The Viability of the IRIS Program Is at Risk

In March 2008, we reported that the IRIS program is at serious risk of  becoming obsolete because the agency has not been able to complete  timely, credible chemical assessments or decrease its backlog of 70  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 timeliness, credibility, and  transparency of IRIS assessments. Among other things, we concluded the  following:    EPA was unable to routinely complete IRIS assessments in a timely  manner. From 2000 to 2007, EPA completed on average about five IRIS  assessments a year. The more recent trend has been a decline in  productivity: In fiscal years 2006 and 2007, EPA completed two  assessments each year; in 2008, EPA completed five assessments—four of  which were related chemicals assessed and peer reviewed together but  finalized individually; and thus far in fiscal year 2009, EPA has finalized  one assessment.
Further, as we reported in 2008, because EPA staff time was dedicated to  completing assessments in the backlog, EPA’s ability to both keep the  more than 540 existing assessments up to date and initiate new  assessments was limited. We found that 48 of the 70 assessments being  conducted as of December 2007 had been in process for more than 5  years—and 12 of those, for more than 9 years. These time frames have  lengthened. Currently, of those 70 assessments, 58 have now been ongoing  for more than 5 years—and 31 of those for more than 9 years.
We also found that EPA’s efforts to finalize IRIS assessments have been  thwarted 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 and transparency of, and hinders EPA’s ability to manage,  IRIS assessments. For example, some of these agencies’ review comments  could be influenced by the potential for increased environmental 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 its IRIS assessments, in 2007 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  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. As we  testified before this subcommittee in May 2008, the new process was  largely the same as the draft 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 credibility and  productivity concerns we had 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 have stated, it is critical that input from all parties— particularly agencies that may be directly affected by the outcome of IRIS  assessments—be publicly available. In addition, the estimated time frames  under the revised process, especially for chemicals of key concern, would  have likely perpetuated 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 chemicals of  key concern that are both widespread and likely to cause cancer or other  serious health effects. This was particularly problematic because of the  substantial rework often required to take into account changing science  and methodologies.

	EPA’s Latest IRIS Process Reforms Appear Largely Responsive to Our Recommendations, but Their Success Will Depend on Effective Management

Overall, EPA’s May 2009 IRIS assessment process reforms represent  significant improvements and, if implemented effectively, would be largely  responsive to the recommendations made 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.
Fourth, as outlined in the EPA Administrator’s memorandum announcing  the new IRIS process, the President’s budget request for fiscal year 2010  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 to the IRIS program  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 EPA’s ability to manage its  IRIS assessment process, 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 credibility and increase the productivity of this  important program. While these broad reforms provide a sound general  framework for conducting IRIS assessments, the manner in which EPA  implements the new process will determine whether the agency will be  able to overcome its long-standing productivity problems and complete  credible and transparent assessments. Specifically, management attention  is warranted on certain aspects of the new process that are incomplete or  lack clarity.
EPA’s estimated time frames of about 2 years for standard IRIS  assessments—those that are not particularly complex or controversial— do not include the time required to complete two steps that are  nonetheless included in the assessment process. As a result, EPA has  likely understated the time required to complete an assessment. The steps  lacking time frames—the scientific literature review and the request to the  public and other agencies to submit relevant research (the data call-in)— are integral to developing an assessment. In prior IRIS assessment  processes, EPA provided time frames for these steps. Importantly,  including the time frames for these steps would likely bring the estimated  overall time for completing standard assessments closer to 3 years. We  note that this more realistic time frame may be problematic because when  assessments take longer than 2 years, they can become subject to  substantial delays stemming from the need to redo key analyses to take  into account changing science and assessment methodologies.
While EPA states that some IRIS assessments may take longer because of  their complexity, large scientific literature base, or high profile, the agency  does not provide any guidance on likely or expected time frames for  assessments of these chemicals. This is noteworthy because we found that  EPA has not been able to complete assessments of the most important  chemicals of concern, such as those likely to cause cancer or other  significant health effects. For example, EPA’s assessment of dioxin has  been ongoing for 18 years. It is critical that EPA establish time frames to  enable the agency to manage complex assessments.
EPA’s new process does not include a discussion of key planning steps.
Specifically, it omits important preassessment steps included in prior  processes—such as a call for nominations of chemicals to be assessed and  the establishment of the IRIS agenda, which is list of chemicals that EPA  plans to assess. Accordingly, it is not clear whether or when EPA will  implement our recommendation that it provide at least 2 years’ notice of  planned assessments. Among other things, doing so would give agencies  and the public more advance notice of planned assessments and enable  external parties with an interest in a given chemical to, for example,  complete relevant research before the start of an IRIS assessment.
Particularly in light of the fact that EPA’s estimates for completing  assessments are likely understated, we believe that the agency should  continue to look for additional opportunities to streamline its process. For  example, it is not clear why EPA could not solicit comments from other  federal agencies at the same time it sends the initial draft assessment to  independent peer reviewers and publishes it in the Federal Register for  public comment. In addition to reducing overall assessment time frames,  this change could enhance transparency. Specifically, by obtaining the first  draft of the assessment at the same time as the other federal agencies, the  public and peer reviewers could have greater assurance that the draft had  not been inappropriately biased by policy considerations of these  agencies, including ones that may be affected by the assessment’s  outcome, such as the Departments of Defense and Energy. Some of these  agencies and their contractors could, for example, 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.
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 specified in its new assessment process that written comments  provided by other federal agencies will become part of the public record.  However, it is silent as to the purpose of the consultation meetings and, if  applicable, whether EPA plans to document for the public record any  significant oral agreements or decisions made at the consultation  meetings. In order to ensure transparency and alleviate any concerns of  potential bias in the assessments, it will be important for EPA to be clear  on these matters.
In addition to addressing these issues, the viability of the IRIS program  will depend on effective and sustained management and oversight.  Collectively, a number of factors that can impede the progress of IRIS  assessments present significant management challenges. These include the  following:    Unlike a number of other EPA programs with statutory deadlines for  completing various activities, no enforceable deadlines apply to the IRIS  program. We have stated in previous testimonies on the IRIS program that  if EPA is not able to effectively maintain this critical program, other  approaches, including statutory requirements, may need to be explored.  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 consistently are. These chronic  delays in completing IRIS assessments have detrimental consequences for  EPA’s ability to develop timely and scientifically sound decisions, policies,  and regulations.
Science and methodologies are constantly changing. Thus, there will  always be a tension between assessing the best available science and  waiting for more information. IRIS will remain viable only if it returns to  its model of using 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 impacted 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,  credible expert review, and completing the assessments.
The IRIS assessment process has been frequently changed in recent years;  IRIS process reforms, such as those recently issued, are not established in  a regulation or statute and thus can easily be altered. As we have reported,  EPA’s continual changes present a challenge to the chemical managers  who are undertaking the assessments, particularly in the absence of  current operating procedures to guide chemical managers on basic  procedures and program management responsibilities for the  development, review, and finalization of IRIS assessments.
In conclusion, EPA’s most recent changes to the IRIS assessment process  appear to represent a significant improvement over the process put in  place in 2008. That is, if implemented effectively, the changes may  appropriately restore to EPA its control of the IRIS process, increase the  transparency of the process, and streamline aspects of the process, among  other things. We believe that the agency’s ability to produce timely,  credible, and transparent assessments will also depend in large measure  on clear implementation procedures and rigorous management oversight,  given the numerous factors that can impede EPA’s ability to complete  timely IRIS assessments and the lack of clarity on some aspects of the new  process. Perhaps most importantly, EPA needs to hold itself more  accountable to the public and Congress for carrying out this important  component of its mission, especially since the IRIS program is  discretionary.
Mr. Chairman, 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 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.

