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EPA Can Better Document
Resolution of Ethics and
Partiality Concerns in Managing
Clean Air Federal Advisory
Committees
Report No. 13-P-0387
September 11, 2013

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Report Contributors:	Rick Beusse
James Hatfield
Rich Jones
Alicia Mariscal
Michael Young
Abbreviations
CAA
Clean Air Act
CASAC
Clean Air Scientific Advisory Committee
CFR
Code of Federal Regulations
Council
Advisory Council on Clean Air Compliance Analysis
DAEO
Designated Agency Ethics Official
DEO
Deputy Ethics Official
DFO
Designated Federal Officer
EPA
U.S. Environmental Protection Agency
FAC
Federal Advisory Committee
FACA
Federal Advisory Committee Act
FY
Fiscal Year
GAO
U.S. Government Accountability Office
GSA
U.S. General Services Administration
ISA
Integrated Science Assessment
ISI
Influential Scientific Information
NAAQS
National Ambient Air Quality Standards
NCEA
National Center for Environmental Assessment
no2
Nitrogen Dioxide
OAQPS
Office of Air Quality Planning and Standards
OFACMO
Office of Federal Advisory Committee Management and Outreach
OIG
Office of Inspector General
OMB
Office of Management and Budget
ORD
Office of Research and Development
PM
Particulate Matter
PPM
Parts Per Million
SAB
Science Advisory Board
SGE
Special Government Employee
S02
Sulfur Dioxide
Hotline
To report fraud, waste, or abuse, contact us through one of the following methods:
email: OIG Hotline@epa.gov	write: EPA Inspector General Hotline
phone: 1-888-546-8740	1200 Pennsylvania Avenue, NW
fax:	202-566-2599	Mailcode 2431T
online:
http://www.epa.gov/oiq/hotline.htm
Washington, DC 20460

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U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
13-P-0387
September 11, 2013
Why We Did This Review
The U.S. Environmental
Protection Agency Office of
Inspector General conducted this
review in response to a
congressional request about the
EPA's management of the Clean
Air Scientific Advisory Committee
and the Advisory Council on
Clean Air Compliance Analysis.
We sought to determine whether
the EPA has managed the
CASAC and Council in
accordance with applicable laws,
regulations and guidance
pertaining to (1) potential conflicts
of interest, (2) appearances of a
lack of impartiality, (3) rotation of
members (i.e., term limits),
(4)	balance of committee
viewpoints and perspectives and
(5)	peer review. The EPA's
Science Advisory Board Staff
Office manages the CASAC and
Council, which provide advice to
the EPA on setting air quality
standards and in developing
cost-benefit analyses of the
Clean Air Act.
This report addresses the
following EPA Goals or
Cross-Cutting Strategies:
•	Taking action on climate and
improving air quality.
•	Advancing science, research,
and technological innovation.
For further information, contact
our Office of Congressional and
Public Affairs at (202) 566-2391.
The full report is at:
www.epa.aov/oia/reports/2013/
20130911-13-P-0387.pdf
EPA Can Better Document Resolution of Ethics and Partiality
Concerns in Managing Clean Air Federal Advisory Committees
What We Found
In general, the EPA managed the CASAC and Council in accordance with
applicable statutes and regulations. These regulations allow agencies discretion
in choosing federal advisory committee members and achieving balance.
We reviewed 47 CASAC and Council member appointments, including all
ozone panel appointments for the last two ozone standard reviews. We found
that the EPA has adequate procedures for identifying potential ethics concerns,
including financial conflicts of interest, independence issues and appearances
of a lack of impartiality. However, the EPA can better document its decisions on
selecting members with independence and partiality concerns. This would allow
for better transparency, thus giving assurance that CASAC and the Council
provide independent and objective advice to the Administrator on such
important decisions as setting ambient air standards. We also identified one
instance where agency procedures involving a potential conflict of interest were
not followed.
We also reviewed the peer review process for three EPA-developed analyses
included in scientific assessments peer reviewed by the CASAC. Peer review
is one method for enhancing the quality and credibility of the government's
scientific information. One of these analyses was not peer reviewed in
accordance with Office of Management and Budget and agency guidance.
The EPA's National Center for Environmental Assessment did not have a
formal process for determining whether such analyses were subject to OMB
requirements and the EPA's peer review guidance before public dissemination.
Recommendations and Planned Corrective Actions
We recommend that the EPA instruct staff on the proper process for addressing
potential conflicts of interest, develop procedures to document decisions and
mitigating actions regarding independence and partiality concerns, and
implement a process to determine whether its scientific work products are
influential scientific information that require peer review in accordance with
OMB and the EPA's guidance. The agency completed corrective action for one
recommendation and that recommendation is closed. The agency agreed with
three other recommendations and provided corrective action plans that we
accepted. The agency disagreed with one recommendation but proposed an
alternative action that we accepted. Thus, four recommendations are resolved
but open pending completion of the corrective actions.
Noteworthy Achievements
Although not required, the EPA applies many Federal Advisory Committee Act
guidelines and procedures to managing subcommittees and panels.

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
September 11, 2013
MEMORANDUM
SUBJECT: EPA Can Better Document Resolution of Ethics and Partiality Concerns in
Managing Clean Air Federal Advisory Committees
Report No. 13-P-0387
Office of Research and Development
Avi Garbow, General Counsel
Office of General Counsel
Christopher Zarba, Director
Science Advisory Board Staff Office
This is our final report on the management of Clean Air Act federal advisory committees conducted by
the Office of Inspector General of the U.S. Environmental Protection Agency. This report contains
findings that describe the problems the OIG has identified and corrective actions the OIG recommends.
This report presents the opinion of the OIG and does not necessarily represent the final EPA position.
Final determinations on matters in this report will be made by EPA managers in accordance with
established audit resolution procedures.
Action Required
The agency agreed with recommendation 1 and provided evidence of corrective action taken. This
recommendation is closed and no further action is required. The agency agreed with recommendations
2, 3 and 5 and provided planned corrective actions and completion dates that meet the intent of these
recommendations. The agency disagreed with recommendation 4 but provided an alternative action that
we accepted. Therefore, the agency is not required to provide a written response for these four
recommendations, which remain open with corrective actions ongoing. For these recommendations,
please update the EPA's Management Audit Tracking System as you complete the planned corrective
actions. Please notify my staff if there is a significant change in the agreed-to corrective actions.
We will post this report to our website at http://www.epa.gov/oig.
If you or your staff have any questions regarding this report, please contact Assistant Inspector General
for Program Evaluation Carolyn Copper at (202) 566-0829 or copper.carolyn@epa.gov. or Director for
Air Evaluations Rick Beusse at (919) 541-5747 or beusse.rick@epa.gov.
FROM: Arthur A. Elkins Jr
TO:
Lek Kadeli, Principal Deputy Assistant Administrator

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EPA Can Better Document Resolution of Ethics and Partiality
Concerns In Managing Clean Air Federal Advisory Committees
13-P-0387
Table of C
Chapters
1	Introduction		1
Purpose		1
Background		1
Prior Audit Reports		5
Noteworthy Achievements		6
Scope and Methodology		6
2	Financial Conflicts of Interest		8
SGEs Are Generally Subject to Federal Statutes and Regulations
Governing Financial Interests		8
The EPA's Process for Identifying Conflicts of Interest		9
Receipt of Federal Grant Is Not a Financial Conflict of Interest		9
Review of Financial Conflict of Interest Procedures		10
Conclusions		10
Recommendation		10
Agency Comments and OIG Evaluation		10
3	Independence and Impartiality		12
The EPA's Guidance Recommends Avoiding Experts Who
Appear to Lack Impartiality		12
The EPA's Financial Disclosure Forms Include Questions to Identify
Independence Concerns and Appearances of a Lack of Impartiality....	13
The EPA Can Better Document Identification and Resolution of
Independence and Impartiality Concerns		14
SAB Staff Office Does Not Treat Viewpoints Expressed as Part of
Committee Functions as Appearance of a Lack of Impartiality		18
Procedures for Addressing and Documenting Resolution of Concerns
Raised During Disclosure Form Reviews Could be Strengthened		18
Conclusions		19
Recommendations		19
Agency Comments and OIG Evaluation		20
4	Membership Tenure		21
The EPA's Policy Limits Committee Terms to 6 Years		21
The EPA Followed Its Policy on Tenure		22
Many Members Served More than 6 Years If Service on
Review Panels Were Considered		22
Conclusions		23
-continued-

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EPA Can Better Document Resolution of Ethics and Partiality
Concerns In Managing Clean Air Federal Advisory Committees
13-P-0387
5	Committee Balance		25
FACs Should be Fairly Balanced in Terms of Viewpoints
Represented and Functions Performed		25
Preparation of Balance Plans Could Provide More Transparency to
Efforts to Achieve Balanced CASAC and Council Committees		26
New Agency Procedures Designed to Improve Diversity and Balance		27
Conclusions		28
6	Peer Review		29
Federal and Agency Guidance Require Peer Review of Influential
Scientific Information Before Public Dissemination		29
NCEA's Review of One Analysis Did Not Adhere to OMB
Requirements and EPA Peer Review Guidance for
Influential Scientific Information		30
NCEA Did Not Have a Process for Determining Whether
Internal Analyses Were Influential Scientific Information		33
Subsequent Peer Review Did Not Alter Overall Conclusions of
NCEA's Ozone Reanalysis		34
Conclusions		34
Recommendation		34
Agency Comments and OIG Evaluation		34
Status of Recommendations and Potential Monetary Benefits		35
Appendices
A EPA Response to Draft Report	 36
B Distribution	 42

