United States      EPA Science Advisory      EPA-SAB-EPEC-02-005
      Environmental      Board (1400A)           February 2002
      Protection Agency     Washington DC         www.epa.gov/sab

&EPA PLANNING FOR ECOLOGICAL

      RISK ASSESSMENT:

      DEVELOPING MANAGEMENT

      OBJECTIVES: An SAB Report
      A Review by the Ecological
      Processes and Effects Committee
      (EPEC) of the EPA Science
      Advisory Board (SAB)

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                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                    WASHINGTON, D.C. 20460
                                      February 19, 2002

EPA-SAB-EPEC-02-005
                                                                 OFFICE OF THE ADMINISTRATOR
                                                                   SCIENCE ADVISORY BOARD
Honorable Christine Todd Whitman
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460

       Subject:      Planning for Ecological Risk Assessment: Developing Management
                    Objectives: an SAB Report

Dear Governor Whitman:

       On July 18-19, 2001, the Ecological Processes and Effects Committee (EPEC) Panel on
Ecological Risk Management (hereafter, the Committee or EPEC) of the EPA Science Advisory
Board reviewed the Agency's draft: Planning for Ecological Risk Assessment: Developing
Management Objectives (EP A/63 0/R-0 1/001 A, June 2001) (US EPA, 200 la), a document
prepared by the Agency's Risk Assessment Forum. The stated purpose of the draft guidance
document is to help decision-makers work with risk assessors, stakeholders, and other analysts to
plan ecological risk assessments that will effectively inform the decisions they make.

       The Committee strongly supports a concerted,  cross-Agency effort to develop sound,
consistent principles and guidance for ecological risk assessment and management. The current
Ecological Risk Assessment Guidelines (US EPA, 1998) continue to provide valuable structure
and discipline for the assessment of ecological risks. The draft guidance document being
reviewed is intended to complement the Ecological Risk Assessment Guidelines by providing
additional detail about the planning that should precede the actual risk assessment.  Specifically,
the draft guidance addresses the development of objectives that summarize a community's
desires regarding the outcome of a risk management decision. It is the Agency's initial  attempt
to outline consistent principles and procedures for ecological risk management, in parallel with
the principles and procedures for risk assessment.

       Once completed, the guidance will be broadly useful not only to the Agency's program
offices, but also to other federal and state agencies and the private sector. The draft guidance
incorporates recent experience in building broader stakeholder networks, integrating public
values, and balancing diverse and sometimes conflicting expectations and values.  The resulting
dialogue among risk managers and risk assessors is critical for ecological risk management
decisions, for which there are often more diversified views and fewer initial areas of initial
consensus than in human health risk decisions.

       In the attached report, the Committee provides responses to the charge questions posed
by the Agency. These questions covered: a) usefulness of the draft  and its ability to help
decision-makers improve planning of ecological risk assessments; b) whether steps outlined in
setting management objectives are clear, the process is logical, and key concepts are well
defined; c) whether the depth of discussion and level of technical detail is appropriate; d)
flexibility of the guidance; and e) effectiveness of the graphics and tables used in the draft.

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       While the Committee found the document to be generally useful, we provide the
following recommendations for improvement:

       a)    Definition of Focus - In order to be of optimal value to decision-makers, the focus
             of the document needs better definition. While we understand that the guidance is
             intended to address the planning process prior to an ecological risk assessment,
             the document also alludes to the broader issue of setting risk management
             objectives for environmental decision-making. While it may not be inappropriate
             for this planning document to do both tasks, the focus and purpose of the
             guidance should be made clearer throughout the text.

       b)    Presentation - Although the general procedure that is outlined appears
             fundamentally sound, the description of each step and the relationships among the
             steps should be presented more clearly and succinctly. The attached report
             provides several specific examples and suggests potential remedies.

       c)    Distinguish Planning from Problem Formulation - We recommend clarification of
             the distinction between "planning" in preparation for the risk assessment (which
             involves a wide range of participants in addition to the risk manager) and
             "problem formulation" within the  risk assessment itself (which involves the risk
             assessor in consultation with the risk manager). The current Guidelines for
             Ecological Risk Assessment (US EPA, 1998) envision risk assessment as
             primarily a science-directed process that provides objective information to the
             risk manager and other participants and, therefore,  distinguish "planning" steps
             from "problem formulation" steps. The draft guidance muddles this distinction
             without providing a well-defined alternative.

       d)    Substantive Definitions of "What to Protect" - We  recommend that the Agency
             either delete or substantially redraft the section that provides advice regarding the
             types of ecological attributes that the objectives should consider. Several portions
             of this section lacked a recognizable scientific foundation. As a result, the list of
             relevant ecological "objects" omits important ecosystem components. We are
             concerned that this section, if left unchanged,  will impede rather than enhance
             sound, long-term  ecological risk management. For the Agency's convenience, the
             Committee has provided two detailed examples showing how this section might
             be redrafted to effectively accomplish its intended purpose.

       e)    Validation with Current Practices  - We recommend that experienced risk
             managers in each of the Program offices lend their expertise and perspective to
             ensure the document reflects their principles and experience in developing
             management objectives. The Agency could retrospectively review past decision
             processes to assess how these may have benefitted from the guidance offered in
             this document. The document should also be systematically revised to make it
             more consistent with previous guidance from the documents on the "ecological
             risk assessment bookshelf (and to the extent possible, other key advancements in
             risk management  in the Federal government.)

       f)     Scope - We recommend that the Agency identify whether and how future
             guidance in ecological risk management will be developed.  Importantly, this
             topic includes the considerations and criteria which the Agency  employs in the
             crucial decision-making process, and the means for communicating the risks and
             management decision to interested parties.

