United States
Environmental Protection
Agency
EPW600/9-91/050
March 1992

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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

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Safeguarding 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

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                           recommend ways to: (a) ensui
                           decisionmaking, (b) ensure th; it EPA's planning,
                           knowledge base needed to acl ieve the Agency7:
                           To accomplish this task, we in
                           these issues.
                           offices and programs,
                           organizations. In addition,
                           than 25 individuals,
                           people wished to
                           January 8,1992

                           Mr. William K.Reilly
                           Administrator
                           U.S. 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 t ie Agency's policy and program decisions. You asked us to
                          ije that EPA has up-to-date, objective scientific information for
                                         y, resources, and leadership produce the
                                         's new vision, (c) ensure that the research and
sdentificinformation needs oil the programs and regions are met, and (d) enhance the staturt
of science within EPA and am< >ng the many constituencies with which EPA interacts.
                           erviewed more than 30 individuals who have experience with
           We also held threfe public meetings that included individuals from various EPA
                              unent agencies, industry, environmental groups, and othei
                         •e requested written comments and received letters from more
                              a the EPA regional offices. We were impressed that so man
               help EPA fin i better ways to acquire and use sound scientific information.
                           A number of consistent theme; emerged from the discussions and comments. Everyone who
                           spoke with the Panel agreed tl at 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 tc
                           improve the quality of its sciet ice and the way science is used in decisionmaking. In this
                           report, we have developed the se themes as a series of findings and recommendations about
                           science at EPA. Included are si iggestions for both short- and long-term measures to enhance
                           the use of sound scientific and
                           We look forward to your seriojis 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

                           Raymond C. Loehr, Chair
                           Bernard D. Goldstein
                           AnilNerode
                           Paul G. Risser
              the Role of Sd ence at EPA
ii
                           technical information throughout the Agency.

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Contents
                                                        Page
TRANSMITTAL LETTER	'.	ii
EXECUTIVE SUMMARY	1
THE EXPERT PANEL	10
BACKGROUND	13
FINDINGS AND RECOMMENDATIONS
   I.   THE MISSION AND DIRECTION OF EPA SCIENCE	16
   H.  THE QUALITY OF SCIENCE AT EPA	23
   IE.  THE QUALITY OF SCIENTISTS AT EPA	29
   IV.  HOW THE BUDGET PROCESS AFFECTS SCIENCE AT EPA	33
   V.  HOW EPA USES SCIENCE IN DEOSIONMAKING	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 EXPERTPANEL 	46
   D.  RECORD OF PUBLIC MEETING ATTENDANCE
       AND WRITTEN COMMENTS	49
                                                         m

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ACKNOWLEDGMENTS  nphe Expert Panel acknowledges the support provided by EPA for this
                        JL endeavor. Our thanks to Wendy Cleland-Hamnett, Jay Benforado, and Gai
                       Robarge for their diligent efforts, which were critical to the successful completii
                       of this project.

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                       Executive Summary
BACKGROUND        nphe mission of the U.S. Environmental Protection Agency (EPA) is to preserve
                        JL and 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 dearly 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 thatlielps 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

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BACKGROUND
(CONTINUED)
THE EXPERT PANEL
ON THE ROLE OF
SCIENCE AT EPA
Several recent reports, including Future Risk: Research Strategies for the 1990s (1988,
SAB-EG-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.

  In early 1991, EPA Administrator William K. ReiUy 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 CLoehr (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
     Computer Science, Gold win Smith Chair and
     Director, Mathematical Sciences Institute, Cornell
     University.
   •  Dr. Paul G. Risser, Provost and Vice President for
     Academic Affairs, University of New Mexico.
     Executive Summary

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                        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            f^lver a Period of four months, the Panel held three public meetings and inter-
                        \~/ viewed 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 decisiortmaking.

                      The Panel defined science as encompassing a range of activities, including
                      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 dedsionmaking. It also included the
                      quantitative social sciences, such as economics, in addition to the physical,
                      chemical, and biological sciences.


                                                                         Executive Summary    3

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MAJOR FINDINGS
AND
RECOMMENDATIONS
Overall, the Panel
affirms that EPA needs
its own strong science
lose to provide the
background required for
effective environmental
protection programs.
   the 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, EP£
science is of uneven quality, and the Agency's policies and regulations are
frequently perceived as lacking a strong scientific fotmdation. 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.
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.
     Executive Summary

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The Panel recommends
that EPA leadership
undertake a deliberate
md continuing effort to
create the climate,
culture, and incentives
necessary to encourage
superior science.
FINDING: EPA has riot 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.
FINDING: The sdence advice function-—that is, the process of ensuring that
policy decisions are informed by a dear1 understanding of the relevant sdence—
is not well defined or coherently organized within EPA.

