United States EPA Science Advisory EPA-SAB-04-002
Environmental Board (1400A) November 2003
Protection Agency Washington DC www.epa.qov/sab
&EPA IMPLEMENTATION PLAN
FOR THE NEW STRUCTURAL
ORGANIZATION OF THE EPA
SCIENCE ADVISORY BOARD
A REPORT OF THE EPA SCIENCE
ADVISORY BOARD STAFF
OFFICE
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ACKNOWLEDGMENTS
The EPA Science Advisory Board Staff Office gratefully acknowledges the contribution
of the following members of the EPA Implementation Work Group for their participation
in the development and review of this report: Ed Bender (ORD), David Cooper
(OSWER), Norman Dyer (Region 6), GailFroiman (OEI), Roland Hemmett (Region 2),
Vincia Holloman (OEI), Marilyn Kuray (OGC), CarlMazza (OAR), Rosemarie Russo
(ORD), Rita Schoeny (OW), Jennifer Seed (OPPTS), and Mary White (Region 5). Special
thanks go to the following members of the SAB Staff Office who are the authors of the
report: Suhair Shallal, Tom Miller, Phil Sayre, Joseph Bachman, andRobertFlaak.
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TABLE OF CONTENTS
1. INTRODUCTION 1
2. OVERVIEW OF ORGANIZATIONAL COMPONENTS, FUNCTIONS, AND THE
ADVISORY PROCESS OF THE EPA SCIENCE ADVISORY BOARD 2
3. SAB MEMBERSHIP 4
3.1 Membership and Composition 7
3.2 SAB Committees Structure 7
3.3 Process for Nominations 7
3.4 Evaluation and Selection of Board and Committee Members 8
4. IDENTIFICATION AND SELECTION PROCESS FOR SAB ADVISORY
PROJECTS 9
4.1 Criteria for Project Selection 9
4.2 Emerging Issues 11
4.3 Nomination and Selection of SAB Projects 11
5. SELECTION AND FORMATION OF SAB PANELS FOR ADVISORY PROJECTS 11
5.1 Selection of SAB Panels 12
5.2 Formation of SAB Panels 12
6. ADVISORY MEETINGS AND REPORT WRITING 15
6.1 Role of Key Meeting Participants 17
6.2. Deliberations and Report Development 17
7. REVIEW AND APPROVAL OF SAB REPORTS 18
8. FEEDBACK AND EVALUATION 19
9. SAB STRUCTURE FOR FY 2004 19
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FIGURES
FIGURE 1 STRUCTURE AND WORKFLOW WITHIN THE EPA SCIENCE
ADVISORY BOARD (SAB) 3
FIGURE 2 SAB ADVISORY PROJECT CYCLE 5
FIGURE 3 APPROXIMATE TIME LINE FOR ADVISORY ACTIVITIES 6
FIGURE 4 PROCESS FOR SELECTING TYPES OF SAB COMMITTEES OR
PANELS: EPA REQUESTED PROJECTS 13
FIGURE 5 PROCESS FOR SELECTING TYPES OF SAB COMMITTEES:
SAB ORIGINAL STUDIES 14
FIGURE 6 PROCESS FOR IDENTIFYING MEMBERS TO SERVE ON A
DENOVO REVIEW PANEL 16
TABLE
TABLE 1 PROCESS FOR SELECTING SCIENCE ADVISORY BOARD (SAB)
PROJECTS 10
in
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1. INTRODUCTION
The U.S. Environmental Protection Agency (EPA) Science Advisory Board (SAB) is a
chartered Federal Advisory Committee, established in 1978 by the Environmental Research,
Development, and Demonstration Authorization Act (ERDDAA). Composed of renowned
experts, the SAB provides the EPA Administrator with outside, independent advice on the
scientific and technical aspects of environmental issues to help inform environmental
decision-making. The SAB has a distinguished record of providing valuable and sound advice on
a wide range of scientific, engineering, economics, and social science issues that impact the
technical bases of EPA policies, regulations, research and science programs.
The work of the SAB is supported by the SAB Staff Office, which is housed within the
Office of the Administrator. The SAB Staff Office performs management and administrative
functions and provides technical assistance to the SAB, the Clean Air Scientific Advisory
Committee (CASAC), and the Advisory Council on Clean Air Compliance Analysis
(COUNCIL), both of which are also EPA chartered Federal Advisory Committees, established
under the Clean Air Act Amendments of 1977 and 1990, respectively. The Staff Office serves as
the interface for the these advisory bodies for their interactions with EPA and the public. The
Staff Office also ensures that the SAB, CASAC, and COUNCIL conduct advisory activities in
public, and that the public has an opportunity to provide input during the advisory process.
As part of an effort to help the SAB keep pace with complex environmental challenges
facing the Agency, the SAB Staff Office has recently recommended a structural and functional
realignment of the SAB1. The new SAB structure incorporates flexibility and reaffirms the
importance of the advisory role of the SAB, i.e., both early, forward-looking advice and rigorous
peer reviews of EPA technical and scientific work products that directly impact major EPA
policies and decisions.
