Scientific Integrity
EPA's Efforts to Enhance the Credibility and Transparency of Its Scientific Processes Gao ID: GAO-09-773T June 9, 2009The Environmental Protection Agency's (EPA) ability to effectively implement its mission of protecting public health and the environment relies largely on the integrity and transparency of (1) its assessments of the potential human health effects of exposure to chemicals and (2) its federal advisory committees, which are to provide independent, expert reviews of EPA's scientific work, among other functions. EPA's Integrated Risk Information System (IRIS) program is critical in developing the agency's scientific positions on the potential health effects of exposure to toxic chemicals. These positions, used as a basis for environmental risk management decisions by EPA and others, are maintained in IRIS' database of more than 540 chemical assessments. Since 2001, GAO has issued a number of reports addressing the importance of integrity and transparency to EPA's chemical assessments and to EPA's federal advisory committees. GAO work on EPA's advisory committees has focused on its Science Advisory Board--1 of 24 EPA federal advisory committees--which convenes panels to review many of the agency's scientific assessments and proposals. This testimony highlights scientific integrity and transparency issues GAO has reported on and relevant EPA reform efforts regarding (1) the IRIS assessment process and (2) federal advisory committee policies and procedures and appointment mechanisms. GAO has supplemented information from its prior reports with a preliminary review of the IRIS assessment process EPA issued on May 21, 2009, and the current appointment mechanisms for members of EPA's federal advisory committees.
In March 2008, GAO reported that the database of chemicals assessed under the IRIS program was at serious risk of becoming obsolete because EPA had not been able to complete timely, transparent, and credible assessments or decrease its backlog of ongoing assessments. A revised IRIS assessment process EPA issued in April 2008 did not respond to GAO's recommendations; rather, it made changes likely to further exacerbate concerns GAO had identified. Largely as a result of EPA's lack of responsiveness, GAO added EPA's processes for assessing and controlling toxic chemicals as a high-risk area in its January 2009 biennial status report on governmentwide high-risk areas requiring increased attention by executive agencies and Congress. Taking positive action, EPA issued a new IRIS assessment process on May 21, 2009. In announcing these reforms, EPA echoed GAO's findings that the April 2008 assessment changes reduced the transparency, timeliness, and scientific integrity of the IRIS process. The IRIS reforms, if implemented effectively, will represent significant improvements. Among other things, they restore EPA's control of the process and increase its transparency. For example, under the prior process, interagency reviews were required and managed by the Office of Management and Budget (OMB) and EPA was not allowed to proceed with assessments at various stages until OMB notified EPA that it had sufficiently responded to comments from OMB and other agencies. In contrast, under the recently announced process, EPA is to manage the entire IRIS assessment process, including what are now called interagency consultations. In 2001, GAO reported on limitations in the policies and procedures developed by EPA's Science Advisory Board to ensure that its panels' peer reviewers are independent and that a balance of viewpoints is represented on each panel. These limitations could have reduced the effectiveness of the Board by contributing to its being perceived as biased and could have inadvertently exposed panelists to violations of federal conflict-of-interest laws. EPA revised the Board's policies and procedures, as GAO had recommended. In a broader 2004 report on federal advisory committees, GAO highlighted the Board's revised policies and procedures, and those of the National Academies, which can--if implemented effectively--provide an assurance that relevant conflicts of interest are identified and addressed and that the committees are balanced in terms of points of view. However, EPA currently appoints members to 16 of its federal advisory committees using an appointment mechanism reserved for cases in which members are to speak as representatives of identified entities and are not subject to conflict-of-interest reviews, rather than as individuals speaking on behalf of the government on the basis of their best judgment. While EPA may be appropriately seeking stakeholder advice from some of its advisory committees, a number of these committees focus on scientific and technical questions for which EPA is likely to be seeking advice on behalf of the government. As EPA works to enhance scientific integrity, a review of advisory committee appointments could help ensure that committee work is not jeopardized by allegations of conflicts of interest or bias.