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       In light of these needs and the Committee's strong support for this initiative, we would
appreciate the opportunity to again review this Guidance once our recommendations have been
addressed.

       We appreciate the opportunity to review and provide advice on the Agency's draft
document Planning for Ecological Risk Assessment: Developing Management Objectives, and
we look forward to your response.
                                 Sincerely,
                                       /Signed/

                                 Dr. William H. Glaze, Chair
                                 EPA Science Advisory Board
                                       /Signed/

                                 Dr. Terry Young, Chair
                                 Ecological Processes and Effects Committee
                                 EPA Science Advisory Board
                                       /Signed/

                                 Dr. Charles Pittinger, Chair
                                 Ecological Risk Assessment Panel
                                 Ecological Processes and Effects Committee
                                 EPA Science Advisory Board

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                                      NOTICE
       This report has been written as part of the activities of the EPA Science Advisory Board,
a public advisory group providing extramural scientific information and advice to the
Administrator and other officials of the Environmental Protection Agency. The Board is
structured to provide balanced, expert assessment of scientific matters related to problems facing
the Agency. This report has not been reviewed for approval by the Agency and, hence, the
contents of this report do not necessarily represent the views and policies of the Environmental
Protection Agency, nor of other agencies in the Executive Branch of the Federal government, nor
does mention of trade names or commercial products constitute a recommendation for use.
Distribution and Availability: This EPA Science Advisory Board report is provided to the EPA
Administrator, senior Agency management, appropriate program staff, interested members of the
public, and is posted on the SAB website (www.epa.gov/sab). Information on its availability is
also provided in the SAB's monthly newsletter (Happenings at the Science Advisory Board).
Additional copies and further information are available from the SAB Staff [US EPA Science
Advisory Board (1400A), 1200 Pennsylvania Avenue, NW, Washington, DC 20460-0001; 202-
564-4533].

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                                     ABSTRACT
       The Ecological Processes and Effects Committee (EPEC) of the EPA Science Advisory
Board reviewed the Agency's draft: Planning for Ecological Risk Assessment: Developing
Management Objectives (EPA/630/R-01/001 A, June 2001). This draft guidance document is
designed to help decision-makers work with risk assessors, stakeholders, and other analysts to
plan ecological risk assessments that will effectively inform the decisions they make.

       The Committee was asked to responded to the following charge questions: a) usefulness
of the draft and its ability to help decision-makers improve planning of ecological risk
assessments; b) whether steps outlined in setting management objectives are clear, the process is
logical, and key concepts are well defined; c) whether the depth of discussion and level of
technical detail is appropriate; d) flexibility of the guidance; and e)  effectiveness of the graphics
and tables used in the draft.

       While the Committee found the document to be generally useful, it provided the
following recommendations for improvement: a) In order to be of optimal value to decision-
makers, the focus of the  document needs better  definition; b) Although the general procedure
that is outlined appears fundamentally  sound, the description of each step and the relationships
among the steps should be presented more clearly and succinctly; c) The distinction between
"planning" in preparation for the risk assessment (which involves a wide range of participants in
addition to the risk manager) and "problem formulation" within the risk assessment itself (which
involves the risk assessor in consultation with the risk manager) should be clarified; d) The
Agency should either delete or substantially redraft the  section that  provides advice regarding the
types of ecological attributes that the objectives should  consider; e) The authors should request
that experienced risk managers in each of the Program offices lend their expertise and
perspective to ensure the document reflects their principles and experience in developing
management objectives;  and f) The Agency should identify whether and how future guidance in
ecological risk management will be developed.

       In light of these needs and the Committee's strong support for this initiative, the
Committee asked to review the revised document.

Keywords:    Ecological risk assessment; ecological risk management; management objectives
                                            11

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                    U.S. Environmental Protection Agency
                         EPA Science Advisory Board
                  Ecological Processes and Effects Committee
                    Panel on Ecological Risk Management

EPEC CHAIR
Dr. Terry F. Young, Environmental Defense, Oakland, CA
            Also Member: Executive Committee

PANEL CHAIR
Dr. Charles A. Pittinger, Procter and Gamble, Cincinnati, OH

EPEC/SAB MEMBERS
Dr. Steven Bartell, Cadmus Group, Oak Ridge, TN

Dr. Gregory R. Biddinger, ExxonMobil Refining and Supply, Fairfax, VA

Dr. Virginia Dale, Oak Ridge National Laboratory, Oak Ridge, TN

Dr. Ivan J. Fernandez, University of Maine, Orono, ME

Dr. Cynthia Gilmour, The Academy of Natural Sciences/Estuarine Research Center, St.
      Leonard, MD

Dr. Lawrence L. Master, Association for Biodiversity Information, Boston, MA

Dr. William Smith, Yale University (emeritus), Moultonborough, NH
            Also Member: Executive Committee

Dr. Frieda B. Taub, University of Washington, Seattle, WA

SAB MEMBERS
Dr. Granger Morgan, Carnegie Mellon University, Pittsburgh, PA
            Also Member: Executive Committee

SCIENCE ADVISORY BOARD STAFF
Ms. Stephanie Sanzone, Designated Federal Officer, US EPA Science Advisory Board,
      Washington, DC

Mr. Robert Flaak, Designated Federal Officer, US EPA Science Advisory Board, Washington,
      DC

Ms. Mary Winston, Management Assistant, US EPA Science Advisory Board, Washington, DC
                                       in

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                             TABLE OF CONTENTS
1.  EXECUTIVE SUMMARY 	1

