Chemical Regulation: Observations on Improving the Toxic Substances Control Act
Published: 2009-12-02T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The Environmental Protection Agency (EPA) is authorized under the Toxic Substances Control Act (TSCA) to obtain information on the risks of chemicals and to control those that it determines to pose an unreasonable risk. EPA also conducts assessments of chemicals under its Integrated Risk Information System (IRIS) program. Nonetheless, EPA does not have sufficient information to determine whether it should establish controls to limit public exposure to many chemicals that may pose substantial health risks. The Government Accountability Office (GAO) has recommended statutory changes to TSCA to, among other things, provide EPA with additional authorities to obtain health and safety information from the chemical industry and to shift more of the burden to chemical companies for demonstrating the safety of their chemicals. GAO has also recommended that EPA adopt a streamlined, more transparent IRIS assessment process to address significant productivity and credibility issues. Problems with TSCA and IRIS led GAO to add transforming EPA's processes for assessing and controlling toxic chemicals to its list of high-risk areas warranting attention by Congress and the executive branch This testimony, based on prior GAO work, addresses EPA's implementation of TSCA and IRIS and options for (1) obtaining more information on chemical risks, (2) controlling these risks, and (3) sharing more of the information collected under TSCA.
section_title: What GAO Found
paragraphs: EPA lacks adequate scientific information on the toxicity of many chemicals. One major reason is that TSCA generally places the burden of obtaining data about existing chemicals on EPA rather than on chemical companies. For example, the act requires EPA to demonstrate certain health or environmental risks before it can require companies to further test their chemicals. As a result, EPA does not routinely assess the risks of the over 83,000 chemicals already in use. Moreover, TSCA does not require chemical companies to test the approximately 700 new chemicals introduced into commerce each year for toxicity, and companies generally do not voluntarily perform such testing. Furthermore, the procedures EPA must follow to obtain test data from companies can take years. Regarding IRIS, in 2008, GAO reported that this significant chemical assessment program--which provides EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals--is at serious risk of becoming obsolete because the agency has not been able to complete timely, credible assessments. In May 2009, EPA announced reforms to its IRIS assessment process, citing GAO's conclusions and its high-risk designation. Overall, GAO believes that, if the reforms are effectively implemented, they will address GAO's recommendations and provide a sound framework for conducting IRIS assessments. However, given the number of obstacles that can impede the progress of IRIS assessments, the viability of this program will depend on effective and sustained management. While TSCA authorizes EPA to ban, limit, or otherwise regulate existing toxic chemicals, EPA must meet a high legal threshold, which has proven difficult. For example, EPA must demonstrate "unreasonable risk" to ban or limit chemical production, which EPA believes requires it to conduct extensive cost-benefit analyses that can take many years to complete. Since 1976, EPA has issued regulations to control only five existing chemicals. Furthermore, its 1989 regulation phasing out most uses of asbestos was largely vacated by a federal appeals court in 1991 because it was not based on "substantial evidence." In contrast, the European Union and a number of other countries have largely banned asbestos, a known human carcinogen that can cause lung cancer and other diseases. GAO previously suggested that Congress amend TSCA to reduce the evidentiary burden EPA must meet to control toxic substances and continues to believe such change warrants consideration. Because of TSCA's prohibitions on the disclosure of confidential business information, EPA has limited ability to share information on chemical production and risk. According to EPA officials, about 95 percent of the notices companies have provided to EPA on new chemicals contain some information claimed as confidential. Evaluating the appropriateness of confidentiality claims is time- and resource-intensive, and EPA does not challenge most claims. GAO previously suggested that Congress, among other things, consider amending TSCA to authorize EPA to share the confidential business information that chemical companies provide to EPA with states.

