
Available online at http://www.aag.org/galleries/nalcs/CH12.pdf.
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APPENDIX E
WORKGROUP RECOMMENDATIONS
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Each of the four work groups developed position statements and recommendations for
their topics. Most of this material, including all of Workgroup 1 's products, was integrated into
the main text or appear in Appendix E as responses to specific Science Advisory Board (SAB)
and NRC recommendations. Other recommendations are presented here.
WORKGROUP 2
Review of the existing Ecological Risk Assessment (ERA) guidance leads to the
following conclusions:
While general in nature, there is a sufficient body of guidance on the process for
conducting ERAs; while there can be improvement on specific aspects of the process.
A notable area of insufficient guidance is ecological risk communication. This topic area
is viewed to overlap with stakeholder involvement in the there is a need to effectively
communicate with stakeholders (including the public) on issues related to the risk assessment
itself (process and methodologies) but also the risk characterization and ultimately the risk
management decisions.
A second area which guidance is lacking is data quality objectives (DQOs) and quality
assurance/quality control (QA/QC). There is Agency guidance on DQO process and
requirements for the development of investigation objectives and design. While the DQO
guidance which exists, if followed, should result in improved problem formulation; guidance
translating DQO guidance into a format specific to the ERA process would facilitate conducting
ERAs. With respect to QA/QC issues there is limited guidance on handling data (typically only
chemical data) within a risk assessment; and given data quality limitations, how the data may be
used within a risk assessment. However, guidance on QA/QC directly related to
biological/ecological data, in ERAs, was not evident in the documents reviewed.
There is a continuing need for development and improvement of hazard
assessment/toxicological data bases and guidance. Of notable absence is the lack of toxicity data
on reptiles and amphibians. The chemical risk data base for other organisms is also lacking in
many areas and/or the quality of the data is questionable. Data bases/guidance on other stressors
may also be insufficient.
Risk integration was noted as being having limited guidance and the guidance developed
largely focuses on human health risk assessment. Guidance needs in this are could include how
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and when hazard quotients may be defensibly combined in the risk characterization, or how to
combine risks from multiple stressors.
There will be a need for additional stressor specific risk guidance; nanotechnology was
called out as an example.
Receptor specific risk guidance was also noted as limited. As presented above, reptile
and amphibian toxicity guidance is notably lacking however there are significant limitations on
available toxicological data for all organism groups for many stressors (toxicants).
The review of the Agency guidance on ERA and ERA related documents does
demonstrate that there is an uneven distribution of program-specific guidance. While this may
be an artifact of the utilization of the Agency-wide guidance; the observation may warrant
further evaluation.
WORKGROUP 3
Identify potential linkages between assessments in different programs and create a
mechanism for creating them. Although contaminants move among media and receptors, a lack
of integration across media and contaminant specific assessments can result in unintended
consequences. Means to address this problem potentially include:
* Representation of other programs during Problem Formulations
* A standing interprogram liaison group
* Standard links
* Make a "regulatory LCA" part of the problem formulation
* Create an Agency ERA committee to determine how to make links
o Create a linkage diagram
Create interest groups for ecological assessors
The Nanometers and ERAF are models
Create avenues for interagency data sharing
Office of Science and Technology Policy should lead?
Create means to routinely share methods and tools across regions and programs
Simple tools e.g., check lists, boiler plate
Common problems such as endangered species consultations
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We want new laws!
Develop RAF guidelines for fully integrated framework to facilitate communication and clarify
tasks
WORKGROUP 4
Initial Investigative Priorities
• Biomarker and mechanistic data in exposures assessment
* Consideration of ongoing global change processes and indirect effects at different scales
as part of risk
• Interface between risk assessment and monitoring programs
* Tools for cumulative risk from multiple stressors
• Methods for Ecosystem services
Initial Implementation Priorities
* Explore adaptive management with iterative triggers for risk assessment and risk
management to deal with uncertainties
» Beneficial ecological consequences from risk management decisions
* Life cycle analysis for product safety evaluations
» Promote dialogue between RA/RM through post decision auditing and monitoring to
develop standards of practice
* Characterize and communicate uncertainty in all key computational steps of RA
RECOMMENDATIONS FROM PRECOLLOQUIUM INTERVIEWS
Aspects of the Process that Could be Strengthened
Largest dilemma is how to define "protective." E.g., protect population or community?
