EPA Health Risk Assessments
Sustained Management and Oversight Key to Overcoming Challenges Gao ID: GAO-11-824T July 14, 2011In Process
From March through September 2008, we reported on shortcomings in EPA's IRIS process that limited the agency's ability to complete timely and credible IRIS assessments. For example, the Office of Management and Budget (OMB) required and managed interagency reviews of IRIS assessments, and OMB determined when assessments could proceed to the next process step, frequently resulting in delayed IRIS assessments. Such shortcomings contributed to our decision to designate the IRIS program as a high-risk area in January 2009. In June 2009, we testified that EPA's May 2009 IRIS assessment process reforms, if implemented effectively, would represent a significant improvement over the previous IRIS process by restoring EPA control, establishing transparency, and streamlining the process. We are currently undertaking a review of EPA's revised 2009 IRIS assessment process and the agency's progress in implementing it and plan to issue a report later this year.
GAO-11-824T, EPA Health Risk Assessments: Sustained Management and Oversight Key to Overcoming Challenges
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United States Government Accountability Office:
GAO:
Testimony:
Before the Subcommittee on Investigations and Oversight, Committee on
Science, Space, and Technology, House of Representatives:
For Release on Delivery:
Expected at 10:00 a.m. EDT:
Thursday, July 14, 2011:
EPA Health Risk Assessments:
Sustained Management and Oversight Key to Overcoming Challenges:
Statement of David Trimble, Director:
Natural Resources and Environment:
GAO-11-824T:
Chairman Broun, Ranking Member Edwards, and Members of the
Subcommittee:
I am pleased to be here today to discuss our prior work on the
Environmental Protection Agency's (EPA) Integrated Risk Information
System (IRIS) program and database. As you know, IRIS is one of the
most significant tools that EPA has developed to support its mission
to protect people and the environment from harmful chemical exposures.
The IRIS database contains EPA's scientific position on the potential
human health effects that may result from exposure to more than 540
chemicals in the environment and is a critical component of EPA's
capacity to support its mission.
EPA created IRIS in 1985 to help the agency develop consensus opinions
within the agency about the health effects from chronic exposure to
chemicals. Over time, the importance of the program has increased as
EPA program offices, state and local environmental programs, and some
international regulatory bodies have increasingly relied on IRIS
health risk assessment information to support risk-based decision
making to protect public health and the environment. As the IRIS
database became more widely used and accepted, EPA took steps,
beginning in the early 1990s, to improve and maintain the IRIS program
and database. Over the years, the agency has implemented a variety of
new operational procedures aimed at improving the IRIS program and
database--with the most recent change to its IRIS assessment process
occurring in May 2009.
Because of the potential for EPA's health risk assessments to lead to
regulations that can significantly affect certain industries or
federal agencies, IRIS assessments have frequently received
considerable attention. For example, in recent months, much attention
has been focused on EPA's draft health risk assessment of formaldehyde
and the National Academies' review of the draft assessment.[Footnote
1] In addition to reviewing the draft assessment of formaldehyde, the
National Academies' report also offered some suggestions for improving
the preparation and presentation of draft health risk assessments in
general. Our work to date has not focused on these aspects of IRIS
assessments.
Instead, our body of work on the IRIS program has more broadly
evaluated the overall IRIS assessment process and the challenges the
program has faced in implementing it. In March 2008, we reported that
the IRIS database was at serious risk of becoming obsolete because EPA
had not been able to routinely complete timely, credible assessments.
[Footnote 2] After subsequent reports,[Footnote 3] in January 2009 we
added EPA's processes for assessing and controlling toxic chemicals to
our list of areas at high risk for waste, fraud, abuse, and
mismanagement or in need of broad-based transformation.[Footnote 4] We
are currently undertaking a review of EPA's revised 2009 IRIS
assessment process and the agency's progress in implementing it and
plan to issue a report later this year.
In this context, my testimony today discusses our past work on (1) the
timeliness and credibility of IRIS assessments and (2) EPA's May 2009
IRIS assessment process. We conducted the performance audit work that
supports this statement in accordance with generally accepted
government auditing standards. Additional information on our scope and
methodology is available in each issued product.
