Chemical Assessments: EPA's New Assessment Process Will Further Limit the Productivity and Credibility of Its Integrated Risk Information System
Published: 2008-05-21T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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. This testimony discusses (1) highlights of 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 (2) key aspects of EPA's revised IRIS assessment process, released on April 10, 2008. For the March 2008 report, GAO reviewed and analyzed EPA data and interviewed officials at relevant agencies, including the Office of Management and Budget (OMB). For this testimony, GAO supplemented the prior audit work with a review of EPA's revised IRIS assessment process announced on April 10, 2008.
section_title: What GAO Found
paragraphs: In its March 2008 report, GAO concluded that the IRIS database is at serious risk of becoming obsolete because EPA has not been able to routinely complete timely, credible assessments or decrease its backlog of 70 ongoing assessments--a total of 4 were completed in fiscal years 2006 and 2007. In addition, recent assessment process changes, as well as other changes EPA was considering at the time of GAO's review, further reduce the timeliness and credibility of IRIS assessments. EPA's efforts to finalize assessments have been thwarted by a combination of factors, including two new OMB-required reviews of IRIS assessments by OMB and other federal agencies; EPA management decisions, such as delaying some assessments to await new research; and the compounding effect of delays-even one delay can have a domino effect, requiring the process to essentially be repeated. 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, the OMB/interagency reviews lack transparency, and OMB required EPA to terminate five assessments EPA had initiated 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 review, would have added to the already unacceptable level of delays in completing IRIS assessments and further limited the credibility of the assessments. On April 10, 2008, EPA issued its revised IRIS assessment process, effective immediately. In its February 2008 comments on GAO's draft report, EPA said it would consider the report's recommendations, which were aimed at streamlining the process and better ensuring that EPA has the ability to develop transparent, credible assessments. However, EPA's new process is largely the same as the draft GAO evaluated, and some key changes are likely to further exacerbate the productivity and credibility concerns GAO identified. For example, while the draft process would have made comments from other federal agencies on IRIS assessments part of the public record, EPA's new process expressly defines such comments as "deliberative" and excludes them from the public record. GAO continues to believe that 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, the estimated time frames under the new process, especially for chemicals of key concern, will likely perpetuate the cycle of delays to which the majority of ongoing assessments have been subject. Instead of significantly streamlining the process, which GAO recommended, EPA has institutionalized a process that from the outset is estimated to take 6 to 8 years to complete. This is problematic because of the substantial rework such cases often require to take into account changing science and methodologies. Since EPA's new process is not responsive to GAO's recommendations, the viability of this critical database has been further jeopardized.

section_title: Letter
paragraphs: I am pleased to be here today to discuss issues associated with the  Environmental Protection Agency’s (EPA) Integrated Risk Information  System (IRIS)—one of the most significant tools that EPA has developed  to effectively support its mission of protecting people and the environment  from harmful chemical exposures. IRIS 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 scientifically sound risk management decisions,  policies, and regulations. IRIS is also relied upon by state and local  environmental programs and some international regulatory bodies for  managing their environmental protection programs. As shown in figure 1,  the toxicity assessments in the IRIS database fulfill the first two critical  steps of the four-step risk assessment process—providing hazard  identification and quantitative dose-response assessments. IRIS  information can then be used with the results of exposure assessments  (typically conducted by EPA’s program or regional offices) to provide an  overall characterization of the public health risks for a given chemical in a  given situation. The development of health risk assessments is thus  directly dependent on the development of toxicity assessments such as  those developed in the IRIS program.
Under the National Academies’ risk assessment and risk management  paradigm, policy considerations are relevant in the risk management  phase, which occurs after the risk assessment phase. With risk  assessment information, decision makers can make informed risk  management decisions on how to protect public health, reflecting other  important data and considerations, such as the costs and benefits of  mitigating identified risks, the technological feasibility of managing risks,  and the concerns of various stakeholders. Examples of risk management  decisions include deciding how much of a chemical a company may  discharge into a river, determining the extent to which a hazardous waste  site must be cleaned up, and setting allowable levels of contamination in  drinking water.
Thus, although IRIS assessments are not regulatory in nature, the  quantitative IRIS values may influence many risk management decisions  and serve as a basis for regulatory consideration. However, EPA’s  productivity in finalizing IRIS assessments is poor, and EPA has a  significant backlog of incomplete IRIS assessments and a growing number  of outdated assessments. Importantly, EPA has not been able to complete  assessments of key chemicals of concern to public health, including  dioxin, formaldehyde, trichloroethylene (TCE), naphthalene, and  tetrachloroethylene (perc) (see app. I).
In this context, my testimony today discusses (1) highlights of our 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 (2) key aspects of EPA’s  revised IRIS assessment process, released on April 10, 2008. For our March  2008 report, we examined the outcome of steps EPA has taken to ensure  that IRIS contains current, credible chemical risk information; to address  the backlog of ongoing assessments; and to respond to new requirements  from the Office of Management and Budget (OMB). We also examined the  potential effects of planned changes to the IRIS assessment process on  EPA’s ability to ensure that IRIS provides current, credible risk  information. In conducting our work, we obtained and analyzed  information on EPA’s productivity and the resources provided to the  program for fiscal years 2000 through 2007, user needs, and EPA’s  assessment completion goals. We also interviewed EPA’s National Center  for Environmental Assessment officials who manage the IRIS assessment  program; officials from other EPA program offices and federal science and  health agencies involved in the IRIS assessment process; and officials from  the Department of Defense, the Department of Energy (DOE), the National  Aeronautics and Space Administration (NASA), and OMB. For this  testimony, we supplemented our report with a review of the IRIS  assessment process that EPA released on April 10, 2008. We conducted  this work from May 7 to May 21, 2008, in accordance with generally  accepted government auditing standards. Those standards require that we  plan and perform the audit 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.
subsections: section_title: Background
paragraphs: IRIS was created in 1985 to help EPA develop consensus opinions within  the agency about the health effects of chronic exposure to chemicals. Its  importance has increased over time as EPA program offices and the states  have increasingly relied on IRIS information in making environmental  protection decisions. Currently, the IRIS database contains assessments of  more than 540 chemicals. According to EPA, national and international  users access the IRIS database approximately 9 million times a year. EPA’s  Assistant Administrator for the Office of Research and Development has  described IRIS as the premier national and international source for  qualitative and quantitative chemical risk information; other federal  agencies have noted that IRIS data are widely accepted by all levels of  government across the country for application of public health policy,  providing benefits such as uniform, standardized methods for toxicology  testing and risk assessment, as well as uniform toxicity values. Similarly, a  private-sector risk assessment expert has stated that the IRIS database has  become the most important source of regulatory toxicity values for use  across EPA’s programs and is also widely used across state programs and  internationally.
