Chemical Regulation: Actions are Needed to Improve the Effectiveness of EPA's Chemical Review Program
Published: 2006-08-02T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Chemicals play an important role in everyday life, but some may be harmful to human health and the environment. Chemicals are used to produce items widely used throughout society, such as cleansers and plastics as well as industrial solvents and additives. However, some chemicals, such as lead and mercury, are highly toxic at certain doses and need to be regulated because of health and safety concerns. In 1976, the Congress passed the Toxic Substances Control Act (TSCA) to authorize the Environmental Protection Agency (EPA) to control chemicals that pose an unreasonable risk to human health or the environment. This testimony is based on GAO's June 2005 report, Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program (GAO-05-458). GAO's report describes EPA's efforts to (1) assess chemicals used in commerce, (2) control the use of chemicals not yet in commerce, and (3) publicly disclose information provided by chemical companies under TSCA. GAO recommended that the Congress consider providing EPA additional authorities under TSCA to improve EPA's ability to assess chemical risks, and that the EPA Administrator take several actions to improve EPA's management of its chemical review program. EPA did not disagree with our findings and is currently implementing some of our recommendations.
section_title: What GAO Found
paragraphs: EPA's authority under TSCA to obtain the data needed to assess existing chemicals does not facilitate its review process because the costly and time-consuming burden of obtaining the data is on EPA, rather than chemical companies. Consequently, EPA has used its authorities to require testing of fewer than 200 of the 62,000 chemicals in commerce when EPA began reviewing chemicals under TSCA in 1979. To obtain more data on existing chemicals, EPA implemented its High Production Volume Challenge Program, under which chemical companies voluntarily provide test data on about 2,800 chemicals produced or imported in amounts of 1 million pounds or more a year. While the purpose of the program is laudable, several problems remain, including that the chemical industry has not agreed to provide test data for over 200 chemicals with high production volumes. Moreover, after obtaining test data, EPA is required under TSCA's provisions to determine that a chemical poses an unreasonable risk before EPA can act to regulate its production or use. EPA officials say the act's legal standards for demonstrating unreasonable risk are so high that they have generally discouraged EPA from using its authorities to ban or restrict the manufacture or use of existing chemicals. Since Congress enacted TSCA in 1976, EPA has issued regulations to ban or limit the production of only five existing chemicals or groups of chemicals. EPA's reviews of new chemicals provide only limited assurance that health and environmental risks are identified because TSCA does not require companies to test chemicals before they notify EPA of their intent to manufacture the chemicals. Because of a general lack of data on new chemicals, EPA has developed methods to predict their potential exposure and toxicity levels by using scientific models to compare the new chemicals with chemicals that have similar molecular structures and for which toxicity information is available. However, the use of these models can be problematic because the models are not always accurate in predicting chemical properties and EPA's evaluation of general health effects of the chemicals is contingent upon the availability of information on chemicals with similar molecular structures. Additionally, the estimates of a chemical's production volume and anticipated uses, which EPA uses to assess exposure, can change substantially after EPA completes its review. Despite these limitations, EPA's reviews have resulted in some action being taken to reduce the risks of over 3,600 new chemicals. EPA's ability to provide the public with information on chemical production and risk is generally limited by the confidential business information provisions of TSCA. As a result, state agencies and foreign governments interested in obtaining this data for important purposes are denied access to the information. Recently, chemical companies have expressed interest in working with EPA to identify ways of enabling the agency to share confidential information with other organizations, provided that appropriate safeguards are adopted to prevent the unauthorized use of the information.

section_title: Letter
paragraphs: I am pleased to appear today before the Senate Committee on  Environment and Public Works, to discuss our work on the Environmental  Protection Agency’s (EPA) implementation of the Toxic Substances  Control Act (TSCA). Tens of thousands of chemicals are currently in  commercial use in the United States and, on average, over 700 new  chemicals are introduced into commerce each year. Although these  chemicals are an integral component in the production of important goods  and services, some may be toxic and may adversely affect human health  and/or the environment. It was in this context, that the Congress passed  TSCA in 1976, authorizing EPA to obtain manufacturer information on the  risks of chemicals and to control those that EPA determines will pose an  unreasonable risk.
