EPA's Science Advisory Board Panels: Improved Policies and
Procedures Needed to Ensure Independence and Balance (12-JUN-01,
GAO-01-536).
This report reviews the policies and procedures of the
Environmental Protection Agency's Science Advisory Board 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. GAO
found that the policies and procedures used by the staff office
to ensure the independence of the Board's peer reviewers and the
balancing of viewpoints have limitations that reduce their
effectiveness. 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. Furthermore, conflicts of
interest may not be identified and mitigated in a timely manner.
GAO also found that the staff office's policies and procedures
for providing the public with information on the backgrounds of
the Board's peer review panelists do not adequately inform the
public about the points of view represented on the panels.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-01-536
ACCNO: A00974
TITLE: EPA's Science Advisory Board Panels: Improved Policies
and Procedures Needed to Ensure Independence and Balance
DATE: 06/12/2001
SUBJECT: Environmental law
Environmental monitoring
Public health legislation
Public health research
******************************************************************
** This file contains an ASCII representation of the text of a **
** GAO Testimony. **
** **
** No attempt has been made to display graphic images, although **
** figure captions are reproduced. Tables are included, but **
** may not resemble those in the printed version. **
** **
** Please see the PDF (Portable Document Format) file, when **
** available, for a complete electronic file of the printed **
** document's contents. **
** **
******************************************************************
GAO-01-536
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 interest 1 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
Page 3 GAO- 01- 536 EPA's Science Advisory Board Panels
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.
10 OGE 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.
11 Because 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
12 Unless 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.
13 Later 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.
14 The panelists did not consistently disclose the sponsors of the butadiene
research they identified. 15 The 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 Academies 16 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
16 The 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
17 EPA?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
18 According 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 Exxon 7
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-
�- 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.
10 As 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- �- 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 Dragan a
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. Bull a Battelle 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 McConnell b ToxPath, Inc. President Dr.
Michele Medinsky c Toxicology 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. Bull a Battelle 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)
The first copy of each GAO report is free. Additional copies of reports are
$2 each. A check or money order should be made out to the Superintendent of
Documents. VISA and MasterCard credit cards are also accepted.
Orders for 100 or more copies to be mailed to a single address are
discounted 25 percent.
Orders by mail:
U. S. General Accounting Office P. O. Box 37050 Washington, DC 20013
Orders by visiting:
Room 1100 700 4 th St., NW (corner of 4 th and G Sts. NW) Washington, DC
20013
Orders by phone:
(202) 512- 6000 fax: (202) 512- 6061 TDD (202) 512- 2537
Each day, GAO issues a list of newly available reports and testimony. To
receive facsimile copies of the daily list or any list from the past 30
days, please call (202) 512- 6000 using a touchtone phone. A recorded menu
will provide information on how to obtain these lists.
Orders by Internet
For information on how to access GAO reports on the Internet, send an e-
mail message with ?info? in the body to:
Info@ www. gao. gov or visit GAO?s World Wide Web home page at: http:// www.
gao. gov
Contact one:
Web site: http:// www. gao. gov/ fraudnet/ fraudnet. htm
E- mail: fraudnet@ gao. gov
1- 800- 424- 5454 (automated answering system) Ordering Information
To Report Fraud, Waste, and Abuse in Federal Programs
*** End of document. ***