Report to the Ranking Minority

Member, Committee on Government

Reform, House of Representatives

United States General Accounting Office

GAO

June 2001 EPA’S SCIENCE

ADVISORY BOARD

PANELS

Improved Policies and

Procedures Needed to

Ensure Independence

and Balance

GAO-01-536
Page i GAO-01-536 EPA's Science Advisory Board Panels

Letter 1

Appendix I Financial Conflict-of-Interest Provisions 23

Appendix II The 1,3-Butadiene Health Risk Assessment Panel 26

Appendix III The Three Panels on EPA’s Guidelines for Assessing

the Health Risks of Carcinogens 34

Tables

Table 1: 1,3-Butadiene Health Risk Assessment Panelists, Primary

Employment, and Titles 28

Table 2: Proposed Cancer Risk Guidelines Panels 35

Table 3: Revised Cancer Risk Guidelines Panelists, Primary

Employment, and Titles (First Panel) 37

Table 4: Revised Cancer Risk Guidelines Panelists, Primary

Employment, and Titles (Second Panel) 40

Table 5: Revised Cancer Risk Guidelines Pertaining to Children

Panelists, Primary Employment, and Titles (Third Panel) 45

Figure

Figure 1: Criteria for Determining if an SGE Has a Financial

Conflict of Interest 24

Abbreviations

EPA Environmental Protection Agency

OGE Office of Government Ethics

SGE special government employee

Contents
Page 1 GAO-01-536 EPA's Science Advisory Board Panels

June 12, 2001

The Honorable Henry A. Waxman

Ranking Minority Member

Committee on Government Reform

House of Representatives

Dear Mr.Waxman:

Since its inception in 1978, the Environmental Protection Agency’s (EPA)

Science Advisory Board has reviewed key scientific studies and

methodologies used by the agency in formulating rules to protect the

environment and public health. The Board comprises more than 100

nongovernment experts and provides technical advice directly to the EPA

Administrator primarily on the basis of its peer reviews—that is, critical

evaluations by panels of independent experts. Through such peer reviews,

EPA and the Board seek to enhance the quality and credibility of the

agency’s highly specialized products. To be effective, peer review panels

must be—and also be perceived to be—free of any significant conflict of

interest and uncompromised by bias. Peer review panels should also be

properly balanced, allowing for a spectrum of views and appropriate

expertise.

You expressed concern about potential conflicts of interest on panels

convened by the Board to assess health risk assessment issues. As agreed

with your office, we determined whether the policies and procedures of

the Board are adequate to ensure that (1) its peer review panelists are

independent and the panels are properly balanced and (2) the public is

sufficiently informed about the points of view represented on the panels.

These policies and procedures are the responsibility of EPA’s Science

Advisory Board Staff Office, which reports to the Administrator and

provides logistical and administrative support to the Science Advisory

Board under the leadership of a staff director.

Federal requirements relevant to independence and balance include

(1) the criminal financial conflict-of-interest statute (18 U.S.C. 208) and

related U.S. Office of Government Ethics (OGE) regulations that prohibit

federal employees from participating in a “particular matter” in which they

United States General Accounting Office

Washington, DC 20548
Page 2 GAO-01-536 EPA's Science Advisory Board Panels

have a financial interest1 and (2) the Federal Advisory Committee Act,

which requires, among other things, balancing viewpoints represented on

government committees and providing information about committee

activities to the public.2

 The financial conflict-of-interest statute is

applicable to the Board’s panelists because they are hired as special

government employees.

To determine how the Board addresses these requirements, we reviewed

the written policies and procedures developed by the staff office and also

examined their application to four peer review panels you asked us to

examine—three on EPA’s draft revised guidelines for assessing cancer

health risks and one on a health risk assessment of the chemical

1,3-Butadiene. According to the director of the staff office, these panels

are generally representative of Board peer review panels both in subject

matter—they address a significant risk assessment methodology and a

health risk assessment—and in the processes used in establishing and

conducting them. We reviewed the confidential financial disclosure forms

of the panelists, along with other information, and discussed with staff

office officials the office’s policies and procedures generally as well as

how they were applied to the four panels. We did not, however, make

independent judgments on whether conflicts of interest existed for

members of the four panels or assess whether these panels were properly

balanced.

The policies and procedures developed by the staff office to ensure the

independence of the Board’s peer reviewers and the balancing of

viewpoints represented on each panel have limitations that reduce their

effectiveness. Specifically, prior to our review, the staff office did not

determine whether the subjects to be reviewed were “particular matters”

as defined by the financial conflict-of-interest statute—the necessary first

step for determining whether proposed panelists could have conflicts of

interest under the statute. Moreover, the staff office has not routinely

ensured that panelists’ financial disclosures are complete and that it has

obtained sufficient information to evaluate potential conflicts of interest.

 1

A “particular matter” is one that involves deliberation, decision, or action that is focused

on the interests of specific people or a discrete and identifiable class of people (5 CFR

2640.103(a)(1)).

2

The Federal Advisory Committee Act governs the creation and operation of advisory

committees in the executive branch of the federal government.

Results in Brief
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These shortcomings exist, in part, because of the staff office’s uncertainty

regarding what constitutes a “particular matter.” In addition, the staff

office has not systematically requested certain information that is

pertinent to assessing the independence and overall balance of viewpoints

represented on the panel—such as previous public positions the panelists

have taken on the matter being reviewed—until the first meeting, when the

panelists have already been selected. These and other shortcomings could

reduce the effectiveness of the Board overall if they contribute to its being

perceived as biased and could inadvertently expose some panelists to

violations of federal conflict-of-interest laws. We are making

recommendations to the EPA Administrator to better address potential

conflicts of interest and support the development of balanced panels.

The staff office’s policies and procedures for providing the public with

information on the background of the Board’s peer review panelists do not

adequately inform the public about the points of view represented on the

panels. While the staff office does provide the public with information

about the panelists’ primary employment, this information alone is often

insufficient to understand the perspectives and potential biases of the

panelists because they may have other significant affiliations. For this

reason, the staff office developed a voluntary disclosure session,

conducted at the panel’s first public meeting, during which panelists

discuss their background associated with the issue at hand to better

inform the public about their viewpoints. However, because the

disclosures are not systematically recorded in the minutes of the meetings,

in many cases only the members of the public who are able to attend the

public meetings have access to the disclosures. In addition, our review of

the minutes of the four panels showed that some of the disclosures raised

more questions or were too vague to be of use—such as a panelist’s

disclosure that he had made public pronouncements, without clarifying

their relationship to the matter at hand. We are making recommendations

to the EPA Administrator designed to ensure that the public is adequately

informed of panelists’ points of view.

The Science Advisory Board, which comprises more than 100

nongovernment technical experts, was established in 1978 by the Congress

to provide independent scientific and engineering advice to the EPA

Administrator on the technical bases for EPA regulations. The Board’s

work is coordinated and administered by 19 EPA employees assigned to

the Science Advisory Board Staff Office, which is under the leadership of a

staff director. The Board and its staff office both report directly to the

Administrator. The Board often convenes peer review panels to assess the

Background
Page 4 GAO-01-536 EPA's Science Advisory Board Panels

scientific and technical rationales underlying current or proposed EPA

regulations and policies. The Board convenes these panels in public

meetings, and the panels’ recommendations are provided to the

Administrator in published reports. In fiscal year 2000, the Board

conducted 54 public meetings and issued 37 reports on a wide range of

scientific issues.

Board members, who are appointed by the Administrator, have expertise

in various technical disciplines and retain their primary employment in

academia, industry, state government, and environmental organizations

while serving on the Board. The appointments are for 2 years, generally

renewable for not more than two additional terms. The Board members

serve on 1 or 2 of the Board’s 10 permanent committees, such as the

Drinking Water Committee and the Health Effects Committee. As

members of these committees, Board members may be assigned to a

number of peer review panels depending upon, among other things, their

availability. The Board also has some 300 consultants, including scientists,

social scientists, engineers, and economists, appointed by the staff

director to provide the additional expertise needed for specific peer

review panels. In this report, we refer to the members and consultants

who serve on the peer review panels as panelists.

In general, a topic for Board peer review is assigned to one of the

permanent committees by the Board’s executive committee. The chair of

the permanent committee and a staff office employee have primary

responsibility for forming a review panel for the topic.3

 The panel may

include some or all members of the committee and often some

consultants. Often the staff member solicits suggestions for panel

members from other EPA staff and sources outside EPA, such as industry

groups, environmental organizations, and other experts. The staff director

makes the final decision on appointment of panelists in consultation with

the staff member and the committee chair.

The policies and procedures governing conflicts of interest, balanced

viewpoints on panels, and public disclosures are included in a staff office

document, “Guidelines for Service on the Science Advisory Board.” This

six-page document covers the selection process and criteria for members

and consultants, time limits on service, the panel selection process, and

 3

The staff member with day-to-day responsibility for the panel, including logistical support

and panel formation, is called the designated federal officer.
Page 5 GAO-01-536 EPA's Science Advisory Board Panels

guidance on conflicts of interest and the public disclosure session at

Board meetings. In addition, a November 1999 handbook prepared by the

staff office for panelists includes information on how the staff evaluate

conflicts of interest and provides copies of EPA ethics advisories that

address conflicts of interest and other ethics requirements for federal

employees.

As a federal advisory committee, the Board must comply with the Federal

Advisory Committee Act and related regulations. The act was passed, in

part, out of concern that certain special interests had too much influence

over federal agency decisionmakers. Among other things, this law requires

that committees, such as the Board’s peer review panels, “be fairly

balanced in terms of the points of view represented and the functions to

be performed.” The advice of such committees should reflect their

independent judgment, without improper influences from special interests.

The balance requirement thus recognizes that it may be necessary or

desirable to include experts on the panel who represent a particular

viewpoint in order to conduct an effective and thorough review of an

issue, but that as a whole the panel is to be balanced. As required by the

act, the Board has an approved charter, announces its meetings in the

Federal Register, and provides opportunities for public comment on issues

before the Board.

The criminal financial conflict-of-interest statute is applicable to Board

panelists because they are hired as “special government employees” in

light of their intermittent service to the Board.4

 With some important

modifications, special government employees are subject to the ethics

requirements applicable to federal employees, including the conflict-ofinterest requirements. The financial conflict-of-interest statute prohibits

federal employees from acting personally and substantially in any

“particular matter” that has a direct and predictable effect on their

financial interests; those of their spouse or children; or those of

organizations with which they have certain associations, including

employers (see app. I). However, under an exemption in the regulations,

special government employees who serve on a federal advisory committee

(such as the Board) are allowed to participate in particular matters that

have a direct and predictable effect on their employer’s financial interests

 4

Special government employees may be appointed to perform services, temporarily or

intermittently, for not more than 130 days during a 1-year period. Board members and

consultants generally are employed by the Board for 60 days or less annually.
Page 6 GAO-01-536 EPA's Science Advisory Board Panels

if the employer is affected as part of a discrete and identifiable class—that

is, is not singularly affected. This exemption is limited, however, and does

not include the financial and other interests of the panelists in the

particular matter, such as stock ownership in the employer. If a financial

interest is not covered under this or other exemptions, waivers of the

conflict-of-interest provisions are allowed upon a determination by the

appointing official that the need for the special government employee’s

services outweighs the potential for a conflict of interest.