TSCA addresses those chemicals manufactured, imported, processed,  distributed in commerce, used, or disposed of in the United States, but  excludes certain substances including pesticides regulated under the  Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and food  additives, drugs, and cosmetics regulated under the Federal Food, Drug,  and Cosmetic Act (FFDCA). TSCA authorizes EPA to review those  chemicals already in commerce – what are referred to as existing  chemicals — and to assess chemicals before they enter commerce – so- called new chemicals. EPA lists chemicals currently in commerce in the  TSCA inventory. Of the over 82,000 chemicals currently in the TSCA  inventory, about 62,000 were already in commerce when EPA began  reviewing chemicals in 1979. Since then, approximately 20,000 new  chemicals were added to the inventory and are now in use as existing  chemicals.
Prior to the passage of TSCA, chemical substances generally entered the  marketplace without review or controls. Without government intervention,  and often with little or no knowledge of their potential adverse health and  environmental impacts, some of these chemicals were produced and used  in high volumes. Earlier legislation on clean water and air had primarily  addressed releases of chemicals into the environment. In contrast, TSCA  authorized EPA to control the entire life cycle of chemicals from their  production and distribution to their use and disposal—including options  for the outright banning of chemical substances to mandating  requirements for chemical testing or product labeling. Now, chemical  companies are required to submit to EPA, 90 days before beginning to  manufacture a new chemical, a premanufacture notice containing  information including the chemical’s identity, categories of uses, estimated  production volumes, and any test data possessed by the chemical  company.
My testimony today, which is based on our June 2005 report, Chemical  Regulation: Options Exist to Improve EPA’s Ability to Assess Health  Risks and Manage Its Chemical Review Program, describes EPA’s  efforts to (1) assess existing chemicals used in commerce, (2) control the  risks of new chemicals not yet in commerce, and (3) publicly disclose  information provided by chemical companies under TSCA.
In summary, EPA does not routinely assess the human health and  environmental risks of existing chemicals and faces challenges in  obtaining the information necessary 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 fewer than 200 of the 62,000  chemicals in commerce when EPA began reviewing chemicals under  TSCA in 1979. Recognizing the need for additional information on existing  chemicals, in the late 1990s EPA implemented its High Production Volume  (HPV) Challenge Program, under which chemical companies have begun  to voluntarily provide test data on about 2,800 chemicals produced or  imported in amounts of 1 million pounds or more a year. While the HPV  Challenge Program is a laudable effort to develop data on these chemicals,  several problems remain, including that the chemical industry has not  agreed to provide testing for over 200 chemicals originally identified in the  HPV Challenge Program and that even with the test data provided under  the program, 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, according to EPA  officials the standard has been difficult to meet. In order to withstand  judicial scrutiny, a TSCA rule must be supported by substantial evidence  in the rulemaking 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. Since  Congress enacted TSCA in 1976, EPA has issued regulations under the act  to ban or limit the production of only five existing chemicals or groups of  chemicals.
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 sophisticated methods to predict the potential exposure and  toxicity levels of new chemicals by using scientific models to compare  them with chemicals with similar molecular structures for which toxicity  information is available. 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. TSCA generally prohibits the disclosure  of confidential business information and, 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 the Congress consider  providing EPA additional authorities under TSCA to improve its ability to  assess chemical risks, such as providing the EPA Administrator the  authority to require 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. For example, EPA is  currently launching a pilot project to review claims of confidentiality for  data on certain older chemicals.
