United State. Sdonca Advwory !; EPA-SAB-EPEC-92-006
Environmental Board (A-101) November 1991
&EPA AN SAB REPORT:
EVALUATION OF ERA'S
ECORISK ASSESSMENT
RESEARCH PROGRAM
PREPARED BY THE ECORISK
RESEARCH SUBCOMMITTEE OF THE
ECOLOGICAL PROCESSES AND
EFFECTS COMMITTEE
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
THE ADMINISTRATOR
EPA-SAB-EPEC-92-006
November 20, 1991
Mr. William Reilly
Administrator
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
SUBJECT: Science Advisory Board Evaluation of EPA*s Ecological Risk
Assessment Research Program
Dear Mr. Reilly;
The EcoRisk Assessment Subcommittee of the Ecological Processes and Effects
Committee of the Science Advisory Board met on 20-22 May 1991 at Callaway Gardens,
Georgia, to review the Agency's Ecological Risk Assessment Research Program. The title of
the Research Plan is misleading, because the program currently functions primarily in
support of the Office of Pesticide Programs and Toxic Substances (OPTS). However, it is
the only research program within EPA that is addressing the complex and essential issues of
ecological risk assessment and it could provide useful insights for planning broader and more
general plan for the Agency as whole. The objectives of the review were to examine QRD's
five-year plan for EcoRisk research for: the consistent use of sound scientific methods; the
effectiveness of project integration; the mix of oil-site versus university research; the
contribution to EPA and other agency ecological risk assessment needs; consistency with
developments in the ecological risk assessment paradigm; optimal allocation of resources in
light of priorities; and its adequacy for addressing extrapolation issues.
The Science Advisory Board*s Reducing Risk report concluded that ecological
concerns should be given parity with human health issues and that risk reduction should be a
key criterion to evaluate program progress and eventually to allocate resources. Taking note
of your personal support of these conclusions as operational principles for the Agency, the
Subcommittee evaluated the EcoRisk Research Program in this broader. Agency-wide
context. The major conclusions and recommendations of the Subcommittee are as follows:
-------
a) The Agency needs to develop scientifically sound methodologies and data
fegjfs for Conducting ecological risk assessments on the diversity of anthro-
pogenic stresses and ecological systems of the United States. The current
budget for the OKD EcoEisk Research Program is grossly inadequate to
address the scientific issues that must be resolved to meet that need. EPA
should provide the level and consistency of funding for research to improve
EcoRisk assessment methodologies commensurate with the importance of this
need,
b) QKD should revise the Ecolisk Research Program to reflect the fundamental
role of ecorisk throughout the Agency. The EcoRisk Program requires a
broader scope than it presently derives from the Emited program office
clientele.
Further, the Ecorisk Research Program should:
c) Develop research projects that explore techniques and methods to quantify
uncertainties associatedjwlth.ecological risk assessments:.
d) Conduct research to systematically quantify uncertainties associated with each
element of (ecological risk assessment to provide the primary basis for prioriti-
jdng research and allocating resources in the EcoRisk Research Program;
e) Significantly enhance research to advance population-. community-t ecosystem-
-^ and landscape-level ecological risk assessment methodologies to yield a
more appropriate balance of projects designed to address higher levels of
biological complexity, multiple stresses, and extrapolation issues;
f) Establish effective interactions with other research orjnsk_assessment efforts
within the Agency (such as EMAP and the Risk Assessment Forum);
g) Focus on the development and testing of new methods for ambient monitoring
of ecological responses of communities and ecosystems. This effort should be
coordinated with the development of an ecological indicator research program;
and
h) Conduct research on risk characterization that would include statistical treat-
ment of data, uncertainty analysis, and integration of data. This characteriza-
tion should also be linked to research on ecological valuation. Finally,
-------
i) EPA should £StabIish_anJntegration and synthesis task and an intellectual or
think-tank component to develop new ideas for ecological risk assessment
methodologies. Most of the research plan lacks the degree of innovation that
is commensurate with the research needs or the importance of ecorisk research
to Agency-wide decision-making. The extramural research program, based on
scientifically peer-reviewed proposals, should be expanded and all research
conducted by on-site contractors should be peer-reviewed.
We look forward to your response to our recommendations. We particularly offer
our assistance to you in facilitating significant increases in funding for ecological risk
assessment research and in institutionalizing the Ecorisk Assessment Research Program as a
part of the Core Ecological Research Program within QRD. We also look forward to the
development and future review of an Agency-wide EcoRisk Research Plan.
Sincerely yours,
Dr. Raymond Loehr, Chairman
Executive Committee
Science Advisory Board
eth Dickson, Chairman
Ecological Processes and
Efieets Committee
Dr. Mark Harwell, Chairman
EcoRisk Research Subcommittee
Enclosure
-------
U.S. ENVIRONMENTAL PROTECTION AGENCY
NOTICE
This report has been written as a part of the activities of the Science Advisory Board, a
public advisory group providing extramural scientific in-formation and advice to the
Administrator and other officials of the Environmental Protection Agency, The Board is
structured to provide a 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 does not necessarily represent the views and policies of the
Environmental Protection Agency or other Agencies in Federal Government. Mention of trade
names or commercial products do not constitute a recommendation for use.
-------
ABSTRACT ?
This report presents the conclusions and recommendations of the U.S. Environmental
Protection Agency's Science Advisoiy Board following a review of EPA's Ecological Risk
Assessment Research Program. The Subcommittee considered that the Ecorisk research
program was fundamental to support the Agency's extensive need in ecological risk assess-
ment; however, they felt that the funding and the scope of the current program were
inadequate. They recommended expanded efforts on methodologies for population, commu-
nity, ecosystem, and landscape level assessments and on quantifying uncertainty of risk
estimation. Overall, they recommended that the Agency expand support for this research to
cover aU of the Agency program offices.
KEY WORDS; Ecological Risk Assessment; Ecorisk; Uncertainty Analysis; Risk Character-
ization,
11
-------
U.S. ENVIRONMENTAL PROTECTION AGENCY
SCIENCE ADVISORY BOAED
ECOLOGICAL PROCESSES AND EFFECTS COMMITTEE
ECORISK ASSESSMENT SUBCOMMITTEE
ROSTER
CHAIRPERSON
Dr. Mark A. Harwell, Rosenstiel School of Marine and Atmospheric Science,
University of Miami
MEMBERS AND CONSULTANTS
Dr. Stanley Auerbach> Environmental Sciences Division, Oak Midge National
Laboratory (Member of Executive Committee)
Dr. William E, Cooper, Chairman, Zoology Department., Michigan State
University
Dr. Kenneth Dickson, Director, Institute of Applied Sciences, University of
North Texas (Member of Executive Committee)
Dr. James A. Fava, Roy F, Weston, Inc.
Dr. Daniel Goodman, Department of Biology, Montana State University
Dr, Rolf Hartung, Professor, School of Public Health, University of Michigan
Dr. Robert Huggett, Professor, Virginia Institute of Marine Science
School of Marine Sciences, College of William and Mary
Dr. Richard Kimerie, Monsanto Corporation
Dr. Allan MaM» Exxon Corporation
Dr. Kenneth H. Reckhow, School of Forestry and Environmental
Studies, Duke University
Dr. G. Bruce Wiersma, Dean, College of Forest Resources, University of
Maine
ill
-------
SCIENCE ADVISORY BOARD STAFF
Dr. Edward S, Bender, Designated Federal Official & Executive Secretary, U.S.
