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United States Government Accountability Office: 
GAO: 

Testimony: 

Before the Subcommittee on Environment and the Economy, Committee on 
Energy and Commerce, House of Representatives: 

For Release on Delivery: 
Expected at 9:00 a.m. EDT:
Thursday, October 6, 2011: 

EPA Health Risk Assessments: 

Oversight and Sustained Management Key to Overcoming Challenges: 

Statement of David C. Trimble, Director:
Natural Resources and Environment: 

GAO-12-148T: 

Chairman Shimkus, Ranking Member Green, 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 550 
chemicals in the environment and is a critical component of EPA's 
capacity to support its mission. IRIS assessments provide the 
scientific input to risk management decisions, such as whether EPA 
should establish air and water quality standards to protect the public 
from exposure to toxic chemicals or set cleanup standards for 
hazardous waste sites. Consequently, IRIS assessments are a critical 
component of EPA's capacity to support scientifically sound decisions, 
policies, and regulations. 

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 and July 2011, 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 
Department of Defense. 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 July 2011,[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 July 2011 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, continual 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. 

In addition to these challenges, in our May 2011 report on EPA's 
implementation of the Safe Drinking Water Act,[Footnote 9] we noted 
that the inability of the IRIS program to provide the Office of Water 
with new and updated IRIS assessments in a timely manner has impeded 
effective implementation of EPA's regulatory determinations for 
drinking water contaminants.[Footnote 10] When publishing the latest 
list of chemicals being considered for regulation (contaminant 
candidate list) in 2009, EPA identified health effects information 
gaps for 44 of the 104 chemicals on the list. We also note that EPA 
must address its backlog of demand for IRIS assessments. Moreover, EPA 
program offices and state and local entities have identified needs for 
assessments of hundreds of chemicals not yet in IRIS. In addition, as 
we previously reported, chemicals currently in the IRIS database may 
potentially need to be updated with new information that would either 
(1) change an existing risk estimate and/or (2) allow EPA to develop 
additional risk estimates. 

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; Antoinette C. Capaccio; Lorraine Ettaro; Robert Grace; Carol 
Kolarik; and Jamie Meuwissen. 

[End of section] 

Related GAO Products: 

EPA Health Risk Assessments: Sustained Management and Oversight Key to 
Overcoming Challenges. [hyperlink, 
http://www.gao.gov/products/GAO-11-824T]. Washington, D.C.: July 14, 
2011. 

Safe Drinking Water Act: EPA Should Improve Implementation of 
Requirements on Whether to Regulate Additional Contaminants. 
[hyperlink, http://www.gao.gov/products/GAO-11-254]. Washington, D.C.: 
May 27, 2011. 

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 Health Risk Assessments: Sustained Management and 
Oversight Key to Overcoming Challenges, [hyperlink, 
http://www.gao.gov/products/GAO-11-824T] (Washington, D.C.: July 14, 
2011). 

[8] [hyperlink, http://www.gao.gov/products/GAO-09-774T]. 

[9] GAO, Safe Drinking Water Act: EPA Should Improve Implementation of 
Requirements on Whether to Regulate Additional Contaminants. 
[hyperlink, http://www.gao.gov/products/GAO-11-254] (Washington, D.C.: 
May 27, 2011). 

[10] Under the 1996 amendments to the Safe Drinking Water Act, which 
remain in effect, EPA is to select for consideration those unregulated 
contaminants that present the greatest public health concern, evaluate 
their occurrence and the potential health risks associated with them, 
and decide whether a regulation is needed for at least five 
contaminants every 5 years. 

[End of section] 

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