Historically and currently, the focus of IRIS toxicity assessments has been  on the potential health effects of long-term (chronic) exposure to  chemicals. According to OMB, EPA is the only federal agency that  develops qualitative and quantitative assessments of both cancer and  noncancer risks of exposure to chemicals, and EPA does so largely under  the IRIS program. Other federal agencies develop quantitative estimates of  noncancer effects or qualitative cancer assessments of exposure to  chemicals in the environment. While these latter assessments provide  information on the effects of long-term exposures to chemicals, they  provide only qualitative assessments of cancer risks (known human  carcinogen, likely human carcinogen, etc.) and not quantitative estimates  of cancer potency, which are required to conduct quantitative risk  assessments.
EPA’s IRIS assessment process has undergone a number of formal and  informal changes during the past several years. While the process used to  develop IRIS chemical assessments includes numerous individual steps or  activities, major assessment steps include (1) a review of the scientific  literature; (2) preparation of a draft IRIS assessment; (3) internal EPA  reviews of draft assessments; (4) two OMB/interagency reviews, managed  by OMB, that provide input from OMB as well as from other federal  agencies, including those that may be affected by the IRIS assessments if  they lead to regulatory or other actions; (5) an independent peer review  conducted by a panel of experts; and (6) the completion of a final  assessment that is posted to the IRIS Web site.
Unlike many other EPA programs that have statutory requirements,  including specific time frames for completing mandated tasks, the IRIS  program is not subject to statutory requirements or timeframes. In  contrast, the Department of Human Health and Services’ Agency for Toxic  Substances and Disease Registry (ATSDR), which develops quantitative  estimates of the noncancer effects of exposures to chemicals in the  environment, is statutorily required to complete its assessments within  certain timeframes.
section_title: Findings and Recommendations from Our March 2008 Report on the Productivity and Credibility of EPA’s Integrated Risk Information System
paragraphs: The IRIS database is at serious risk of becoming obsolete because the  agency has not been able to routinely complete timely, credible  assessments or decrease a backlog of 70 ongoing assessments.  Specifically, although EPA has taken important steps to improve the IRIS  program and productivity since 2000 and has developed a number of draft  assessments for external review, its efforts to finalize the assessments  have been thwarted by a combination of factors including the imposition  of external requirements, the growing complexity and scope of risk  assessments, and certain EPA management decisions. In addition, the  changes to the IRIS assessment process that EPA was considering at the  time of our review would have added to the already unacceptable level of  delays in completing IRIS assessments and further limited the credibility  of the assessments.
subsections: section_title: EPA’s Efforts to Improve the IRIS Assessment Program Have Not Produced the Desired Results
paragraphs: EPA has taken a number of steps to help ensure that IRIS contains current,  credible chemical risk information; to address its backlog of ongoing  assessments; and to respond to new OMB requirements. However, to date,  these changes—including increasing funding, centralizing staff conducting  assessments, and revising the assessment process—have not enabled EPA  to routinely complete credible IRIS assessments or decrease the backlog.  That is, although EPA sent 32 draft assessments for external review in  fiscal years 2006 and 2007, the agency finalized only 4 IRIS assessments  during this time (see fig. 2).
Several key factors have contributed to EPA’s inability to achieve a level  of productivity that is needed to sustain the IRIS program and database:  new OMB-required reviews of IRIS assessments by OMB and other federal  agencies; the growing complexity and scope of risk assessments; certain  EPA management decisions and issues, including delaying completion of  some assessments to await new research or to develop enhanced analyses  of uncertainty in the assessments; and the compounding effect of delays.  Regarding the last factor, even a single delay in the assessment process  can lead to the need to essentially repeat the assessment process to take  into account changes in science and methodologies.
A variety of delays have impacted the majority of the 70 assessments being  conducted as of December 2007—48 had been in process for more than 5  years, and 12 of those for more than 9 years. These time frames are  problematic because of the substantial rework such cases often require to  take into account changing science and methodologies before they can be  completed. For example, EPA’s assessment of the cancer risks stemming  from exposure to naphthalene—a chemical used in jet fuel and in the  production of widely used commercial products such as moth balls, dyes,  insecticides, and plasticizers—was nearing completion in 2006. However,  prior to finalizing this assessment, which had been ongoing for over 4  years, EPA decided that the existing noncancer assessment had become  outdated and essentially restarted the assessment to include both cancer  and noncancer effects. As a result, 6 years after the naphthalene  assessment began, it is now back at the drafting stage. The assessment  now will need to reflect relevant research completed since the draft  underwent initial external peer review in 2004, and it will have to undergo  all of the IRIS assessment steps again, including the additional internal and  external reviews that are now required (see app. I).
Further, because EPA staff time continues to be 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 is limited.  Importantly, EPA program offices and state and local entities have  requested assessments of hundreds of chemicals not yet in IRIS, and EPA  data as of 2003 indicated that the assessments of 287 chemicals in the  database may be outdated—that is, new information could change the risk  estimates currently in IRIS or enable EPA to develop additional risk  estimates for chemicals in the database (for example, developing a cancer  potency estimate for assessments with only noncancer estimates). In  addition, because EPA’s 2003 data are now more than 4 years old, it is  likely that more assessments may be outdated now.