The staff office recognizes that the Board’s peer review activities can be

harmed not only by financial conflicts of interest but also by the

appearance of bias. That is, some panelists may be unable or potentially

unable to render impartial assistance or advice because of activities,

interests, or relationships with other people, such as a spouse. For

example, a peer review panelist may be so closely aligned with a point of

view or an organization that his or her ability to provide objective and

independent advice is impaired or appears to be impaired. The staff

office’s written policies and procedures use varying terms when discussing

circumstances in which a person’s impartiality may be called into

question, such as “apparent conflict of interest” and “perceived conflict of

interest.”

The staff office’s policies and procedures are intended to ensure that the

Board’s panelists are independent and that panels as a whole are balanced

in their viewpoints and expertise. However, because of shortcomings in

the policies and procedures, the Board does not have adequate assurance

that this is actually the case. Specifically, the staff office’s policies and

procedures do not provide for

• determining at the time a panel is being developed and convened what

financial conflict-of-interest requirements, if any, the panel is subject to;

• routinely ensuring that potential panelists’ financial disclosure forms

contain sufficient information to evaluate potential conflicts of interest;

• systematically requesting other information pertinent to assessing

independence and overall balance of the panel, such as previous public

positions that panelists have taken on the matter being reviewed, before

the panel members are appointed; and

• adequately training prospective panel members on the financial conflictof-interest requirements and other issues that could raise questions about

their impartiality.

Procedures Do Not

Adequately Ensure

Independence and

Balance
Page 7 GAO-01-536 EPA's Science Advisory Board Panels

Further, while one of the goals of the staff office is to ensure that Board

panels are properly balanced, it has no systematic way of doing so. These

limitations are discussed in the following sections.

Individual Board peer review panels are subject to different requirements

under the financial conflict-of-interest provisions depending upon the

subject matter being reviewed. If the panel is reviewing a matter that is

“broadly applicable,” the panel is not subject to the statutory financial

conflict-of-interest requirements. For the requirements to apply, the panel

must be reviewing a “particular matter”—one involving a deliberation,

decision, or action that is focused on the interest of specific people or an

identifiable class of people. There are two types of particular matters:

(1) particular matters of general applicability, such as those involving

general regulations, policies, or standards that distinctly affect a particular

industry or other class of people or entities and (2) particular matters

involving specific parties, such as those involving contracts and grants that

affect specific individuals or entities. The specific requirements for

panelists vary depending on which type of particular matter the panel is to

review. However, in many cases the line between a broadly applicable

matter and a particular matter of general applicability is not clear. As

shown in appendix I, the conflict-of-interest provisions are complex and

subject to interpretation.

In the past, the staff office concluded that almost all of the Board’s reviews

were broadly applicable and did not involve particular matters. The staff

office believed, therefore, that the panelists serving on the review panels

generally were not subject to the financial conflict-of-interest

requirements.5

 This view is reflected in the staff office’s “Guidelines for

Service on the Science Advisory Board,” which states that the Board

generally does not get involved in “particular party matters,” and thus legal

conflicts of interest are rare.6

While this view appears to be reasonable for panels that review matters of

such broad applicability as risk assessment methodologies, the Board may

 5

The staff director told us that, as a result of our review, the office has started to identify at

the outset those panels involving particular matters that are subject to the financial

conflict-of-interest requirements.

6

The guidelines point out that technical conflicts of interest could occur, particularly for

participants from academic institutions, in connection with committee recommendations

for additional research studies, and that these are addressed with waivers.

Relevant Conflict-ofInterest Requirements

Have Not Been Identified
Page 8 GAO-01-536 EPA's Science Advisory Board Panels

review more particular matters and be subject to the conflict-of-interest

requirements in more cases than it has considered. As a result of our

review, the staff director has reexamined the conflict-of-interest

provisions and now believes that more of the Board’s reviews—including

the review of EPA’s risk assessment of 1,3-Butadiene—are likely subject to

the conflict-of-interest requirements than previously thought.

Because the staff office did not believe the 1,3-Butadiene risk assessment

review was a particular matter at the time it developed and convened the

panel, it did not identify potential conflicts of interest that should have

been examined. For example, the staff office did not identify the

manufacturers and distributors of this chemical or carefully review the

information provided by the panelists to ensure that potential conflicts of

interest were identified and mitigated, as appropriate. Although two

panelists owned stock in companies that manufacture 1,3-Butadiene,

distribute it, or both, the staff office did not obtain information from these

panelists about their investments to determine whether they would need a

waiver in order to participate on the panel.7

 (See app. II for more

information on the 1,3-Butadiene panel.)

In our view, the uncertainty about which legal requirements a panel may

be subject to suggests it would be better to err on the side of caution to

protect the Board and its members from embarrassment or potential legal

problems. Further, even when the staff office determines that a panel is to

review a matter that is not subject to the financial conflict-of-interest

requirements, determining whether any of the panelists have interests or

relationships that could raise questions about their impartiality would help

the staff office assess the interests and also help ensure that the panel is

balanced as a whole. To do this, the staff office would have to start

identifying the industries and companies that have an interest in the

matters being examined.

To identify potential financial conflicts of interest, the staff office relies

primarily on a confidential financial disclosure form that panelists must

complete before serving on a panel. Prepared by OGE for executive

branch employees, the confidential disclosure form, OGE form 450,

 7

Stock ownership in an affected company is prohibited above certain dollar thresholds. If

the threshold is exceeded, a panelist may still participate in the panel, but a waiver given by

the appointing official concluding that the need for the panelist’s services outweighs the

potential conflict of interest is required. Such waivers are to be disclosed to the public.

Use of Financial

Disclosure Forms Is

Problematic
Page 9 GAO-01-536 EPA's Science Advisory Board Panels

requires information on assets and income, liabilities, and outside

positions during the prior year and on existing employment agreements or

arrangements, such as promises of future employment and leaves of

absence.8

 The form requests information on the sources of income and the

identification of assets but does not ask for the related dollar amounts. We

found that the staff office’s policies and procedures do not provide for

(1) routinely ensuring that forms are complete or following up on

information disclosed and (2) reviewing the forms promptly to make them

most useful for particular panels.

For the four panels we reviewed, some panelists did not identify all

income sources or provide complete information on the confidential

financial disclosure form—identifying a source of income, for example,

only as fees from “various clients” or excluding a primary employer

entirely. According to a deputy ethics officer in EPA’s Office of General

Counsel who reviews these forms for EPA employees, respondents often

make errors in completing the confidential financial disclosure form. For

example, he said that he often must speak with individuals who have

completed these forms because they are not completed properly.

Similarly, OGE guidance on reviewing the disclosure forms directs

appropriate follow-up with individuals who prepare the forms and

documentation of the responses on the forms. However, the staff office

has not taken steps to routinely ensure that all of the required disclosure

information is provided.9

In reviewing the disclosure forms provided by members of the four panels

included in our study, we found that the information—while correctly

provided—could raise questions or issues that may be relevant in

determining potential conflicts of interest or in assessing impartiality and

balance among panelists. For example, some panelists reported fees from

what appear to be law firms as well as from companies, including

chemical companies. In some of these cases, the reported legal and

consulting work was extensive. While the staff director told us, for

example, that it is relevant for the staff office to know whether a panelist

 8

Income includes salaries, fees, and honoraria of the individual and his or her spouse and

dependent children. Assets producing more than $200 in income during the prior year are

also to be reported, such as rent, interest, dividends, and capital gains.

9

The staff director told us that as a result of this review, staff have started to record on the

disclosure forms additional information obtained from the panelists. However, this practice

has not been adopted in formal policies and procedures.

Follow-up on Financial

Information Is Inadequate
Page 10 GAO-01-536 EPA's Science Advisory Board Panels

has provided expert legal testimony—and on behalf of whom—the staff

office has neither taken steps to clarify information reported on disclosure

forms that suggests such activity nor asked for information on the type of

work performed for an affected industry. We believe the staff office would

be better able to assess panelists’ impartiality and ensure that panels are

properly balanced if it had an understanding of the work performed by the

panelists for law firms and industry, particularly for chemical companies.

Staff office officials, including the staff director, told us that from time to

time they have asked some panelists for additional information, but they

acknowledged that this has occurred infrequently and that they have not

required this information to be noted in the panelists’ records.

A case in point involves a panelist participating in a review of EPA’s draft

revised guidelines for assessing the health risks of carcinogens who had

identified a substantial number of consulting fees from companies and law

firms, including a tobacco company and a research organization funded by

the tobacco industry. (See app. III for more information on the three

panels on guidelines for assessing the health risks of carcinogens.) While

staff office officials said they were aware of the panelist’s relationships

with the tobacco industry, they acknowledged that they did not obtain

information about the numerous consulting fees reported. In balancing the

panel, the staff office judged this individual to be in the “broad middle”

—as opposed to reflecting either an environmental or industry

perspective—on the basis of both the panelist’s academic credentials and

the staff’s observations at previous panel meetings. While the staff office’s

assessment of this panelist may be accurate, it would be more credible if it

were based on more complete information about the panelist’s extensive

industry and legal consulting work. Furthermore, when this panelist first

joined the Board, the staff office’s evaluation had to be performed without

the benefit of personal observations.

After reviewing the disclosure forms, the staff office does not notify the

panelists whether specific items they reported on their financial disclosure

forms could potentially present a conflict of interest in some cases. In

contrast, EPA’s Office of General Counsel sends what it terms a

“cautionary letter” to employees identifying any item or items reported on

the confidential financial disclosure form that could present a conflict of

interest in the event the employee was called upon to participate in a

“particular matter.” The deputy ethics official in EPA’s Office of General

Counsel told us that one benefit of the cautionary letter is that it reminds

employees of their responsibility to consider and identify potential

conflicts of interest that may arise in the course of their work.
Page 11 GAO-01-536 EPA's Science Advisory Board Panels

Compounding the reliance on the financial disclosure form to identify

potential conflicts of interest, the staff office does not necessarily review

the financial disclosure forms in the context of forming a specific peer

review panel. This situation occurs primarily with Board members, who

are required to complete the disclosure forms at the start of each fiscal

year. When Board members send in their forms, the specific panels the

individual members will serve on throughout the year are not yet

determined. In contrast, consultants assigned to a specific peer review

panel generally are required to complete the disclosure forms when they

are selected for that panel.10 While a staff office official said that the

disclosure forms of Board members may be reexamined when the member

is assigned to a specific panel, this step is not taken systematically, and the

staff office’s policies and procedures do not require that the forms be

reviewed within the context of each peer review panel.

In addition, some Board members do not return their forms at the

beginning of the fiscal year as requested but instead submit them shortly

before or at the first meeting of a panel. Moreover, the staff office may

review some consultants’ forms too late to affect the composition of a

panel. For example, on the basis of the 47 financial disclosure forms we

reviewed for the four panels, we found seven instances in which panelists

submitted their forms either within 2 days of the first panel meeting or

after the meeting; eleven cases in which the staff office reviewed the forms

after the first panel meeting; and three cases in which the staff office never

reviewed the forms.11 This last case involved panelists who had also served

on another EPA advisory committee. In such cases, the staff office relies

on the previous advisory committee’s conflict-of-interest review rather

than reviewing the individual’s disclosure forms. Moreover, we found that

one of the three financial disclosure forms was not reviewed by either the

other EPA advisory committee or the staff office. As a result of these

various review shortcomings, the staff office could allow individuals who

have conflicts of interest to serve as panelists, without taking appropriate

steps to mitigate the conflicts or granting a waiver.

 10OGE regulation 5 CFR 2634.903 (b)(3) states that special government employees who

have been appointed to serve on an advisory committee shall file financial disclosure forms

before any advice is rendered, or in no event later than the first meeting.

