10019945
Memoranda and letters from the Administrator's Office on the topic of EPA's peer review process and
Science Policy Council (SPC):
Memorandum: Date:
Subject:
From:
Memorandum: Date:
Subject:
From:
To:
Memorandum: Date:
Subject:
From:
To:
Memorandum: Date:
Subject:
From:
Letter:
Date:
Topic:
From:
To:
December 22, 1993
Creation of a Science Policy Council
the Administrator
May 26, 1994
Priorites for the Science Policy Council
Robert Sussman, Chair, Science Policy Council
Lynn Goldman, Vice-Chair
the Administrator
May 31, 1994
"Science and Judgment in Risk Assessment", a Report by the
Rational Research Council (NRC)
Robert Sussman, Chair, Science Policy Council
Lynn Goldman, Vice-Chair
the Administrator
June 7, 1994.
Peer Review Program
the Administrator
September 30, 1994
EPA's "expanded program for peer review. . ."
the Administrator
John D. Dingell, Chairman, House Committee on Energy and
Commerce
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ATTACHMENT 2
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 20460
DEC 2 2 1993
THE ADMINISTRATOR
MEMnfr ANPUM
SUBJECT: Creation of a Science Policy Council
TO: Assistant Administrators
Associate Administrators
Regional Administrators
Today, I am announcing the establishment of an Agency mechanism to address the
many significant science policy issues that go beyond regional or program boundaries.
Building on the Agency's previous experience with organizations such as the Risk .
Assessment Council, I am establishing a Science Policy Council with a broader mission as a
replacement.
The goal of the new Council will be to Integra*, policies that guide Agency decision
makers in their use of scientific and technical informa'ion. The Council will help address the
'concerns raised by the Agency Science Advisory Board, the National Research Council, and
other groups about how the Agency integrates policy and science in decision making. It will
also act as the principal interagency contact on major science policy issues. Attached is a
Framework describing the Science Policy Council and the Steering Committee that will help
the Council do its work.
The new Science Policy Council will draw on the perspectives of my appointees as
well as career scientists and managers from throughout the regions and programs. I am
pleased to announce that the Council will be chaired by Deputy Administrator Robert
Sussman and the Vic*-Chair will be Lynn Goldman, Assistant Administrator, Office of
Prevention, Pesticides and Toxic Substances (OPPTS). The members of the Council for the
initial term win be:
Lynn Goldman, Assistant Administrator, OPPTS
Margo Oge, Director, Office of Radiation and Indoor Air
in the Office of Air and Radiation (OAR)
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Gary Foley, Acting Assistant Administrator, Office of
Research and Development (ORD)
Karl Hausker, Deputy Assistant Administrator, Office of
Policy Planning and Evaluation (OPPE)
Paul Keough, Acting Regional Administrator, Region 1
William Muszynski, Acting Regional Administrator,
Region 2
Tudor Davies, Director, Office of Science and
Technology in the Office of Water (OW)
Michael Shapiro, Director, Office of Solid Waste in the
Office of Solid Waste and Emergency Response (OSWER)
Donald Barnes, Director of the Science Advisory Board
(ex officio)
William Raub, Administrator's Science Advisor (ex
officio)
Sylvia Lowrance, Associate Deputy Administrator
Until an Assistant Administrator for ORD is confirmed, I have asked Gary Foley to
represent that Office on the Science Policy Council. Similarly, I have asked Paul Keough
and Bill Muszynski to represent the regions until my full team of Regional Administrators is
confirmed. . .
As one of its initial tasks, the Council will designate a Steering Committee of career
scientists and managers who will assess science policy needs on an ongoing basis, plan for
meetings of the Science Policy Council, resolve issues that do not need the Council's
attention, and oversee and evaluate the success of programs and regions in implementing new
and existing Agency science policies. The Council will recommend candidates for the
Steering Committee to the Deputy Administrator from nominations we have already received
from the regions and programs or from among other individuals whom they may identify.
The Steering Committee members will be selected based upon their breadth of
experience and expertise i science policy, ability to frame and communicate science policy
issues for decision makers, and effectiveness in marshalling resources for identified projects.
Bill Raub, in his role as my Science Advisor, will chair the Steering Committee. The
members of the Steering Committee are expected to serve staggered terms to provide
continuity and a constant influx of new expertise.
I am asking the Council to meet immediately after the first of the year to initiate
activities. Its first charge comes in response to the urgency of the issues before us: to
identify the highest priority issues for resolution and develop a process for resolving them.
The Council will report back to me on these priorities within the first 60 days of operation.
They must also work quickly to define their relationships with a number of groups within the
Agency, such as the Council of Science Advisors and Risk Assessment Forum, which have
been working on ;«MM Tinted to risk assessment, peer review, and other science policy
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concerns. Similarly, it must work quickly to define-its process for identifying science policy
issues with other agencies.
To ensure that the Council and its Steering Committee have adequate resources, the
Office of Policy, Planning and Evaluation and the Office of Research and Development will
provide staff support for both the Council and Steering Committee.
I urge you to give the Council and Steering Committee your full support because I
believe their actions will provide enormous benefit to the way our programs work to protect
human health and environmental well being.
Carol M. Browner
Attachment
cc: Members of the Science Policy Council
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ATTACHMENT 2
Praaavork for creating aa Agency
•cienee Policy Couaeil
to Address Croat-Program, Cross-Media
Science Policy issues
Tne problem
The Agency has no consistent and timely mechanism for
addressing major science policy issues that affect multiple program
offices. Science is defined to include quantitative social
sciences such as economics such as the physical, chemical, and
biological sciences.
• No mechanisms exist to identify major cross-program, cross-
media policy issues and bring them to the Administrator and/or
the Senior Leadership Council (SLC) for resolution.
• Cross-media, cross-program issues are often "orphans" with no
champions, inadequate resources, and staff to provide
resolution. Many of these issues also require integrating
analyses across many disciplines . \
• EPA's research agenda needs Agency-wide input and clear
criteria for establishing research priorities to address
— policy needs. •
framework for the Science Policy Council
The Science Policy Council (SPC) will have primary
responsibility within the Agency to address and resolve cross-
media, cross-program, and cross-disciplinary science policy issues.
This Council will:
1. Determine priorities among issues identified by EPA
regions and programs and other Federal agencies, the Risk
AssesstteiiC F^rua (SAF) and the Agency's Science Advisory
Board (SAB) and other major working groups and
committees;
2. Identify appropriate mechanisms [e.g., utilization of
' existing groups such as the RAF or Council of Science
Advisors (CSA) or establishing ad hog working groups,
subcommittees, etc.] for resolving high priority issues.
Wherever • appropriate, the SPC will assign lead
responsibility for chairing any new groups or
subcommittees.
3. Identify and provide resources necessary to resolve
issues (e.g., commitment of program staff, travel funds,
extramural funds);
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4. Make policy recommendations to tha Sanior Leadership
Council and/or tha Administrator;
5. Sarva as tha EPA's forum for discussing scianca policy
issuas of concarn also to other Fadaral agancias;
6. Sarva as tha aajor point of contact to tha SAB on scianca
policy issues;
7. Provida a policy-oriantad forua for discussion of tha
products froa tha RAF and othar sciantific and technical
groups.
Tha Scianca Policy Council will hava no acre than 12 aaabars
who will ba appointed by the Deputy Adainistrator. Career aanagers
serving on the Council are expected to serve 2-year overlapping
terms . The Deputy Adainistrator will serve as chair. The Council
will have a vice-chair selected by the Adainistrator. The vice-
chair will act in the Chair's absence to sustain the activities of
the Council. The aeabership will include the following Assistant
and Regional Administrators or their designees:
The Assistant Adainistrator for Policy Planning and Evaluation
The Assistant Adainistrator for Research and Development .
The Assistant Adainistrator for Prevention, Pesticides and ,
Toxic Substances
The Assistant Administrator for Air and Radiation
The Assistant Adainistrator for Water
The Assistant Administrator for Solid Waste and Emergency
Response
Two Regional Adainistrators
The Adaini at rater's science Advisor and the Director of the Science
Advisory Board will serve as ex officio members of the SPC. The
Adainistrator will have the discretion to add other full or ex
officio members.
The SPC will aeet at least quarterly to address issues and
recommendations made by its Steering Committee.