The consequences of not having current, credible IRIS information can be  significant. EPA’s inability to complete its assessment of formaldehyde,  which the agency initiated in 1997 to update information already in IRIS on  the chemical, has had a significant impact on EPA’s air toxics program.  Although in 2003 and 2004, the National Cancer Institute and the National  Institute of Occupational Safety and Health (NIOSH) had released updates  to major epidemiological studies of industrial workers that showed a  relationship between formaldehyde and certain cancers, including  leukemia, EPA did not move forward to finalize an IRIS assessment  incorporating these important data. Instead, EPA opted to await the  results of another update to the National Cancer Institute study. While this  additional research was originally estimated to take, at most, 18 months to  complete, at the time of our report (more than 3 years later) the update  was not complete. In the absence of this information, EPA’s Office of Air  and Radiation decided to use risk information developed by an industry- funded organization—the CIIT Centers for Health Research—for a  national emissions standard. This decision was a factor in EPA exempting  certain facilities with formaldehyde emissions from the national emissions  standard. The CIIT risk estimate indicates a potency about 2,400 times  lower than the estimate in IRIS that was being re-evaluated and that did  not yet consider the 2003 and 2004 National Cancer Institute and NIOSH  epidemiological studies. According to an EPA official, an IRIS cancer risk  factor based on the 2003 and 2004 National Cancer Institute and NIOSH  studies would likely be close to the current IRIS assessment, which EPA  has been re-evaluating since 1997. The discrepancy between these two risk  estimates raises concerns about whether the public health is adequately  protected in the absence of current IRIS information. For example, in  1999, EPA published a national assessment that provided information  about the types and amounts of air toxics to which people are exposed.  The assessment, which also used the CIIT risk estimate for formaldehyde,  concluded, for example, that formaldehyde did not contribute significantly  to the overall cancer risk in the state of New Jersey. However, in carrying  out its own risk assessment on formaldehyde, the New Jersey Department  of Environmental Protection opted to use the risk information that is  currently in IRIS (dating back to 1991) and found that the contribution  from formaldehyde to overall cancer risk in New Jersey is quite significant,  second only to diesel particulate matter. (App. I provides additional  information on EPA’s IRIS assessment for formaldehyde.)
One of the factors that has contributed to EPA’s inability to complete  assessments in a timely manner—the new OMB-directed OMB/interagency  review process—also limits the credibility of the assessments because it  lacks transparency. Specifically, neither the comments nor the changes  EPA makes to the scientific IRIS assessments in response to the  comments made by OMB and other federal agencies, including those  whose workload and resource levels could be affected by the assessments,  are disclosed. In addition, the OMB/interagency reviews have hindered  EPA’s ability to independently manage its IRIS assessments. For example,  without communicating its rationale for doing so, OMB directed EPA to  terminate five IRIS assessments that for the first time addressed acute,  rather than chronic exposure—even though EPA initiated this type of  assessment to help it implement the Clean Air Act.
section_title: The Expansion of Agencies’ Roles in IRIS Assessments That EPA Was Considering at the Time of Our Review Would Have Caused Further Delays and Limited the Assessments’ Credibility
paragraphs: For our March 2008 report, we reviewed the additional assessment  process changes EPA was planning and concluded that they would likely  exacerbate delays in completing IRIS assessments and further affect their  credibility. Specifically, despite the OMB/interagency review process that  OMB required EPA to incorporate into the IRIS assessment process in  2005, certain federal agencies continued to believe they should have  greater and more formal roles in EPA’s development of IRIS assessments.  Consequently, EPA had been working for several years to establish a  formal IRIS assessment process that would further expand the role of  federal agencies in the process—including agencies such as DOD, which  could be affected by the outcome of IRIS assessments. For example, some  of these agencies and their contractors 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. In  addition, the agencies could be required to, for example, redesign systems  and processes to eliminate hazardous materials; develop material  substitutes; and improve personal protective clothing, equipment, and  procedures. Under the changes that EPA was planning at the time of our  review, these potentially affected agencies would have the opportunity to  be involved, or provide some form of input, at almost every step of EPA’s  IRIS assessment process. Most significantly, the changes would have  provided federal agencies, including those facing potential regulatory  liability, with several opportunities during the IRIS assessment process to  subject particular chemicals of interest to additional process steps. These  additional process steps, which would have lengthened assessment times  considerably, include  giving federal agencies and the public 45 days to identify additional  information on a chemical for EPA’s consideration in its assessment  or to correct any errors on an additional assessment draft that would  provide qualitative information;  giving potentially affected federal agencies 30 days to review the  public comments EPA received and initiate a meeting with EPA if  they want to discuss a particular set of comments;  allowing potentially affected federal agencies to have assessments  suspended for up to 18 months to fill a data gap or eliminate an  uncertainty factor that EPA plans to use in its assessment; and  allowing other federal agencies to weigh in on (1) the level of  independent peer review that would be sought (that is, whether the  peer reviews would be conducted by EPA Science Advisory Board  panels, National Academies’ panels, or panels organized by an EPA  contractor); (2) the areas of scientific expertise needed on the panel;  and (3) the scope of the peer reviews and the specific issues they  would address.
