Philip Morris
Safeguarding the Future: Credible Science, Credible Decisions
Fields
- Author
- Goldstein, B.D.
- Loehr, R.C.
- Nerode, A.
- Risser, P.G.
- Loehr, R.C.
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- CORPORATE AFFAIRS/EEMA ARCHIVE
- Attachment
- 2501205636/2501205694
- 2501205637/2501205694
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- Stmn/Rl-002
- Stmn/R1-048
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- REPT, REPORT, OTHER
- Recipient (Organization)
- Epa, Environmental Protection Agency
- Document File
- 2501205235/2501205695/Ets Epa II 910000 - 930000
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- Reilly, W.K.
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- Expert Panel on the Role of Science at E
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- Named Person
- Wilson, J.D.
- Benforado, J.
- Clelandhamnett, W.
- Delaney, S.C.
- Goldstein, B.D.
- Leopold, A.
- Loehr, R.C.
- Nerode, A.
- Reilly, W.K.
- Risser, P.G.
- Robarge, G.
- Barrera, L.L.
- Barrera, T.N.
- Belton, K.
- Benjamin, M.
- Camp, P.J.
- Carton, R.
- Cohen, S.
- Davies, P.
- Flamm, W.G.
- Garvin, P.
- Goodell, J.
- Jarman, R.
- Jones, J.
- Kaupert, A.W.
- Keeler, A.
- Lee, N.L.
- Mcdavid, S.
- Page, B.
- Putzrath, R.M.
- Riser, S.
- Santalla, A.
- Sudja, R.
- Trauben, B.K.
- Turner, S.
- Wamsteed, D.
- Ware, P.
- Benforado, J.
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This report was written by the Expert Panel on the Role
of Science at EPA. The Panel is an independent advisory
committee established solely to provide to the EPA
Administrator a set of recommendations for how the
Agency can best meet the goal of using sound science
for its decisionmaking. The contents of this report do
not necessarily represent the views and policies of EPA
or of other federal agencies.
Cover photos by S.C. Delaney
Saf eguarding the Future:
Credible Science, Credible Decisions
The Report of the Expert Panel
on the Role of Science at EPA
to
William K. Reilly
Administrator
U.S. Environmental Protection Agency
March 1992
I
n
Mr. William K. Reilly
Administrator
US. Environmental Protection Agency
Washington, DC 20460
Dear Mr. Reilly:
Earlier this year, you asked us to help identify how EPA can meet the goal of using sound
science as the foundation for the Agency's policy and program decisions. You asked us to
recommend ways to: (a) ensure that EPA has up-to-date, objective scientific information for
decisionmaldng, (b) ensure that EPA's planning, resources, and leadership produce the
knowledge base needed to achieve the Agency's new vision, (c) ensure that the research and
scientific information needs of the programs and regions are met, and (d) enhance the stature
of science within EPA and among the many constituencies with which EPA interacts.
To accomplish this task, we interviewed more than 30 individuals who have experience with
these issues. We also held three public meetings that included individuals from various EPA
offices and programs, other government agencies, industry, environmental groups, and other
organizations. In addition, we requested written comments and received letters from more
than 25 individuals, primarily from the EPA regional offices. We were impressed that so many
people wished to help EPA find better ways to acquire and use sound scientific information.
A number of consistent themes emerged from the discussions and comments. Everyone who
spoke with the Panel agreed that EPA needs its own strong science base to carry out its
mission effectively. At the same time, the Agency needs to make certain structural changes to
improve the quality of its science and the way science is used in decisionmaldng. In this
report, we have developed these themes as a series of findings and recommendations about
science at EPA. Induded are suggestions for both short- and long term measures to enhance
the use of sound scientific and technical information throughout the Agency.
We look forward to your serious consideration of these findings and recommendations
and encourage you to take the necessary next steps as soon as possible. We appreciate the
opportunity to be of assistance.
Sincerely,
Expert Panel on the Role of Science at EPA
Raymond C. Loehr, Chair
Bernard D. Goldstein
Anil Nerode
Paul G. Risser
Contents
a
Page
TRANSMITTAL LETTER .................................................... ii
EXECUTIVE SiJMMARY ...................................................... 1
THE EXPERT PANEL ....................................................... 10
BACKGROUND ...........................................................13
FINDINGS AND RECOMMENDATIONS
I. THE MISSION AND DIRECTION OF EPA SCIENCE .................. 16
II. THE QUALITY OF SCIENCE AT EPA ................................ 23
IlL THE QUALITY OF SCIENTISTS AT EPA ............................. 29
IV. HOW THE BUDGET PROCESS AFFECTS SCIENCE AT EPA ........... 33
V. HOW EPA USES SCIENCE IN DECISIONMAKING ................... 36
APPENDICES
A. STRATEGIC DIRECTION FOR THE US. ENVIRONMENTAL
PROTECTION AGENCY ........................................... 39
B. CHARGE TO THE EXPERT PANEL (MAY 22,1991)
AND AFFILIATIONS OF PANEL MEMBERS ......................... 43
C. PERSONS INTERVIEWED BY THE EXPERT PANEL .................. 46
D. RECORD OF PUBLIC MEETING ATTENDANCE
AND WRITTEN COMMENTS ...................................... 49
iii
ACKNOWLEDGMEIVTS he Expert Panel acknowledges the support provided by EPA for this
Tendeavor. Our thanks to Wendy Cleland-Hamnett, Jay Benforado, and Gail
Robarge for their diligent efforts, which were critical to the successful completion
of this project.
iv
~~-- -_-~
Executive Summary
BACKGROUND he mission of the U.S. Environmental Protection Agency (EPA) is to preserve
Tand improve the quality of the environment, protect human health, and
safeguard the productivity of natural resources on which all human activity
depends. To achieve these aims, the Agency is committed to ensuring that
"national efforts to reduce environmental risk are based on the best available
scientific information communicated clearly to the public" (Strategic Direction for
the U.S. Environmental Protection Agency: EPA...Preserving Our Future Today, 1991).
EPA also is dedicated to "providing leadership in the nation's environmental
science, research, and assessment efforts." This includes:
Gathering and analyzing the data needed to
evaluate environmental risks and trends, measure
environmental results, and inform the choices of
institutions and individuals throughout society.
Promoting and supporting innovative
technological solutions to environmental
problems.
Encouraging and conducting research that
improves our understanding of health and
ecological risks.
Providing objective, reliable, and understandable
information that helps build trust in EPA's
judgment and actions.
Sharing research findings and innovative
technologies with other nations.
In addition, EPA must be able to anticipate environmental problems caused by
new and existing technologies and by societal changes.
Executive Summary 1
I
BACKGROUND Several recent reports, including Future Risk Research Strategies for the 1990s (1988,
(CONTIIwED) SAB-EC-88-040) and Reducing Risk: Setting Priorities and Strategies for Environmen-
tal Protection (1990, SAB-EC-90-021), stressed that EPA must have a strong science
base to accomplish these goals. Scientific knowledge has assumed an increasingly
critical role as the environmental issues faced by the nation and the world grow
in complexity and cut across all environmental media. The Agency must improve
the scientific data and analytical methodologies needed to make sound decisions;
to set risk-based priorities for protecting health and the environment; to support
a new emphasis on protecting the health of the nation's ecosystems (such as
forests, lakes, and wetlands); and to contribute to international environmental
efforts.
THE EXPERT PANEL
ON THE ROLE OF
SCIENCE AT EPA
2 Executive Summary
In early 1991, EPA Administrator William K. Reilly established the Expert Panel
on the Role of Science at EPA as an independent advisory committee under the
Federal Advisory Committee Act. The Expert Panel was charged with evaluating
how EPA can meet the goal of using sound science as the foundation for Agency
decisionmaking. The four members of the Panel were:
Dr. Raymond C. Loehr (Chair of the Panel), H.M.
Alharthy Centennial Chair in Civil Engineering,
University of Texas.
Dr. Bernard D. Goldstein, Director, Environmental
and Occupational Health Sciences Institute,
Rutgers University and University of Medicine
and Dentistry of New Jersey-Robert Wood
Johnson Medical School.
Dr. Anil Nerode, Professor of Mathematics and N
tn
Computer Science, Goldwin Smith Chair and ~
~
Director, Mathematical Sciences Institute, Cornell ~
University. Ln
Dr. Paul G. Risser, Provost and Vice President for ~
Academic Affairs, University of New Mexico. ~
These individuals conduct extensive research programs and have had consider-
able experience with various EPA programs. In addition, they have served on
national committees evaluating scientific and technical programs.
APPROACH ver a period of four months, the Panel held three public meetings and inter-
Oviewed more than 30 individuals from EPA, other government agencies,
industry, environmental groups, and other organizations. The Panel also
requested written comments and received letters from more than 25 individuals,
primarily from the EPA regional offices.