GAO-09-773T, Scientific Integrity: EPA's Efforts to Enhance the Credibility and Transparency of Its Scientific Processes
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Testimony:
Before the Committee on Environment and Public Works, U.S. Senate:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 9:30 a.m. EDT:
Tuesday, June 9, 2009:
Scientific Integrity:
EPA's Efforts to Enhance the Credibility and Transparency of Its
Scientific Processes:
Statement of John B. Stephenson, Director:
Natural Resources and Environment:
GAO-09-773T:
GAO Highlights:
Highlights of GAO-09-773T, a testimony before the Committee on
Environment and Public Works, U.S. Senate.
Why GAO Did This Study:
The Environmental Protection Agency‘s (EPA) ability to effectively
implement its mission of protecting public health and the environment
relies largely on the integrity and transparency of (1) its assessments
of the potential human health effects of exposure to chemicals and (2)
its federal advisory committees, which are to provide independent,
expert reviews of EPA‘s scientific work, among other functions. EPA‘s
Integrated Risk Information System (IRIS) program is critical in
developing the agency‘s scientific positions on the potential health
effects of exposure to toxic chemicals. These positions, used as a
basis for environmental risk management decisions by EPA and others,
are maintained in IRIS‘ database of more than 540 chemical assessments.
Since 2001, GAO has issued a number of reports addressing the
importance of integrity and transparency to EPA‘s chemical assessments
and to EPA‘s federal advisory committees. GAO work on EPA‘s advisory
committees has focused on its Science Advisory Board”1 of 24 EPA
federal advisory committees”which convenes panels to review many of the
agency‘s scientific assessments and proposals.
This testimony highlights scientific integrity and transparency issues
GAO has reported on and relevant EPA reform efforts regarding (1) the
IRIS assessment process and (2) federal advisory committee policies and
procedures and appointment mechanisms. GAO has supplemented information
from its prior reports with a preliminary review of the IRIS assessment
process EPA issued on May 21, 2009, and the current appointment
mechanisms for members of EPA‘s federal advisory committees.
What GAO Found:
In March 2008, GAO reported that the database of chemicals assessed
under the IRIS program was at serious risk of becoming obsolete because
EPA had not been able to complete timely, transparent, and credible
assessments or decrease its backlog of ongoing assessments. A revised
IRIS assessment process EPA issued in April 2008 did not respond to GAO‘
s recommendations; rather, it made changes likely to further exacerbate
concerns GAO had identified. Largely as a result of EPA‘s lack of
responsiveness, GAO added EPA‘s processes for assessing and controlling
toxic chemicals as a high-risk area in its January 2009 biennial status
report on governmentwide high-risk areas requiring increased attention
by executive agencies and Congress. Taking positive action, EPA issued
a new IRIS assessment process on May 21, 2009. In announcing these
reforms, EPA echoed GAO‘s findings that the April 2008 assessment
changes reduced the transparency, timeliness, and scientific integrity
of the IRIS process. The IRIS reforms, if implemented effectively, will
represent significant improvements. Among other things, they restore
EPA‘s control of the process and increase its transparency. For
example, under the prior process, interagency reviews were required and
managed by the Office of Management and Budget (OMB) and EPA was not
allowed to proceed with assessments at various stages until OMB
notified EPA that it had sufficiently responded to comments from OMB
and other agencies. In contrast, under the recently announced process,
EPA is to manage the entire IRIS assessment process, including what are
now called interagency consultations.
In 2001, GAO reported on limitations in the policies and procedures
developed by EPA‘s Science Advisory Board to ensure that its panels‘
peer reviewers are independent and that a balance of viewpoints is
represented on each panel. These limitations could have reduced the
effectiveness of the Board by contributing to its being perceived as
biased and could have inadvertently exposed panelists to violations of
federal conflict-of-interest laws. EPA revised the Board‘s policies and
procedures, as GAO had recommended. In a broader 2004 report on federal
advisory committees, GAO highlighted the Board‘s revised policies and
procedures, and those of the National Academies, which can”if
implemented effectively”provide an assurance that relevant conflicts of
interest are identified and addressed and that the committees are
balanced in terms of points of view. However, EPA currently appoints
members to 16 of its federal advisory committees using an appointment
mechanism reserved for cases in which members are to speak as
representatives of identified entities and are not subject to conflict-
of-interest reviews, rather than as individuals speaking on behalf of
the government on the basis of their best judgment. While EPA may be
appropriately seeking stakeholder advice from some of its advisory
committees, a number of these committees focus on scientific and
technical questions for which EPA is likely to be seeking advice on
behalf of the government. As EPA works to enhance scientific integrity,
a review of advisory committee appointments could help ensure that
committee work is not jeopardized by allegations of conflicts of
interest or bias.