EPA estimated that assessments that undergo these additional process  steps would take up to 6 years to complete. While it is important to ensure  that assessments consider the best science, EPA has acknowledged that  waiting for new data can result in substantial harm to human health,  safety, and the environment. Further, although coordination with other  federal agencies about IRIS assessments could enhance their quality,  increasing the role of agencies that may be affected by IRIS assessments in  the process itself reduces the credibility of the assessments if that  expanded role is not transparent. In this regard, while EPA’s proposed  changes would have allowed for including federal agencies’ comments in  the public record, the implementation of this proposal was delayed for a  year, in part, because of OMB’s view that agencies’ comments about IRIS  assessments represent internal executive branch communications that  may not be made public—a view that is inconsistent with the principle of  sound science, which relies on, among other things, transparency. (App. II  and III provide flow charts of the IRIS process that was in place at the time  of our review and EPA’s draft proposed process being considered at the  time of our review, respectively).
section_title: Recommendations Made in Our March 2008 Report
paragraphs: To address the productivity and credibility issues we identified, we  recommended that the EPA Administrator require the Office of Research  and Development to re-evaluate its draft proposed changes to the IRIS  assessment process in light of the issues raised in our report and ensure  that any revised process, among other things, clearly defines and  documents an IRIS assessment process that will enable the agency to  develop the timely chemical risk information it needs to effectively  conduct its mission. One of our recommendations—that EPA provide at  least 2 years’ notice of IRIS assessments that are planned—would, among  other things, provide an efficient alternative to suspending assessments  while waiting for new research because interested parties would have the  opportunity to conduct research before assessments are started.
In addition, we recommended that the EPA Administrator take steps to  better ensure that EPA has the ability to develop transparent, credible IRIS  assessments—an ability that relies in large part on EPA’s independence in  conducting these important assessments. Actions that are key to this  ability include ensuring that EPA can (1) determine the types of  assessments it needs to support EPA programs and (2) define the  appropriate role of external federal agencies in EPA’s IRIS assessment  process, and (3) manage an interagency review process in a manner that  enhances the quality, transparency, timeliness, and credibility of IRIS  assessments. In its February 21, 2008, letter providing comments on our  draft report, EPA said it would consider each of our recommendations in  light of the new IRIS process the agency was developing.
section_title: Key Aspects of the Revised IRIS Assessment Process Implemented in April 2008 Which Is Not Responsive to GAO’s Recommendations
paragraphs: On April 10, 2008, EPA issued a revised IRIS assessment process, effective  immediately. Overall, EPA’s revised process is not responsive to the  recommendations made in our March 2008 report—it is largely the same  as the draft proposed process we evaluated in our March 2008 report (see  app. III and IV). Moreover, changes EPA did incorporate into the final  process are likely to further exacerbate the productivity and credibility  issues we identified in our report.
We recommended that EPA ensure that, among other things, any  revised process clearly defines and documents a streamlined IRIS  assessment process that can be conducted within time frames that  minimize the need for wasteful rework.
As discussed in our report, 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. However, EPA’s revised process institutionalizes a process  that the agency estimates will take up to 6 years to complete. Further, the  estimated time frames do not factor in the time for peer reviews  conducted by the National Academies, which can take 2 years to plan and  complete. EPA typically uses reviews by the National Academies for  highly controversial chemicals or complex assessments. Therefore,  assessments of key chemicals of concern to public health that are  reviewed by the National Academies are likely to take at least 8 years to  complete. These time frames must also be considered in light of OMB’s  view that health assessment values in IRIS are out of date if they are more  than 10 years old and if new scientific information exists that could  change the health assessment values. Thus, EPA’s new process  institutionalizes time frames that could essentially require the agency to  start assessment updates as soon as 2 years after assessments are finalized  in order to keep the IRIS database current. Such time frames are not  consistent with our recommendation that EPA develop, clearly define, and  document a streamlined IRIS process that can be conducted within time  frames that minimize the need for wasteful rework. Further, the agency  would need a significant increase in resources to support such an  assessment cycle.
In addition, EPA had previously emphasized that, in suspending  assessments to allow agencies to fill in data gaps, it would allow no more  than 18 months to complete the studies and have them peer reviewed.  However, under the new process, EPA states that it generally will allow no  more than 18 months to complete the studies and have them peer  reviewed. As we concluded in our report, we believe the ability to suspend  assessments for up to 18 months would add to the already unacceptable  level of delays in completing IRIS assessments. Further, we and several  agency officials with whom we spoke believe that the time needed to plan,  conduct, and complete research that would address significant data gaps,  and have it peer reviewed, would likely exceed 18 months. Therefore, the  less rigid time frame EPA included in its new process could result in  additional delays.
Finally, the new process expands the scope of one of the additional steps  that initially was to apply only to chemicals of particular interest to federal  agencies. Specifically, under the draft process we reviewed, EPA would  have provided an additional review and comment opportunity for federal  agencies and the public for what EPA officials said would be a small group  of chemicals. However, under EPA’s new process, this additional step has  been added to the assessment process for all chemicals and, therefore, will  add time to the already lengthy assessments of all chemicals.
We also recommended that the EPA Administrator take steps to better  ensure that EPA has the ability to develop transparent, credible IRIS  assessments—an ability that relies in large part on EPA’s independence  in conducting these important assessments.
Contrary to our recommendation, EPA has formalized a revised IRIS  process that is selectively, rather than fully, transparent, limiting the  credibility of the assessments. Specifically, while the draft process we  reviewed provided that comments on IRIS assessments from OMB and  other federal agencies would be part of the public record, under the  recently implemented process, comments from federal agencies are  expressly defined as “deliberative” and will not be included in the public  record. Given the importance and sensitivity of IRIS assessments, we  believe it is critical that input from all parties, particularly agencies that  may be affected by the outcome of IRIS assessments, be publicly available.  However, under EPA’s new process, input from some IRIS assessment  reviewers—representatives of federal agencies, including those facing  potential regulatory liability, and private stakeholders associated with  these agencies—will continue to receive less public scrutiny than  comments from all others.