11Because the staff office could not locate forms for 8 of the 55 total panelists on the four

panels, we could not determine whether the staff office had ever received or reviewed

them. Of the 11 forms reviewed after the first meeting, 3 had been submitted late by the

panelists, and we could not determine when 1 of the (undated) forms was submitted.

Reviews Can Be Untimely
Page 12 GAO-01-536 EPA's Science Advisory Board Panels

Beyond the financial disclosure form, the staff office does not

systematically request certain information that is pertinent to assessing

both the impartiality of the panelists and the overall balance of viewpoints

represented on the panels until a selected panel is conducting its first

meeting.

The primary source of background information that the staff office has

used—the confidential financial disclosure form—is limited in focus.

While the information it elicits covering the prior year is pertinent to

assessing financial conflicts of interest, it does not identify other

information relevant to assessing impartiality and balancing peer review

panels. That is, the confidential financial disclosure form does not request

information on the panelists’ backgrounds in the subject matter the panel

will review, such as research conducted and previous public statements or

positions on the matter being reviewed, or on the interests of the panelists’

employers or clients in the matter.12

This information is not systematically requested until the panelists have

been selected and are participating in the first meeting of the peer review

panel—the public disclosure session. At that time, the panelists are asked,

but not required, to disclose to the public and the other panelists

additional information regarding their backgrounds, including research

conducted and previous public statements or positions on the matter

being reviewed, participation in legal proceedings on the matter, interests

of their employers or clients in the matter, and prior or current research

grants that could be affected by the matter. Panelists are also asked to

provide a general description of any other financial interest in the matter,

such as having investments that might be directly affected by the matter.

However, the staff’s guidance on public disclosure states that panelists are

not obligated to reveal information contained in their confidential

disclosure form that would otherwise remain confidential.

The staff director told us that generally the staff is already aware of the

information that the panelists report at the first meeting of the panel as a

result of ongoing communications between the staff and the panelists, and

in some cases, information from the organization that recommended the

panelists to the staff office. Moreover, according to the handbook the staff

 12Unless panelists received grant funds directly in the prior year, research grants will not

generally be identified on the financial disclosure forms. Many research grants are entered

into with institutions, such as universities; thus, the grant funds are not paid directly to the

researchers but rather to the institutions, which then pay researchers’ salaries.

Additional Relevant

Information Is Not

Systematically Obtained

Before Appointing

Panelists
Page 13 GAO-01-536 EPA's Science Advisory Board Panels

office developed for Board panelists, the confidential financial disclosure

forms; annual conflict-of-interest training; “regular” briefings on conflictof-interest issues; and “regular, informed” contact with the panelists

“normally identify actual, as well as perceived, conflict-of-interest issues”

before the panel is convened in a public meeting.13 Nevertheless, the staff

office director acknowledged that the staff office policies and procedures

do not include a requirement that the staff discuss with the panelists, in

advance, the specific information the panelists are asked to provide at the

first meeting of the panel. Further, the handbook for panelists does not

include such discussions among the duties the staff perform to support the

peer review panels. While the staff director said the office’s goal was to

avoid any surprises when disclosures are made at the first meeting, he

acknowledged that the staff do not always know what the panelists will

say.

The public disclosure session can elicit informative, detailed statements

about panelists’ backgrounds not previously brought out in financial

disclosure forms, resumes, or information from the organizations that

nominated the panelists. Examples of disclosures made at Board meetings

by panelists of the type of information that is not requested on the

confidential disclosure form follow:

• A panelist on the 1,3-Butadiene peer review panel reported having worked

on a legal case involving 1,3-Butadiene for a manufacturer of this chemical

and also having a leadership role on a major industry-funded study on

1,3-Butadiene.

• Several other 1,3-Butadiene panelists identified completed or ongoing

research studies on the chemical that they had conducted,14 some of which

were sponsored by organizations that receive funding from chemical

companies such as the Chemical Manufacturers Association.15

• A panelist on the revised cancer risk guidelines panel reported a prior

long-term affiliation with a chemical industry organization that had

commented to EPA on its revised guidelines.

 13Later in this report, we identify shortcomings in the training materials the panelists

receive. We also report that the briefings on conflict of interest have not been occurring on

a regular basis.

14The panelists did not consistently disclose the sponsors of the butadiene research they

identified.

15The new organization name for the Chemical Manufacturers Association is the American

Chemistry Council.
Page 14 GAO-01-536 EPA's Science Advisory Board Panels

In our view, while the above disclosures may not represent activities or

affiliations that would necessarily preclude any of these individuals from

participating on the peer review panel, they do represent information that

should be evaluated by the staff office before finalizing its selection of

panelists. Because the Board’s policies and procedures do not require the

staff office to obtain and document such background information earlier,

it is not possible to determine the extent to which the staff were aware of

or considered the above information before the first panel meeting. The

staff files for the panels we reviewed did not contain any information

about these relationships and activities. In contrast, the policies and

procedures of the National Academies16 provide that peer review panel

selections will not be finalized until officials have reviewed and evaluated

written information on potential sources of bias and conflicts of interest.

The Academies send potential panelists a form requesting relevant

information about organizational affiliations, financial interests, research

support, government service, and public statements and positions.

According to EPA’s “Science Policy Council Handbook on Peer Review,”

the issue of conflicts of interest should be addressed with prospective

panelists before finalizing the panel membership. However, the staff

office’s policies and procedures do not require that potential conflicts of

interest be discussed directly with each panelist. As a result, peer review

panelists generally are not asked directly whether there is anything in their

backgrounds that could present a conflict of interest. This omission is

especially significant in light of the limitations of the disclosure forms the

staff office relies on to identify conflicts of interest and assess impartiality.

It is also important in that panelists may choose the extent to which they

participate in the voluntary disclosure process conducted at the first panel

meeting.

In contrast, not only does EPA recommend that conflicts of interest be

explored directly with each potential panelist before a peer review panel is

convened, it also emphasizes the importance of discussing the issue with

the panelists by recommending that a “peer review conflict-of-interest

inquiry form” be sent to peer reviewers. This form identifies the types of

affiliations and activities (both financial and nonfinancial) that could

 16The National Academies consist of four private, nonprofit organizations that advise the

federal government on scientific and technical matters: the National Academy of Sciences,

the National Academy of Engineering, the Institute of Medicine, and the National Research

Council.
Page 15 GAO-01-536 EPA's Science Advisory Board Panels

potentially lead to conflicts of interest and solicits a pledge from the peer

reviewers that if any of these pertain to them, they will discuss these

issues with relevant officials by a specific date. Similarly, before

appointments are finalized, the National Academies require their panelists

to provide certain information about their backgrounds in relation to their

panels, such as relevant articles, testimony, and speeches; sources of

research support; and organizational affiliations. In addition, the peer

reviewers must respond to the following:

“If there are other circumstances in your background or present connections that in your

opinion might reasonably be construed as unduly affecting your judgment in matters within

the assigned task of the group to which you have been appointed or which might be

reasonably viewed as creating an actual or potential bias or conflict of interest or the

appearance of a bias or conflict of interest, please describe them briefly.”

The staff office’s annual training program for Board panelists that covers

conflicts of interest consists primarily of a 1-hour study of ethics materials

that the panelists complete independently.17 However, the lengthy

materials sent to the panelists do not explain clearly how the effectiveness

of the Board can be diminished if they are found to have conflicts of

interest or other issues that raise questions about their impartiality that

have not been identified and appropriately mitigated. Neither do the

training materials clearly identify the financial conflict-of-interest

requirements that the panelists are subject to, depending upon the review

panel. As a result, the panelists may not provide the staff office with all of

the information it needs to correctly identify potential conflicts of interest,

assess impartiality, and properly balance the panel.

The training materials cover a broad range of complex ethics issues that

apply to regular government employees as well as to special government

employees. However, most of the information is targeted to regular

government employees. In a number of cases, the requirements are

different for special government employees. Panelists are left to interpret

complex legal information on their own and take the initiative to call the

staff office with any questions. We note that the fiscal year 2001 training

materials did not include a February 2000 document prepared by OGE

 17EPA’s Office of General Counsel has determined that Board panelists can meet OGE

special government employees’ ethics training requirements using this approach because of

time constraints and the agency’s budget considerations.

Conflict-of-Interest

Training Is Inadequate
Page 16 GAO-01-536 EPA's Science Advisory Board Panels

entitled, “Summary of Ethical Requirements Applicable to Special

Government Employees,” which could be helpful to the panelists. While

the staff office would still need to summarize the key points of this legal

document, it is superior to the information currently provided to the

panelists because it focuses exclusively on special government employees.

In contrast to the materials the staff office provides to its panelists, the

National Academies provide their panelists with a succinct,

straightforward paper on potential conflicts of interest and bias. Similarly,

Board panelists would be better informed and potentially have an

increased incentive to provide timely information to the staff office if they

received clear, targeted information on the conflict-of-interest

requirements to which they are subject. In addition, the independent study

of ethics that the staff office requires of its panelists would be enhanced

by periodic briefings on conflict-of-interest issues. While the policies and

procedures of the staff office state that it is to deliver briefings on conflictof-interest issues to the panelists on a regular basis, we found that it had

conducted such briefings for only 2 of its 10 committees between October

1998 and March 2001.

Although the staff office aims to ensure that the Board’s panels are

properly balanced, it has no systematic way of doing so. The staff office’s

goal is to generally select panelists representing the “broad middle”

spectrum of opinion on the technical issue under discussion. When

developing a panel, the staff director and a designated staff member

review a list of potential panelists to select a panel with the proper balance

of viewpoints and expertise. The selection process is not structured in

some cases. However, in some cases, the staff office does use a structured

process, ranking the candidates along a numeric scale of 1 to 10, according

to whether their perspectives generally reflect the broad middle spectrum

of opinion on the technical issue or are more aligned with industry

interests or environmental interests.18 The staff director acknowledges that

this judgment is a subjective one, but it may be more subjective than it

needs to be. That is, this decision may be made before the staff office

reviews the prospective panelist’s financial disclosure forms or discusses

 18According to staff office officials, this process has been used for sensitive or controversial

peer reviews. The individual scores of the panelists are summed and then divided by the

number of panelists. The goal is for the result to be in the middle category (between four

and six) to reflect a balanced panel. The staff office has not retained documentation of this

process in the cases for which it has been used.

No Systematic Process

Exists for Balancing

Panels
Page 17 GAO-01-536 EPA's Science Advisory Board Panels

with him or her the background information that would provide an

indication of the panelist’s perspective.

The staff director told us that, in retrospect, there are a few cases among

the four panels we reviewed in which he might have judged the viewpoints

of the panelists differently if the staff office had known certain

information about them earlier. However, the staff office does not have

established procedures for ensuring that (1) relevant information about

the panelists’ backgrounds is known before panels are finalized and

(2) evaluation of the overall balance of panelists takes place once the staff

office has determined who is available to serve on a specific panel. In

contrast to the Board, the policies and procedures of the National

Academies not only require obtaining relevant background information on

panelists before making panel selections, they also require posting

information on its Web page about its proposed panels and soliciting

comments on potential appointments to committees or panels. According

to an official of the National Academies, this process has proved beneficial

to them in selecting balanced peer review panels. Similarly, the staff office

could request input from the public about potential panelists and overall

balance once it has developed a proposed panel.