Environmental Protection Agency, Science Advisory Board, 401 M. Street, SW.,
Washington, D.C, 20460
Ms. Marcia K. Jolly, Staff Secretary, U.S. Environmental Protection Agency, Science
Advisory Board, 401 M. Street, SW., Washington, D.C. 20460
Mr. Robot Flaak, Assistant Staff Director, U.S. Environmental Protection Agency,
Science Advisory Board, 401 M. Street, SW., Washington, D.C. 20460
Dr. Donald G. Barnes, Staff Director, U.S. Environmental Protection Agency, Science
Advisory Board, 401 M, Street, SW., Washington, D.C. 20460
IV
-------
TABLE OF CONTENTS
1. EXECUTIVE SUMMARY 1
2. INTRODUCTION , 4
2.1 Charge to the Subcommittee 4
2,2 Subcommittee Review Procedures 5
3. RESPONSE TO THE QUESTIONS OF THE CHARGE 7
3.1 Use of Scientific Method in Project Selection, Design, and Protocol
Development 7
3,2 Project Integration 7
3.3 On-site Versus University Research Activities 8
3.4 Contribution to Broad EcoRisk Needs of the Agency , 9
3.5 Consistency with State-of-Science .......................... 10
3.6 Identification of Knowledge Gaps and Critical Projects 11
3.7 Extrapolations and Interrelationships to Other Levels of Biological Orga-
nization 12
4. CRITICAL ISSUES AND COMMENTS 14
4.1 Uncertainty 14
4.2 Total Funding and the Allocation of Funds Across Levels of Biological
Organization 16
4.3 Communication 18
4.4 Risk Communication 19
4.5 Monitoring and Lessons From Other Research Programs ............ 20
4.6 Risk Characterization 21
4.7 Research on Mechanisms and Processes ..,.,.,........ 22
4.8 Research on Multiple Stresses and Complex Mixtures .............. 23
4.9 Research on Community-, Ecosystem-, and Landscape-Level Processes , , . 24
4.10 Innovation 25
5. SUMMARY OF RECOMMENDATIONS 28
6. REFERENCES CITED R-l
-------
I. EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency (EPA) Office of Research and Develop-
ment (OKD) began a multidisciplinary research program In 1985 to develop scientifically
defensible methods to assess ecological risks. This program, known as the EeoRisk Research
Program, is primarily in support of the Office of Pesticide Programs and Toxic Substances
(OPTS); however, it is the only research program wifiiin EPA that is addressing the complex
and essential issues of ecological risk assessment. A five-year (FY92-FY96) research plan
was prepared by ORD and subjected to review by the EcoRisk Research Subcommittee of the
Science Advisory Board (SAB) Ecological Processes and Effects Committee. The objectives
of the review were to examine the program for: the consistent use of sound scientific
methods; the effectiveness of project integration; the mix of on-site versus university
research; the contribution to EPA and other agency ecological risk assessment needs;
consistency with developments in the ecological risk assessment paradigm; optimal allocation
of resources in light of priorities; and its adequacy for addressing extrapolation issues.
The Subcommittee met on 20-22 May 1991 at Galloway Gardens, GA, Presentations
by ORD staff and background materials provided by the EcoRisk Research Program provided
the bases for deliberations by the Subcommittee. The Subcommittee answered the specific
questions in its charge and reached consensus on several key issues.
The conclusions and recommendations of the Subcommittee are as follows:
m) The development of scientifically sound methodologies and data bases for
conducting ecological risk assessments on the diversity of anthropogenic
stresses and ecological systems of the United States is a critical need for the
Agency and the nation. The current budget for the ORD EcoRisk Research
Program is grossly inadequate to address the scientific issues that must be
resolved to meet that need. The Subcommittee strongly recommends that
EPA provide the level and consistency of funding for research to improve
EcoRisk assessment methodologies commensurate with the importance of this
need.
b) The Subcommittee recommends that ORD revise the EcoRisk Research
Program to reflect the fundamental role of ecorisk throughout the Agency,
The EcoRisk Program requires a broader scope than it presently derives from
1
-------
i
the limited program office clientele. •'<
c) Uncertainty analysis is a critical aspect of ecological risk assessment that is
inadequately addressed within the research plan. The Subcommittee recom-
mends that research projects be developed that explore techniques and methods
to quantify uncertainties associated with ecological risk assessments.
d) The Subcommittee strongly recommends that a systematic quantification of
uncertainties associated with each element of ecological risk assessment be
undertaken. The Subcommittee further recommends that such an evaluation
constitute the primary basis for prioritizing research and allocating resources in
the EcoRisk Research Program, i.e., selecting research activities to reduce the
most important uncertainties most effectively.
e) The Subcommittee recommends that the EeoRisk Research Program signifi-
cantly enhance research to advance population-, community-, ecosystem-, and
landscape-level ecological risk assessment methodologies. This emphasis
should result in a more appropriate balance of projects designed to address
higher levels of biological complexity, multiple stresses, and extrapolation
issues.
f) The Subcommittee recommends that the EcoRisk Research Program establish
effective interactions with other research or risk assessment efforts within the
Agency (such as EMAP and the Risk Assessment Forum),
g) The Subcommittee recommends that the EcoRisk Research Program focus on
the development and testing of new methods for ambient monitoring of
ecological responses of communities and ecosystems. Existing data sets (such
as NAPAP and EMAP) may provide the most comprehensive and useful
information for such testing. This effort should be coordinated with the
development of an ecological indicator research program.
h) The Subcommittee recommends that the EcoRisk Research Program conduct
research on risk characterization that would include statistical treatment of
data, uncertainty analysis, and integration of data. This characterization
should also be linked to research on ecological valuation.
-------
i) The Subcommittee is particularly concerned that most of the research plan
lacks the degree of innovation that is commensurate with the research needs or
the importance of ecorisk research to Agency-wide decision-making. The
Subcommittee highly recommends the establishment of an integration and
synthesis task and an intellectual cy Aink-tank component to develop new ideas
for ecological risk assessment methcKlologies. The Subcommittee further
recommends significant enhancement of an extramural research program that is
based on scientifically peer-reviewed proposals, and recommends significant
increase in the use of peer review for research conducted by on-site contrac-
tors. •
-------
2. INTRODUCTION
The U.S. Environmental Protection Agency (EPA) Office of Research and Develop-
ment (ORD) initiated in 1985 a multidisciplinary research program to develop scientifically
defensible methods to assess ecological risks for use by the Office of Pesticide Programs and
Toxic Substances (OPTS). This initial program (known as the EcoRisk Research Program)
has been the subject of two external peer reviews and one previous EPA Science Advisory
Board (SAB) review; the latter occurred in 1987. While the EcoRisk Research Program has
direct ties to the EPA Office of Pesticides and Toxic Substances programs, it also serves as
the only research program within EPA that is addressing the complex and essential issues of
ecological risk assessment.
Based on the experience of the Agency and projected needs of OPTS, a new five-year
research plan for the ORD EcoRisk Research Program was developed for FY92-FY96,
Before implementing this research plan, the Agency sought review by the SAB. The
EcoRisk Research Subcommittee of the SAB Ecological Processes and Effects Committee
convened a review workshop during 20-22 May 1991 at Galloway Gardens, GA, The
present report provides the findings and recommendations of the Subcommittee as determined
in its review.
This report details the charge to the Subcommittee and the specific responses to each
of seven questions provided in the charge. The report then includes a discussion of the
findings of the Subcommittee organized around eight key issues identified at the workshop.
Finally, a summary of recommendations is provided,
2.1 Charge to the Subcominittee
The Office of Research and Development requested that the Science Advisory Board
review its research plans for the next five years in the uea of ecological risk assessment. In
a letter to the SAB dated 30 April 1991, Dr. Courtney Riordan, Director of the Office of
Environmental Processes and Effects Research, requested that the SAB EcoRisk Research
Subcommittee address the following questions as part of the charge for its review:
a. Has the ongoing program been consistent in the use of sound scientific meth-
ods, e.g., selection of projects with testable hypotheses, development of
appropriate experimental designs, and choice of field-sampling protocols?
-------
b. Have the research results demonstrated an effective level of project integration,
i.e., an intercorinectedness that enhances the opportunities for scientific
innovation and productivity?
c. Does the program have an appropriate mix of on-slte and university research?
d. How does the review panel see this program contributing to the ecological risk
assessment needs of EPA or other federal research programs like the Global
Change Research Program and Environmental Monitoring and Assessment
Program (EMAP)?
e. Considering current approaches to ecological risk assessment, vis a" vis the
traditional 1983 National Academy of Science (NAS) risk assessment para-
digm, is the research plan consistent with the state of the science? Is there
appropriate balance in research devoted to the components of ecological risk
' assessment or should changes be considered (e.g., more/less hazard identifica-
tion work, more/less exposure work, more attention to higher levels of
biological organization)?
f. The research plan has been developed to conform to anticipated resources
available over the next five years (Level I). Are knowledge gaps appropriately
identified? Have critical projects (Le.» those of immediate need to the regula-
tory program or those recognized as necessary "first stages" in a long-term
project) been identified and appropriately prioritized?
g. Does the research, as presently planned, adequately address extrapolation
issues, e.g.» laboratory-to-fidd, single species responses to population- or
community-level effects?
