Toxic Chemicals: EPA's New Assessment Process Will Increase Challenges EPA Faces in Evaluating and Regulating Chemicals
Published: 2008-04-29T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The Environmental Protection Agency's (EPA) mission includes evaluating and regulating toxic chemicals. EPA's Integrated Risk Information System (IRIS) program is a chemical evaluation program that is a critical component of EPA's capacity to support scientifically sound environmental regulations and policies. The IRIS database contains EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals. This testimony highlights GAO's work on toxic substances, focusing on (1) its 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 changes to the IRIS assessment process EPA included in its revised IRIS assessment process released on April 10, 2008. It also highlights the findings of two GAO reports on EPA's regulation of toxic chemicals. For the IRIS report, GAO analyzed EPA data and interviewed officials at relevant agencies, including the Office of Management and Budget (OMB). For this testimony, GAO supplemented the IRIS report with a review of EPA's revised IRIS assessment process announced earlier this month. Given the importance of the IRIS program to EPA's ability to protect public health and the environment, Congress should consider requiring EPA to suspend its new process and develop one that is responsive to GAO's recommendations.
section_title: What GAO Found
paragraphs: 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. Although EPA has taken steps to improve the IRIS program since 2000 and has developed a number of draft assessments for external review, its 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 to incorporate changing science and methods. The 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 GAO's 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 a 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 also are likely to further exacerbate the productivity and credibility concerns GAO identified. For example, while the draft process would have made comments on IRIS assessments from other federal agencies 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 it is critical that input from all parties--particularly agencies that may be affected by the outcome of IRIS assessments--be publicly available. As recommended in GAO's March 2008 report, to effectively maintain IRIS, EPA must, among other things, 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 considerations. 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) evaluation and regulation of  toxic chemicals. Over the past few years, GAO has issued a number of  reports on this topic. Today I will focus primarily on our most recent  report in this area that examined EPA’s 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 environmental decisions,  policies, and regulations. It is also relied upon by state and local  environmental programs and some international regulatory bodies for  managing their environmental protection programs.
The toxicity assessments in the IRIS database fulfill the first two critical  steps of the 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. 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, as EPA has recognized, 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 the last several years, GAO issued a number of reports on EPA’s toxics  programs, highlighting program shortcomings and recommending  management improvements. My testimony today addresses (1) the  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, being  released today, and (2) key changes to the IRIS assessment process that  EPA included in its revised process released on April 10, 2008. We are also  providing information on two of our prior reports on EPA’s regulation of  toxic chemicals (see app. II). 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 an analysis of the IRIS assessment process that EPA  released on April 10, 2008. We conducted this work from April 16 to April  29, 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.
A typical IRIS assessment contains a qualitative hazard identification  description and quantitative dose-response assessments. 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.
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. 1).
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. Further, because EPA staff time continues to be dedicated to  completing these assessments, 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.
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.
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 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 Changes to the IRIS Assessment Process That EPA Implemented in April 2008
paragraphs: On April 10, 2008, EPA issued a revised IRIS assessment process, effective  immediately (see app. III for a flow chart of the process). Overall, EPA’s  revised process is not responsive to the recommendations made in our  March 2008 report. While the revised process is largely the same as the  draft proposed process we evaluated in our March 2008 report, there are  several key differences that are likely to further exacerbate the  productivity and credibility issues we identified in our report. These  changes are as follows.
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. (Making these comments public would have  been a change from the OMB/interagency review process that has been in  place since 2004.) 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. Thus, 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 all other comments.
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. As we highlighted in our report, 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. EPA’s new, broader characterization of IRIS raises concerns  about the agency’s 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.
The new process includes several revisions to the time frames associated  with various process steps. Most notably, while EPA has estimated that  under the new process assessments may take up to 6 years to complete,  the estimated time frames do not factor in the time needed 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 reviewed by the National Academies are likely to take at least  8 years to complete. However, 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. As a result,  we concluded that it was critical that EPA streamline its process to  routinely support timely completion of assessments and avoid being  caught in an endless cycle of delays. Further, EPA’s lengthy assessment  time frames must 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. 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 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.
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.
Finally, EPA and OMB 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. For example, in its letter commenting on our draft report,  OMB emphasized that EPA had not completed the development of the IRIS  assessment process, adding: “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.” However, as stated  above, EPA released its new assessment process without obtaining public  input and made it effective immediately.
section_title: Conclusions
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. 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. Federal  agencies may appropriately participate in policy dialogues through the  rule-making process and other interagency working groups, which are risk  management activities that should occur after the risk assessment process  that encompasses IRIS assessments. Finally, suspending assessments 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.
section_title: Matter for Congressional Consideration
paragraphs: In light of the importance of the IRIS program to EPA’s ability to protect  the public health and the environment, the Congress should consider  requiring EPA to suspend implementation of its new IRIS assessment  process and develop a process that is responsive to our recommendations  for a streamlined process that is transparent and otherwise responsive to  our recommendations aimed at improving the timeliness and credibility of  IRIS assessments. In addition, 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.