Fraaevork fer the Science Policy Council Steering Committee
That Science Policy Council will be supported by a Steering
Committee that will have the following responsibilities:
1. Identify cross-program, cross-media policy issues of
concern to programs, regions, and other Federal agencies;
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2. Coordinate the activities of the SPC with those of other
Agency group* such as th« SAB and RAP to establish
priorities for SPC actions;
3. Assess the status of existing efforts to address these
issues;
4. Recommend priorities aaong science policy issues to the
SPC;
5. Resolve cross-cutting issues that need central guidance
and decisions but da not merit the attention of the SPC;
6. Identify issues that should be assigned to the RAF or
some other groups for resolution and facilitate actions
by those committees to address these issues;
7. Monitor the status of the activities assigned by the SPC
to working groups and subcommittees;
8. Work with the working groups and subcommittees to
identify and recommend options for the SPC;
9. Develop agendas and meeting materials for the SPC; *
10. Communicate SPC activities to EPA programs and regions;
11. Facilitate implementation of nev policies in the programs
and regions;
12. Oversee and evaluate success of programs and regions in
implementing nev and existing science policies.
The Science Policy Council Steering Committee will include:
(1) a core group of 6-9 members who would be chosen by the Deputy
Administrator with the assistance of the Council and who are
expected to serve for 2-year overlapping terms and (2) the chairs
or co-chairs of the major working groups 'and subcommittees
identified by the SPC (for example, such groups might include the
Environmental Monitoring Management Council and IRIS Reference Dose
Committee)> The members of the steering committee will have the
breadth of experience to address cross-media, cross-program policy
issues and ability to frame and communicate science policy issues
for decision makers. Some of the members will need the ability to
command or obtain resources from programs to facilitate the
activities of subcommittees. The Committee will be chaired by the
Administrator's Science Advisor.
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Tha Steering Conaittee will maat at laast onca par month. It
will aatabliah working groups and subeoaaittaas as appropriata and
monitor and assist thosa groups in addition to tha RAF and Council
of Seianca Advisors in resolving issuas and davaloping options and
recommendations for tha SPC. Tha Staaring Committee would draw on
these analyses, options and recommendations as part of its
responsibility for developing agendas and recommendations for tha
SPC.
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Mfty-26-1994 14:45 EPfl Science Policy Staff 202 260 1935 P.002/008
£ »5jji- I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
VS3E*V WASHINGTON, D.C. 20460
^<.**«r
MAY 2 6 1994
OFFICE OF
THE ADMINISTRATOR
MEMORANDUM
SUBJECT: Priorities for the Science Policy Council
FROM: Robert Sussman,
Science Policy Counci
Lynn Goldman, Vice-Chair L(M/\/JL G^k^M/l/^u-i/^--
Science Policy Council i
Science Policy
TO: Carol M. Browner, Administrator
In response to your charge when you created the Science Policy Council (SPC), we
have identified a set of high priority science policy issues where conceited Agency action can
make a significant contribution in strengthening the Agency's science program. We believe
these activities are critical to improving quality science at EPA but probably will not proceed
with the requisite focus and pace unless the SPC accords them special attention. Our
proposed initial agenda is summarized in the Attachment and discussed below.
The SPC developed its proposed agenda as follows. First, the SPC Steering
Committee reviewed the range of the Agency's science policy issues, beginning with the
results of a previous Agency-wide survey conducted jointly by ORD and OPPE at my request
during the latter half of 1993. SPC staff enlarged that list with topics suggested by members
of SPC and the Steering Committee, respectively, as well as with topics that arose in the
course of developing the EPA strategic plan, participating in the interagency Committee on
Environment and Natural Resources, and developing our response to the report from the
National Research Council entitled "Science and Judgment in Risk Assessment."
Next, the Steeripg Committee met several times with the objective of analyzing the
issues, formulating realistic near-term tasks through which EPA might best address those
issues, and identifying a manageable set of immediate initiatives to recommend for high-
priority attention by SPC. Based on this review, the SPC recommends that its immediate
priorities should be to initiate and guide a process for strengthening the Agency's peer review
and risk characterization. These two issues are key weaknesses that have been recognized by
EPA scientists, risk managers and outside groups. The correction of these weaknesses will
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MflY-26-1994 14:46 EPfi Science Policy Staff 202 260 1935 P.003/008
significantly improve both the quality of science and our ability to communicate the science
to decisionmakers in EPA and externally. EPA currently has policies in place for peer
review and risk characterization, but implementation varies widely across the Agency. Thus,
both issues are ripe for attention by the SPG.
With respect to peer review, we are proposing that you reaffirm EPA's commitment
to peer review and set in motion an implementation program. The program would initiate
development of a model guideline for EPA offices to use in developing standard operating
procedures for peer review which are tailored to each office's needs. On a parallel track,
we will assist the offices in identifying major technical work products for peer review.
These efforts will be coordinated by a subcommittee of the Steering Committee, which will
also address budgetary, administrative and legal concerns related to implementation.
For risk characterization, we will recommend that you affirm the Agency's risk
characterization policy and its applicability to all Agency risk assessments. We will work
with EPA offices to identify several rules that can be used to refine and further develop risk
characterization methods - the results of these efforts will serve as models for risk
characterization. Additionally, we will propose to institute a review mechanism to ensure
that appropriate risk characterizations are developed for major rules. We recommend that
the Science Policy Council coordinate this internal effort with the Agency's participation in a
study being conducted by the National Research Council on risk characterization. This
study, sponsored by EPA and other federal agencies, was initiated this spring and is
scheduled to be completed in two years. It will result in additional recommendations for
improvements in risk characterization across the federal government.
In addition to these activities which the SPC will "initiate and guide," the SPC
proposes to "facilitate and endorse" a number of other activities, some of which may already
be ongoing, in the near term. Activities in this category will be carried out by existing or
new cross-media groups, and the SPC will be involved when policy decisions or other
guidance is needed. For example, upgrading of our Integrated Risk Information System
(IRIS) is indispensable for quality science, and we contemplate that efforts to place IRIS on
better scientific, financial, and organizational footing should be undertaken jointly by ORD
and the SPC Steering Committee.
During the next few months, the SPC Steering Committee also will undertake a
complementary effort to analyze further the additional issues that SPC might elevate to
•initiate and guide" status later this year, assign relative priorities and develop a work plan
as appropriate. Examples of issues under consideration as SPC priorities include exposure
assessment and cumulative risk - two areas with important environmental justice and risk
management implications.
As it proceeds with its work, the Council will look for efficiencies, not only through
integrating efforts to address cross-Agency issues but also through focussing scarce resources
on the most important issues before the Agency. New initiatives to address significant
science policy issues, however, may call for resources to be channeled in new directions.
We will be working together to identify resource needs as early as possible and to raise the
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nftY~26-1934 14=47 EFfl Science Policy Staff 202 260 1935 P.004/00B
associated multi-media, multi-program science policy issues as part of the budget formulation
process.
The Council, through its Steering Committee, plans to continue to track a wide array
of other science policy issues and bring action items to the Council as necessary. This
tracking effort is designed to provide an overview of the Agency's science policy and ensure
that the Council's agenda at any time includes those science policy areas where its attention
is most needed.
The Council, Steering Committee, and I are enthusiastic about the work we have
begun and in particular are eager to pursue those science policy activities that are most likely
to help fulfill your vision for EPA. We will welcome your comments and guidance with
respect to the course we propose to follow.
Attachment
cc:
Assistant Administrators
Regional Administrators
Members of the Science Policy Council
Members of the Science Policy Council Steering Committee
Michael Vandenbergh
Sylvia Lowrance
Dana Minerva
Richard Parker
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INITIATE & GUIDE
1. Begin activity immediately
Peer review
Risk characterization
Recommended Issues lor Attention by Science Policy Council
FACILITATE & ENDORSE
2. Analyze further (possible activities later this year)
Upgrading the Integrated Risk Information System (IRIS)
Exposure assessment and cumulative risk
(with emphasis on environmental justice)
Comparative risk assessment
Social sciences framework
Quality assurance
Laboratory accreditation
Peer review of environmental regulatory models
Guide for ecological risk management
Risk assessment: risks to children
Ecological risk assessment & indicators
Access to environmental information
Cancer risk assessment guidelines
Non-cancer risks
Human variability re toxins
Environmental justice: use of databases
Environmental hormones
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ISSUES
1. Begin activity immediately
Peer review
Risk characterization
"INITIATE & GUIDE" PROJECTS FOR SPC
ACTIVITIES
— Administrator to reiterate peer review policy
— Agency-wide group to develop model implementation procedures
— EPA offices to identify technical products lo be peer-reviewed, and adopt implementation
procedures (modified as needed)
- Administrator to clarify risk characterization policy and its applicability to all EPA risk
assessments
— Selected rules will be used as vehicles to refine and further develop risk characterization
methods, results will serve as models
— Review/approval mechanism will be developed for major rules
2. Analyze further (possible activities later this year)
Integrated Risk Information
System (IRIS)
Exposure assessment and
cumulative risk (with
emphasis on environ-
mental justice)
Comparative risk assessment
Social sciences framework
Develop a multi-year plan to put IRIS on a sound basis with respect to priorities for database
development, quality control and other operating procedures, peer review, budget, and
organizational status (SPC-SC and ORD)
- Develop guidance applicable across EPA with respect to use of current methods for assessing
multi-source and multi-path exposures (both direct and indirect) and cumulative risks. Emphasize
applications in support of environmental justice objectives.