2.2 Subcommittee Review Procedures
The Science Advisory Board accepted the charge for the review and assigned it to the
Ecological Processes and Effects Committee (EPEC). EPEC established the Ecorisk
Research Subcommittee, which conducted the review.
The Subcommittee met on 20-22 May 1991 at Galloway Gardens, GA. Background
materials were provided to the Subcommittee prior to the meeting, and briefings were
-------
presented at the review by the EcoRisk Research Program teatn and were discussed by the
Subcommittee. The meeting, briefing, and background materials provided the bases for
deliberations by the Subcommittee. The Subcommittee answered the specific questions in its
charge and reached additional consensus on several key issues.
-------
3, RESPONSE TO THE QUESTIONS OF THE CHARGE
3.1 Use of Scientific Method in Project Selection, Design, and Protocol Development
Because of the large number of projects, the limited time for the review, and the
primary focus of the review process on larger issues, the Subcommittee did not undertake a
detailed project-by-preject review and this is not able to respond in depth to this charge.
However, sufficient information was presented to the Subcommittee for it to make some
comments. It is clear from the presentations and provided material that the scientific rigor
and quality of the individual research projects vary considerably, In many cases, the precise
hypotheses to be tested were not carefully stated and did not appear to have been well-def-
ined in the research plan. Often protocols were presented only in summary fashion. Some
projects clearly were well-defined and do reflect state-of~the~science research; other projects
appeared to be much weaker in conceptualization, scientific rigor, and implementation. The
Subcommittee strongly recommends that a more consistent and intensive set of external peer
reviews of individual proposed projects and ongoing activities be established, as discussed
more fully later in this report.
3.2 Project Integration
The Subcommittee concluded that in general there is an inadequate level of project
integration, and that opportunities for scientific innovation and significant advancement of the
state-of-the-seience of ecological risk assessment are being missed in the presently designed
EeoMsk Research Program. In only a very few projects is there an explicit attempt at
integration (one positive example is Project MM-2, which proposes to use GIS to connect
biogeographic and ecologic databases in risk assessments).
In general, the critical research issues associated with explicit linkage of projects from
contaminant/stress introduction, through transport, fate, and stress regime characterization, to
characterization of effects on ecological assessment endpoints are lacking. The Subcommit-
tee strongly recommends that the EcoRisk Research Program incorporate a significant
activity to establish this integration and linkage, in order that systematic uncertainty analyses
can be used to identify critical research needs (i.e., those uncertainties that have the greatest
consequence on the ecological endpoints and on regulatory decision-making). This systemat-
ic exercise, if conducted periodically, would provide the basis for prioritizing research on
-------
ecological risk assessment methodologies and would provide the basis for evaluating the
efficacy of ecological risk assessment methodologies available to the decision-maker at any
point in time. These issues are more fully addressed later in this report.
3,3 On-site Versus University Research Activities
Within the limits of the information provided in this review, it appears that the use of
extramural versus on-site researchers is intended to strike a balance between the need to
maintain a focus for the research program and the need to take advantage of specific skills
and experience not available in the EPA environmental research laboratories. It is not clear
to the Subcommittee how extramural groups fit into the overall EcoRisk Research Program.
It would have been very interesting and informative to have seen the geographical distribu-
tion of off-site contractors, their relationship to particular EPA laboratories, and their areas
of research expertise and responsibilities,
A major concern of the Subcommittee involves the level of peer review and quality
control imposed on the on-site contractors that represent basic operating agreements (BOA)
and contracts. Most of the individual laboratories participating in IcoRisk research activities
allocate 40% to 60% of EcoRisk research funds to on-site contractors to conduct the actual
research. Many of the EPA laboratory scientists are in fact program managers and are not
directly involved in the research, to the detriment of the overall program. Moreover, there
appears to be little external peer review of the individual research proposals prior to
assignment to the on-site contractors. This is especially true of the field-oriented ecological
experiments. The Subcommittee believes that this lack of sufficient external peer-review of
the technical elements of the EcoRisk Research Program detracts from the quality of the
research and its perceived value in the outside scientific community. The Subcommittee
recommends that external peer review be established for each proposed research activity,
whether conducted by the laboratories, on-site contractors, or extramurally, and that the
opportunities for university and other extramural scientists to participate in the EcoRisk
Research Program be significantly increased.
3.4 Contribution to Broad EcoRisk Needs of the Agency
Most of the presently designed EcoRisk Research Program is concerned with the
specific needs and objectives of OTS and OPP. For this reason there is heavy emphasis on
8
-------
research to validate the hazard assessment approach, as opposed to research aimed at
developing needed methodologies for conducting ecological risk assessment on higher-level
ecological systems and on non-chemical stresses. Ecosystem-level risk assessment research
must take into account higher4evd interactive processes between various components of
ecosystems. This should include knowledge of rates of processes, causality and feedback
mechanisms, and networks and hierarchies. On the other hand, OPTS deserves credit for
sustaining this effort, because there is no other active research on developing ecological risk
assessment techniques.
loth the EMAP and the EPA Global Change Program are concerned with detecting
potential deleterious changes in ecosystem structure and function. Each of these programs is
intended to examine the nation's ecological resources in a geographic context that eventually
may be related to perturbations at the population, community, ecosystem, and landscape
levels of ecological organization, EMAP is focusing on developing a monitoring strategy,
whereas the Global Change Program is directed at understanding ecosystem processes and
interactions in relation to temperature and precipitation change and the global carbon dioxide
budget in response to anthropogenic alterations of the atmosphere. Research on ecological
consequences of global climate change is also concerned with understanding and quantifying
linkages and dynamics of higher-order ecological processes as well as providing input to
global carbon cycle and vegetation models.
If the Ecolisk Research Program is to contribute scientifically to these major
programs, it must put more emphasis on utilizing real-world field monitoring data and on
development of methodologies to relate anthropogenic stresses to ecological effects. As
noted elsewhere in this report, the present EcoRisk modeling effort bears little relation to
population, community, ecosystem, or landscape problems, yet it is at those levels that we
are primarily concerned about impacts on the environment. With the present level of funding
and current research direction for the Ecolisk Research Program, it is the opinion of the
Subcommittee that the program will have minimal impact on meeting the needs of the major
EPA interests and priorities reflected in the EMAP and Global Change programs or those
reflected in the SAB Reducing Risk reports (SAB 1990a, b). In this sense, it bears little
relationship to ORD's Core EcoRisk Research Program outlined in their 1991 research plan
entitled Ecological Risk Assessment Propam.
Nevertheless, the EcoRisk Research Program has the potential to contribute to these
programs for a variety of reasons. It has a core of scientists experienced with the methods
and techniques of linking stresses with biological effects. The bottom-up approach historical-
-------
',
ly used by the EcoRisk Program, with careful delineation of hypotheses for experimentation,
could contribute to the understanding of the mechanisms and causes of the change that is
identified through a top-down approach in programs like EMAP and Global Change.
Finally, the EcoRisk Program could contribute to the identification of ecological endpoints
and measurement indicators around which ecological risk assessments can be developed.
3,5 Consistency with State-of-Scieoce
The current EcoRisk Research Program is consistent with the MAS paradigm (NEC,
1983), which suggested that risk assessment consists of a combination of hazard assessment
(evaluating the inherent ability of a chemical to cause harm) and exposure assessment
(evaluating the dose to individual organisms). However, through the present EPA Risk
Assessment Forum activities, that risk assessment paradigm is being modified and expanded
to be more appropriate for ecological risk assessments, rather than human health risk
assessments, and to be more capable of addressing non-chemical as well as chemical stresses
(Ftva et al, 1991; Harwell et al., in preparation). Discussions at the workshops included, as
one possibility, an ecological risk assessment paradigm with three substantive additions to the
health risk paradigm: 1) exposure assessment is expanded into a stress characterization
process; 2) hazard assessment is expanded into an ecological effects characterization process;
and 3) the ecological effects characterization component accounts for ecological recovery
processes. The first two elements proceed in parallel, with inputs and feedbacks occurring at
several stages; this approach contrasts with the traditional health risk assessment paradigm in
which hazard and exposure elements are independent and only combined at the end of the
process in the risk characterization step.