2.  INTRODUCTION  	3
       2.1    Background 	3
       2.2    Charge to the Committee	3

3.  RESPONSE TO THE CHARGE  	5
       3.1    The primary audience for the guidance is EPA risk managers, but
             [the guidance] also should be useful to managers and decision-makers
             outside the Agency. Overall, does the SAB think this guidance may be
             useful and help decision-makers improve the planning of ecological risk
             assessments? What additional principles should be included or excluded
             in the document?  	5
             3.1.1  Utility in Planning Ecological Risk Assessments 	5
             3.1.2  Additional Principles	6
       3.2    Are the steps in setting management objectives clear and is the overall
             process logical? Are the key concepts well defined?	7
             3.2.1  General Recommendations  	7
             3.2.2  Recommendations for Components	8
       3.3    Is the depth of discussion and level of technical detail appropriate? If not,
             how would  SAB change it?	9
       3.4    Discuss the flexibility afforded by the guidance and its applicability to
             different situations (e.g., site-specific, national level, etc.)	11
       3.5    Comment on the effectiveness of the examples, figures, tables and text
             boxes 	12
             3.5.1  Examples  	12
             3.5.2  Figures	12
             3.5.3  Text Boxes	13
             3.5.4  Tables	13
       3.6    Other Issues	13

REFERENCES CITED  	R - 1
                                          IV

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                           1. EXECUTIVE SUMMARY
       There is no question that sound, consistent principles and guidance in ecological risk
management will be useful for decision-makers within and beyond the Agency, including other
federal and state agencies and the private sector.  Principles for sound ecological management
would be a valuable complement to the Guidelines for Ecological Risk Assessment in order to
demonstrate the respective roles of risk managers and risk assessors.  It is also timely to
summarize the Agency's emphasis on building broad stakeholder networks, integrating public
values, and balancing diverse and, sometimes, conflicting values. This dialogue among risk
managers, risk assessors, and the public is particularly critical for ecological risk management
decisions, for which there is often a more diverse range of views and less consensus than in
human health risk assessments.

       The draft guidance, however, needs additional input and development to ensure it can
support the breadth of Agency needs and concerns related to ecological risk management. It is
not clear that the process and principles outlined  represent a consensus among program office
risk managers or have been validated by systematic application of the process.  In addition,
confirmation is needed that the document is consistent with other Agency guidance documents
on risk assessment and management.

       In the attached report, the Committee has provided responses to the charge questions
posed by the Agency. These questions covered: a) usefulness of the draft and its ability to help
decision-makers improve the planning of ecological risk assessments; b) whether steps outlined
in setting management objectives are clear, the process is logical, and key concepts are well
defined; c) whether the depth of discussion and level of technical detail is appropriate; d)
flexibility of the guidance; and e) the effectiveness of graphics and tables used in the draft.

       While the Committee found the document to be generally useful, we provide the
following recommendations for improvement:

       a)      Definition of Focus - In order to be of optimal value to decision-makers, the focus
              of the document needs better definition.  While we understand that the guidance is
              intended to address the planning process prior to an ecological risk assessment,
              the document also alludes to the broader issue of setting risk management
              objectives for environmental decision-making. While it may not be inappropriate
              for this planning document to do both tasks, the focus and purpose of the
              guidance should be made clearer throughout the  text.

       b)     Presentation - Although the general procedure that is outlined appears
              fundamentally sound, the description of each step and the relationships among the
              steps should be presented more clearly and succinctly.  The attached report
              provides several specific examples and  suggests  potential remedies.

       c)      Distinguish Planning from Problem Formulation - We recommend clarification of
              the distinction between "planning" in preparation for the risk assessment (which
              involves a wide range of participants in addition to the risk manager) and
              "problem formulation" within the risk assessment itself (which involves the risk
              assessor in consultation with the risk manager).  The current Guidelines for
              Ecological Risk Assessment (US EPA,  1998) envision risk assessment as
              primarily a science-directed  process that provides objective information to the

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             risk manager and other participants and, therefore, distinguish "planning" steps
             from "problem formulation" steps.  The draft guidance muddles this distinction
             without providing a well-defined alternative.

       d)     Substantive Definitions of "What to Protect" - We recommend that the Agency
             either delete or substantially redraft the section that provides advice regarding the
             types of ecological attributes that the objectives should consider.  The Committee
             found this section to be inconsistent with ecological principles and a potential
             detriment to sound, long-term ecological risk management.  For the Agency's
             convenience, the Committee has provided two detailed examples  showing how
             this section might be redrafted to effectively accomplish its intended purpose.

       e)     Validation with Current Practices - We recommend that experienced risk
             managers in each of the Program offices lend their expertise and perspective to
             ensure the document reflects their principles and experience in developing
             management objectives. The Agency could retrospectively review past decision
             processes to assess how these may have benefitted from the guidance offered in
             this document. The document should also be systematically revised to make it
             more consistent with previous guidance from the documents on the "ecological
             risk assessment bookshelf  (and to the extent possible, other key advancements in
             risk management in the Federal government.)

       f)     Scope - We recommend that the Agency identify whether and how future
             guidance in ecological  risk management will be developed.  Importantly, this
             topic includes the considerations and criteria which the Agency employs in the
             crucial decision-making process, and the means for communicating the risks and
             management decision to interested parties.

       There was general consensus among the EPEC members that the current  planning
guidance is too general to help decision-makers significantly improve planning of ecological risk
assessment.  The Committee, therefore, suggests that the Agency consider revising the draft
guidance prior to its release.

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                               2. INTRODUCTION
2.1    Background
       For many years, the US Environmental Protection Agency has been assessing risks
associated with environmental stressors and adverse effects to human health. The risk
assessment guidelines resulting from these efforts have provided general procedures for
assessing these risks in a systematic and consistent manner. To ensure the scientific adequacy of
these guidelines, most have been subjected to rigorous peer review by the EPA Science Advisory
Board (SAB).