The staff office’s policies and procedures for providing the public with

information on the backgrounds of its peer review panelists are not

sufficient to ensure that the public is adequately informed about the points

of view represented on the panels. Specifically, the staff office (1) relies on

panelists’ voluntary disclosures of some information that could help

inform the public and (2) does not consistently record and make available

to the public at large the information that panelists voluntarily disclose.

To provide the public with information about its peer review panelists, the

staff office distributes rosters identifying the names of the panelists; their

primary employment; and, in some cases, panelists’ titles and requests that

panelists discuss their background associated with the issue at hand at the

first public meeting. This disclosure process—which is voluntary—is

intended to allow the public and other panelists to consider the

perspectives or potential bias, if any, that the panelists bring to the issue.

This approach is consistent with the Federal Advisory Committee Act,

which recognizes the benefits of openness in safeguarding the public

interest. The staff office requests that the panelists discuss relevant

research they have conducted; previous public statements or positions

they have taken; the interests of their employers; their own financial

interests in the matter; and research grants from parties—including

Limited Information

Is Available to the

Public on the Board’s

Panelists
Page 18 GAO-01-536 EPA's Science Advisory Board Panels

EPA—that would be affected by the matter. However, this voluntary

process does not consistently provide the public with sufficient

information to understand the points of view represented on the panel.

Specifically, while the Board does provide minutes of its meetings as

required by the Federal Advisory Committee Act, in many cases,

disclosures made by the panelists at the meeting are not recorded in the

minutes. For example, the minutes of one of the panels on EPA’s revised

cancer risk guidelines panel reflect that the recorder left the room during

the public disclosures; thus, the comments, if any, of five of the panelists

are not available. In another case that is more typical of meeting minutes

prepared by the staff office, the minutes state only that no conflicts of

interest were identified during the disclosures and do not provide any

information on the disclosures that were made. As a result, members of

the public not present at the meeting have limited opportunities to obtain

information the panelists provided during the public disclosure session.

In addition, our review of the minutes of the meetings of the four peer

review panels we examined indicated that panelists may not provide

information during the voluntary public discussion. For example, the

meeting minutes for the 1,3-Butadiene panel include public disclosure

comments for only 10 of the 15 panelists reported as being in attendance.

Also, some panelists gave disclosures that were too vague for the public to

get an accurate picture of the panelists’ points of view related to the issue

under review. For example, a panelist may report publishing articles

relating to the subject of the panel but not elaborate on any viewpoints or

positions taken in the articles, report conducting research on the matter

but not identify the sources of funding for the research, or disclose public

pronouncements without clarifying their relationship to the matter at

hand. According to an EPA Office of General Counsel deputy ethics

official, panelists make general or vague statements because they are often

unsure of what to say. As a result of panelists’ uncertainty, their comments

may either leave the public wondering about the panelists’ impartiality or

be interpreted incorrectly as indicating bias.

This same Office of General Counsel deputy ethics official has expressed

concerns about the public disclosure process. The official believes that the

disclosures may confuse the public more than enlighten it and has

discussed these concerns with staff office officials. The staff director

acknowledged that the current approach has flaws and said that changes

are being considered. Specifically, the staff office has considered having a

staff official introduce the panelists at the first meeting and provide
Page 19 GAO-01-536 EPA's Science Advisory Board Panels

background about each individual to the public. As of March 2001, the

Board had not decided what changes, if any, it will make to this process.

EPA’s Science Advisory Board panels are an important element in

ensuring that sound scientific and technical information is available to the

agency’s decisionmakers. The regulatory process benefits from the

scientific and technical knowledge, expertise, and competencies of panel

members. However, the work of fully competent peer review panels can

be undermined by allegations of conflict of interest and bias. Therefore,

the best interests of the Board are served by effective policies and

procedures regarding potential conflicts of interest, impartiality, and panel

balance.

The policies and procedures used by the staff office to date have

limitations. Specifically, because the conflict-of-interest requirements to

which the panels may be subject are not identified at the outset, potential

conflicts of interest are not identified and mitigated in a timely manner in

some cases. In addition, because relevant background information is not

consistently available at the time of the selection process, it is difficult for

the staff office to have assurance that it has an accurate sense of the

viewpoints of the candidates and that the panel is balanced in terms of

viewpoints and expertise. Similarly, Board panelists would be better

informed and potentially have an increased incentive to provide timely

information to the staff office if they received clear, targeted information

on the conflict-of-interest requirements to which they are subject.

Moreover, the staff office’s varying approaches to balancing panelists in

terms of expertise and viewpoints hamper its ability to consistently ensure

the appropriate balance is obtained on its panels. Guidelines that specify

the type of information needed about a prospective panelist and about the

entire panel before final decisions are made would help the staff office

ensure appropriate panel balance is achieved. The staff office could also

expand its outreach to help it ensure that its panels are balanced.

Implementation shortcomings, such as not recording the background

information panelists discuss during the voluntary disclosure process,

hinder the effectiveness of the staff office’s policies and procedures aimed

at providing the public with information about the viewpoints and

expertise represented on the Board’s peer review panels. As a result, the

public is not provided with consistent, relevant background information

about the panelists that would enable interested parties to evaluate the

viewpoints and expertise of the panelists.

Conclusions
Page 20 GAO-01-536 EPA's Science Advisory Board Panels

To better ensure that peer review panels are independent and reflect an

appropriate balance of viewpoints and expertise, we recommend that the

EPA Administrator direct the Science Advisory Board to develop policies

and procedures that better identify and mitigate potential conflicts of

interest and support the development of balanced panels. Such changes

should include the following:

• Determine whether each panel will be reviewing a “particular matter”

before selecting the panel in order to identify the financial conflict-ofinterest requirements, if any, to which the panelists will be subject.

• Obtain and evaluate relevant background information on peer review

panel candidates before appointing panel members. The evaluation should

include explicitly discussing with potential panelists (1) items not

adequately reported on the confidential financial disclosure form as well

as items reported that could present conflicts of interest; (2) other

information relevant to assessing impartiality, such as research conducted

and previous public statements or positions on the matter being reviewed,

interest of the employer or clients in the matter, participation in legal

proceedings, work for chemical companies or other affected industries,

and prior or current research grants that could be affected by the matter;

and (3) whether they have any potential conflicts of interest related to the

specific panel being established. Further, pertinent information obtained

from discussions with panelists should be documented.

• Develop training that clearly identifies for the panelists the conflict-ofinterest requirements that apply to them, addresses impartiality, and

identifies the background information the staff office needs from the

panelists to assess (1) the appropriateness of their participation on

specific panels and (2) the balance of viewpoints and expertise on the

panels themselves.

• Develop criteria for and guidance on the process to be used to achieve the

proper balance of viewpoints and expertise on peer review panels.

We further recommend that the EPA Administrator direct the Science

Advisory Board to (1) provide consistent, relevant information to the

public about panelists to enable the public to sufficiently understand the

points of view represented on a panel and (2) ensure that this information

is properly recorded in the meeting minutes. In addition, we recommend

that the Board consider allowing the public the opportunity to comment

on proposed panels before final selection decisions are made.

Recommendations for

Executive Action
Page 21 GAO-01-536 EPA's Science Advisory Board Panels

We provided a draft copy of this report to EPA for its review and

comment. In commenting on the draft, the staff director of the Science

Advisory Board Staff Office generally agreed with the report’s findings and

recommendations. He said the staff office is planning actions in response

to the report that will improve its operations. The staff director also

provided us with an outline of the policies and procedures that the office

is planning to implement to address our recommendations, as well as

other actions the staff office believes are warranted in light of the

information provided in our report, such as reviewing and improving its

record-keeping systems.

To determine whether the Board’s policies and procedures are adequate to

ensure panel independence and balance and to provide sufficient

information to the public, we analyzed the criminal financial conflict-ofinterest statute (18 U.S.C. 208) and OGE regulations regarding conflicts of

interest. The financial conflict-of-interest provisions are particularly

relevant to the Board’s peer review panelists because, as is typical of

special government employees who retain their nonfederal primary

employment, the panelists often have substantial outside activities and

financial interests. We also analyzed Federal Advisory Committee Act

requirements, including those on balancing the viewpoints represented on

government committees and providing information about committee

activities to the public. We reviewed the staff office’s written policies and

procedures and their application to three peer review panels that reviewed

EPA’s draft revised guidelines for assessing cancer health risks and one

that reviewed EPA’s health risk assessment of the chemical 1,3-Butadiene.

Two of the peer reviews were conducted by the Environmental Health

Committee, which has focused on risk assessment matters, and two other

subcommittees of the Board conducted the other two reviews. According

to the staff director, these panels were generally representative of Board

peer review panels both in subject matter—they addressed a significant

risk assessment methodology and a health risk assessment—and in the

processes used in establishing and conducting them. We reviewed the

confidential financial disclosure forms of the panelists, along with other

information, and discussed with staff office officials the office’s policies

and procedures generally as well as how they were applied to the four

panels. We did not, however, make independent judgments on whether

conflicts of interest existed for members of the four panels or assess

whether these panels were properly balanced. We also interviewed

cognizant officials from the Science Advisory Board’s Staff Office; EPA’s

Office of General Counsel; OGE; and other scientific organizations, such

Agency Comments

and Our Response

Scope and

Methodology
Page 22 GAO-01-536 EPA's Science Advisory Board Panels

as the National Academies, to identify policies and procedures that might

better support the Board’s efforts to develop balanced, independent peer

review panels. We conducted our work from August 2000 through June

2001 in accordance with generally accepted government auditing

standards.

As agreed with your office, unless you publicly announce its contents

earlier, we plan no further distribution of this report until 30 days after the

date of this letter. At that time we will send copies of this report to the

EPA Administrator, appropriate congressional committees, and other

interested parties. We will also make copies available on request.

Please call me or Christine Fishkin at (202) 512-3841 if you or your staff

have any questions about this report. Other key contributors to this report

include Greg Carroll, Bruce Skud, and Amy Webbink.

Sincerely yours,

David G. Wood

Director, Natural Resources

 and Environment
Appendix I: Financial Conflict-of-Interest

Provisions

Page 23 GAO-01-536 EPA's Science Advisory Board Panels

The financial conflict-of-interest statute (18 U.S.C. 208) prohibits federal

employees, including special government employees (SGE), from

participating personally and substantially in a particular matter in which

they have a financial interest. A particular matter is one that involves

deliberation, decision, or action that is focused on the interests of specific

people or a discrete and identifiable class of people. There are two types

of particular matters: (1) particular matters of general applicability, such

as general regulations, policies, or standards that distinctly affect a

particular industry or other class of people or entities and (2) particular

matters involving specific parties, such as contracts and grants that affect

specific individuals or entities.

If a federal employee’s spouse, minor child, or general partner has a

financial interest in the particular matter, that interest is treated as the

employee’s interest and therefore disqualifies the employee from

participating. In general, the federal employee also may not participate in a

particular matter if he or she serves as an officer, director, trustee, general

partner, employee, or prospective employee of an organization that has a

financial interest in that matter.

U.S. Office of Government Ethics (OGE) regulations provide a number of

exemptions for financial interests determined to be too remote or

inconsequential to affect the integrity of the federal employee’s services.

For example, an employee may participate in a “particular matter of

general applicability” if the financial interest arises from ownership of

publicly traded stock issued by one or more entities affected by the

matter, but the market value of the stock must not exceed $25,000 for any

one entity or $50,000 for all affected entities. In addition, some employee

benefit plans, diversified mutual funds, and certain government securities

are exempt.