A second important difference is recognition of the multitude of different endpoints
that may be appropriate in differing circumstances, reflecting different types of ecosystems,
different components that are ecologically or societally important, and different types and
combinations of anthropogenic stresses. The ecological risk characterization component
involves sequential stages of assessment, utilizing a diversity of specific stress-response
analysis methodologies or data bases that explicitly account for ecological recovery process-
es. The ecological risk assessment process is designed to provide ecologically relevant
information in a form understandable by non-scientists for appropriate weighing with other
factors affecting the environmental decision.
The Subcommittee recommends that the EcoRisk Research Program take cognizance
of the evolving methodology for ecological risk assessment and explicitly examine modifica-
10
-------
•t
tions in the proposed research activities to be more in accord -with current ideas. As one
example of this, the Subcommittee believes that more attention should be given to the
relationship between lower and higher levels of ecological organization (extrapolation and
calibration issues) to increase our confidence that use of lower-level studies in fact reflects
higher-level effects. Another example is emphasis on developing methodologies for
conducting ecological risk assessments in toto following the ecological risk assessment
paradigm discussed at recent workshops of the risk assessment forum, father man the present
strong emphasis on conducting traditional laboratory experiments on toxic effects on
organisms from exposure to individual chemicals.
3,6 Identification of Knowledge Gaps and Critical Projects
In general, the Subcommittee feels the EcoRisk Research Program does not reflect the
important strategic distinction between the value of incremental progress and the value of
substantive resolution of specific issues. The resources available fell short of the needs for
the proposed research by a factor of at least 10 (and possibly as much as 100), if the
research program is to make substantive advancements in the understanding of stress ecology
necessary for conducting ecological risk assessments. This discrepancy magnifies the
importance both of setting correct priorities and recognizing what can realistically be
accomplished with a given commitment of resources and time. The level of committed
resources in itself indicates that such a realistic appraisal has not been done. In 1987, the
Society of Environmental Toxicology and Chemistry (SETAC) published the results of a
workshop which recommended the.establishment of a 10 year, $75 million/year research
initiative in Ecological Risk Assessment (SETAC,, 1987). A research initiative of this
magnitude is still needed.
The evident priorities in the research plan do not reflect what is needed and what is
feasible. The Subcommittee believes that priorities must be established by looking at the full
process for ecological risk assessment and explicitly examining the uncertainties at each step
(e.g., dose-response data, extrapolation across species, extrapolation to higher levels of
organization, implications of multiple stresses and multiple endpoints, etc.). The Subcom-
mittee identified four pressing needs for advancing ecological risk assessment: 1) develop-
ment of a standard risk assessment protocol that quantifies and uses estimates of uncertainty
in each step in the assessment of risk; 2) development of a standard protocol for model
validation to apply to the models that are being used in the course of risk assessment; 3)
identification and justification of specific higher-level (community and ecosystem) endpoints
for characterizing the ecological components that might be at risk and that, if adversely
11
-------
affected, would constitute harm to the environment; and 4) quantification of the performance
(false positives, false negatives) of proposed testing and screening procedures for conducting
risk assessment. Needs (1), (2), and (3) are not identified as foci of specific projects in the
present EcoRisk Research plan. Need (4) is addressed in the research plan, but with a
limited emphasis (i.e., "validating the quotient method") that impresses the panel as inade-
quate and inappropriate, and on a scale (sample size of cases examined, linkage to monitor-
ing) that is insufficient to answer the question at an acceptable level of statistical certainty.
3.7 Extrapolations and Interrelationships to Other Levels of Biological Organization
The Subcommittee noted that whereas most of the research activities within the
EcoRisk Research Program are on lower levels of organization (and on chemical stresses),
decision-makers and the public primarily are concerned about anthropogenic impacts on
higher levels of organization (populations, communities, ecosystems, and landscapes). The
Subcommittee believes that bridging the gap between the information being collected and the
ecological assessment endpoints and anthropogenic stresses of primary concern is inadequate-
ly addressed by the EcoRisk Research Program.
A considerable focus in the research plan is on questions, phrased in presentations to
the Subcommittee in terms that would allow "yes/no" answers, about the validity of a long
list of assumptions that are part of present practice of conduct in routine risk assessments on
pesticides and toxic substances. Such yes/no answers are not likely to be very useful
advances, since we already know that the assumptions stated in the research plan (e.g., is the
quotient method valid for ecological risk assessment? are effects from multiple stresses
simple combinations of effects from individual stresses?) are not true. The real questions
should be more refined, such as: What is the frequency distribution of the actual deviations
from these assumptions? How will these deviations affect the frequency distribution of the
effects in terms of ecological endpoints of concern? Is there an acceptably inexpensive and
simple modification of present practices that will yield better, performance?
The Subcommittee noted that much of the proposed research is in the nature of case
studies. The number of cases to be examined, however, is very limited. Each case study is
necessarily very specific with respect to variables such as site, subject organisms, and
pollutant. For this reason, each case study is essentially only one "data point" from a very
large and multi-dimensioned space to be sampled. In this situation, there are severe
difficulties in extrapolating or generalizing from a handful of case studies to the larger
universe of the myriad of chemicals and stresses for which ecological risk assessment must
12
-------
1 I
be conducted. The presentations seemed not to be sensitive to this sample-size problem, and
the plan seems overly optimistic about the breadth of the conclusions that can be drawn from
the proposed case studies.
13
-------
4. CRITICAL ISSUES AND COMMENTS
While the Subcommittee recognizes that the ORD EcoRisk Research Pro-gram has
stated goals to improve the ability of the Agency to conduct ecological risk assessments in
the broader context of diverse ecosystems, diverse ecological endpoints, and complex
human-induced stress regimes, the actual proposed re-search program, with its emphasis only
on toxic chemicals and pesticides and emphasis on traditional methods of ecotoxicology, falls
well short of those goals and of the emerging needs of the Agency. Indeed, the Agency has
indicated, through endorsement of the SAB Reducing Risk reports (SAB 1990a} b) and in
other forums, that managing for risks on real-world ecosystems imposed by the many differ-
ent types of anthropogenic activities is a, if not the, critical priority over the next several
years. Unfortunately, the consensus of the Subcommittee is that the scientific basis for
meeting this priority does not exist at present and will not exist in the future if the EPA
ecological risk assessment research program is limited, as the present program is, in its per-
spective, its scope, and its resources.
The Subcommittee's review and discussions covered a wide range of issues concern-
ing ecological risk assessments, uncertainties, the present proposed research plan, and the
full range of research needed to implement a defensible and effective ecological risk
assessment capability. These discussions are summarized below in sections that reflect the
key issues identified by the Subcommittee, Consequently, a central recommendation of the
Subcommittee is to expand the scope of the Ecorisk research Program to be Agency-wide,
long-term, and anticipatory, while recognizing the continued need for program-specific and
shorter-term research on ecological risks.
4.1 Uncertainty
Uncertainty analysis is a critical aspect of risk assessment. By definition, risk
assessment has a probabilistic dimension. While the current state-of-the-science in ecological
risk assessment may in many cases preclude probabilistic statements regarding the likelihood
that an effect will be observed, the quantification and reduction of uncertainty in assessing
ecological risk should be a central goal of the EcoRisk Research Program. The program
should conduct research that addresses the areas of greatest uncertainty in stress characteriza-
tion and effects characterization assessments. Thus, the Subcommittee strongly feels that the
EcoRisk Research Program's individual projects should be chosen and prioritized based on
their potential contributions to quantifying and then reducing uncertainties. While uncertainty
is discussed throughout the EcoRisk Research Plan, there is almost no information on how it
14
-------
will be estimated, how it is propagated across extrapolations or through models, or how it is
used in ecological risk assessments in interpreting risk assessments or setting research
priorities.