View [hyperlink, http://www.gao.gov/products/GAO-09-773T] or key
components. For more information, contact John B. Stephenson at (202)
512-3841 or stephensonj@gao.gov.
[End of section]
Madam Chairman and Members of the Committee:
I am pleased to be here today to discuss the importance of scientific
integrity and transparency at the Environmental Protection Agency
(EPA). EPA's ability to effectively carry out its mission to protect
human health and the environment is critically dependent on timely and
credible scientific and technical information and health risk
assessments. Since 2001, we have issued a number of reports
underscoring the importance of integrity and transparency in processes
that (1) develop the science used to inform policy decisions and (2)
are used to establish federal advisory committees that, among other
things, provide independent peer reviews of EPA's scientific
determinations.
Notably, our work on EPA's Integrated Risk Information System (IRIS)
program and its database--which contains the agency's scientific
position on the potential human health effects of exposure to more than
540 chemicals--identified significant concerns about both the lack of
transparency in the process EPA uses to assess toxic chemicals and the
resulting effect on the credibility, or integrity, of these
assessments.[Footnote 1] The consequences of these transparency and
credibility issues are considerable because IRIS assessments are the
cornerstone of scientifically sound environmental decisions, policies,
and regulations. That is, the toxicity assessments in IRIS constitute
the first two critical steps of the risk assessment process. This
process, in turn, provides the foundation for risk management
decisions, such as determining whether EPA should establish controls
for particular substances to protect the public under such
environmental laws as the Clean Air Act and the Safe Drinking Water
Act. (See figure 1.)
Figure 1: National Academies' Risk Assessment and Risk Management Model
Used by EPA:
[Refer to PDF for image: illustration]
Risk assessment:
IRIS toxicity assessment:
1. Hazard identification;
2. Dose-response assessments;
Combines with:
Exposure assessment, to form:
Risk characterization.
Risk management:
Development of regulatory options;
Evaluation of public health, economic, social, and political
consequences of regulatory options;
Combines with Risk characterization to form:
Agency decisions and actions.
Source: National Academies.
[End of figure]
EPA also seeks to enhance the quality and credibility of its highly
specialized scientific and technical products by using independent,
expert peer reviews. The 24 federal advisory committees EPA has
established can be important vehicles for such peer review. For
example, the EPA Science Advisory Board convenes panels to review many
of the agency's scientific assessments and proposals. Because the work
of fully competent peer review panels can be undermined by allegations
of conflict of interest and bias, the best interests of federal
advisory committees are served by effective policies and procedures
regarding potential conflicts of interest, impartiality, and overall
committee balance.
In this context, my testimony today discusses scientific integrity and
transparency issues and, where applicable, EPA reforms of the IRIS
assessment program and federal advisory committee policies and
procedures. My statement is based on findings from a number of reports
and testimonies we have issued since 2001 involving scientific
integrity and transparency issues at EPA.[Footnote 2] We have
supplemented this testimony with a preliminary review of EPA's May 21,
2009, revisions to the IRIS assessment process and of the current
appointment mechanisms for EPA's 24 federal advisory committees. Our
preliminary analysis of IRIS reforms focuses primarily on issues
related to scientific integrity and transparency and does not include
IRIS productivity issues. We conducted our work from May 26 to June 9,
2009, in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform our work to
obtain sufficient, appropriate evidence to provide a reasonable basis
for our findings and conclusions based on our audit objectives. We
believe that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
EPA Reforms Have the Potential to Significantly Improve IRIS, but EPA
Could Clarify Some Issues:
In March 2008, we reported that the IRIS database--a critical component
of EPA's capacity to support scientifically sound risk management
decisions, policies, and regulations--was at serious risk of becoming
obsolete because the agency had not been able to complete timely,
transparent, and credible chemical assessments or decrease its backlog
of ongoing assessments. In addition, assessment process changes EPA had
recently made, as well as other changes EPA was considering at the time
of our review, would have further reduced the credibility,
transparency, and timeliness of IRIS assessments. Among other things,
we concluded the following:
* EPA's efforts to finalize IRIS assessments have been impeded by a
combination of factors. These factors include (1) the Office of
Management and Budget's (OMB) requiring two additional reviews of IRIS
assessments by OMB and other federal agencies with an interest in the
assessments, such as the Department of Defense, and (2) EPA management
decisions, such as delaying some assessments to await the results of
new research.