section_title: Letter
paragraphs: I am pleased to appear here today to discuss the need to transform EPA’s  processes for assessing and controlling toxic chemicals. The  Environmental Protection Agency’s (EPA) ability to effectively implement  its mission of protecting public health and the environment is critically  dependent on credible and timely assessments of the risks posed by toxic  chemicals. Such assessments are the cornerstone of scientifically sound  environmental decisions, regulations, and policies. In previous reports, we  have recommended both statutory and regulatory changes to, among other  things, strengthen EPA’s authority to obtain additional information from  the chemical industry, shift more of the burden to chemical companies for  demonstrating the safety of their chemicals, and enhance the public’s  understanding of the risks of chemicals to which they may be exposed. In  2009, we added transforming EPA’s processes for assessing and  controlling toxic chemicals to our list of areas at high risk for waste, fraud,  abuse, and mismanagement because EPA has failed to develop sufficient  chemical assessment information on the toxicity of many chemicals that  may be found in the environment and tens of thousands of chemicals used  commercially in the United States. We reported that the lack of this  information significantly limits the agency’s ability to limit public exposure  to many chemicals that may pose substantial health risks in fulfillment of  its mission of protecting human health and the environment.
The Toxic Substances Control Act (TSCA) was enacted in 1976 to  authorize EPA to obtain information on the risks of chemicals and to  control those chemicals that EPA determines to pose unreasonable risks.  TSCA authorizes EPA to review chemicals already in commerce (existing  chemicals) and chemicals yet to enter commerce (new chemicals). TSCA  also provides that certain information, such as data disclosing chemical  processes, can be claimed as confidential business information by  chemical manufacturers and processors. EPA’s ability to provide the  public with information on chemical production and risk has been limited  by TSCA’ s strict confidential business information provisions, which  generally prohibit the disclosure of such information. In addition to its  authorities under TSCA, EPA conducts assessments of toxic chemicals in  the environment under its Integrated Risk Information System (IRIS)  program. EPA’s IRIS database provides the agency’s scientific position on  the potential health effects that may result from exposure to more than  540 chemicals in the environment. IRIS toxicity assessments constitute  critical steps of the risk assessment process and provide the basic  information EPA needs to determine whether it should establish controls  to protect the public from exposure to toxic chemicals in the air and water  and at hazardous waste sites, among other things.
My testimony today is based on our prior work on EPA’s processes for  assessing and controlling toxic chemicals, in which we identified  challenges associated with implementing TSCA and some of the legislative  options available to address these challenges. Specifically, my statement  addresses EPA’s implementation of TSCA and options for (1) obtaining  more information on the risks posed by chemicals, (2) controlling these  risks, and (3) sharing more of the information gathered under TSCA.
subsections: section_title: Background
paragraphs: TSCA provides EPA with the authority, upon making certain  determinations, to collect information about the hazards posed by  chemical substances and to take action to control unreasonable risks by  either preventing dangerous chemicals from making their way into use or  placing restrictions on those already in commerce. Of the over 83,000  chemicals currently in the TSCA inventory, about 62,000 were already in  commerce when EPA began reviewing chemicals in 1979. Since then, over  21,000 new chemicals—about 700 each year, on average—have been  added to the inventory and are now in use as existing chemicals. To assess  a chemical’s risks, EPA examines its toxicity or potential adverse effects  and the amount of human and environmental exposures.
TSCA generally requires the industry to notify EPA at least 90 days before  producing or importing a new chemical. These notices are to contain such  information as the chemical’s molecular structure and intended uses,  which EPA uses to evaluate the chemical’s potential risks. TSCA also  authorizes EPA to promulgate rules to require manufacturers to perform  tests on chemicals in certain circumstances or to provide other data, such  as production volumes, on existing chemicals. In addition, TSCA requires  chemical companies to report to EPA any data that reasonably support a  conclusion that a chemical presents a substantial risk. If EPA finds that a  chemical’s risks are unreasonable, it can prohibit or limit the chemical’s  production, processing, distribution, use, and disposal or take other  action, such as requiring warning labels on the substance. While TSCA  authorizes EPA to release some chemical information obtained by the  agency under the act, it allows chemical companies to claim certain  information, such as data disclosing chemical processes, as confidential  business information. EPA generally must not disclose such information  unless such disclosure is necessary to protect against an unreasonable risk  of injury to health or the environment. Evaluating the appropriateness of  confidentiality claims is time- and resource-intensive, and EPA does not  challenge most 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. In previous reports,  we have identified options for statutory changes to improve EPA’s ability  to make more chemical information publicly available.