RECOMMENDATION: The Administrator should appoint a "sdence 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 sdentific advice to the
Administrator.
                                                                            Executive Summary

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MAJOR FINDINGS
AND
RECOMMENDATIONS
(CONTINUED)
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.
                        FINDING: 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.
     Executive Summary

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6	:	:	
FINDING: EPA requires that its scientific research products undergo peer review.
However, the Agency does not have a Tiniform 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, including 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.
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.
                                                    Executive Summary

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MAJOR FINDINGS     8
AND                  FINDING: For EPA to establish a reputation for having high-quality science to
RECOMMENDATIONS  suppOrt ife decisionmaking, its science activities must become more widely
(CONTINUED)            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.
                       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.

                       RECOMMENDATION: 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

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 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

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                       The Expert Panel
                          EPA'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.
10  The Expert Panel

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 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 closed fact-finding 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 arid 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

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                        In this report, the Panel vises the term "science" in its broadest sense: it encom-
                        passes a range of activities, including 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 includes 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 includes 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.
12  The Expert Panel

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 Background
     The 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-EC-88-040) 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.
                                                         Background   13

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THF ROT E OF           A ccording to EPA's 1991 statement of strategic direction (Appendix A), EPA is
SCIENCE! ATEPA        Acommitted to ensuring that national efforts to reduce environmental risk are
SCIENCE AT hi A        ^^ ^ ^ ^^ ayailable scientific information communicated clearly 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.

                        Akey role of science at EPA is to reduce uncertainties in environmental decision-
                        makrns. 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
                        include the impact of chemical mixtures and other general stressors on the
                        environment. 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 tie
                        greatest risks  to human health, ecosystems, and the economy. In the absence of
                        sound scientific information, it is likely that high-profile but low-risk problems
                        will be targeted, while more significant threats are ignored. When science and
 14  Background

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 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 amd 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.

 Finally, 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.
                                                          Background   15

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                      The  Mission and Direction
                      of EPA Science
                      CU.1 CUCCI&/ LLLC jTi.gCJ.iV-y JULIWJJU V^l*-«.*..ajr v^-*-"-"^ »—•.•— —— ——	
                      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 EPA science:
                         •  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
                          • shaping the mission and direction of EPA science?
                         •  To what extent is EPA's desire to base decisions pn the
                           best scientific information recognized outside EPA?
                         •  What is the perception of EPA science in the
                           broader scientific community and among
                           decisionmakers who draw upon scientific and
                           technical knowledge?
16  Mission and Direction

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FINDINGS              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 decisionmaking.
                           • 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 microorganisms
                           to break down oil on contaminated beaches.
                                                                          Mission and Direction   17

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FINDINGS             2.  Regulations are based on both technical and policy considerations. Improper
(CONTINUED)                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 arid 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:
                            Research Strategies for the 1990s, EPA established a core research program. The
                            core program is designed to generate knowledge to support all 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

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    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.

8.   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.
                                                   Mission and Direction   19

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                           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 U.S. 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.

RECOMMENDATIONS  1. 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, clear, 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 include:

                           •  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 npn-EPA as well as EPA scientists, with
                              senior EPA management expected to attend.
20  Mission and Direction

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 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
     materials in the environment, including pathways
     of exposure for humans and ecosystems.
   • Evaluation of ecological effects on a range of
     geographic scales (such as local, regional, and
     global effects).
   • Ecological risk assessment.
                                                  Mission and Direction   21

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 RECOMMENDATIONS      •  Risk reduction technology research and
 (CONTINUED)                  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, including those outside
                            EPA's areas of science expertise, and in developing a multi-agency plan.

                        8.  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

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The Quality of Science at EPA



nphe Expert Panel attempted to determine the quality of science obtained and
 1 used by EPA. The Panel defined a high-quality science program as one that
clearly 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 included:

   • 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 decisionmaking 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.
                                                    Quality of Science   23

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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
    Onalitv o

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                           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.


RECOMMENDATIONS   1.  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
                           function 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:

                           •  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

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 RECOMMENDATIONS      •  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 office. 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 Administrato]
                            for Science, Engineering, and Technology would be the science advisor. He 01
                            she would have two Deputy Assistant Administrators, separately responsible
26  Quality of Science

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    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 heeds identified through the science advice process.

    Each of these approaches has both advantages and disadvantages.
    F6r 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
      Administrator for Science, Engineering, and
      Technology would both manage the research
      organization and provide objective, independent
      scientific advice; in some cases, these
      responsibilities might conflict. For example, a
      conflict might arise between promoting EPA
      research products and providing :indepehdent
      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 scienfific 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

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RECOMMENDATIONS     program for all its science-dependent products, including those developed by
                           the program and regional offices. The current peer review process in ORD
                           ^^ 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 scientificall)
                           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 al
                           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).
28   Quality of Science

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                       The  Quality of Scientists at EPA
                       TPhe Panel considered a number of issues related to the quality of the
                        JL individuals at EPA who acquire, develop, and evaluate scientific and
                       technical information. These issues included:

                          • What is the current quality of scientists at EPA?
                          • Does EPA provide a supportive environment with
                            sufficient incentives to encourage excellence in
                            science?