* The two new OMB/interagency reviews of draft assessments involve
other federal agencies in EPA's IRIS assessment process in a manner
that limits the credibility of IRIS assessments and hinders EPA's
ability to manage them. For example, some of the agencies participating
in these reviews could face increased cleanup costs and other legal
liabilities if EPA issued an IRIS assessment for a chemical that
resulted in a decision to regulate the chemical to protect the public.
Moreover, the input these agencies provide to EPA is treated as
"deliberative" and is not released to the public. Regarding EPA's
ability to manage IRIS assessments, without communicating its rationale
for doing so, OMB required EPA to terminate five assessments that for
the first time addressed acute, rather than chronic, exposure--even
though EPA had initiated this type of assessment to help it implement
the Clean Air Act.
* The changes to the IRIS assessment process that EPA was considering,
but had not yet issued at the time of our 2008 review, would have added
to the already unacceptable level of delays in completing IRIS
assessments and would have further limited the credibility of the
assessments. For example, the changes would have allowed potentially
affected federal agencies to have assessments suspended for up to 18
months to conduct additional research. As we reported in 2008, even one
delay can have a domino effect, requiring the assessment process to
essentially be repeated to incorporate changing science.
In April 2008, EPA issued a revised IRIS assessment process. The
process was largely the same as the draft process we had evaluated
during our review and did not respond to the recommendations in our
March 2008 report. Moreover, some key changes were likely to further
exacerbate the productivity and credibility concerns we initially
identified. For example, EPA's revised process formally defined
comments on IRIS assessments from OMB and other federal agencies as
"deliberative" and excluded them from the public record. As we stated
in our report, it is critical that input from all parties--particularly
agencies that may be affected by the outcome of IRIS assessments--be
publicly available. In addition, we concluded that the estimated time
frames under the revised process, especially for chemicals of key
concern, would likely perpetuate the cycle of delays to which the
majority of ongoing assessments have been subject. Instead of
streamlining the process, as we had recommended, EPA institutionalized
a process that from the outset was estimated to take 6 to 8 years for
some widely used chemicals that are likely to cause cancer or other
serious health effects. This was particularly problematic because of
the substantial rework such cases often require to take into account
changing science and methodologies.
Largely as a result of EPA's lack of responsiveness, we added
transforming EPA's processes for assessing and controlling toxic
chemicals as a high-risk area in our January 2009 biennial status
report on governmentwide high-risk areas requiring increased attention
by executive agencies and Congress.[Footnote 3] Taking positive action,
on May 21, 2009, EPA issued a new IRIS assessment process, effective
immediately. In a memorandum announcing the reforms to the IRIS
assessment process, the EPA Administrator echoed our prior findings
that the April 2008 changes to the process reduced the transparency,
timeliness, and scientific integrity of the IRIS process. She noted
that the President's recent emphasis on the importance of transparency
and scientific integrity in government decision making compelled a
rethinking of the IRIS process.[Footnote 4] If effectively implemented,
the new process would be largely responsive to the recommendations
outlined in our March 2008 report.
* First, the new process and the memorandum announcing it indicate that
the IRIS assessment process will be entirely managed by EPA, including
the interagency consultations (formerly called OMB/interagency
reviews). Under EPA's prior process, these two interagency reviews were
required and managed by OMB--and EPA was not allowed to proceed with
assessments at various stages until OMB notified EPA that it had
sufficiently responded to comments from OMB and other agencies. The
independence restored to EPA under the new process is critical in
ensuring that EPA has the ability to develop transparent, credible IRIS
chemical assessments that the agency and other IRIS users, such as
state and local environmental agencies, need to develop adequate
protections for human health and the environment.
* Second, the new process addresses a key transparency concern
highlighted in our 2008 report and testimonies. As we recommended, it
expressly requires that all written comments on draft IRIS assessments
provided during the interagency consultation process by other federal
agencies and White House offices be part of the public record.