This document describes how the SAB Staff Office will implement the new structural
and functional changes in the SAB. Processes and procedures are either currently in place, being
enhanced, or added to meet these SAB changes and to ensure the delivery of timely and high
quality advice. First, the document provides an overview of the new SAB organizational
components, the workflow within the SAB, and an overview of the advisory process. It then
details the management, administrative, and technical tasks for each of the major elements of the
advisory process. Finally, it discusses the SAB structural components for FY 2004 designed to
ensure an effective transition.
The focus of this report is on the changes to the SAB structure and function. It should be
recognized that certain processes and procedures described in this report may or may not be
applicable to the CASAC and COUNCIL. The SAB Staff Office plans to develop a series of
public and internal documents that complement this report for the SAB, CASAC and COUNCIL,
as deemed appropriate.
1 See the "Reorganization of the EPA Science Advisory Board (SAB)" (November 2003)
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2. OVERVIEW OF ORGANIZATIONAL COMPONENTS, FUNCTIONS AND THE
ADVISORY PROCESS OF THE EPA SCIENCE ADVISORY BOARD
As shown in Figure 1, the advisory functions of the SAB will be accomplished by the
Board, its Standing and Ad Hoc Committees, and its De Novo Review Panels. The advisory
functions of the SAB will include the following kinds of activities:
Consultation - Provides non-consensus, oral, advice on a technical issue before EPA
begins substantive work on that issue.
Advisory - Provides written advice on EPA's technical works-in-progress.
Peer Review - Conducts a review of EPA's final draft technical reports (e.g., guidelines,
assessments, research strategies) or work products (e.g., analytical methods, models,
databases).
Commentary - Provides forward-looking advice on an important technical or emerging
issue in the form of a short communication.
Original Study - Conducts original work on an emerging or overarching topic of
importance to EPA.
Other Activity - Receives information briefings from EPA and conducts scientific
workshops on specific technical subject matters.
The Board and its Standing and Ad Hoc Committees are a source of knowledge and
continuity for the Agency, particularly as they provide early advice when requested by EPA
Programs and Regions on issues related to specific disciplinary or multi-disciplinary and
programmatic areas. These interactions are normally associated with early and mid-course
efforts that the Agency would bring to the SAB, but also with the peer reviews of EPA final draft
reports or products that provide overarching strategies, plans, or guidance on how EPA conducts
its scientific and technical activities. Peer reviews of EPA final draft technical products that
directly support EPA policies and/or risk management decisions will be conducted by De Novo
Review Panels to be created for each specific peer review.
As required by the Federal Advisory Committee Act (FACA), the Board, as the parent
chartered committee, must approve all advice developed by its Committees and Panels prior to
transmittal to the EPA Administrator. To ensure the high quality and independence of the SAB
peer review reports, a specialized Quality Review Committee will be established to review each
draft report before the report is sent to the Board for final review and approval. Original works
of SAB Standing or Ad Hoc Committees will also be reviewed by a Quality Review Committee
prior to the Board's final review and approval. The Board will also provide forward-looking
advice on environmental progress, trends, priorities and innovative approaches to achieve
environmental challenges and on the scientific and technical investments necessary to achieve
greater and more cost-effective public health and environmental protection. A Council of Chairs,
composed of the Chairs of SAB Standing and Ad Hoc Committees and the Chairs of the
CASAC, and the COUNCIL, will foster open and constructive dialogue and cross-disciplinary
interactions among the committees, and advise the Board as a whole on matters that are
considered important to the SAB mission.
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FIGURE 1 NEW STRUCTURE AND WORKFLOW WITHIN THE EPA
SCIENCE ADVISORY BOARD
BOARD
[ Council of Chairs J
QUALITY
REVIEW
COMMITTEE
STANDING
AND Ad Hoc
COMMITTEES
De Novo
REVIEW
PANELS
The dotted lines show the flow of comments and directions from the oversight and
approving groups.
*Some Standing or Ad Hoc Committee reports may go directly to the Board for review
and approval.
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The mix of Standing and Ad Hoc committees will be based on the current and future
needs of the Agency. Standing committees are expected to exist for an extended number of years
while Ad Hoc Committees will be established for shorter periods to provide advice on matters
that cannot be addressed by existing Standing Committees. As required by the enabling SAB
legislation, a Board member will serve as the Chair of each SAB Committee or Panel. Board
members and Committee members will be drawn from the scientific community. Collectively,
they should encompass the breadth and depth of experience and expertise necessary to
accomplish the anticipated work of the SAB and have a diversity of scientific perspectives.
Section 3 of this report details the process for evaluating the appropriate mix of SAB
Committees, and the process for nomination, selection, and appointment of Board and
Committee members by the EPA Administrator.
Figure 2 depicts a SAB advisory project cycle. The SAB provides advice in response to
the Agency's requests and in response to original project ideas developed by the Agency and/or
the SAB. The process for the nomination and selection of SAB advisory projects is detailed in
Section 4 of this report. Depending on the nature of the approved SAB projects, the Staff Office
will consult with the Agency and the SAB and determine who would be the most appropriate
body of experts to provide the requested advice. The process for selecting the types of SAB
Committees or Panels is described in Section 5. Section 5 also outlines the many steps involved
in assembling a balanced SAB Panel as required under the terms of F AC A, and in accordance
with federal and EPA requirements and SAB policies. Expert consultants invited to assist SAB
Committees or to serve on De Novo Review Panels would be drawn from the scientific
community and be appointed by the SAB Staff Office Director for the duration of a specific
advisory activity.