                          0 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 externalty recognized outstanding scientists. The
                          Agency does not yet have the critical mass of such scientists needed to make
                          EPA science generally credible to the brqader 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.
                                                                        Quality of Scientists  29

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RECOMMENDATIONS  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-class 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 clear 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 include:

                           •  Risk reduction methods and technology.

                           •  Broad-scale ecological effects and risks.
                           •  Transport and fate of materials, including
                              multi-media pathways of exposure of humans
                              and ecosystems.
                           •  Cost-effective monitoring on a range of
                              geographic scales.
                           •  The biological basis for the prediction of health
                              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

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    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 include 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 include 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 nori-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,
    including 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
                                                    Quality of Scientists   31

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RECOMMENDATIONS     other scientific organizations. It would improve the Agency's ability to plan
(CONTINUED)                an
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                      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 science
                      the Agency undertakes. Key questions considered by the Panel included:

                         • How does the budget process affect the quality of
                           science at EPA?

                         • Does the budget process discourage long-term
                           strategic planning for high-risk/Mgh-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?

FINDINGS             1.  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 jthe 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.

                      2.   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
                                                                         Budget Process  33

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FINDINGS                 for science without first developing a coherent strategic plan for its science
(CONTINUED)               efforts.
                        3.  EPA science programs currently are unable to carry out prolonged research o
                           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. Th<
                           current budget process makes it difficult, if not impossible, to ensure conti-
                           nuity of funding for the long-term, anticipatory research and assessment thai
                           are essential to reducing uncertainty in future decisionmaking. These long-
                           term needs are often preempted by short-term deadlines, leaving EPA and th
                           nation unprepared for later problems.

                        4.  GRID'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 ir
                           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.


RECOMMENDATIONS  I-  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 shoul
                           include 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 t
                           support the Agency's mission. A scientific understanding of cross-media
34   Budget Process

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    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 clearly 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 include 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, including grants and centers, contracts, and cooperative
   agreements.                     '
                                                        Budget Process   35

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                       How EPA Uses Science in

                       Decisionmaking

                          EPA 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 severa
                       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 decisionmaking 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             1.  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.
    Science and Decisionmakine;

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.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, Confliclting science policies between EPA
   programs create confusion and a lack of credibility for EPA decisions.
                                              Science and Decisionmaking   37

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                        7. Scientists at all levels throughout EPA believe that the Agency does not use
                           their science effectively.

                                                                                        |
RECOMMENDATIONS  I. 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 ol
                           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 consistent!]
                           provided an open forum for review and discussion of the science underlying
                           EPA's national ambient air quality standards. Consequently, this committee i
                           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.
38   Science and Decisionmaking

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                      Appendix A
                      Strategic Direction for the
                      U.S. Environmental Protection Agency
                      "EPA... Preserving Our Future Today"
MISSION             nphe people who work at the Environmental Protection Agency are dedicated
                       JL 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

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                           • Schools and community institutions promote
                             environmental stewardship as a national ethic.

GOALS AND           T? PA's unique role in protecting the environment
OBJECTIVES            Jdincludes:

                           • 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
40

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   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 coimtry;
-  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

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GOALS AND
OBJECTIVES
(CONTINUED)
- Enabling state and local governments, as partners,
  to implement and enforce environmental programs;
- Conveying clear, 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;
- Working 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.


                                         April 1991
•B

42

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                      Appendix B
                      Charge to the Expert Panel and Affiliations of Panel
                      Members
PURPOSE OF THE
REVIEW
OBJECTIVES
U.S. Environmental Protection Agency
Charge to the Expert Panel on the Role of Science at EPA
May22,1991                          ',

The Agency's new statement of strategic direction calls for sound science
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.

   •  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

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                       Appendix C
                       Persons Interviewed By the Expert Panel
                      Name

                      Alvin L. Aim


                      D.Allan Bromley

                      J. Clarence Da vies


                      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
                                       j
Director and Senior Vice President, Science Application
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
                                       i
Vice President for Environment, Electric Power
Research Institute

Director, Institute of Ecosystem Studies

Director, Biotechnology Project, National Wildlife
Federation
                                       i
Director, U.S. Geological Survey

Professional Staff Member, Senate Environment and
Public Works Committee

Vice President, Environmental Affairs and Safety, Amoc
Corporation
46

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                      Appendix B
                      Charge to the Expert Panel and Affiliations of Panel
                      Members
PURPOSE OF THE
REVIEW
DBJECTIVES
U.S. Environmental Protection Agency
Charge to the Expert Panel on the Role of Science at EPA
May 22,1991

The Agency's new statement of strategic direction calls for sound science
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.