Summary:
From March through September 2008, we reported on shortcomings in
EPA's IRIS process that limited the agency's ability to complete
timely and credible IRIS assessments. For example, the Office of
Management and Budget (OMB) required and managed interagency reviews
of IRIS assessments, and OMB determined when assessments could proceed
to the next process step, frequently resulting in delayed IRIS
assessments. Such shortcomings contributed to our decision to
designate the IRIS program as a high-risk area in January 2009. In
June 2009, we testified that EPA's May 2009 IRIS assessment process
reforms, if implemented effectively, would represent a significant
improvement over the previous IRIS process by restoring EPA control,
establishing transparency, and streamlining the process. We are
currently undertaking a review of EPA's revised 2009 IRIS assessment
process and the agency's progress in implementing it and plan to issue
a report later this year.
EPA's Inability to Complete Timely, Credible IRIS Assessments
Contributed to the Program's High-Risk Designation:
From March through September 2008, we reported on shortcomings in
EPA's IRIS process that limited the agency's ability to complete
timely and credible IRIS assessments.[Footnote 5] These shortcomings
contributed to our decision to designate the IRIS program as a high-
risk area. Specifically, beginning in 2004, OMB began requiring and
managing two interagency reviews of IRIS assessments by OMB and other
federal agencies with an interest in these assessments, such as the
Departments of Defense and Energy. These reviews contributed to
concerns about the timeliness and credibility of IRIS assessments. In
particular, EPA was not allowed to move forward with an assessment
until OMB determined that EPA had satisfactorily addressed all OMB and
other federal agency comments. As a result, IRIS assessments were
frequently delayed. In addition, the content of the OMB-required
reviews was not publicly available, thus limiting the transparency and
the credibility of IRIS assessments. The credibility of the
assessments was further limited by the involvement of other federal
agencies that could be affected by the assessments if they led to
regulatory actions. That is, if EPA issued an IRIS assessment that
resulted in a decision to regulate a chemical to protect the public,
some of the agencies participating in these reviews, such as the
Department of Defense, could face increased cleanup costs and other
legal liabilities.
In addition, some EPA management decisions to suspend ongoing IRIS
assessments to wait for new and ongoing scientific studies to be
completed also limited the timeliness of IRIS assessments. In fact,
EPA's decisions to await the results of new and ongoing studies before
completing some IRIS assessments resulted, in some cases, in delaying
them for years. We understand that there may be exceptional
circumstances under which 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. However,
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 would best support a goal of completing assessments within
reasonable time periods and minimizing the need to conduct significant
levels of rework, as we reported in March 2008.
Moreover, in April 2008, EPA revised its IRIS assessment process, but
the revised process did not address the issues we raised in our March
2008 report.[Footnote 6] More specifically, our report contained
recommendations for EPA to reevaluate its proposed revisions to the
IRIS assessment process and to streamline the process to better ensure
that EPA had the ability to develop transparent, credible assessments.
However, in April 2008, EPA issued a revised IRIS assessment process
that was largely the same as the proposed revisions that we had
evaluated and had taken issue with during our review.
As a result of these and other issues, in January 2009 we added
transforming EPA's processes for assessing and controlling toxic
chemicals to our list of high-risk areas.
EPA's May 2009 IRIS Assessment Process Reforms Appeared to Represent
Significant Improvement, but the Viability of the IRIS Program Will
Depend on Effective and Sustained Management and Oversight:
As we testified before the House Subcommittee on Investigations and
Oversight in June 2009,[Footnote 7] the IRIS assessment process
reforms instituted by EPA in May 2009 appeared to represent a
significant improvement over the previous IRIS process and, if
implemented effectively, with sustained management and oversight,
could help EPA restore the credibility and increase the timeliness of
this important program. The reforms included the following:
* Restored EPA control. The new process and the memorandum announcing
it indicated that the IRIS assessment process would be entirely
managed by EPA, including the interagency science consultations
(formerly called interagency reviews). Under EPA's prior process,
these two interagency reviews were required and managed by OMB, and
OMB determined when assessments could proceed to the next process
step. The control 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.
* Established transparency. The new process addressed a key
transparency concern highlighted in our 2008 report and subsequent
testimonies. As we recommended, the new process expressly required
that all written comments on draft IRIS assessments provided during
interagency science consultations by other federal agencies and OMB be
part of the public record.
* Streamlined process. The new process streamlined the previous one by
consolidating and eliminating some steps. Importantly, EPA eliminated
the step under which other federal agencies could cause IRIS
assessments to be 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 noted
previously, long delays to await the results of new scientific
research do not support a goal of completing assessments within
reasonable time periods and minimizing the need to conduct significant
levels of rework.