IRIS was created in 1985 to help EPA develop consensus opinions within  the agency about the health effects from chronic exposure to chemicals.  Its importance has increased over time. EPA, state and local  environmental programs, international regulatory bodies, academia,  industry, and others now rely heavily on the IRIS database to support risk- based decision making to protect public health and the environment. A  typical IRIS assessment contains a qualitative description of the hazard  posed by a chemical and a quantitative assessment of the relationship  between exposure and the likelihood and severity of adverse health  effects. The focus of IRIS toxicity assessments is on the potential health  effects of long-term (chronic) exposure to chemicals. According to the  Office of Management and Budget (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. The quantitative estimates of potency that EPA provides  are particularly important, as they are required to conduct quantitative risk  assessments. EPA uses risk assessments developed with IRIS toxicity data  to determine whether the identified health risks warrant regulatory or  other actions. Examples of subsequent decisions that could stem from a  determination that action is necessary to protect public health include  how much of a chemical a company may discharge into a river, which  substances may be stored at a hazardous waste facility, the extent to  which a hazardous waste site must be cleaned up, levels for air emissions,  and allowable levels of contamination in drinking water.
section_title: EPA Lacks Adequate Information on Potential Health and Environmental Risks of Chemicals
paragraphs: EPA lacks adequate scientific information on the toxicity of many  chemicals that are or may be found in the environment. For existing  chemicals, TSCA generally places the burden of obtaining data on EPA,  rather than on the companies that produce the chemicals. This approach  requires that EPA demonstrate certain health or environmental risks  before it can require companies to further test their chemicals. As a result,  EPA has only limited information on the health and environmental risks  posed by these chemicals. Furthermore, while TSCA authorizes EPA to  review existing chemicals, it generally provides no specific requirement,  time frame, or methodology for doing so. Significantly, chemical  companies are not required to develop and submit toxicity information to  EPA on existing chemicals unless the agency finds that a chemical may  present an unreasonable risk of injury to human health or the environment  or is or will be produced in substantial quantities and that either (a) there  is or may be significant or substantial human exposure to the chemical or  (b) the chemical enters the environment in substantial quantities. EPA  must also determine there are insufficient data on a chemical to  reasonably determine its effects on health or the environment and that  testing is necessary to develop such data before the agency can require a  company to test its chemicals for harmful effects. This structure places the  burden on EPA to demonstrate a need for data on a chemical’s toxicity  rather than on a company to demonstrate that a chemical is safe. As a  result, EPA does not routinely assess the risks of the more than 83,000  commercial chemicals in use.
As we have previously reported, TSCA’s chemical review provisions could  be strengthened by requiring EPA’s systematic review of existing  chemicals. TSCA could be amended to establish a time frame for the  review of existing chemicals, putting existing chemicals on a more equal  footing with new chemicals. However, because of the large number of  existing chemicals, EPA would need the flexibility to identify which  chemicals should be given priority. TSCA could be amended to require  individual chemical companies or the industry as a whole to compile and  submit chemical data as a condition of manufacture or import above some  specified volume or other criteria.
Regarding new chemicals, TSCA generally requires chemical companies t submit a premanufacture notice to EPA before they manufacture or impo new chemicals and to provide any available test data. Yet EPA estimates  that most premanufacture notices do not include any test data, and onlyabout 15 percent include health or safety test data. These tests may takeover a year to complete and cost hundreds of thousands of dollars, and  chemical companies usually do not perform them voluntarily. Because  EPA generally does not have sufficient data on a chemical’s properties an effects when reviewing a new chemical, EPA uses models to compare new chemicals with chemicals that have similar molecular structures and for  which test data on health and environmental effects are available,  which  can take years. Furthermore, EPA bases its exposure estimates for new  chemicals on information contained in premanufacture notices— information that chemical companies generally are not bound by and that  may change without notice. For example, companies m production levels or expand the uses of a chemical, potentially increasing  the risk of injury to human health or the environment.