A Committee or Panel will begin its advisory activity first by thoroughly reviewing and
understanding its charge, and being fully prepared for the advisory meetings. Advisory meetings
will be conducted in public sessions, and advisory reports will be developed as detailed in
Section 6. The SAB Committee or Panel draft report will then undergo a quality review and
approval process by the Board as described in Section 7. The general process for the transmittal
of the approved SAB reports to the EPA Administrator and the Agency's response to the SAB
advisory reports is described in Section 8.
As shown in Figure 3, depending on the nature of the Agency's request, the entire
advisory process would generally take from 4 to 12 months from the initial discussion with EPA
Offices and Regions to the delivery of the final SAB report. For example, a consultation to be
conducted by an existing Standing or Ad Hoc Committee without additional expert consultants
could be accomplished within 4 months. On the other hand, a peer review of a major technical
work product to be conducted by a Review Panel created De Novo may require up to 12 months
to complete. After the Agency submits the final charge questions and review materials, a draft
SAB report can be available in approximately 6 months, and about 3-4 additional months for the
quality review, Board approval and delivery of the final report to the Administrator.
3. SAB MEMBERSHIP
The SAB addresses a wide range of topics requiring different kinds of science advice to
EPA. As the SAB continues to provide credible technical and strategic advice concerning current
and future environmental challenges, it is essential that the membership of the Board and
Committees encompasses the relevant breadth and depth of experience and expertise.
Additionally, the SAB should reflect a diversity of scientific perspectives and demonstrate a
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FIGURE 2
SAB ADVISORY PROJECT CYCLE
SELECTION OF
COMMITTEE ,
\
OR PANEL TYPE /
FORMATION \
OF
COMMITTEE
OR PANEL /
SELECTION
OF PROJECT
/ ADVISORY \
/ MEETING \
AND REPORT
DEVELOPMENT
NOMINATION
OF PROJECT
FEEDBACK
AND
EVALUATION
TRANSMITTAL
OF SAB REPORT
APPROVAL OF
SAB REPORT
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FIGURE 3
APPROXIMATE TIME LINE FOR ADVISORY ACTIVITIES
Initial Discussions Panel Formation
Preliminary Charge
Advisory meeting
Report Development
Report Approval and
Transmittal
2 - 4 months
D
1-5 months
1-3 months
D
up to 12 months
Final Charge and
Advisory Materials
3-9 months
up to 9 months
After receipt of final charge and advisory materials, approximate time for completion of:
Consultation
Advisory/ Review - with an existing committee
De Novo Panel
3 months (letter only)
7 months (draft report in about 5 months)
9 months (draft report in about 7 months)
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broad knowledge and appreciation of EPA's missions and environmental programs. Members of
the Board and Committees (and Panels) would be drawn from academia, industry, federal, state
and tribal governments, research institutes and non-governmental organizations (NGO)
throughout the United States. Collectively, the SAB should constitute a distinguished body of
scientists, engineers, economists and social scientists who are widely recognized for their record
of scholarly and leadership achievement in their respective fields. Members of the Board,
Committees and Panels should also have demonstrated ability and experience to examine and
analyze issues incisively with the highest level of scientific quality, objectivity, and integrity.
Furthermore, they should be known for having excellent committee-related skills and
experience, including interpersonal, oral and written communication, consensus-building, and
other skills necessary for working alongside their peers in committees and advisory panels.
3.1 Membership and Composition
The Board will consist of about 30 members, including a Chair and a Vice-Chair. In
addition to the desired attributes as described above, Board members, in particular, should have
demonstrated experience and ability to integrate and cross-connect disciplines in the pursuit of
public health, ecological health and environmental protection to provide forward-looking advice
to the Administrator and Agency senior leadership. The membership and composition of the
Board will change over time as new environmental challenges arise and the need for a different
mix of experience and expertise becomes apparent.
Because Standing and Ad Hoc Committees constitute the core of SAB expertise, each
Committee should have the breadth of knowledge to address subjects within its purview.
Committee members are expected to have the needed attributes to assimilate new information
and adapt to changes in scientific knowledge and key developments in science and technology.
Collectively, SAB Committees should include a wide range of scientific and technical
disciplines to lead a majority of the peer reviews, advisories and consultations for the Agency.
Each SAB Committee will be chaired by a Board member having appropriate stature and
expertise in the relevant area. The size of each committee may vary but typically will be
composed often to fifteen members.