The Panel performed no other independent evaluation of science at EPA; it did
not review current research programs, visit EPA laboratories, or examine reports
and data generated by EPA program and regional offices. Given the short time
available for the Panel's review, the Panel determined that interviews and meet
ings with knowledgeable individuals within and outside EPA would be a more
effective means of responding to its charge.
The meetings and discussions focused on five topics that are crucial to obtaining
and using sound science for credible decisions:
The mission and direction of EPA science.
The quality of science at EPA.
The quality of scientists at EPA.
How the budget process affects science at EPA.
How EPA uses science in decisionmaking.
The Panel defined science as encompassing a range of activities, induding
research and development, technical and regulatory support, monitoring, data
collection, review and interpretation of technical studies, and assessments of
health and environmental risk. The Panel intentionally included the science
activities carried out in EPA program, policy, and regional offices, since such
activities are part of the science EPA uses for decisionmaking. It also included the
quantitative social sciences, such as economics, in addition to the physical,
chemical, and biological sciences.
Executive Summary 3
MAJOR FINDINGS
AND
RECOMMENDATIONS
~
Overall, the Panel
affirms that EPA needs
its own strong science
base to provide the
' background required for
effective environmental
,j
protection programs.
T he Panel found that several consistent themes and concepts emerged from
the meetings, interviews, and letters. These are summarized in the findings
and recommendations presented in subsequent sections of this report. Overall,
the Panel affirms that EPA needs its own strong science base to provide the back-
ground required for effective environmental protection programs. Currently, EPA
science is of uneven quality, and the Agency's policies and regulations are
frequently perceived as lacking a strong scientific foundation. To remedy these
problems, the Panel recommends that EPA leadership undertake a deliberate and
continuing effort to create the climate, culture, and incentives necessary to
encourage superior science. The Panel recommends several specific structural
changes to enable EPA to obtain and use the high-quality science it needs to
realize its mission. These changes address science throughout the Agency, not
only in the Office of Research and Development (ORD). The Panel's central
findings and recommendations are listed below
1
FINDING: EPA does not have a coherent science agenda and operational plan to
guide scientific efforts throughout the Agency and support its focus on relatively
high-risk environmental problems.
RECOMMENDATION: The Agency has moved in the right direction with its
new issue-based planning process. EPA should further develop this process with
the overall goal of producing a broadly based, rational plan to acquire and use
the best scientific information. This planning process should apply to science
throughout the Agency. Through this process, EPA can break from the past and
shift toward the cross media, anticipatory research needed to address complex,
long-term, and global environmental problems.
4 Executive Summary
The Panel recommends
that EPA leadership
undertake a deliberate
and continuing effort to
create the climate,
culture, and incentives
necessary to encourage
superior science.
2
FINDING: EPA has not dearly conveyed to those outside or even inside the
Agency its desire and commitment to make high-quality science a priority.
RECOMMENDATION: EPA should send strong, dear signals to the scientific
community and the public about its commitment to develop and use the best
science for guidance and decisions. One immediate step to accomplish this could
be the initiation of regular science briefings for the Administrator by EPA and
non-EPA scientists on topics of critical concern to the Agency.
3
FINDING: The science advice function-that is, the process of ensuring that
policy decisions are informed by a dear understanding of the relevant science-
is not well defined or coherently organized within EPA.
RECOWviENDATION: The Administrator should appoint a "science advisor" to
ensure that credible scientific information for EPA guidance and decisions is
available from both EPA scientists and the broader scientific community. The
science advisor would implement a peer review and quality assurance program
for all EPA's science-based products, improve the Agency's responsiveness to the
science needs of EPA policymakers, play a key role in evaluating the professional
activities of all scientists at EPA, and provide scientific advice to the
Administrator.
MAJOR FINDINGS
AND
RECOMMENDATIONS
(CONTINUED)
4
FINDING: In many cases, appropriate science advice and information is not
considered early or often enough in the decisionmaking process.
RECOMMENDATION: EPA should take steps to ensure that science enters the
decisionmaking process early and often. In regulatory development, EPA should
implement a widely advertised, open process enabling the Agency to hear the
scientific opinions of all parties. In addition, the Agency should analyze how it
used science in developing one or more major regulations. The goal of this
analysis would be to determine the type of scientific and technical information
needed to ensure scientifically credible decisions, as well as the points in the
regulatory process at which scientific input is most effective. The analysis should
take into account the varying needs and decisionmaking processes of the
different EPA program offices.
5
FIlVDING: The development and nurturing of human resources are central to
improving science at EPA.
RECOMMENDATION: For ORD scientists, the Panel recommends continued
attention to appropriate science and science management career tracks. For
scientists in EPA program and regional offices, the Panel recommends
establishing a science career track similar to that in place for those providing
legal advice. The Agency also should enhance rotational opportunities that allow
EPA scientists to participate in the broader scientific community and non EPA
scientists to work more closely with EPA's science programs.
2501205640
6 Executive Summary
6
FINDING: EPA requires that its scientific research products undergo peer review.
However, the Agency does not have a uniform process to ensure a minimum
level of quality assurance and peer review for all the science developed in
support of Agency decisionmaking.
RECOMMENDATION: Quality assurance and peer review should be applied to
the planning and results of all scientific and technical efforts to obtain data used
for guidance and decisions at EPA, induding such efforts in the program and
regional offices. Such a requirement is essential if EPA is to be perceived as a
credible, unbiased source of environmental and health information, both in the
United States and throughout the world.
7
FINDING: A number of outstanding externally recognized scientists work at
EPA. However, the Agency lacks the critical mass of externally recognized
scientists needed to make EPA science generally credible to the wider scientific
community.
RECOMMENDATION: EPA should recruit four to six research scientists or
engineers with world-class reputations and provide them with a significant,
long-term commitment of support. These individuals should be national and
international leaders in scientific areas vital to the Agency's long-term strategy
and direction. They would serve as mentors for developing scientists and
provide access to networks of world-class scientists.
2501205649
Executive Summary 7
%= 1
MAJOR FINDINGS
AND
RECOMMENDATIONS
(CONTINUED)
8
FINDING: For EPA to establish a reputation for having high-quality science to
support its decisionmaking, its science activities must become more widely
known. Academia, Congress, other federal agencies, industry, and the public
generally are unfamiliar with the work of EPA scientists.
RECOMMENDATION: The Agency should undertake a communications,
outreach, and education effort to publicize the activities and accomplishments of
EPA scientists.
9
FINDING: EPA often does not evaluate the impact of its regulations. Implementa-
tion of an environmental policy or regulation provides a unique opportunity to
study the environmental response to changes brought about by regulations, such
as changes in the type and amount of pollutants.
RECOIViMENDATION: The Agency should scientifically evaluate the environ-
mental improvements brought about by the major regulations it promulgates.
This will help EPA better understand the effectiveness of its regulatory strategies
and how those strategies affect environmental processes.
8 Executive Summary
a
10
FINDING: EPA science could benefit substantially from increased scientific
contact and openness with other organizations.
RECOMMENDATION: The Agency should encourage increased participation of
its scientists in the activities of the scientific community. It should enhance
relationships with other federal agencies and appropriate industrial and
academic research organizations and promote the participation of EPA scientists
in the technical activities of professional societies.
11
FINDING: EPA has not consistently enlisted the nation's best scientists to
provide the research and technical information needed for decisionmaking.
Problems in the Agency's approach to academic grants and centers have
discouraged many university-based experts from working with EPA. In addition,
the program and regional offices and ORD laboratories often rely on contractual
mechanisms that prevent EPA from obtaining the best outside scientists to work
on EPA issues.
RECOMMENDATION: EPA should move quickly to bolster its grants and
centers program. The Agency also should implement a long-term plan to replace
contractual mechanisms that may be detrimental to obtaining the best possible
scientific information.
Executive Summary 9
il
The Expert Panel
E PA's 1991 statement of strategic direction (Appendix A) calls for sound
science to serve as the foundation for the Agency's policy and program
decisions. In May 1991, EPA Administrator William K. Reilly established the
Expert Panel on the Role of Science at EPA as an independent advisory
committee to the Agency under the Federal Advisory Committee Act. The Panel,
consisting of Drs. Raymond C. Loehr (Chair), Bernard D. Goldstein, Anil Nerode,
and Paul G. Risser, was charged with developing recommendations to help the
Agency achieve the following goals:
Identify how best to provide the Administrator
with up-to-date, objective scientific information in
keeping with the Agency's new strategic direction.
Ensure that the knowledge base necessary to
achieve the new vision is available through proper
planning, adequate resources, and necessary
leadership.
Ensure that the research and scientific information
needs of the programs and regions are adequately
met and their views incorporated in the scientific
advice provided to the Administrator.
Enhance the stature of science within EPA and
among the many constituencies with which the
Agency interacts.
The Administrator asked the Panel to work with the Assistant Administrator for
Research and Development and other EPA offices to accomplish this task and
asked the program Assistant Administrators to cooperate fully in this endeavor.
