Philip Morris
Safeguarding the Future: Credible Science, Credible Decisions
Fields
- Author
- Goldstein, B.D.
- Loehr, R.C.
- Nerode, A.
- Risser, P.G.
- Loehr, R.C.
- Area
- CORPORATE AFFAIRS/EEMA ARCHIVE
- Attachment
- 2501205636/2501205694
- 2501205637/2501205694
- Request
- Stmn/Rl-002
- Stmn/R1-048
- Type
- REPT, REPORT, OTHER
- Recipient (Organization)
- Epa, Environmental Protection Agency
- Document File
- 2501205235/2501205695/Ets Epa II 910000 - 930000
- Recipient
- Reilly, W.K.
- Site
- E34
- Named Organization
- Goldwin Smith
- Ks State Univ
- Leopold Scholars
- Mathematical Sciences Inst
- Natl Comm
- Natl Federation of Federal Employees
- Office of Communications + Public Affair
- Office of Congressional + Legislative Af
- Office of Management + Budget
- Office of Research + Development
- Office of Science Eng + Technology
- Office of Water
- Org Resources Counselors
- Rutgers Univ
- Science Advisory Board
- Scientific Comm
- Search Comm
- Soil Conservation Service
- Univ of Medicine + Dentistry of Nj
- Univ of Nm
- Univ of Tx
- Academia
- Advisory Comm
- Alharthy Centennial
- American Industrial Health Council
- Center for Environmental Research Inform
- Center for Environmental Statistics
- Clean Air Scientific Advisory Comm
- Congress
- Congressional Comm
- Cornell Univ
- Environmental + Occupational Health Scie
- Environmental Criteria + Assessment Offi
- Environmental Groups
- Environmental Services Division
- Epa Office of Science + Technology
- Epa Office of Solid Waste
- Epa Region 10
- Epa Region 3
- Epa Region 5
- Epa Region 6
- Epa Region 7
- Epa Women in Science + Engineering
- Epa, Environmental Protection Agency
- Expert Panel on the Role of Science at E
- Exxon Valdez
- Ks State Univ
- Litigation
- Stmn/Produced
- Author (Organization)
- Epa, Environmental Protection Agency
- Expert Panel on the Role of Science at E
- Attendee (Organization)
- American Chemical Society
- American Industrial Health Council
- Amoco
- Barrera Associates
- Bna Environment Reporter
- Business Publishers
- Chemical Specialities Mfg
- Covington Burling
- Distilled Spirits Council of US
- Environmental Policy Center
- Environmental Week
- Flamm Associates
- General Motors
- Health + Environmental Science Group
- Hima
- Inside Epa
- Monsanto
- Natl Federation of Federal Employees
- Nfpa
- Org Resources Counselors
- OSHA, Occupational Safety & Health Administration
- SC+A
- Toxic Material News
- American Industrial Health Council
- Named Person
- Wilson, J.D.
- Benforado, J.
- Clelandhamnett, W.
- Delaney, S.C.
- Goldstein, B.D.
- Leopold, A.
- Loehr, R.C.
- Nerode, A.
- Reilly, W.K.
- Risser, P.G.
- Robarge, G.
- Barrera, L.L.
- Barrera, T.N.
- Belton, K.
- Benjamin, M.
- Camp, P.J.
- Carton, R.
- Cohen, S.
- Davies, P.
- Flamm, W.G.
- Garvin, P.
- Goodell, J.
- Jarman, R.
- Jones, J.
- Kaupert, A.W.
- Keeler, A.
- Lee, N.L.
- Mcdavid, S.
- Page, B.
- Putzrath, R.M.
- Riser, S.
- Santalla, A.
- Sudja, R.
- Trauben, B.K.
- Turner, S.
- Wamsteed, D.
- Ware, P.
- Benforado, J.
- Date Loaded
- 05 Jun 1998
- UCSF Legacy ID
- qup22e00
Document Images
The Panel recommends
that EPA leadership
undertake a deliberate
and continuing effort to
create the climate,
culture, and incentives
necessary to encourage
superior science.
2
FINDING: EPA has not dearly conveyed to those outside or even inside the
Agency its desire and commitment to make high-quality science a priority.