3.2 SAB Committees
The SAB Staff Office, in consultation with the SAB and the Agency, will review and
adjust the mix of Standing and Ad Hoc committees periodically. The mix of SAB Committees
should reflect the needs of EPA, i.e., to protect human health and the environment and the kinds
of environmental challenges facing the Agency. The mix of such committees should foster
diverse perspectives across EPA national and regional environmental programs and promote
interactions among SAB Committees. To minimize the overhead for supporting and maintaining
the committees, Standing Committees would be organized to address the needs of the Agency in
a prompt and efficient manner. Ad hoc Committees, on the other hand, will be created when a
new need arises and will exist for a short period of time (2 to 3 years). On the other hand, if an
Ad Hoc Committee is needed on a long-term basis, it may evolve into a Standing Committee. As
discussed in Section 9, the SAB's current mix of Standing and Ad Hoc Committees will provide
the initial basis for the new SAB Committee structure for FY 2004 and beyond.
3.3 Process for Nominations
Under the new SAB structure, Board and Committee members will be appointed by the
EPA Administrator as Special Government Employees (SGEs) to serve for a term of three years
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(may be renewable for an additional three-year term)2. As SGEs, Board and Committee
members are subject to many Federal requirements including those dealing with
conflict-of-interest and ethics statutes. It is essential that the process for nomination, selection
and appointment of Board members and Committee members be transparent to the public and
that the public be given an opportunity to nominate individuals for SAB Board and Committee
membership during the annual process, as described below.
The SAB Staff Office is responsible for making recommendations to the EPA
Administrator regarding the annual updates to the membership of the Board and Committees by
October of each year. The process would generally begin in April with the identification of
vacancies in the coming year and the newly needed expertise for the Board and individual
Committees. From May through June, the Staff Office will solicit public nominations for
potential candidates via a notification in the Federal Register. The Staff Office will seek
nominations from other government departments and agencies, scientific and research
organizations, professional societies, and non-governmental organizations, as well as from EPA
and the SAB via letters and direct contacts.
During July through August, the SAB Staff Office will contact the nominees to: (a)
acknowledge the nomination; (b) ascertain their interest in serving on the SAB; (c) provide
background information about the SAB; (c) inform them of the selection and appointment
process; (d) acquaint them with the process involved in becoming a Special Government
Employee (including the conflict of interest and ethics requirements); and (e) discuss
expectations of workload, compensation and travel.
3.4 Evaluation and Selection of Board and Committee Members
Scientific and technical quality and credibility are paramount factors in selecting
members for the Board and its Committees. From August through September, the Staff Office
will complete an evaluation of each nominee who is interested in serving on the SAB with regard
to expertise and experience, potential conflicts of interest, and bias. The Staff Office will then
consult with the Agency and the SAB, in developing list of potential candidates for new
members of the Board and individual Committees, taking into account the needed (a) breadth
and depth of experience and expertise; (b) balance of scientific perspectives; (c) continuity of
knowledge and understanding of EPA missions and environmental programs; and (d) diversity
factors, including, geographical areas and professional affiliations. A similar process will also
be used when Standing or Ad Hoc Committees are augmented with candidates that possess
specific expertise needed for a particular review and when De Novo Panels are formed (see
Section 5).
The SAB Staff Office Director will submit the recommended SAB annual membership
and the rationale for each recommendation for the EPA Administrator's consideration and
approval. Selected members will be notified of their appointment by a letter from the
Administrator appointing them to the Board or a specific SAB Committee. New Board and
Committee members will also receive a welcome letter from the SAB Staff Office Director. New
appointees will comply with the federal personnel process by submitting a series of personnel
forms and questionnaires and completing the "Confidential Financial Disclosure Form for
Special Government Employees Serving on Federal Advisory Committees at the U.S.
Environmental Protection Agency" (EPA Form 3310-48). All SAB appointees are also required
to take and certify their completion of annual ethics training programs.
2 SAB Committee members appointed under the existing SAB structure will continue to be
reappointed for 2 year- terms for a maximum of 6 years.
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4. IDENTIFICATION AND SELECTION PROCESS
FOR SAB ADVISORY PROJECTS
As described in Section 2, the SAB advisory activity may be a consultation, an advisory,
a peer review, a commentary or an original study. The SAB Staff Office generally receives
nominated advisory projects for SAB consideration from various EPA Offices including Office
of Research Development, Program and Regional Offices, the Congress (through the
Administrator), and the SAB. Original studies and other project types can focus on emerging or
overarching scientific or technical issues. Emerging issues are those that are likely to exert a
major influence on environmental policy development or research programs in the next two to
five years, and hence are issues that EPA would be expected to raise to the SAB for early advice.
Original project ideas could be suggested through different sources- EPA, the SAB, the scientific
community and the public. The process for identifying emerging issues that can lead to an
approved SAB advisory project is discussed below in section 4.2 and summarized in Table 1.
Table 1 also outlines the annual process for SAB projects that are nominated by EPA Offices.
However, it is important to note that the EPA Administrator always has the discretion to ask the
SAB to take on any type of advisory project at anytime.