An option that we have previously reported could make TSCA more  effective and provide EPA with adequate information on chemicals is  revising the act to require companies to test their chemicals and submit  the results to EPA with their premanufacture notices. Currently, s uch a  step is required only if EPA makes the necessary findings and promul a testing rule. A major drawback to testing is its cost to chemical  companies, which may reduce their willingness to perform chemical  research and invest in innovation. To reduce such costs or to delay them  until production is sufficient to offset them, requirements for testing could  be based on production volume. For example, in Canada and the European  Union, testing requirements for low-volume chemicals are less extens and complex than for high-volume chemicals. We previously rep Congress could give EPA, in addition to its current authorities under  section 4 of TSCA, the authority to require chemical substanc manufacturers and processors to develop test data based on, for example,  substantial production volume and the necessity for testing.
Another option we reported was to provide EPA with greater authority to  require additional testing in areas where EPA’s analysis models do not  adequately predict toxicity.  Under such an option, EPA cou minimal set of tests for new chemicals to be submitted with  premanufacture notices. Additional and more complex and costly testing  could be required as a new chemical’s potential risks increase, based on ,  for example, production or environmental release levels. According to  some chemical companies, the cost of initial testing could be reduced by  hey are  amending TSCA to require EPA to review new chemicals before t marketed, rather than before they are manufactured. This could  substantially reduce the expense of testing because, according to EP about half of the premanufacture notices the agency receives from  chemical companies are enter the marketplace.   for new chemicals that, for various reasons, never  In addition to TSCA, EPA assesses chemicals under its IRIS program reported in March 2008 that this key program was at serious risk of  becoming obsolete because the agency has not been able to keep its  existing assessments current; decrease its backlog of 70 assessments complete assessments of key chemicals of concern, such as dioxin,  formaldehyde, and trichloroethylene (TCE). Among other things, we  found that EPA’s efforts to finalize IRIS assessments were impeded by a  combination of factors, including OMB’s requiring two additional reviews  of IRIS assessments by OMB and other federal agencies with an interest i the assessments, such as the Department of Defense. Moreover, the  two  interagency reviews involved other federal agencies in EPA’s IRIS  assessment process in a manner that hindered EPA’s ability to manage its  assessments and limited their credibility and transparency. For example,  the input these agencies provided to EPA was treated as “deliberative” a was not released to the public. As a result, we recommended that EPA adopt a streamlined, more transparent assessment process. A revised  process that EPA subsequently adopted in 2008 did not incorporate our  recommendations and actually exacerbated the concerns we identifi ed  about productivity and credibility. As a result, we included the IRIS  program along with TSCA in our high-risk designation on assessing and  controlling toxic chemicals. nd  However, in May 2009, EPA again announced comprehensive reform its IRIS assessment process, citing our designation of this program as high  risk as well as key conclusions from our reports. We reviewed EPA’s  reforms and testified that overall, if implemented effectively, these  reforms will address our recommendations and provide a sound  framework for conducting IRIS assessments and significantly improve the  IRIS process. e  entire assessment process, including the interagency reviews. Under EPA prior process, these reviews were required and managed by OMB—and at  various stages, EPA was not allowed to proceed with assessments until  OMB notified EPA that it had sufficiently responded to comments from  OMB and other agencies. The independence restored to EPA under the  new process will be critical to ensuring that EPA has the ability to develop  transparent, credible IRIS chemical assessments. While the broad r eforms  provide a sound general framework for conducting IRIS assessm manner in which EPA implements the new process will determine whet the agency will be able to overcome its long-standing productivity  problems and complete credible and transparent assessments.  Specifically, certain aspects of the new process are incomplete or lack  clarity and thus warrant management attention. For example, EPA h as  likely understated the time required to complete an assessment because its estimated time frames do not include the time required to complete tw key steps. Overall, the viability of the IRIS program will depend on effective and sustained management, given the number of factors that can  impede the progress of IRIS assessments—even one delay can have a  domino effect, requiring the process to essentially be repeated to  incorporate changing science. We note that, unlike some other EPA programs with statutory deadlines for completing various activitie s, the  IRIS program is discretionary. As we have previously stated, we believe  th contribute to EPA’s failure to complete timely IRIS assessments.