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Chapter 1
Introduction
Purpose
In response to a congressional request, our objective was to determine whether the
U.S. Environmental Protection Agency has managed the Clean Air Scientific
Advisory Committee and the Advisory Council on Clean Air Compliance Analysis
in accordance with applicable laws, regulations and guidance pertaining to:
•	Potential conflicts of interest.
•	The appearances of a lack of impartiality.
•	The rotation (i.e., term limits) of members.
•	A balance of committee viewpoints and perspectives.
•	Peer review.
Background
Advisory committees have provided advice to the federal government since its
inception. Congress enacted the Federal Advisory Committee Act in 1972 to
address the use of federal advisory committees that had developed over the years.
Congress had two major concerns with FACs before 1972. First was a public
perception that many commissions were duplicative, inefficient, and lacked
adequate controls or oversight. Second was a widespread belief that FACs did not
adequately represent the public interest and that meetings were often closed to the
public.
FACA addressed these concerns by creating a process for establishing, operating,
overseeing and terminating FACs. FACA requires that no FAC can meet or take
any action until a charter has been filed with the head of the agency to whom the
FAC reports and with the appropriate standing committees of the Senate and
House of Representatives. FAC members appointed as Special Government
Employees are subject to federal financial conflict of interest laws with some
exceptions. FACA requires each agency sponsoring a FAC to appoint a
committee management officer to oversee the administration of FACA's
requirements. Further, a designated federal officer must be assigned to each FAC
to ensure compliance with FACA.
FACA also required the administrator of the U.S. General Services
Administration to prescribe administrative guidelines and management controls
for FACs. Each federal agency head must establish administrative guidelines and
management controls for FACs formed by its agency, consistent with the
directives issued by GSA.
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Federal Advisory Committee Rule
GSA's rule1 on FAC management provides administrative and interpretative
guidelines and management controls for federal agencies to implement FACA.
The rule provides requirements for many aspects of managing a FAC. For
example, the rule establishes requirements for FAC charters, recordkeeping and
public notification. However, the rule allows for agency discretion in managing
certain aspects of a FAC. For example, unless otherwise provided by statute or
presidential directive, the length of FAC memberships is at the sole discretion
of the appointing authority.
The rule restates the FACA requirement that FACs be fairly balanced with
respect to the points of view represented and function to be performed.
However, the rule does not prescribe specific procedures for achieving balance.
Instead, the rule provides factors for an agency to consider in developing a
fairly balanced FAC.
GSA's rule does not prescribe procedures for addressing appearances of a lack
of impartiality or peer review. However, the EPA has established procedures
governing these and for balancing FAC member viewpoints, potential conflicts
of interest, and rotation of members.
The EPA's FACA Management Process
The EPA's Office of Federal Advisory Committee Management and Outreach is
the national program manager for the EPA's committee management program.
OFACMO provides policy, coordination, oversight, consultation, advice and
technical assistance to FAC managers and the EPA's senior officials. OFACMO
has issued a handbook2 which provides the EPA's administrative guidelines and
management controls for FACs.
The EPA's key personnel for establishing and managing an FAC include the
Administrator, the Deputy Administrator, the relevant program office's assistant
administrator, the committee management officer, and the designated federal
officer. Table 1 shows FAC responsibilities of key agency officials.
1	GSA Final Rule on Federal Advisory Committee Management, 41 CFR Parts 101-6 and 102-3.
2	EPA Federal Advisory Committee Handbook, March 2012. The previous EPA Handbook was issued in October
2003.
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Table 1: FAC Responsibilities of key EPA officials
EPA official
Summary of FAC responsibilities
Administrator
Responsible for the establishment, management and termination of the EPA's
FACs. The Administrator has delegated most of these responsibilities to other
agency personnel but remains fully accountable for ensuring compliance with
the statutory and regulatory requirements of the FACs. The Administrator also
appoints FAC members and FAC subcommittee members.
Deputy
Administrator
Approves membership packages for FACs (authority delegated to the Deputy
Administrator by the Administrator). Approves establishment and renewal
charters for FACs.
Assistant
Administrator
Responsible for the request and justification of the establishment of proposed
FACs. The assistant administrator ensures that the FAC is balanced by points
of view for the function to be performed, appoints a DFO for each FAC, and
ensures that the FAC's advice and recommendations are the result of the
FAC's independent judgment.
Committee
Management
Officer
Provides oversight for the establishment and operation of the EPA's FACs.
The committee management officer also serves as a resource for DFOs and
ensures proper recordkeeping for FACs (appointed by the director of
OFACMO).
Designated
Federal
Officer
Responsible for the day-to-day operations and management of the FAC. The
DFO works closely with the committee management officer to ensure full
compliance with FACA requirements.
Source: Office of Inspector General-developed based on information in the EPA's Federal Advisory
Committee Handbook (2012).
Clean Air Scientific Advisory Committee Created to Provide Advice
on Ambient Air Quality Standards
The Clean Air Act required the EPA to establish an independent scientific review
committee to provide advice to the Administrator in developing criteria and
standards for national ambient air quality. Thus, the EPA established the CASAC.
The CASAC has seven members who provide advice on criteria and standards for
six air pollutants. These pollutants are carbon monoxide, lead, nitrogen dioxide,
ozone, particulate matter and sulfur dioxide.
The CAA requires the EPA, with the assistance of CASAC, to review the criteria
for the National Ambient Air Quality Standards every 5 years. The EPA augments
CASAC with panels of expert consultants to help review the six pollutants. The
review panels we examined generally included 16 consultants plus the seven
CASAC members.
Each panel reviews and comments on the supporting documentation for its
specific pollutant. Prior to 2007, the two primary documents the panels reviewed
were the criteria document and the staff white paper. The EPA's Office of
Research and Development prepared the criteria document. This document was a
comprehensive and integrative assessment of relevant scientific studies related to
the pollutant. The EPA's Office of Air Quality Planning and Standards prepared
the staff white paper. The staff used the information in ORD's criteria document
and the results of the EPA's OAQPS risk and exposure assessments to develop
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and support their conclusions and recommendations for an air quality standard.
The OAQPS staff paper also included various ranges of standards for the
Administrator to consider.
The EPA revised its process for developing NAAQS in December 2006. The EPA
replaced the criteria document and the staff white paper with an integrated science
assessment, a risk/exposure assessment, and a policy assessment. The EPA also
decided it would publish the policy assessment in the Federal Register as an
Advanced Notice of Proposed Rulemaking. The revised process also called for
CASAC to be more involved in the initial planning for conducting the NAAQS
review. In May 2009, the EPA ended the requirement to publish the policy
assessment in an Advanced Notice of Proposed Rulemaking. Instead, the EPA
releases a draft of the policy assessment to CASAC and for public comment.
This policy assessment includes the air quality staffs conclusions and
recommendations for a range of standards for senior agency management to
consider.
Advisory Council on Clean Air Compliance Analysis Created to
Provide Advice on Cost-Benefit Analyses
The Advisory Council on Clean Air Compliance Analysis was established in
1991, pursuant to the CAA Amendments of 1990. The Council's purpose is to
review the data, methodology and findings of a statutorily mandated agency
report3 that assesses the costs and benefits of the CAA. The Council must include
at least nine members. The Council is to include experts in the fields of the health
and environmental effects of air pollution, economic analysis, and environmental
sciences. Members can also be appointed from other fields that the Administrator
determines to be appropriate.
As of July 2012, the Council included 15 members. The Council is supplemented
with subcommittees and consultants as needed. The Council has commented on
three CAA cost-benefit studies.4 In 2002, the agency requested the Council's
assistance in planning a third study assessing the benefits and costs of the CAA
for the period 1990 through 2020. From 2004 through 2011, the Council issued
several reports providing advice to the agency with respect to the third study. This
included advice on planning the study and selecting data, methods and models,
and commenting on draft findings and conclusions. To review the study, the EPA
augmented the Council with the Special Council Panel, the Air Quality Modeling
Subcommittee, the Health Effects Subcommittee and the Ecological Effects
Subcommittee.
3	This report was mandated by Section 812 of the CAA Amendments of 1990 but the requirement for the report to
Congress was repealed by the Federal Reports Elimination and Sunset Act of 1995 (P.L. 104-66).
4	The Benefits and Costs of the Clean Air Act, 1970 to 1990, October 1997; The Benefits and Costs of the Clean Air
Act, 1990 to 2010, November 1999, EPA-410-R99-001; and The Benefits and Costs of the Clean Air Act from 1990
to 2020, March 2011.
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Science Advisory Board Staff Office Manages the CASAC and Council
The EPA's Science Advisory Board Staff Office manages the CASAC and the
Council. The SAB Staff Office develops the required FAC documentation,
including charters and membership packages. The SAB Staff Office also collects
and reviews financial disclosure forms submitted by prospective SGEs. The SAB
Staff Office director recommends members for the committees to the
Administrator for approval. The SAB Staff Office director also has the authority
to select expert consultants to assist the chartered FACs. These consultant
appointments are not submitted to the Administrator for approval.
All CASAC and Council committee, subcommittee and panel members are
appointed to serve as SGEs, or in rare cases as regular government employees.
As government employees, they are covered by federal ethics and conflicts of
interest statutes and regulations. The SAB Staff Office director is also the agency
deputy ethics official for the office. The DEO is responsible for reviewing and
resolving ethics and conflicts of interest concerns with respect to members of the
CASAC, the Council, and their respective subcommittees and panels.
Prior Audit Reports
The OIG has not conducted any prior audits or evaluations of CASAC or Council
activity, or of the EPA's management of FACs. We reported on the EPA's external
peer review process in April 2009.5 Our 2009 report focused on contractor-
developed peer review panels. In response to the report, the EPA developed an
addendum to the Peer Review Handbook that provided additional guidance for
identifying appearances of a lack of impartiality in any of the peer reviewers.
The U.S. Government Accountability Office reported on FAC independence and
balance in 2004.6 GAO's report was based on a review of policies and practices at
nine federal departments and agencies, including the EPA. According to the GAO
report, GSA's guidance on FAC management did not address what types of
information could be helpful to agencies in assessing the points of view of potential
FAC members. Additionally, agency procedures did not identify the type of
information that should be collected about potential members to make decisions
about FAC balance. Thus, eight of the nine departments and agencies that GAO
reviewed did not identify and systematically collect and evaluate information
pertinent to determining the points of view of potential FAC members. Such
information would include previous public positions or statements on matters being
reviewed. The EPA was the only agency to routinely collect and evaluate this
information.
5	EPA Can Improve Its Process for Establishing Peer Review Panels, EPA OIG Report No. 09-P-0147, April 29,
2009.
6	GAO-04-328, FEDERAL ADVISORY COMMITTEES: Additional Guidance Could Help Agencies Better Ensure
Independence and Balance, April 2004.
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Noteworthy Achievements
FACA regulations do not apply to subcommittees or working groups that provide
advice to the parent FAC. Still, the EPA applies many of its FACA guidelines and
procedures when assembling these subcommittees and panels. That includes:
•	Requiring subcommittee and panel members designated as SGEs to
complete financial disclosure forms.
•	Reviewing and vetting these forms for financial conflicts of interest and
appearances of a lack of impartiality.
•	Preparing membership grids showing each proposed member's
qualifications and background.
The EPA's revised Federal Advisory Committee Management Handbook
incorporates new procedures and factors to consider in selecting FAC members.
The Handbook now requires the EPA's DFOs to prepare an outreach plan. This
plan describes how the DFO plans to publicize the proposed FAC and solicit
members from various groups to achieve FAC diversity.
Scope and Methodology
Our evaluation assessed the EPA's management of the CAS AC and Council
during the period 2006 through 2011, although we did review older records as
necessary. In particular, we focused on management of CASAC's ozone and
PM panels, and the Council's Health Effects Subcommittee. We evaluated the
procedures the EPA used to ensure compliance with FACA and applicable
federal and agency guidance. We did not evaluate the quality of scientific
advice the CASAC or Council provided to the EPA.
We performed our work at the EPA's OFACMO, SAB Staff Office, and Office of
General Counsel in Washington, D.C. We also conducted work at the ORD's
National Center for Environmental Assessment in Research Triangle Park,
North Carolina. We interviewed the EPA staff and managers tasked with
overseeing the EPA's compliance with FACA, and obtained data and documents as
appropriate. We also interviewed staff and managers responsible for managing the
CASAC and Council.
To assess the EPA's management of the CASAC and Council we selected a
sample of FAC, subcommittee and panel member appointments for review. Our
selection criteria were all members of the last two NAAQS ozone panels, any
expert who served on both the 2006 and 2011 PM review panels, and any expert
specifically cited in the requester's letters to the OIG. This represented 47 of 126
members appointed during the period of fiscal years 1998 through 2012. We
reviewed the SAB Staff Office case files for these 47 members for evidence of
independence, impartiality, or financial conflicts of interest concerns. Based on
potential concerns we identified during our initial file review, we reviewed 27 of
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these cases in depth. We also interviewed six CASAC members to obtain their
views on membership balance.
We conducted our evaluation from April 2012 through May 2013. We conducted
this evaluation in accordance with generally accepted government auditing
standards. Those standards require that we obtain sufficient, appropriate
evidence to provide a reasonable basis for our findings and conclusions based on
our objectives. We believe the evidence obtained provides a reasonable basis for
our findings and conclusions based on our objectives.
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Chapter 2
Financial Conflicts of Interest
The EPA has implemented a process to manage the CASAC and Council in
accordance with applicable laws, regulations and guidance regarding financial
conflicts of interest. The EPA requires prospective and active SGEs to complete
financial disclosure forms. The SAB Staff Office reviews these forms for
financial conflicts of interest. We identified one instance where agency
procedures involving a potential conflict of interest were not followed.
SGEs Are Generally Subject to Federal Statutes and Regulations
Governing Financial Interests
Rules governing conflicts of interest for federal employees can be found in the
Code of Federal Regulations. Specifically, 5 CFRPart 2635 Subpart D provides in
part that:
An employee is prohibited by criminal statue, 18 U.S.C. 208(a),
from participating personally and substantially in an official
capacity in any particular matter in which, to his knowledge, he or
any person whose interests are imputed to him under this statute
has a financial interest, if the particular matter will have a direct
and predictable effect on that interest.
SGEs are generally subject to financial conflict of interest provisions with some
exceptions. In certain circumstances, SGEs who serve on FACs, within the
meaning of the FACA, are uniquely eligible for a particular waiver of the
prohibition of Section 208(a). Under 18 U.S.C. 208(b)(3), an SGE serving on a
FAC may be eligible for a waiver where the official responsible for his or her
appointment certifies in writing that the need for the SGE's services outweighs
the potential for a conflict of interest posed by the otherwise disqualifying
financial interest involved. EPA Order 1000.28A states that only the designated
agency ethics official or the alternate agency ethics official may issue such
waivers. According to the EPA's OGC, this should occur only upon consultation
with the U.S. Office of Government Ethics.
SGEs serving on FACs are also covered by certain exemptions from Section 208
that have been promulgated by the U.S. Office of Government Ethics, pursuant to
18 U.S.C. 208(b). The most significant of these is 5 CFR 2640.203(g), which
pertains to certain financial interests arising from the SGE's outside employment.
This exemption permits SGEs serving on FACs to participate in matters of
general applicability where the disqualifying interest arises from the SGE's non-
federal employment or prospective employment. This exemption is subject to the
following limitations:
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•	The matter cannot have a special or distinct effect on either the SGE or the
SGE's non-federal employer, other than as part of a class.
•	The exemption does not cover interests arising from the ownership of
stock in the employer or prospective employer.
Further, according to the EPA's OGC the non-federal employment must involve
an actual employee/employer relationship, as opposed to an independent
contractor relationship.
The EPA's Process for Identifying Conflicts of Interest
The EPA requires prospective charter FAC, panel and subcommittee members to
complete the EPA's Form 3110-48.7 Active members must also update their forms
annually as well as before any particular matter is considered by a given member.
The form includes sections for listing employment and consulting work, paid
expert testimony, research or project funding for the past 2 years, and assets. The
form also includes a section for describing prior activities or statements that could
affect, or appear to affect, an expert's ability to provide impartial advice.
The SAB Staff Office's ethics officer (assistant to the SAB Staff Office DEO) and
the SAB Staff Office DEO review each active or prospective member's financial
disclosure form for potential ethical issues, including financial and other conflicts,
and possible lack of impartiality. Both reviewers sign and date the first page of
the form to document their review. The forms may include the reviewer's
handwritten notes if issues are noted.
If the review identifies potential issues, the SAB Staff Office informs the
prospective or active member and asks for an explanation. The SAB Staff Office
may also discuss any concerns with the member and require that the member take
action to mitigate the concern. The SAB Staff Office director's personal practice
was to not grant financial conflict of interest waivers. We did not identify any
waivers for financial conflicts of interest for the 47 CASAC and Council charter,
subcommittee and panel members we reviewed from FYs 2002 through 2012.
Receipt of Federal Grant Is Not a Financial Conflict of Interest
The EPA does not consider a prospective or current member's receipt of an
agency or other federal research grant to create the basis for a financial conflict of
interest. This is consistent with other federal guidance in this area. For example,
OMB's Final Bulletin on Peer Review states that:
When an agency awards grants through a competitive process that
includes peer review, the agency's potential to influence the
scientist's research is limited. As such, when a scientist is awarded
1 Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory
Committees at the U.S. Environmental Protection Agency (EPA Form 3110-48).
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a government research grant through an investigator-initiated,
peer-reviewed competition, there generally should be no question
as to that scientist's ability to offer independent scientific advice to
the agency on other projects.
The above guidance does not mean that a prospective or active member's work on
a specific grant or research project could not potentially present an independence
concern. A prospective or active member's research or grant is a potential area of
concern if the FAC, panel, or subcommittee plans to address work performed
under the research grant. Prospective and active EPA SGE members must report
any research grants received during the past 2 years in Section 4 of the EPA's
Form 3110-48. Our review of impartiality and independence is discussed in
chapter 3.
Review of Financial Conflict of Interest Procedures
We reviewed 47 financial disclosure forms completed by prospective CASAC and
Council committee, panel and subcommittee members from 2002 through 2012.
We identified one instance where agency procedures regarding a potential conflict
of interest were not followed.
Conclusions
The EPA has adequate procedures for identifying financial conflicts of interest.
Nonetheless, we identified one instance where the agency's procedures for
handling a potential conflict of interest were not followed. As such, we believe the
agency should remind DEOs of the proper procedures for addressing potential
conflicts of interest to prevent any future occurrences.
While receipt of grant funds from the EPA may not constitute a financial conflict of
interest on the part of a FACA member, receipt of such funding could raise
concerns of independence depending upon the nature of the research conducted
under the grant and the issues addressed by the FAC.
Recommendation
We recommend that the EPA designated agency ethics official:
1. Instruct DEOs and assistant DEOs on the proper process for handling
potential conflicts of interests for SGEs, including the process for
implementing any applicable steps to remedy the conflicts of interest.
Agency Comments and OIG Evaluation
The agency agreed with our recommendation and responded that the DAEO will
review already available reference material and guidance to determine whether
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any additional guidance is warranted for SGEs. Further, the agency provided us
with documentation that the DAEO has instructed DEOs on the proper process to
follow in addressing conflicts of interest. Thus, this recommendation is closed and
no further response is required from the agency.
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Chapter 3
Independence and Impartiality
In general, the EPA has implemented an adequate process to identify
independence and impartiality concerns. However, the EPA can improve its
controls over this process by better documenting how it addressed concerns
identified during the financial disclosure review process. We reviewed financial
disclosure forms and associated SAB Staff Office files for 47 members from
FYs 2002 through 2012. In nine instances, final determination on and steps
taken to mitigate independence or partiality matters were either not adequately
documented or, in our view, needed additional steps to sufficiently address
potential independence or partiality concerns. Better documentation of ethics
decisions will help ensure that the FAC process is transparent and that advice to
the Administrator on important issues such as setting ambient air standards to
protect public health and the environment is impartial and objective.
The EPA's Guidance Recommends Avoiding Experts Who
Appear to Lack Impartiality
FACA requires that FACs provide independent advice free of inappropriate
influence from the appointing authority or special interests. FACA does not
establish requirements for reviewing the independence or impartiality of FAC
members. However, SGEs are subject to federal ethics regulations and should
avoid appearances of a lack of impartiality in performing their work. Title 5 CFR
Part 2635.502(a) in large part addresses impartiality with respect to particular
matters involving specific parties. Since the CASAC and Council address matters
of general applicability this provision would not normally apply to CASAC and
Council members. However, 5 CFR Part 2635.502(a)(2) addresses impartiality
concerns that may arise under other circumstances. It states that:
An employee who is concerned that circumstances other than those
specifically described in this section would raise a question
regarding his impartiality should use the process described in this
section to determine whether he should or should not participate in
a particular matter.
Based on 5 CFR 2635.502 (c) and (d), EPA Order 1000.28A authorizes DEOs to
make determinations as to whether a reasonable person would be likely to
question the employee's impartiality in a particular matter under 5 CFR Part
2635, Subpart E. In instances where impartiality is likely to be questioned, but
would not violate 18 USC 208(a), the Order further authorizes DEOs to determine
whether the employee should be allowed to participate in the matter, and if so,
authorize participation in writing.
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The EPA's Peer Review Handbook provides guidance for how the EPA should
address impartiality and independence concerns on peer review panels. The