4.1 Criteria for Project Selection
Nominated advisory projects which are best suited for the SAB's consideration are those
that meet several criteria. Selection criteria include the following:
General Criterion
Provides an opportunity to make a difference in the science that supports the
Agency's mission
Client-related Criteria
Supports major regulatory or risk management initiatives
Serves leadership interests (e.g. the Administrator or Congress)
Supports EPA strategic priorities
Science-Driven Criteria
Involves scientific approaches that are new to the Agency
Addresses areas of substantial uncertainties
Problem-driven Criteria
Involves major environmental risks
Relates to emerging environmental issues
Exhibits a long-term outlook
Organizational Criteria
Serves as a model for future Agency methods
Requires the commitment of substantial resources to scientific or technological
development
Transcends organizational boundaries, within or outside EPA (includes
international boundaries)
Strengthens the Agency's basic capabilities.
In addition, the SAB Staff Office will need to consider the overall mix of the nominated
projects for a given fiscal year as well as the time and available resources needed to take on these
projects.
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TABLE 1
PROCESS FOR SELECTING SCIENCE ADVISORY BOARD (SAB) PROJECTS
^""---v.^^^ STEPS TO SAB
^""--ssPROJECT
""^v^SELECTION
TYPE OF x,^^
PROJECT ^>-->v>>is^
IDENTIFYING EMERGING
ISSUES FOR SAB
STRATEGIC ADVICE AND
DENOVO STUDIES
AGENCY REQUESTS
IDENTIFICATION
Achieved through
Interactions with:
EPA Program/Regional
Offices
Scientific Community
Public
Science Advisory Board
SAB Staff Office
Achieved through
discussions within EPA
Offices to determine
projects which would
benefit from external
review.
FORA FOR
DISCUSSION AND
NOMINATION
SAB Annual Meeting
SAB Committee
Meetings
Meetings with Public
Science Policy Council
EPA Program/Regional
Offices
Scientific Workshops
Staff Office receives
nominations from EPA
Assistant Administrators
(AAs) or Regional
Administrators (RAs)
- Annually
- As needed basis
PRIORITIZATION AND
SELECTION
Achieved through joint discussions
with:
- Science Policy Council
- EPA Program/Regional offices
- SAB
To identify projects for further
consideration.
-Strategic Advice by SAB
-De novo SAB project
Selection based on:
- Impact on Agency's mission
- Innovative nature of project
- Agency needs
Achieved through joint discussions
with:
- Science Policy Council
- EPA Program/Regional offices
- SAB
Selection based on:
- Statutory Requirement
- Agency needs
DEFINING THE
SCOPE AND CHARGE
Achieved through joint
discussions with:
- Designated SAB
Committee
- EPA
Program/Regional Office
Achieved through joint
discussions with:
-SAB Staff Office
- the requesting EPA
Program/Regional office
APPROVAL
SAB Staff Office considers:
- Availability of resources
SAB Staff Office considers:
- Availability of resources
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4.2 Emerging Issues
Relevant emerging and/or overarching issues for SAB project proposals may be
identified by various sources including EPA, the SAB and Staff Office, EPA stakeholders and
the public at large, as well as scientific organizations. Selected issues and topics relevant to
EPA's mission could then be further discussed internally through the EPA Science Policy
Council, and at different public fora such as the SAB Annual Meeting and Committee Meetings,
EPA or SAB sponsored scientific workshops and seminars, or Staff Office sponsored public
sessions. In particular, the SAB Annual Meeting would provide an opportunity to bring in all
members of the Board and Committees to benefit from extended presentations and discussions of
selected emerging issues. These discussions would identify the most important and relevant
topics to be considered further by the Agency and the SAB. This would then result in the
development of project proposals from either EPA Offices or SAB Committees to be submitted
formally for SAB consideration as part of the annual nomination and selection process (see
Sections 4.3).
4.3 Nomination and Selection of SAB Projects
The annual process for selecting EPA nominated SAB advisory projects for the next
fiscal year normally begins in March with a formal request from the EPA Deputy Administrator
to the Assistant Administrators and Regional Administrators. The Assistant Administrators and
Regional Administrators are requested to send the SAB Staff Office Director a memorandum
identifying a prioritized list of projects nominated for the SAB consideration. A list of
high-priority science activities that do not warrant the SAB's attention are to be provided to the
Staff Office for information. EPA Offices will also be asked to prepare a SAB Project Sheet for
each nominated project. This project sheet describes in more detail the nature of the nominated
projects. These requests will also be entered into EPA's Science Inventory database and the SAB
Project Sheets will be entered into the SAB Project Database. Also in March, the Board and
Committees are asked to nominate SAB project ideas on important and relevant emerging issues
as identified by various mechanisms as described above (Section 4.2). Nominated SAB projects
for a given fiscal year will be made available on the SAB website.
After receiving the list of requested projects, the SAB Staff Office will hold discussions
with EPA Offices and identify the Agency's overall priorities via discussions with the EPA
Science Policy Council. The Staff Office will also hold discussions with the Board to obtain their
input and then develop a recommended final list of SAB advisory projects based on the Board
and EPA rankings and the available Staff Office resources. The SAB Staff Office Director will
inform the EPA Administrator and Deputy Administrator concerning the SAB operating plan
particularly of projects dealing with emerging or overarching issues and highly visible peer
reviews. At any time during the fiscal year, SAB projects may be added or deleted, as requested
by the EPA Administrator and Deputy Administrator, Assistant Administrators, Regional
Administrators, or the Congress (through the Administrator), and the SAB.