* Third, the new process streamlines the previous one by consolidating
and eliminating some steps. Importantly, EPA eliminated the step under
which other federal agencies could have IRIS assessments suspended in
order to conduct additional research, thus returning to EPA's practice
in the 1990s of developing assessments on the basis of the best
available science. As we highlighted in our report, as a general rule,
requiring that IRIS assessments be based on the best science available
at the time of the assessment is a standard that best supports the goal
of completing assessments within reasonable time periods and minimizing
the need to conduct significant levels of rework.[Footnote 5]
* Fourth, as outlined in the EPA Administrator's memorandum announcing
the new IRIS process, the President's fiscal year 2010 budget request
includes an additional $5 million and 10 full-time-equivalent staff
positions for the IRIS program, which is responsive to our
recommendation to assess the level of resources that should be
dedicated in order to meet user needs and maintain a viable IRIS
database.
We are encouraged by the efforts EPA has made to adopt most of our
recommendations, including those addressing transparency practices and
streamlining the lengthy IRIS assessment process. The changes outlined
above reflect a significant redirection of the IRIS process that, if
implemented effectively, can help EPA restore the integrity and
productivity of this important program. Nevertheless, on the basis of
our preliminary review of the new IRIS assessment process, we have some
initial questions that EPA may wish to consider as it implements its
new process. For example, regarding integrity and transparency, it is
not clear:
* whether any significant agreements reached among the federal agencies
during interagency consultation meetings will be documented in the
public record, since the new policy specifies only that written
comments provided by other federal agencies will become part of the
public record; and:
* why comments from other federal agencies cannot be solicited at the
same time the initial draft is sent to independent peer reviewers and
public comments are solicited. This change would enhance transparency
and would further reduce overall assessment time frames. Specifically,
the public and peer reviewers could have greater assurance that the
draft had not been inappropriately biased by policy considerations of
other agencies, including those that may be affected by the outcome,
such as the Department of Defense and the Department of Energy.
In addition, the new assessment process states that "White House
offices" will be involved in the interagency consultation process but
does not indicate which offices. Given that (1) EPA will be performing
the coordinating role that OMB exercised under the prior process and
(2) the purpose of these consultations is to obtain scientific
feedback, it is unclear whether OMB will continue to be involved in the
interagency consultation process.
EPA Has Improved the Policies and Procedures of Its Science Advisory
Board, but Their Wider Use by Other EPA Scientific Advisory Committees
Could Enhance EPA's Scientific Integrity:
Independent, expert peer review of EPA's scientific and regulatory
products, such as risk assessments and proposed rules, is integral to
the agency's ability to effectively protect public health and the
environment. Specifically, using peer review, EPA seeks to enhance the
quality and credibility of the agency's highly specialized products.
One of the several ways EPA obtains expert peer review is from advice
and recommendations it requests of its 24 federal advisory committees
comprising independent experts.[Footnote 6] For example, since its
inception in 1978, one of EPA's largest and most prominent federal
advisory committees--the EPA Science Advisory Board--has convened
hundreds of peer review panels to assess the scientific and technical
rationales underlying a wide range of current or proposed EPA
regulations and policies. The IRIS program uses Science Advisory Board
panels to peer review some of its particularly complex chemical
assessments,[Footnote 7] and the Board is currently expanding a panel
that will review existing IRIS assessment values established more than
10 years ago. Federal advisory committees such as the Science Advisory
Board are subject to the requirements of the Federal Advisory Committee
Act (FACA), which include broad requirements for balance, independence,
and transparency.
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.
These standards, reflected in the act, are important because the work
of fully competent peer review panels can be undermined by allegations
of conflict of interest and bias.
In 2001, we reported on limitations in the policies and procedures
developed by EPA's Science Advisory Board to ensure that its panels'
peer reviewers are independent and that a balance of viewpoints is
represented on each panel. These limitations could reduce the
effectiveness of the Board overall by contributing to its being
perceived as biased and could inadvertently expose some panelists to
violations of federal conflict-of-interest laws.[Footnote 8]
Demonstrating a strong commitment to the integrity of its peer reviews,
EPA took a number of actions to implement our report's recommendations,
including:
* establishing a standard process for Science Advisory Board panel
formation that includes a requirement to document decisions about
conflicts of interest and balance of viewpoints and expertise in
forming each panel, as well as prospective panelists' responses to
several standardized questions aimed at assessing impartiality;
* developing a new confidential financial disclosure form designed to
capture needed information to evaluate potential conflicts of interest;
* allowing the public to review a "short list" of candidates selected
for a specific Science Advisory Board panel and to comment on the
appropriateness of including any of these candidates on the panel; and:
* developing CD-based conflict-of-interest training for Science
Advisory Board panelists.