RECOMMENDATION: EPA should send strong, dear signals to the scientific
community and the public about its commitment to develop and use the best
science for guidance and decisions. One immediate step to accomplish this could
be the initiation of regular science briefings for the Administrator by EPA and
non-EPA scientists on topics of critical concern to the Agency.
3
FINDING: The science advice function-that is, the process of ensuring that
policy decisions are informed by a dear understanding of the relevant science-
is not well defined or coherently organized within EPA.
RECOWviENDATION: The Administrator should appoint a "science advisor" to
ensure that credible scientific information for EPA guidance and decisions is
available from both EPA scientists and the broader scientific community. The
science advisor would implement a peer review and quality assurance program
for all EPA's science-based products, improve the Agency's responsiveness to the
science needs of EPA policymakers, play a key role in evaluating the professional
activities of all scientists at EPA, and provide scientific advice to the
Administrator.
MAJOR FINDINGS
AND
RECOMMENDATIONS
(CONTINUED)
4
FINDING: In many cases, appropriate science advice and information is not
considered early or often enough in the decisionmaking process.
RECOMMENDATION: EPA should take steps to ensure that science enters the
decisionmaking process early and often. In regulatory development, EPA should
implement a widely advertised, open process enabling the Agency to hear the
scientific opinions of all parties. In addition, the Agency should analyze how it
used science in developing one or more major regulations. The goal of this
analysis would be to determine the type of scientific and technical information
needed to ensure scientifically credible decisions, as well as the points in the
regulatory process at which scientific input is most effective. The analysis should
take into account the varying needs and decisionmaking processes of the
different EPA program offices.
5
FIlVDING: The development and nurturing of human resources are central to
improving science at EPA.
RECOMMENDATION: For ORD scientists, the Panel recommends continued
attention to appropriate science and science management career tracks. For
scientists in EPA program and regional offices, the Panel recommends
establishing a science career track similar to that in place for those providing
legal advice. The Agency also should enhance rotational opportunities that allow
EPA scientists to participate in the broader scientific community and non EPA
scientists to work more closely with EPA's science programs.
2501205640
6 Executive Summary
6
FINDING: EPA requires that its scientific research products undergo peer review.
However, the Agency does not have a uniform process to ensure a minimum
level of quality assurance and peer review for all the science developed in
support of Agency decisionmaking.
RECOMMENDATION: Quality assurance and peer review should be applied to
the planning and results of all scientific and technical efforts to obtain data used
for guidance and decisions at EPA, induding such efforts in the program and
regional offices. Such a requirement is essential if EPA is to be perceived as a
credible, unbiased source of environmental and health information, both in the
United States and throughout the world.
7
FINDING: A number of outstanding externally recognized scientists work at
EPA. However, the Agency lacks the critical mass of externally recognized
scientists needed to make EPA science generally credible to the wider scientific
community.
RECOMMENDATION: EPA should recruit four to six research scientists or
engineers with world-class reputations and provide them with a significant,
long-term commitment of support. These individuals should be national and
international leaders in scientific areas vital to the Agency's long-term strategy
and direction. They would serve as mentors for developing scientists and
provide access to networks of world-class scientists.
2501205649
Executive Summary 7
%= 1
MAJOR FINDINGS
AND
RECOMMENDATIONS
(CONTINUED)
8
FINDING: For EPA to establish a reputation for having high-quality science to
support its decisionmaking, its science activities must become more widely
known. Academia, Congress, other federal agencies, industry, and the public
generally are unfamiliar with the work of EPA scientists.
RECOMMENDATION: The Agency should undertake a communications,
outreach, and education effort to publicize the activities and accomplishments of
EPA scientists.
9
FINDING: EPA often does not evaluate the impact of its regulations. Implementa-
tion of an environmental policy or regulation provides a unique opportunity to
study the environmental response to changes brought about by regulations, such
as changes in the type and amount of pollutants.
RECOIViMENDATION: The Agency should scientifically evaluate the environ-
mental improvements brought about by the major regulations it promulgates.
This will help EPA better understand the effectiveness of its regulatory strategies
and how those strategies affect environmental processes.