Additional details about the charge to the Panel and the affiliations of Panel
members are included in Appendix B.
2501205652
10 The Expert Panel
The Administrator asked that the Panel report back with its recommendations in
four to six months. Given this short time frame, the Panel decided to rely
primarily on interviews with key science and policy leaders, both within and
outside EPA, to identify areas of concern and generate ideas for solutions. The
Panel did not conduct any other independent evaluation of science at EPA; it did
not review current research programs, visit EPA laboratories, or examine reports
and data generated by the program and regional offices.
Over a period of four months, the Panel held three public meetings to discuss the
role of science at EPA. It also interviewed more than 30 individuals from EPA,
other government agencies, industry, environmental groups, and other organi-
zations. These discussions took place in dosed fact fmding sessions to ensure an
open expression of views. Because the time available for interviews was limited,
the Panel also requested written comments. More than 25 individuals, mostly from
the EPA regional offices, sent written comments to the Panel. Appendix C lists
the individuals interviewed by the Expert Panel and Appendix D lists those who
attended the public meetings or provided written comments.
The Panel completed its fact-finding in September 1991. The Panel thanks
everyone who attended the public meetings, participated in discussions, and
submitted comments for their candid and helpful input. The Panel apologizes to
the many people it was unable to interview in person.
During the meetings and discussions, the Panel focused its attention on five
topics crucial to the acquisition and use of sound science in support of decision
making at EPA:
The mission and direction of EPA science.
The quality of science at EPA.
The quality of scientists at EPA. '
How the budget process affects science at EPA.
How EPA uses science in decisionmaking.
The Expert Panel 11
In this report, the Panel uses the term "science" in its broadest sense: it encom-
passes a range of activities, induding research and development, technical and
regulatory support, monitoring and data collection, review and interpretation of
technical studies, and assessments of health and environmental risks. By using
this definition, the Panel intentionally indudes the scientific activities conducted
by EPA program, policy, and regional offices; these activities are part of the
science EPA uses in its decisionmaking. The Panel also indudes the quantitative
social sciences, such as economics, as well as the biological, chemical, and
physical sciences.
A number of consistent concepts and views emerged during the Panel's fact
finding process. Everyone who spoke with the Panel agreed that EPA needs its
own strong science base to carry out its mission effectively. At the same time, all
expressed concerns about the quality of EPA science and encouraged improve-
ments in the way EPA uses science in decisionmaking. The following pages detail
the Panel's findings concerning science at EPA and recommendations for addressing
those concerns. These findings and recommendations represent the Panel's
synthesis and evaluation of the ideas provided in the interviews, public
meetings, and written comments.
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Background
e basic mission of EPA is to preserve and improve the quality of the environ
ment, protect human health, and safeguard the productivity of natural
resources on which all human activity depends. In carrying out this mission, EPA
must implement the programs mandated by law as its first priority. However, it
has responsibilities beyond the activities mandated by legislation. It also must
provide leadership on the scientific and policy issues involved in environmental
protection. In addition, EPA must develop, evaluate, and use risk reduction
strategies, including those that go beyond the conventional command and-
control regulatory approach, in varying political, cultural, and social contexts.
Previous advisory reports stressed that EPA needs a strong scientific base for its
decisions. Future Risk: Research Strategies for the 1990s (1988, SAB-EG88-040) and
Reducing Risk: Setting Priorities and Strategies for Environmental Protection
(1990, SAB-EC-90-021) made many recommendations about science at EPA. Fu-
ture Risk, for example, recommended that EPA plan and implement a long-term
research program in specific core research areas, improve its capability to
anticipate environmental problems, and expand its efforts to understand how
and to what extent people are exposed to environmental pollutants. Reducing Risk
argued that, to take advantage of the best opportunities to reduce risk, EPA must
improve the data and analytical methodologies that support the assessment,
comparison, and reduction of different environmental risks.
Many changes are under way in ORD, the program offices, and the regional
offices to bring about needed changes in EPA science. This report builds on
previous advisory reports to EPA, current activities within EPA, and the
knowledge of individuals in other government agencies and the private sector
who have faced similar problems in providing high-quality science for decision
making. The report focuses on structural changes to ensure that EPA science can
help the Agency realize its new vision for environmental protection. These
findings and recommendations are another building block in EPA's efforts to
safeguard human health and the environment. 2501205655
~
Background 13
.-; - - --- -
I
_-~~~_
THE ROLE OF According to EPA's 1991 statement of strategic direction (Appendix A), EPA is
SCIENCE AT EPA ,['&committed to ensuring that national efforts to reduce environmental risk are
based on the best available scientific information communicated dearly to the
public. EPA should be a credible source of science information for all parties
within and outside EPA. To achieve this goal, the Agency must acquire scientific
information from its own programs as well as from industry, academic
institutions, other government agencies, private organizations, and other nations.
A key role of science at EPA is to reduce uncertainties in environmental decision-
making. While scientists have made significant progress in measuring and com-
paring risks to human health and the environment, many uncertainties remain.
For example, most of our current knowledge concerning how humans respond to
environmental pollutants comes from research with laboratory animals under
conditions very different from those that humans actually experience. Many
uncertainties, therefore, are involved in deducing how the information gained
through this laboratory research applies to people. Other areas of uncertainty
indude the impact of chemical mixtures and other general stressors on the
envirornnent. People and ecosystems are exposed not simply to single chemicals,
but to mixtures of different chemicals. The environment is also affected by
complex, diffuse factors such as temperature changes, habitat loss, and ozone
depletion. EPA historically has focused on chemical specific impacts and has not
developed methods to assess or control the effects of chemical mixtures and
general stressors on humans and ecosystems.
Science is especially necessary to characterize today's subtle and complex
environmental problems that cut across all environmental media (air, water, and
land) and transcend national boundaries, such as loss of species diversity, acid
deposition, and stratospheric ozone depletion. Science, in fact, is inherently
cross-media and international in nature and can be the catalyst for focusing
greater attention on cross-media environmental issues.
Science is also key to determining which environmental problems pose the
greatest risks to human health, ecosystems, and the economy. In the absence of
sound scientific information, it is likely that high-proffle but low-risk problems
will be targeted, while more significant threats are ignored. When science and
14 Background
2501205656 --
data are uncertain, regulations and policies are often developed to protect every
person or every ecosystem uniformly against hazards that few will actually
experience. This can impose a heavy burden on the economy and society without
providing better protection for most of the population or the nation's ecosystems.
The technical support programs maintained by EPA and other agencies are essen
tial to developing the scientific information needed to accurately gauge the costs
and benefits of proposed regulations and nonregulatory strategies.
In addition, science is critical for developing cost-effective strategies to reduce
environmental risks. It provides a foundation for the Agency's efforts to make
greater use of alternatives to traditional approaches to risk reduction, to develop
and improve pollution control technologies, and to identify changes that all
sectors of society can make to prevent or reduce pollution.
F'inally, science is needed to help anticipate future environmental problems. For
example, carefully structured monitoring programs combined with rigorous
analysis can paint an accurate picture of present conditions, describe what is
happening to an individual or an ecosystem over time, and help predict the
environmental consequences of future actions. If scientists can identify emerging
environmental trends and their consequences, EPA and the nation can take steps
now to reduce the risks posed by these trends, rather than pay the much larger
costs to address problems that have evolved to maturity
In short, science is one of the soundest investments the nation can make for the
future. Strong science provides the foundation for credible environmental
decisionmaking. With a better understanding of environmental risks to people
and ecosystems, EPA can target the hazards that pose the greatest risks, anti
cipate environmental problems before they reach a critical level, and develop
strategies that use the nation's, and the world's, environmental protection dollars
wisely.
250120565?
Background 15
1
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.Z.
The Mission and Direction
of EPA Science
~ EPA's environmental protection strategies are undergoing important shifts--for
example, toward setting risk based priorities, a greater emphasis on pollution
~ prevention, and increased attention to reducing ecological risks. To support and help
define these changes, the mission and direction of EPA science must evolve as well.
In addition, because limited resources prevent EPA from being equally strong in
all areas, the Agency must dearly define the mission and direction of its science
activities. Other organizations (such as other government agencies, academic
institutions, and industry) have strong programs in scientific and technical areas
pertinent to the interests of EPA; information from those programs should be
available and used for EPA guidance and decisionmaking. Therefore, it is impor-
tant to identify the scientific areas in which EPA should maintain its own strength
The Panel addressed the following questions regarding the mission and direction
of EPAscience:
In which scientific areas should EPA be a leader,
and in which should it be primarily a catalyst for
and a user of information?
How can the Agency be aware of and acquire
information from the broader scientific
community?
How is the Agency's strategic planning process r~j
shaping the mission and direction of EPA science? un
' v
To whatexbent is EPA's desire to base decisions on the ~
best scientific information recognized outside EPA? o
t1t
What is the perception of EPA science in the M
broader scientific community and among o~o
decisionmakers who draw upon scientific and
technical knowledge?