Handbook states that the EPA should make every effort to use reviewers who are
independent and do not have an appearance of a lack of impartiality. The Handbook
states, as a general rule, experts who have made public pronouncements on an issue
or who have clearly "taken sides" may lack impartiality and should be avoided. The
Handbook recognizes that these reviewers with appearances of a lack of impartiality
may still serve on a panel to fill the need for experience or technical balance and
representation. For example, if an SGE has an appearance of a lack of impartiality, it
may still be possible to make a written determination that the SGE may serve on the
FAC or to ensure that the SGE is recused from certain areas of a review. With
respect to impartiality, the Handbook states:
... it is also important that any decision that is made concerning
advisory committee members or peer reviewers be appropriately
documented. . . .
The Peer Review Handbook defines an independent reviewer as an expert who
was not associated with developing the work product, either directly by
substantial contribution to its development or indirectly by significant
consultation during its development.
The EPA's Financial Disclosure Forms Include Questions to Identify
Independence Concerns and Appearances of a Lack of Impartiality
As discussed in chapter 2, the EPA requires FAC committee, subcommittee and
panel candidates who are designated as SGEs to complete EPA Form 3110-48.
Once selected, members must also periodically update their form. The form
includes a supplemental set of questions specifically designed to help the EPA
identify any potential appearance of a lack of impartiality (table 2).
Table 2: Supplemental questions to identify concerns with independence and impartiality
No.
Questions asked
1
Do you know of any reason that you might be unable to provide impartial advice on the matter to come before
the panel/committee/subcommittee or any reason that your impartiality in the matter might be questioned?
2
Have you had any previous involvement with the review document(s) under consideration including
authorship, collaboration with the authors, or previous peer review functions? If so, please identify and
describe that involvement.
3
Have you served on previous advisory panels, committees or subcommittees that have addressed the topic
under consideration? If so, please identify those activities.
4
Have you made any public statements (written or oral) on the issue that would indicate to an observer that you
have taken a position on the issue under consideration? If so, please identify those statements.
Source: OIG-developed table based on section 6 of EPA Form 3110-48.
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The EPA Can Better Document Identification and Resolution of
Independence and Impartiality Concerns
We reviewed the SAB Staff Office's files for 47 of the 126 SGE appointments to
CASAC and the Council, including subcommittees and review panels, over the
period of FYs 1998 through 2012. We reviewed 27 appointments in greater detail
based on information in the case files that in our opinion indicated the SGE's
appointment might raise ethical concerns with respect to the FAC's or panel's
work. We also reviewed the meeting minutes for 14 Council meetings held
between 2003 and 2010. We found:
•	Four instances where recusals for independence concerns were not
documented or came after the expert had participated in activities related
to the concern.
•	Three instances where, in our view, potential independence concerns were
not identified or their resolution was not adequately documented.
•	Two instances where, in our view, potential appearances of a lack of
impartiality were not identified or adequately resolved.
The following sections discuss in more detail the results of our review.
Some Recusals Were Not Documented or Came After SGE
Participation in Activities That Created an Independence Concern
The SAB Staff Office determined that four members of the chartered Council
should recuse themselves from certain meetings where the charge questions were
related to work these members had produced. SAB Staff Office procedures state
that the DFO should start each meeting by stating for the record that all
participating panel members are in compliance with ethics and conflict of interest
rules. If not, the DFO should note any instances where a member will recuse
him/herself from discussion on a particular aspect of the meeting. The EPA's
FAC Handbook also recommends that meeting minutes document all recusals.
•	In two instances, the EPA appointed experts as members to the chartered
Council who had co-authored studies that the EPA used to support
conclusions in the EPA's CAA Section 812 cost benefit analysis. These
studies pertained to the monetized benefit of reducing ozone and PM
mortality. The DFO told us they orally instructed members to recuse
themselves from any meeting where charge questions related to the
application of their work in the Section 812 study were discussed.
However, the meeting minutes did not state whether these two members
recused themselves from meetings where the charge questions related to
their work.
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•	In one instance, a potential independence concern about a Council
member was raised and discussed at a Council meeting. The concern was
that the member was one of five experts selected to serve on a pilot expert
elicitation study panel on PM mortality. The Council was asked to review
the design of the pilot study. Because of the information discussed at this
meeting, the DFO sent a written notice to the member instructing him to
recuse himself from meetings where his prior work on the pilot elicitation
study was to be discussed. Meeting minutes we reviewed indicate that this
member recused himself from applicable meetings after receiving SAB's
notice for a period of several years. The member later served as one of 12
participants in the full-scale expert elicitation study. According to the SAB
Staff Office, when the Council met in 2008 to advise the agency on the
potential use and presentation of expert elicitation study results, the
member did not participate in the meeting. However, 6 years after the
initial independence issue arose, this member attended a meeting as a
member of the Council's Health Effects Subcommittee where the
interpretation and presentation of the results of the elicitation study were
discussed. Meeting minutes did not indicate whether this member recused
himself from discussing the EPA's application of the results of the study
he had worked on.
•	In one instance, a Council member had contributed significantly to a
product peer reviewed by the Council. Both the member and the SAB
Staff Office identified this member's participation as an independence
concern. The SAB Staff Office director noted that the member would be
required to recuse himself from any discussion of that portion of the
document. The meeting minutes for two Council subcommittee meetings
did not indicate whether this member recused himself from any portion of
the deliberations. A draft peer review report was prepared after these two
meetings. Prior to a third meeting where this topic was discussed, the DFO
sent the member a written recusal reminder notice. Meeting minutes we
reviewed indicated the member recused himself from meetings after
receiving the written recusal notice.
Some Potential Independence Concerns Were Not Identified
We identified three instances where the SAB Staff Office appointed experts to
panels that reviewed work products that the experts had helped develop or
incorporated extensive information from work products the experts had
developed. In all three instances, the experts reported their involvement in these
precursor work products on EPA Form 3110-48.
•	In two instances, experts appointed to a CASAC review panel had
participated substantially in preparing chapters included in ORD's ozone
and PM criteria documents for the prior review period. These members
were allowed to serve as reviewers for the next 5-year review's criteria
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document. The SAB Staff Office director told us that these members were
allowed to serve because they had not worked on producing the document
under review by the CAS AC. However, our review of the integrated science
assessments (formerly known as criteria documents) found that these work
products included conclusions and information from the chapters that had
been written by the experts for the prior criteria documents. Further, the
charge questions for the ISA reviews included commenting on the
usefulness and completeness of the scientific information in chapters that
included information from these experts' prior work. Thus, even though
these experts did not develop the ISA documents, in our view, their service
on the panels created a risk that they could potentially review their own
work. Further, the agency should document in writing its determination that
the expert's service will not create an independence concern and any steps
needed to reduce the risk that this could occur.
•	In one instance, an expert selected to serve on the Council's Health Effects
Subcommittee was a member of the project team that developed the
methodology for both the pilot and later full-scale expert elicitations. This
member also interviewed experts for the elicitation study. This member's
participation in the expert elicitation studies was noted at a Council
meeting. Later, this member attended at least two meetings where the
Health Effects Subcommittee charge included interpretation and
presentation of the results of the pilot expert elicitation study for the
section 812 cost-benefit analysis. The meeting minutes did not record any
recusals from the member. We found no indication in the SAB case file
that the SAB Staff Office identified this as a potential independence issue.
In our view, this member indirectly participated in the work product being
reviewed based on his significant consultation during its development. We
concluded that such participation does not meet the definition of an
independent reviewer as described in the EPA's Peer Review Handbook.
Appearances of a Lack of Impartiality Not Identified or Adequately
Resolved
The Peer Review Handbook states that, as a general rule, "... experts who have
made public pronouncements or have had a predominant influence on the position for
a given organization on an issue, those who have clearly "taken sides," may have an
appearance of a lack of impartiality." We reviewed two instances where experts had
expressed public viewpoints on NAAQS standards but were appointed to serve on
the CASAC or one of its panels.
•	The requester questioned the appointment of a CASAC member who had
co-authored an article8 in 2006 opposing the EPA's PM standard and was
later appointed chair of the PM review panel. This member's case file
8 William N. Rom and Jonathan M. Samet, "Small Particles with Big Effects," 173 Am. J. Resp. & Crit. Care Med.
365, 366 (2006).
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included a bibliography of publications that included the article in
question. However, the member did not list this article in section 6 of the
disclosure forms we reviewed, and the EPA's notes to the file did not
include any discussion regarding this article. The article made the
following conclusion about the PM standard:
In the face of the extensive evidence on PM and health and
the strong mandate of the Clean Air Act for public health
protection, the PM NAAQS proposed by Administrator
Johnson appear lax. Based on the same evidence, the
American Thoracic Society and other health organizations
have recommended 12 and 25 (j,g/m3 for the average annual
and 24-h PM2.5 standards, respectively. The proposed, less
stringent standard does not protect the nation's health, as
required by the Clean Air Act.
In our view, the above statement presents an appearance of a lack of
impartiality based on guidance in the Peer Review Handbook. This
guidance states that, generally, experts who have made a public
pronouncement on an issue should be avoided. This expert served as a
consultant on the PM review panel that advised the Administrator on the
2006 proposed and final PM standard. This expert was later appointed to
the CASAC and the next 5-year PM review panel in 2007. While public
statements expressing an opinion would not automatically disqualify a
member, we believe that the SAB Staff Office, if aware of this article,
should have prepared a written determination justifying the selection.
We noted that the case file did include documentation of the SAB Staff
Office's resolution of potential concerns with respect to an article the
expert had co-authored in 2004. According to notes in the case file, the
SAB Staff Office intended to remind the expert to list such articles in
section 6 of his disclosure form.
• In the remaining instance, a nitrogen oxide/sulfur oxide review panel
member reported on his disclosure form that he had made statements at
scientific meetings and in classrooms that the body of epidemiological
evidence warranted consideration of a lower nitrogen oxide standard. The
SAB Staff Office initially flagged this as a potential appearance of a lack
of impartiality. However, the Staff Office later noted in the case file that
there was not an appearance of a lack of impartiality since the member
stated that he had not made these statements while serving on the panel
during the past year. Guidance in the EPA's Peer Review Handbook does
not limit statements that could create the appearance of a lack of