Madam Chairman, this concludes my prepared statement. I would be  happy to respond to any questions that you or other Members of the  Committee may have at this time.
section_title: GAO Contact and Staff 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 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,  Nancy Crothers, David Bennett, and Crystal M. Huggins.
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: Summary of Two GAO Reports on EPA’s Toxic Substances Control Act and Chemical Control Regulations in the EU
paragraphs: This appendix summarizes information presented in two prior GAO  reports and related work on EPA’s regulation of toxic chemicals. In 1976,  Congress passed the Toxic Substances Control Act (TSCA) to authorize  the Environmental Protection Agency (EPA) to obtain information on  chemicals and regulate chemicals that pose an unreasonable risk to  human health or the environment. In 2005, we reviewed EPA’s efforts to  assess the risks of new chemicals—those not yet in commerce—and the  risks of existing chemicals—those already being used in commerce. In  summary, EPA faces challenges in obtaining the information necessary to  assess the human health and environmental risks of chemicals.
Like the United States, the European Union has laws governing the  production and use of chemicals. The European Union has recently  revised its chemical control policy through legislation known as  Registration, Evaluation and Authorization of Chemicals (REACH). In  another report, we provided comparative information on TSCA and  REACH. In summary, REACH generally requires that chemical companies  develop and provide government regulators with information on  chemicals’ effects on human health and the environment, while TSCA  generally does not. REACH is based on the principle that chemical  companies have the responsibility to demonstrate that the chemicals they  place in the market, distribute, or use do not adversely affect human  health or the environment, while TSCA generally requires EPA to  demonstrate that chemicals pose risks to human health or the  environment prior to controlling risks related to their production,  distribution, or use. The findings of these reports are summarized below.
subsections: section_title: Key Findings in GAO’s 2005 Report and Related Testimony
paragraphs: Overall, we found that EPA has limited information on the health and  environmental risks of chemicals. EPA does not routinely assess the  human health and environmental risks of existing chemicals and faces  challenges in obtaining the information to do so. TSCA’s authorities for  collecting data on existing chemicals do not facilitate EPA’s review  process because they generally place the costly and time-consuming  burden of obtaining data on EPA, rather than requiring chemical  companies to develop and submit such data to EPA. Consequently, EPA  has used its authorities to require testing for few of the over 60,000  chemicals already in commerce when EPA began reviewing chemicals  under TSCA in 1979. Recognizing the need for additional information on  existing chemicals, EPA has initiated voluntary programs. While these  programs are a laudable effort to develop data on these chemicals, several  problems remain, including that the chemical industry may not provide  testing results in a timely manner for all chemicals in these programs and  that even with additional test data, EPA would need to demonstrate that  the chemicals pose unreasonable risks in order to control their production  or use under TSCA. While TSCA does not define what risk is unreasonable,  EPA has found it difficult to meet this standard. In order to withstand  judicial scrutiny, a TSCA rule must be supported by substantial evidence  in the rule-making record. In this regard, EPA officials say the act’s legal  standards are so high that they have generally discouraged EPA from using  its authorities to ban or restrict the manufacture or use of chemicals.
Further, EPA’s reviews of new chemicals can provide only limited  assurance that health and environmental risks are identified before the  chemicals enter commerce because TSCA does not require chemical  companies to test new chemicals before notifying EPA of their intent to  manufacture a chemical. Furthermore, chemical companies generally do  not voluntarily perform such testing. Because of a general lack of data,  EPA has developed scientific models to predict the potential exposure and  toxicity levels of new chemicals. However, the use of these models can  present weaknesses in the assessment because the models are not always  accurate in predicting physical chemical properties and the evaluation of  general health effects is contingent on the availability of information on  chemicals with similar molecular structures. Additionally, chemical  company estimates of a chemical’s production volume and anticipated  uses provided in the premanufacture notices that EPA uses to assess  exposure can change substantially after EPA completes its review and  manufacturing begins. However, these estimates do not have to be  amended by companies unless EPA promulgates a rule determining that a  use of a chemical constitutes a significant new use, which EPA has done  for only a small percentage of new chemicals. Despite limitations in the  information available on new chemicals, EPA’s reviews have resulted in  some action being taken to reduce the risks of over 3,600 new chemicals  submitted for review.