In 2004, we reported on the policies and procedures at nine federal
departments and agencies, including EPA, that extensively use federal
advisory committees.[Footnote 9] We also identified practices that
promote independence and balance used by the National Academies
[Footnote 10] and the EPA Science Advisory Board.[Footnote 11]
Regarding the latter issue, we concluded that the National Academies
and the EPA Science Advisory Board have developed clear processes that,
if effectively implemented, can provide these organizations with an
assurance that relevant conflicts of interest are identified and
addressed--and that committees are appropriately balanced in terms of
points of view. Specifically, we found that the processes used by the
National Academies and EPA's Science Advisory Board[Footnote 12]
clearly and consistently:
* identify the information they deem necessary to assess candidates for
independence and to balance committees,
* explain to the candidates why the required information is important
to protect the integrity of the committee's work,
* request public comment on proposed committee membership, and:
* require evaluation of the overall balance of committees before
committees are finalized.
Regarding the federal advisory committee policies and procedures at
nine departments and agencies, in 2004 we found that the Departments of
Agriculture, Energy, and the Interior had a long-standing practice of
appointing most or all members of their federal advisory committees as
"representatives"--expected to reflect the views of the entity or group
they are representing and not subject to conflict-of-interest reviews-
-even when the departments called upon the members to provide advice on
behalf of the government on the basis of their best judgment and thus
should have appointed them as special government employees. That is,
members of federal advisory committees that are providing advice on
behalf of the government should be appointed as "special government
employees"--short-term or intermittent employees subject, with some
important modifications, to the conflict-of-interest requirements
applicable to other federal employees.[Footnote 13] We also reported
that representative appointments are generally not appropriate for
scientific and technical advisory committees, which typically provide
advice on behalf of the government. We made recommendations to the two
agencies responsible for overseeing aspects of federal advisory
committees to, among other things, provide additional guidance to
federal agencies on the appropriate use of representative appointments.
In response, these agencies issued such guidance in 2004 and 2005. (See
appendix I for additional information on our 2004 federal advisory
committee recommendations.)
The two scientific EPA federal advisory committees we assessed in our
2004 report appropriately appointed their members as special government
employees. We note that 16 of the 24 EPA federal advisory committees
currently use representative appointments, according to the
government's database of federal advisory committee information. While
EPA may be appropriately seeking stakeholder advice from some of these
advisory committees, a number of its committees focus on scientific and
technical questions for which EPA is likely to be seeking advice on
behalf of the government on the basis of committee members' best
judgment, rather than stakeholder advice. EPA's scientific and
technical committees using representative appointments include the
National Advisory Committee for Acute Exposure Guideline Levels for
Hazardous Substances, the Coastal Elevations and Sea Level Rise
Advisory Committee, the Environmental Laboratory Advisory Board, and
the Children's Health Protection Advisory Committee. In reviewing
information about EPA's committees, we found that descriptions of the
objectives and scope of committee activities for EPA committees using
representative appointments are similar to such descriptions for EPA
committees using special government employees, such as the Science
Advisory Board; the Federal Insecticide, Fungicide, and Rodenticide
Science Advisory Panel; the National Drinking Water Advisory Council;
and the Human Studies Review Board.
As EPA moves forward with actions to enhance its scientific integrity,
it will be appropriate for the agency to review its federal advisory
committee appointments, especially those for which it appoints members
as representatives, to help ensure that committee work is not
jeopardized by allegations of conflict of interest or bias. As
discussed earlier, committee members appointed as representatives are
not evaluated for potential conflicts of interest. If some EPA
committee members are inappropriately appointed as representatives, EPA
cannot be assured that any real or perceived conflicts of interest of
their committee members who provided advice on behalf of the government
were identified and appropriately mitigated. Further, allegations that
the members had conflicts of interest could call into question the
independence of the committee and jeopardize the credibility of the
committee's work.