GAO, Scientific Integrity: EPA’s Efforts to Enhance the Credibility and Transparency of  Its Scientific Processes, GAO-09-773T (Washington, D.C.: June 9, 2009).
section_title: TSCA’s Regulatory Framework Impedes EPA’s Efforts to Control Risks Posed by Chemicals
paragraphs: While TSCA authorizes EPA to issue regulations that may ban, limit, or  otherwise regulate the production or use of existing toxic chemicals, EPA  must meet a high legal threshold, which has proven to be difficult.  Specifically, in order to regulate an existing chemical under section 6 of  TSCA, EPA must find that there is a reasonable basis to conclude that the  chemical presents or will present an unreasonable risk of injury to health  or the environment. EPA officials have said that this requires an extensive  cost-benefit analysis. In addition, before regulating a chemical under  section 6, the EPA Administrator must consider and publish a statement  regarding the following:  the effects of the chemical on human health and the magnitude of human  exposure to the chemical;  the effects of the chemical on the environment and the magnitude of the  environment’s exposure to the chemical;  the benefits of the chemical for various uses and the availability of  substitutes for those uses; and  the reasonably ascertainable economic consequences of the rule, after  consideration of the effect on the national economy, small business,  technological innovation, the environment, and public health.
Moreover, while TSCA offers EPA a range of control options when  regulating existing chemicals, the agency must choose the least  burdensome regulation that will be adequately protective. For example, if  EPA finds that it can adequately manage the risk of a chemical by  requiring chemical companies to place warning labels on the chemical,  EPA may not ban or otherwise restrict its use. EPA must also develop  substantial evidence in support of the action it proposes to take in order to  withstand judicial review. Under TSCA, a court reviewing a TSCA rule  must set it aside if such evidence is lacking. As several courts have noted,  this standard is more rigorous than the “arbitrary and capricious” standard  normally applied to rulemaking. Furthermore, according to EPA officials,  the economic costs of regulating a chemical are usually more easily  documented than the risks of the chemical or the benefits associated with  controlling those risks, and it is difficult to show substantial evidence that  EPA is promulgating the least burdensome requirement.
EPA has had difficulty demonstrating that harmful chemicals pose an  unreasonable risk and consequently should be regulated. In fact, since  Congress passed TSCA in 1976—over 33 years ago—EPA has issued TSCA  regulations on only five existing chemicals or chemical classes. In 1991,  one of these regulations—the 1989 regulation banning most uses of  asbestos—was largely vacated by a federal appeals court decision that  cited EPA’s failure to meet statutory requirements. In contrast to the  United States, the European Union and a number of other countries have  banned all, or almost all, asbestos and asbestos-containing products.  Asbestos is a known human carcinogen that can cause lung cancer and  other diseases if inhaled. Asbestos has been used widely in products such  as fireproofing; thermal insulation; and friction products, including brake  linings.
EPA spent 10 years exploring the need for the asbestos ban and  developing the regulation. On the basis of its review of over 100 studies of  the health risks of asbestos as well as public comments on the proposed  rule, EPA determined that asbestos is a potential carcinogen at all levels of  exposure—that is, that it has no known safe exposure level. EPA’s 1989  rule under TSCA section 6 prohibited the future manufacture, importation,  processing, and distribution of asbestos in almost all products. In  response, some manufacturers of asbestos products filed suit against EPA  arguing, in part, that the rule was not promulgated on the basis of  substantial evidence regarding unreasonable risk. In October 1991, the  U.S. Court of Appeals for the Fifth Circuit agreed with the manufacturers,  concluding that EPA had failed to muster substantial evidence to justify its  asbestos ban. Specifically, the court concluded that EPA did not consider  all necessary evidence and failed to show that the control action it chose  was the least burdensome regulation that would adequately protect human  health or the environment. EPA had not calculated the risk levels for  intermediate levels of regulation because it believed there was no asbestos  exposure level for which the risk of injury or death was zero. As  articulated by the court, the proper course of action for EPA would have  been to consider each regulatory option listed in TSCA, beginning with the  least burdensome, and the costs and benefits of each option. Since  completing the 1989 asbestos rule, EPA has completed only one regulation  to ban or limit the production or use of an existing chemical (for  hexavalent chromium in 1990).