The OGE regulations provide a financial interest exemption to SGEs

serving on an advisory committee that other federal employees do not

receive. An SGE, such as a member of the Science Advisory Board, may

participate in a “particular matter of general applicability” on an advisory

committee when the disqualifying financial interest arises from the SGE’s

principal employment. The employer’s, or prospective employer’s,

financial interest is not treated as the SGE’s financial interest. This

exemption, however, does not cover the SGE’s ownership of stock in the

employer or consulting relationships.

Even if SGEs have a financial interest that would be affected by the

activities of the advisory committee, they may receive a waiver of the

Appendix I: Financial Conflict-of-Interest

Provisions
Appendix I: Financial Conflict-of-Interest

Provisions

Page 24 GAO-01-536 EPA's Science Advisory Board Panels

conflict if the official responsible for appointing them certifies, after

reviewing the financial disclosure report, that the need for the SGEs’

services outweighs the potential for a conflict of interest.

Figure 1 identifies questions that should be addressed in determining

whether an SGE has a financial conflict of interest.

Figure 1: Criteria for Determining if an SGE Has a Financial Conflict of Interest

a “Particular matter” refers only to matters that involve deliberation, decision, or action that is focused

upon the interests of specific people, or a discrete and identifiable class of people. The term may

include matters that do not involve formal parties and may extend to legislation or policy-making that

is narrowly focused on the interests of a discrete and identifiable class of people. But the term does

not cover consideration or adoption of broad policy options directed to the interests of a large and

diverse group of people. 5 C.F.R 2640.103(a)(1).

b

Participating personally means participating directly. Personal participation includes the direct and

active supervision of the participation of a subordinate in the matter. 5 C.F.R. 2640.103(a)(2).
Appendix I: Financial Conflict-of-Interest

Provisions

Page 25 GAO-01-536 EPA's Science Advisory Board Panels

c

Participating substantially refers to involvement that is of significance to the matter. Participation may

be substantial even though it is not determinate of the outcome of a particular matter. However, to be

considered substantial, participation must extend beyond having official responsibility, knowledge,

perfunctory involvement, or involvement on an administrative or peripheral issue. A finding of

substantiality should be based not only on the effort devoted to the matter, but also on the importance

of the effort. While a series of peripheral involvements may be insubstantial, the single act of

approving or participating in a critical step may be substantial. 5 C.F.R. 2640.103(a)(2).

d

A particular matter has a direct effect on a financial interest if a close causal link exists between any

decision or action to be taken in the matter and any expected effect of the matter on the financial

interest. An effect may be direct even though it does not occur immediately. A particular matter does

not have a direct effect on a financial interest, however, if the chain of causation is attenuated or is

contingent upon the occurrence of events that are speculative or that are independent of, and

unrelated to, the matter. A particular matter that has an effect on a financial interest only as a

consequence of its effects on the general economy is not considered to have a direct effect. 5 C.F.R.

2640.103 (a)(3)(i).

e

A particular matter has a predictable effect if there is an actual, as opposed to a speculative,

possibility that the matter will affect the financial interest. To be considered a predictable effect, the

magnitude of the gain or loss need not be known, and the dollar amount of the gain or loss is

immaterial. 5 C.F.R. 2640.103 (a)(3)(ii).
Appendix II: The 1,3-Butadiene Health Risk

Assessment Panel

Page 26 GAO-01-536 EPA's Science Advisory Board Panels

The Environmental Protection Agency’s (EPA) Office of Research and

Development asked the Science Advisory Board to review its draft health

risk assessment of 1,3-Butadiene, a synthetic chemical compound used

principally in the manufacture of synthetic rubber, nylon, and latex paint.

According to Chemcyclopedia, The Buyer’s Guide of Commercially

Available Chemicals, as of January 2001, 11 companies manufacture

1,3-Butadiene, distribute it, or both.1

 1,3-Butadiene is used extensively in

the production of synthetic rubber for vehicle tires, plastics for the

automobile industry, and nylon fibers and plastics. Rubber and tire

workers can be exposed to 1,3-Butadiene through accidental releases, and

1,3-Butadiene derived from motor vehicle combustion can also be found in

outdoor (ambient) air. This appendix includes an overview of the peer

review panel on 1,3-Butadiene, followed by information about the

panelists.

EPA’s Office of Research and Development asked the Board to review the

health risk assessment on 1,3-Butadiene for technical quality,

comprehensiveness, and clarity. The Board was asked to address specific

questions, including the following: (1) Does the science support the

classification of 1,3-Butadiene as a “known” human carcinogen? (2) Are

the approaches taken to characterize plausible cancer risk reasonable

given the science? (3) Are the conclusions and quantitative estimations for

reproductive/developmental effects adequately supported?

A 15-member peer review panel met April 30 through May 1, 1998, to

conduct the review. A key consideration was whether the panelists would

recommend classifying 1,3-Butadiene as a known human carcinogen or as

a likely carcinogen. The classification will affect future regulatory actions

regarding this chemical and represents one of the areas of controversy in

the proposed revised cancer health risk assessment guidelines also

reviewed by the Board (see app. III). The Board issued its final report on

the draft health risk assessment of 1,3-Butadiene on November 19, 1998.2

The Board’s 1,3-Butadiene panel did not support classifying 1,3-Butadiene

 1

The 11 companies cited are Air Products and Chemicals, Inc.; BP Amoco Chemicals;

Chevron Phillips Chemical Company, LP; CONDEA Vista Company; Equistar Chemicals,

LP; ExxonMobil Chemical Co.; Huls Aktiengesellschaft; Matheson Gas Products;

Occidental Chemical Corp./OxyChem; Scott Specialty Gases; and Shell Chemical Company.

2

EPA, Science Advisory Board, An SAB Report: Review of the Health Risk Assessment of

1,3-Butadiene (Washington, D.C., Nov. 11, 1998).

Appendix II: The 1,3-Butadiene Health Risk

Assessment Panel

Background
Appendix II: The 1,3-Butadiene Health Risk

Assessment Panel

Page 27 GAO-01-536 EPA's Science Advisory Board Panels

as a known human carcinogen as had been recommended in EPA’s draft

health risk assessment. Although the panel did not reach consensus

position on this issue, a majority of the panelists recommended that

1,3-Butadiene be classified as a “probable” human carcinogen.

This appendix contains information on the panel that reviewed EPA’s draft

health risk assessment of 1,3 Butadiene. For this panel, we identify the

panelists, their primary employment, their job titles (when available), and

other pertinent information the panelists provided about themselves

(1) on the confidential financial disclosure forms and (2) at the voluntary

public disclosure session.3

 We also present the staff director’s assessments

of the viewpoints of the panelists.

The following information on the panelists is based on the roster of

panelists that was provided to the public at the first meeting of the panel:

• 10 of the 1,3-Butadiene panelists were professors, medical directors, or

both at academic or medical institutions;

• 4 worked for companies or industry-affiliated research organizations; and

• 1 worked for a state environmental protection agency. (See table 1.)

 3

To maintain the confidentiality of the information, we do not identify the panelists

associated with the confidential financial disclosure information.

1,3-Butadiene Peer

Review Panelists
Appendix II: The 1,3-Butadiene Health Risk

Assessment Panel

Page 28 GAO-01-536 EPA's Science Advisory Board Panels

Table 1: 1,3-Butadiene Health Risk Assessment Panelists, Primary Employment, and Titles

Panelist name Primary employment Title

Professor or medical director, academic or medical

institution

Dr. Richard Albertini University of Vermont Adjunct Professor, Medical

Microbiology and Molecular

Genetics, and Professor of

Medicine

Dr. Cynthia Bearer Case Western Reserve University Assistant Professor, Division of

Neonatology, Department of

Pediatrics, and Department of

Neurosciences

Dr. John Doull University of Kansas Medical Center Professor Emeritus, Department

of Pharmacology, Toxicology,

and Therapeutics

Dr. Karl Kelsey Harvard School of Public Health Professor, Department of Cancer

Biology and Department of

Environmental Health

Dr. Elaine Faustman University of Washington Professor, Department of

Environmental Health

Dr. David G. Hoel Medical University of South Carolina Distinguished University

Professor, Department of

Biometry and Epidemiology

Dr. David Parkinson L.I. Occupational and Environmental

Health Center

Medical Director

Dr. Roy Shore New York University Medical School Director, Division of

Epidemiology and Biostatistics

Dr. James Swenberg University of North Carolina Director, Curriculum in

Toxicology, and Professor,

Environmental Science and

Engineering, Nutrition and

Pathology

Dr. Mark Utell, Chair University of Rochester Medical Center Professor of Environmental

Medicine, Pulmonary Unit

Companies or industry-affiliated research

organizations

Dr. R. Jeff Lewis Exxon Biomedical Sciences, Inc. Staff Epidemiologist

Dr. Abby Li Monsanto Company Toxicology Manager/

Neurotoxicology Technical

Leader

Dr. Judith MacGregor Toxicology Consulting Services Consultant

Dr. Michele Medinsky Chemical Industry Institute of Toxicology Senior Scientist

State environmental protection agency

Dr. Lauren Zeise California Environmental Protection

Agency

Chief, Reproductive and Cancer

Hazard Assessment Section

Note: The roster provided at the meeting also included Dr. Emil Pfitzer as the panel chair and Dr.

Utell as the cochair. Dr. Pfitzer did not attend the 1,3-Butadiene meeting, and he subsequently left the

Board. Dr. Utell became the chair of this panel.

Source: EPA Science Advisory Board, 1,3-Butadiene Panel Roster (Apr. 30-May 1,1998).
Appendix II: The 1,3-Butadiene Health Risk

Assessment Panel

Page 29 GAO-01-536 EPA's Science Advisory Board Panels

The staff office obtained other pertinent information from the panelists

relevant to identifying potential conflicts of interest, assessing impartiality,

and achieving a properly balanced peer review panel. Some of the

following information was obtained in advance of the panel’s first meeting

from financial disclosure forms, and the rest of the information was

obtained before the voluntary public disclosure session at the first panel

meeting, during it, or both.

The staff office had access to information from the confidential financial

disclosure statements that most of the panelists provided to the staff office

before the first meeting.4

 On the basis of our review of the minutes of the

meeting, at the public disclosure session the panelists did not volunteer

information about the following items that could be relevant to

understanding their perspectives.

• One panelist was also an official of an environmental health organization.

• During the prior year, one panelist received fees from 60 companies and

organizations, including chemical companies and law firms, and research

funding from several entities, including a chemical company.

• During the prior year, one panelist received fees from about 23 companies

and organizations, including chemical companies and law firms.

• One panelist reported fees for serving as an expert legal witness, and

several panelists reported fees for legal consulting work during the prior

year.

• One panelist worked for a company that manufactures and distributes

1,3-Butadiene.

• Two panelists owned stock in companies that manufacture 1,3-Butadiene,

distribute it, or both.

Regarding the last item—ownership of stock in companies that

manufacture or distribute 1-3,Butadiene—the staff office would have

known that two panelists owned such stock if it had identified the

companies that manufacture or distribute this chemical. This information

is relevant because federal conflict-of-interest provisions prohibit stock

ownership in an affected company above certain dollar thresholds. If

thresholds are exceeded, a panelist can still participate in the panel, but a

 4

The staff office did not review two panelists’ financial disclosure forms until after the first

meeting, at least one of which was submitted to the Board after the meeting. The other

panelist’s form was not dated.