Industry often wants community-level protection because it takes longer and the results are
ambiguous.
Problem formulation is weak because there are poorly defined assessment endpoints and
often no decision criteria. Also, there is a sense that there is just too much paper and information
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to manage. In some cases, problem formulation becomes an assessment in itself, but without the
rigor or protocols to guide the process.
Cost analysis considers only crop and property damage, not socioeconomic costs or
environmental justice issues or costs incurred to comply with statutes other than the Federal
Insecticide, Fungicide and Rodenticide Act.
Coordination and harmonize assessment practices so that all laws are met.
Suggestions for Assuring that Scientific Information Informs and Improves
Decision-Making
Need a forum for RA's with negative results. This serves several purposes. The cases
help to illustrate that these results do occur and that helps to build confidence when others
determine similar results. For archival purposes, the RA should be recorded if at a later date new
science suggests otherwise. Also, sharing these decisions increases the sharing of knowledge.
Compare our processes with Canada and the Park Service to get ideas.
Need Eco-Risk training course for Superfund and hazardous waste sites. New generation
does not have the hard learned experience. Current training emphasizes human health and
eco-risk is glossed over.
Web sites need to be improved so that it will be easier to access and search for
information.
Benchmarks are needed for pesticides and pharmaceuticals and personal care products.
Decision tools need to bridge the perceived disconnect between human health and
ecosystem health.
Guidance
The 1998 Guidelines for Ecological Risk Assessment are good for site specific
assessments, but less satisfactory for national assessments that have so many assessment
endpoints, sources, and geographic variability.
* Additional development of predictive models for additional chemical classes is needed.
» Not adequate for nano materials.
• New chemicals assessment procedures could be published as an integrated document.
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There is a need for guidance on Ecological Systems Risk rather than species. This might
include functions, species dependence, and movement of stressor through ecosystems. This
could begin with development of conceptual models and then improving basic scientific
understanding through testing resulting in guidance to inform decision-making using that
information.
* Guidance before developing criteria to establish causal relationship
« It would be helpful to have a single document describing the roles of different agencies.
» It would be helpful if there were a framework or guidance for developing environmental
policy and environmental vision for the Agency.
• It would also be helpful to have guidance for determining emerging issues and for
identifying questions that need to be answered as a concerted effort of an Agency rather
than separate activities.
Communication Tools
How do we make uncertainties less influential? How do we explain that directionally
correct tightening of a standard may still result in a loss of the resource if the protection?
Improve communication by providing a list of who is doing what, congruent offices in
Regions because now they all have different nomenclature and structure and it is hard to find
other experts.
Decision Tools
Greater accessibility or authority to require data would help inform decisions s not
enough?
Other
Compare our processes with Canada and the Park Service to get ideas.
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APPENDIX F
NOTES FROM THE CLOSING SESSION
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The following notes represent highlights from the plenary discussion in the last few hours
of the Colloquium. They are not prioritized or otherwise ordered or sequenced. Names of
speakers have been deleted.
Eco-risk communication needs to be developed. A workshop or research of
methods for effective eco-risk communication may be a mechanism to do this.
Outside experts in communication could be brought in to train or help us craft the
products. Different groups need different communication tactics.
RAF could focus on "state of the science" papers. It was felt that a workshop
would be a productive way to collect the information for the paper as NGO's,
industry, and academia could all be involved.
State-of-science papers that integrate eco and human health should be preferred.
Some topics may be of interest to both groups and these would be good ones to
focus on initially and would help us build rapport with the human health folks.
EPA relies on contractor support to the detriment of training internal people to be
experts in fields. We need to think about our current skill mix and where we need
to be in 5 years.
Important to mentor new employees so that they can learn the Agency, history,
and useful skill sets.
Workshops and forums for new EPA employees could be a good mechanism for
them to learn what is going on at the Agency. These are much more informative
than reading guidance.