       The SAB's Ecological Processes and Effects Committee (EPEC) has had a long and
fruitful interaction with EPA on the Agency's development of its ecological risk assessment
guidelines. In September 1996, the Committee favorably reviewed (EPA Science Advisory
Board, 1997a) EPA's draft Ecological Risk Assessment Guidelines (US EPA, 1996), a document
designed to provide structure and discipline to the assessment of ecological risks. In July 1997,
in its report on the need to develop Ecological Risk Management Guidelines (EPA Science
Advisory Board,  1997b), the EPEC encouraged the Agency to develop additional guidance on
planning for and communicating results of risk assessments. In July 1998, the Committee
consulted with the Risk Assessment Forum on proposed projects to complement and extend the
guidance contained in the final Guidelines for Ecological Risk Assessment (US EPA, 1998).
Now, the Agency has asked that the Committee peer review the Agency's external review draft:
Planning for Ecological Risk Assessment: Developing Management Objectives (EPA/630/R-
01/001A, June 2001) (EPA, 2001a) that was prepared by the Agency's Risk Assessment Forum.
The stated purpose of this draft guidance document is to help decision-makers work with risk
assessors,  stakeholders, and other analysts to plan ecological risk assessments that will
effectively inform the decisions they make.

       To perform this review, the Ecological Processes and Effects Committee formed the
EPEC Panel on Ecological Risk Management (hereafter the Committee or EPEC). This EPEC
Review Panel consisted of Members of EPEC plus an additional Member of the Executive
Committee of the SAB.

2.2    Charge to the Committee

The following questions and requests were posed to EPEC for this review.

       a)     The primary audience for the  guidance is EPA risk managers, but the guidance
             also should be useful to managers and decisionmakers outside the Agency.
             Overall, does the SAB think this guidance may be useful and help decision-
             makers improve the planning of ecological risk assessments? What additional
             principles should be included or excluded in the document?

       b)     Are the steps in setting management objectives clear and is the overall process
             logical? Are the key concepts well defined?

       c)     Is the depth of discussion and level of technical  detail appropriate? If not, how
             would SAB change it?

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d)     Discuss the flexibility afforded by the guidance and its applicability to different
       situations (e.g., site-specific, national level, etc.)

e)     Comment on the effectiveness of the examples, figures, tables and text boxes

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                        3.  RESPONSE TO THE CHARGE
       There is no question that sound, consistent principles and guidance for conducting
ecological risk management will be useful for decision-makers, both within the Agency and in
other federal and state agencies and the private sector. Principles for sound ecological
management would be a valuable complement to the Guidelines for Ecological Risk Assessment
(US EPA, 1998), which continue to provide valuable structure and discipline for the assessment
of ecological risks. The Committee applauds the Agency for generating this draft guidance on
one primary component of ecological risk management - developing objectives that summarize
the community's desires regarding the outcome of the risk management decision.

3.1     The primary audience for the guidance is EPA risk managers, but [the guidance]
       also should be useful to managers and decision-makers outside the Agency. Overall,
       does the SAB think this guidance may be useful and help decision-makers improve
       the planning of ecological risk assessments? What additional principles should be
       included or excluded in the document?

       3.1.1   Utility in Planning Ecological Risk Assessments

       There was general consensus among the EPEC members that the current planning
guidance is too general to help decision-makers significantly improve planning of ecological risk
assessment. The Committee, therefore, suggests that the Agency consider revising the draft
guidance prior to its release. Specific suggestions for making the draft guidance more focused
and improving its practical utility are provided below and in answer to other charge questions.

       a)      Definition of Focus - In order to be of optimal value to decision-makers, the focus
              of the planning guidance needs better definition. Our understanding of this
              document is that it is an extension and expansion of the 1998 Guidelines for
              Ecological Risk Assessment (US EPA, 1998), specifically providing additional
              guidance for the planning process prior to an ecological risk assessment. Setting
              management objectives for environmental decision making, as alluded to in the
              second Charge Question, is a much broader issue. While it may not be
              inappropriate for this planning document to do both tasks, the focus and purpose
              of the guidance should be made clearer throughout the text.

              A useful means to clarify the focus would be for the Risk Assessment Forum to
              define its ultimate vision for additional guidance on ecological risk management.
              Is additional guidance envisioned?  If so, some of the discussion on setting
              management objectives may not be necessary in this document.  If not, then
              additional principles pertaining to how management decisions are made and
              communicated should be considered.

              The title of this document implies a focus on the Planning Dialogue preceding the
              formal ecological risk assessment process. Therefore, one might presume that
              similar guidance will be developed for the two processes following ecological
              risk assessment in the pivotal 1998 ecological risk assessment diagram (US EPA,
              1998): ["Communicating Results to the Risk Manager,"  and "Risk Management
              and Communicating Results to Interested Parties"].  Will supplemental guidance
              be developed that addresses the processes of identifying stakeholders, identifying
              management alternatives, characterizing the decision criteria and process,

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              identifying other information tools that may be required beyond risk assessment,
              etc.?

       b)     Validation with Current Practices - As the Agency is revising the draft guidance,
              we suggest that the authors gather additional input from experienced risk
              managers in each of the Agency's Program Offices in order to test or ground-truth
              the draft guidance. The risk managers could provide insight into the draft's
              utility, as well as its consistency with current best practices and policies of risk
              management.  In addition, the Committee suggests that the guidance be validated
              by applying it retrospectively to ecological risk assessments (preferably regional
              in scope) that the Agency has already produced in order to determine whether
              those assessments would have been significantly improved by application of the
              new guidance. If the answer is yes, then the value of the guidance has been
              validated.

       c)     Consistency with Previous Guidance - Confirmation is  needed that the draft
              document is consistent with other Agency guidance documents on risk assessment
              and management.  In particular, the present guidance needs to be fully consistent
              with the 1998  Guidelines on Ecological Risk Assessment (US EPA,  1998)
              pertaining to problem formulation. In some respects, it is not clear whether and
              how the planning process described in the present document differs from or
              contributes to  problem formulation.