With EPA’s limited actions to control toxic chemicals under TSCA, state  and federal actions have filled the void by establishing controls for some  toxic chemicals. For example, a California statute enacted in 2007  prohibits the manufacture, sale, or distribution of certain toys and child  care articles after January 1, 2009, if the products contain concentrations  of phthalates exceeding 0.1 percent. In 2008, Congress took similar action.  California has also enacted limits on formaldehyde in pressed wood. In  response to a petition asking EPA to use section 6 of TSCA to adopt the  California formaldehyde regulation, EPA recently issued an advance  notice of proposed rulemaking suggesting several regulatory options the  agency could pursue under its TSCA section 6 authority to limit exposure  to formaldehyde. However, because of the legal hurdles the agency would  face in regulating formaldehyde under TSCA, some stakeholders have  recommended that EPA pursue legislation instead.
In our previous reports, we identified a number of options that could  strengthen EPA’s ability to regulate harmful chemicals under TSCA.  Potential changes to TSCA include reducing the evidentiary burden that  EPA must meet to take regulatory action under the act by amending (1)  the unreasonable risk standard; (2) the standard for judicial review, which  requires substantial evidence in the rulemaking record; and (3) the  requirement that EPA choose the least burdensome regulatory  requirement.
section_title: TSCA Limits EPA’s Ability to Share Information
paragraphs: TSCA’ s confidential business information provisions limit EPA’s ability to  make the information that it collects under the act available to outside  entities if chemical companies designate such information as confidential  business information. EPA is required under the act to protect trade  secrets and privileged or confidential commercial or financial information  against unauthorized disclosures, and this information generally cannot be  shared with others, including state health and environmental officials and  foreign governments that may have legitimate needs for the information.  For example, some state officials said this information would be useful for  informing and managing their environmental risk programs.
EPA officials told us that some claims of confidential business information  may be unwarranted, but challenging the claims is resource-intensive. EPA  has not performed any recent studies of the appropriateness of  confidentiality claims, but a 1992 EPA study indicated that problems with  inappropriate claims were extensive. This study examined the extent to  which companies made confidential business information claims, the  validity of the claims, and the impact of inappropriate claims on the  usefulness of TSCA data to the public. While EPA may suspect that some  chemical companies’ confidentiality claims are unwarranted, the agency  does not have data on the number of inappropriate claims. According to  EPA officials, about 95 percent of premanufacture notices contain some  information that chemical companies claim as confidential. EPA officials  also told us that the agency does not have the resources that would be  needed to investigate and challenge claims to determine the number that  are inappropriate. Consequently, EPA focuses on investigating primarily  those claims that it believes may be both inappropriate and among the  most potentially important—that is, claims relating to health and safety  studies performed by the chemical companies involving chemicals  currently used in commerce. The EPA official responsible for initiating  challenges to confidentiality claims told us that EPA challenges about 14  such claims each year and that the chemical companies withdraw nearly  all of the claims challenged.
As we have previously reported, state officials who have various  responsibilities for protecting public health and the environment from the  dangers posed by chemicals have said that having access to confidential  TSCA information would allow them to examine information on chemical  properties and processes that they currently do not possess, which could  enable them to better control the risks of potentially harmful chemicals.  The general public may also find information provided under TSCA useful.  Individual citizens or community groups may have a specific interest in  information on the risks of chemicals that are produced or used in nearby  facilities. For example, neighborhood organizations could use such  information to engage in dialogue with chemical companies about  reducing chemical risks, preventing accidents, and limiting chemical  exposures.