Interagency coordination and communication on eco issues are necessary.
It is hard to figure out who is doing what at the EPA. We need better
communication across EPA program offices.
We need to simplify the terms we use when we are communicating with each
other and the public. "Ecosystem Services" does not make much sense to most
people. Saying things like "we have found that if we protect ecosystems, human
health will improve" is comprehensible to almost everyone. Essentially, we could
use phrases like these to raise the importance of eco in people's minds.
At the beginning of the risk assessment process, we should set criteria so you can
know how you are going to make your decision (RAF could aid in this effort).
RAF is here to help documents through the onerous Agency review process.
Half-finished self-started efforts can be identified and brought to the RAF to help
them along the rest of the way.
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A lot of guidance in programs never gets finalized and published because is hard
to get through peer review and clearance. The Forum exists for getting
documents out, reviewed, and cleared. The Forum can do that for you if you have
Agency-wide or multiprogram significance.
So far, the idea of throwing more science at ecological problems hasn't worked as
well as hoped. Someone has to say, take ecological effects more seriously.
Office and Division directors would be especially good targets for the message
because they are the career professionals who have a major influence over EPA's
path.
The water program is taking ecological issues seriously. Your water bill is 2/3 is
sewer charges to treat conventional pollutants, and that is all eco. So, society is
actually spending money on eco protection. The attention to ecology depends on
the program. Don't be wining.
We need an ecological liaison in the Administrator's office so that we can convey
that ecological endpoints that are meaningful. This is critical.
We need to emphasize risk communication and think outside the box. We don't
do research in sociology and environmental economics.
The STPC has no official eco risk group. We need some kind of unifying body at
top of agency. There needs to be a cross-agency body that has people with right
expertise on it to make decisions on eco issues.
RAF can focus on state of science rather than guidance. Extremely useful to have
papers on where we are on these things to allow program offices to trigger only
see where going, small things that can be implemented. Guidance is 5 years
away. Program office and regions love to see state of science on all those issues.
May not be able to deal with all uncertainty, challenge, see state of science and
move that piece along.
We need to change the business model. Managers should be asking question,
how are we dealing with eco risk in this project? Many managers believe that if
they take care of human health issues, eco issues are being addressed at the same
time. Needs to be a mind change within managers to consistently ask—are we
dealing with ecological risk? Training for managers could be useful but better to
make them accountable. Make it a critical job element.
Our field is so complex that need to be familiar with—someone working in
regional office, work under someone? Spend some time in OW or work in ORD
so understand resources tools, apprenticeship type program. Maybe pick from
several categories. Would love to know more about X, Y, Z. would be helpful.
When things became concrete, then people get it. Make useful guidance by
pulling together documents that exist. Then you need good examples.
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In the late 60s and 70s bathing beaches on Lake Erie were closed by alewife die
offs. There was not a communication problem. The impetus wasn't from within
the Agency. It was external to bring resources to bear. Did the Agency ever tell
the stories of where we were and get credit for those good things that have
occurred. It would be worth the effort to try a history of where our environment
stood in 1960s and where we are now.
I have been starving for a forum like this since I started 5 years ago. I have
learned more last 3 days than last 5 years. There is no motivation to read
guidelines. This is where the pieces are put together. I wished we had more
venues like this, encourage new scientists to learn about the Agency, where it has
been, where it is going and issues are on the table. We need to have more things
like this annual/semiannual to get new employees, middle management and older
folks who think they know everything to get together.
Guidelines are open-ended by necessity because they are applied so many
different ways. Case studies are ultimately way more helpful. Getting together to
hear someone else's good ideas is super helpful.
Other agencies are doing ERA. We should do better job coordinating with other
federal agencies.
We need to clearly defining critical terms at the beginning when meeting with
stakeholders, and risk managers. What is adverse or protective? Define criteria
for how the decision will be made and know what information to provide.
If you want to have any legacy, develop professional networks to really look at
what need to do and not just look at as a crush of work.
The STPC and RAF hear from senior and more experienced staff. They need to
hear from the younger staff as well.
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