              The draft planning guidance suggests that the fundamental distinction between
              planning and problem formulation advanced in the Guidelines be removed.
              EPEC members were uncomfortable with this  abrupt change. Such a change
              requires justification and the demonstration of consensus among the scientific
              community that is not readily apparent. As we understand it, the rationale behind
              the Guidelines distinction is that the planning process should include input from
              all stakeholders, while the subsequent phases of problem formulation and
              conceptual model development should remain  in the scientific/expert realm.  The
              draft guidance muddles this distinction without providing a well-defined
              alternative.

              The planning document could be further strengthened by explicitly describing
              how it feeds into the process of problem formulation, exposure analysis, effects
              assessment, and  risk characterization.  Specifically, both the Executive Summary
              and the introduction should state that the document is meant as guidance for
              planning prior to ecological risk assessment, as a supplement to the 1998
              Guidelines (US EPA,  1998), but that this guidance could be extended to general
              environmental decision-making.

       3.1.2   Additional Principles

       This draft planning guidance framework emphasizes key features of ecological risk
assessment planning that have not been brought out in prior ecological risk assessment
frameworks. These features include the need for a clear formulation of both the problem and the
goals (or objectives) for environmental management, clear identification of the decision context,
and inclusion of risk managers and other affected and interested parties in ecological risk
assessment planning. Regardless of whether this document will be a "stand-alone" document or
be supplemented with  additional guidance, we recommend addressing the following additional
principles:

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       a)      Combining Ecological Risk Assessments with other Studies - In addition to the
              problem formulation feedback loop described above, the planning document
              could describe how ecological risk assessments interact with parallel assessments
              such as socio-economic studies or technological feasibility analyses. The
              planning guidance should clearly distinguish those aspects of planning that
              incorporate scientific expertise versus those that rely more on social and
              economic considerations. In this vein, Figure 4 is effective in presenting the
              multiple considerations involved in a management decision, but the text is
              inadequate. This discussion will certainly benefit from the completion of several
              documents evidently underway (e.g., "A Framework for the Economic
              Assessment of Ecological Benefits", cited as USEPA (200 Ib); "Improving
              Science-Based Environmental Stakeholder Processes, cited as USEPA (200la)).
              [Note: cited as US EPA (2001) and EPA Science Advisory Board (2001),
              respectively,  in the References Cited section of this report]. Perhaps these
              documents would be key supplements to the "bookshelf of guidance documents
              originally envisioned.

       b)      Integrating Other Assessment Tools - The draft planning guidance should include
              references to other information tools such as ecological assessment (e.g.,
              monitoring),  and eco-epidemiological techniques that emphasize  dose-response
              information.  The document describes hierarchies of objectives, but other decision
              tools might contribute usefully to the ecological risk assessment process (e.g.,
              contributing factors diagrams, influence diagrams, operation decision models).

       c)      Striking the Balance - Pivotal to a sound management decision is finding an
              acceptable and defensible balance among conflicting values and priorities. How
              the risk manager and/or decision maker identifies and weighs scientific, social,
              economic, and, sometimes political criteria may be the most valuable guidance
              that this or other documents must address.  This topic may warrant separate
              guidance in itself.

3.2    Are the steps in setting management objectives clear and is the overall process
       logical? Are the key concepts well defined?

       The planning process as presented in Figure 2 (US EPA, 200la) includes three main
components: a) identifying the  decision context; b) developing objectives; and c) identifying
information needs. Each topic  contains a series of sub-components, which collectively identify
the major considerations for planning virtually any type of risk assessment.  As described in our
response to the first Charge  Question, however, steps for setting management objectives for
environmental decision making or ecosystem management are fundamentally different from
those for planning a risk assessment. The decision of which is being addressed by the report will
determine the validity of the logic. In any case, the steps require expansion and  clarification.
For example, it is not clear that the process is flexible and iterative, (i.e., that any of the three
steps can come first or can proceed concurrently with the other steps).

       3.2.1   General Recommendations

       a)      Roles of Risk Assessors and Managers - In many areas the document supports
              close interaction between risk managers and risk assessors; yet it  remains
              tentative in describing where and how interactions should occur to maximize
              cross-functional collaboration. In particular, the respective roles  and
              responsibilities of risk managers and risk assessors across the boundary of

                                           7

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       "planning" and "problem formulation" need to be explicitly presented. For
       example, does the process of identifying information needs (Figure 6) belong in
       planning or in problem formulation? Is it the responsibility of the managers or
       the assessors to decide?

b)     Feedback Mechanism - We suggest that the Agency consider a feedback
       mechanism between the problem formulation step of a risk assessment and the
       steps of developing risk management objectives. Risk assessors should have the
       opportunity to provide decision-makers with information relevant to defining the
       management objectives, as well as to identify other risks relevant to specific
       ecosystem management and decision issues. In addition, a more direct
       presentation is needed of the process for developing Risk Management Objectives
       and associated roles and responsibilities of risk managers and assessors.

3.2.2   Recommendations for Components

a)     Identify Decision Context

       1)      If the Presidential Commission on Risk Assessment and Risk Management
              (1997) formed the basis for this discussion, it would be valuable to
              explicitly reference this source.  Perhaps a relevant figure from the
              Commission's Report could be substituted for Figure 3, which does  not
              seem to capture all aspects that are subsequently discussed in this section.
              There also appear to be other ecological risk management documents in
              press or under development that should be incorporated.