In commenting on a draft of our March 2008 report, and in a recent  congressional hearing, EPA’s Assistant Administrator, Office of Research  and Development, stated that the IRIS process is transparent because all  final IRIS assessments must undergo public and external peer review.  However, as we stated in our report, the presence of transparency at a  later stage of IRIS assessment development does not explain or excuse its  absence earlier. Under the new process, neither peer reviewers nor the  public are privy to the changes EPA makes in response to the comments  OMB and other federal agencies provide to EPA at several stages in the  assessment process—changes to draft assessments or to the questions  EPA poses to the peer review panels. Importantly, the first IRIS  assessment draft that is released to peer reviewers and to the public  includes the undisclosed input from federal agencies potentially subject to  regulation and therefore with an interest in minimizing the impacts of IRIS  assessments on their budgets and operations.
In addition, EPA’s revised process does not provide EPA with sufficient  independence in developing IRIS assessments to ensure they are credible  and transparent. We made several recommendations aimed at restoring  EPA’s independence. For example, we recommended that the EPA  Administrator ensure that EPA has the ability to, among other things,  define the appropriate role of external federal agencies in the IRIS  assessment process and determine when interagency issues have been  appropriately addressed. However, under the newly implemented IRIS  assessment process, OMB continues to inform EPA when EPA has  adequately addressed OMB’s and interagency comments. This  determination must be made both before EPA can provide draft  assessments to external peer reviewers and to the public and before EPA  can finalize and post assessments on the IRIS database. While EPA  officials state that ultimately IRIS assessments reflect EPA decisions, the  new process does not support this assertion given the clearances EPA  needs to receive from OMB to move forward at key stages. In fact, we  believe the new IRIS assessment process may elevate the goal of reaching  interagency agreement above achieving IRIS program objectives. Further,  as discussed above, because the negotiations over OMB/interagency  comments are not disclosed, whether EPA is entirely responsible for the  content of information on IRIS is open to question.
In our report, we also emphasized the importance of ensuring that IRIS  assessments be based solely on science issues and not policy concerns.  However, under the new IRIS assessment process, EPA has further  introduced policy considerations into the IRIS assessment process. That  is, the newly implemented IRIS assessment process broadens EPA’s  characterization of IRIS assessments from “the agency’s scientific  positions on human health effects that may result from exposure to  environmental contaminants” to “the agency’s science and science policy  positions” on such effects. EPA’s new, broader characterization of IRIS  raises concerns about the agency’s stated intent to ensure that scientific  assessments are appropriately based on the best available science and that  they are not inappropriately impacted by policy issues and considerations.  For example, in discussing science and science policy at a recent Senate  hearing, EPA’s Assistant Administrator of Research and Development  described science policy considerations as including decisions about  filling knowledge gaps (e.g., whether and to what extent to use default  assumptions) and assessing weight-of-the-evidence approaches to make  scientific inferences or assumptions. We believe that these are scientific  decisions that should reflect the best judgment of EPA scientists who are  evaluating the data, using the detailed risk assessment guidance the  agency has developed for such purposes. We have concerns about the  manner and extent to which other federal agencies, including those that  may be affected by the outcome of assessments, are involved in these  decisions as well as the lack of transparency of their input. As we  highlighted earlier, under the National Academies’ risk assessment and  risk management paradigm, policy considerations are relevant in the risk  management phase—which occurs after the risk assessment phase that  encompasses IRIS assessments. The National Academies recently  addressed this issue as follows: “The committee believes that risk  assessors and risk managers should talk with each other; that is, a  ‘conceptual distinction’ does not mean establishing a wall between risk  assessors and risk managers. Indeed they should have constant  interaction. However, the dialogue should not bias or otherwise color the  risk assessment conducted, and the activities should remain distinct; that  is, risk assessors should not be performing risk management activities.”
section_title: Concluding Observations
paragraphs: The new IRIS assessment process that EPA implemented in April 2008 will  not allow the agency to routinely and timely complete credible  assessments. In fact, it will exacerbate the problems we identified in our  March 2008 report and sought to address with our recommendations—all  of which were aimed at preserving the viability of this critical database,  which is integral to EPA’s mission of protecting the public and the  environment from exposure to toxic chemicals. Specifically, under the  new process, assessment time frames will be significantly lengthened, and  the lack of transparency will further limit the credibility of the  assessments because input from OMB and other agencies at all stages of  the IRIS assessment process is now expressly defined as deliberative and  therefore not subject to public disclosure. The position of the Assistant  Administrator, Office of Research and Development, that the IRIS process  is transparent because all final IRIS assessments must undergo public and  external peer review is unconvincing. Transparency at a later stage of the  IRIS assessment process—after OMB and other federal agencies have had  multiple opportunities to influence the content of the assessment without  any disclosure of their input—does not compensate for its absence earlier.
We continue to believe that to effectively maintain IRIS EPA must  streamline its lengthy assessment process and adopt transparency  practices that provide assurance that IRIS assessments are appropriately  based on the best available science and that they are not inappropriately  biased by policy issues and considerations. As discussed in our April 29,  2008, testimony before the Senate Environment and Public Works  Committee, we believe that the Congress should consider requiring EPA to  suspend implementation of its new IRIS assessment process and develop a  streamlined process that is transparent and otherwise responsive to our  recommendations aimed at improving the timeliness and credibility of  IRIS assessments. For example, suspending assessments to obtain  additional research is inefficient; alternatively, with longer-term planning,  EPA could provide agencies and the public with more advance notice of  assessments, enabling them to complete relevant research before IRIS  assessments are started.
In addition, as discussed in our April 2008 testimony, the Congress should  consider requiring EPA to obtain and be responsive to input from the  Congress and the public before finalizing a revised IRIS assessment  process. We note that while EPA and OMB initially had planned for EPA to  release a draft revised IRIS assessment process to the public, hold a public  meeting to discuss EPA’s proposed changes, and seek and incorporate  public input before finalizing the process, EPA released its new  assessment process without obtaining public input and made it effective  immediately. This was inconsistent with assertions made in OMB’s letter  commenting on our draft report, which emphasized that EPA had not  completed the development of the IRIS assessment process and stated:  “Indeed, the process will not be complete until EPA circulates its draft to  the public for comments and then releases a final product that is  responsive to those comments.”