— Develop and evaluate new methods for these purposes.
- Survey current EPA efforts with respect to development and use of methods for comparing risks.
- Seek guidance from the SAB for improving these methods and their applications.
- Update and develop implementation plan for EPA's draft Social Science Research Agenda.
Needed research includes development of better methods for assessing, quantifying and
communicating environmental and economic benefits and costs - as well as socioeconomic
impacts — of environmental measures as they affect stakeholders at all levels. As part of this
process, codify acceptable principles governing the use of social science data and methods in
Agency decision making.
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ISSUES
1. Begin activity immediately
Quality assurance
Laboratory accreditation
Peer review of environmental.
regulatory models
Guide for ecological risk
management
"FACILITATE ft ENDORSE" PROJECTS FOR SPC
ACTIVITIES (lead entity indicated in parentheses - see next page for abbreviations)
Expand and intensify the use of quality assurance procedures by completing six Management
Systems Reviews by Fall 1994 (ORD)
Achieve commitment from AAs to support a national conference with the slates on
accreditation of environmental laboratories in November 1994 (OA, EMMC)
Review and approve the agency-wide guidance on peer review of environmental regulatory
models (SPC, ATFERM)
Review and adopt as Agency guidance "Managing Ecological Risk: A Guide for Decision-
makers" (SPC, AERMCG)
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Risk assessment: risks to children Ensure Agency-wide coordination and agreement on OPPTS-led effort to develop risk
Ecological risk assessment &
indicators
assessment policy regarding risks to children (OPPTS)
Report on ongoing projects related to the topic (RAF, SPC-SC)
2. Analyze further (possible activities later this year)
Access to environmental
information
Cancer risk assessment guidelines
Non-cancer risks
Human variability re toxins
Report ongoing OPPTS/OIRM effort to coordinate with other federal agencies (OPPTS, SPC-
SC)
Prepare draft guidelines update, addressing any science policy or cross-Agency issues (RAP,
ORD)
— Develop an EPA-wide strategy to improve methods for non-cancer risk assessment and
promote their broader application. Begin with consultation with SAB.
-- Begin to use the benchmark dose approach in the RfD/RfC workgroup (ORD)
Review activities across EPA, identify gaps/needs, and develop EPA-wide approach to inter-
individual variation in susceptibility (ORD)
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"FACILITATE & ENDORSE" (CONT'D)
2. Analyze further (possible activities later this year)(cont'd)
Environmental justice: use of
databases
Environmental hormones
Pollution prevention & environmental justice initiative in FY1995 (OPPTS)
— Build the data systems to allow information on toxic chemical releases to be
combined with census data on population characteristics to support analyses of
environmental justice issues.
- Make the data user friendly, by supplying a system interface, ready \o use software,
and accessible documentation.
- Create outreach programs and educational materials on data use and pollution
prevention.
Agency scientists and managers to identify research needs on environmental hormones, and
coordinate efforts with other agencies. Develop Agency policy based on state of current
knowledge. (ORD, OPPTS)
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AERMCG Agency Ecological Risk Management Communication Group
ATFERM Agency Task Force on Environmental Regulatory Modeling
EMMC Environmental Monitoring Management Council
OA Office of the Administrator
OPPTS Office of Prevention, Pesticides, and Toxic Substances
ORD Office of Research and Development
RAF Risk Assessment Forum
SPC Science Policy Council
SPC-SC Science Policy Council Steering Committee
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MAY 3 I 1994
OFFICE OF
THEADMWISTRATOR
MEMORANDUM
SUBJECT: "Science and Judgment in Risk Assessment",
A Report by the National Research Council (NRC)
FROM: Robert M. Sussman, Chair (J QSi
Science Policy Council \^/eJ^-^~
Lynn R. Goldman, Vice-Chair
Science Policy Council
i*
TO: Carol Browner
Administrator
As you requested, the Science Policy Council (SPC) has
reviewed the subject report. This memorandum transmits our
analysis and proposed EPA response (Attachment).
In accord with Section 112(o) of the Clean Air Act
Amendments (CAAA) of 1990, NRC evaluated the methods used by EPA
to assess the risks posed by exposure to hazardous air
pollutants. The study was intended to guide the further
development of risk-assessment methods to be used in the residual
risk provisions of the Title III of the CAAA. However, as a
consequence of the wide applicability of the risk-assessment
paradigm adopted by EPA and other agencies in the wake of NRC's
seminal 1983 report on risk assessment, most of the findings and
recommendations have relevance throughout EPA and across the
Executive Branch.
As characterized in its accompanying NRC press release,
report offers a two-part message: " ... EPA's overall approach to
assessing risks is fundamentally sound despite often-heard
criticisms, but the agency must more clearly establish the
scientific and policy basis for its risk assessments and better
describe the uncertainties in its estimates of risk." To that
end, the report includes 70 specific recommendations whereby EPA
might improve ics policies, practices, and methods for risk
assessment. The recommendations cover a wide variety of
objectives from near-term methodological refinements to long-term
research.
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The SPC agrees with the general course of action that NRC
advocates. In particular, we view the 70 recommendations, taken
together, as providing a sound conceptual framework for our
continuing efforts to upgrade health-risk assessments (i.e., both
cancer and non-cancer hazards), strengthen the linkages between
risk assessment and risk-management, and improve the ways EPA
communicates about risk with all interested parties.
The SPC has identified eight thematic areas within which to
begin implementing NRC's recommendations. For example, we
propose to improve the quality of risk characterizations
throughout EPA and make them more prominent in the rule-
development process during the coming year. Also, looking
further into the future, we propose a special initiative to
advance the science of exposure assessment - especially as it
relates to dealing "with multi-path, multi-source exposure
scenarios and cumulative risks, such as those experienced
disproportionately by many minority populations and other
disadvantaged groups. The Attachment provides a detailed
description of our envisioned actions in all eight thematic
areas.
r
In view of the broad scope and inherent complexity of the
NRC recommendations, the steps we envision necessarily are only
the beginning. A comprehensive response will require a sustained
resource-intensive effort for the foreseeable future. The SPC
and its Steering Committee plan to update the Attachment from
time to time based on our progress, new developments in relevant
science and technology, and advice from the Science Advisory
Board and others within the many communities of interest outside
EPA. Further, we are prepared to work with you and the Senior
Leadership Council to integrate the basic themes of the NRC
report and the EPA response into the Agency-wide processes for
strategic planning and budgeting.
The SPC believes that the combination of the NRC report and
our proposed response constitute a realistic, multifaceted
approach to improving both our capability for health-risk
assessment and its applications in support of environmental
protection. We look forward to your comments and guidance as we
embark upon the next phase.
Attachment
cc: Assistant Administrators ,
Regional Administrators
Members of the Science Policy Council
Members of the Science Policy Council Steering Committee
Michael Vandenbergh
Sylvia Lowrance
Dana Minerva
Richard Parker
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REPORT OF THE EPA SCIENCE POLICY COUNCIL
ON ADDRESSING
•SCIENCE AND JUDGMENT IN RISK ASSESSMENT",
A REPORT BY THE NATIONAL RESEARCH COUNCIL
BACKGROUND
Pursuant to Section 112(o) of the Clean Air Act Amendments of
1990 (CAAA), the National Research Council (NRC) prepared a report
to Congress evaluating the methods used by EPA to assess the risks
posed by exposure to hazardous air pollutants (HAPs). The core of
the NRC Report focuses necessarily on issues specific to the
Office of Air and Radiation (OAR). However, as a consequence of
the wide applicability of the risk-assessment paradigm adopted by
EPA and other agencies in the wake of an earlier NRC report ,
most of the findings and recommendations have relevance throughout
EPA and across the Executive Branch.
The NRC report contains a comprehensive analysis of the state
of the science of cancer-risk assessment and its uses in relation
to decision-making at EPA. Risk assessment related to other
health hazards is discussed only briefly, and ecological risks are
not treated explicitly because they are outside the statutorily
defined scope. Nevertheless, many of the concepts discussed in
relation to cancer also are germane to non-cancer risks; and
several of the fundamental principles apply to ecological risks as
'well.