       2)      The sub-sections of Section 2 do not seem of equal stature. For example,
              "Legal, Regulatory and Institutional Context" (Section 2.2.2) and
              "Geographic and Temporal Context" (Section 2.2.4) are titled differently
              than "Risk Management Options" (Section 2.2.3) and "Public Values"
              (Section 2.2.1). Public values might be described as the "social context."
              The process of identifying and engaging stakeholders needs to either be
              expanded or addressed separately in a whole other work (e.g., EPA
              Science Advisory Board, 2001).

       3)      It seems that "Risk Management Options" could be elevated as its own
              component,  as it is in the Presidential Commission on Risk Assessment
              and Risk Management (1997) and the SET AC Workshop Proceedings on
              Ecological Risk Management (SETAC, 1999).

       4)      Certain other "contexts" appear missing, such as the economic context, the
              ecological context (e.g., which communities and ecosystems are
              threatened, and through which media), and the human health context.
              These contexts are represented in Figure 4 but are not discussed.

b)     Develop Objectives -  See EPEC's response to the Charge Question below
       pertaining to the critical question of "what to protect".

c)     Identify Information Needs

       1)      See 3.1.1(c) for discussion of whether this component fits under
              "planning" or "problem formulation".

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              2)      Section 4.2 needs to be rethought and revised accordingly. The title,
                     "What do we need to know to decide what to do?" is cumbersome and the
                     logic is weak. Impacts of "decision alternatives" upon management
                     objectives seems to be circular reasoning.  Does this topic refer to
                     management options?  Questions such as: "If we leave this Superfund site
                     as is (or register this pesticide), how will that affect our objectives?" imply
                     that the selection of management options or the decision itself could be
                     pre-ordained or influenced by the consequences.  The text doesn't appear
                     to say what the authors likely intended.  Also, consideration of "money
                     available for remediation" seems more related to Section 4.3 ("What do
                     we have to work with?") than "what information may be needed".

              3)      Section 4.3 similarly requires extensive revision. It contains a statement
                     that, even if true in a probabilistic sense, speaks poorly of the Agency and
                     the discipline of risk assessment: "we are never 100% certain about our
                     conclusions or that our decision is in fact the correct one."  Other
                     statements advocate "personal rules of thumb" and "a network of
                     colleagues who can offer advice and perspective" that would be chaotic if
                     not illegal.

3.3    Is the depth of discussion and level of technical detail appropriate? If not, how
       would SAB change it?

       To better identify specific areas the guidance should address, EPA organized three
colloquia for EPA users, other government users, and private-sector users, respectively.
Participants in these colloquia asked for advice such as "criteria for deciding what to protect,
types of ecosystems or ecological values to protect, how to define protection, and how to engage
interested parties (draft report (US EPA, 200la), section 1.1)." EPEC feels that the draft
document, while providing procedural guidance that may be too detailed and redundant in some
respects, gives inadequate guidance on the substantive questions raised by colloquium
participants. In particular, guidance for deciding what types of ecological attributes, ecosystems,
and ecological values to protect is inadequate.  This omission is glaring, particularly given the
fact that protection criteria is the area most needed by non-technical managers. There is a well-
developed literature on ecological condition assessments, classifications, and valuation of natural
resources that could be used for such guidance. In addition, the invited papers by Daily (2000)
and by Noss (2000) to the colloquium for private-sector users provide valuable suggestions.

       The following discussion provides one option for rewriting section 3.2.1 ("Keys to What
to Protect"), as an example. Other equally valid options certainly exist. We suggest, for
example, replacing the first key with the option presented in Figure 1.

       Gretchen Daily's (Daily, 2000) classification (Table 3.1) provides one good method for
categorizing "Ecosystem Services" and could be used as the second key. One of the attractive
attributes of Table 3.1 is that it highlights many ecosystem services, such as pollination,
attenuation of floods, and self-sustaining option values that are often overlooked by both
managers and the public. The Table, therefore, provides a useful tool for eliciting preferences
and subsequently defining objectives for ecosystem management. It would be helpful to add an
annotated bibliography for each of the listed ecosystem service categories as an appendix to  the
guidance document for those readers who want additional  detail regarding the definition or value
to society of a particular category of ecosystem service.

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                                 Ecosystem
                               Characteristics
               Ecosystem
                 Services
 Ecological
   Integrity
or Condition
              Figure 1 - Suggested  Option for the "First Key"
       Several options are available for the "Ecological Integrity or Condition" key, but we
recommend that the key be based on fundamental ecological principles and that it systematically
characterize the attributes required to sustain ecological systems. One method of accomplishing
this task was outlined in the invited article by Noss (2000), as follows:

       "...biodiversity and ecological integrity can be decomposed into structural, functional,
       and compositional components, and measurable indicators can be selected that
       correspond to these components (Noss, 1990; Noss et al.,1999).  A comprehensive index
       or collection of metrics should include measures of structure, function, and composition
       at several levels of biological organization (e.g., ecosystem, community, species) and be
       measurable at a variety of spatial and temporal scales."

Noss (1990), in particular, presents a graphic (Figure 1) that could be converted into a table, then
expanded upon with examples in order to provide a key.

       Similarly, the Ecological Processes and Effects Committee (EPEC) will shortly release a
white paper (EPA Science Advisory Board, 2002 - under development) that provides a similar
hierarchical checklist of ecological attributes that should be addressed in order to assess the
condition of an ecosystem, with  sample indicators for each attribute.  The attributes are derived
from categories that represent ecological patterns and processes, and systematically incorporate
structural, functional, and compositional elements at each hierarchical level of ecological
organization.  The EPEC checklist includes each of the elements of the Noss (1990) graphic (and
vice versa), but may promote greater emphasis on attributes that are commonly unrecognized,
such as landscape structure. Either of these examples could be used as a key to guide the
discussion regarding suitable objectives for ecosystem management and analysis of risks to the
system.