Finally, if EPA is not able to take the steps we have recommended to  effectively maintain this critical program, other approaches, including  statutory requirements, may need to be explored.
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.
section_title: Contacts and Acknowledgments
paragraphs: For further information about this testimony, please contact John B.  Stephenson on (202) 512-3841 or stephensonj@gao.gov. Contact points for  our Congressional Relations and Public Affairs Offices may be found on  the last page of this statement. Contributors to this testimony include  Christine Fishkin (Assistant Director), Laura Gatz, Richard P. Johnson,  and Nancy Crothers.
section_title: Appendix I: Examples of Key IRIS Assessments That Have Been Delayed
paragraphs: Some key IRIS assessments have been in progress for a number of years,  in part because of delays stemming from one or more of the key factors we  identified that have hindered EPA’s productivity. Examples include the  following:  Naphthalene. EPA started the IRIS assessment of cancer risks stemming  from the inhalation of naphthalene in 2002. Naphthalene is used in jet fuel  and in the production of widely used commercial products such as moth  balls, dyes, insecticides, and plasticizers. According to a presentation  delivered at the 2007 annual meeting of the Society for Risk Analysis by an  Army Corps of Engineers toxicologist, “The changing naphthalene  regulatory environment includes a draft EPA risk assessment that if/when  finalized, will change naphthalene’s status from ‘possible’ to ‘likely’ human  carcinogen.” Thus, according to this presentation, one potential impact of  this IRIS assessment on DOD is that DOD would need to provide many  employees exposed to naphthalene with equipment measuring their  exposure to the chemical. In addition, because many military bases are  contaminated with naphthalene, a component of jet fuel (approximately 1  percent to 3 percent) used by all DOD services, DOD could face extensive  cleanup costs. By 2004, 2 years after starting the assessment, EPA had  drafted a chemical assessment that had completed internal peer reviews  and was about to be sent to an external peer review committee. Once it  returned from external review, the next step, at that time, would have  been a formal review by EPA’s IRIS Agency Review Committee. If  approved, the assessment would have been completed and released.
However, in part because of concerns raised by DOD, OMB asked to  review the assessment and conducted an interagency review of the draft.  In their 2004 reviews of the draft IRIS assessment, both OMB and DOD  raised a number of concerns about the assessment and suggested to EPA  that it be suspended until additional research could be completed to  address what they considered to be significant uncertainties associated  with the assessment. Although all of the issues raised by OMB and DOD  were not resolved, EPA continued with its assessment by submitting the  draft for external peer review, which was completed in September 2004.  However, according to EPA, OMB continued to object to the draft IRIS  assessment and directed EPA to convene an additional expert review  panel on genotoxicity to obtain recommendations about short-term tests  that OMB thought could be done quickly. According to EPA, this added 6  months to the process, and the panel, which met in April 2005, concluded  that the research that OMB was proposing could not be conducted in the  short term. Nonetheless, EPA officials said that the second expert panel  review did not eliminate OMB’s concerns regarding the assessment, which  they described as reaching a stalemate. In September 2006, EPA decided,  however, to proceed with developing the assessment. By this time, the  naphthalene assessment had been in progress for over 4 years; EPA  decided that the IRIS noncancer assessment, issued in 1998, was outdated  and needed to be revisited. Thus, EPA expanded the IRIS naphthalene  assessment to include both noncancer and cancer assessments. As a  result, 6 years after the naphthalene assessment began, it is now back at  the drafting stage. The assessment now will need to reflect relevant  research completed since the draft underwent initial external peer review  in 2004, and it will have to undergo all of the IRIS assessment steps again,  including additional internal and external reviews that are now required.  This series of delays has limited EPA’s ability to conduct its mission. For  example, the Office of Air and Radiation has identified the naphthalene  assessment as one of its highest-priority needs for its air toxics program.  In addition, the Office of Solid Waste and Emergency Response considers  the naphthalene assessment a high priority for the Superfund program— naphthalene has been found in at least 654 of Superfund’s current or  former National Priorities List sites. Although EPA currently estimates  that it will complete the assessment in 2009, meeting this revised estimate  will be challenging, given all of the steps that are yet to be completed and  the extensive external scrutiny to which it will continue to be subjected.
Royal Demolition Explosive. This chemical, also called RDX or  hexahydro-1,3,5-trinitrotriazine, is a highly powerful explosive used by the  U.S. military in thousands of munitions. Currently classified by EPA as a  possible human carcinogen, this chemical is known to leach from soil to  groundwater. Royal Demolition Explosive can cause seizures in humans  and animals when large amounts are inhaled or ingested, but the effects of  long-term, low-level exposure on the nervous system are unknown. As is  the case with naphthalene, the IRIS assessment could potentially require  DOD to undertake a number of actions, including steps to protect its  employees from the effects of this chemical and to clean up many  contaminated sites. Although EPA started an IRIS assessment of Royal  Demolition Explosive in 2000, it has made minimal progress on the  assessment because EPA agreed to a request by DOD to wait for the  results of DOD-sponsored research on this chemical. In 2007, EPA began  to actively work on this assessment, although some of the DOD-sponsored  research is still outstanding.