16 Mission and Direction
-a=
FINDIlVGS 1 EPA needs its own strong science base to provide the scientific foundation for
effective decisionmaking. This is true for a number of reasons:
EPA decisions frequently are controversial and
affect broad sectors of society and the economy.
Controversial issues demand a strong science base
when decisions are made.
EPA cannot rely only on other government
agencies to develop the scientific information it
needs for decisionmaldng.
The existence of its own science base allows EPA
to tie science to long term regulatory objectives
and other environmental protection strategies.
Interaction between scientists and policymakers is
essential for sound decisionmaking.
Some scientific activities, such as controlled
human exposure studies, require special facilities
that are beyond the capability of most
university-based research programs.
Several examples clearly illustrate the importance of in house EPA expertise.
In the early 1980s, non ionizing radiation was thought to present little risk to
human health. As a result, EPA lost its funding for the handful of researchers
it had in this area. This loss of in house expertise has left the Agency in an
awkward position as it attempts to respond to today's rapidly escalating
concerns about the health effects of non ionizing radiation.
In contrast, in the mid-1980s, EPA was able to obtain adequate funding to
begin a research program in the new field of biotechnology. The Agency
recruited a number of scientists who were experts in using the tools of
modern biology. When the Exxon Valdez spilled 11 million gallons of crude oil
in Prince William Sound, Alaska, in 1989, these scientists helped lead a highly
acclaimed research effort to develop a cleanup method using nlicroorganisms
to break down oil on contaminated beaches.
Mission and Direction 17
FINDINGS Z Regulations are based on both technical and policy considerations. Improper
(corrrIIVUED) decisions can result if either the scientific or policy input is flawed. A percep-
tion exists that regulations based on unsound science have led to unneeded
economic and social burdens, and that unsound science has sometimes led to
decisions that expose people and ecosystems to avoidable risks.
3. Despite substantial efforts on the part of the Agency, most people outside EPA
do not recognize that EPA has made strong science a priority
4. A number of scientists and engineers at EPA are recognized as being very
knowledgeable, conducting state-of-the-art research, and/or being highly
skilled at synthesizing and analyzing information. Overall, however, the
science base at EPA is not perceived as strong by the university community,
Congress, other federal agencies, or industry. Most EPA scientists are not seen
as playing a dominant or even influential role in the scientific community.
Several individuals indicated that EPA science has been virtually invisible
when broad national environmental policy issues are discussed and
developed.
5. Many officials involved in funding EPA science are uncertain about what
science products EPA has produced, and whether the quality and quantity of
these products are commensurate with the dollars expended. When Congres-
sional committees ask for a justification of proposed laws or regulations,
expert EPA scientists rarely are made available as a matter of course to
answer questions about the scientific defensibility of Agency decisions.
EPA policy and regulatory work receives a great deal of public attention; EPA
science receives a similar degree of attention only when the scientific basis of
a decision is questioned. It is crucial, therefore, that the Agency consistently
place its scientific goals and achievements before the public eye.
6. In response to the Science Advisory Board's recommendations in Future Risk:
18 Mission and Direction
Research Strategies for the 1990s, EPA established a core research program. The
core program is designed to generate knowledge to support atl areas of
environmental decisionmaking, not just the immediate needs of the program
offices.'The program also is intended to maintain a core of expertise and
2501 Za5660 _
resources that will provide the continuity needed for effective research. The
original priorities of the core program included:
Monitoring baseline conditions and trends in the
nation's ecosystems.
Developing new tools and strategies for pollution
prevention.
Establishing a national database on the extent and
nature of human exposure to pollutants.
Determining the human health effects of multiple
exposures to low levels of pollutants.
Supporting academic research on environmental
problems.
There appears to be increasing recognition across the Agency that funda-
mental research is needed to support EPA's strategic direction. The areas
addressed in the core program are somewhat narrow, however, and the core
research budget, while growing, is a small fraction of the Agency's overall
science budget.
7. EPA lacks a coherent agenda for science throughout the Agency. It also lacks a
coherent operational plan for its science activities (that is, a plan for iden-
tifying the most important scientific issues and a rational organizational
approach to acquiring the necessary scientific information). Both are essential
to support the Agency's focus on relatively high risk, cross-media environ-
mental problems. EPA's science strategy must include plans for science
activities to anticipate future environmental problems. The only certain
prediction for the future is that an environmental issue of critical importance
that no one has predicted will appear, EPA must have a strong science base
and flexibility to deal with unanticipated problems.
& EPA must draw on the expertise of other organizations to obtain the best
scientific information available. Currently, however, the Agency lacks
adequate mechanisms for acquiring such information from the broader
scientific community.
2501205661
Mission and Direction 19
- . _-~----~a~-.~ -~ - z
- =---=-~_
Global environmental issues represent one area in which EPA needs to tap the
expertise of other scientific organizations. EPA unquestionably is the lead
agency representing the United States on international environmental
matters, such as global warming and deforestation. This role has grown in
importance as the nation realizes how events elsewhere on the planet affect
the US. environment, as well as how environmental controls can improve
economic productivity and international competitiveness. EPA cannot fulfill
this role, however, unless it obtains scientific information from scientists
throughout the nation and the world.
RECONIlVIIIVDATIONS L EPA should make a deliberate effort to create and maintain the climate,
culture, and incentives necessary to encourage superior science at EPA.
2 The Administrator should send broad, dear, and continuing signals within
EPA, to the wider scientific community, and to the public about the
importance of having high-quality science to protect health and the
environment. Examples of actions EPA could undertake indude:
Requesting periodic briefings for the
Administrator by EPA and non EPA scientists on
issues of concern to the Agency.
Obtaining a full, documented discussion of the
scientific pros, cons, and uncertainties as decisions
and policies are developed.
Requiring credible, independent peer review of all
scientific and technical efforts by ORD and the
program and regional offices (including model
development and use, data collection and
evaluation, monitoring plans, research, technical
studies, scoping studies, and assessments).
Hosting workshops and meetings on scientific
issues for non EPA as well as EPA scientists, with
senior EPA management expected to attend.
20 Mission and Direction
3. To be seen as an unbiased source of environmental and health information,
EPA needs to make its scientific and technical efforts more widely known.
The Agency should develop and implement a coherent communications,
outreach, and education plan to publicize the scientific and technical output
the Agency is producing for the budget provided. This should be a high-
priority team effort on the part of ORD, the Office of Congressional and
Legislative Affairs, and the Office of Communications and Public Affairs.
The communications materials should be prepared in terms that non EPA
scientists, Congress, and the public can understand. They should describe the
short term research in support of regulation and policy and the long-term
anticipatory research performed by EPA laboratories, by other agencies with
EPA support, by external commercial contractors, and through university
grants and contracts.
4 EPA's current effort to modify its research planning process should be
watched carefully to ensure that it leads to a coherent science agenda and
operational plan for science throughout the Agency. The plan should define
the year-by-year structural changes and programs needed to implement the
Agency's risk-based approach. °
5. The Agency should assemble an anticipatory research program that draws on
the expertise of EPA and non EPA scientists. Such a program will help ensure
that EPA does not lose sight of future environmental problems while carrying
out its day-to-day activities.
6. EPA should build its core research program to address comprehensively the
following areas:
Release, transformation, transport, and fate of N
materials in the environment, induding pathways Ln
of exposure for humans and ecosystems. 0
~
Evaluation of ecological effects on a range of ,~p
geographic scales (such as local, regional, and Ln
global effects). Mrn
w
Ecological risk assessment.
Mission and Direction 21
r"r #.' . sq~
RECOrnvIENDATIONS Risk reduction technology research and
(corrrlNt7M) development.
Monitoring and evaluation of environmental
trends.
Prediction and evaluation of environmental risks
to humans.
7. EPA should initiate collaboration with other agencies and the broader
scientific community to formulate a joint national strategy for the
environment, recognizing that a stronger EPA science base is required for
such an initiative. A joint national strategy will allow EPA to exert leadership
in identifying current and long-range problems, induding those outside
EPA's areas of science expertise, and in developing a multi-agency plan.
& EPA should consider changing the name of the Office of Research and
Development to the Office of Science, Engineering, and Technology to
recognize the broader science responsibilities of the Agency.
I
22 Mission and Direction
The Quality of Science at EPA
obtained and
el attempted to determine the quality of science
The Panel defined a high-quality science prograT=m as one that
dearly identifies the most relevant scientific and technical issues; uses the most
powerful experimental and analytical designs; employs accurate measurement
techniques; evaluates the results with the most appropriate mathematical
models; and subjects the methods, results, and interpretations to independent
review by a wide variety of experts.
Issues the Panel considered regarding the quality of EPA science induded:
How can the quality of science be ensured?
To whom should contract or federal scientists be
accountable for the quality of their science:
scientific leaders or policymakers?
