U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF INSPECTOR GENERAL

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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about the EPA OIG. 
 

 

 

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 

SO2 Sulfur Dioxide 

Hotline 

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email: OIG_Hotline@epa.gov write: EPA Inspector General Hotline 

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online: http://www.epa.gov/oig/hotline.htm Washington, DC 20460 
U.S. Environmental Protection Agency 13-P-0387 

September 11, 2013 Office of Inspector General 

At a Glance
 

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.gov/oig/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. 
 

 

 

 

SUBJECT: EPA Can Better Document Resolution of Ethics and Partiality Concerns in 

Managing Clean Air Federal Advisory Committees 

 Report No. 13-P-0387 

FROM: Arthur A. Elkins Jr. 

Lek Kadeli, Principal Deputy Assistant Administrator 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

THE INSPECTOR GENERAL 

September 11, 2013 

MEMORANDUM 

TO: 

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. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EPA Can Better Document Resolution of Ethics and Partiality 13-P-0387 

Concerns In Managing Clean Air Federal Advisory Committees 

Table of Contents 

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- 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EPA Can Better Document Resolution of Ethics and Partiality 13-P-0387 

Concerns In Managing Clean Air Federal Advisory Committees 

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 
 

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. 

13-P-0387 1 
 

 

 

   

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.
 

13-P-0387 2 
 

 

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 

13-P-0387 3 
 

 

 

 

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 staff’s 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. 

13-P-0387 4 
 

 

 

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 contractordeveloped 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.
 

13-P-0387 5 
 

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 CASAC 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 

13-P-0387 6 
 

 

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. 

13-P-0387 7 
 

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 CFR Part 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 nonfederal employment or prospective employment. This exemption is subject to the 

following limitations: 

13-P-0387 8 
 

 

 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 

7 Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory 

Committees at the U.S. Environmental Protection Agency (EPA Form 3110-48). 

13-P-0387 9 
 

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 

13-P-0387 10 
 

 

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. 

13-P-0387 11 
 

 

 

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. 

13-P-0387 12 
 

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. 

13-P-0387 13 
 

 

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. 

13-P-0387 14 
 

	 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 

13-P-0387 15 
 

 

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 CASAC. 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). 

13-P-0387 16 
 


 

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 μg/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. 

13-P-0387 17 
 

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: 

13-P-0387 18 
 

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. 

13-P-0387 19 
 

 

 

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 CFR Part 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. 

13-P-0387 20 
 

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 

13-P-0387 21 
 

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 

13-P-0387 22 
 

  

       

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. 

0%

5%

10%

15%

20%

25%

30%

35%

40%

Chartered

CASAC

Chartered

Council

Chartered

CASAC +

Consultants

Chartered

Council +

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 

13-P-0387 23 
 

 

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. 

13-P-0387 24 
 

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: 

 Committee’s mission. 

 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 

13-P-0387 25 
 

 

 

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). 

13-P-0387 26 
 

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. 

13-P-0387 27 
 

 

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. 

13-P-0387 28 
 

Chapter 6

Peer Review 

In addition to assessing the EPA’s management of CASAC 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 CASAC. The requester questioned whether CASAC 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 Final 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. 

13-P-0387 29 
 

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 SO2 (SO2 analysis). 

3.	 An update to a previously published meta-analysis on the effects of human 

exposure to NO2 (updated NO2 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 SO2 analysis was sufficiently peer reviewed. The updated 

NO2 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. 

13-P-0387 30 
 

 

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.
 

13-P-0387 31 
 

 

 

 

 

 

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 SO2 Analysis 

In 2007, in support of the SO2 NAAQS review, NCEA began working on a draft 

analysis of SO2 human exposure data from studies conducted in the 1980s and 

1990s. This draft analysis was circulated to CASAC in December 2007, and 

CASAC encouraged NCEA to proceed with the analysis. NCEA’s SO2 analysis 

was included in the EPA’s second draft integrated science assessment14 for sulfur 

oxides in 2008. NCEA concluded that human responses to SO2 concentrations 

increased as exposures to SO2 increased and that more pronounced effects were 

observed at lower concentrations among SO2-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 SO2 

analysis and, in our view, this review fulfilled OMB and EPA peer review 

requirements. 