Formaldehyde. EPA began an IRIS assessment of formaldehyde in 1997  because the existing assessment was determined to be outdated.  Formaldehyde is a colorless, flammable, strong-smelling gas used to  manufacture building materials, such as pressed wood products, and used  in many household products, including paper, pharmaceuticals, and  leather goods. While EPA currently classifies formaldehyde as a probable  human carcinogen, the International Agency for Research on Cancer  (IARC), part of the World Health Organization, classifies formaldehyde as  a known human carcinogen. Since 1986, studies of industrial of workers  have suggested that formaldehyde exposure is associated with  nasopharyngeal cancer, and possibly with leukemia. For example, in 2003  and 2004, the National Cancer Institute (NCI) and the National Institute of  Occupational Safety and Health (NIOSH) released epidemiological studies  following up on earlier studies tracking about 26,000 and 11,000 industrial  workers, respectively, exposed to formaldehyde; the updates showed  exposure to formaldehyde might also cause leukemia in humans, in  addition to the cancer types previously identified. According to NCI  officials, the key findings in their follow-up study were an increase in  leukemia deaths and, more significantly, an exposure/response  relationship between formaldehyde and leukemia—as exposure increased,  the incidence of leukemia also rose. As with the earlier study, NCI found  more cases of a rare form of cancer, nasopharyngeal cancer, than would  usually be expected. The studies from NCI and NIOSH were published in  2003 and 2004, around the time that EPA was still drafting its IRIS  assessment. In November 2004, the Chairman of the Senate Environment  and Public Works Committee requested that EPA delay completion of its  IRIS assessment until an update to the just-released NCI study could be  conducted, indicating that the effort would take, at most, 18 months. EPA  agreed to wait—and more than 3 years later, the NCI update is not yet  complete. As of December 2007, NCI estimates that the study will be  completed in two stages, one in mid-2008 and the second one later that  year. An NCI official said that the additional leukemia deaths identified in  the update provide “greater power” to detect associations between  exposure to formaldehyde and cancer. EPA’s inability to complete the IRIS  assessment it started more than 10 years ago in a timely manner has had a  significant impact on EPA’s air toxics program. Specifically, when EPA  promulgated a national emissions standard for hazardous air pollutants  covering facilities in the plywood and composite wood industries in 2004,  EPA’s Office of Air and Radiation took the unusual step of not using the  existing IRIS estimate but rather decided to use a cancer risk estimate  developed by an industry-funded organization, the CIIT Centers for Health  Research (formerly, the Chemical Industry Institute of Toxicology) that  had been used by the Canadian health protection agency. The IRIS cancer  risk factor had been subject to criticism because it was last revised in 1991  and was based on data from the 1980s. In its final rule, EPA stated that  “the dose-response value in IRIS is based on a 1987 study, and no longer  represents the best available science in the peer-reviewed literature.” The  CIIT quantitative cancer risk estimate that EPA used in its health risk  assessment in the plywood and composite wood national emissions  standard indicates a potency about 2,400 times lower than the estimate in  IRIS that was being re-evaluated and that did not yet consider the 2003 and  2004 NCI and NIOSH epidemiological studies. According to an EPA  official, an IRIS cancer risk factor based on the 2003 and 2004 NCI and  NIOSH studies would likely be close to the current IRIS assessment, which  EPA has been attempting to update since 1997. The decision to use the  CIIT assessment in the plywood national emissions standard was  controversial, and officials in EPA’s National Center for Environmental  Assessment said the center identified numerous problems with the CIIT  estimate. Nonetheless, the Office of Air and Radiation used the CIIT value,  and that decision was a factor in EPA exempting certain facilities with  formaldehyde emissions from the national emissions standard. In June  2007, a federal appellate court struck down the rule, holding that EPA’s  decision to exempt certain facilities that EPA asserted presented a low  health risk exceeded the agency’s authority under the Clean Air Act.  Further, the continued delays of the IRIS assessment of formaldehyde— currently estimated to be completed in 2010 but after almost 11 years still  in the draft development stage—will impact the quality of other EPA  regulatory actions, including other air toxics rules and requirements.
Trichloroethylene. Also known as TCE, this chemical is a solvent widely  used as a degreasing agent in industrial and manufacturing settings; it is a  common environmental contaminant in air, soil, surface water, and  groundwater. TCE has been linked to cancer, including childhood cancer,  and other significant health hazards, such as birth defects. TCE is the most  frequently reported organic contaminant in groundwater, and  contaminated drinking water has been found at Camp Lejeune, a large  Marine Corps base in North Carolina. TCE has also been found at  Superfund sites and at many industrial and government facilities, including  aircraft and spacecraft manufacturing operations. In 1995, the  International Agency for Research on Cancer classified TCE as a probable  human carcinogen, and in 2000, the Department of Health and Human  Services’ National Toxicology Program concluded that it is reasonably  anticipated to be a human carcinogen. Because of questions raised by peer  reviewers about the IRIS cancer assessment for TCE, EPA withdrew it  from IRIS in 1989 but did not initiate a new TCE cancer assessment until  1998. In 2001, EPA issued a draft IRIS assessment for TCE that proposed a  range of toxicity values indicating a higher potency than in the prior IRIS  values and characterizing TCE as “highly likely to produce cancer in  humans.” The draft assessment, which became controversial, was peer  reviewed by EPA’s Scientific Advisory Board and released for public  comment. A number of scientific issues were raised during the course of  these reviews, including how EPA had applied emerging risk assessment  methods—such as assessing cumulative effects (of TCE and its  metabolites) and using a physiologically based pharmacokinetic model— and the uncertainty associated with the new methods themselves. To  help address these issues, EPA, DOD, DOE, and NASA sponsored a  National Academies review to provide guidance. The National Academies  report, which was issued in 2006, concluded that the weight of evidence of  cancer and other health risks from TCE exposure had strengthened since  2001 and recommended that the risk assessment be finalized with  currently available data so that risk management decisions could be made  expeditiously. The report specifically noted that while some additional  information would allow for more precise estimates of risk, this  information was not necessary for developing a credible risk assessment.  Nonetheless, 10 years after EPA started its IRIS assessment, the TCE  assessment is back at the draft development stage. EPA estimates this  assessment will be finalized in 2010. More in line with the National  Academies’ recommendation to act expeditiously, five senators introduced  a bill in August 2007 that, among other things, would require EPA to both  establish IRIS values for TCE and issue final drinking water standards for  this contaminant within 18 months.