5. SELECTION AND FORMATION OF SAB PANELS
FOR ADVISORY PROJECTS
The SAB Staff Office is responsible for determining the most efficient and effective way
for the SAB to provide the Agency with timely and sound advice on requested projects and for
selecting and assembling the most qualified body of experts. This determination would
significantly influence the timing and the level of resources required to accomplish the advisory
activity and would be made in consultation with the SAB and the EPA Office that requests the
advice.
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5.1 Selection of SAB Panels
As illustrated in Figure 4, an advisory activity as requested by EPA could be performed
by an existing Standing or Ad Hoc Committee with or without additional expertise, or a newly
created (De Novo) Review Panel. The determination would be based on a number of
considerations and in consultation with the requesting EPA office and the SAB. These
considerations may include the stages of development of the EPA work product, the subject
focus and scope, the impact the advisory activity may have on an EPA action, and the level of
public interest. For example, existing Standing or Ad Hoc Committees may provide early advice
on an EPA initiative (consultation) or peer review a completed work product that is over-arching
(e.g., research strategies, guidelines). In another example, a De Novo review panel may be
created to conduct peer review of a risk assessment that may have a direct impact on EPA
actions. The generic criteria described in Figure 4 are only to be used as guidelines when
selecting an SAB committee or panel type.
5.2 Formation of SAB Panels
The SAB Staff Office has been implementing the SAB panel formation process (as
described in the "Overview of the Panel Formation Process at the Environmental Protection
Agency Science Advisory Board\ http://www.epa.gov/sab/pdf/ec02010.pdf) since June 2002.
There are generally four basic types of Panels, each requires a different level of time and
resources. The most efficient and direct way is to utilize an existing Standing or Ad Hoc SAB
Committee, whereas the most resource intensive and time consuming is to create a De Novo
Review Panel.
a) A Project to be performed by an existing SAB Committee
The SAB Staff Office will publish a Federal Register Notice announcing an advisory
project to be conducted by a particular SAB Standing or Ad Hoc Committee and
informing the public that no additional expertise is needed to augment the selected
committee. The SAB Staff Office will post on the SAB Website biosketches of members
of the selected committee and will request the public for information that will help in
finalizing the panel. The SAB Staff Office will consider public comments and document
the selection of panel members.
b) A Project to be performed by an existing Committee with additional experts from
other SAB Committees and/or EPA Federal Advisory Committees
The SAB Staff Office will publish a Federal Register Notice announcing an advisory
project to be conducted by an existing Standing or Ad Hoc Committee with additional
appointed members of other SAB Committees and/or other EPA Federal Advisory
Committees. The SAB Staff Office will post on the SAB Website biosketches of
proposed Panel members and request the public for information that will help in
finalizing the panel. The SAB Staff Office will consider public comments and document
the selection of panel members.
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FIGURE 4
PROCESS FOR SELECTING TYPES OF SAB COMMITTEES OR PANELS
EPA REQUESTED PROJECTS
Characterize the nature of
EPA-requested SAB projects
Stage of development
- early to late
Subject Focus
Scope of Subject
- Broad / Narrow
Relationship to EPA
Actions
- Direct / Indirect
Level of Public Interest
- Low to High
- Technically
Controversial
C>
Selection of Advisory Groups
STANDING OR AD HOC
COMMITTEE
Consultation (early)
Advisory (mid way)
Review (completed
products)
DE NOVO REVIEW PANEL
Review (e.g., Direct
support to EPA's actions,
technically controversial,
precedent setting)
Standing or Ad Hoc Committee
without additional
expertise
with additional expertise
- other SAB committees
- other EPA F AC A
Committees
- scientific community
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FIGURE 5
PROCESS FOR SELECTING TYPES OF SAB COMMITTEES
SAB ORIGINAL STUDIES
Characterize the nature of
Original Study
Determine Subject Focus
Identify Expertise
Standing or Existing Ad Hoc
Committee
without additional
expertise
with additional expertise
- other SAB committees
- other EPA FACA
committees
- scientific community
New Ad Hoc Committee
created specifically for the
approved study
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c) A Project to be performed by an existing Committee supplemented with
additional experts drawn from the scientific community
The SAB Staff Office will announce in a. Federal Register Notice the formation
of a SAB panel and solicit public nominations for additional experts to augment
the existing Standing or Ad Hoc Committee. The SAB Staff Office will select
potential candidates from the pool of nominees needed to augment the Standing
or Ad Hoc Committee and post biosketches for these potential candidates on the
SAB website. The SAB Office will ask the public for information that will help
in finalizing the panel. The SAB Staff Office will consider public comments and
document the selection of panel members.
d) A Project to be conducted by a De Novo Panel (see Figure 6)
The SAB Staff Office will announce in & Federal Register Notice the formation
of a new SAB panel, identify the expertise needed for the Panel, and solicit public
nominations for experts to serve on the Panel. The SAB Staff Office will select
potential candidates to serve on the Panel and post their biosketches on the SAB
website. The SAB Office will request the public for information that will help in
finalizing the panel. The SAB Staff Office will consider public comments and
document the selection of panel members.