As characterized in its accompanying NRC press release, the
report offers a two-part message: " ... EPA's overall approach to
assessing risks is fundamentally sound despite often-heard
criticisms, but the agency must more clearly establish the
scientific and policy basis for its risk assessments and better
describe the uncertainties in its estimates of risk.1* To that
end, the report includes 70 specific recommendations whereby EPA
might improve its policies, practices, and methods for risk
assessment. Nothing in the report, however, militates for
wholesale replacement of the current paradigm.
The recommendations cover a wide variety of objectives from
near-term methodological refinements to long-term research.
Although some of the recommendations can be implemented in the
short term, a comprehensive response will require a sustained
resource-intensive effort for the foreseeable future. The Science
Policy Council (SPC) views them as a sound basis for upgrading
health-risk assessments in general (i.e., both {cancer and non-
cancer hazards), strengthening the linkages between risk
^•National Research Council. 1983. Risk Assessment in the
Federal Government: Managing the Process. National Academy
Press, Washington, D.C.
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assessment and policy-making, and improving the ways EPA
communicates about risk with all interested parties.
Of special note is the fact that many of the issues raised by
NRC are relevant to the issue of environmental justice. For
example, NRC highlights the need to consider the variability in
both exposure and susceptibility to chemicals when conducting a
risk assessment. This supports the need to consider potentially
high-risk subgroups. In addition, the report points out that
certain populations may be exposed to multiple chemicals and that
risk assessments should consider the "aggregation" or cumulative
risks associated with these exposures whenever practical.
SPC identified eight thematic areas within which to begin
implementing NRC's recommendations:
Risk Assessments for Hazardous Air Pollutants
Risk Characterization
Integrated Risk Information System
Cancer Risk Assessment Guidelines
Assessment of Non-Cancer Risks
Multi-Path and Multi-Source Exposure Assessment
Susceptibility to Chemicals: Inter-Individual Differences
Research to Improve Risk Assessment Tools
These themes and the Agency's initial actions to address them are
summarized below.
THEMES AND PROPOSED ACTIONS
1. Risk Assessments for Hazardous Air Pollutants (HAPs)
Background
Title III of the Clean Air Act Amendments of 1990 requires
that between 1998-2006 EPA set residual-risk standards for HAPs
that protect public health with an ample margin of safety if it
concludes that the technology-based standards have not done so.
To accomplish this, EPA must evaluate the level of risk that
remains after the application of best available technology to HAPs
emission sources. The NRC study was intended to guide the further
development of risk-assessment methods to be used in this stage of
the regulation of HAPs emissions from point sources.
The NRC report called for EPA to: 1) obtain key data for
assessing risks from HAPs; 2) update methods for determining
carcinogenic risks associated with HAPs; and 3) improve risk
assessment methods for noncancer risks from HAPs. As a first step
in implementing NRC's recommendations, EPA's Office of Air and
Radiation will accord high priority to acquiring toxicity data on
HAPs and improving methods for air toxics exposure modeling.
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Objectives and tasks listed directly below describe
activities focussed on HAPs. The seven themes discussed in this
report are oriented towards improving risk assessment generally
throughout the Agency and are also linked to recommendations from
the NRC for improving assessments of HAPs.
Objective Is Acquire toxicity data on HAPs
Initial Task: Complete proposals for acquiring
additional data on HAPs.
Responsibility: Office of Air and Radiation; Office of
Research and Development; Office of Prevention,
Pesticides and Toxic Substances
Target date: Summer 1994
Comment: More and better data on HAPs would be of value to
other EPA programs as well. For example, all HAPs are listed
as hazardous substances under Superfund; many are of concern
to the Office of Water; and many are subject to reporting
under the Toxics Release Inventory.
Objective 2: Improve air toxics exposure modeling
Improve capabilities for modeling air-toxics exposures,
including use of emissions inventory and exposure data, validating
model evaluations against field measurements, and incorporation of
uncertainty quantification in a consistent manner.
Initial Task: Update modeling section of air toxics issue
plan for research, including estimate of resource
requirements.
Responsibility: Office of Research and Development;
Office of Air and Radiation
Target date: Fall 1994
Comment: Improved modeling for exposures to air toxics could
benefit other EPA programs that deal with air-borne hazards,
particularly as the Agency moves towards multi-path exposure
assessment as an EPA-wide practice, (See also "Multi-path,
Multi-Source Exposure Assessment").
2. Risk Characterization ,
Background
The NRC report emphasizes the importance of risk
characterization. In general, the comments reinforce current EPA
policies in these areas while recognizing that EPA practices need
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to be improved. The effort here will be to initiate specific
actions to bring practices more closely into line with the
Agency's stated policies2 including:
Use of Default assumptions
Inclusion of Qualitative Uncertainty Analysis
Application of Quantitative Uncertainty Analysis
Objective it Create a mechanism for evaluating BPA's progress
Task 1: Design oversight mechanism.
Responsibility: Group designated by SPC Steering Committee
Target date: July 1994
Task 2: Implement oversight mechanism.
Responsibility: Group designated by SPC Steering Committee;
periodic review by SPC
Target date: Begin implementation Augvfst 1994. Report to
Administrator no later than one year after implementation.
Objective 2: Create models of good risk characterizations for
different kinds of rules and actions and identify institutional or
resource barriers by working closely with several Headquarter
offices and regions on a select number of rules or major
assessments.
Task 1: Develop schedules and processes.
Responsibility: Coordination/resource group to be designated
by SPC Steering Committee
Target date: July 1994
Task 2: Work with programs and regions to identify suitable
candidates representing different kinds of rules
and actions.
Responsibility: SPC Steering Committee and program offices
Target date: July 1994
2"Guidance on Risk Characterization for Risk Managers and
Risk Assessors". Memorandum from the EPA Deputy Administrator to
Agency Regional Administrators and Assistant Administrators.
February 26, 1992.
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Task 3: Report on status of model development to SPC
Steering Committee.
Responsibility: Coordination/resource group to be designated
by SPC Steering Committee
Target date: September 1994
3. Integrated Risk Information System (IRIS)
Background
IRIS is a public data base that holds the consensus findings
of EPA scientists on human-health hazard and dose-response
characteristics of several hundred chemicals and mixtures. IRIS
originally was a resource strictly for internal EPA use but now is
available publicly, including on-line access through, the National
Library of Medicine and international distribution through the
World Health Organization. In many respects, IRIS is the public
face of EPA risk assessment.
The NRC Report contains many recommendations that affect IRIS
including several that mirror the suggestion* of EPA's IRIS
Quality Action Team. In recent years, the EPA investment in the
maintenance and improvement of IRIS (especially support of the two
interdisciplinary teams of EPA scientists who develop the
information it contains) has not kept pace with the needs of users
within EPA and elsewhere. Over the past two years, EPA has
mounted an effort (through the activities of a quality action
team) to examine mechanisms to gain more peer review and public
involvement in the IRIS process.
SPC proposes that its Steering Committee and the Office of
Research and Development (ORD) create a multi-year plan to put
IRIS on a sound basis. This will involve establishing priorities
for data-base development, quality control and other operating
procedures, budget, and organizational status. These actions seem
the most direct way to address NRC's calls for major improvements
in such aspects as the descriptive narratives and justifications;
the characterizations of data deficiencies, uncertainties and
assumptions; and the scope and intensity of the peer review for
IRIS entries.
Objective: Improve IRIS management and data quality
Develop Agency policy on the use of information in IRIS,
agreed-upon management practices, scope, quality1 assurance
methods, and budget.
Initial Task: Review report from existing IRIS Quality Action
Team and decide whether to act on those recommendations
and/or to re-energize that cross-Agency effort or another
effort to address Agency-wide IRIS issues
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Responsibility: SPC Steering Committee
Target date: July 1994
4. Cancer Risk Assessment Guidelines
Background
The NRC Report is generally supportive of the current EPA
approach to cancer-risk assessment for those instances when, in
the absence of compelling evidence to the contrary, reliance is
placed on conservative default assumptions. Examples include the
reliance on the results of animal studies in estimating
carcinogenicity in humans and the non-threshold assumption for
carcinogens. The NRC Report urges that EPA articulate these
default assumptions more clearly and define criteria under which
these assumptions could be supplanted by specific data or more
biologically based approaches.
To a large extent the points elucidated by the NRC are
consistent with ongoing efforts to revise the EPA cancer-risk
assessment guidelines. Important parts ofrEPA's guidelines for
cancer risk assessment have become out-of-date as a result of
recent research advances, especially new insights into the
.cellular and molecular events involved in carcinogenesis.
Revision of the guidelines will address several of the major
themes raised by the NRC report, including: default options and
reasons for departing from them in particular instances,
variations within human populations with respect to both exposures
and susceptibilities to toxic substances, and cumulative effects
of environmental hazards.