Is the science provided for decisionmaldng at EPA
the best available in the scientific community, or
only the best available within the EPA community?
What type of research should be done in house,
and what research should be subject to widely
advertised open competition?
At EPA, science in support of regulation is performed under contract to the
program and regional offices, in ORD laboratories, by contract employees, by
external contractors, by external grantees, and through external cooperative
agreements. It is in this context that the Panel discussed the above issues and
developed its recommendations.
2501205665
Quality of Science 23
=
-17------X4-1:--1
~-~^- --
,_~=~=~~='==
= y~__.= ~--=-
- - ~~-
_w
FINDINGS 1. Science should never be adjusted to fit policy. Yet a perception exists that EPA
lacks adequate safeguards to prevent this from occurring.
2 Quality assurance and peer review are essential for ensuring that the best
scientific information is used for decisionmaking. EPA requires that its
research products undergo peer review, but does not have an Agency-wide
policy for all science products.
Science activities to support regulatory development particularly those
carried out by the program and regional offices-do not always have ade-
quate, credible quality assurance, quality control, or peer review. Technical
studies and data collection efforts, for example, are an important component
of science at EPA, and are as important to environmental decisionmaking as
scientific and technical research projects. Yet they often lack significant
quality assurance and peer review.
In a significant number of instances, EPA receives sound advice from peer
review panels. However, this advice is not always heeded. The Agency lacks
a system of accountability that actively considers external advice and con
sciously makes decisions about its applicability and use.
3. EPA, like many other scientific organizations, does not give sufficient atten-
tion to validating the models, scientific assumptions, and databases it uses.
4. The present constituency served by EPA science consists primarily of the EPA
program offices and regions, not the broad scientific community In addition,
EPA does not regularly consult or sponsor the research of most of the best
external scientists working in areas of direct interest to EPA. These problems
stem, in part, from the inability of EPA's grants and centers program to inter-
face with the scientific community, given the limited funding available. The
many starts and stops in this program have been counterproductive for
eliciting the interest and cooperation of scientists outside EPA.
5. The use of large level-of-effort contracts in many parts of the Agency does not
promote or ensure the use of high-quality science. The program, regional, and
policy offices often use large level-of-effort contracts to conduct technical
2501205666
/
l
I
1
24 Quality of Science
I
0
studies. Many ORD laboratories have onsite contractors that may provide
services beyond basic support functions; scientists employed by contractors
sometimes even co-author EPA publications. In these situations, large
contracts apparently are used for administrative convenience. The Panel
believes that EPA's reliance on these types of contracts for technical expertise
prevents EPA from getting the best outside scientists to work on EPA issues.
In addition, work performed for EPA through level-of-effort type contracts
may not receive adequate quality assurance or peer review.
RECOr+MENDATIONS L The science advice function within EPA-that is, the process of ensuring that
policy decisions are informed by a clear understanding of the relevant
science-should be enhanced and coherently organized within EPA. The
Administrator should appoint a distinguished scientist or engineer to
#unction as EPA's science advisor. This individual could be selected from
within or outside EPA. The Panel feels strongly that the Agency needs a
science advisor with an appropriate level of support to ensure that credible
science for guidance and decisionmaking is available from both EPA scientists
and the broader scientific community.
The role of the science advisor would include:
0
I
Ensuring that EPA reaches out to the broader
scientific community for information.
- Bridging the potential gap between scientists and
decisionmakers within the Agency.
Being a key player when EPA makes policy
decisions. He or she would make sure that, before
the Agency makes a decision, it considers the
pros, cons, and uncertainties of the science
relevant to a policy or regulatory issue.
Playing a key role in evaluating the professional
activities of all EPA scientists as they are
considered for awards, promotions, and merit
salary increases.
Quality of Science 25
RECOIUIlvIIIVDATIONS Implementing a peer review and quality
(CONTINUED) assurance program (see Recommendation #2
below) for all EPA science-based products,
wherever they originate. This would provide
accountability for high-quality science throughout
EPA and would demonstrate that rigorous peer
review is expected for all scientific and technical
information used for decisionmaking.
Developing an appropriate relationship with
EPA's Science Advisory Board.
Although the details may differ, the role of the science advisor would be
analogous to the role of the General Counsel, who will not release a docu-
ment destined for an external audience until it is judged legally defensible.
This recommendation could be implemented using one of several different
models. In one model, the science advisor would be a strong senior scientist
on the Administrator's staff. He or she would provide independent scientific
opinions for all policy decisions and would directly influence the Admini
strator's final decisions. To ensure a relationship of confidence between the
science advisor and the Administrator, this individual could be chosen anew
by each Administrator. The science advisor would require a small staff and
would need access to the science advisory staff of the Assistant Administrators.
In a second model, the science advisor function would be performed by the
Agency's science off'ice. This model could be implemented using two
different organizational options: (a) The science advisor would be a career
scientist in the position of a Deputy Assistant Administrator under the Assistant
Administrator for Science, Engineering, and Technology. (ORD would be
renamed to acknowledge the Assistant Administrator's responsibility for
science throughout the Agency) (b) Alternatively, the Assistant Administrator
for Science, Engineering, and Technology would be the science advisor. He or
she would have two Deputy Assistant Administrators, separately responsible
2501205660
26 Quality of Science
1
for the science advice function and research operations. Under this model, the
science advisor would be in a position to direct scientific resources to address
the information needs identified through the science advice process.
Each of these approaches has both advantages and disadvantages.
For example:
A science advisor on the Administrator's staff
would be somewhat removed from scientists in
the Agency and would not be able to direct
resources to address scientific issues.
A science advisor who served as a Deputy
Assistant Administrator for Science, Engineering,
and Technology might have difficulty exercising a
strong role on the inner counsels of the
Administrator.
A science advisor who served as the Assistant PJ
Administrator for Science, Engineering, and Ln
Technology would both manage the research ~
...
organization and provide objective, independent NJ
scientific advice; in some cases, these Ln
responsibilities might conflict. For example, a ~
conflict might arise between promoting EPA ~
research products and providing independent
opinions on those products.
Ultimately, the model chosen will depend on the capabilities and require-
ments of the individual who is selected to be EPA's science advisor, as well as
the preference of the EPA Administrator.
2 Quality assurance and peer review should be applied to the planning and
results of all scientific and technical efforts, including research, technical
studies, and data collection, used for guidance or decisions at EPA. EPA's goal
should be to provide uniform peer review for the most significant science
activities in the Agency. EPA should institute an independent peer review
Quality of Science 27
S
RECONMENDATIONS program for all its science-dependent products, including those developed by
(coNTNi7ED) the program and regional offices. The current peer review process in ORD
should be reviewed, strengthened, and organized to ensure that all in-house
and extramural science programs receive timely, credible review.
Peer review and quality assurance should be required at early as well as final
stages of an effort. Peer review should be specified in the original study
design rather than considered only after the results are obtained. This will
ensure that the plans for such products, as well as the results, are scientifically
defensible.
3. EPA should give more attention to validating the models, scientific assump-
tions, and databases it uses.
4. EPA should place a high priority on establishing an effective grants and
centers program aimed at enlisting the nation's scientific expertise to address
issues of central importance to EPA.
5. EPA should thoroughly review the use of in house contracts by ORD and
level-of-effort contracts by program, regional, and policy offices. The
Agency's goal should be to replace many of these contractual approaches
with approaches that enlist the best scientific expertise for a given task. For all
research, studies, data collection, and other related scientific and technical
efforts, EPA should attempt to obtain the best scientists by using widely
advertised requests for proposals. EPA should look for ways to improve
administrative contracting procedures to facilitate the use of open,
competitive contracting by EPA offices and laboratories. The Agency should
develop and use explicit criteria for matching a scientific issue to be addressed
with the most appropriate research vehicle (such as in-house scientists,
university-based researchers, or researchers in other organizations).
Z5ai205670
28 Quality of Science
The Quality of Scientists at EPA
~+he Panel considered a number of issues related to the quality of the
j mdividuals at EPA who acquire, develop, and evaluate scientific and
technical information. These issues induded:
What is the current quality of scientists at EPA?
Does EPA provide a supportive environment with
sufficient incentives to encourage excellence in
science?
,
,
How can EPA attract, nurture, and keep scientists
of high quality?
FINDINGS 1 An inadequate infrastructure and a lack of long term support have limited
EPA to a small number of externally recognized outstanding scientists. The
Agency does not yet have the critical mass of such scientists needed to make
EPA science generally credible to the broader scientific community.
2 Many EPA scientists do not perform laboratory research, but rather provide
technical and regulatory support. The quality of these scientists should be
judged by somewhat different criteria than those that apply to research
scientists, but in both cases, standards for high quality science must prevail.
3. EPA provides insufficient incentives to reward the production of high-quality
science. The current reward system encourages scientists supporting
regulatory development to finish their analyses on time, even if additional
time might allow them to produce analyses that are sounder and more
credible from a scientific or technical standpoint.