6. ADVISORY MEETINGS AND REPORT WRITING
As required under the terms of F AC A, the SAB conducts advisory meetings which are
open to the public. The SAB generally discusses their advice and recommendations in response
to the charge questions at face-to-face meeting(s). They may conduct teleconferences as they
prepare and plan for the face-to-face meetings or conduct follow up discussions to review draft
reports. Except for relatively simple issues, it is likely that deliberations on the charge questions
may require more than one meeting or public teleconference. Minutes of each meeting and
public teleconference, approved by the Committee or Panel Chair as required by FACA, are
made publicly available within 90 calendar days after the meeting date and placed on the SAB
web site.
All meetings subject to FACA are formally convened by the Designated Federal Officer
(DFO) who is a member of the SAB Staff Office with technical expertise related to the area of
the Committee or Panel's responsibility. The DFO makes a statement certifying that the
Committee or Panel membership is in compliance with Federal ethics and conflict-of-interest
laws, and introduces the Chair and members of the Committee or Panel. The Chair makes some
introductory remarks, reviews the meeting agenda and commences with the business of the
meeting. At initial meetings of a particular advisory activity, EPA representatives may make a
brief presentation on the subject matter of the meeting and the charge questions. Oral statements
from members of the public usually are heard during a specific public comment portion of the
meeting, and there may be an opportunity for a brief interchange of questions between public
presenters and the members of the Panel or Committee. The Committee or Panel then conducts
its deliberations on the charge questions.
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FIGURE 6
PROCESS FOR IDENTIFYING MEMBERS TO SERVE
ON A DENOVO REVIEW PANEL
INITIATON
Identify Needed
Expertise
WIDECAST
Publish a Federal
Register Notice to
Announce meeting
Solicit Nominations
SHORT LIST*
Publish List of
Potential Candidates
on SAB website
if needed
DENOVO PANEL
SELECTION
Select Panel
Membership
Publish Panel
Roster
Publish Selection
Determination
Document
SELECTION OF
EXPERTS FOR
QUALITY REVIEW
OF PANEL'S
REPORT **
Publish List of
Experts
Publish Selection
Determination
Document
* with public participation
"selection of experts will occur during the preparation of the final panel report (See Section 7)
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6.1 Role of Key Meeting Participants
The DFO is responsible for ensuring that the legal requirements of FACA are met. This
includes arranging for meetings to be open to the public at reasonably accessible and convenient
locations and convenient times, ensuring that advance notice of the meeting is published in the
Federal Register, and making available for public inspection and copying (subject to the
Freedom of Information Act) documents and other materials prepared by or for the Committee
or presented to the Committee, including detailed minutes of the meeting. The DFO, in
consultation with the Committee or Panel Chair, develops the agenda for the meeting. It should
be noted that although the DFO assists the Committee or Panel in the preparation of documents
and reports, the advice and recommendations contained in those materials are solely the
responsibility of the Committee or Panel.
The Committee or Panel Chair presides after the DFO convenes the meeting, and informs
the public of key departures from the agenda, if there are any. The Chair assigns Committee
members as discussion leaders for specific charge questions. The Chair concludes the meeting
with a summary of its major outcomes - the areas of consensus, the areas where there are
different views among the members, the major views expressed, and key follow-up steps. After
the meeting, the Chair certifies that meeting minutes are complete and accurate and is
responsible for coordinating the writing of the report (or delegating the task to another
member). The Chair acts as a spokesperson for the entire Committee or Panel. Committee or
Panel Members (including the chair) consider Agency presentations, public comments and
background material on the subject, and then deliberate and provide advice. Members have the
shared responsibility to write the report summarizing the results of their deliberations.
Representatives of EPA offices provide briefings on scientific issues and how these
issues affect Agency decisions. They are a resource for the panel members, and answer
questions about relevant Agency programs and policies.
Members of the public attend the meeting both as presenters of statements they wish to
have considered by the panel and as members of the audience to observe the proceedings.
6.2. Deliberations and Report Development
Ideally, the deliberative process should lead to consensus conclusions. Consensus can be
described as a decision that all of the members of the Committee (or Panel) can accept. At
times, it may not be possible to form a consensus, and discussion will reveal the range of views
held by members. Where consensus is not reached, the major substantive areas of agreement
and disagreement are captured in the final report.
Report preparation is a collaborative process. Individual Committee members may write
chapters or sections, which will then be integrated into a cohesive report by the Committee or
Panel Chair with the assistance of the DFO. The details of the process may vary among the
Committees or Panels, but the "author of record" is the entire Committee or Panel, not any
particular individual member.
As the report is being developed, the members who are writing sections may
communicate with each other through the DFO. Copies of this correspondence are retained by
the DFO in the official file. In addition, at every major stage of report development, a draft
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copy of the report is made available on the SAB web site. The public will have an opportunity
to provide comments on the draft report during the SAB review and approval of the report.