The Subcommittee noted that the proposed EcoRisk Research Plan contains no
projects specifically addressing the area of uncertainty analysis. This appears to be a critical
deficiency of the proposed plan. An uncertainty analysis research component should address
the following issues/topics;
a. estimation of uncertainties
• from sample variability
• from expert judgment
* from model lack-of-fit
b. error propagation methods
- Monte Carlo simulation
• first-order error analysis
c. use of error estimates
* in risk assessment
* in setting research priorities
d. other
• estimation of covarianee terms
• fitting distributions (probability models)
* sample estimators of center and dispersion
It was evident to the Subcommittee that the EcoRisk Research team has only limited
expertise or experience in the area of uncertainty analysis. Adding such expertise to the
program is critical to the development of a sound research program on ecological risk
assessment. The research plan should include projects mat specifically explore techniques
and methods to quantify uncertainties.
The Subcommittee has two specific recommendations related to uncertainty: 1) the
EcoRisk Research Plan should be designed specifically, and as its primary goal, to quantify
and then reduce the uncertainties associated with ecological risk assessment; and 2) proposed
research projects should be chosen and prioritized based on the contributions they will make
to quantifying and reducing uncertainty.
15
-------
4.2 Total Funding and the Allocation of Funds Across Levels of Biological Organi-
zation
EPA is to be commended for developing a strategy of emphasizing ecological risk
assessment research programs for regulatory purposes under OTS and QPP and the Office of
Research and Development (ORD). Recognition of the importance of maintaining the
integrity of our terrestrial and aquatic ecosystems is an important direction for the Agency to
take and a most worthwhile result to work toward. However, the Subcommittee concluded
that the scope of the stated goals (and needs of the Agency) of the EcoRisk Research
Program is completely out of proportion to the available budget. For this reason it is
necessary to be much more specific in the statement of goals to distinguish between an
expectation of incremental progress and an expectation of actual resolution on a particular
issue. Actual resolution can realistically be expected only if all the resources are concen-
trated on one or at most two items. Distribution of resources over more items, as in the
presently designed research program, makes it unrealistic to expect more than slight
incremental progress. The EcoRisk Research Plan does not seem to recognize this con-
straint, and Che presentations to the Subcommittee did not make the strategic distinction to
allow weighing the value of marginal progress versus substantial resolution of unresolved
issues.
EPA experienced an exciting change in its mode of operation when Administrator
William Reilly embraced the SAB recommendations that ecological concerns be given
attention on a parity with the human health, and that risk reduction is to be utilized as the
diagnostic endpoint of regulatory activities. Consequently, technologies needed to evaluate
ecological risk assessments in all programs throughout the Agency must now fundamentally
cross the various levels of structural hierarchy (individuals, populations, communities, and
ecosystems). The EcoRisk Research Program must service the whole of the Agency, not just
the traditional OPP, OTS, and portions of the ORD programs. Furthermore, the EcoRisk
assessment research activities must include the development and validation of new methodol-
ogies, as well as a new technology transfer and support to the regulatory programs. This
requires a scope and vision for the EcoRisk Research Program that substantially transcends
the present perspective within the program, i.e., addressing the immediate needs for chemical
reviews under TSCA or FIFRA.
The proposed FY92-FY96 research plan includes a variety of activities that the
Subcommittee classified into levels of organization (individuals/populations and communi-
ty/ecosystem) and into types of activities (laboratory, field, modeling). These are presented
in Table 1 (below), indicating the proposed level of funding and, thus, reflecting present
operational priorities. Data for this table were supplied to the Subcommittee by ORD during
the review. Given the increasing levels of complexity and the resulting increasing costs per
experimental effort as one increases the level of biological complexity, it is obvious that most
of the proposed activities remain at the individual and population level. This reflects the
traditional level of lexicological risk assessment and will not, by itself, support ecological
16
-------
risk assessments at the community and ecosystem level. The Subcommittee recommends the
program be appropriately modified to increase its emphasis on issues related to the uncertain-
ty of risk assessments at the community and ecosystem levels of organization.
Table 1 Average Yearly Research Expenditures (proposed $K)
Organizational Laboratory Field Model Total
level
individual iOO 800 700 2,400
fi population
community & 100 650 550 1,300
ecosystem
total 1,000 1,450 1,250 3,700
The Subcommittee agreed on two major recommendations involving future funding
responsibilities:
a) The programmatic funding base should reflect the new fundamental role of
ecological risk assessment within all programs at the Agency. EPA should
develop an Agency-wide research program to develop ecological risk assess-
ment methods. The Q1D funding should not be justified only by OPP and
OTS needs, but should be supported by the full range of EPA Program
Offices. The program should be based upon a clearly identified strategy that
cuts across Agency needs for long-term development of ecological risk assess-
ment capabilities. The program should draw upon resources from all media,
and should be designed to develop theories and mechanisms that can be applied
in concert with ecological risk assessment guidelines to reduce risk at all levels
of ecological organization.
b) The level of support must be substantially increased to allow the development
and field validation of population-, community-, and ecosystem-level risk
assessment methodologies. The research recommendations identified in the
5-year plan, if all were funded, total in the many millions of dollars. A policy
team, representing the program offices and other clients (including EMAP),
should be charged with developing a funding strategy commensurate with the
development and validation needs to implement ecological risk assessment
research. Because of the complexity of abiotic and biotic components at the
ecosystem level and the current lack of methods to test ecosystems directly
and economically, the present research activities emphasize effects at the
individual level and seek to establish adequate protection by extrapolating to
the ecosystem. The approach is simplistic and does not establish a conceptual
linkage of effects noted at the individual level with effects that may occur at
17
-------
the ecosystem level. The exposure component has relied mostly upon predict-
ing chemical concentrations with models recently developed by the Agency.
Toxicity effect models have not progressed to the state of exposure models,
except at the QSAR level for individual chemicals on populations. Virtually
no models have been developed for ecosystemlevel effects.
A need exists for the EcoRisk Research Program to maintain a balance in support for
simple laboratory studies of individual and populations with the more complex community-
level and ecosystem-level activities. In addition, because of the present and likely future
reliance upon lower-level studies, the Agency must calibrate these tests against ecosystem
effects. There is also a need to validate the accuracy of all predictive exposure models and
lexicological effects tests against the existing monitoring data from the real world, A critical
research need is to focus on the linkages of lower levels of organization to higher levels of
organization. These linkages need to be exploited in the construction of a better ecological
risk assessment paradigm. This also implies a research strategy that addresses the problem
of "topHfown" (ecosystem to individual) as well as the "bottom-up" (individual to ecosystem)
espoused in the EcoRisk Research Plan, We simply must establish for ourselves (the
scientific community), as well as demonstrate to the public, that we understand the predictive
power and utility of environmental assessment tools.
4.3 Communication
Communication problems between Q1D and the GTS and QPP Program Offices have
been cited by previous reviews and continue to be a major issue of concern to the Subcom-
mittee, Since the inception of EPA, a dichotomy and competition between the Agency's
R&D community and regulatory program offices have existed. The R&D laboratories must
build their research strategies upon guidance from the program offices as to how resultant
data may be used to enhance the development of new regulatory initiatives or improve the
application of existing regulations. The program offices must look sufficiently far into the
future to identify fundamental research needs for decision-making and support them through
a significant, anticipatory exploratory research program in ORB and user workshops in the
program. In programs such as OTS and OPP which have a large scientific staff, some
program-specific needs (e.g., compiling databases, assessing Type I and Type H errors, the
utility of endpoints, or compiling an inventory of regulatory decision criteria) can perhaps
best be accomplished within the program. However, in such cases, ORD and OPTS must
routinely coordinate and collaborate among scientific staff to avoid the distrust that comes
from isolation and parochial work habits.
The proposed EcoRisk Research Program appears to be a three-dimensional matrix-
managed program, involving laboratory projects and headquarters programs. This arrange-
ment poses difficult communication problems, in part because there is no single source of
accountability. Under such circumstances, much potentially productive effort is dissipated
because the time of so many individuals is required simply to maintain communications
among all components of this overly complex system. It is not surprising that project
18
-------
, f
investigators have little opportunity for building outreach and -'connections to other programs,
such as EMAP or Global Climate Change, each of which could contribute substantive
intellectual input and opportunities to the EcoRisk Research Program.