Z501205671
Quality of Scientists 29
RECONA~IEENDATIONS 1 To increase the number of outstanding scientists and engineers in EPA
laboratories, the Agency should immediately recruit and make a long-term
commitment of support for four to six research scientists and engineers with
world-dass reputations. These individuals should be national and
international leaders in scientific areas vital to the Agency's long-term
strategy and direction. They would serve as examples and mentors for all
scientists within EPA. They also would bring with them access to networks of
world-class scientists, benefiting both younger scientists and EPA as a whole.
These scientists should be designated as special Scholars or Scientists (such as
Leopold Scholars, after the pioneering conservationist Aldo Leopold) to
provide dear recognition of their status and role. Qualified scientists and
engineers currently at EPA also should be eligible for recognition as named
Scholars or Scientists.
EPA should use a national and international competition with external
evaluation to attract these individuals. The Agency should ask the Science
Advisory Board to form a search committee and to recommend which
disciplines the four to six scientists should represent. The research areas
should be ones that are not strong in other agencies, but that are essential to
reducing uncertainties in EPA decisionmaking. Examples indude:
Risk reduction methods and terhnology.
Broad-scale ecological effects and risks.
Transport and fate of materials, including N
multi media pathways of exposure of humans 0
and ecosystems.
Cost-effective monitoring on a range of v
geographic scales. Ln
The biological basis for the prediction of health NJ
risks.
2 EPA should expand the use of career development paths, such as those in
place for research scientists. The Agency should establish a separate science
30 Quality of Scientists
career track for individuals in the program offices who have appropriate
scientific and technical background and who are regularly involved in
providing science advice or reviewing science issues and data for regulatory
purposes. This track would be analogous to that in place for those providing
legal advice (i.e., attorneys in Agency programs). It would indude the
requirement that the Agency's science advisor approve promotions (see "The
Quality of Science at EPA; Recommendation #1). Criteria for a scientist's
promotion should indude evidence of continuing advancement in his or her
discipline, such as completion of coursework, receipt of board certification, or
other professional recognition; publications in the relevant scientific
literature; and contributions to the work of scientific organizations.
Recommendations from leading non EPA scientists should also play a
significant role in advancement of scientists at EPA. A panel of scientists from
universities and other agencies should regularly evaluate the scientific
productivity of EPA scientists. This evaluation should be a requirement for
promotion of scientists within the Agency.
3. To ensure that EPA scientists are continually exposed to and challenged by
current knowledge and methodologies, the Agency should increase scientific
contact and openness with other government and private sector organizations,
induding industry, universities, trade associations, professional societies, and
environmental organizations. An example of a successful effort in this area is
the Soil Conservation Service's annual Science Day, where hundreds of
government scientists gather to network and hear technical reports on the
activities of sister agencies.
In addition, the Panel strongly recommends that the Agency expand oppor-
tunities for rotations that allow scientists from other organizations to work in
EPA's science programs and EPA scientists to participate in the scientific
efforts of other organizations. When an EPA scientist rotates to an academic
setting, the Agency should expect that he or she will produce peer-reviewed
publications. A successful rotation should assist an EPA scientist in obtaining
promotions and salary increases. An enhanced rotation program would not
only benefit EPA scientists but also promote joint research efforts by EPA with
2501205673
Quality of Scientists 31
RECOMMENDATIONS other scientific organizations. It would improve the Agency's ability to plan
tCpNTNUEDi and implement scientific studies needed for environmental guidance and
decisionmaking. A possible model for a rotation program might be found in
Japan, where industry scientists work in government laboratories.
4 EPA should use its reward structure to encourage superior science and
science management in the Agency. For example, to qualify for raises and
promotions, EPA scientists should be routinely required to prepare papers for
peer-reviewed journals and participate in relevant scientific societies in ways
that gain recognition for EPA science (for example, through involvement in
the conduct of meetings or governance of organizations). To support these
activities and enhance the Agency's scientific environment, EPA must
minimize its scientists' bureaucratic duties and ensure that they spend a
significant percentage of their time on scientific activities. In addition, EPA
should develop competitive compensation packages allotted on the basis of
comparison with the best of one's peers.
I
32 Quality of Scientists
How the Budget Process Affects
Science at EPA
The Panel addressed the issue of how EPA's research and science budget affects
the numbers and types of scientists at EPA, as well as the quality of the saence
the Agency undertakes. Key questions considered by the Panel included:
FnvDnvcs 1..
2.
How does the budget process affect the quality of
science at EPA?
Does the budget process discourage long-terln
strategic planning for high riskJhigh return
research?
Does the budget process hinder EPA in
conducting anticipatory research to identify
environmental problems before they become
critical?
Should a long term, anticipatory research budget
be separated from a short-term research and
development budget?
Finding solutions to today's increasingly complex environmental problems
requires a greater emphasis on a cross-media approach. EPA's budget,
however, does not adequately reflect this fact. The current budget process is
an obstacle to formulating and carrying out a coherent science strategy.
Currently, the yearly budget process for ORD is governed by a media-specific
approach that extends from within the Agency to the Office of Management
and Budget (OMB) and Congress. The process places an undue emphasis on
media-specific endpoints, to the detriment of science related to important
cross-media environmental problems.
Congress, OMB, and others currently do not understand the strategic direc-
tion EPA wishes to pursue in environmental science. EPA, in turn, cannot
present Congress with a rational argument for an appropriate funding level
2501205675
Budget Process 33
FINDINGS for science without first developing a coherent strategic plan for its science
(CONTIIWED) efforts.
RECOMMENDATIONS
3. EPA science programs currently are unable to carry out prolonged research or
anticipate future information needs. This is true for two reasons: first, the
Agency is not yet looking far enough ahead to be able to anticipate emerging
environmental problems; second, EPA's science programs are not structured
to allow for the continuity of funding needed to pursue long-term issues. The
current budget process makes it difficult, if not impossible, to ensure conti-
nuity of funding for the long-term, anticipatory research and assessment that
are essential to reducing uncertainty in future decisionmaking. These long-
term needs are often preempted by short term deadlines, leaving EPA and the
nation unprepared for later problems.
4. ORD's contribution to the technical support of regulations does not receive
the recognition it deserves, because these activities are not identified
separately from other science activities in the research budget.
5. Scientists outside EPA regard EPA contracts as the least desirable funding
mechanisms among those of all federal agencies because of inconsistencies in
direction and lack of funding continuity. These problems are imposed
primarily by the budget process. The consequences to the Agency are
enormous, because many of the nation's best scientists are deterred from
becoming involved in scientific efforts of importance to EPA.
L A comprehensive, long term scientific strategy should drive annual budget
decisions concerning EPA science. EPA should continue and strengthen its
current strategic issue planning process. Goals of the planning process should
indude developing dear objectives and obtaining continuity in funding.
2 EPA should place greater emphasis on cross-media planning and scientific
efforts, with the aim of examining all the effects of environmental processes
across all media. The Agency's environmental research program should have
a large cross-media component that defines the scientific activities required to
support the Agency's mission. A scientific understanding of cross-media
25012O5676 -
34 Budget Process
effects ultimately will result in a more coherent effort by the Agency to
address cross-media problems.
This new emphasis will require enhanced cross-media budgeting. EPA's
presentation of its research programs to OMB should reflect a cross-media
perspective rather than a perspective that fragments environmental
protection into different media.
3. EPA needs to dearly define the mission of each of its laboratories. When
laboratories collaborate on a topic, the Agency needs to determine how each
laboratory will organize and discharge its responsibilities. EPA must provide
the laboratories with the consistent support they require to accomplish their
missions.
4. EPA's budget must indude long term funding and support for anticipatory
scientific studies. The importance of these studies must be explained to
Congress and OMB so that, over the next few years, a portion of the Agency's
budget can be directed to critical future problems. EPA then can shift
resources to critical issues as they are discovered and mitigate their potential
impact.
5. EPA should use its budget to obtain the best possible scientific information
and ensure that the nation's scientific expertise is enlisted in the service of
EPA's mission. EPA should use the full suite of mechanisms available to
achieve these goals, induding grants and centers, contracts, and cooperative
agreements.
Budget Process 35
How EPA Uses Science in
Decisionmaking
E PA needs to obtain the best up-to-date, objective scientific and technical
information for decisionmaking. Equally important is how the Agency
applies that information to make credible decisions. The Panel addressed several
questions regarding how the Agency uses science in decisionmaking:
What is the role of science in the development of
regulations and policy? How is science
represented in the decisionmaking process?
Is university and industry science adequately
identified and used by EPA?
At what stages in the decisionmaking process
should science input from non-EPA sources be
available? Should the entire process of using
science in decisioranaldng be more open?
How can reputable scientific views, irrespective of
the policies being considered, be fairly
represented and assessed in all reports?