Revision of the guidelines is underway by the Cancer
Oversight Group of the Risk Assessment Forum. In consultation
with SPC, ORD has agreed to accelerate this effort to complete a
new draft by summer 1994, thereby enabling the Risk Assessment
Forum to conduct a public workshop on the draft guidelines later
this year.
Objective: Complete a new version of the cancer risk assessment
guidelines
Task 1: Develop a draft of the guidelines that will be ready
for Agency review in May, 1994, and hold an external peer
involvement workshop in the fall of 1994.
Responsibility: Risk Assessment Forum
Target date: September 1994
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Task 2: After the workshop, report to SPC on the issues
raised, the process for their resolution,, and the overall
schedule and resource requirements for completion.
Responsibility: Risk Assessment Forum
Target date: Fall 1994
5. Assessment of Non-Cancer Risks
Background
NRC points to the need to develop better quantitative methods
for assessing the incidence and likelihood of non-cancer effects
in exposed populations. It included discussions of non-cancer
risks in its general discussions of variability and uncertainty,
models, methods and data, and aggregation of separate but related
causes and effects of risk. The EPA Science Advisory Board
(SAB) is scheduling a consultation for later this year to discuss
the implications of the subject report for non-cancer risk
assessment. SPC strongly endorses this consultation and urges
that it be accorded high priority. The outcome should provide the
basis for developing an expanded program of "research and
applications with respect to assessing non-cancer health effects.
Objective 1: Develop EPA-wide strategy on non-cancer risk
assessment
Develop an EPA-wide strategy to improve methods for non-
cancer risk-assessment and promote their broader application.
This strategy would identify whether new or revised Agency
guidelines are needed and how and when they could be developed.
Initial Task: Two-step consultation with the Science
Advisory Board to review the potential implications of
the NRC report for the Agency's assessment of non-cancer
risks. The consultation will build upon ongoing work
related to neurotoxicity, developmental toxicity, and
other non-cancer effects and could facilitate efforts to
reduce risks from pesticides in the diets of infants and
children.
Responsibility: Office of Research and Development
Target date: first consultation, spring 1994
Objective 2: Assess the utility of the benchmark dose
The benchmark dose concept has been developed as an
alternative methodology for deriving quantitative estimates of
hazard, which can be used for both cancer and non-cancer endpoints
of toxicity. EPA will analyze what is required to implement the
benchmark dose approach (implications on assessments per chemical,
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potential effects on risk management decisions, and resources
required).
Initial Task: Develop both reference standard doses (RfDs)
and benchmark doses for next year wherever there are suitable
data. This report would be followed by an evaluation to
assess general implementation issues associated with adoption
of benchmark dose approach.
**
Responsibility: SPC Steering Committee and RfD Workgroup
Target date: Summer, 1994
(. Multi-Path and Multi-Source Exposure Assessment
Background
The EPA has not employed multi-path/multi-source exposure
assessment routinely in all programs. The NRC Report recommends
that EPA consider exposure to air toxics through indirect pathways
(such as food sources) and from other air sources (such as mobile
and indoor sources) as well as from outdoor stationary sources.
SPC concurs in the NRC recommendation not only as it applies to
the air-toxics program but also as it affects most other EPA
programs. Similarly, the NRC Study on Pesticides in the Diets of
Infants and Children recommended consideration of multiple routes
of exposure (e.g., dietary and non-dietary) in the evaluation of
pesticide risks. Therefore, SPC proposes to initiate the
development of an EPA-wide policy on this issue so as to promote
systematic consideration of multiple paths and multiple sources of
exposure wherever appropriate in the course of risk assessment.
Improving exposure assessment in these areas will address
environmental justice concerns by helping to identify subgroups of
the population which are highly exposed. More use of multi-path
exposure assessment could improve the quality and utility of risk
assessments in general as well as accelerate the emergence of
multi-media and industrial-sector-specific approaches to
protecting humans and the environment
Objective 1: Develop an EPA policy on multi-path and multi-source
exposure assessment
Develop an Agency-wide policy directing programs to look at
multiple routes of exposure in exposure analyses. The policy will
address how to use screening techniques and sensitivity analyses,
as advocated by the NRC, to focus such assessments on those
pathways which are likely to present the most significant risk.
8
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Task 1: Review the report of the existing Agency-wide
Relative Source Contribution Task Force, which is developing
a consistent Agency approach to issues such as pesticide
exposure via drinking water sources.
Responsibility: SPC Steering Committee
Target date: Spring, 1994
Task 2: Monitor experience of the Office of Pesticide
Programs as they begin to assess multiple routes of exposure
to pesticides. Identify issues of Agency-wide concern.
Responsibility: SPC Steering Committee
Target date: Fall, 1994
Objective 2: Improve methodologies for assessing exposures via
multiple pathways and from multiple sources
Wider use of multi-source and multi-path exposure assessment
will depend on the availability of appropriate methodologies and
supporting data. EPA needs to expand current exposure assessment
efforts, especially in the area of fate and transport modelling to
trace indirect routes of exposure.
Initial Task: Review the current research plan on human
exposure and other efforts ongoing in the Agency, and
evaluate current priorities in light of the NRC
recommendations.
Responsibility: Office of Research and Development and
Program Offices
Target date: Summer 1994
7. Susceptibility to Chemicals: Inter-Individual Differences
Background
The NRC Report recommends that EPA give more emphasis to the
issue of human variation in sensitivity to environmental
pollutants. This has both policy and research implications. The
recommendation builds on and extends the recommendations in the
NRC report on "Pesticides in the Diets of Infants and Children"
published last year. '
The Office of Research and Development and the Office of
Prevention, Pesticides and Toxic Substances will summarize the
current state of knowledge about human variability in sensitivity
to different kinds of chemical pollutants. This paper will be
developed in conjunction with ongoing efforts to respond to that
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Report and will contain recommendations for additional Federal
research and short-term policy options for addressing individual
variability in EPA risk assessments.
Objective: Develop EPA-vide Approach to inter-individual
variation in susceptibility
Develop a policy statement and implementation strategy to
help risk assessors and risk managers accord appropriate attention
to inter-individual differences in susceptibility to toxic
chemicals.
Increased attention to inter-individual differences in
susceptibility to toxic chemicals could facilitate progress toward
several of the Administrator's high-priority goals such as
promoting environmental justice and reducing risks from pesticides
in the diets of infants and children.
Task 1: Participate in effort to plan research
strategies across the federal government through the
process established by the National Science and
Technology Council (NSTC), Committee on Environmental
and Natural Resources, and prepare a position paper
summarizing the current state of knowledge and the major
research needs in this area.
Responsibility: Office of Health and Environmental
Assessment/Office of Research and Development; Office of
Prevention, Pesticides and Toxic Substances
Target date: Fall 1994
Task 2: Identify policy issues and options for risk
assessors and managers, based on current state of knowledge.
Effort should coordinate with Agency's response to NRC Study
on Pesticides in the Diet of Infants and Children in the
areas of toxicology; multi-pathway exposures through
consumption of food and water; assessment of pesticide
tolerances; and risk assessment methods.
Responsibility: SPC Steering Committee
Target date: Winter 1994
8. Research to Improve Risk Assessment Tools
Background
The NRC Report recommends that EPA augment existing research
with a more broadly-based effort to improve risk-assessment
methodologies. The NRC report acknowledges that the
responsibility for conducting such risk-related research does not
10
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lie exclusively with EPA but rather is also the responsibility of
several other agencies with environmental and public-health
responsibilities (e.g., the National Institute of Environmental
Health Sciences and the Centers for Disease Control and
Prevention).
SPC recommends that, in responding to NRC's call for more
research related to improving risk assessment, EPA should maintain
its existing research program in many of the areas that are
highlighted in the NRC report, including the examination of
developmental and reproductive toxicity and pharmacokinetics and
metabolism. SPC also recommends that EPA seek to integrate its
research with that of other agencies - both directly and through
the Committee on Environmental and Natural Resources under the
National Science and Technology Council.
Objective 1: Coordinate research needs through the N8TC
Highlight needs and opportunities for risk assessment
research for consideration by the NSTC as it sets interagency '
research priorities relative to the environment and natural
resources, food safety and nutrition, and fundamental science.
Initial Task: Contribute ideas about risk assessment
research to the research planning efforts being conducted by
the committees of the NSTC.
Responsibility: EPA representatives to NSTC Committees
Target date: Spring 1994
Objective 2: Reexamine EPA research priorities for risk
assessment research in light of the NRC report
Task 1: Review by Science Advisory Board of the risk
assessment research plan.
Responsibility: Office of Research and Development; i
staff directorate, Science Advisory Board
Target date: Summer 1994
Task 2: Report results of review to SPC.