This issue of communication has consistently been a key topic recommendation from
numerous previous extramural and SAB program reviews, yet the problem remains today.
Clearly, a more formalized network providing for regular working session meetings is
needed to focus development and application of R&B programs for EcoRisk.
Another area of interaction is among researchers on larger multi-disciplinary research
projects. Some of the proposed projects reflect an integration of activities associated with
effects and exposure. This integration is encouraged because it helps to provide an iterative
feedback loop on ways to improve the research as it progresses. For example, recognition of
how a stress behaves in the environment provides insights on where and how to focus effects
research. Clearly, the closer the researchers on exposure and effects work together, the
more likely the research results will be useful as tools to enhance EcoRisk assessments and to
advance our understanding of the risks of anthropogenic stresses in the environment.
The Subcommittee recommends that the Agency encourage research projects mat
integrate stress characterization (i.e., exposure) and ecological effects characterization (i.e.,
hazard) elements within larger multi-disciplinary projects. For this reason, it is critical that
ecological risk assessment should be accomplished through a team approach that identifies
and brings together the correct technical expertise to perform the assessment. The EcoRisk
Research Program should reflect this basic philosophy.
4.4 Risk Communication
The continued emphasis on the States as the dominant permitting and regulatory
authority has given rise to a wide range of standards and permit authorities among the 50
States. It appears that in many instances, State regulatory initiatives are being promulgated
without the benefit of the body of experience, data, or literature available from the Agency's
R&D community. Often, these State and regional initiatives are launched by well-meaning
but ill-informed citizen groups. Clearly, a void exists between the scientific R&B community
and public perception of ecological risks, as demonstrated by the SAB Reducing Risk reports
(SAB 199Qa, b). A well-focused and directed effort to communicate ecological risks to the
public is essential if the findings and precepts of EPA's EcoRisk program are to gain public
acceptance.
4,5 Monitoring and Lessons From Other Research Programs
The primary mission and goal of the Ecolisk Research Program are to improve the
technical bases for ecological risk assessments. In order to accomplish this, the Subcommit-
tee believes that mere must be an increased emphasis on the role of monitoring. By contrast,
many of the projects and much of me staff time and fiscal resources in the EcoRisk Research
19
-------
Program are currently directed toward minor or very subtle corrections of existing fate-and--
effects methods. Experience has proven that real-world receiving-water communities and
terrestrial environments are highly variable and subject to significant spatial and temporal
oscillations. It is more important to gather real data on these large-scale variations rather
than to fine-tune unrealistic equilibrium models.
Previous peer reviews in 1985, 1986, and 1990 have also pointed out the need for and
importance of monitoring. However, the EcoRisk program has to date failed to respond to
this advice. We believe this failure has resulted in slowing the rate of attainment of the
ultimate program goals and has resulted in a situation where real-world data were missed
(e.g., Department of Defense data on modeling of atmospheric spray dispersion or data
from States on biological integrity of streams) that could have provided guidance and needed
mid-course corrections to the program. The Subcommittee hopes that this same recommen-
dation from a fourth peer-review panel will not be ignored.
This is a particularly important issue today because of the existence of the National
Acid Precipitation Assessment Program (NAPAP) data base and the more recent implementa-
tion of the Environmental Monitoring and Assessment Program (EMAP). There is no more
complete and comprehensive data set that relates stress to higher-level ecological response
than that developed under auspices of NAPAP. Although the program has completed its
assessment as required under the law establishing the initial assessments, there remain many
opportunities to examine or reexamine data on communities and ecosystems that cover a wide
variety of ecosystems types at landscape, regional, or in some cases, national scales. The
Subcommittee recognizes the opportunity to utilize real-world monitoring data, collected
under specific protocols with defined resources at risk, that could be reexamined in the
context of the ecological risk assessment paradigm.
Similarly, the Subcommittee could detect only the weakest of links between the
EcoRisk research program and EMAP. This is highly regrettable, since both programs have
much to offer to one another. It seems reasonable to the Subcommittee that an effectively
designed and implemented EMAP program (see NAS [1990] for guidance on monitoring
systems design), could act as an effective safety net for evaluating the tier system employed
in OPTS. The Panel believes, as discussed in the next section (4.6), that additional research
should be conducted to improve upon risk characterization procedures, only one of which is
the quotient method.
EPA research programs continue to evolve without consideration of how an interna-
tional perspective could significantly improve real-world predictability and applications. As
one important example, since the goals of many of the EcoRisk Research Program activities
are to develop better physical and mathematical models and to measure and predict fate and
effects of applied stress agents, a closer examination of existing highly stressed ecosystems
from Eastern Europe could prove useful (cf., Grodzinski et al. 1990), Cooperative programs
to examine structure and function of these highly stressed terrestrial and aquatic ecosystems
20
-------
would provide extremely useful data on ecosystem response and recovery from chronic stress
agents.
4.6 Risk Characterization
Risk characterization is the essential end-product of the scientific component of an
ecological risk assessment. It is the output from the risk characterization process that is
input to decision-makers for risk management consideration. Only when the component
pieces of the process are put together in a risk characterization can we can judge whether
these pieces are adequate, which pieces are missing, and what the influence is of component
uncertainties on the overall uncertainty of the actual risk assessment.
In this light, an understanding of risk characterization is as important as the risk
analysis components (Le.» stress characterization and response characterization). Many of
the ecological risk characterization efforts by the Agency for single chemicals have used the
quotient method (i.e., comparing exposure assessment and single-species toxicity measure-
ments). As such, this does not constitute a quantitative estimate of the magnitude of risk.
Because of this limitation in the quotient method and overall state-of-devdopment of risk
characterization procedures in ecology, additional research on the risk characterization
component of ecorisk is critical.
The importance of risk characterization is not emphasized in the EcoRisk Research
Program Plan and is allocated in the proposed budget less than one-tenth of the funds. The
Subcommittee recommends that the Agency expand research activities in die area of risk
characterization to enhance and complement research on stress characterization and effects
characterization.
Additional efforts for interpretation of information (e.g., statistical treatment of data,
probabilistic assessment, uncertainty analysis, and innovative ways of integrating and
presenting data) are also needed. This should be linked to research on ecological valuation,
to develop a metric for expressing the ecological cost component of risk.
Much of the emphasis of the EcoRisk Research Program described in the Plan is
directed at attempting to obtain predictions in situations where historically predictions have
not been feasible, and where, for theoretical reasons, we should expect predictive power to
remain limited. This means that risk characterization research should devote attention to
developing an assessment procedure that copes with uncertainty, i.e., incorporates uncertain-
ty in a realistic and, insofar as possible, quantitative way, rather than just wishing that the
uncertainty would go away. In fact, though there was mention of probability and uncertainty
in the presentations to the Subcommittee, none of the proposed research activities addresses
explicit quantification of probabilities and uncertainties. Since there seems not to be a
professional consensus on what the protocol should be for uncertainty analysis, development
of such a protocol should be a high priority in an ecological risk assessment research
21
-------
program. In particular, the discipline of decision theory should be explored as a model for
the formalization of risk characterization.
4.7 Research on Mechanisms and Processes
A review of the research projects in the EcoRisk Research Program Plan lead the
Subcommittee to several conclusions. One is that although the client offices, OTS and QPP,
have different core functions, their needs, relative to ecological risk assessments, are
essentially the same. While a specific project may be considered of primary importance by
one office and of secondary importance by the other, it is still needed by both. Once the
similarities are recognized and conveyed to management, there may be more opportunities
for close coordination and collaboration between QRD and program offices. For example,
the laboratory and field data available to OPP could be used to calibrate the models and
structure-activity predictions used by OTS for a few specific compounds.
Collaboration should also lead to the coordinated development of standardized
methods for evaluating biological effects and provide justification for obtaining critical data
on chemicals under the Pre-Manufacturing Notice and Toxic Release Inventory, If a
minimum data set of analytical properties and biological effects information is available for
chemicals covered by TSCA (see recommendation in the SAB report EPA-SAB-EPEC-91-0-
04, November, 1991, entitled "Evaluation of Research on Expert Systems for Predicting the
Environmental Fate and Effects of Chemicals"), collaborative efforts could be extended to
other program offices within EPA. The Subcommittee recommends that the research plan
include a strategy to encourage data sharing and the use of standardized effects testing
methods between OPP and OTS. The OPP data could be used to validate some of the OTS
evaluation tools, and the use of standard methods among the programs would improve the
chemical review process in both offices.