Other Pertinent

Information About the

Panelists

Information From Confidential

Financial Disclosure Forms
Appendix II: The 1,3-Butadiene Health Risk

Assessment Panel

Page 30 GAO-01-536 EPA's Science Advisory Board Panels

waiver concluding that the need for the panelist’s service outweighs the

potential conflict of interest is required.5

 However, as discussed earlier, the

staff office did not identify the manufacturers and distributors of

1,3-Butadiene before or after the panel was convened. As a result, the staff

office did not obtain information from these panelists about their

investments to determine whether they would need a waiver in order to

participate in the panel.

The meeting minutes provide public disclosure comments for 10 of the 15

panelists reported as being in attendance. On the basis of these minutes, it

appears that five panelists, including the chair, may not have provided

additional background information at the voluntary disclosure session.

However, it could also be that the recorder was not available during these

disclosures, a situation reported in the minutes of another panel we

reviewed. In any event, the public record of the 1,3-Butadiene panel

includes the following background information from 10 of the 15 panelists,

which we are presenting as it appeared in the minutes with only minor

edits.

• Dr. Albertini reported (1) developing assays that were used to study

1,3-Butadiene; (2) being asked by the International Life Sciences Institute

to write a test case using gene toxicity data under EPA’s guidelines;

(3) being asked to comment on the Canadian 1,3-Butadiene document;

(4) consulting for the Chemical Industry Institute of Toxicology; and

(5) working with the Czechoslovakian government to study 1,3-Butadiene,

a study being funded by the Chemical Manufacturers Association and the

International Institute of Synthetic Rubber Workers.6

• Dr. Doull reported involvement with 1,3-Butadiene as a participant on the

American Conference of Governmental Industrial Hygienists Threshold

Limit Value Committee.

• Dr. Faustman reported receiving a grant from EPA to look at doseresponse assessment methods for noncancer endpoints; variations of

these published methods were used for 1,3-Butadiene.

• Dr. Kelsey reported (1) receiving a grant to study 1,3-Butadiene from the

National Institute for Occupational Safety and Health and publishing the

 5

Such waivers, given by the appointing official, are to be disclosed to the public.

6

Neither we nor the staff office could locate an organization called the International

Institute of Synthetic Rubber Workers, and this citation in the minutes appears to be an

error. The correct citation may be the International Institute of Synthetic Rubber

Producers.

Information From Public

Disclosure Session
Appendix II: The 1,3-Butadiene Health Risk

Assessment Panel

Page 31 GAO-01-536 EPA's Science Advisory Board Panels

findings and (2) collaborating on an NIH-funded grant to look at

pharmacokinetics and low exposure to humans with principal investigator

Tom Smith.

• Dr. Lewis reported working on a legal case involving butadiene for Exxon7

and serving as the Chairman of the Epidemiology Steering Committee for

the Styrene-Butadiene Rubber Worker Mortality Study for the

International Institute of Synthetic Rubber Producers.

• Dr. MacGregor reported (1) working until 1992 for Chevron Corporation, a

company that manufactures petrochemical products containing

1,3-Butadiene, and (2) that her spouse had published several mutagenicity

studies on 1,3-Butadiene.

• Dr. Medinsky reported working for the Chemical Industry Institute of

Toxicology which receives dues from chemical companies, and publishing

papers on pharmacokinetics pertaining to 1,3-Butadiene that were funded,

in part, by the Institute.

• Dr. Parkinson reported being a consultant representing rubber workers

and having discussed a joint position on 1,3-Butadiene with Dr. Matanoski

in the past.

• Dr. Swenberg reported that he was completing a study on 1,3-Butadiene in

China, being a reviewer for the Canadian health assessment of

1,3-Butadiene, having received funding from the Health Effects Institute,

and being a subcontractor on a 1,3-Butadiene study for another member of

the panel (Dr. Albertini).

• Dr. Zeise reported peer reviewing a study on 1,3-Butadiene as a

subcommittee member of the NTP Board of Scientific Counselors,

involvement in time-dependent analyses of 1,3-Butadiene rodent studies,

and working for a state agency that has evaluated the risks of

1,3-Butadiene.

The staff office does not maintain documentation on how it assesses its

panels for balance in points of view and expertise represented. As a result,

we could not determine how, and to what extent, the staff office

considered background information about the panelists in selecting this

panel and ensuring that it was appropriately balanced. The Board’s goal is

generally to select members from the broad middle spectrum of opinion

on the technical issue. This is a subjective assessment based, in part, on

the information panelists provide on their confidential financial disclosure

forms. The staff office may also receive information about the panelists

from the organizations that recommend individuals to serve as panelists,

 7

Exxon is a manufacturer of 1,3-Butadiene.

The Staff Office’s Views on

the Panel
Appendix II: The 1,3-Butadiene Health Risk

Assessment Panel

Page 32 GAO-01-536 EPA's Science Advisory Board Panels

such as the Natural Resources Defense Council and the American

Industrial Health Council. We note that the staff office’s assessments may

be more subjective than necessary because staff office officials may make

decisions before reviewing the prospective panelists’ disclosure forms or

without having discussed all relevant background information that would

provide a good indication of the panelists’ impartiality.

We discussed the composition of this panel with staff office personnel,

including the staff director, to understand how they viewed this panel

vis-à-vis their stated policy of generally selecting members and consultants

from the broad middle spectrum of opinion on the technical issues being

reviewed. Since no documentation was preserved, the staff director

attempted to recreate how the panel was balanced.8

 To categorize the

potential viewpoints of panelists, the staff director told us that in some

cases they use a scale of 1 to 10 representing a continuum of viewpoints

from an environmental perspective to an industry perspective.9

 On this

continuum, 1 to 3 reflects an environmental perspective, 4 to 6 the middle

spectrum, and 7 to 10 an industry perspective. The staff director said that

when the 1,3-Butadiene panel was formed he believed he viewed six of the

panelists as reflecting the broad middle perspective, three as reflecting an

environmental perspective, and six reflecting an industry perspective.

The staff director’s recollections indicate that the other affiliations and

activities of the panelists are often as relevant to assessing the points of

view panelists may be expected to bring to peer review panels as is the

information on their primary employment. For example, for the

1,3-Butadiene panel, the staff director viewed two panelists who worked

for academic or medical institutions as reflecting an industry perspective

and two others as reflecting an environmental perspective.

When discussing his views on the panelists, the staff director agreed with

us that in a few cases, additional information would have been helpful in

better assessing the points of view the panelists represented. For example,

 8

We also spoke with the staff member with primary responsibility for this panel, who no

longer works for the Board or EPA. She said that she knew of no records on how this panel

was balanced other than what is in the Federal Advisory Committee Act file. We reviewed

this file, and it does not contain information on how the staff office assessed the panel for

balance of viewpoints and expertise.

9

The staff director said that the individual scores of the panelists are summed and divided

by the number of panelists. The goal is to have the result in the middle—that is, between

four and six.
Appendix II: The 1,3-Butadiene Health Risk

Assessment Panel

Page 33 GAO-01-536 EPA's Science Advisory Board Panels

one panelist served as an expert legal witness and several others reported

legal consulting fees, but the staff office did not have information on the

clients or the scientific views presented in these instances. While the staff

director characterized most of these panelists as in the middle spectrum,

additional information could have shifted their scores toward either the

environmental or industry viewpoint. In addition, the staff director

considered one panelist who worked for an academic or medical

institution who also performs extensive consulting for industry (including

chemical companies and law firms) as reflecting the middle spectrum.

However, the staff director did not have information on the nature of the

consulting work. Such information could have provided insight into the

viewpoints this panelist might have brought to the panel, and the

assessment would have been more credible if it had been based on more

complete information about the panelist’s extensive consulting work.10

We agree with the staff director that working for industry or

environmental organizations, having consulting or research affiliations

with industry or environmental organizations, and providing legal

testimony for chemical companies or for individuals do not, necessarily,

represent conflicts of interest that automatically bar an individual from

serving on a peer review panel. Nonetheless, these associations should be

assessed to determine the overall balance of viewpoints represented on a

panel, identify any potential conflicts of interest, and assess impartiality.

 10As a result of our review, in January 2001 the staff director did ask this panelist about the

numerous fees reported. The response from the panelist was general and appeared to

address the legal fees reported but not the fees from various companies.
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 34 GAO-01-536 EPA's Science Advisory Board Panels

EPA issued health risk assessment guidelines for carcinogens in 1986, the

most widely used and arguably most significant of EPA’s health risk

assessment methodologies. The guidelines incorporate some

precautionary assumptions aimed at ensuring that the agency does not

underestimate health risks.1

 Some experts believe the guidelines are too

precautionary while others believe they are not protective enough. Partly

because of controversies that proposed changes to the guidelines have

engendered, EPA’s efforts to revise and update the 1986 guidelines are not

yet completed, although the agency started the process more than 10 years

ago. This appendix includes background on the three peer review panels

that the Science Advisory Board conducted on EPA’s cancer risk

guidelines, followed by information about the three panels and the

panelists serving on them.

In 1996, EPA first requested a Board peer review of the agency’s April 1996

proposed revisions to its guidelines for assessing the health risks of

carcinogens. The Board has convened three different panels consisting of

26 panelists in total. Fifteen of the panelists—or more than half—

participated on only one panel, and two of the panelists participated on all

three panels. The first peer review panel met in February 1997. In

September 1997, this panel recommended that EPA add a number of

changes and clarifications to the proposed revisions, including language

explicitly addressing the health risks of infants and children. In January

1999, the Board convened a second peer review panel to review the

revisions EPA had made in response to the first panel; in July 1999 the

second panel reported its evaluation of EPA’s responses. Prior to

convening the second panel, the Board had received several criticisms,

including that the second panel was not properly balanced because it did

not include pediatricians or other experts on the vulnerability and

susceptibility of infants and children. The Board subsequently convened a

third panel to focus on children’s issues in July 1999. In its September 2000

report, the majority of that panel urged EPA to issue the guidelines

promptly and then undertake a program of research and risk assessment

improvement to enable EPA to address the childhood susceptibility issue

more completely in future guideline revisions.

 1

See our report, Environmental Protection Agency: Use of Precautionary Assumptions in

Health Risk Assessments and Benefits Estimates (GAO-01-55, Oct. 16, 2000), for

additional information on the precautionary assumptions used.

Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Background
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 35 GAO-01-536 EPA's Science Advisory Board Panels

The staff office believes that these panels were not subject to the financial

conflict-of-interest provisions because they addressed a broadly applicable

methodology that will be applicable to all of EPA’s cancer risk

assessments. Thus, the staff office believes the panelists were not subject

to the financial conflict-of-interest requirements that apply only to

particular matters that affect a specific party or a group or class of entities.

Nonetheless, the staff office’s responsibility for evaluating the impartiality

of the panelists and ensuring the overall balance of the panel remains. In

this regard, the Natural Resources Defense Council questioned, in a letter

to the EPA Administrator, whether it was appropriate for the Board to

include industry scientists and consultants who received funding from the

chemical industry on a peer review panel whose purpose was to advise

EPA on cancer risk assessment guidelines that would directly affect the

agency’s future regulation of carcinogens. In our view, this question

highlights the importance of ensuring that the peer review panels are

properly balanced in terms of points of view and expertise represented.

This appendix contains information on each of the three panels

(summarized in table 2) that reviewed EPA’s proposed revised guidelines

for assessing cancer health risks. For each panel, we identify the panelists,

their primary employment, their job titles (when available), and other

pertinent information the panelists provided about themselves (1) on the

confidential financial disclosure forms and (2) at the voluntary public

disclosure session.2

 We also present the staff director’s assessments of the

viewpoints of the panelists.