   •  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

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                          • 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 programs—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?
                                                                                      I
                           •  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

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                            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?

COMPOSITION OF     Raymond C. Loehr (Chair of the Panel)
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

                       PaulG. 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
                                                                                          45

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                       Appendix C
                       Persons Interviewed By the Expert Panel
                       Name

                       AlvinL. Aim


                       D. Allan Bromley

                       J. Clarence Da vies


                       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
                                       i
Director and Senior Vice President, Science Application
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, Amoc
Corporation
46

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Michael L. Rodemeyer  Chief Counsel, House Science, Space and Technology
                      Committee
David P. Rail


Terry F. Yosie


Frank E. Young



Donald G. Barnes

Erich W. Bretthauer


Don R. Clay


Thomas P. Dunne


Lester D. Grant


Edward J. Hartley


Victor J. Kimm
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, U.S. 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
Richard D. Morgenstern  Acting Assistant Administrator, Office of Policy, Planning
                      and Evaluation

Thomas A. Murphy     Director, Environmental Research Laboratory - Corvallis
                                                                       47

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EPA
(CONTINUED)
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
48

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                      Appendix D
                      Record of Public Meeting Attendance and
                      Written Comments
MEMBERS OF THE
3UBLIC ATTENDING
5XPERT PANEL
>UBLIC MEETINGS
July 24,1991
Lisa L. Barrera
Ted N. Barrera
Mark Benjamin
Robert Carton
Patrick Davies
W. Gary Hamm
Paul Garvin
Andrew W. Kaupert
Nora L. Lee
Soonie McDavid
Resha M. Putzrath
Anne Santalla
Susan Turner
Barrera Associates, Inc.
Barrera Associates, Inc.
Environmental Policy Center
National Federation of Federal Employees
Covinston & Burlling
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
                      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.
                     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
                                                                                          49

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 MEMBERS OF THE
 PUBLIC ATTENDING
 EXPERT PANEL
 PUBLIC MEETINGS
 (CONTINUED)
August 19,1991
Ted N. Barrera
Keith Belton
Peter J. Camp
Robert Carton
Sanford Cohen
Joanne Goodell
Richjarman
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
5ft
1 Jarrera Associates, Inc.
 American Chemical Society
^ [100 Massachusetts Avev NW, #314, Washington, DC
 sTational Federation of Federal Employees
 !C&A
 DSHA Policy Directorate
 sIFPA
 nsideEPA
 General Motors
] invironmental Policy Center
] lealth and Environmental Science Group
1BMA
 iusiness Publishers Inc. (Toxic Materials News)
i American Industrial Health Council
: rOO 13th St., NW, Suite 700, Washington, DC 20005
j American Chemical Society
 'nmronment Week
1 IN A - Environment Reporter

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•JDIVIDUALSWHO
*OVIDED WRITTEN
DMMENTS
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
Arnold Kuzmack

Robert Layton
Dominique Lueckenhoff

Suzanne Lussier
BillMuir
Richard Nagle
Ron Preston
Resha M. Putzrath
Charlie Rhodes
Arthur Spingarn
Neil Swanson
Orterio Villa
                                                EPAB
EPA Region 3
EPA Region 3
Senior Vice President, National Federation of
Federc 1 Employees
EPA Region 3         :
      >r, Environmental Services Division, EPA Region 10
      y Office Director, EPA Office of Solid Waste
      Scientific Committee, American Industrial
      Council
Regional Administrator, EPA Region 6
Professor and Director, Center for Hazardous
         Research, Kansas State University
      egion 3         :
       :, EPA Region 5
Assist int Regional Administrator, EPA Region 7
      r, Environmental Criteria and Assessment Office,
Office of Research and Development
      nmental Protection Specialist, EPA Region 5
Regional Administrator, EPA Region 7
      Science Advisor, EPA Office of Science and
       _y, Office of Water
Regio ial Administrator, EPA Region 6
National Chair, EPA Women in Science and
                                                Direct
                                                Depui
                                                Chair,
                                                Health
                                                Engineering (WISE)
                                                Regio ial Scientist,
     egion 3
:, EPA Region 3

        ;, EPA Region 5
                                                Assistant Regional Counsel,
                                                EPA E egion 3
                                                Orgai ization Resources Counselors, Inc.
                                                EPA E egion 3
                                                EPA E egion 3
                                                EPA E egion 3
                                                EPA Region 3
                                                                                                      51

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                        A
Idditional 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
52

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