Related GAO Products

Scientific Integrity: EPA’s Efforts to Enhance the Credibility and  Transparency of Its Scientific Processes. GAO-09-773T. Washington, D.C.:  June 9, 2009.
High-Risk Series, An Update. 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. 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. 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.  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. GAO-08-440. Washington, D.C.: March 7, 2008.
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Summary:
Why GAO Did This Study

The Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) contains EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals. Toxicity assessments in the IRIS database constitute the first two critical steps of the risk assessment process, which in turn provides the foundation for risk management decisions. Thus, IRIS is a critical component of EPA's capacity to support scientifically sound environmental decisions, policies, and regulations. GAO's 2008 report on the IRIS program identified significant concerns that, coupled with the importance of the program, caused GAO to add 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. This testimony discusses (1) the findings from GAO's March 2008 report Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA's Integrated Risk Information System and related testimonies and (2) GAO's preliminary evaluation of the revised IRIS assessment process EPA issued on May 21, 2009. For this testimony, GAO supplemented its prior audit work with a preliminary review of the new assessment process and some IRIS productivity data.

What GAO Found

In March 2008, GAOreported that the viability of the IRIS program is at risk because EPA has been unable to complete timely, credible chemical assessments or decrease its backlog of ongoing assessments. In addition, assessment process changes EPA had recently made, and other changes itwas considering at the time of GAO's review, would have further reduced the timeliness, credibility, and transparency of IRIS assessments. Among other things, GAO found that EPA's efforts to finalize IRIS assessments have been impeded by a combination of factors, including 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. Moreover, the two OMB/interagency reviews involved other federal agencies in EPA's IRIS assessment process in a manner that hindered EPA's ability to manage its assessments and limited their credibility and transparency. For example, the input these agencies provided to EPA was treated as "deliberative" and was not released to the public. In April 2008, EPA issued a revised IRIS assessment process. As GAO testified before this subcommittee in May 2008, the new process did not respond to GAO's March 2008 recommendations, and some key changes were likely to further exacerbate the credibility and productivity concerns GAO had identified. Overall, EPA's May 2009 IRIS assessment process reforms represent significant improvements and, if implemented effectively, would be largely responsive to GAO's March 2008 recommendations. For example, under the new process EPA is to manage the entire assessment process, including the interagency reviews. Under EPA's prior process, these reviews were required and managed by OMB--and at various stages, EPA was not allowed to proceed with assessments 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 will be critical to ensuring that EPA has the ability to develop transparent, credible IRIS chemical assessments. While the broad reforms provide a sound general framework for conducting IRIS assessments, the manner in which EPA implements the new process will determine whether the agency will be able to overcome its long-standing productivity problems and complete credible and transparent assessments. Specifically, certain aspects of the new process are incomplete or lack clarity and thus warrant management attention. For example, EPA has likely understated the time required to complete an assessment because its estimated time frames do not include the time required to complete two key steps. Overall, the viability of the IRIS program will depend on effective and sustained management and oversight, especially given the number of factors that can impede the progress of IRIS assessments. For example, even one delay in an assessment can have a domino effect, requiring the process to essentially be repeated to incorporate changing science. In addition, unlike some other EPA programs with statutory deadlines for completing various activities, the IRIS program is discretionary. GAO believes the absence of legal consequences for delays in completing assessments may contribute to EPA's failure to complete timely IRIS assessments.