Advisory committee charters generally expire at the end of 2 years
unless renewed by the agency or Congress. The EPA committees with
representative members discussed earlier have charters expiring in 2009
and 2010. As it reviews its policies and procedures to ensure
scientific integrity, EPA could either comprehensively review the
appointments of its 16 committees with representative members or,
alternatively, review them as the charters are renewed. We note that
EPA has in-house expertise in managing federal advisory committees
composed of special government employees--for example, the staff who
administer and coordinate Science Advisory Board committees--and thus
should be well positioned to address this issue.
In conclusion, EPA's most recent changes to the IRIS assessment
process, if effectively implemented, would represent a significant
improvement over the process put in place in 2008. Among other things,
the reforms appropriately restore EPA's control of the IRIS process and
increase the transparency of the process. In addition, EPA was
responsive to our 2001 recommendations for improving the independence
and balance of committees convened by EPA's Science Advisory Board by
developing policies and procedures that represent best practices. As a
result, if these policies and procedures are implemented effectively,
EPA can have an assurance that its Science Advisory Board panels are
independent and balanced as a whole. However, a number of EPA's other
federal advisory committees do not appear to have benefited from the
steps the Science Advisory Board has taken to enhance the integrity and
transparency of its committees. As EPA takes additional steps to comply
with the President's March 9, 2009, memorandum on scientific integrity,
we believe that EPA's scientific processes could be further enhanced by
considering our questions about some aspects of the IRIS assessment
process and reviewing its federal advisory committee appointments.
Madam Chairman, this concludes my prepared statement. I would be happy
to respond to any questions that you or other Members of the Committee
may have at this time.
GAO Contacts and Staff Acknowledgments:
For further information about this testimony, please contact John B.
Stephenson at (202) 512-3841 or stephensonj@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this statement. Contributors to this testimony
include Christine Fishkin (Assistant Director), Laura Gatz, Richard P.
Johnson, Summer Lingard, Nancy Crothers, Antoinette Capaccio, and Carol
Kolarik.
[End of section]
Appendix I: Information on GAO's 2004 Federal Advisory Committee
Recommendations:
Following are highlights of the recommendations in our 2004 report,
Federal Advisory Committees: Additional Guidance Could Help Agencies
Better Ensure Independence and Balance,[Footnote 14] to the General
Services Administration (GSA) and the Office of Government Ethics
(OGE). These agencies oversee aspects of federal advisory committees.
Specifically, GSA develops guidance on establishing and managing
Federal Advisory Committee Act (FACA) committees, and OGE develops
regulations and guidance for statutory conflict-of-interest provisions
that apply to special government employees.
Our 2004 report contained recommendations to GSA and OGE to, among
other things, provide additional guidance to federal agencies on the
appropriate use of representative appointments. Specifically, we
recommended that guidance from OGE to agencies be improved to better
ensure that members appointed to committees as representatives were, in
fact, representing a recognizable group or entity. OGE agreed that some
agencies may have been inappropriately identifying certain advisory
committee members as representatives instead of special government
employees and issued guidance documents in July 2004 and August 2005
that clarified the distinction between special government employees and
representative members. In particular, as we recommended, OGE's
clarifications included that (1) members should not be appointed as
representatives purely on the basis of their expertise and (2)
appointments as representatives are limited to circumstances in which
the members are speaking as stakeholders for the entities for groups
they represent.
We also recommended that OGE and GSA modify their FACA training
materials to incorporate the changes in guidance regarding the
appointment process, which they have done. In addition, we recommended
that GSA expand its FACA database to identify each committee member's
appointment category and, for representative members, the entity or
group represented. GSA quickly implemented this recommendation and now
has data on appointments beginning in 2005. Finally, we recommended
that OGE and GSA direct agencies to review their appointments of
representative and special government employee committee members to
make sure they are appropriate. OGE's 2004 and 2005 guidance documents
addressed this issue by, among other things, recommending that agency
ethics officials periodically review appointment designations to ensure
they are proper.
[End of section]
Related GAO Products:
High-Risk Series, An Update. [hyperlink,
http://www.gao.gov/products/GAO-09-271]. Washington, D.C.: January.
2009.
EPA Science: New Assessment Process Further Limits the Credibility and
Timeliness of EPA's Assessments of Toxic Chemicals. [hyperlink,
http://www.gao.gov/products/GAO-08-1168T]. Washington, D.C.: September
18, 2008.