Responsibility: Office of Research and Development
Target date: Fall 1994
11
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SUMMARY OF COMMUNICATIONS PLAN FOR
EPA Response to NAS/NRC Report "Science and Judgment
in Risk Assessment"
Key Word Title: Risk Assessment
Official Title: EPA Response to NAS/NRC Report "Science and
Judgment in Risk Assessment"
Importance: medium visibility
1. Action:
Projected Announcement
Date: May 15, 1994
EPA is responding to the recommendations of the
NAS/NRC Subcommittee that conducted a review
mandated by the Clean Air Act Amendments. This
review evaluated the methods used by EPA to assess
the risk posed by the exposure to hazardous air
pollutants. It also commented more broadly on
risk assessment and its use in decision making at
EPA.
Message: In response to NAS's many constructive
recommendations, EPA is moving forward in 8 key
areas to improve risk assessment, the use of risk
assessment in decision making and communicating
with the public about risks. These improvements
complement a broader initiative within the Agency
to improve assessments of dietary risks from
pesticides, of non-cancer risks, and of ecological
risks and to coordinate such actions with other
relevant federal agencies.
Audience: Scientific community in public and private sector;
Capitol Hill staff that follow risk assessment;
industry, public interest, other government
agencies, inter-Agency groups, and White House
groups that follow risk assessment
Overall strategy:
outreach designed to reach key
officials, decision makers, and leaders
in the scientific community.
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FEDERAL REGISTER NOTICE
EPA Response to NRC Report "Science and Judgment
in Risk Assessment"
Key Word Title: Risk Assessment
Official Title: EPA Response to NRC Report "Science and Judgment
in Risk Assessment"
5. Background: The Clean Air Act Amendments of 1990 required
the National Research Council of the National Academy of Sciences
evaluate the methods used by EPA to assess the risks posed by
exposure to hazardous air pollutants. As a consequence of the
wide applicability of the risk assessment paradigm adopted by
EPA, most of the findings and recommendations have relevance
throughout EPA.
6. Detailed Description of Action: See attached memorandum.
7. Effect of Agency Action: Action will influence planning of
research on risk and the assessment, characterization, and
communication of risks by the Agency.
8. Anticipated Reactions: The scientific community will see
this effort as EPA's initial response to the NAS/NRC report and
will expect to hear additional information about the Agency's
ongoing activities to address risk assessment issues. Capital
Hill staff will rely on the reactions of members of the NAS
committees that developed the report to gauge the effectiveness
of EPA's response.
9. Detailed Strategy: Central Coordinator of Activities
Described Below: Carl Mazza
Strategy - External Audiences
Subgroup from EPA's Science Policy Council (SPC) to meet
with key officials/board members from NAS to discuss Agency
response
Deputy Administrator to brief the Office of Science and
Technology Policy on EPA response
Deputy Administrator to brief/inform inter-agency risk
assessment group chaired by Sally Katzen about EPA response
SPC members conduct briefing for Hill Staff, including
Domenici committee, responsible for NAS provision
send Domenici copy of material from SPC to
Administrator
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Deputy Administrator to outline EPA's overall approach to
risk assessment highlighting response to NAS for EPA's
Science Advisory Board
Members of Science Policy Council or Steering Committee to
outline EPA's overall approach for:
Major meetings of scientific organizations (Society for
Risk Analysis, Society of Toxicology, American Academy
for the Advancement of Science
Industry associations interested in risk assessment
(AIHC etc.)
Public interest groups
Other federal inter-agency/White House groups
Publish letter/article in Science, or other trade press
The Deputy Administrator and other members of the SPC and
Steering Committee will provide a press briefing on the
substance and impact of EPA actions in response to the
NAS/NRC Report.
Strategy - Internal Audiences
Discuss Agency response at meeting Senior Leadership Council
Article in Risk Assessment Review describing reaffinnation
of EPA's risk characterization policy
SPC members distribute Administrator's memorandum
reaffirming risk characterization policy to staff in their
offices.
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REPORT OF THE EPA SCIENCE POLICY COUNCIL
ON ADDRESSING
"SCIENCE AND JUDGMENT IN RISK ASSESSMENT",
A REPORT BY THE NATIONAL RESEARCH COUNCIL
BACKGROUND
Pursuant to Section 112(o) of the Clean Air Act Amendments of
1990 (CAAA), the National Research Council (NRC) prepared a report
to Congress evaluating the methods used by EPA to assess the risks
posed by exposure to hazardous air pollutants (HAPs). The core of
the NRC Report focuses necessarily on issues specific to the
Office of Air and Radiation (OAR). However, as a consequence of
the wide applicability of the risk-assessment paradigm adopted by
EPA and other agencies in the wake of an earlier NRC report1,
most of the findings and recommendations have relevance throughout
EPA and across the Executive Branch.
The NRC report contains a comprehensive analysis of the state
of the science of cancer-risk assessment and its uses in relation
to decision-making at EPA. Risk assessment related to other
health hazards is discussed only briefly, and ecological risks are
not treated explicitly because they are outside the statutorily
defined scope. Nevertheless, many of the concepts discussed in
relation to cancer also are germane to non-cancer risks; and
several of the fundamental principles apply to ecological risks as
well.
As characterized in its accompanying NRC press release, the
report offers a two-part message: " ... EPA's overall approach to
assessing risks is fundamentally sound despite often-heard
criticisms, but the agency must more clearly establish the
scientific and policy basis for its risk assessments and better
describe the uncertainties in its estimates of risk." To that
end, the report includes 70 specific recommendations whereby EPA
might improve its policies, practices, and methods for risk
assessment. Nothing in the report, however, militates for
wholesale replacement of the current paradigm.
The recommendations cover a wide variety of objectives from
near-term methodological refinements to long-term research.
Although some of the recommendations can be implemented in the
short term, a comprehensive response will require a sustained
resource-intensive effort for the foreseeable future. The Science
Policy Council (SPC) views them as a sound basis for upgrading
health-risk assessments in general (i.e., both cancer and non-
cancer hazards), strengthening the linkages between risk
National Research Council. 1983. Risk Assessment in the
Federal Government: Managing the Process. National Academy
Press, Washington, D.C.
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assessment and policy-making, and improving the ways EPA
communicates about risk with all interested parties.
Of special note is the fact that many of the issues raised by
NRC are relevant to the issue of environmental justice. For
example, NRC highlights the need to consider the variability in
both exposure and susceptibility to chemicals when conducting a
risk assessment. This supports the need to consider potentially
high-risk subgroups. In addition, the report points out that
certain populations may be exposed to multiple chemicals and that
risk assessments should consider the "aggregation" or cumulative
risks associated with these exposures whenever practical.
SPC identified eight thematic areas within which to begin
implementing NRC's recommendations:
Risk Assessments for Hazardous Air Pollutants
Risk Characterization
Integrated Risk Information System
Cancer Risk Assessment Guidelines
Assessment of Non-Cancer Risks
Multi-Path and Multi-Source Exposure Assessment
Susceptibility to Chemicals: Inter-Individual Differences
Research to Improve Risk Assessment Tools
These themes and the Agency's initial actions to address them are
summarized below.
THEMES AND PROPOSED ACTIONS
1. Risk Assessments for Hazardous Air Pollutants (HAPs)
Background
Title III of the Clean Air Act Amendments of 1990 requires
that between 1998-2006 EPA set residual-risk standards for HAPs
that protect public health with an ample margin of safety if it
concludes that the technology-based standards have not done so.
To accomplish this, EPA must evaluate the level of risk that
remains after the application of best available technology to HAPs
emission sources. The NRC study was intended to guide the further
development of risk-assessment methods to be used in this stage of
the regulation of HAPs emissions from point sources.
The NRC report called for EPA to: 1) obtain key data for
assessing risks from HAPs; 2) update methods fbr determining
carcinogenic risks associated with HAPs; and 3) improve risk
assessment methods for noncancer risks from HAPs. As a first step
in implementing NRC's recommendations, EPA's Office of Air and
Radiation will accord high priority to acquiring toxicity data on
HAPs and improving methods for air toxics exposure modeling.
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*• 4% % UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
1394
THE ADMINISTRATOR
KIMORXNPUK
SUBJECT: Peer Review Program
TO: Assistant Administrators
General Counsel
Inspector General
Associate Administrators
Regional Administrators
Staff Office Directors
Today, I am reaffirming the central role of peer review in
our efforts to ensure that EPA policy decisions rest on sound,
credible science and data (see attached policy statement).
Toward that end, as its first major task, EPA's Science Policy
Council (SPC) is instituting a program to expand and improve peer
review in all EPA offices. This memorandum gives an overview of
current practices and outlines the new program.