       The items that were listed in the keys in section 3.2.1 of the EPA Draft are embedded in
both the Noss (1990) and the EPEC (EPA Science Advisory Board, 2002 - under development)
checklists. For example, "special places" relate to landscape patterns and composition, and can
be highlighted accordingly. The  invited article by Noss (2000) provides a solid proposal for
                                         10

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identifying ecosystems warranting special protection.  In sum, the Committee recommends that
section 3.2.1 be omitted or substantially redrafted so that it systematically presents the complete
array of important ecosystem characteristics.

3.4    Discuss the flexibility afforded by the guidance and its applicability to different
       situations (e.g., site-specific, national level, etc.)

       Among reasons the planning guidance is so general and may be of limited utility to
"front-line" risk managers is that it attempts to generically address virtually all types and scales
of ecological risk assessment.  This undertaking is indeed enormous. It begs the question of how
much practical advice a risk manager in the Office of Pollution, Pesticides and Toxics
Substances or the Office of Solid Waste and Emergency Response,  for example, could give to a
manager in the Office of Water dealing with very different issues?  The compromise to
maximizing the guidance's flexibility is lessening its specificity and practical applicability.  Only
the most fundamental and generic principles can be presented in a document that spans the
breadth of ecological risk assessment and management.

       One way to provide more specific guidance might be to categorize types of risk
assessments and management decisions.  This breakdown could be  approached in a number of
ways (recognizing that each could be a thesis in itself, likely requiring resources beyond the Risk
Assessment Forum).  For example, risk assessments and management decisions regarding, for
example, a new commercial chemical, a Superfund site, a municipal discharge or a proposed
land development project certainly involve different sets of  stakeholders, legal and economic
criteria, and scales of authority.  Consideration should be given to how these issues might require
different planning processes, as well as the commonalities they share.

       Site-based risk assessments and management decisions affecting large geographic areas
are more complex and involve a greater variety of natural and anthropogenic stressors than those
affecting smaller areas. The geographic scale and the number of stressors influence the
management objectives at the onset, the precision of the data during the assessment, the degree
of specificity in the interpretation of the results, and the authority and cost required to implement
a management decision.  Risk assessments on a large geographic scale would seem to support
broader, longer-term, and yet less specific management decisions than localized assessments, for
which more immediate and targeted solutions may be possible.

       To the authors' credit, this  concept of scale was recognized  in Section 2.1, in
distinguishing among "unique and wide-impact decisions," "repeated wide-impact decisions,"
and "routine and narrow-impact decisions." EPEC concurs  with the logic but feels these
concepts deserve better definition and expanded discussion. It is not stated, for example, why
routine and narrow-impact decisions "are more amenable to standardization."  Perhaps
expansion of the references would help, particularly the "somewhat standardized routines" (for
decision-making) that are cited by the National Research Council (1996).

       Finally, the types of chemicals (e.g., metals, nutrients, polar organics, pesticides, etc.)
and their physical-chemical properties (e.g., persistence, bioaccumulation potential,  toxicity,
bioavailability) logically influence the design of the conceptual model in problem formulation.
This approach has implications in planning and may deserve special consideration in providing
practical advice in forming management objectives. This concern again argues for greater
involvement in the development and validation of this guidance document by risk managers
across the Agency's Program Offices.
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3.5    Comment on the effectiveness of the examples, figures, tables and text boxes.

       3.5.1  Examples

       The use of a series of examples is valuable for demonstrating the implementation and
potential efficacy of this planning document. Examples can illustrate where the implementation
of this process is successful or demonstrate how a better outcome would result through the
implementation of this process. For example, the Salton Sea example (Appendix A-l of the draft
document) did a good job of demonstrating the problems that can result from conflicting
objectives.  However, the selected examples should focus on demonstrating the elements of the
guidance document.  The use of examples should demonstrate how things could be done better if
planning as prescribed is carried out. The Committee thought one approach that could be
instructive would be to send the draft document to those who provided the Case Examples given
in Appendix A of the draft  document and ask for feedback (i.e., had they followed the
procedures outlined in this  document, would the objectives turn out differently or would the
process have been more efficient?).

       3.5.2  Figures

       Figures offer a compelling and succinct way to provide information about the structure
and context of the document.  It could be instructive to include a  figure at the beginning  of the
document showing the constellation of activities within EPA involved with ecological risk
assessment and highlighting how this initiative of the Risk Assessment Forum relates to  other
units of the Agency.  For example, Figure 4 could be moved to the front of the document, as it
illustrates the parallel processes ongoing with ecological risk assessment and the cross-linking of
the planning process across all of these initiatives. Figure 1 might follow to demonstrate how
the focus of this document  was an elucidation of one element of Figure 4. Figure 2 is excellent
in that it allows the reader to track the evolution of the discussion.

       Figures 3, 5 and 6 should be reevaluated, as it is not clear how they relate to the larger
diagram. There is no numbering of the elements of the figure to coincide with the text. In
addition, the Committee felt the questions posed were overly simplistic and somewhat
redundant.  They could be rewritten as clear statements of what was to be accomplished  in each
step (see our discussion in  section 2.2.1 of this report).

       Figures dealing with the Keys do not have a graphic context to demonstrate how  they fit
into the larger scope of the  document.  It is not clear what "keys" are, and why they are not
included as part of the figure series of the overall document. In addition, they are not easily
linked to the critical unifying figures of the document, namely figures 1,  2 and 4.  Where would
the "keys" fit into or be utilized in Figure 2?

       Since the figures are critical in providing the framework for the document and the
document describes a process, showing how these are components are related is important to the
document. Figures could also be developed to clarify how Problem Formulation and the
Planning Process are  carried out and how these processes map to one another. In a number of
instances (e.g., Figures 1 and 4), there may be the opportunity to  emphasize the iterative nature
of the process.