EPA’s ability to provide the public with information on chemical  production and risk has also been hindered by strict confidential business  information provisions of TSCA, which generally prohibits the disclosure  of confidential business information. According to EPA officials, about 95  percent of the premanufacture notices for new chemicals contain some  information that is claimed as confidential. While EPA has the authority to  evaluate the appropriateness of confidentiality claims, these efforts are  time and resource-intensive, and the agency does not have the resources  to challenge a significant number of claims. State environmental agencies  and others have expressed interest in obtaining information claimed as  confidential business information for use in various activities, such as  developing contingency plans to alert emergency response personnel to  the presence of highly toxic substances at manufacturing facilities.  Chemical companies recently have expressed interest in working with  EPA to identify ways to enable other organizations to use the information  given the adoption of appropriate safeguards.
In our June 2005 report, we recommended that Congress consider  providing EPA with additional authorities under TSCA to improve its  ability to assess chemical risks, such as providing the EPA Administrator  with the authority to require that chemical companies develop test data  when production volumes reach certain levels. We also recommended that  the EPA Administrator take several actions to improve EPA’s management  of its chemical program, including revising its regulations to require that  companies reassert confidentiality claims under TSCA within a certain  time period after the information is initially claimed as confidential. EPA  did not disagree with the report’s findings and is in the process of  implementing several of our recommendations.
section_title: Key Findings in GAO’s 2007 Report and Related Correspondence
paragraphs: Overall, we found that REACH, the legislation through which the  European Union has recently revised its chemical control policy, requires  chemical companies to develop more information than TSCA on the  effects of chemicals on human health and the environment. REACH  generally requires that chemical companies develop and provide  government regulators information on chemicals’ effects on human health  and the environment, while TSCA generally does not. For example, under  REACH, chemical companies provide, and in some cases develop,  information on chemicals’ physical/chemical properties and health and  environmental effects for both new and existing chemicals produced over  specified volumes. REACH also provides regulators the general authority  to require chemical companies to provide additional test data and other  information when necessary to evaluate a chemical’s risk to human health  and the environment. In contrast, TSCA places the burden on EPA to  demonstrate that data on health and environmental effects are needed  before requiring chemical companies to develop the data. In this regard,  while TSCA requires chemical companies to notify EPA before producing  or importing a new chemical, it does not require chemical companies to  develop and provide data on health and environmental effects unless EPA  promulgates a rule requiring them to do so. In promulgating such a rule,  EPA must demonstrate that data already available are insufficient and that  either (1) the chemical may present an unreasonable risk or (2) the  chemical is or will be produced in substantial quantities and that there is  or may be substantial human or environmental exposure to the chemical.
REACH is based on the principle that chemical companies have the  responsibility to demonstrate that the chemicals they place in the market,  distribute, or use do not adversely affect human health or the  environment, while TSCA generally requires EPA to demonstrate that  chemicals pose risks to human health or the environment prior to  controlling risks related to their production, distribution, or use. Under  REACH, chemical companies must obtain authorization to continue to use  a chemical of very high concern, such as a chemical for which there is  scientific evidence of probable serious health or environmental effects.  Generally, to obtain such authorization, each chemical company needs to  demonstrate that it can adequately control risks posed by the chemical,  such as by requiring that workers wear safety equipment when working  with the chemical or otherwise ensuring that the chemical is produced  under safe conditions. If the chemical company cannot provide evidence  of adequate control, authorization would be granted only if the  socioeconomic advantages of a specific use of the chemical are greater  than its potential risks, and if there are no suitable alternatives or  technologies.
Under TSCA, EPA has differing authorities to control the risks posed by  new and existing chemicals. For new chemicals, EPA can restrict a  chemical’s production or use if the agency determines that insufficient  information exists to permit a reasoned evaluation of the health and  environmental effects of the chemical and that, in the absence of such  information, the chemical may present an unreasonable risk to human  health or the environment; the chemical is or will be produced in  substantial quantities and either enters or may reasonably be anticipated  to enter the environment in substantial quantities; or there is or may be  significant or substantial human exposure to the substance. For existing  chemicals, EPA may regulate those chemicals for which it finds a  reasonable basis exists to conclude that they present or will present an  unreasonable risk to human health or the environment. In this regard, EPA  can promulgate a rule that bans or restricts the chemical’s production,  processing, distribution in commerce, use, or disposal, or that requires  warning labels be placed on the chemical. However, TSCA requires EPA to  choose the least burdensome requirement on the chemical industry that  will adequately protect against the risk.
TSCA and REACH both have provisions to protect information claimed by  chemical companies as confidential or sensitive business information;  however, REACH requires greater public disclosure of certain information,  including information about (1) basic chemical properties such as melting  and boiling points and (2) analytical methods that make it possible to  detect a dangerous substance when discharged into the environment and  to determine the effects of direct exposure to humans. In addition, REACH  places greater restrictions on the kinds of information companies may  claim as confidential or sensitive. For example, REACH generally does not  allow confidentiality claims to apply to the chemical’s trade name, and it  does not allow such claims to apply to guidance on the chemical’s safe  use.
section_title: Appendix III: 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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