subsections: section_title: EPA Has Limited Information on the Health and Environmental Risks of Existing Chemicals and Has Issued Few Regulations Controlling Such Chemicals
paragraphs: Because chemical companies are generally not required to develop and  submit toxicity information to EPA, when the agency decides to review  existing chemicals, it generally has only limited information on the risks  that the chemicals pose to human health and the environment.  Furthermore, EPA’s authority under TSCA to require industry testing that  would provide the information to review the chemicals is difficult to use,  according to EPA officials. EPA has used its authority to require testing for  fewer than 200 of the 62,000 chemicals in commerce when EPA began  reviewing chemicals under TSCA in 1979. Furthermore, EPA has rarely  banned, limited the production, or restricted the use of existing chemicals.  Since 1998, EPA has focused its efforts on obtaining information on  existing chemicals through voluntary programs, such as the HPV  Challenge Program. This program is intended to provide basic data on the  characteristics of about 2,800 chemicals produced in excess of 1 million  pounds a year.
subsections: section_title: EPA Has Limited Toxicity and Exposure Data with Which to Review Existing Chemicals
paragraphs: EPA’s toxicity and exposure data on existing chemicals is often  incomplete and TSCA’s authority to require testing in support of the  agency’s review process is difficult to use. While TSCA authorizes the  review of existing chemicals, it generally provides no specific requirement,  time frame, or methodology for doing so. Chemical companies are not  required to develop and submit toxicity information to EPA unless the  agency promulgates a testing rule, thus placing the burden for obtaining  data on EPA. In addition, if chemical company testing shows that a  chemical is not toxic, there is generally no standing requirement that the  chemical companies submit this data to EPA. Consequently, when EPA  decides to review existing chemicals, it generally has only limited  information on the risks of injury the chemicals pose to human health and  the environment.
EPA officials told us that in cases where chemical companies do not  voluntarily provide test data and health and safety studies in a complete  and timely manner, requiring the testing of existing chemicals of  concern—those chemicals for which some suspicion of harm exists—is  the only practical way to ensure that the agency obtains the needed  information. For example, there are currently over 200 high-production- volume chemicals for which chemical companies have not agreed to  provide the minimal test data that EPA believes are needed to initially  assess their risks. Furthermore, many additional chemicals are likely to be  added to become high production chemicals because the specific  chemicals used in commerce are constantly changing, as are their  production volumes. Chemical industry representatives told us that TSCA  provides EPA with adequate authority to issue rules requiring companies  to provide EPA with any test and exposure data possessed by the  companies, and that EPA could use such authority to obtain company  information on existing chemicals of concern. EPA could then use that  information to determine whether additional rules should be issued to  require companies to perform additional testing of the chemicals.
However, EPA officials told us that it is time-consuming, costly, and  inefficient for the agency to use a two-step process of (1) issuing rules  under TSCA (which can take months or years to develop) to obtain  exposure data or available test data that the chemical industry does not  voluntarily provide to EPA and then (2) issuing additional rules requiring  companies to perform specific tests necessary to ensure the safety of the  chemicals tested. Officials also said that EPA’s authority under TSCA to  issue rules requiring chemical companies to conduct tests on existing  chemicals has been difficult to use because the agency must first make  certain findings before it can require testing. Specifically, TSCA requires  EPA to find that current data is insufficient; testing is necessary; and that  either (1) the chemical may present an unreasonable risk or (2) that 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.
Once EPA has made the required findings, the agency can issue a  proposed rule for public comment, consider the comments it receives, and  promulgate a final rule ordering chemical testing. EPA officials told us that  finalizing rules can take from 2 to 10 years and require the expenditure of  substantial resources. Given the time and resources required, the agency  has issued rules requiring testing for fewer than 200 chemicals. Because  EPA has used authority to issue rules to require testing so sparingly, it has  not continued to maintain information on the cost of implementing these  rules. However, in our October 1994 report on TSCA, we noted that EPA  officials told us that issuing such a rule can cost hundreds of thousands of  dollars.