       In both the figures and text, the process described appears linear, rather than emphasizing
the multiple opportunities for feedbacks.  Correct this misconception with additional emphasis in
the text and by modifications of figures (e.g., arrows showing these feedback opportunities, such
                                           12

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as between Problem Formulation and Risk Characterization in Figure 1, and across parallel
activities in Figure 4).

       To help managers use this guidance, the document should have a summary text box or
figure that outlines the new and expanded features in this guidance relative to the 1998
ecological risk assessment guidance.

       3.5.3   Text Boxes

       The Committee felt that information in the text boxes was valuable, and often was
developed in a clear and succinct manner that should be the model for revisions to the text.
Indeed, rather than text boxes being used as elaborations of some point in the text, this document
appeared to succinctly organize and summarize information in the text boxes and to detail  at
great length the concepts in the text itself.  If the document is to be tightened up by making it
shorter and more structured, then perhaps text boxes should take on a different role and should
be used for a few key elaborations.

       3.5.4   Tables

       Tables were  effectively used to summarize information in a succinct and organized
manner in several instances in the document.  It may be possible to make greater use of tabular
information in a revision that is shorter in text but not in content. One table of critical
importance that could be developed would identify how this document fits into a bookshelf of
current and planned documents from EPA on ecological risk assessment.  Are other documents
planned for communicating the results of an ecological risk assessment to Risk Managers?
Interested Parties? Is there an overall plan for how many documents will exist in this ecological
risk assessment bookshelf, how they are integrated in  content and in time, and perhaps even how
the process of their development and revision is expected to take place?  On a more trivial note,
an additional table in the back that could complement the glossary is a table of acronyms used in
the document and their definitions.

3.6     Other Issues

       The language used to describe the sub-components of the process is too colloquial and,
therefore, imprecise.

       In several respects, the current Guidance does  not appear to be consistent with that
provided for Planning in the Ecological Risk Assessment Guidelines from 1998 (US EPA, 1998).
Some definitions differ, e.g., ecological risk assessment and the definition of management goal
in Table 1-1 on page 15 of the planning document differs from that given in Text Box 2-7 of the
1998 Guidelines.  These discrepancies should be resolved or the new definition of these terms
and reasoning behind any changes made clear.

       A title change to reflect that the document is primarily meant as guidance for a planning
process prior to ecological risk assessment (as a supplement to the 1998 Guidelines) might be
considered. Use of a version of Figure 4 in the introduction would be one way to illustrate that
the type of planning discussed in this guidance could lead to a formal ecological risk assessment,
and/or other analyses, leading up to risk-management decisions.
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                             REFERENCES CITED
Daily, G.C. 2000. Management Objectives for the Protection of Ecosystems Services.
      Environmental Science and Policy 3(6):333-340.

EPA Science Advisory Board. 1997a. An SAB Report: Review of the Agency's Draft
      Ecological Risk Assessment Guidelines. US EPA Science Advisory Board, Washington,
      DC. EPA-SAB-EPEC-97-002, January 21, 1997.

EPA Science Advisory Board. 1997b. Advisory on the Need to Develop Ecological Risk
      Management Guidelines. US EPA Science Advisory Board, Washington, DC. EPA-SAB-
      EPEC-ADV-97-002, September 30, 1997.

EPA Science Advisory Board. 2001. Improved Science-Based Environmental Stakeholder
      Processes: An SAB Commentary. US EPA Science Advisory Board, Washington, DC.
      EPA-SAB-EC-COM-01-006, August 22, 2001.

EPA Science Advisory Board. 2002 (undergoing final development).  A Framework for
      Reporting on Ecological Condition: An SAB Report.  US EPA Science Advisory Board,
      Washington, DC. EPA-SAB-EPEC-02-OOX.

National Research Council.  1996.  Understanding Risk: Informing Decisions in a Democratic
      Society, Committee on Risk Characterization,  Commission on Behavioral and Social
      Sciences and Education, Washington, DC, National Academy Press.

Noss, R.F. 1990. Indicators for monitoring biodiversity: A hierarchical approach. Conservation
      Biology  4:355-364.

Noss, R.F., N.C. Slosser, J.R. Strittholt, and C. Carroll. 1999. Metrics of ecological integrity for
      terrestrial ecosystems and entire landscapes. U.S. Environmental Protection Agency,
      Washington, DC.

Noss, R.F. 2000. High-Risk Ecosystems as Foci for Considering Biodiversity and Ecological
      Integrity in Ecological Risk Assessments. Environmental Science and Policy 3(6):321-
      332.

Presidential Commission on Risk Assessment and Risk Management.  1997. Framework for
      Environmental Health Risk Management. Washington, DC

SETAC.  1999.  A Multi-Stakeholder Framework for Ecological Risk Management: Summary of
      a SETAC Technical Workshop. C.A. Pittinger (ed.), Society of Environmental
      Toxicology and Chemistry (SETAC). SETAC Press, Pensacola, FL.

US EPA. 1996. Proposed Ecological Risk Assessment Guidelines. US Environmental
      Protection Agency, Office of Research and Development, Washington, DC. EPA/630/R-
      95/002B, August 1996.

US EPA. 1998. Guidelines for Ecological Risk Assessment. US Environmental Protection
      Agency, Office of Research and Development, Washington, DC. EPA/630/R-95/002F.
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US EPA. 200la. Planning for Ecological Risk Assessment: Developing Management
      Objectives. US Environmental Protection Agency, Office of Research and Development,
      Washington, DC. EPA/630/R-01/001 A, June 2001, External Review Draft.

US EPA. 200Ib (under development). A Framework for the Economic Assessment of
      Ecological Benefits. US Environmental Protection Agency, Office of Research and
      Development, Washington, DC.  [Document under development].
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