Table 2: Proposed Cancer Risk Guidelines Panels

Panel Meeting date Report issued

Revised Cancer Risk Guidelines February 1997 September 1997

Revised Cancer Risk Guidelines January 1999 July 1999

Revised Cancer Risk Guidelines Pertaining to

Children

July 1999 September 2000

Because the staff office does not maintain documentation on how it

assessed its panels for balance in points of view and expertise

represented, we could not determine how, and to what extent, the staff

 2

To maintain the confidentiality of the information, we do not identify the panelists

associated with the confidential financial disclosure information.
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 36 GAO-01-536 EPA's Science Advisory Board Panels

office considered background information about the panelists in selecting

them and ensuring that the panels were appropriately balanced. However,

we discussed the composition of each of the panels with the staff director

to understand how he viewed this panel vis-à-vis the staff office’s stated

policy of generally selecting members and consultants from the broad

middle spectrum of opinion on the technical issue being reviewed. Since

no documentation had been preserved, the staff director attempted to

recreate the panel balancing that was conducted in these cases. The staff

director ranked the panelists using a scale of 1 to 10 representing a

continuum of viewpoints from an environmental perspective to an

industry perspective.3

 On this continuum, 1 to 3 reflects an environmental

perspective, 4 to 6 the middle spectrum, and 7 to 10 an industry

perspective.

EPA’s Office of Research and Development asked the Board to review

seven issues in the proposed guidelines, including (1) hazard classification

descriptors and narratives, (2) information requirements necessary to

depart from default assumptions when gaps in data or knowledge were

encountered, and (3) dose-response assessment. The 11-member cancer

risk panel met in February 1997 and issued its report in September 1997.

The report generally commended EPA’s efforts to update its guidelines

and identified areas for improvement.

The following information on the panelists is based on the roster of

panelists that was provided to the public at the first meeting of the panel:

• six of the panelists worked for academic or medical institutions,

• three worked for companies or industry-affiliated research organizations,

• one worked for a state environmental protection agency, and

• one panelist’s employment was not identified.

As shown in table 3, most of the panelists’ job titles were not provided,

and neither the primary employment nor the title was provided for one

panelist. These omissions limit the ability of the public to assess the

panelists.

 3

The staff director said that this approach is used for some panels to assess balance. The

individual scores of the panelists are summed and divided by the number of panelists. The

goal is to have the result in the middle—between four and six.

First Peer Review

Panel
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 37 GAO-01-536 EPA's Science Advisory Board Panels

Table 3: Revised Cancer Risk Guidelines Panelists, Primary Employment, and Titles (First Panel)

Panelist name Primary employment Title

Professor or medical director, academic or medical

institution

Dr. Charles Capen Department of Veterinary

Biosciences, Ohio State

University

a

Dr. Adolpho Correa The Johns Hopkins University

School of Hygiene and Public

Health

a

Dr. Frederica Perera Columbia University School of

Public Health

a

Dr. Henry C. Pitot McArdle Laboratory for Cancer

Research, Department of

Oncology, Medical School

a

Dr. James A. Swenberg University of North Carolina Professor, Environmental

Science and Engineering

Dr. Mark Utell University of Rochester Medical

Center, Environmental Medicine

Pulmonary Unit

Professor of Medicine

Companies or industry-affiliated research organizations

Dr. Kenny Crump ICF Kaiser a

Dr. Roger O. McClellan Chemical Industry Institute of

Toxicology

a

Dr. Emil Pfitzer, Acting Chair Research Institute for Fragrance

Materials, Inc.

President

State environmental protection agency

Dr. Lauren Zeise California Environmental

Protection Agency

a

Employer not identified

Dr. Ernest McConnell a a

a

Information not provided.

Source: EPA Science Advisory Board, Revised Cancer Risk Guidelines Panel Roster (Feb. 13-14,

1997).

The staff office obtained other pertinent information from the panelists

relevant to reviewing for potential conflicts of interest, impartiality, and

achieving a properly balanced peer review panel. Some of the information

was obtained from financial disclosure forms that should have been

provided to the staff office in advance of the meeting. Other information

was obtained before or during the voluntary public disclosure session that

the panelists are asked, but not required, to participate in at the first panel

meeting.

Other Pertinent

Information About the

Panelists
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 38 GAO-01-536 EPA's Science Advisory Board Panels

Much of the additional information the staff office may have obtained

about the panelists from confidential financial disclosure forms is not

available because the staff office was unable to locate 7 of the 11 forms.4

Three of the four panelists for whom confidential disclosure forms were

found provided the following information that could be relevant to

understanding their perspectives.5

• One panelist was also a board member of an environmental advocacy

organization.

• One panelist received fees from 19 companies and organizations, including

the CMA (likely referring to the Chemical Manufacturers Association),

during the previous year.6

• One panelist was a member of a chemical company committee on

biohazards.

Because the public disclosures were not recorded, we could not determine

whether any of these panelists provided this information at the meeting.

No information that the panelists provided during the public disclosure

session at the first meeting of this panel is available because the meeting

minutes only summarize the disclosure session: they simply state that the

public disclosure discussion was held and that no conflicts of interest

were identified.7

Retrospectively, the Board’s staff director said he believed that when this

panel was formed he viewed two of the panel members as reflecting an

environmental perspective, seven a middle perspective, and two an

industry perspective. Given these assessments, it is clear that information

more than simply the primary employment of the panelists, such as other

affiliations and activities of the panelists, is relevant to assessing the

 4

These forms were prepared about 3 years prior to our request. An OGE regulation

indicates that agencies are to keep confidential disclosure forms for 6 years. Of the four

confidential disclosure forms that were located, the staff office reviewed two after the first

meeting, including one submitted by a panelist after the meeting.

5

The fourth panelist did not report other affiliations.

6

The new organization name for the Chemical Manufacturers Association is the American

Chemistry Council.

7

We examined other meeting minutes that are posted on the Board’s Web site and found

this to be the case in a number of instances.

Information From Confidential

Financial Disclosure Forms

Information From Public

Disclosure Session

The Staff Office’s Views on

the First Panel
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 39 GAO-01-536 EPA's Science Advisory Board Panels

points of view they may be expected to bring to the peer review panels.

For example, for this first cancer guidelines panel, the staff director

viewed one panelist who worked for an academic or medical institution as

reflecting an industry perspective and another panelist who worked for an

academic or medical institution as reflecting an environmental

perspective.

Because most of the confidential disclosure forms were not available and

the public disclosures were not recorded, our discussions with staff office

officials about the panelists’ backgrounds were necessarily limited.

However, we did find that the staff office did not obtain or review the

confidential disclosure form for one panelist it classified as representing

the middle viewpoint, either at the time the panel was formed or later.

Staff office officials do not review disclosure forms of panelists who also

serve on other EPA advisory committees, as was the case with this

panelist. As a result, the staff office’s assessment did not consider specific

employment and background information the panelist had already

provided to EPA.

EPA asked the Board to comment on sections of the cancer risk guidelines

that had been revised to address the Board’s initial recommendations as

well as the public’s comments. Specific issues to be addressed included

(1) the adequacy of proposed hazard descriptors, (2) the use of

information on the ways an agent produces cancer, and (3) dose-response

analysis. A 17-member panel, which met January 20 and 21, 1999,

conducted the review. The report, issued in July 1999, addressed each of

these topics.

The following information on the panelists is based on the roster of

panelists that was provided to the public at the first meeting of the panel:

• nine panelists were professors or medical directors of academic or

medical institutions,

• seven held various positions with companies or industry-affiliated

research organizations, and

• one worked for a state environmental protection agency.

The panelists’ names, primary employment, and titles were provided to the

public at the panel’s initial meeting (see table 4).

Second Peer Review

Panel
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 40 GAO-01-536 EPA's Science Advisory Board Panels

Table 4: Revised Cancer Risk Guidelines Panelists, Primary Employment, and Titles (Second Panel)

Panelist name Primary employment Title

Professor or medical director, academic

or medical institution

Dr. John Doull University of Kansas Medical Center Professor Emeritus, Department of

Pharmacology, Toxicology and

Therapeutics

Dr. Yvonne Dragana Ohio State University, College of

Medicine and Public Health

Assistant Professor

Dr. Lovell A. Jones MD Anderson Cancer Center Director, Experimental GynecologyEndocrinology, Department of

Gynecologic Oncology, and Professor of

Gynecologic Oncology

Dr. George Lambert University of Medicine and Dentistry of

New Jersey-Robert Wood Johnson

Medical School;

Robert Wood Johnson University Hospital

and St. Peter’s Medical Center; Center for

Child and Reproductive Environmental

Health

Associate Professor of Pediatrics and

Director of Pediatric Pharmacology and

Toxicology; Attending Neonatologist;

Director

Dr. Grace K. LeMasters University of Cincinnati Director, Division of Epidemiology and

Biostatistics, Department of

Environmental Health

Dr. Frederica P. Perera Columbia University School of Public

Health

Professor of Public Health

Dr. Roy E. Shore New York University Medical School Director, Division of Epidemiology and

Biostatistics

Dr. James A. Swenberg University of North Carolina Director, Curriculum in Toxicology, and

Professor, Environmental Science and

Engineering, Nutrition and Pathology

Dr. Mark Utell, Chair University of Rochester Medical Center Acting Chairman, Department of

Medicine; Director, Pulmonary Unit; and

Professor of Medicine and Environmental

Medicine

Companies or industry-affiliated research

organizations

Dr. Richard J. BullaBattelle Pacific Northwest National

Laboratory, Molecular Biosciences

Senior Staff Scientist

Dr. Kenny Crump KS Crump Group, Inc. Vice President

Dr. Abby A. Li Monsanto Company Neurotoxicology Technical Leader

Dr. Roger O. McClellan Chemical Industry Institute of Toxicology President

Dr. Ernest McConnellbToxPath, Inc. President

Dr. Michele Medinsky cToxicology Consultant

Dr. M. Jane Teta Union Carbide Corporation Director of Epidemiology, Health

Information and Risk and TSCA

State environmental protection agency

Dr. Lauren Zeise California Environmental Protection

Agency

Chief, Reproductive and Cancer Hazard

Assessment Section, Office of

Environmental Health Hazard

Assessment
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 41 GAO-01-536 EPA's Science Advisory Board Panels

a

This panel member is listed on the roster as a liaison from the Board’s Drinking Water Committee.

b

This panel member is listed on the roster as a liaison from EPA’s Scientific Advisory Panel.

c

Information not provided.

Source: EPA Science Advisory Board, Revised Cancer Risk Guidelines Panel Roster (Jan. 20-21,

1999).

The staff office obtained other pertinent information from the panelists

relevant to reviewing for potential conflicts of interest, impartiality, and

achieving a properly balanced peer review panel. Some of the information

was obtained before the panel convened from financial disclosure forms.

Other information was obtained before or during the voluntary public

disclosure session conducted at the first panel meeting.

The staff office had access to information from confidential financial

disclosure statements that most of the panelists provided to the staff

office.8

 The following information that could be relevant to understanding

five of the panelist’s perspectives was indicated on the forms:

• During the prior year, one panelist had received fees from 35 companies,

including chemical companies, a research organization funded by the

tobacco industry, and law firms. This panelist had also received research

funding from a chemical company and a tobacco company.

• One panelist had been a consultant to 16 companies, including 4 chemical

companies, during the prior year.

• One had been a consultant to 11 companies or organizations, including a

chemical company, during the prior year.

• One owned stock in 11 companies, including 2 chemical companies.

• One held stock in a chemical company.

