September 30, 1997
EPA-SAB-EPEC-ADV-97-002
Honorable Carol M. Browner
Administrator
U.S. Environmental Protection Agency
401 M. Street, SW
Washington, DC 20460
Subject: Advisory on the Need to Develop Ecological Risk Management
Guidelines
Dear Ms. Browner:
The Ecological Processes and Effects Committee (EPEC) of the Science
Advisory Board met on July 22, 1997 in part to discuss with Agency staff approaches
and key issues for future Agency guidelines on ecological risk management.
Background materials provided to the Committee included the Agency document
entitled Priorities for Ecological Protection: An Initial List and Discussion Document for
EPA (hereafter referred to as the discussion document), prepared under the leadership
of the Office of Research and Development's National Center for Environmental
Assessment. In addition, the Committee received an oral briefing from Agency staff at
the July meeting on preliminary efforts within the Agency to define the format and
scope of possible ecological risk management guidelines. The Committee's advice on
how to move forward in developing ecological risk management guidance for the
Agency, contained in this SAB Advisory, was requested by Acting Assistant
Administrator for Research and Development Henry Longest.
We appreciate the opportunity to provide comments on the subject of guidance
on ecological risk assessment for risk managers. Based on the briefing provided at the
EPEC meeting, it was apparent that the discussion document resulted from the
initiative of a small group of individuals in different parts of the Agency who saw the
need for such a document and made it happen. We wish to commend them for their
initiative. Clearly, the topic of ecological risk management guidelines is very timely and
deserves additional attention by the Agency. There is growing interest in the academic
and private sector communities in establishing a dialogue on the subject. For example,
the Society of Environmental Toxicology and Chemistry (SETAC) held a Pellston
Workshop in June devoted to the subject of ecological risk management and the
development of guidelines for risk managers. The Committee also noted that the EPA
Office of Research and Development's Ecological Research Strategy, reviewed by the
Committee on July 21, 1997, identified Ecosystem Risk Management as a Core
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Research Area for the Agency. The Committee encourages the Agency to think more
broadly about ecological entities to be protected, to include guidance for risk managers
on the entire risk assessment process. This guidance should include discussion of how
the risk characterization, including quantitative risk measures, can and should be used
in making risk management decisions.
The Committee's response to the specific questions posed in the Charge to the
Committee are provided below.
Charge Question 1: To what extent would the attached document
(Priorities for Ecological Protection: An Initial List and Discussion
Document for EPA) serve as a basis for guidance to risk management
concerning what to protect? To what extent is it a basis for the process of
setting goals during the planning stage of an ecological risk assessment?
What additional endpoints, if any, would you recommend be included?
As a general summary, the discussion document is a good starting point for
laying out first principles for selecting ecological entities to be protected and goals to
be set. The document should help to increase the focus by risk managers on the
Problem Formulation stage of the risk assessment process, which is often mistakenly
slighted. It is during this part of the risk assessment that the entities to be protected
are selected and upon which the remainder of the risk assessment is devoted.
Carefully selecting the entities to be protected with the full support of the stakeholders
is critical to the entire process.
The discussion document provides basic information on the process and criteria
for selecting resources to be protected. The Committee is somewhat concerned,
however, that the list of "eight ecological entities that are of wide spread concern" is too
narrow to cover all ecosystems. The Committee discussed two possible options for
providing guidance on ecological entities that should be considered in risk
management decisions: the first option would be to define a list of entities that would
serve as a minimum set that must be considered, and the second option would be to
provide an expanded, comprehensive list of entities that would subsequently be
narrowed for a particular decision based upon interaction and discussion among risk
managers, risk assessors, and stakeholders. The Committee favors the second
approach as the most likely to ensure that sufficient consideration is given to the
appropriate entities. We suggest, therefore, that Table 4-1 be characterized as
examples of entities to be protected and that it be expanded to include other areas,
such as terrestrial ecosystems and managed ecosystems (crops, forests, etc.). In
addition, a nested hierarchical list of entities and attributes might be developed such
that a risk manager would be led through a series of questions that would ensure that
sufficient thought and depth had gone into the selection process.
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Relative to endpoint selection, the Committee suggests that in the future, as the
list of ecological entities is expanded, the Agency might provide an additional set of
tables with examples of assessment endpoints that could be developed for each entity.
Subsequently, this list of assessment endpoints would serve as the basis for the risk
assessors to select measurement endpoints. In order to avoid overwhelming risk
managers with technical material, the revised discussion document might be thought of
as the "primer," with additional detail provided in supporting documents.
Charge Question 2: From the SAB's viewpoint, to what extent does this
document deal with the most important risk management issues during the
planning and problem formulation stages?
The most critical portion of the Problem Formulation stage of ecological risk
assessment is determining the entity or entities to be protected. The risk manager's
role at this stage is to help ensure that the Conceptual Model and Problem Formulation
are framed in such a way that appropriate data are collected to provide a scientific
basis that helps inform risk management decisions. The discussion document provides
information on entity selection, but falls short of putting that guidance into the context of
problem formulation and conceptual model development. We suggest that future
documents include explicit discussion of how the selected entities are used in the
problem formulation process.
In summary, the Committee compliments the Agency on the preparation of this
initial document on ecological risk management and we urge the Agency to develop
additional guidance for Agency risk managers, not only for the Problem Formulation
stage of the risk assessment, but for the other stages as well. We would welcome the
opportunity to continue this dialogue with the Agency as additional work is conducted
on ecological risk management guidelines, and we look forward to a response to this
letter from Assistant Administrator Longest.
Sincerely,
/signed/
Dr. Genevieve M. Matanoski, Chair
Executive Committee
/signed/
Dr. Mark Harwell, Chair
Ecological Processes and
Effects Committee
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NOTICE
This report has been written as a part of the activities of the 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 faced by 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 or other agencies in the
Federal government. Mention of trade names or commercial products does not
constitute a recommendation for use.
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U.S. ENVIRONMENTAL PROTECTION AGENCY
SCIENCE ADVISORY BOARD
ECOLOGICAL PROCESSES AND EFFECTS COMMITTEE
July 21-22. 1997
CHAIR
Dr. Mark A. Harwell, Rosenstiel School of Marine and Atmospheric Science,
University of Miami, Miami, Florida
VICE CHAIR
Dr. Alan W. Maki, Exxon Company, USA, Houston, Texas
MEMBERS
Dr. William Adams, Kennecott Utah Copper Corp, Magna, Utah
Dr. Virginia Dale, Environmental Sciences Division, Oak Ridge National
Laboratory, Oak Ridge, Tennessee
Dr. Carol Johnston, Natural Resources Research Institute, Duluth, Minnesota
Dr. Frederick K. Pfaender, Director, Carolina Federation for Environmental
Programs, University of North Carolina, Chapel Hill, North Carolina
Dr. William H. Smith, Professor of Forest Biology, School of Forestry and
Environmental Studies, Yale University, New Haven, Connecticut
Dr. Terry F. Young, Environmental Defense Fund, Oakland, California
CONSULTANTS
Alison G. Power, Cornell University, Ithaca, New York
Leslie A. Real, Indiana University, Bloomington, Indiana
SCIENCE ADVISORY BOARD STAFF
Ms. Stephanie Sanzone, Designated Federal Official, US EPA, Science Advisory
Board (1400), 401 M Street, SW, Washington, DC 20460
Ms. Wanda R. Fields, Staff Secretary, US EPA, Science Advisory Board (1400),
401 M Street, SW, Washington, DC 20460
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