How can science enter the decisionmaking
process along with political pressures and input
from special interest groups and still maintain its
integrity?
FINDINGS L EPA should be a source of unbiased scientific information. However, EPA
has not always ensured that contrasting, reputable scientific views are
well-explored and well-documented from the beginning to the end of the
regulatory process. In addition, the Agency is perceived to have a conflict of
interest because it needs science to support its legal activities. The legal
process fosters the presentation of the extremes of scientific opinion. This
runs contrary to the preferred process of developing a consensus within the
scientific community. 2501205678
36 Science and Decisionmaking
2 EPA science is perceived by many people, both inside and outside the Agency,
to be adjusted to fit policy. Such "adjustments" could be made consciously or
unconsciously by the scientist or the decisionmaker.
3. While the public frequently expects immediate "yes or no" answers to
questions about environmental risks, scientific uncertainties often make such
answers elusive. EPA has not been successful in communicating to Congress
and the public about the nature of uncertainties in science and how these
uncertainties are handled when decisions are made.
4. EPA program offices often conduct scoping studies or other preliminary
assessments in the early stages of regulatory development. These studies are
frequently carried out without the benefit of peer review or quality assurance.
They sometimes escalate into regulatory proposals with no further science
input, leaving EPA initiatives on shaky scientific ground and affecting the
credibility of the Agency
5. EPA often does not scientifically evaluate the impact of its regulations. The
implementation of an environmental policy or regulation provides a unique
opportunity to study the environmental response to changes in the type and
amount of pollutants. It also represents the best time to begin evaluating the
effectiveness of a regulation or policy.
The importance of evaluating the effectiveness of regulations is demonstrated
by the way EPA has regulated primary air pollutants. The Clean Air Act
mandates that EPA review the primary air quality standards every five years.
While this schedule has not been met, the scientific basis for the regulation of
each of these agents has improved as a result of periodic reviews. In the case
of particulates, researchers have learned that small particulates that are easily
breathed into the lungs are mainly responsible for adverse health effects. This
knowledge has allowed EPA to replace the ineffective standard for total
suspended particulates and the emphasis on technological approaches aimed
at only the heavier particulates.
6. The interpretation and use of science is uneven and haphazard across
programs and issues at EPA. Conflicting science policies between EPA
programs create confusion and a lack of credibility for EPA decisions.
25012056?9
ience and Decisionmaking 37 i
t I+
7. Scientists at all levels throughout EPA believe that the Agency does not use
their science effectively.
RECONIlViENDATIONS
L The climate and culture within EPA should emphasize that science should
never be adjusted to fit policy, either consciously or unconsciously. For
example, the Agency must promote an atmosphere of open discussion in
which the scientific staff feels free to express conflicting opinions and
judgments without fear of reprisals.
2 To ensure that unbiased information is used to support decisionmaking, EPA
must be open to all scientific views and should develop mechanisms for
obtaining the consensus of the scientific community. In regulatory development,
EPA should implement a widely advertised, open process whereby the scien
tific views of all parties are heard prior to regulatory decisions. The results of
these discussions should be conveyed to EPA decisionmakers.
A successful model for this open process is the Clean Air Scientific Advisory
Committee of EPA's Science Advisory Board. This committee has consistently
provided an open forum for review and discussion of the science underlying
EPA's national ambient air quality standards. Consequently, this committee is
well-respected by scientific experts in the field.
3. EPA should implement a decisionmaking process whereby science advice is
provided as early as possible, beginning in the problem identification and
scoping phase and continuing throughout the development of policy, regula-
tions, and nonregulatory strategies.
To support this effort, EPA should examine how the Agency used science in
the past in developing one or more major regulations. The goal of such a
study would be to determine the type of scientific and technical information
needed for decisionmaking and the points at which scientific input is most
effective. This analysis may help the Agency identify places in the regulatory
process where science input is needed but was not included in previous
regulatory efforts. The study should take into account the varying needs and
decisionmaking processes of the different EPA program offices.
2501205680
38 Science and Decisionmaking
Appendix A
Strategic Direction for the
U.S. Environmental Protection Agency
"EPA... Preserving Our Future Today"
MISSION ~e people who work at the Environmental Protection Agency are dedicated
1 to improving and preserving the quality of the environment, both national
and global. We work to protect human health and the productivity of natural
resources on which all human activity depends. Highly skilled and culturally
diverse, we are committed to using quality management processes that
encourage teamwork and promote innovative and effective solutions to
environmental problems. In particular, we are committed to ensuring that:
Federal environmental laws are implemented and
enforced effectively.
U.S. policy, both foreign and domestic, fosters the
integration of economic development and
environmental protection so that economic
growth can be sustained over the long term.
Public and private decisions affecting energy,
transportation, agriculture, industry, international
trade, and natural resources fully integrate
considerations of environmental quality.
National efforts to reduce environmental risk are
based on the best available scientific information
communicated clearly to the public.
Everyone in our society recognizes the value of
preventing pollution before it is created.
People have the information and incentives they
need to make environmentally responsible choices
in their daily lives.
39
Schools and community institutions promote
environmental stewardship as a national ethic.
GoALS AND
PA's unique role in protecting the environment
E
includes:
OBjECTIVES
Providing leadership in the nation's
environmental science, research, and assessment
efforts. We are committed to:
- Gathering and analyzing the data needed to
evaluate environmental risks and trends, measure
environmental results, and inform the choices of
institutions and individuals throughout society;
- Promoting and supporting innovative technological
solutions to environmental problems;
- Encouraging and conducting research that
improves our understanding of health and
ecological risks;
- Providing objective, reliable, and understandable
information that helps build trust in EPA's
judgment and actions; and
- Sharing research findings and innovative
technologies with other nations.
Making sound regulatory and program decisions.
We are committed to:
- Implementing current environmental laws
effectively, and helping to improve those laws as
they are reauthorized in the future;
- Evaluating health and ecological risks, and
targeting our environmental protection resources at
the problems and the geographical areas posing the
greatest risks;
Promoting public and private actions that prevent
pollution at the source before it becomes a problem;
Protecting the environment as a whole by
developing programs that control the movement of
pollutants across environmental media;
Devising innovative, integrated solutions to
environmental problems, especially when they are
concentrated in specific geographic areas or
industries;
Improving the economic analyses that promote
efficiency and cost-effectiveness in our decisions;
Applying market mechanisms and economic
incentives when they are appropriate and effective;
and
Working with other government agencies to ensure
they consider the environmental implications of
their actions.
Effectively carrying out our programs and
policies. We are committed to:
- Meeting federal statutory obligations while
retaining sufficient flexibility to address priority
risks in different parts of the country;
- Maintaining a vigorous and credible enforcement
program, with emphasis on multi-media and
criminal violations;
- Promoting cross-media and interstate initiatives,
such as multi-media permitting and enforcement;
41
GOALS AND
OBJECTIVES
(CONTINUED)
April 1991
Enabling state and local governments, as partners,
to implement and enforce environmental programs;
Conveying dear, accurate, and timely information
to the public, and incorporating information from
the public in EPA activities; and
Involving other government agencies, public
interest groups, the regulated community, and the
general public in achieving national and global
environmental goals.
Improving the global environment. We are
committed to:
Maintaining and strengthening U.S. leadership to
protect and improve the global commons;
Worldng with other government agencies and
nations, the private sector, and public interest
groups to identify and solve transboundary
pollution problems;
Ensuring that environmental concerns are
integrated into U.S. foreign policy, including trade,
economic development, and other policies; and
Providing technical assistance, new technology, and
scientific expertise to other nations.
I
42
Appendix B
Charge to the Expert Panel and Affiliations of Panel
Members
U.S. Environmental Protection Agency
Charge to the Expert Panel on the Role of Science at EPA
1VIay 22, 1991
PURPOSE OF THE The Agency's new statement of strategic direction calls for sound science
gEV1EW serving as the foundation for the Agency's policy and program decisions.
The Administrator of EPA is establishing an Expert Panel to advise him on how
best to achieve the objectives set forth below. The Administrator has asked the
Panel to work with the Assistant Administrator for the Office of Research and
Development (ORD) and other EPA offices to accomplish this task. The
Administrator has also asked the program Assistant Administrators to cooperate
fully in this endeavor.
OBJECTNES To identify how best to provide the Administrator
with up-to-date, objective scientific information in
keeping with the new strategic direction.
To assure that the knowledge base necessary to
achieve the new vision is available through proper
planning, adequate resources, and necessary
leadership.
To ensure that the research and scientific
information needs of the programs and regions
are adequately met and their views incorporated
in the scientific advice provided to the
Administrator.
43
IF-
To enhance the stature of science within the
Agency and among the many constituencies with
which EPA deals.
CHARGE TO THE By the end of September 1991, provide to the Administrator a set of recom-
EXPERT PANEL mendations for achieving EPA science objectives. Among the specific issues
the Panel should consider:
How can the role of ORD and its significant
resources be enhanced to help fulfill these
objectives?