8 Executive Summary
a
10
FINDING: EPA science could benefit substantially from increased scientific
contact and openness with other organizations.
RECOMMENDATION: The Agency should encourage increased participation of
its scientists in the activities of the scientific community. It should enhance
relationships with other federal agencies and appropriate industrial and
academic research organizations and promote the participation of EPA scientists
in the technical activities of professional societies.
11
FINDING: EPA has not consistently enlisted the nation's best scientists to
provide the research and technical information needed for decisionmaking.
Problems in the Agency's approach to academic grants and centers have
discouraged many university-based experts from working with EPA. In addition,
the program and regional offices and ORD laboratories often rely on contractual
mechanisms that prevent EPA from obtaining the best outside scientists to work
on EPA issues.
RECOMMENDATION: EPA should move quickly to bolster its grants and
centers program. The Agency also should implement a long-term plan to replace
contractual mechanisms that may be detrimental to obtaining the best possible
scientific information.
Executive Summary 9
il
The Expert Panel
E PA's 1991 statement of strategic direction (Appendix A) calls for sound
science to serve as the foundation for the Agency's policy and program
decisions. In May 1991, EPA Administrator William K. Reilly established the
Expert Panel on the Role of Science at EPA as an independent advisory
committee to the Agency under the Federal Advisory Committee Act. The Panel,
consisting of Drs. Raymond C. Loehr (Chair), Bernard D. Goldstein, Anil Nerode,
and Paul G. Risser, was charged with developing recommendations to help the
Agency achieve the following goals:
Identify how best to provide the Administrator
with up-to-date, objective scientific information in
keeping with the Agency's new strategic direction.
Ensure that the knowledge base necessary to
achieve the new vision is available through proper
planning, adequate resources, and necessary
leadership.
Ensure that the research and scientific information
needs of the programs and regions are adequately
met and their views incorporated in the scientific
advice provided to the Administrator.
Enhance the stature of science within EPA and
among the many constituencies with which the
Agency interacts.
The Administrator asked the Panel to work with the Assistant Administrator for
Research and Development and other EPA offices to accomplish this task and
asked the program Assistant Administrators to cooperate fully in this endeavor.
Additional details about the charge to the Panel and the affiliations of Panel
members are included in Appendix B.
2501205652
10 The Expert Panel
The Administrator asked that the Panel report back with its recommendations in
four to six months. Given this short time frame, the Panel decided to rely
primarily on interviews with key science and policy leaders, both within and
outside EPA, to identify areas of concern and generate ideas for solutions. The
Panel did not conduct any other independent evaluation of science at EPA; it did
not review current research programs, visit EPA laboratories, or examine reports
and data generated by the program and regional offices.
Over a period of four months, the Panel held three public meetings to discuss the
role of science at EPA. It also interviewed more than 30 individuals from EPA,
other government agencies, industry, environmental groups, and other organi-
zations. These discussions took place in dosed fact fmding sessions to ensure an
open expression of views. Because the time available for interviews was limited,
the Panel also requested written comments. More than 25 individuals, mostly from
the EPA regional offices, sent written comments to the Panel. Appendix C lists
the individuals interviewed by the Expert Panel and Appendix D lists those who
attended the public meetings or provided written comments.
The Panel completed its fact-finding in September 1991. The Panel thanks
everyone who attended the public meetings, participated in discussions, and
submitted comments for their candid and helpful input. The Panel apologizes to
the many people it was unable to interview in person.
During the meetings and discussions, the Panel focused its attention on five
topics crucial to the acquisition and use of sound science in support of decision
making at EPA:
The mission and direction of EPA science.
The quality of science at EPA.
The quality of scientists at EPA. '
How the budget process affects science at EPA.
How EPA uses science in decisionmaking.
The Expert Panel 11
In this report, the Panel uses the term "science" in its broadest sense: it encom-
passes a range of activities, induding research and development, technical and
regulatory support, monitoring and data collection, review and interpretation of
technical studies, and assessments of health and environmental risks. By using
this definition, the Panel intentionally indudes the scientific activities conducted
by EPA program, policy, and regional offices; these activities are part of the
science EPA uses in its decisionmaking. The Panel also indudes the quantitative
social sciences, such as economics, as well as the biological, chemical, and
physical sciences.