Given the difficulties involved in requiring testing, EPA officials do not  believe that TSCA provides an effective means for testing a large number  of existing chemicals. They believe that EPA could review substantially  more chemicals in less time if they had the authority to require chemical  companies to conduct testing and provide test data on chemicals once  they reach a substantial production volume, assuming EPA had first  determined that these data cannot be obtained without testing. We have  long held a similar view based on our reviews involving TSCA, and in our  in June 2005 report, we recommended that the Congress consider giving  EPA the authority to require chemical manufacturers and processors to  develop test data based on substantial production volume and the  necessity for testing.
section_title: EPA Has Had Difficulty Proving That Chemicals Pose Unreasonable Risks and Has Regulated Few Existing Chemicals under TSCA
paragraphs: Even when EPA has toxicity and exposure information on existing  chemicals, the agency stated that it has had difficulty demonstrating that  harmful chemicals pose an unreasonable risk and that they should be  banned or have limits placed on their production or use. Indeed, EPA has  rarely banned, limited the production, or restricted the use of existing  chemicals. Since the Congress enacted TSCA in 1976, EPA has issued  regulations under the act to ban or limit the production or restrict the use  of only five existing chemicals or chemical classes. For an additional 173  existing chemicals, EPA has required chemical companies to submit  notices of any significant new uses of the chemical, providing EPA the  opportunity to review the risks posed by the new use.
section_title: EPA Implemented a Voluntary Program to Collect More Industry Data on Existing Chemicals
paragraphs: Facing difficulties obtaining information on existing chemicals, EPA took  steps to address this shortcoming with the implementation of the HPV  Challenge Program in 1998. According to EPA, the lack of information on  existing chemicals and the relative difficulty of requiring testing under  TSCA on the scale that would be necessary for the thousands of chemicals  produced at high volumes, has led EPA, in cooperation with chemical  companies, environmental groups, and other interested parties, to  implement a voluntary program to obtain test data on high-production- volume chemicals from chemical companies. The HPV Challenge Program  focuses on obtaining chemical company “sponsors” to voluntarily provide  data on the approximately 2,800 chemicals that chemical companies  reported in 1990, that they produced at a high volume—generally over 1  million pounds.
Through this program, sponsors develop a minimum set of data on the  chemicals, either by gathering available information, using models to  predict the chemicals’ properties, or conducting testing of the chemicals.  EPA plans to use the data collected under the program to prioritize high- production chemicals for further assessment, but it has not yet adopted a  methodology for prioritizing the chemicals or for determining those that  require additional information. In our June 2005 report, we recommended  that EPA develop and implement such a methodology for using  information collected through the HVP Challenge Program to prioritize  chemicals for further review and to identify and obtain additional  information needed to assess their risks. At EPA’s request, a federal  advisory group has proposed a methodology for prioritizing the HPV  Challenge Program chemicals, and EPA anticipates that the agency will  implement the proposal during 2006.
Nonetheless, other problems exist in the HPV Challenge Program.  Chemical companies have not volunteered to provide data on all the  chemicals currently in the HPV Program. In addition, despite the fact that  companies may begin raising the production volumes of other chemicals,  EPA has no mechanism for placing these chemicals on the HPV Challenge  Program list once they are produced in greater volume. We believe that  action to implement our previously mentioned recommendation that the  Congress consider giving EPA additional authority to require chemical  testing could ameliorate such problems.
section_title: EPA Lacks Sufficient Data to Ensure That the Potential Health and Environmental Risks of New Chemicals Are Identified
paragraphs: EPA’s review of new chemicals provides only limited assurance that health  and environmental risks are identified because the agency has limited  information with which to review them. In the absence of chemical test  data, EPA largely relies on scientific models that do not always accurately  determine chemicals’ properties or the full extent of their adverse effects.  Further, information that companies provide in the premanufacture  notices that EPA uses to assess potential exposures to new chemicals are  estimates that can change substantially once manufacturing begins.  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.