7. REVIEW AND APPROVAL OF SAB REPORTS
Draft reports prepared by SAB Committees or Panels will need to be reviewed and
approved by the Board before transmittal to the EPA Administrator. The Board will make a
determination in an open, public meeting consistent with FACA about the quality of the draft
report by answering the following questions:
whether the original charge questions to SAB Standing or Ad Hoc Committees were
adequately addressed;
whether there are any technical errors or omissions in the report or issues that are
inadequately dealt with in the Committee's report;
whether the Committee's report is clear and logical; and
whether the conclusions drawn or recommendations provided are supported by the body
of the Committee's report.
The outcome of the Board's evaluation would be one of the following:
approve the report;
return the draft report for further work;
reject the work and request a reconsideration and a revised report in the future; or
constitute an entirely new Committee or Panel.
To strengthen the quality of SAB peer review reports, a Quality Review Committee
(QRC) will be established to review each SAB De Novo Review Panel's draft report. The
Board's Vice Chair will chair all Quality Review Committees. In addition to the Vice Chair,
each QRC will generally include three Board members with appropriate and relevant expertise
for a particular quality review. If additional expertise is needed, three to four experts would be
identified and selected from the pool of candidates as the SAB De Novo Review Panel is being
formed. However, the selection process for the Review Panel and the QRC will not be handled
by the same DFO and they will not be announced until the drafting of the peer review report is
nearing completion. This process is intended to ensure the independence of the QRC from the
actual peer review activities of the Panel. The overall process for selecting additional experts
for the QRC will follow the same general procedures that are described in section 5.2 (also see
Figure 6) for De Novo Peer Review Panel members. These experts will be selected based on
similar criteria for selection of panel members.
Quality Review Committees will conduct their reviews of draft reports in an open, public
meeting consistent with FACA. Based on its own review and written input from expert
consultants, the QRC will provide the full Board with its evaluation of the draft report and its
recommendations. The QRC will not repeat the work of the Peer Review Panel; rather, each QRC
will only determine the quality of the draft Peer Review Report by answering the same
questions as described above.
Quality Review Committees, with the assistance of additional experts, will also be
established to conduct a review of original works performed by SAB Committees and to make
appropriate recommendations to the Board. Additionally, some reports of Standing or Ad Hoc
Committees that require special expertise or are particularly complex may also be reviewed by a
QRC before going to the Board for approval. The Board will make the final determination
before these reports are transmitted to the Administrator.
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8. FEEDBACK AND EVALUATION
Depending on the nature of the advisory project, the transmittal package to the EPA
Administrator generally includes a letter from the Chair of the Board which provides an overall
summary of the charge and advice, and a SAB report detailing the response to the charge
questions along with general and specific recommendations. In the transmittal letter to the
Administrator, the SAB asks that the Agency respond to the advice within 60 days. Since this is
controlled correspondence, the EPA Office preparing the response may request an extension.
The response should address each recommendation and note whether it is accepted by the
Agency, or the reason why it is not being accepted. The response is addressed to the Chair of
the Board, at the SAB Staff Office address.
The SAB Staff Office will transmit the Agency's response to the full Board and the
Committee or Panel that provided the advice. The SAB will evaluate the comments and then
determine whether further analysis is needed, as appropriate. This analysis will become an
important vehicle for improving the performance of the Board and its Committees to meet the
needs of the Agency. The Agency's response will also be maintained in the FACA file and
posted on the SAB website.
The SAB Staff Office will develop a response questionnaire that will ensure a more
complete and thorough review of the SAB advice and recommendations and their likely impact
on the Agency's decision-making process. The development of this survey for use by Agency
officials to provide feedback will be an important priority for FY 04.
9. SAB STRUCTURE FOR FY 2004
A new Board of about 30 members will replace the existing SAB Executive Committee.
The new Board's membership will cover the breadth and depth of experience and expertise
needed to oversee the advisory functions of the SAB Committees, and to provide forward-
looking and technical advice to the Agency on critical overarching issues in the pursuit of
public health and environmental protection. The new Board will continue to benefit from
having liaison members representing the other three EPA Federal Advisory Committees, i.e,
EPA's Federal Fungicide, Insecticide, Rodenticide Act (FIFRA) Scientific Advisory Panel
(SAP), EPA's Children Health Protection Advisory Committee (CHPAC), and EPA's Office of
Research and Development (ORD)'s Board of Scientific Counselors or (BOSC).
To ensure an effective and smooth transition, the new FY 2004 SAB committee structure
will retain seven of the eight former Standing Committees and will include four Ad Hoc
Committees, two of which are in the process of being formed (see text box). The functions of
the Research Strategy Advisory Committee (RSAC), i.e., to advise the Agency on strategic
plans and overall research strategies and plans and the annual review of the President's Budget
Request for EPA Science and Technology, will be addressed by the new Board. Any additional
changes to the SAB Committee structure will be explored during FY 2004.
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SAB Committees for FY 2004
Standing SAB Committees
Drinking Water Committee
Ecological Processes and Effects Committee
Environmental Economics Advisory Committee
Environmental Engineering Committee
Environmental Health Committee
Integrated Human Exposure Committee
Radiation Advisory Committee
Ad Hoc SAB Committees
Committee on Valuing the Protection of Ecological Systems and Services
Science and Technological Achievement Award Committee
Bioethics Advisory Committee
Homeland Security Advisory Committee
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