How should other organizational components of
EPA that carry out scientific work help assure
overall quality of science across the Agency?
How can organizational elements that collect,
store, manage, and interpret Agency data help
ensure the integrity and interpretive quality of
environmental data? Are changes needed in
cross-media data systems or program?G-e.g., the
proposed Center for Environmental Statistics?
How should EPA decisionmaking processes be
modified to ensure that regulatory policies are
consistent with the current state of science? How
can EPA ensure that the new emphasis on
nonregulatory approaches to environmental
problems will be based on a sound scientific
foundation?
How should current and planned science
resources be allocated to improve the scientific
basis for EPA decisionmaking?
How can EPA ensure that research is focused on
the highest priority environmental problems and
44
COMPOSITION OF
THE PANEL
anticipates the future information needs of EPA
programs? How can advances in scientific
understanding be incorporated into the Agency's
research programs and priorities?
How can the stature and reputation of science in
the Agency be improved?
How can EPA leverage the work of other federal
agencies and scientific institutions? How can EPA
work most effectively in the international scientific
community?
Raymond C. Loehr (Chair of the Panel)
H.M. Alharthy Centennial Chair in Civil Engineering
Department of Civil Engineering
University of Texas
Bernard Goldstein, M.D.
Professor and Chairman, Department of Environmental and
Community Medicine
Director, Environmental and Occupational Health Sciences Institute
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson
Medical School
Paul G. Risser
Provost and Vice President for Academic Affairs
University of New Mexico
Anil Nerode
Professor of Mathematics and Computer Science
Goldwin Smith Chair and Director, Mathematical Sciences Institute
Cornell University
Z5012D5687
45
Appendix C
Persons Interviewed By the Expert Panel
Name
Alvin L Alm
D. Allan Bromley
J. Clarence Davies
Paul M. Deisler, Jr.
Allan M. Ford
David M. Gibbons
George M. Hidy
Gene E. Likens
Margaret G. Mellon
Dallas L. Peck
Jimmie R. Powell
Walter R. Quanstrom
Affiliation
Director and Senior Vice President, Science Applications
International Corporation
President's Science Advisor
Executive Director, National Commission of the
Environment, Conservation Foundation
Vice President for Health, Safety, and
Environment (retired), Shell Oil Company
Member, Committee on Environmental Improvement,
American Chemical Society
Deputy Associate Director for Natural Resources,
Office of Management and Budget
Vice President for Environment, Electric Power
Research Institute
Director, Institute of Ecosystem Studies
Director, Biotechnology Project, National Wildlife
Federation
Director, U.S. Geological Survey
Professional Staff Member, Senate Environment and
Public Works Committee
Vice President, Environmental Affairs and Safety, Amoco
Corporation ' 2501205688
Michael L. Rodemeyer
David P. Rall
Terry F. Yosie
Frank E. Young
EPA Donald G. Barnes
Erich W. Bretthauer
Don R. Clay
Thomas P. Dunne
Lester D. Grant
Edward J. Hanley
Victor J. Kimm-
Richard D. Morgenstern
Thomas A. Murphy
Chief Counsel, House Science, Space and Technology
Committee
Former Director, National Institute for Environmental
Health Sciences
Vice President, Health and the Environment, American
Petroleum Institute
Deputy Assistant Secretary for Health/Science and
Environment, US. Department of Health and Human Services
Director, Science Advisory Board
Assistant Administrator, Office of Research and
Development
Assistant Administrator, Office of Solid Waste and
Emergency Response
Associate Administrator, Office of Regional Operations
and State/Local Relations
Director, Environmental Criteria and Assessment Office -
Research Triangle Park
Deputy Assistant Administrator, Office of Administration
and Resources Management
Deputy Assistant Administrator, Office of Pesticides and
Toxic Substances
Acting Assistant Administrator, Office of Policy, Planning
and Evaluation
Director, Environmental Research Laboratory - Corvallis
2501205689
47
I
EPA
(CONTINUED)
48
Dorothy E. Patton
Peter W. Preuss
Frank T. Princiotta
Courtney Riordan
William G. Rosenberg
Michael H. Shapiro
Director, Risk Assessment Forum
Director, Office of Technology Transfer and
Regulatory Support, ORD
Director, Air and Energy Engineering Research Laboratory -
Research Triangle Park
Director, Office of Environmental Processes and Effects
Research, ORD
Assistant Administrator, Office of Air and Radiation
Deputy Assistant Administrator, Office of Air and
Radiation
1 T =
i
.
1~
P
E
P
MEMBERS OF THE
PUBLIC ATTENDING
EXPERT PANEL
PUBLIC MEETINGS
App endix D
Record -of Public Meeting Attendance and
Written Comments
July 24,1991
Lisa L. Barrera
Ted N. Barrera
Mark Benjamin
Robert Carton
Patrick Davies
W. Gary Flamm
Paul Garvin
Andrew W. Kaupert
Nora L. Lee
Soonie McDavid
Resha M. Putzrath
Anne Santalla
Susan Turner
July 25,1991
Ted N. Barrera
Mark Benjamin
James Jones
Andrew W. Kaupert
Nora L. Lee
Anne Santalla
Robin Sudja
James D. Wilson
Barrera Associates, Inc.
Barrera Associates, Inc.
Environmental Policy Center
National Federation of Federal Employees
Covinston & Burling
Flamm Associates
Amoco Corporation
General Motors
Health and Environmental Science Group
Chemical Specialities Manufacturers
Organization Resources Counselors, Inc.
American Industrial Health Council
American Chemical Society
Barrera Associates, Inc.
Environmental Policy Center
Inside EPA
General Motors
Health and Environmental Science Group
American Industrial Health Council
Distilled Spirits Council of U.S.
Monsanto Co., St. Louis, MO
©
MEMBERS OF THE
PUBLIC ATTENDING
EXPERT PANEL
PUBLIC MEETINGS
(CONTIMJED)
August 19,1991
Ted N. Barrera
Keith Belton
Peter J. Camp
Robert Carton
Sanford Cohen
Joanne Goodell
Rich jarman
james Jones
Andrew W. Kaupert
Allison Keeler
Nora L Lee
Barry Page
Steve Riser
Anne Santalla
Bruce K. Trauben
Susan Turner
Dennis Wamsted
Pat Ware
Barrera Associates, Inc.
American Chemical Society
4100 Massachusetts Ave., NW, #314, Washington, DC
National Federation of Federal Employees
SC&A
OSHA Policy Directorate
NFPA
Inside EPA
General Motors
Environmental Policy Center
Health and Environmental Science Group
HIMA
Business Publishers Inc. (Toxic Materials News)
American Industrial Health Council
70013th St., NW, Suite 700, Washington, DC 20005
American Chemical Society
Environment Week
BNA - Environment Reporter
INT
PR(
CC
50
jNDIVIDUALS WHO
PROVIDED WRTI"TEN
COMMENTS
Jeff Barnett
Mary Ann Boyer
Dr. Robert J. Carton
Al Cimorelli
Robert Courson
Jeffery Denit
Gerard F. Egan
Edwin B. Erickson
Larry E. Erickson
Debra Forman
Robert J. Gnaedinger, Jr.
Susan C. Gordon
Terry Harvey
Nike J. Horoszewicz
Morris Kay
Arno1d Kuzmack
Robert Layton
Dominique Luetkenhoff
Suzanne Lussier
Bill Muir
Richard Nagle
Ron Preston
Resha M. Putzrath
Charlie Rhodes
Arthur Spingarn
Neil Swanson
Orterio Villa
EPA Region 3
EPA Region 3
Senior Vice President, National Federation of
Federal Employees
EPA Region 3
Director, Environmental Services Division, EPA Region 10
Deputy Office Director, EPA Office of Solid Waste
Chair, Scientific Committee, American Industrial
Health Council
Regional Administrator, EPA Region 6
Professor and Director, Center for Hazardous
Substance Research, Kansas State University
EPA Region 3
Chemist, EPA Region 5
Assistant Regional Administrator, EPA Region 7
Director, Environmental Criteria and Assessment Office,
Office of Research and Development
Environmental Protection Specialist, EPA Region 5
Regional Administrator, EPA Region 7
Senior Science Advisor, EPA Office of Science and
Technology, Office of Water
Regional Administrator, EPA Region 6
National Chair, EPA Women in Science and
Engineering (WISE)
Regional Scientist, EPA Region 3
EPA Region 3
Assistant Regional Counsel, EPA Region 5
EPA Region 3
Organization Resources Counselors, Inc.
EPA Region 3
EPA Region 3
EPA Region 3
EPA Region 3
51
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= - - ~~~~ . ~~ =_~~ ~, ~ _ - _
Additional copies of this report may be obtained
by writing:
Center for Environmental Research Information
U.S. Environmental Protection Agency
26 West Martin Luther King Drive
Cincinnati, OH 45268
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