The meeting minutes state that the disclosures of 5 of the 17 members of

this panel are not reported because the recorder left the room for a time

during the disclosure session. The public record of the panel includes the

following information from 12 of the panelists, which we are presenting as

it appeared in the minutes with only minor edits.

• Dr. Bull, senior staff scientist at the Battelle Pacific Northwest National

Laboratory, reported (1) having a particular interest in the EPA cancer

 8

The staff office reviewed six confidential financial disclosure forms after the first meeting,

including one submitted by a panelist after the meeting.

Other Pertinent

Information About the

Panelists

Information From Confidential

Financial Disclosure Forms

Information From Public

Disclosure Session
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 42 GAO-01-536 EPA's Science Advisory Board Panels

guidelines in his role as chair of the EPA Science Advisory Board Drinking

Water Committee, (2) serving on the International Life Science Institute

chloroform steering group, and (3) conducting research related to the EPA

cancer guidelines with the EPA and the National Aeronautics and Space

Administration.

• Dr. Crump, Vice President of KS Crump Group, Inc., reported conducting

research on some of the methodology included in the EPA cancer

guidelines.

• Dr. Dragan, Assistant Professor at Ohio State University, reported

conducting carcinogenesis research and serving on the International Life

Science Institute subcommittee that had reviewed the cancer guidelines.

• Dr. Jones, the Director for Experimental Gynecology-Endocrinology in the

Department of Gynecologic Oncology at the MD Anderson Medical Center,

reported (1) conducting research that was not directly related to the

guidelines and (2) serving as a member of the EPA Endocrine Disrupter

Screening and Testing Advisory Committee.

• Dr. Lambert, Associate Professor of Pediatrics and Director of Pediatric

Pharmacology and Toxicology at the University of Medicine and Dentistry

of New Jersey-Robert Wood Johnson Medical School, and Attending

Neonatologist at the Robert Wood Johnson University Hospital and St.

Peter’s Medical Center, reported (1) working as director for the Center for

Child and Reproductive Environmental Health and (2) conducting

research on endocrine disruptors and their effect on human development.

• Dr. McConnell, President of Toxpath, Inc., reported (1) serving as the

chair of EPA’s Scientific Advisory Panel, that will be using the cancer

guidelines and (2) conducting research with Dr. James Swenberg on

combining tumor and tissues sites, which is referenced throughout EPA’s

background material on the cancer guidelines.

• Dr. McClellan reported (1) working as president of the Chemical Industry

Institute of Toxicology, a not-for-profit research institution that is

supported by chemical manufacturers and that receives supplemental

funding for research in which cancer is a disease endpoint; (2) serving on

the International Life Science Institute’s chloroform steering committee

group; (3) making numerous public pronouncements, including

congressional testimony; (4) holding advisory roles with several

organizations, such as Resources for the Future and the Center for Risk

Management; and (5) conducting research on the biological effects of low

doses of radon and alternative toxicological hazards.

• Dr. Medinsky reported (1) working as a toxicology consultant and

(2) conducting physiologically based pharmacokinetic modeling research

on hazardous air pollutants, many of which are known human

carcinogens.
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 43 GAO-01-536 EPA's Science Advisory Board Panels

• Dr. Perera reported (1) having published papers in peer reviewed journals

and (2) having received funding for research related to the cancer

guidelines from the EPA, DOD, NIEHS, and private foundations.

• Dr. Teta, Director of Epidemiology, Health Information, Risk Assessment,

and TSCA for Union Carbide Corporation, reported (1) having investments

in her employer, a producer of chemicals; (2) serving for 10 to 12 years

with the American Industrial Health Council, which submitted comments

to EPA on the cancer guidelines; (3) serving as chair of the American

Industrial Health Council panel and Chemical Manufacturers Association

butadiene panel; (4) writing a yet-unpublished paper on the application of

the guidelines using ethylene oxide; and (5) providing public comments as

an International Life Science Institute member.

• Dr. Utell, who works for the University of Rochester, reported (1) the

general interest of his employer in the EPA cancer guidelines,

(2) involvement with research with the Health Effects Institute and EPA,

(3) serving as a member of the Health Effects Institute’s research

committee, and (4) serving as a board member of the Annapolis Center.

• Dr. Zeise, Chief of the Reproductive and Cancer Hazard Assessment

Section for the Office of Environmental Health Hazard Assessment at the

California Environmental Protection Agency, reported (1) working

extensively in the areas of risk assessment methodologies and cancer risk

assessment and (2) serving as an expert witness in several court cases.

Retrospectively, the staff director said he believed that at the time the

second panel was appointed the staff office viewed four of the panel

members as reflecting an environmental perspective, nine a middle

perspective, and four an industry perspective. In the staff director’s view,

panelists from academic or medical institutions do not necessarily

represent the broad middle spectrum, and panelists from industry may not

reflect an industry perspective. For this panel, the staff director

categorized three panelists who worked for industry as having a middle

perspective, one panelist who worked for an academic or medical

institution as having an industry perspective, and three panelists who

worked for academic or medical institutions as reflecting an

environmental perspective.

When discussing his views on the panelists, the staff director agreed that,

in some cases, additional information would have helped to better assess

the points of view the panelists represented. Without that information, the

assessments are more subjective than they might have been. For example,

the staff director considered one panelist who worked for an academic or

medical institution as reflecting the middle spectrum. On the confidential

The Staff Office’s Views on

the Second Panel
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 44 GAO-01-536 EPA's Science Advisory Board Panels

financial disclosure form, however, this panelist reported a substantial

number of consulting fees from companies and law firms, including a

tobacco company and a research organization funded by the tobacco

industry. While staff office officials said they were aware of the panelist’s

relationships with the tobacco industry, they acknowledged that they did

not obtain information about the numerous consulting fees reported. The

assessment of this individual may have been accurate; however, it would

have been more credible if it had reflected specific knowledge about the

panelist’s extensive industry and legal consulting work. Moreover, staff

office officials acknowledged they were not aware another panelist they

considered to represent the middle perspective had industry clients

because they did not review this individual’s confidential financial

disclosure form.

One outstanding issue from the first peer review panel was the

recommendation to expand the discussion in the guidelines regarding

children. EPA requested that the Board provide comments on further

revisions to the guidelines that were intended to address children’s risk.

An 11-member panel met on July 27 and 28, 1999, to conduct the review. In

the panel’s September 2000 report, a majority of the panelists urged EPA

to issue the guidelines promptly and then to undertake a program of

research and risk assessment improvement to enable EPA to address the

childhood susceptibility issue more completely in future guideline

revisions. Several panel members disagreed with the majority, however,

asserting that the agency should fully address the childhood susceptibility

issue--that is, conduct the research before finalizing the guidelines.

The following information on the panelists is based on the roster of

panelists that was provided to the public at the first meeting of the panel:

• five panelists worked for academic or medical institutions,

• four panelists worked for companies or industry-affiliated research

institutions, and

• two panelists worked for a state environmental protection or health

agency.

The panelists’ names, primary employment, and titles were provided to the

public at the panel’s initial meeting (see table 5).

Third Peer Review

Panel
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 45 GAO-01-536 EPA's Science Advisory Board Panels

Table 5: Revised Cancer Risk Guidelines Pertaining to Children Panelists, Primary Employment, and Titles (Third Panel)

Panelist name Primary employment Title

Professor, medical director or doctor at academic or

medical institution

Dr. Cynthia Bearer Case Western Reserve University Assistant Professor

Dr. Michael DeBaun Washington University School of

Medicine

Medical Doctor, St. Louis

Children’s Hospital Division of

Hematology

Dr. George Lambert University of Medicine and

Dentistry of New Jersey-Robert

Wood Johnson Medical School;

Robert Wood Johnson University

Hospital and St. Peter’s Medical

Center

Associate Professor of Pediatrics

and Director of Pediatric

Pharmacology and Toxicology;

Attending Neonatologist

Dr. Genevieve Matanoski The Johns Hopkins University

School of Hygiene and Public

Health

Professor of Epidemiology

Dr. Mark J. Utell, Chair University of Rochester Medical

Center

Acting Chairman, Department of

Medicine; Director, Pulmonary

Unit; and Professor of Medicine

and Environmental Medicine

Companies or industry-affiliated research organizations

Dr. Stephen L. Brown Risk of Radiation and Chemical

Compounds

Director

Dr. Richard J. BullaBattelle Pacific Northwest

National Laboratory

Senior Staff Scientist, Molecular

Biosciences

Dr. Abby A. Li Monsanto Company Neurotoxicology Technical Leader

Dr. M. Jane Teta Union Carbide Corporation Director of Epidemiology, Health

Information, Risk Assessment and

TSCA

State environmental or health protection agency

Dr. Henry A. Anderson Wisconsin Bureau of Public

Health

Chief Medical Officer

Dr. Lauren Zeise California Environmental

Protection Agency

Chief, Reproductive and Cancer

Hazard Assessment

a

This panel member is listed on the roster as a liaison from the Board’s Drinking Water Committee.

Source: EPA Science Advisory Board, Cancer Risk Guidelines Pertaining to Children, Panel Roster

(July 27 and 28, 1999).

The staff office obtained other pertinent information from the panelists

relevant to reviewing for potential conflicts of interest, impartiality, and

achieving a properly balanced peer review panel. Some of the information

was obtained before the panel convened from financial disclosure forms,

and other information was obtained before or during the voluntary public

disclosure session at the first panel meeting.

Other Pertinent

Information About the

Panelists
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 46 GAO-01-536 EPA's Science Advisory Board Panels

The staff office had access to the following information from confidential

financial disclosure statements that the panelists provided to the staff

office.9 The following information that could be relevant to understanding

two of the panelist’s perspectives was indicated on the forms:

• One panelist was a consultant for the Chemical Manufacturers

Association.

• One panelist had received consulting fees from 3 organizations, including a

chemical industry research organization; received professional fees from 7

law firms; and held stock in about 50 companies, including 2 tobacco

companies.

Regarding the public disclosure session held at the first meeting of the

panel, the minutes state only that none of the panelists identified any

possible conflicts of interest. The record does not indicate whether any of

the individuals provided additional background information or what they

said.

Retrospectively, the staff director said that at the time the panel was

appointed, he believed he viewed two of the panel members as reflecting

an environmental perspective, seven a middle perspective, and two an

industry perspective. In the staff director’s view, panelists from academic

or medical institutions do not necessarily represent the broad middle

spectrum, panelists from industry may not reflect an industry perspective,

and panelists from environmental or health organizations may not reflect

an environmental perspective. For this panel, the staff director evaluated

one panelist who worked for an academic or medical institution as

reflecting an environmental perspective, two panelists who worked for

companies or industry-affiliated research organizations as reflecting the

middle perspective, and one panelist who worked for a state

environmental or health agency as reflecting the middle perspective.

As was the case with the other panels, we believe the staff office would

have benefited from additional information in assessing the points of view

the panelists represented. For example, the assessments would have been

more credible if they had reflected specific information about the

 9

The staff office reviewed one confidential financial disclosure form after the first meeting.

In addition, the confidential financial disclosure form for 1 of the 11 panelists could not be

found.

Information From Confidential

Financial Disclosure Forms

Information From Public

Disclosure Session

The Staff Office’s Views on

the Third Panel
Appendix III: The Three Panels on EPA’s

Guidelines for Assessing the Health Risks of

Carcinogens

Page 47 GAO-01-536 EPA's Science Advisory Board Panels

consulting and professional fees and stocks owned by one of the panelists

and the work performed by another panelist for the Chemical

Manufacturers Association.

(160543)

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