In our June 2005 report, we suggested that Congress consider amending  TSCA to authorize EPA to share the confidential business information that  chemical companies provide to EPA with states and foreign  governments. This amendment would be subject to regulations to be  established by EPA in consultation with the chemical industry and otherinterested parties, which would protect the information from unauthoriz ed  disclosures. In our September 1994 report, we recommended that ay  Congress consider limiting the length of time for which information m be claimed as confidential without resubstantiation of the need for  confidentiality.
section_title: Concluding Observations
paragraphs: Although we have identified significant shortcomings with TSCA in  numerous reports and made recommendations to remedy them, EPA still does not have the authority to develop sufficient information to su critical decisions regarding how to protect human health and the  environment from toxic chemicals. In our previous reports on TSC have recommended both statutory and regulatory changes to (1)  strengthen EPA’s authority to obtain additional information from the  chemical industry, (2) shift more of the burden to chemical companies for demonstrating the safety of their chemicals, and (3) enhance the public’s understanding of the risks of chemicals to which they may be exposed,  among other things. With regard to IRIS, it is too soon to know if EPA’s  new IRIS assessment process will enable the agency to develop timely and   to  credible assessments of chemicals of concern. Without greater attention ance that  EPA’s efforts to assess toxic chemicals, the nation lacks assur human health and the environment are adequately protected.
Madam Chairman, Ranking Member, this concludes my prepared  statement. I would be happy to respond to any ques Members of the Committee may have at this time.
section_title: GAO C Staff Acknowledgments
paragraphs: For further information about this testimony, please contact John B.  Stephenson at (202) 512-3841 or stephensonj@gao.gov. Contact points for  our Offices of Congressional Relations and Public Affairs may be found the last page of this statement. Contributors to this testimony include  David Bennett, Ben Shouse, Antoinette Capaccio, Christine Fishkin, and  Ed Kratzer.
section_title: Related GAO Products
paragraphs: EPA Chemical Assessment: Process Reforms Offer the Potential to  Address Key Problems. GAO-09-774T. Washington, D.C.: June 11, 2009.
Scientific Integrity: EPA’s Efforts to Enhance the Credibility and  Transparency of Its Scientific Processes. GAO-09-773T. Washington, D.C.:  June 9, 2009.
Biomonitoring: EPA Needs to Coordinate Its Research Strategy and  Clarify Its Authority to Obtain Biomonitoring Data. GAO-09-353.  Washington, D.C.: April 30, 2009.
Chemical Regulation: Options for Enhancing the Effectiveness of the  Toxic Substances Control Act. GAO-09-428T. Washington, D.C.: February  26, 2009.
High-Risk Series: An Update. GAO-09-271. Washington, D.C.: January 22,  2009.
EPA Science: New Assessment Process Further Limits the Credibility  and Timeliness of EPA’s Assessments of Toxic Chemicals. GAO-08-1168T.  Washington, D.C.: September 18, 2008.
Chemical Assessments: EPA’s New Assessment Process Will Further  Limit the Productivity and Credibility of Its Integrated Risk  Information System. GAO-08-810T. Washington, D.C.: May 21, 2008.
Toxic Chemicals: EPA’s New Assessment Process Will Increase  Challenges EPA Faces in Evaluating and Regulating Chemicals.   GAO-08-743T. Washington, D.C.: April 29, 2008.
Chemical Assessments: Low Productivity and New Interagency Review  Process Limit the Usefulness and Credibility of EPA’s Integrated Risk  Information System. GAO-08-440. March 7, 2008.
Chemical Regulation: Comparison of U.S. and Recently Enacted  European Union Approaches to Protect against the Risks of Toxic  Chemicals. GAO-07-825. Washington, D.C.: August 17, 2007.
Chemical Regulation: Actions Are Needed to Improve the Effectiveness of  EPA’s Chemical Review Program. GAO-06-1032T. Washington, D.C.:  August 2, 2006.
Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess  Health Risks and Manage Its Chemical Review Program. GAO-05-458.  Washington, D.C.: June 13, 2005.
Toxic Substances Control Act: Legislative Changes Could Make the Act  More Effective. GAO/RCED-94-103. Washington, D.C.: September 26, 1994.
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