impartiality to those only made while serving on a panel. In our view,
refraining from making public statements on a topic while on the panel
does not mitigate any appearances created by making public statements
prior to an expert's appointment to the panel.
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SAB Staff Office Does Not Treat Viewpoints Expressed as Part of
Committee Functions as Appearance of a Lack of Impartiality
The requester raised concerns about two letters from CASAC members to the
EPA Administrator. These letters encouraged the EPA Administrator to set the
NAAQS at the levels CASAC had recommended following its review of the
supporting technical documents and proposed standards. Many of the members
who signed these letters were later re-appointed to the CASAC review panels that
convened for the next 5-year NAAQS review cycle. The requestor expressed
concerns that these members had an appearance of a lack of impartiality based on
their publicly expressed viewpoints.
The SAB Staff Office director told us that her office distinguishes between
viewpoints expressed outside of the FAC's activities and those expressed as part
of the FAC's chartered function to provide advice to the Administrator. She
considered these letters to be a normal part of the FAC's advice function and did
not consider the viewpoints expressed to be appearances of a lack of impartiality
that would affect the member's future service. However, she noted that if a panel
member were to express a personal viewpoint outside of the FAC process, this
could potentially present the appearance of a lack of impartiality. For opinions
voiced outside of the member's FAC duties, the director told us that an expert
must advocate a specific NAAQS level for the SAB Staff Office to consider it a
viewpoint that would present the appearance of a lack of impartiality. According
to the agency's alternate agency ethics official, she would instruct the CASAC
after they have made their final communications to the Administrator to make any
further communications through the DFO.
Procedures for Addressing and Documenting Resolution of Concerns
Raised During Disclosure Form Reviews Could be Strengthened
The SAB Staff Office procedures include documenting any relevant
correspondence between the file reviewer and the active or potential member
regarding ethics questions. Further, these procedures state that the DFO should
start each meeting by stating for the record that all participating panel members
are in compliance with ethics and conflict of interest rules. If not, the DFO should
note any instances where a member will recuse him/herself from discussion on a
particular aspect of the meeting.
SAB Staff Office procedures do not address making written determinations when
members with ethical concerns are allowed to serve. The EPA's Peer Review
Handbook states that written determination should be made when SGEs with the
appearance of a lack of impartiality are allowed to serve on FACs. Further, EPA
Order 1000.28.A, Duties of EPA Ethics Officials, states that DEOs are authorized
to:
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When informed by an employee of an impartiality issue under
5 CFR Part 2635, Subpart E, or when requested by the employee's
supervisor or other person responsible for the employee's
assignment, make determinations as to whether a reasonable
person would be likely to question the employee's impartiality in a
particular matter. If impartiality is likely to be questioned,
determine whether the employee should be allowed to participate
in the matter, and if so, authorize participation in writing
[5 CFR § 2635.502(c) and (d)].
In general, the files we reviewed contained handwritten notes, typed notes to the
file, emails, or other documentation pertaining to concerns that arose during the
review. However, in some cases the files did not contain the SAB Staff Office's
final determination explaining how potential issues they identified were resolved.
We needed additional oral explanation from SAB staff to ascertain how the Staff
Office resolved these cases and the reasoning behind those determinations.
Further, the meeting minutes we reviewed did not contain a record of the DFO's
statements on recusals when the SAB Staff Office had recommended recusals.
Conclusions
The SAB Staff Office has adequate procedures for identifying independence and
impartiality concerns. However, SAB's final determinations and evidence that
mitigating measures were implemented were not always documented in the files
we reviewed. Such documentation will better ensure that the FAC process is
transparent and the advice from FACs is impartial. When experts with
independence or impartiality concerns are allowed to serve on FACs without
sufficient written justification it can potentially undermine the credibility of:
(1) the FAC's advice, (2) the agency's scientific and technical documents, and
(3) the corresponding regulations issued by the agency.
Recommendations
We recommend that the director, Science Advisory Board Staff Office:
2. Develop procedures to adequately document the resolution of ethical
concerns. This should include:
a.	Preparing written determinations as to why members with
independence concerns or the appearance of a lack of impartiality
are allowed to serve on FACs, subcommittees and panels,
including any steps recommended for mitigating these concerns or
appearances.
b.	Documenting that all recommended steps for mitigating independence
concerns, such as recusals from certain meetings, are implemented.
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We recommend that the EPA designated agency ethics official:
3.	Periodically review the SAB Staff Office's resolution of independence
concerns and appearances of a lack of impartiality, including the
sufficiency of recordkeeping documentation, and recommend corrective
actions to the SAB Staff Office as appropriate.
We recommend that the director, Science Advisory Board Staff Office:
4.	Develop a framework to guide decisions regarding public pronouncements
made by current or prospective FAC members related to topics under
consideration by the FAC.
Agency Comments and OIG Evaluation
The agency agreed with recommendations 2 and 3, and provided a corrective
action plan and milestones that meet the intent of these recommendations. The
agency did not agree with recommendation 4 and offered an alternative corrective
action. The agency responded that public pronouncements did not fall under the
purview of federal ethics regulations since they were not "covered relationships"
and that the SAB typically deals with matters of general applicability, not
"specific party" matters. We interpreted 5 CFRPart 2635.502(a)(2), which
addresses impartiality concerns that may arise under other circumstances not
described in that section, as potentially applying to particular matters of general
applicability. However, we believe the SAB Staff Office's proposal to develop a
framework to guide decisions regarding public pronouncements by current or
prospective FAC members will be an appropriate management control. As such,
the agency's proposed alternative action meets the intent of the draft report's
recommendation. Thus, we revised our recommendation to reflect the agency's
proposed alternative corrective action. All three recommendations are resolved
and open pending the agency's completion of the agreed-to corrective actions.
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Chapter 4
Membership Tenure
The EPA's policy on tenure generally limits FAC members to 6 years of service,
with any service over 6 years based on written justification from the program
office and approval by the Administrator or Deputy Administrator. The EPA
generally followed this policy in its management of the CASAC and Council.
In three instances prior to 2010, EPA approved FAC chairs to serve more than
6 years based on written justification submitted to the Administrator. Beginning in
FY 2010 under former Administrator Jackson's term (2009-2013), the EPA has
more strictly limited the granting of extensions for service more than 6 years.
The EPA's policy on tenure does not apply to review panel or subcommittee
memberships. From FYs 1998 through 2012, 36 percent of all CASAC
members/consultants served more than 6 years as a charter CASAC member or
review panel consultant. During the same period, 12 percent of all Council
members/consultants served more than 6 years as a Council charter member, or
review panel or subcommittee consultant. By not applying its membership policy
to review panels and subcommittees, the EPA may be not be achieving the
policy's intent of providing fresh perspectives to its FACs.
The EPA's Policy Limits Committee Terms to 6 Years
Title 41 CFR Section 102-3.130(a), regarding policies that apply to the
appointment and compensation or reimbursement of advisory committee
members, staff, experts and consultants, states that:
Unless otherwise provided by statue, Presidential directive, or
other establishment authority, advisory committee members serve
at the pleasure of the appointing or inviting authority. Membership
terms are at the sole discretion of the appointing or inviting
authority.
As noted in the EPA's 2003 Federal Advisory Committee Handbook membership
terms should be no longer than 6 years to provide fresh perspectives on the FAC.
The Handbook notes the deputy administrator may grant appointments beyond the
6-year limit if the program office provides adequate justification as to why the
office cannot find an appropriate replacement. In the case of the CASAC and
Council, appointments are made by the Administrator, who may grant (and has
granted) appointments beyond the 6-year limit if the SAB Staff Office provides
adequate justification for the extension.
According to the former SAB Staff Office director and staff in the EPA's
OFACMO, since 2010 former Administrator Jackson more strictly limited FAC
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service to no longer than 6 years. OFACMO noted that Administrator Jackson
granted some extensions but only in exceptional circumstances based on a
detailed written justification. The EPA's 2012 revised Handbook reiterated the
6-year limit and clarified that members should be appointed for no longer than a
total of 6 years (typically in 2- or 3-year terms), with an extension limited to
1-year upon approval of a detailed written justification.
The EPA applies its term policy only to FAC charter members and not to SGEs
who serve on panels or subcommittees that supplement the charter FAC. The SAB
Staff Office director noted that the consultants on the CASAC review panel are
not voting members. Further, these panels often meet over a period of several
years. Thus, the time spent in service on one NAAQS review panel could last
approximately 6 years. The director also noted that the Staff Office's practice is to
replace about two-thirds of the members on subsequent panels. In their view,
subsequent panels benefit from the experience and working knowledge provided
by having some of the previous panel members serve on the next panel.
The EPA Followed Its Policy on Tenure
The EPA generally applied its policy of limiting terms of service. We reviewed
the length of service for all CASAC and Council members who served from FYs
1998 through 2012. Only three members served more than 6 years (one CASAC
and two Council committee members). In all three instances written justifications
were provided for the members' extended service. These three FAC members'
length of service ranged from 7 to 10 years. Figure 1 (see next page) shows the
percentage of CASAC and Council charter members who served more than
6 years from FYs 1998 through 2012.
Many Members Served More than 6 Years If Service on Review Panels
Were Considered
The EPA augmented both the CASAC and Council with review panels and
subcommittees comprised of consultants that provided technical advice on
important matters under consideration by the FAC. While not voting members of
the FAC, these consultants could influence the FAC's advice with their input.
Therefore, we applied the 6-year term limit to all types of FAC and consultant
services starting in 1998, including service on chartered FACs, subcommittees
and review panels. If time served as a charter FAC member and review panel
consultant or subcommittee member were combined, the percentage of experts
exceeding 6-year terms is greater than the percentage for charter members only.
During FYs 1998 through 2012, the CASAC had 74 members either serve as one
of the seven chartered FAC members or as an expert consultant on a NAAQS
review panel. When this combined service is considered, 27 of 74 members (or
36 percent of CASAC members) served more than 6 years. Of the 27 CASAC
members/consultants who served more than 6 years, the years of service as a
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member and/or consultant ranged from 7 years (12 members/consultants) to
15 years (one member/consultant).
During FYs 1998 through 2012, the Council had 67 members serving either
directly on the FAC, on a related subcommittee, or as a consultant. When this
combined service is considered, eight members (or 12 percent of Council
members) served more than the 6 years. Of the eight members who served more
than 6 years, the years of service ranged from 7 years (six members) to 10 years
(one member). Figure 1 shows the percentage of all CASAC- and Council-related
members with length of service of more than 6 years.
Figure 1: Percentage of CASAC and Council members serving more than 6 years,
FY 1998-FY 2012.
Percentage of Members Serving > 6 Years
35%
X
m