Although EPA's May 2009 IRIS assessment process appeared to represent
a significant improvement over the previous IRIS process, we testified
in June 2009 that the viability of the IRIS program would depend on
effective and sustained management and oversight. We identified the
following factors that collectively could present significant
management challenges to EPA's ability to complete timely, credible
IRIS assessments.
* Unlike a number of other EPA programs with statutory deadlines for
completing various activities, no enforceable deadlines apply to the
IRIS program. We believe the absence of statutory deadlines may
contribute to EPA's failure to complete timely IRIS assessments. For
example, assessment schedules can easily be extended--and frequently
are. Chronic delays in completing IRIS assessments have detrimental
consequences for EPA's ability to develop timely and scientifically
sound decisions, policies, and regulations.
* Because science and methodologies are constantly changing, there
will always be a tension between assessing the best available science
and waiting for more information. The IRIS program will remain viable
only if it continues to use the best science available at the time of
its assessments and plans for periodic updates of assessments to
identify the need for revisions.
* An overarching factor that affects EPA's ability to complete IRIS
assessments in a timely manner is the compounding effect of delays--
even one delay can have a domino effect, requiring the process to
essentially be repeated to incorporate changing science. For example,
delays often require repeating reviews of the scientific literature on
a chemical to take into account the time that has passed since the
literature review was completed; this, in turn, may require detailed
analyses of any new studies found to be relevant.
* Long-standing difficulties in completing assessments of chemicals of
key concern--those that are both widespread and likely to cause
significant health issues--stem in part from challenges by external
parties, including those that may be affected by EPA regulation of
chemicals should an assessment lead to such action. Such challenges
are to be expected and can be best addressed by EPA's focusing on the
best available science, obtaining credible expert review, and
completing the assessments.
* IRIS process reforms, such as those issued in May 2009, are not
established in regulation or statute and thus can easily be altered.
As we have reported, continuous changes to the process have presented
a challenge to the chemical managers who undertake the
assessments.[Footnote 8] To produce timely, credible IRIS assessments
over a sustained period of time, it will be important for EPA to
maintain a stable, consistent process going forward.
Chairman Broun, Ranking Member Edwards, and Members of the
Subcommittee, this concludes my prepared statement. I would be happy
to respond to any questions that you or other Members of the
Subcommittee may have at this time.
GAO Contact and Staff Acknowledgments:
For further information on this statement, please contact David
Trimble at (202) 512-3841 or trimbled@gao.gov. Contact points for our
Congressional Relations and Public Affairs offices may be found on the
last page of this statement. Other staff that made key contributions
to this testimony include Diane LoFaro, Assistant Director; Summer
Lingard; Christine Fishkin; Nancy Crothers; Richard P. Johnson; Kiki
Theodoropoulos; Robert Grace; and Jennifer Cheung.
[End of section]
Related GAO Products:
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-11-278]. Washington, D.C.: February
2011.
EPA Chemical Assessments: Process Reforms Offer the Potential to
Address Key Problems. [hyperlink,
http://www.gao.gov/products/GAO-09-774T]. Washington, D.C.: June 11,
2009.
Scientific Integrity: EPA's Efforts to Enhance the Credibility and
Transparency of Its Scientific Processes. [hyperlink,
http://www.gao.gov/products/GAO-09-773T]. Washington, D.C.: June 9,
2009.
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.
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.
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.
[End of section]
Footnotes:
[1] The National Academies comprises four organizations: the National
Academy of Sciences, the National Academy of Engineering, the
Institute of Medicine, and the National Research Council.
[2] 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).
[3] GAO, 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.: Apr. 29, 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); and 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.: Sept. 18, 2008).
[4] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January
2009). This high-risk area addresses EPA's implementation of the IRIS
program as well as implementation of the Toxic Substances Control Act
(TSCA).
[5] [hyperlink, http://www.gao.gov/products/GAO-08-440], [hyperlink,
http://www.gao.gov/products/GAO-08-743T], [hyperlink,
http://www.gao.gov/products/GAO-08-810T], and [hyperlink,
http://www.gao.gov/products/GAO-08-1168T].
[6] [hyperlink, http://www.gao.gov/products/GAO-08-440].
[7] GAO, EPA Chemical Assessments: Process Reforms Offer the Potential
to Address Key Problems, [hyperlink,
http://www.gao.gov/products/GAO-09-774T] (Washington, D.C.: June 11,
2009).
[8] [hyperlink, http://www.gao.gov/products/GAO-09-774T].
[End of section]
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