subsections: section_title: EPA Has Limited Information on New Chemicals and Relies on Modeling Tools to Assess the Health and Environmental Risks of New Chemicals
paragraphs: TSCA generally requires chemical companies to notify EPA of their intent  to manufacture or import new chemicals and to provide any available test  data. Yet EPA estimates that most premanufacture notices do not include  test data of any type, and only about 15 percent include health or safety  test data. Chemical companies do not have an incentive to conduct these  tests because they may take over a year to complete, and some tests may  cost hundreds of thousands of dollars. During a review of a new chemical,  EPA evaluates risks by conducting a chemical analysis, searching the  scientific literature, reviewing agency files (including files of related  chemicals that have already been assessed by EPA), analyzing toxicity  data on structurally similar chemicals, calculating potential releases of and  exposures to the chemical, and identifying the chemical’s potential uses.  On the basis of this review, EPA makes a decision to (1) take no action; (2)  require controls on the use, manufacture, processing, distribution in  commerce, or disposal of the chemical pending development of test data;  or (3) ban or otherwise regulate the chemical pending the receipt and  evaluation of test studies performed by the chemical’s manufacturer.  Because EPA generally does not have sufficient data on a chemical’s  properties and effects when reviewing a new chemical, EPA uses a method  known as structure activity relationships analysis to screen and evaluate a  chemical’s toxicity. This method, also referred to as the nearest analogue  approach, involves using models to compare new chemicals with  chemicals with similar molecular structures for which test data on health  and environmental effects are available.
EPA officials told us that, while the overall accuracy of the models has not  been validated for regulatory purposes, they are effective as screening  tools that allow EPA to focus its attention on the chemicals of greatest  concern—chemicals about which little is known other than that they are  structurally related to known harmful chemicals. By applying approaches  that make conservative predictions, EPA believes that it is more likely to  identify a false positive (where a chemical is determined to be of concern,  but on further analysis is found to be of low concern) than a false negative  (where a chemical is initially viewed as a low concern though on further  analysis is actually of higher concern). According to EPA, only about 20  percent of the premanufacture notices received annually go through the  agency’s more detailed full-review process after they have been initially  screened. That is, according to EPA officials, the majority of new  chemicals submitted for review can be screened out as not requiring  further review because (1) EPA determines on the basis of its screening  models that a chemical has low potential to harm human health or the  environment or (2) on the basis of other information, such as the  anticipated uses, exposures, and releases of the chemicals, only limited  potential risks to people and the environment are expected. In addition,  using these models, EPA identifies for possible regulatory action, those  chemicals belonging to certain chemical categories that based on its prior  experience in reviewing new chemicals are likely to pose potential risks  such that testing or controls are needed. In our June 2005 report, we  recommended that the EPA Administrator develop a strategy for  improving and validating, for regulatory purposes, the models that EPA  uses to assess and predict the risks of chemicals and to inform regulatory  decisions on the production, use, and disposal of the chemicals.
section_title: Estimates of Exposures and Other Information Provided in Premanufacturing Notices Can Change after Manufacturing Begins
paragraphs: EPA bases its exposure estimates for new chemicals on information  contained in premanufacture notices. However, the anticipated production  volume, uses, exposure levels, and release estimates outlined in these  notices generally do not have to be amended once manufacturing begins.  That is, once EPA completes its review and production begins, chemical  companies are not required under TSCA to limit the production of a  chemical or its uses to those specified in the premanufacture notice or to  submit another premanufacture notice if changes occur. However, the  potential risk of injury to human health or the environment may increase  when chemical companies increase production levels or expand the uses  of a chemical. To address this potential, TSCA authorizes EPA to  promulgate a rule specifying that a particular use of a chemical would be a  significant new use. EPA has infrequently issued such rules, which require  manufacturers, importers, and processors of the chemical for the new use  to notify EPA at least 90 days before beginning manufacturing or  processing the chemical for that use.