30%
/



25%
/



20%
/



15%
/



10%
X


T_
5%



¦¦


W 	w /
Chartered	Chartered	Chartered	Chartered
CASAC	Council	CASAC +	Council+
Consultants Consultants
Source: OIG analysis of CASAC and Council membership lists.
Conclusions
Neither the FACA nor its implementing regulations prescribe membership term
limits for FAC members. However, the EPA has established a policy on
membership terms to help provide fresh perspectives on FACs. The EPA's policy
applies only to charter FAC members and not expert consultants who serve on
review panels or members selected to serve on subcommittees. In particular, the
CASAC review panelists provide significant input regarding the EPA's criteria
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and standards for ambient air quality. Our analysis indicated the SAB Staff Office
was achieving its goal of about two-thirds turnover on its NAAQS review panels.
This turnover ratio is intended to balance the need for fresh perspectives versus
maintaining continuity and experience.
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Chapter 5
Committee Balance
In general, we found that the CASAC and Council were balanced with respect to
the primary functions of the FACs and the required scientific "points of view."
The FACA and its implementing regulations require FACs to be fairly balanced
but allow agencies discretion in how they achieve balance. The EPA's guidance
instructs DFOs to describe the agency's plan to attain fairly balanced membership
for their FACs and to prepare membership grids showing proposed members'
qualifications and background. The SAB Staff Office prepared membership grids
for the CASAC and Council. The Staff Office also described the factors that it
considered for selecting members in Federal Register notices announcing
opportunities for the public to nominate members. SAB Staff Office management
and staff told us that their primary concern in achieving balance for the CASAC
and Council was ensuring that the members have the necessary range of technical
expertise. With the EPA's release of its updated FAC Handbook in March 2012,
the EPA added steps to its FAC membership selection process to help achieve
FAC balance. In our view, this new process will provide additional assurance that
balance is achieved on these FACs.
FACs Should Be Fairly Balanced in Terms of Viewpoints Represented
and Functions Performed
FACA requires that the membership of FACs be "fairly balanced in terms of the
points of view represented and the functions to be performed by the advisory
committee." In the preamble to the 2001 FACA Final Rule, the GSA stated it
believed FACA's provisions were broad enough to allow agency discretion in
achieving membership balance. However, the rule included a list of possible
considerations for agencies in developing a plan for achieving balance. These
include the:
•	C ommittee' s mi s si on.
•	Geographic, ethnic, social, economic or scientific impact of the
committee's recommendations.
•	Specific perspectives required, such as those of consumers, technical
experts, the public at-large, academia, business or other sectors.
•	Need to obtain divergent points of view on the issues before the
committee.
•	Relevance of state, local and tribal governments to the development of the
advisory committee's recommendations.
Title 41 CFR Part 102-3.60 requires agencies to describe their plans for achieving
balance on discretionary FACs. These plans are not required for non-discretionary
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FACs such as the CASAC and Council. However, GSA guidance9 issued in 2011
"strongly recommended" these plans for non-discretionary FACs as well.
The EPA's FAC Handbook (prior and current versions) incorporates FACA
requirements on balance and describes the EPA's procedures for ensuring this
requirement is met. The EPA's Handbook requires that the justification
statements that accompany a request to charter or renew a charter for both
discretionary and non-discretionary FACs describe plans for achieving balance.
The Handbook lists general guidelines to consider in achieving balance. The 2012
updated FAC Handbook incorporated an additional consideration for members
with experience with issues of concern to low-income, rural, urban, medically
underserved, sensitive/vulnerable, or disproportionately impacted community
populations, and whether that experience would be useful.
The membership grid is a key tool prepared by the EPA as part of the annual
membership process. The EPA uses the membership grid to review and ensure
balance. For each FAC, the DFO must create a membership grid that provides a
snapshot of the FAC makeup, including both current members and proposed
candidates for membership. The membership grid is part of the overall
membership package, which is submitted to the Administrator for approval.
Both the CASAC and Council are statutorily mandated FACs with specific
membership requirements mandated by the CAA. The CASAC's seven members
must include at least one physician, one member of the National Academy of
Sciences, and one person representing state air pollution control agencies. The
Council must have at least nine members and include recognized experts in the
fields of health and the environmental effects of air pollution, economic analysis,
environmental sciences and such other fields the Administrator deems
appropriate.
Preparation of Balance Plans Could Provide More Transparency to
Efforts to Achieve Balanced CASAC and Council Committees
In general, we found the CASAC and Council were balanced with respect to the
primary functions of the FACs and the required scientific "points of view."
We noted that prior to 2011, the justification packages for these FACs did not
describe the plan for attaining balanced membership. However, in Federal
Register notices announcing opportunities for the public to nominate members for
service on the Council and CASAC, the SAB Staff Office described factors it
considers when selecting FAC members. These factors included relevant
scientific perspectives, which, among other factors can be influenced by work
history and affiliation.10 As part of the annual membership process, the SAB Staff
9
FAC Membership Balance Plan, GSA Committee Management Secretariat, Office of Committee and Regulatory
Management, January 2011.
10See e.g., 69 Fed. Reg. 33,900-01 (June 17, 2004).
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Office prepared membership grids for the CASAC and Council which
summarized the proposed FAC membership in terms of members' expertise,
affiliation category (e.g., academic, state, private sector, nongovernmental
organization), and geographic location (state). The SAB Staff Office used a
similar process in forming panels that work under the auspices of the chartered
FACs.
SAB Staff Office DFOs told us they address balance from the standpoint of
scientific and technical expertise. If a potential or current member were to express
a public opinion on matters before the FAC, this might create an appearance of a
lack of impartiality. One DFO told us the SAB Staff Office would address such a
concern specifically with that individual, not by balancing the panel with an
opposing point of view.
New Agency Procedures Designed to Improve Diversity and Balance
In March 2012, the EPA updated its FAC Management Handbook and
incorporated new procedures for achieving diversity and balance on the EPA's
FACs. The updated Handbook:
•	Added a consideration for whether members with experience with issues
of concern to low-income, rural, urban, medically underserved,
sensitive/vulnerable populations, or communities experiencing
disproportionate environmental or public health burdens, could be useful
on the FAC.
•	Requires an outreach plan for obtaining a diverse pool of nominees.
The plan must be submitted to the EPA's OFACMO for review and
concurrence. The outreach plan should describe in detail how the DFO
intends to solicit a diverse set of nominees, including women and
minorities. For example, it should explain the specific forms of public
solicitation the DFO plans to use and the organizations and academic
institutions the DFO plans to contact.
The SAB Staff Office developed an outreach plan for the April 2012 CASAC
charter renewal. Further, the SAB Staff Office developed a draft outreach plan for
the April 2013 Council charter renewal. The balance plan for CASAC and the
Council, prepared to support charter renewal, describes the plan for ensuring that
the committees are balanced in terms of scientific points of view (including
statutory requirements for membership). The Outreach Plan, developed to support
the annual membership process, is designed to ensure that membership
recommendations draw upon a "diverse set of nominees, including women and
minorities." While there is overlap between the goals of diversity and balance,
they are not synonymous.
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Conclusions
Agencies have discretion in determining how balance is achieved on their FACs.
In requiring descriptions of plans to achieve balance for non-discretionary FACs,
the EPA has established procedures for balance that go beyond the minimum
requirements established by the regulations. Preparing membership balance plans
and implementing outreach plans as described in the EPA's updated FAC
Handbook should make the selection process more transparent and help ensure
that balance is achieved on the CASAC and Council.
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Chapter 6
Peer Review
In addition to assessing the EPA's management of CAS AC and the Council, we
reviewed the EPA's conformity with OMB and the EPA's peer review policies
and guidance with respect to three National Center for Environmental Assessment
analyses supporting NAAQS revisions. All three analyses were conducted in
conjunction with and included in larger assessment documents that synthesized
numerous studies and analyses. These assessment documents underwent formal
peer review by the CAS AC. The requester questioned whether CAS AC review of
assessment documents sufficed for the rigor and specificity of a separate peer
review of each individual analysis.
We determined that two of the three analyses were sufficiently peer reviewed
before the EPA publicly disseminated them by placing them in the rulemaking
docket. However, one of the NCEA analyses containing influential scientific
information—a re-analysis of data from an ozone health effects study—was not
peer-reviewed in accordance with OMB and the EPA's guidance. OMB and the
EPA's guidance call for all ISI to be peer reviewed before public dissemination.
However, NCEA did not have a formal process for determining whether
individual analyses and work products met the definition of ISI. Thus, NCEA did
not subject its ozone data re-analysis to peer review before disseminating it in
support of the ozone NAAQS. The analysis was later peer reviewed and published
in a journal article. This peer review did not alter the conclusions of the analysis
as presented in the EPA documents. Thus, the lack of peer review prior to public
dissemination did not appear to affect the ozone NAAQS rulemaking.
Nonetheless, proper peer review of the EPA's internal analyses before
dissemination to the public is an important tool for ensuring the quality and
integrity of the agency's scientific information.
Federal and Agency Guidance Require Peer Review of Influential
Scientific Information Before Public Dissemination
Peer review involves the review of a draft product for quality by specialists in the
field who were not involved in producing the draft. OMB's I' inal Information
Quality Bulletin for Peer Review establishes government-wide guidance for
peer review of government science documents. The OMB bulletin requires each
agency to subject ISI to peer review prior to dissemination. It defines ISI as
"scientific information the agency reasonably can determine will have or does
have a clear and substantial impact on important public policies or private sector
decisions." The OMB bulletin provides agencies broad discretion in
determining the type of peer review and the procedures used to select reviewers.
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The EPA's Peer Review Handbook (3rd Edition) incorporates the provisions of the
OMB bulletin and outlines the agency's policy, procedures and processes for peer
review. Consistent with OMB guidelines, the EPA's Peer Review Handbook
states that "[t]he principle underlying the Peer Review Policy is that all influential
scientific and technical work products used in decision making will be peer
reviewed" (underlining in original). However, it cites exceptions to this principle.
One of these exceptions states that peer review is not necessary for ISI if an
application of an adequately peer reviewed work product does not depart
significantly from its scientific or technical approach.
The EPA's Peer Review Handbook states that, generally, determinations as to
whether a work product is "influential" will occur on a case-by-case basis. The
agency decision maker should determine whether a work product is ISI. The
applicable assistant administrator or regional administrator is the ultimate agency
decision maker and is accountable for the decisions regarding the identification of
ISI, and the mechanisms of peer review used for these work products. The
assistant administrator or regional administrator may designate office directors or
division directors as the front-line decision maker.
NCEA's Review of One Analysis Did Not Adhere to OMB Requirements
and EPA Peer Review Guidance for Influential Scientific Information
We reviewed NCEA's compliance with OMB and the EPA's peer review
guidance for three work products NCEA produced in support of ambient air
quality standards for ozone, sulfur dioxide and nitrogen dioxide. EPA included
parts of these three analyses in larger assessment documents that the CASAC peer
reviewed. These three NCEA work products were:
1.	A reanalysis of data from a previously published clinical study on the
effects of human exposure to ozone (ozone reanalysis).
2.	An analysis of the results of earlier human clinical studies on the effects of
human exposure to S02 (S02 analysis).
3.	An update to a previously published meta-analysis on the effects of human
exposure to N02 (updated N02 meta-analysis).
In our view, all three analyses fit the description of ISI. However, NCEA did not
have its ozone reanalysis peer reviewed before it was disseminated to the public.
As such, the EPA did not adhere to OMB and EPA peer review guidance for this
particular analysis. The S02 analysis was sufficiently peer reviewed. The updated
N02 meta-analysis primarily updated and re-presented previously peer reviewed
information, and thus was not required to be peer reviewed again per the EPA's
guidance. Details concerning the development, dissemination and peer review of
each of the three analyses follow.
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2007 Ozone Reanalysis
In response to a CASAC comment on the second draft of the 2006 ozone air
quality criteria document, NCEA decided to include the results of a recent human
exposure study (Adams study)11 in the final air quality criteria document.
According to NCEA staff, in reviewing the Adams study they observed certain
traits in the study's data which caused them to question whether the data would
show statistically significant effects of ozone exposure at less than 0.08 parts per
million. In reviewing the final air quality criteria document, one CASAC member
also questioned whether additional statistical analysis of the data would show
statistically significant effects at ozone levels below 0.08 ppm. These
observations led NCEA to re-analyze the Adams study data using a different
statistical approach. NCEA concluded that there was a statistically significant
effect of ozone at 0.06 ppm as compared to filtered clean air (0.00 ppm). NCEA
placed the results of its reanalysis12 in the ozone rulemaking docket in June 2007
without having it peer reviewed.
NCEA's 2007 ozone reanalysis met the definition of ISI. The Adams study was
the first such study to present human exposure data at ozone levels below
0.08 ppm. At that time, the level of the ozone standard was 0.08 ppm averaged