The Subcommittee concluded that the majority of the proposed projects that focus on
effects or hazards will not lead to a fundamental understanding of cause-effect relationships,
This, in turn, will require that in the future, chemicals will continue to need to be tested one
at a time by some standardized set of bioassay protocols. The major pitfall with this
approach is that standardized bioassays appropriate to determine important ecological effects,
such as inhibition of primary productivity, do not exist. It is only through a fundamental
understanding of the modes of action on individual organisms and ecological effects at higher
levels of biological organisms that a more credible approach can be developed.
The existing funding base for Ecolisk research is so limited that coordination
between and among projects must be maximized and redundancy minimized. Further, it is
essential that EcoRisk projects be selected on the primary criterion to quantify and reduce
uncertainties in ecological risk characterizations to the extent possible. This is only possible
when ecological stress-response models are based on realistic understanding of processes and
on causality mechanisms. It is obvious that this is not the case in the present program. A
careful evaluation of the projects relative to these points should be conducted and corrections
22
-------
(e.g., delete, modify, or add projects) made as necessary. However, by having the goal of
quantifying and reducing uncertainty in ecological risk assessment as the foundation of the
EcoRisk Research Program, the limited funding can be put to the optimal use, the potential
for good science can be increased, and the benefits to the client offices maximized.
The Subcommittee recommends that the EcoRisk Research Program not continue to
"micrometer a brick". Many of the propoied laboratory activities continue to be directed
toward subtle refinements of laboratory fete-and-effects methods. In many cases, it appears
that principal investigators have not taken full advantage of the published literature or parallel
research activities developed by State and regional agencies. It is essential to recognize that
the results of the many research programs presented will at best result in only subtle changes
in model parameters too small to be of any realistic advantage or use when applied to
real-world ecosystems where processes not even included in the model come to play a major
role.
4.8 Research on Multiple Stresses and Complex Mixtures
A major shortcoming in our ability to characterize environmental risk from human
activities is the inability to ascertain the hazards of chemical mixtures or multiple stresses.
Rarely is an organism, population, community, or ecosystem exposed to only a single
chemical or stress. Rather, hundreds of substances and/or a variety of physical perturbations
in the environment may affect the well-being of the ecological system in question. Often
exposure to stress will occur near human population centers, where there are multiple
sources, or in areas where contaminants concentrate because of natural physical and chemical
factors. Examples of the latter are the accumulation of hydrophobia substances in areas of
fine-grained sediment in water bodies or in the turbidity maximum of estuaries.
The complexities of standard environmental toxicity tests increase exponentially as
multiple chemicals and/or stresses are employed. The often-used bioassay endpoints of
survival, growth, and reproduction are not sufficient to provide the mechanistic understand-
ing required to predict effects and to avoid the Herculean task of multiple chemi-
cal/perturbation bioassays. A fundamental understanding of the biochemical and physiologi-
cal interactions of hazardous chemicals and stresses with individuals is necessary. For
instance, rather than trying to determine the effect of polyaromatic hydrocarbon compounds
(PAHs) on finfish reproduction by conducting hundreds of egg-to-egg bioassays on each
chemical, a much more efficacious approach might be to understand the mechanisms that
result in the effect (e.g., (he induction of hepatic enzymes by PAH and the resulting potential
for adverse impacts on reproductive hormones that could diminish the animals ability to
reproduce and how mis relates ultimately to alterations in ecosystems). Therefore, the
Agency should make a larger investment in research on the mechanisms of toxicity and stress
at all levels of biological organization
This approach will require a focused research program, involving university and
Agency personnel, and a commitment for long-term funding and support. The long-term
23
-------
ff
benefit of this investment will be that the Agency could shift from a purely reactive role in
processing applications for pesticide registrations and Pre-Manufacturing Notices for toxic
chemicals to an anticipatory, strategic role in identifying risks to the environment and in
stimulating human activities that minimize ecological and health risks.
As an example, the Subcommittee noted that there is apparently only one research
project proposed to focus on modes of action/toxicity in either terrestrial, freshwater, or
estuarine/marine systems. It is unlikely that this effort is sufficient to advance of the
state-of-the-science beyond single chemical- single species toxicity tests.
4.9 Research on Community-, Ecosystem-, and Landscape-Level Processes
The mandate to conduct ecological risk assessment at the community and ecosystem
levels of organization is relatively new to ORD. Many of the proposed projects in the
EcoRisk Research Program assume that one can simply extrapolate effects upward from
observations made on individuals. However, the emergent properties arising from organiza-
tion and structure and the feedback controls and processes that exist at higher levels of
organization produce new characteristics (often unexpected responses) that can not be
predicted by simple extrapolations.
Our ecological landscape models are often based on theory and extrapolations because
of inherent complexities in ecosystems and natural stochasticity in the environment. There
have been, however, an array of ecosystem- and landscape-level experiments, some designed
(e.g., Hubbard Brook Experimental Forest) and some uncontrolled (e.g., fire in Yellowstone
National Park), which may provide valuable case studies to understanding ecosystem-level
responses to and recovery from stress. These studies should be utilized to identify hypothe-
ses concerning interspecific interactions and biogeochemical feedbacks that constitute the
important processes occurring at higher levels. These mechanisms should be incorporated
into the ecosystem risk assessment models and tested with direct field experimentation.
4,10 Innovation
An overall issue identified by the Subcommittee concerned the need for innovative
research to address the fundamental issues of ecological risk assessment. With some
exceptions, the activities proposed or underway in the QRD EcoRisk Research Program lack
the degree of innovation that is commensurate with either the research needs (i.e., complexi-
ty of the issues) or the importance of the research to Agency-wide decision-making. There is
a general consensus among the Subcommittee members that too many projects are proposed,
scattered across the research landscape without sufficient attention to advancing the
state-of-thescience in areas of particular need or generic applicability.
Development of methodologies for ecological risk assessment should be anticipatory,
that is, not merely responding to present, immediate needs, but also to the environmental
issues that will face the Agency in the next years and decades. As discussed previously, the
24
-------
SAB reports on relative environmental risks (SAB 1990a, b) dearly identified stresses of
primary concern that are not chemical in nature. Moreover, even for chemical stresses,
addressing the set of scientific issues required to be* incorporated into a genuine ecological
risk assessment considerably exceeds the present single chemical-single species emphasis,
Interdisciplinary approaches are required, as are integrated activities Jinking the stress regime
component of ecological risk assessment with the ecological effects component. Both stress
and ecological effects characterization, the two central components of ecological risk
assessment methodology which have been discussed during the ecorisk guidelines workshops
(Fava et al. 1991; Harwell et al. in preparation), require examination of issues cutting across
scales of time and space, across ecosystem types and stress types, and across levels of
ecological organization, from individuals through populations and communities, to ecosys-
tems and landscape levels. This fundamentally requires significant advances in understanding
ecological systems and their interactions with human activities, an understanding transcending
the so-called "eeotoxicity" approaches of the past As the core research activity for ecologi-
cal risk assessment methodology development, the ORD program must take the lead in
developing .innovative approaches to these complex problems. That innovation is presently
lacking for the overall program.
It should be noted that there are several research efforts that contribute to the
ecological risk assessment research program and deserve special mention because of their
high caliber. The research on bioaccumulation based upon pharmocokinetic principles is well
conceived, scientifically sound, and innovative. Likewise, the QSAR studies of various
classes of chemicals have provided important insights and should be pursued further. Both
of these programs have been active for some time, and clearly preceded the current ecorisk
research initiative. These examples point out the pay-offs that can result from long-term
research that is well conceived.
The many other individual components of the EcoRisk Research Program need to
attain a comparable level of scientific innovation. More importantly, the Subcommittee
strongly feels that the overall research program as an integrative effort requires new and
innovative thinking. One approach, presently lacking, would be to establish an explicit task
on integration and synthesis that would evaluate research and identify needed research and
targets of opportunity. Perhaps a scientific advisory committee to function as a mink-tank to
the Program could be convened periodically.