section_title: EPA Reviews of New Chemicals Have Resulted in Some Control Actions
paragraphs: When EPA’s assessment of a new chemical identifies health and safety  problems, EPA can issue a proposed rule to prevent chemical companies  from manufacturing or distributing the chemical in commerce, or to  otherwise restrict the chemical’s production or use, if the agency believes  the new chemical may present an unreasonable risk before EPA can  regulate the chemical under the relevant provisions of TSCA. 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 that chemical companies have submitted for review. These  actions ranged from chemical companies voluntarily withdrawing their  notices of intent to manufacture new chemicals, chemical companies  entering into consent orders with EPA to produce a chemical under  specified conditions, and EPA promulgating significant new use rules  requiring chemical companies to notify EPA of their intent to manufacture  or process a chemical for new uses.
For over 1,700 chemicals, companies withdrew their premanufacture  notices, sometimes after EPA indicated that the agency planned to initiate  the process for placing controls on the chemical, such as requiring testing  or prohibiting the production or certain uses of the chemical. EPA officials  told us that after EPA screens a chemical or performs a more detailed  analysis of it, chemical companies often drop their plans to market a new  chemical when the chemical’s niche in the marketplace is uncertain and  EPA requests that the company develop and submit test data.
For over 1,300 chemicals, EPA has issued orders requiring chemical  companies to implement workplace controls or practices during  manufacturing (pending the development of information), and/or perform  toxicity testing when the chemical’s production volumes reached certain  levels. EPA may issue these proposed orders to control the production,  distribution, use, or disposal of a new chemical when there is insufficient  information available to reasonably evaluate the human health or  environmental effects of a chemical and when the chemical (1) may  present an unreasonable risk to human health or the environment or (2) is  or will be produced in substantial quantities and (a) it either enters or may  reasonably be anticipated to enter the environment in substantial  quantities or (b) there is or may be significant or substantial human  exposure to the substance. While TSCA does not authorize EPA to require  that chemical companies develop this information, the act does allow EPA  to control the manufacturing and processing of the chemical until EPA has  sufficient data to determine if the chemical will pose a risk.
For over 570 new chemicals submitted for review, EPA required chemical  companies to submit premanufacture notices for any significant new uses  of the chemical, providing EPA the opportunity to review the risks of  injury to human health or the environment before new uses had begun.
section_title: EPA’s Ability to Share Data Collected Under TSCA Is Limited
paragraphs: EPA’s ability to make publicly available the information that it collects  under TSCA is limited. Chemical companies may claim the information  they provide to EPA under TSCA as confidential business information.  While EPA believes that some claims of confidential business information  may be unwarranted, challenging the claims is resource-intensive.
When companies submit information to EPA through premanufacture  notices, many claim a large portion of the information as confidential.  According to EPA, about 95 percent of premanufacture notices contain  some information that chemical companies claim as confidential. Under  EPA regulations, information that is claimed as confidential shall generally  be treated as such if no statute specifically requires disclosure. Exceptions  include if the information is required to be released by some other federal  law or court order, if the company voluntarily withdraws its confidential  claim, or if the EPA Office of General Counsel makes a final administrative  determination that the information does not meet the regulatory criteria  substantiating a legal right to the claim. EPA has not performed any recent  studies of the appropriateness of confidentiality claims, although a 1992  EPA study indicated that problems with inappropriate claims were  extensive. That 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, they have no data on the number  of inappropriate claims.
EPA officials told us that the agency does not have the resources  necessary to investigate and, where appropriate, challenge claims that it  believes 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, confidentiality claims  relating to health and safety studies performed by the chemical companies  involving chemicals currently 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 when challenged.