A number of consistent concepts and views emerged during the Panel's fact
finding process. Everyone who spoke with the Panel agreed that EPA needs its
own strong science base to carry out its mission effectively. At the same time, all
expressed concerns about the quality of EPA science and encouraged improve-
ments in the way EPA uses science in decisionmaking. The following pages detail
the Panel's findings concerning science at EPA and recommendations for addressing
those concerns. These findings and recommendations represent the Panel's
synthesis and evaluation of the ideas provided in the interviews, public
meetings, and written comments.
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Background
e basic mission of EPA is to preserve and improve the quality of the environ
ment, protect human health, and safeguard the productivity of natural
resources on which all human activity depends. In carrying out this mission, EPA
must implement the programs mandated by law as its first priority. However, it
has responsibilities beyond the activities mandated by legislation. It also must
provide leadership on the scientific and policy issues involved in environmental
protection. In addition, EPA must develop, evaluate, and use risk reduction
strategies, including those that go beyond the conventional command and-
control regulatory approach, in varying political, cultural, and social contexts.
Previous advisory reports stressed that EPA needs a strong scientific base for its
decisions. Future Risk: Research Strategies for the 1990s (1988, SAB-EG88-040) and
Reducing Risk: Setting Priorities and Strategies for Environmental Protection
(1990, SAB-EC-90-021) made many recommendations about science at EPA. Fu-
ture Risk, for example, recommended that EPA plan and implement a long-term
research program in specific core research areas, improve its capability to
anticipate environmental problems, and expand its efforts to understand how
and to what extent people are exposed to environmental pollutants. Reducing Risk
argued that, to take advantage of the best opportunities to reduce risk, EPA must
improve the data and analytical methodologies that support the assessment,
comparison, and reduction of different environmental risks.
Many changes are under way in ORD, the program offices, and the regional
offices to bring about needed changes in EPA science. This report builds on
previous advisory reports to EPA, current activities within EPA, and the
knowledge of individuals in other government agencies and the private sector
who have faced similar problems in providing high-quality science for decision
making. The report focuses on structural changes to ensure that EPA science can
help the Agency realize its new vision for environmental protection. These
findings and recommendations are another building block in EPA's efforts to
safeguard human health and the environment. 2501205655
~
Background 13
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THE ROLE OF According to EPA's 1991 statement of strategic direction (Appendix A), EPA is
SCIENCE AT EPA ,['&committed to ensuring that national efforts to reduce environmental risk are
based on the best available scientific information communicated dearly to the
public. EPA should be a credible source of science information for all parties
within and outside EPA. To achieve this goal, the Agency must acquire scientific
information from its own programs as well as from industry, academic
institutions, other government agencies, private organizations, and other nations.
A key role of science at EPA is to reduce uncertainties in environmental decision-
making. While scientists have made significant progress in measuring and com-
paring risks to human health and the environment, many uncertainties remain.
For example, most of our current knowledge concerning how humans respond to
environmental pollutants comes from research with laboratory animals under
conditions very different from those that humans actually experience. Many
uncertainties, therefore, are involved in deducing how the information gained
through this laboratory research applies to people. Other areas of uncertainty
indude the impact of chemical mixtures and other general stressors on the
envirornnent. People and ecosystems are exposed not simply to single chemicals,
but to mixtures of different chemicals. The environment is also affected by
complex, diffuse factors such as temperature changes, habitat loss, and ozone
depletion. EPA historically has focused on chemical specific impacts and has not
developed methods to assess or control the effects of chemical mixtures and
general stressors on humans and ecosystems.
Science is especially necessary to characterize today's subtle and complex
environmental problems that cut across all environmental media (air, water, and
land) and transcend national boundaries, such as loss of species diversity, acid
deposition, and stratospheric ozone depletion. Science, in fact, is inherently
cross-media and international in nature and can be the catalyst for focusing
greater attention on cross-media environmental issues.
Science is also key to determining which environmental problems pose the
greatest risks to human health, ecosystems, and the economy. In the absence of
sound scientific information, it is likely that high-proffle but low-risk problems
will be targeted, while more significant threats are ignored. When science and
14 Background
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