After the SO2 NAAQS final rule was issued, NCEA’s SO2 analysis was again 

peer reviewed and published in a December 2010 journal article.15 

2008 NO2 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 NO2 

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 NO2 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 NO2 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 al., Analysis 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. 

13-P-0387 32 
 

 

 

An NCEA branch chief told us that the updated NO2 meta-analysis was not 

submitted for publication because the revisions made to the original NO2 metaanalyses 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 metaanalysis 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 metaanalysis 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 metaanalysis. Further, it was an acceptable application of an adequately peer reviewed 

work product. NCEA essentially re-presented the results of the original metaanalysis. 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). 

13-P-0387 33 
 

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. 

13-P-0387 34 
 

 

 

 

 

 

 

 

 

 

Status of Recommendations and 

Potential Monetary Benefits 

POTENTIAL MONETARY 

RECOMMENDATIONS BENEFITS (in $000s) 

Rec. 

No. 

Page 

No. Subject Status1 Action Official 

Planned 

Completion 

Date 

Claimed 

Amount 

Agreed-To 

Amount 

1 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. 

C Designated Agency 

Ethics Official 

8/14/13 

2 

3 

4 

5 

19 

20 

20 

34 

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. 

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. 

Develop a framework to guide decisions regarding 

public pronouncements made by current or 

prospective FAC members related to topics under 

consideration by the FAC. 

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. 

O 

O 

O 

O 

Director, Science Advisory 

Board Staff Office 

Designated Agency 

Ethics Official 

Director, Science Advisory 

Board Staff Office 

Assistant Administrator, 

Office of Research and 

Development 

9/30/13 

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 

13-P-0387 35 

1 
 

 

 

 

 

 

 

 

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. 

13-P-0387 36 
 

 

 

 

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)i to instruct 

deputy ethics officials and

assistant deputy ethics officials 

on the proper process for 

DAEO will review reference 

material already available from

OGC/Ethics and the Office of

Government Ethics to ascertain 

whether any additional SGEhandling potential conflicts of specific guidance is necessary or 4th Quarter 

interest for SGEs, including the

process for implementing any 

applicable steps to mitigate the 

conflicts of interest. 

warranted. OGC notes, however, 

that conflicts issues are necessarily 

fact-specific, so it may not be 

possible or prudent to issue blanket

guidance.19 

FY 2013 

2 Develop procedures to sufficiently 

document the resolution of ethical 

concerns. This should include: 

a) Preparing written 

a) To enhance documentation of 

decisions on potential conflict of

interest (COI) of experts serving 

on FACs, subcommittees and 

panels, the SAB Staff Office 

determinations as to why will document the nature of the 4th Quarter 

members with 

independence concerns or 

the appearance of a lack 

of impartiality are allowed 

to serve on FACs, 

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 

FY 2013 

subcommittees and 

panels, including any 

steps recommended for 

mitigating concerns or 

SAB Staff Office will document 

any decision to authorize

participation. 

appearances. 

b) Documenting that all 

recommended steps for 

mitigating independence 

concerns, such as recusals 

from certain meetings, are 

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

4th Quarter 

FY 2013 

implemented. committee members/panelists 

are in compliance with ethics 

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. 

13-P-0387 37 
 

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 

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 

independence concerns and 

appearances of a lack of 

and that records are kept, when 

appropriate, on advice rendered. 

4th Quarter 

impartiality, including the 

sufficiency of recordkeeping 

documentation, and recommend 

corrective actions to the SAB Staff 

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 

FY 2013 

Office as appropriate. additional consultation and 

instruction. The DAEO will 

ascertain whether any additional 

review beyond what is already

occurring is warranted. 

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: 

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-ofdecision for the classification of a 

work product and the type of peer 

a) Determine and document 

review planned for a work product.

The National Center for 

whether such analyses are 

influential scientific 

information. 

Environmental Assessment 

(NCEA), within the Office of 

Research and Development, is in

the process of addressing this 

4th Quarter 

FY 2013 

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. 

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 

13-P-0387 38 
 

 

 

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. 

13-P-0387 39 
 

 

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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