Peer Review Practices and Policy
Peer review at EPA takes several different forms, ranging
from informal consultations with Agency colleagues who were not
involved in developing the product to the formal, public
processes of the Science Advisory Board (SAB) and the FIFRA
Scientific Advisory Panel (SAP). In any form, peer review
assists the Agency's work by bringing independent expert
experience and judgment to bear on issues before the Agency to
the benefit of the final product.
EPA's peer review policy, which responds in part to
recommendations in the "Credible Science, Credible Decisions"
report, outlines general principles for peer review at EPA.
Different EPA offices have undertaken various implementing
activities, including an Agency-wide information and planning
workshop, internal guideline development, and numerous specific
peer reviews. Even with these activities, however, I am
concerned that EPA does not yet have a comprehensive Agency-wide
program for implementing its peer review policy. I therefore
welcome the SPC initiative toward effective, efficient
implementation of the policy in all the program areas to which it
applies.
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gxpandina and Improving Peer Review
The Science Policy Council and its Steering Committee have
outlined a dual-track implementation program of planning and
assistance for all Agency offices. The first track has three
major milestones.
First, during the next few weeks, Steering Committee members
will consult with senior management in each office to exchange
information on current peer review activities, assistance needed,
possible obstacles to implementation, and implementation
planning.
Second, using information and materials developed during the
first stage, peer review task groups in each office will develop
standard operating procedures (SOPs) for use in each office,
based in part on generic guidance to be issued by the SPC and in
part on peer review needs and capabilities specific to each
office. The resulting SOPs will delineate as appropriate the
scope of application of peer review with respect to various types
of scientific and technical work products such as reports of
original research, risk assessments, and analytical methods of
economic analysis. OARM and OGC staff will assist each office as
needed on legal, budget and administrative matters. Each AA and
RA will submit draft SOPs for Steering Committee review by July
15.
Third, the SPC review group will work with each office to
complete each plan by September 15.
In parallel with the above, consistent with the peer review
policy, the Science Policy Council will work with each AA and RA
to identify "major scientific and technical work products" as
peer review candidates for the coming year. This process will
consider existing and new plans for internal reviews and for SAB,
FIFRA SAP, and other external reviews. The two-fold objective is
to plan reviews for technical products covered by the peer review
policy and to gain experience with options and obstacles. We
will use this experience to review and revise the SOPs as needed.
Also, to establish a baseline for comparison, each AA and RA will
identify the "major technical products" completed within his/her
program during the past 12 months.
The Science Policy Council has sent additional information
to each office offering guidance on the procedures that you are
asked to develop and the schedule for these activities. Please
note, however, that because the policy is effective immediately,
current peer review planning should continue on present schedules
in parallel with developing the formal SOPs.
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To begin this process, I have asked each Assistant
Administrator and Regional Administrator to designate a Peer
Review Coordinator to work with the Steering Committee on
implementation activities specific to each office. I am very
pleased that the Science Policy council is taking this important
step. A comprehensive peer review program is essential to
maintaining and improving the quality of the analyses that
underlie Agency actions. I look forward to working with you and
your staff on this important^activity.
Carol M. Browner
Attachment
cc: Science Policy Council
Science Policy Council Steering Committee
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PEER REVIEW AND PEER INVOLVEMENT
AT THE U. S. ENVIRONMENTAL PROTECTION AGENCY
This document establishes the policy of the United States
Environmental Protection Agency (EPA) for peer review of
scientifically and technically based work products that are
intended to support Agency decisions. Peer review is presented in
the context of the broader concept, peer involvement.
BACKGROUND
The report "Safeguarding the Future: Credible Science,
Credible Decisions"1 focused on the state of science at EPA. The
panel of experts who prepared the report emphasized the. importance
of peer review, especially external peer review, and the need for
broader and more systematic use of it at EPA to evaluate scientific
and technical work products. Their specific recommendation
regarding peer review reads as follows:
"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."
In response to this recommendation, then-Administrator Reilly
directed staff to develop an EPA-wide policy statement, which he
issued in January, 1993. The paragraphs below preserve the core of
that earlier statement while updating it to specify the role of the
Science Policy Council in guiding further implementation of the
policy. Effective use of peer review is indispensable for
fulfilling the EPA mission and therefore deserves high-priority
attention from program managers and scientists within all pertinent
Headquarters and Regional Offices.
1 EPA/600/9-91/050, March 199T.
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PEER INVOLVEMENT AND PEER REVIEW
EPA strives to ensure that the scientific and technical
underpinnings of its decisions meet two important criteria: they
should be based upon the best current knowledge from science,
engineering, and other domains of technical expertise; and they
should be judged credible by those who deal with the Agency. EPA
staff therefore frequently rely upon peer involvement -- that is,
they augment their capabilities by inviting relevant subject-matter
experts from outside the program to become involved in one or more
aspects of the development of the work products that support
policies and actions.
One particularly important type of peer involvement occurs
when scientifically and technically based work products undergo
peer review -- that is, when they are evaluated by relevant
experts from outside the program who are peers of the program
staff, consultants, and/or contractor personnel who prepared the
product. Properly applied, peer review not only enriches the
quality of work products but also adds a degree of credibility that
cannot be achieved in any other way. Further, peer review early in
the development of work products in some cases may conserve future
resources by steering the development along the most efficacious
course.
Peer review generally takes one of two forms. The review team
may consist primarily of relevant experts from within EPA, albeit
individuals who have no other involvement with respect to the work
product that is to' be evaluated (internal peer review) . Or the
review team may consist primarily of independent experts from
outside EPA (external peer review).
*
POLICY STATEMENT
Major scientifically and technically based work products
related to Agency decisions normally should be peer-reviewed.
Agency managers within Headquarters, Regions, laboratories, and
field components determine and are accountable for the decision
<-'hether to employ peer review in particular instances and, if so,
its character, scope, and timing. These decisions are made in
conformance with program goals and priorities, resource
constraints, and statutory or court-ordered deadlines. For those
work products that are intended to support the most important
decisions or that have special importance in their own right,
external peer review is the procedure of choice. Peer review is
not restricted to the penultimate version of work products; in
fact, peer review at the planning stage can often be extremely
beneficial.
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SCOPE
Agency managers routinely make regulatory and other decisions
that necessarily involve many different considerations. This
policy applies to major work products that are primarily scientific
and technical in nature and may contribute to the basis for policy
or regulatory decisions. By contrast, this policy does not apply
to nonmajor or nontechnical matters that Agency managers consider
as they make decisions. Similarly, this policy does not apply to
these ultimate decisions.
This policy applies where appropriate, as determined by the
National and Regional Program Managers, to major scientifically and
technically based work products initiated subsequent to the date of
issuance. Peer review should be employed to the extent reasonable
to relevant work products that currently are under development.
This policy does not apply to the bases for past decisions, unless
and until the relevant scientific and technical issues are
considered anew in the Agency's decision-making processes.
Except where it is required by law, formal peer review (as
distinguished from the Agency's normal internal review procedures)
should be conducted in a manner that will not cause EPA to miss or
need extension of a statutory or court-ordered deadline. Agency
managers still may undertake peer review if it can be conducted
concurrently with necessary rulemaking steps.
LEGAL EFFECT
This policy statement does not establish or affect legal
rights or obligations. Rather, it confirms the importance of peer
review where appropriate, outlines relevant principles, and
identifies factors Agency staff should consider in implementing the
policy. On a continuing basis, Agency management is expected to
evaluate the policy as well as the results of its application
throughout the Agency and undertake revisions as necessary.
Therefore, the policy does not stand alone; nor does it establish
a binding norm that is finally determinative of the issues
addressed. Minor variations in its application from one instance
to another are appropriate and expected; they thus are not a
legitimate basis for delaying or complicating action on otherwise
satisfactory scientific, technical, and regulatory products.
Except where provided otherwise by law, peer review is not a
formal part of or substitute for notice and comment rulemaking or
adjudicative procedures. EPA's decision whether to conduct peer
review in any particular case is wholly within the Agency's
discretion. Similarly, nothing in this policy creates a legal
requirement that EPA respond to peer reviewers. However, to the
extent that EPA decisions rely on scientific and technical work
products that have been subjected to peer review, the remarks of
peer reviewers should be included in the record for that decision.
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IMPLEMENTATION
The Science Policy Council is responsible for overseeing
Agency-wide implementation. Its responsibilities include promoting
consistent interpretation, assessing Agency-wide progress, and
developing recommendations for revisions of the policy as
necessary.