over 8 hours. NCEA's reanalysis concluded that ozone effects occurred at levels
below 0.08 ppm. Thus, NCEA reasonably could determine that its reanalysis
would have an impact on the 2008 NAAQS ozone rulemaking process.
At a technical conference in December 2006, NCEA made a presentation on the
health effects of exposure to air pollutants. This presentation included NCEA's
initial ozone analysis illustrating the distribution of effects for individuals and
group mean estimates at levels below 0.08 ppm. In January 2007, NCEA staff
discussed the ozone reanalysis with the EPA's OAQPS. OAQPS asked NCEA if it
could include the ozone reanalysis in the OAQPS staff paper for the 2008 NAAQS
ozone rulemaking. However, NCEA did not want to do so at that time because staff
believed it might constitute new analysis that had not been peer reviewed. Thus,
OAQPS only presented NCEA's general observations about the Adams study in the
staff paper and not the detailed statistical analysis. NCEA had the reanalysis
internally reviewed by EPA scientists and addressed public comments received at a
March 2007 CASAC meeting. In NCEA's view, it was appropriate to include the
reanalysis after these internal reviews. Thus, they entered the reanalysis into the
rulemaking docket in June 2007.
11	Dr. William Adams, Comparison of Chamber 6.6-h Exposures to 0.04-0.08 PPM Ozone via Square-wave and
Triangular Profiles on Pulmonary Responses, Inhalation Toxicology, February 2006.
12	Dr. James Brown, The effects of ozone on lung function at 0.06 ppm in healthy adults, EPA memorandum,
June 14, 2007.
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NCEA's 2007 ozone reanalysis was published in an August 2008 peer reviewed
journal article.13 However, this peer review was after NCEA disseminated its
reanalysis in the June 2007 memorandum.
2008 S02 Analysis
In 2007, in support of the SO2 NAAQS review, NCEA began working on a draft
analysis of S02 human exposure data from studies conducted in the 1980s and
1990s. This draft analysis was circulated to CAS AC in December 2007, and
CAS AC encouraged NCEA to proceed with the analysis. NCEA's S02 analysis
was included in the EPA's second draft integrated science assessment14 for sulfur
oxides in 2008. NCEA concluded that human responses to S02 concentrations
increased as exposures to SO2 increased and that more pronounced effects were
observed at lower concentrations among S02-sensitive asthmatics. As part of the
normal NAAQS review process, CASAC peer reviewed the draft integrated
science assessments. Prior to submitting the second draft ISA to CASAC for peer
review, the EPA formally requested the CASAC to review its analyses of data
from human clinical studies. We reviewed the CASAC comments on the S02
analysis and, in our view, this review fulfilled OMB and EPA peer review
requirements.
After the S02 NAAQS final rule was issued, NCEA's S02 analysis was again
peer reviewed and published in a December 2010 journal article.15
2008 N02 Meta-Analysis
During a May 1, 2008, CASAC meeting (one of several held for the 5-year review
of the nitrogen dioxide NAAQS), NCEA and CASAC discussed a 1992 N02
meta-analysis16 of 19 studies of individuals with asthma included in the 1993
criteria document. CASAC recommended that NCEA present this data in the
current N02 ISA. Before including the 1992 meta-analysis in the ISA, NCEA
removed one study from the analysis17 and added a recent study that it considered
to be of a similar nature to the other studies. NCEA also added a concentration
range (i.e., 0.1 ppm) to its presentation that was not included in the original 1992
meta-analysis. NCEA's conclusions on the effects of N02 exposure were
essentially the same in its 2008 update as those from the 1992 meta-analysis.
13	Dr. James Brown et al., Effects of Exposure to 0.06 ppm Ozone on FEV in Humans: A Secondary Analysis of
Existing Data, " Environmental Health Perspectives, August 2008.
14	Integrated Science Assessment for Sulfur Oxides - Health Criteria (Second External Review Draft), Table 3-1 and
related text, May 2008.
15	Dr. Douglas Johns et alAnalysis of the concentration-respiratory response among asthmatics following
controlled short-term exposures to sulfur dioxide, Inhalation Toxicology, December 2010.
16	Dr. Lawrence J. Folinsbee, Does Nitrogen Dioxide Exposure Increase Airways Responsiveness?, Toxicology and
Industrial Health, Vol. 8, No. 5, 1992.
17	According to NCEA, one study in the 1992 meta-analysis was based on a specific exposure while all the others
were based on non-specific exposures. Thus, in NCEA's view, this one study should not be included in the 2008
analysis.
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An NCEA branch chief told us that the updated N02 meta-analysis was not
submitted for publication because the revisions made to the original NO2 meta-
analyses were not a new analysis that would merit publication in a journal.
Further, she said all of the information about the revisions to the original meta-
analysis was included in the ISA so a separate memorandum was not necessary.
Both the original 1992 meta-analysis and NCEA's 2008 update of that meta-
analysis were ISI. However, the 2008 updated meta-analysis did not require peer
review. The EPA's Peer Review Handbook notes that peer review is not necessary
for ISI if it is an application of an adequately peer reviewed work product that
does not depart significantly from its scientific or technical approach. In our view,
NCEA's 2008 update did not depart significantly from the original 1992 meta-
analysis. Further, it was an acceptable application of an adequately peer reviewed
work product. NCEA essentially re-presented the results of the original meta-
analysis. Moreover, the conclusions about the health effects of NO2 exposure did
not change. On July 17, 2012, the U.S. Court of Appeals for the District of
Columbia upheld the EPA's final NO2 rule and reached a similar conclusion
regarding the 2008 meta-analysis. The court noted that the EPA's meta-analysis
"merely updated" the original Folinsbee meta-analysis.18
NCEA Did Not Have a Process for Determining Whether
Internal Analyses Were Influential Scientific Information
According to an NCEA branch chief, NCEA does not have a process for
determining whether internal NCEA analyses are "influential" and does not make
"influential calls" on such documents. She said NCEA focuses on determining
which internal analyses are most relevant to the larger assessment documents that
are peer reviewed by CASAC. She said that it would be impossible to have every
internal analysis peer reviewed due to time constraints. She also said that NCEA
does not ask CASAC to peer review each individual analysis.
We reviewed NCEA emails and found no evidence of an NCEA process for
determining whether a work product is influential. However, a January 2007
email showed that some NCEA staff were concerned about sending the ozone
reanalysis to the docket without having the individual analysis peer reviewed.
In the email, NCEA staff did not discuss whether the work product was ISI or
whether peer review was required to meet OMB and EPA guidance. In our view,
the lack of a process to assess whether internal analyses are ISI is a weakness in
NCEA's management controls. This lack of control allowed the 2007 ozone
reanalysis to be included without peer review and without clear accountability for
the decision to proceed even though internally staff had some concerns.
18 American Petroleum Inst. v. EPA, 684 F.3d 1342, 1349 (D.C. Cir. 2012), rehearing en banc denied (D.C. Cir.
Sept. 24, 2012), cert, denied, 133 S. Ct. 1724 (April 2013).
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Subsequent Peer Review Did Not Alter Overall Conclusions of
NCEA's Ozone Reanalysis
The ozone reanalysis was published in a peer reviewed journal article after the
EPA publicly disseminated it. However, the peer review did not result in
significant changes to the journal manuscript. Many of the peer review comments
for the ozone reanalysis were editorial and required only small revisions to the
text. One peer reviewer commented that the authors (including two NCEA staff
members) could have more clearly described their analysis and suggested that the
authors include a more rigorous defense of their analytical strategy. The authors
cited text that described and defended the analysis, and did not significantly
change the manuscript. The external peer reviewers' comments did not materially
alter NCEA's original results or conclusions as they were presented in the EPA's
documents supporting the revised NAAQS for ozone.
Conclusions
NCEA did not have a process to determine whether internal analyses were ISI and
to document its decision regarding the need for peer review. Such a process would
provide accountability for decisions about the need for peer review and help
assure that NCEA complies with OMB and EPA peer review guidance. In the
absence of a formal process to determine whether a work product is influential,
NCEA is at risk of including ISI in broader assessment documents for public
dissemination without the requisite peer review.
Recommendation
We recommend that the assistant administrator for the Office of Research and
Development:
5. Direct NCEA to implement a process to review NCEA scientific analyses
that support the EPA's rulemakings and determine the appropriate type of
peer review for these work products. This process should:
a.	Determine and document whether such analyses are influential
scientific information.
b.	Document the rationale for the type of peer review chosen for ISI,
including any decision not to have such analyses externally peer
reviewed before they are publicly disseminated.
Agency Comments and OIG Evaluation
The agency agreed with our recommendation and provided a corrective action plan
that meets the intent of the recommendation. The recommendation is resolved and
open pending the agency's completion of the agreed-to corrective action.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
POTENTIAL MONETARY
BENEFITS (In $000s)
Rec.
No.
Page
No.
Subject
Status1
Action Official
10 Instruct DEOs and assistant DEOs on the proper
process for handling potential conflicts of interests
for SGEs, including the process for implementing
any applicable steps to remedy the conflicts of
interest.
Designated Agency
Ethics Official
Planned
Completion
Date
Claimed
Amount
Ag reed-To
Amount
8/14/13
19	Develop procedures to adequately document the
resolution of ethical concerns. This should include:
a.	Preparing written determinations as to why
members with independence concerns or
the appearance of a lack of impartiality are
allowed to serve on FACs, subcommittees
and panels, including any steps
recommended for mitigating these concerns
or appearances.
b.	Documenting that all recommended steps
for mitigating independence concerns, such
as recusals from certain meetings, are
implemented.
20	Periodically review the SAB Staff Office's
resolution of independence concerns and
appearances of a lack of impartiality, including the
sufficiency of recordkeeping documentation, and
recommend corrective actions to the SAB Staff
Office as appropriate.
20 Develop a framework to guide decisions regarding
public pronouncements made by current or
prospective FAC members related to topics under
consideration by the FAC.
34 Direct NCEA to implement a process to review
NCEA scientific analyses that support the EPA's
rulemakings and determine the appropriate type
of peer review for these work products. This
process should:
a.	Determine and document whether such
analyses are influential scientific
information.
b.	Document the rationale for the type of peer
review chosen for ISI, including any
decision not to have such analyses
externally peer reviewed before they are
publicly disseminated.
Director, Science Advisory
Board Staff Office
9/30/13
Designated Agency
Ethics Official
Director, Science Advisory
Board Staff Office
Assistant Administrator,
Office of Research and
Development
9/30/13
12/31/14
9/30/13
O = recommendation is open with agreed-to corrective actions pending
C = recommendation is closed with all agreed-to actions completed
U = recommendation is unresolved with resolution efforts in progress
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Appendix A
EPA Response to Draft Report
July 22, 2013
MEMORANDUM
SUBJECT: Response to Office of Inspector General Draft Report No. OPE-FY12-0001
Response to Congressional Request on the EPA's Management of Clean Air
Federal Advisory Committees, dated June 17, 2013
FROM: Lek G. Kadeli, Principal Deputy Assistant Administrator
Office of Research and Development (ORD)
Brenda Mallory, Acting General Counsel
Office of General Counsel (OGC)
Christopher Zarba, Acting Director
Science Advisory Board (SAB) Staff Office
TO:	Arthur A. Elkins, Jr., Inspector General
Office of Inspector General (OIG)
Thank you for the opportunity to respond to the OIG draft report titled, Response to
Congressional Request on the EPA's Management of Clean Air Federal Advisory
Committees. We have provided a summary of the agency's overall position and our response
to the OIG's recommendations. For the one recommendation with which the agency does not
agree, we have provided the legal basis and a proposed alternative to the given
recommendation. For your consideration, we have included our technical comments as
attachments to supplement this response.
AGENCY'S OVERALL POSITION
The EPA appreciates the opportunity to comment on this report and in general agrees with
the OIG's recommendations. For findings and recommendations related to the Office of
General Counsel, we have provided clarifying information about the identity and parameters
of the position that oversees the agency's ethics program.
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AGENCY'S RESPONSE TO REPORT RECOMMENDATIONS
Agreements
No.
Recommendation
High-Level Intended Corrective
Action(s)
Estimated
Completion
by- Quarter
and FY
1
Designated Agency Ethics
Official (DAEO)1 to instruct
deputy ethics officials and
assistant deputy ethics officials
on the proper process for
handling potential conflicts of
interest for SGEs, including the
process for implementing any
applicable steps to mitigate the
conflicts of interest.
DAEO will review reference
material already available from
OGC/Ethics and the Office of
Government Ethics to ascertain
whether any additional SGE-
specific guidance is necessary or
warranted. OGC notes, however,
that conflicts issues are necessarily
fact-specific, so it may not be
possible or prudent to issue blanket
guidance.19
4th Quarter
FY 2013
2
Develop procedures to sufficiently
document the resolution of ethical
concerns. This should include:
a)	Preparing written
determinations as to why
members with
independence concerns or
the appearance of a lack
of impartiality are allowed
to serve on FACs,
subcommittees and
panels, including any
steps recommended for
mitigating concerns or
appearances.
b)	Documenting that all
recommended steps for
mitigating independence
concerns, such as recusals
from certain meetings, are
implemented.
a)	To enhance documentation of
decisions on potential conflict of
interest (COI) of experts serving
on FACs, subcommittees and
panels, the SAB Staff Office
will document the nature of the
issue and any remedies (e.g.,
divestiture, partial recusal)
applied. If there is an issue of
appearance of loss of
impartiality but no statutory
COI under 18 USC 208, the
SAB Staff Office will document
any decision to authorize
participation.
b)	The SAB Staff Office will
develop a standard opening
statement for Designated
Federal Officers to use at the
beginning of all public
meetings. The statement would
note that all participating
committee members/panelists
are in compliance with ethics
4th Quarter
FY 2013
4th Quarter
FY 2013
19 Subsequent to this action plan the Senior Counsel for Ethics and Alternate Agency Ethics Official clarified the
response to Recommendation 1 to note that she had already advised the SAB Director and selected staff about the
proper process for handling conflicts of interest, and would instruct ethics officials across the Agency in her monthly
meetings on August 13 and 14, 2013.
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No.
Recommendation
High-Level Intended Corrective
Action(s)
Estimated
Completion
by- Quarter
and FY