As an example of innovative approaches that could significantly enhance the program,
opportunities should be sought for the EcoRisk Research Program to function in a lead or
coordinating role for evaluations of ecological effects from human activities in the real
world. Bather than investing small funds into tasks that piggy-back onto other ongoing
research, such as the wading bird habitat study, the EPA program should function as a focus
for leveraging and coordinating research funded by other federal agencies or regional/local
interests, directed broadly toward ecological risk assessment research needs. These field
studies can significantly improve the understanding of the extrapolation issues discussed
previously, and offer top-down bases for identifying specific causal relationships and specific
25
-------
hypotheses to be tested in laboratory and model experiments. , Local and regional studies
should be used as examples to identify needs for the ecological risk assessment research
program. Advancing the state-of-the-science on characterizing stress and ecological effects
uncertainties, both qualitatively and quantitatively, warrants a separate research task,
discussed elsewhere in this report. Until one understands the relative magnitudes and nature
of the uncertainties, it is impossible to know what level of confidence to assign to decisions
based on the assessment.
A number of groups within EPA have struggled for some time with the development
of risk assessment methodologies and with attempts to define uncertainties. The Environ-
mental Criteria and Assessment Office (ECAO) in Cincinnati has addressed these issues for
human health. Although the risk assessment methods for human health have limited
applicability to risk assessment for ecosystems, the experience in dealing with extrapolation
problems should be utilized.
Similarly, the issue of model validation, which is mentioned in several proposed
project descriptions, should be addressed as a separate research task. Here the points of
concern are that simulation models are often quite detailed and have many parameters, yet
field data are scarce; as a result, all parameters are not sufficiently estimated from the field
data. If properly and rigorously researched (including such components as statistical tests of
goodness-of-fit, statistical tests of robustness and power, development of innovative graphical
techniques, and systematic examination of previous applications of the model in other situa-
tions), model validation can provide graphical and statistical representations of model
performance under a variety of conditions that are essential to have con-
fidence in the model results. But this is a massive undertaking, which must be planned and
funded accordingly.
Advancing the scientific understanding of higher-level ecological effects is central to
developing a risk assessment capability that truly addresses the regulatory or assessment
endpoints of concern to humans. The research program should include a focused task on
evaluating existing methodologies and identifying new approaches that should be explored.
As one component of this, there should be considerably greater reliance on multidisciplinary
approaches. While we are not recommending that disciplinary-focused activities be replaced
or eliminated, the Subcommittee does recommend that they be significantly supplemented by
multidisciplinary and interdisciplinary activities. These are required to address such issues as
the transformation and partitioning of chemicals in the environment, interactions of chemical
with other chemicals and with physicochemicai conditions in the environment, population
dynamics of exposed and affected species, and the interactions of biological populations,
among many other issues. Present resources will not allow addressing all of the full range of
issues in an interdisciplinary approach; yet significant research must be undertaken to
advance the state-of-thescience in interdisciplinary ecological research if EPA is ever to go
beyond its very limited predictive capability for ecological risk assessment.
26
-------
5. SUMMARY OF RECOMMENDATIONS
The Subcommittee reviewed the information provided and developed responses to the
seven questions in the charge and developed further comments on tight issues. The principal
recommendations from these comments are summarized below.
a) The development of scientifically sound methodologies and data bases for
conducting ecological risk assessments on the diversity of anthropogenic
stresses and ecological systems of the United States is a critical need for the
Agency and the nation. The current budget for the ORD EcoRisk Research
Program is grossly inadequate to address the scientific issues that must be
resolved to meet mat need. The Subcommittee strongly recommends that EPA
provide the level and consistency of funding for research to improve EeoRisk
assessment methodologies commensurate with the importance of this need.
b) The Subcommittee recommends that OMD revise the EcoRisk Research
Program to reflect the fundamental role of eeorisk throughout the Agency.
The EcoRisk Program requires a broader scope than it presently derives from
the limited program office clientele.
c) Uncertainty analysis is a critical aspect of ecological risk assessment that is
inadequately addressed within the research plan. The Subcommittee recom-
mends that research projects be developed that explore techniques and methods
to quantify uncertainties associated with ecological risk assessments.
d) The Subcommittee strongly recommends that a systematic quantification of
uncertainties associated with each element of ecological risk assessment be
undertaken. The Subcommittee further recommends that such an evaluation
constitute the primary basis for prioritizing research and allocating resources in
the EcoRisk Research Program, i.e., selecting research activities to reduce the
most important uncertainties most effectively.
e) The Subcommittee recommends that the EcoRisk Research Program signifi-
cantly enhance research to advance population-, community-, ecosystem*, and
landscape-level ecological risk assessment methodologies. This emphasis
should result in a more appropriate balance of projects designed to address
higher levels of biological complexity, multiple stresses, and extrapolation
issues.
f) The Subcommittee recommends that the Ecolisk Research Program establish
effective interactions with other research or risk assessment efforts within the
Agency (such as EMAP and the Risk Assessment Forom).
27
-------
g) The Subcommittee recommends that the EcoRisk Research Program focus on
the development and testing of new methods for ambient monitoring of
ecological responses of communities and ecosystems. Existing data sets (such
as NAPAP and EMAP) may provide the most comprehensive and useful
information for such testing. This effort should be coordinated with the
development of an ecological indicator research program.
h) The Subcommittee recommends that the Ecolisk Research Program conduct
research on risk characterization that would include statistical treatment of
data, uncertainty analysis, and integration of data. This characterization
should also be linked to research on ecological valuation.
i) The Subcommittee is particularly concerned that most of the research plan
lacks the degree of innovation that is commensurate with the research needs or
the importance of ecorisk research to Agency-wide decision-making. The
Subcommittee highly recommends the establishment of an integration and
synthesis task and an intellectual or think-tank component to develop new ideas
for ecological risk assessment methodologies. The Subcommittee further
recommends significant enhancement of an extramural research program that is
based on scientifically peer-reviewed proposals, and recommends significant
increase in the use of peer review for research conducted by on-site contrac-
tors,
28
-------
6. REFERENCES CITED
Fava, L, L, Barnthouse, J. Faleo, M. Harwell, and K, Reckhow. 1991. Summary Report
on EPA's Draft Framework for Ecological Risk Assessment. Report of the Peer Review
Workshop, 14-16 May 1991, Roekville, MD. U.S. Environmental Protection Agency,
Washington, D.C. ,
GrodzinsM, Wladyslaw, Ellis B. Cowling, AMcja I. Breymeyer, Anna S. Phillips, Stanley I.
Auerbach, Ann M. Bartuska, and Mark A. Harwell [eds]. 1990. Ecological Risks: Perspec-
tivesfrom Poland and the United_States. National Academy of Sciences Press: 415 pp.
Harwell, Mark A. and Jack Gentile, with Steve Bartel, Ann Bartuska, David Weinstein,
Tom Duke, William Smith, Robert Huggett, and Richard Wiegert. Draft in preparation.
Ecological Risk Assessment Guidelines Strategic Planning Workshop, Miami FL, May 1991.
U.S. Environmental Protection Agency, Washington, D.C,
National Research Council (NRC). 1983. Risk Assessment in the Federal Government;
Managing the Process. Committee on the Institutional Means for Assessment of Risks to
Public Health, Commission on life Sciences, National Research Council. National Academy
Press, Washington, D.C.
j-
National Academy of Sciences (NAS). 1990. Monitoring Troubled Waters. National
Academy Press. Washington, D.C.
Science Advisory Board (SAB). 1990a. Reducing Risk: SettingJgriorities and Strategies for
Environmental Protection. EPA SAB-EC-90-Q2L U.S. Environmental Protection Agency,
Washington, D.C.
Science Advisory Board (SAB), 1990b. The Report of the Ecology and Welfare Subcom-
mittee. Relative Risk Reduction Project. Reducing Risk Appendix A. EPA SAB-EC-90-G2-
1A. U.S. Environmental Protection Agency, Washington, .DC.
SETAC. 1987. Research Priorities in Environmental RislcAssessment Editors: Fava,
J.A., WJ, Adams, R.J, Dickson, K.L. Dickson, and W.E. Bishop. Published by the
Society of Environmental Toxicology and Chemistry.
R-l
------- |