The Science Policy Council will oversee a peer-review work
group, which will include representatives from program units
throughout EPA to effect a consistent, workable implementation of
the policy. The work group will assist the programs in (l)
formulating and, as necessary, revising standard operating
procedures (SOPs) for peer review consistent with this policy; (2)
identifying work products that are subject to review; and (3) for
each major work product, selecting an appropriate level and timing
of peer review.
In assisting the programs, the work group will take into
account statutory and court deadlines, resource implications, and
availability of disinterested peer reviewers. The group will work
closely with Headquarters offices and the Regional Offices toward
ensuring effective, efficient uses of peer review in supporting
their mission objectives. However, the Assistant Administrators
and Regional Administrators remain ultimately responsible for
developing SOPs, identifying work products subject to peer review,
determining the type and timing of such review, documenting the
process and outcome of each peer review, and otherwise implementing
the policy within their organizational units.
Because peer review can be time-consuming and expensive,
Agency managers within Headquarters, Regions, laboratories, and
field components are expected to plan carefully with respect to its
use — taking account of program priorities, resource
considerations, and any other relevant constraints as well as the
policy goal of achieving high-quality, credible underpinnings for
decisions. External peer reviewers should be chosen carefully to
ensure an independent and objective evaluation. The affiliations
of peer reviewers should be identified on the public record, so as
to avoid undercutting the credibility of the peer-review process by
conflicts of interest.
This policy is effective immediately. The peer-review work
group mentioned above will identify the focal point to whom
comments and questions should be addressed and, from time to time,
will provide further information about implementation activities.
APPROVED: *z<^a+*Sl*~— DATE: jyfj 7 ™,
CAROL M. BROWNER, ADMINISTRATOR.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
SEP 30 1994 THE ADMINISTRATOR
Honorable John D. Dingell
Chairman, Committee on Energy and Commerce
House of Representatives
Washington, DC 20515
Dear Mr. Chairman:
To follow up on my letter of May 12, 1994, I am pleased to
advise you that the Environmental Protection Agency (EPA) has
embarked on an expanded program for peer review of major
scientifically and technically based work products related to
Agency decisions. As I informed you at that time, peer review is
an important feature of EPA's overall program to assure science
quality at EPA.
Responding to my June 7, 1994 Peer Review Policy statement
(enclosed), each EPA office has completed "Standard Operating
Procedures" (SOPs) for peer review (also enclosed). The SOPs
will govern most EPA peer review activities beginning on October
1, 1994. The Science Policy Council (SPC) and I will use these
SOPs to assure the quality of the scientific and technical
products that underlie EPA regulations and science policies.
Each SOP captures the three major features of EPA's Peer
Review Policy. First, each SOP outlines principles and
procedures relating to peer review of major scientific and
technical work products related to Agency decisions, which
include Agency work on health, ecology, engineering, economics
and other technical issues. This work, enhanced by peer review,
is frequently used as the scientific and technical basis for
Agency regulatory decisions. The regulatory decisions, in turn,
receive broad public review through the notice and comment
process.
Second, each SOP vests responsibility and accountability for
the conduct of peer review with the appropriate Assistant
Administrators (AAs) and Regional Administrators (RAs). To that
end, the SOPs are accompanied by a list of candidate work
products for peer review in FY195 (Appendix D to each SOP).
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Third, the new procedures recognize both internal and
external independent experts as peer reviewers. The SOP's
explain that external experts are more appropriate for
particularly novel, complex, costly, or controversial issues. In
other cases, internal agency experts may be appropriate. In both
cases, relevant expertise and independence — i.e., no other
involvement with the product under review — are critical
requirements, as are the absence of bias and conflicts-of-
interest.
In addition, each SOP includes an appendix listing major
science and technical work products expected in FY'95. These
lists, which help us visualize the overall peer review program,
are dynamic and may be .adjusted to conform with changing
mandates, deadlines, and resources.
Another feature of the SOPs relates to your March 16 letter
asking EPA to protect against premature disclosure of Agency
reports by peer reviewers. The SOPs detail procedures to help
discourage premature disclosure by emphasizing the need for
confidentiality, warning that peer reviewers will not be used
again if they release products without approval, and requiring
that disclaimers and draft status be clearly displayed.
However, EPA's Office of General Counsel (OGC) has advised
that it is difficult to assure that peer reviewers do not
prematurely disclose products under peer review. As a general
matter, there is no statutory prohibition against the disclosure
of material under peer review, except to disclosure on grounds
independent of its status as material under peer review. For
example, the disclosure of a document under peer review that is
also classified as confidential business information may subject
a peer reviewer, who is a federal government employee, to civil
and criminal penalties under the Trade Secrets Act, 18 U.S.C.
Section 1905. Although EPA could include a provision in
contracts for peer review services which states that a deliberate
disclosure of a document under peer review may constitute a
breach of the contract, such an approach may require relatively
expensive and time consuming litigation to enforce the terms of _.
the contract. Furthermore, such an approach would not deter
voluntary peer reviewers from improperly releasing documents.
The SOPs were developed under the auspices of EPA's new
Science Policy Council (SPC), which the Deputy Administrator
chairs. Each AA and RA established a team to work with the SPC
on developing the SOPs. Working from a common template, each
orfice has tailored the procedures into office-specific
procedures for staff and management. As shown in the attached
Appendix, highlights include basic peer review principles and
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definitions, factors related to planning peer reviews, and
procedures for the conduct and completion of peer review
activities. Each office has assigned specific responsibilities
to appropriate staff members.
The attached SOPs will govern the first year of the new
program. We expect to supplement these procedures with special
guidance, including a training/implementation workshop, and to
revisit the current SOPs next spring to confirm successes and'to
determine changes needed for the coming year.
I believe our new program for peer review will augment
existing EPA review activities by expanding peer review to
additional offices and additional work products. Peer review
will not resolve every issue, but we expect the new Policy and
the SOPs to encourage greater use of credible peer review
procedures, which will enhance the quality and credibility of
EPA's scientific and technical work products.
Sine
Carol M. Browner
Enclosures (17)
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cc: Assistant Administrators (without attachments)
Regional Administrators (without attachments)
General Counsel (without attachments)
Deputy Administrator (without attachments)
Science Policy Council (without attachments)
bcc: Team Leaders (without attachments)
Steering Committee (without attachments)
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APPENDIX
Highlights: EPA's Standard Operating Procedures (SOPs)
The SOPs for peer review are more than just standard operating
procedures in the usual sense. They also contain background
information concerning peer review as well as guidance to assist staff
unfamiliar with or new to the Agency's peer review practices. The
preface introduces the Peer Review Policy and gives an overview of -
peer review. The preface is followed by five major sections and then
five appendices.
Section I. Guiding Principles of Peer Review
Provides the principles and definitions relating to peer review,
including: definitions of peer involvement, peer input, and peer
review; discussion of peer reviewers and their independence and
expertise; distinction between peer review and public comment;
and the formulation of a proper charge to peer reviewers.
Section II. Identifying Work Products for Peer Review
Provides the selection process for major scientific and technical
work products, including: criteria for determination of a major
scientific and technical work product; special circumstances for
when or when not to perform peer review; appropriate peer review
mechanisms; and the listing of the office specific categories of
work products.
Section III. Planning and Conducting a Peer Review
Provides procedures and guidance for planning and conducting a
peer review, including: identifying sources and selection of peer
reviewers; constraints in selecting peer reviewers; scheduling
peer reviews; and the proper information to provide peer
reviewers.
Section IV. Completing a Peer Review
Provides procedures for bringing a peer review to a successful
close and producing a final product, including: evaluating
comments and recommendations, utilizing peer review comments for
completing the final work product, and organizing and maintaining
a record of the peer review.
Section V. Accountability and Responsibility in the Office
Provides the office specific responsibilities in implementing the
Peer Review Policy in each office, including: identifying
specific responsibilities for those who make the decisions in the
peer review process, those who organize individual peer reviews,
and those who coordinate overall peer review activities.
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Appendix (continued)
page 2
Attached to each office SOP are five appendices:
Appendix A: Agency Peer Review Policy
Provides the Agency's Peer Review Policy for reference.
Appendix B: Key Personnel
Provides the names of office personnel associated with the
specific responsibilities detailed in Section V.
Appendix C: Listing of Representative Office Products in Each Category
Over the Past 3 Years
Provides a listing of the different scientific and technical work
products each office has had peer reviewed over the past 3 years,
, including the peer review mechanisms used.
Appendix D: Office Candidates for Peer Review in Fiscal Year '95
Provides a listing of the different scientific and technical work
products that have been identified as candidates for peer review
in the upcoming fiscal year, including a projected peer review
mechanism.
Appendix E: Resources for Peer Review Services
Provides an overview of the range of services available to EPA,
including internal, external (voluntary, purchase order,
contractor), and Special Government Employee services.
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