requirements and note any
recusals for the record. The
SAB Staff Office will ensure
that meeting minutes accurately
reflect these opening statements.

3
Designated Agency Ethics
Official (see endnote) to
periodically review the SAB Staff
Office's resolution of
independence concerns and
appearances of a lack of
impartiality, including the
sufficiency of recordkeeping
documentation, and recommend
corrective actions to the SAB Stafi
Office as appropriate.
Pursuant to 5 CFR § 2638.203, the
DAEO is responsible for managing
EPA's ethics program, including
ensuring that financial disclosure
reports are consistently reviewed
and that records are kept, when
appropriate, on advice rendered.
OGC/Ethics has been working in
closer coordination with the new
SAB Acting Director and staff on
an as-needed basis to ensure proper
resolution of concerns, including
additional consultation and
instruction. The DAEO will
ascertain whether any additional
review beyond what is already
occurring is warranted.
4th Quarter
FY 2013
5
Direct NCEA to implement a
process for reviewing NCEA
scientific analyses that support
the EPA's rulemakings to
determine the appropriate type of
peer review for these work
products. This process should:
a)	Determine and document
whether such analyses are
influential scientific
information.
b)	Document the rationale for
the type of peer review
chosen for ISI, including any
decision not to have such
analyses externally peer
reviewed before they are
publicly disseminated.
The Agency is in the process of
revising the Peer Review
Handbook. The new edition of the
Handbook will emphasize the
planning process and include
procedures for creating a record-of-
decision for the classification of a
work product and the type of peer
review planned for a work product.
The National Center for
Environmental Assessment
(NCEA), within the Office of
Research and Development, is in
the process of addressing this
recommendation by establishing a
policy that includes the following
steps.
a) NCEA work products will be
evaluated to determine whether
they are ISI, in accordance with
EPA's Peer Review Handbook,
and the Division Director will
document his or her
4th Quarter
FY 2013
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No.
Recommendation
High-Level Intended Corrective
Action(s)
Estimated
Completion
by- Quarter
and FY


determination.
b) NCEA will conduct a peer
review for any work product that
is determined to be ISI, in
accordance with EPA's Peer
Review Handbook, and NCEA
will document the rationale for
the type of peer review
conducted.

Disagreement
OIG Recommendation No. 4:
Designated Agency Ethics Official (see Endnote 1) to provide clarification or instruction to
Deputy Ethics Officials for assessing whether public statements create an appearance of a lack of
impartiality with respect to when the statements were made and the expert's role at the time of
the statement.
Agency's Response:
Pursuant to 5 CFR § 2638.203, the DAEO is responsible for managing the Agency's ethics
program, including ensuring that EPA employees adhere to the conflict of interest statutes set
forth in Title 18 of the United States Code and to the Standards of Ethical Conduct for
Employees of the Executive Branch, 5 CFR Part 2635. The Standards of Ethical Conduct
include, at 5 CFR Part 2635, Subpart E, specific provisions for "Impartiality in Performing
Official Duties."
The OIG recommendation falls outside the purview of federal ethics. These regulations set forth
the standard that an employee is responsible, in the first instance, for identifying whether any of
his "covered relationships" will cause a reasonable person with knowledge of the relevant facts
to question his ability to carry out his official duties with respect to a specific party matter
impartially. Typically, the SAB does not deal with "specific party" matters but rather with
matters of general applicability. Further, a public statement does not fall within the "covered
relationships" set forth at 5 CFR 2635.502, and therefore OGC ethics is not the responsible
party overseeing these decisions.
From a policy perspective, however, when an individual has made public statements about a
matter that will be considered by the advisory panel that may raise a concern about whether the
individual has an open mind. The agency's current Peer Review Handbook recommends that
staff avoid selecting people for a peer review if they have publicly expressed an opinion on the
matter to be considered by the peer review The Handbook also acknowledges the challenge of
selecting advisory committee members who have the requisite experience or technical expertise
and who have not made public statements. For this reason, the Handbook allows EPA the
discretion to decide to include members who have made public statements.
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Alternative to Given Recommendation:
The SAB Staff Office will develop a framework to guide decisions regarding public statements.
Estimated Completion by Quarter and FY:
1st Quarter FY 2014
CONTACT INFORMATION
If you have any questions for OGC, please contact Justina Fugh, Senior Counsel for Ethics and
Alternate Designated Agency Ethics Official at (202) 564-1786, or Daniel Fort, Ethics Officer,
at (202) 202-564-2200. For questions regarding the SAB Staff Office component of this
response, please contact Christopher Zarba, Acting Director at (202) 564-0760 or Angela
Nugent, Special Assistant, Science Advisory Board Staff Office at (202) 564-2218. Finally, for
questions to the EPA's Office of Research and Development, please contact Deborah
Heckman at (202) 564-7274 or John Vandenberg at (919) 541-4527.
Attachments
A.	Technical Comments from the Office of Federal Advisory Committee Management
and Outreach
B.	Technical Comments from the SAB Staff Office
C.	Technical Comments from the ORD
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ENDNOTE
1 Please note that the General Counsel, a Presidentially appointed/Senate confirmed
position, has neither a statutory nor regulatory role in EPA's ethics program.
OGC/Ethics therefore assumes that the OIG intended to identify the Designated Agency
Ethics Official as the correct action official. Brenda Mallory was designated by the
Administrator pursuant to 5 CFR 2638.202(b) and (c) when she became the Principal
Deputy General Counsel. Although Ms. Mallory is also currently acting as the General
Counsel, the acting position does not imbue her with her authority to oversee EPA's
ethics program. Rather, that authority derives from her appointment as the Designated
Agency Ethics Official (DAEO).
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Appendix B
Distribution
Office of the Administrator
Principal Deputy Assistant Administrator for Research and Development
General Counsel
Director, Science Advisory Board Staff Office
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for External Affairs and Environmental Education
Deputy Assistant Administrator for Science, Office of Research and Development
Director, Office of Science Policy, Office of Research and Development
Principal Deputy General Counsel
Audit Follow-Up Coordinator, Office of Research and Development
Audit Follow-Up Coordinator, Office of General Counsel
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