Officials who have various responsibilities for protecting public health and  the environment from the dangers posed by chemicals believe that having  access to confidential TSCA information would allow them to examine  information on chemical properties and processes that they currently do  not possess and could enable them to better control the risks of  potentially harmful chemicals. For example, on the basis of a study  performed by the state of Illinois with the cooperation of chemical  companies and EPA, Illinois regulators found that toxicity information  submitted under TSCA was useful in identifying chemical substances that  should be included in contingency plans in order to alert emergency  response and planning personnel to the presence of highly toxic  substances at facilities. Additionally, the availability of this information  could assist the states with environmental monitoring and enforcement.  For instance, using TSCA data, Illinois regulators identified potential  violations of state environmental regulations, such as cases where  companies had submitted information to EPA under TSCA but failed to  submit such information to the states as required.
Likewise, 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 can use such  information to engage in dialogue with chemical companies about  reducing chemical risks, preventing accidents, and limiting chemical  exposures.
TSCA’s provisions are in contrast to those of some foreign governments’  environmental laws, such as Canada, which authorizes its environmental  agency to share confidential business information with other governments  under agreements or arrangements where the government undertakes to  keep the information confidential. Chemical industry representatives told  us that the industry also sees benefits in allowing EPA to share  information with other countries in order to harmonize chemical  assessments among developed countries and improve chemical risk  assessment methods by allowing cooperation on improving models used  to predict chemical toxicity. The chemical industry is concerned, however,  that confidential information be protected from inappropriate disclosure.  These chemical industry representatives told us that some countries  currently do not have adequate procedures for protecting confidential  business information. However, they suggested that the policies and  procedures EPA currently uses to protect confidential information are  appropriate. Accordingly, they said that the chemical industry would not  object to TSCA revisions allowing EPA to share confidential information  with foreign countries and organizations, provided that such revisions  contain specific reference to safeguards that EPA would establish and  enforce to ensure that those receiving the information have stringent  policies and procedures to protect it.
Our June 2005 report included two recommendations for addressing the  problems we identified related to the confidential business information  provisions of TSCA. We recommended that EPA revise its regulations to  require companies to reassert claims of confidentiality within a certain  period after the information is initially claimed as confidential. We also  recommended that the Congress consider amending TSCA to authorize  EPA to share with the states and foreign governments the confidential  business information that chemical companies provide to EPA, subject to  regulations to be established by EPA in consultation with the chemical  industry and other interested parties that would set forth the procedures  to be followed by all recipients of the information in order to protect the  information from unauthorized disclosures. EPA did not disagree with the  report’s findings and is in the process of implementing several of our  recommendations. For example, EPA is currently launching a pilot project  to review claims of confidentiality for data on certain older chemicals.
section_title: Concluding Observations
paragraphs: Mr. Chairman, EPA’s efforts to encourage companies to voluntarily  provide data on existing chemicals is commendable. However, the  fundamental and historical problems the agency has experienced with  utilizing its authorities under TSCA continue to limit EPA’s ability to  manage its chemical review program and assess chemical risks. In this  respect, EPA faces considerable difficulties using its authorities to require  testing of existing chemicals, which prevents the agency from reviewing  substantially more chemicals in less time than it could if it had the  authority to require chemical companies to provide test data on chemicals  once they have reached a substantial production volume. Moreover, EPA’s  ability to provide the public with information on chemical production and  risks is hampered by the strict confidential business information  provisions of TSCA. While protecting such information is a legitimate  concern, TSCA currently prohibits EPA from disclosing much data for  important purposes such as assisting state agencies in carrying out their  environmental management responsibilities and foreign governments in  harmonizing international chemical assessment approaches—a goal  generally shared by these governments and the chemical industry. We  believe the actions that we have recommended to both the Congress and  EPA would go a long way in addressing the challenges EPA faces in  exercising its authorities under TSCA.
Mr. Chairman, this concludes my prepared statement. I would be happy to  respond to any questions that you or Members of the Committee may  have.
section_title: Contacts and Acknowledgments
paragraphs: For further information about this testimony, please contact me Mr. John  B. Stephenson at (202) 512-3841. David Bennett, John Delicath, Tyra  DiPalma-Vigil, Richard Johnson, Valerie Kasindi, and Ed Kratzer made key  contributions to this statement.
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