Environmental Health: EPA Efforts to Address Children's Health Issues
Need Greater Focus, Direction, and Top-Level Commitment. [hyperlink,
http://www.gao.gov/products/GAO-08-1155T]. Washington, D.C.: September
16, 2008.
Chemical Assessments: EPA's New Assessment Process Will Further Limit
the Productivity and Credibility of Its Integrated Risk Information
System. [hyperlink, http://www.gao.gov/products/GAO-08-810T].
Washington, D.C.: May 21, 2008.
Toxic Chemicals: EPA's New Assessment Process Will Increase Challenges
EPA Faces in Evaluating and Regulating Chemicals. [hyperlink,
http://www.gao.gov/products/GAO-08-743T]. Washington, D.C.: April 29,
2008.
Federal Advisory Committee Act: Issues Related to the Independence and
Balance of Advisory Committees. [hyperlink,
http://www.gao.gov/products/GAO-08-611T]. Washington, D.C.: April 2,
2008.
Chemical Assessments: Low Productivity and New Interagency Review
Process Limit the Usefulness and Credibility of EPA's Integrated Risk
Information System. [hyperlink,
http://www.gao.gov/products/GAO-08-440]. Washington, D.C.: March 7,
2008.
Federal Advisory Committees: Additional Guidance Could Help Agencies
Better Ensure Independence and Balance. [hyperlink,
http://www.gao.gov/products/GAO-04-328]. (Washington, D.C.: April 16,
2004.
EPA's Science Advisory Board Panels: Improved Policies and Procedures
Needed to Ensure Independence and Balance. [hyperlink,
http://www.gao.gov/products/GAO-01-536]. Washington, D.C.: June 12,
2001.
[End of section]
Footnotes:
[1] GAO, Chemical Assessments: Low Productivity and New Interagency
Review Process Limit the Usefulness and Credibility of EPA's Integrated
Risk Information System, [hyperlink,
http://www.gao.gov/products/GAO-08-440] (Washington, D.C.: Mar. 7,
2008).
[2] See Related GAO Products in Appendix I.
[3] GAO, High Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January
2009).
[4] EPA Memorandum, "New Process for Development of Integrated Risk
Information System Health Assessments" (Washington, D.C.: May 21,
2009).
[5] As also stated in our report, we understand that under exceptional
circumstances, it may be appropriate to wait for the results of an
important ongoing study, such as a major epidemiological study that
will provide new, critical data for an assessment.
[6] EPA peer reviews may also be obtained by letter reviews, panels of
experts established and managed by contractors, and panels convened by
the National Academies.
[7] Other IRIS assessments are peer reviewed by panels convened by an
EPA contractor or the National Academies.
[8] GAO, EPA's Science Advisory Board Panels: Improved Policies and
Procedures Needed to Ensure Independence and Balance, [hyperlink,
http://www.gao.gov/products/GAO-01-536] (Washington, D.C.: June 12,
2001).
[9] The nine departments and agencies are the Departments of
Agriculture; Energy; the Interior; and Health and Human Services (HHS)
and, within HHS, the Centers for Disease Control and Prevention, Food
and Drug Administration, and the National Institutes of Health; the
National Aeronautics and Space Administration; and the Environmental
Protection Agency.
[10] The National Academies consist of four private, nonprofit
organizations that advise the federal government on scientific and
technical matters: the National Academy of Sciences, National Academy
of Engineering, Institute of Medicine, and National Research Council.
[11] GAO, Federal Advisory Committees: Additional Guidance Could Help
Agencies Better Ensure Independence and Balance, [hyperlink,
http://www.gao.gov/products/GAO-04-328] (Washington, D.C.: Apr.16,
2004).
[12] We also reported that EPA's Federal Insecticide, Fungicide, and
Rodenticide Scientific Advisory Panel has a committee formation process
similar to that of the Science Advisory Board.
[13] Special government employees serving on federal advisory
committees are provided with an exemption that allows them to
participate in particular matters that have a direct and predictable
effect on their financial interest if the interest arises from their
nonfederal employment and the matter will not a have a special or
distinct effect on the employee or employer other than as part of a
class.
[14] [hyperlink, http://www.gao.gov/products/GAO-04-328].
[End of section]
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