Tetrachloroethylene. EPA started an IRIS assessment of  tetrachloroethylene—also called perchloroethylene or “perc”—in 1998.  Tetrachloroethylene is a manufactured chemical widely used for dry  cleaning of fabrics, metal degreasing, and making some consumer  products and other chemicals. Tetrachloroethylene is a widespread  groundwater contaminant, and the Department of Health and Human  Services’ National Toxicology Program has determined that it is  reasonably anticipated to be a carcinogen. The IRIS database currently  contains a 1988 noncancer assessment based on oral exposure that will be  updated in the ongoing assessment. Importantly, the ongoing assessment  will also provide a noncancer inhalation risk and a cancer assessment. The  IRIS agency review of the draft assessment was completed in February  2005, the draft assessment was sent to OMB for OMB/interagency review  in September 2005, and the OMB/interagency review was completed in  March 2006. EPA had determined to have the next step, external peer  review, conducted by the National Academies—the peer review choice  reserved for chemical assessments that are particularly significant or  controversial. EPA contracted with the National Academies for a review  by an expert panel, and the review was scheduled to start in June 2006 and  be completed in 15 months. However, as of December 2007, the draft  assessment had not yet been provided to the National Academies. After  verbally agreeing with both the noncancer and cancer assessments  following briefings on the assessments, the Assistant Administrator, Office  of Research and Development, subsequently requested that additional  uncertainty analyses—including some quantitative analyses—be  conducted and included in the assessment before the draft was released to  the National Academies for peer review. As discussed in our March 2008  report on IRIS (GAO-08-440), quantitative uncertainty analysis is a risk  assessment tool that is currently being developed, and although the agency  is working on developing policies and procedures for uncertainty analysis,  such guidance currently does not exist. The draft tetrachloroethylene  assessment has been delayed since early 2006 as EPA staff have gone back  and forth with the Assistant Administrator trying to reach agreement on  key issues such as whether a linear or nonlinear model is most appropriate  for the cancer assessment and how uncertainty should be qualitatively and  quantitatively characterized. EPA officials and staff noted that some of the  most experienced staff are being used for these efforts, limiting their  ability to work on other IRIS assessments. In addition, the significant delay  has impacted the planned National Academies peer review because the  current contract, which has already been extended once, cannot be  extended beyond December 2008. The peer review was initially estimated  to take 15 months. As a result, a new contract and the appointment of  another panel may be required.
Dioxin. The dioxin assessment is an example of an IRIS assessment that  has been, and will likely continue to be, a political as well as a scientific  issue. Often the byproducts of combustion and other industrial processes,  complex mixtures of dioxins enter the food chain and human diet through  emissions into the air that settle on soil, plants, and water. EPA’s initial  dioxin assessment, published in 1985, focused on the dioxin TCDD  (2,3,7,8-tetrachlorodibenzo-p-dioxin) because animal studies in the 1970s  showed it to be the most potent cancer-causing chemical studied to date.
Several years later, EPA decided to conduct a reassessment of dioxin  because of major advances that had occurred in the scientific  understanding of dioxin toxicity and significant new studies on dioxins’  potential adverse health effects. Initially started in 1991, this assessment  has involved repeated literature searches and peer reviews. For example, a  draft of the updated assessment was reviewed by a scientific peer review  panel in 1995, and three panels reviewed key segments of later versions of  the draft in 1997 and 2000. In 2002, EPA officials said that the assessment  would conclude that dioxin may adversely affect human health at lower  exposure levels than had previously been thought and that most exposure  to dioxins occurs from eating such American dietary staples as meats, fish,  and dairy products, which contain minute traces of dioxins. These foods  contain dioxins because animals eat plants and commercial feed and drink  water contaminated with dioxins, which then accumulate in animals’ fatty  tissue. It is clear that EPA’s dioxin risk assessment could have a  potentially significant impact on consumers and on the food and  agriculture industries. As EPA moved closer to finalizing the assessment,  in 2003 the agency was directed in a congressional appropriations  conference committee report to not issue the assessment until it had been  reviewed by the National Academies. The National Academies provided  EPA with a report in July 2006. In developing a response to the report,  which the agency is currently doing, EPA must include new studies and  risk assessment approaches that did not exist when the assessment was  drafted. EPA officials said the assessment will be subject to the IRIS  review process once its response to the National Academies’ report is  drafted. As of 2008, EPA has been developing the dioxin assessment,  which has potentially significant health implications for all Americans, for  17 years.
section_title: Appendix II: EPA’s IRIS Assessment Process Being Implemented at the Time of Our Review (Includes OMB Requirements as of 2005)
section_title: Appendix III: EPA’s Draft Proposed IRIS Assessment Process Being Considered at the Time of Our Review (Dated March 2007)
paragraphs: No, it is not mission critical.
Development of a draft  qualitative assessment critical?
Yes, it is mission critical.
No, there is no  new research to  close data gaps. gaps?
Ye, there is interest in conducting  research to close data gaps.
Is the chemical  mission critical?
Darker shaded boxes are additional steps, under EPA’s planned changes, to its assessment process and indicate steps where EPA has provided additional opportunity for input from potentially affected federal agencies for mission-critical chemicals.
Lighter shaded boxes with dotted lines indicate steps where EPA has provided additional opportunity for input from potentially affected federal agencies for all chemicals.
White boxes with heavy lines indicate steps where potentially affected federal agencies already had an opportunity for input.
section_title: Appendix IV: EPA’s IRIS Assessment Process as of April 10, 2008
paragraphs: No, it is not mission critical. critical?
Ye, it is mission critical. new research to close data gaps. gaps?
Ye, there is interest in conducting research to close data gaps.
Is the chemical mission critical?
Darker shaded boxes are additional steps under EPA’s changes to its assessment  process and indicate where EPA has provided additional opportunity for input from potentially affected federal agencies for mission-critical chemicals.
Lighter shaded boxes with dotted lines indicate steps where EPA has provided additional opportunity for input from potentially affected federal agencies for all chemicals.
White boxes with heavy lines indicate steps where potentially affected federal agencies already had an opportunity for input.
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