Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program
Published: 2005-06-13T00:00:00

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, including consumer products such as cleansers, paints, plastics, and fuels, 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. GAO reviewed EPA's efforts to (1) control the risks of new chemicals not yet in commerce, (2) assess the risks of existing chemicals used in commerce, and (3) publicly disclose information provided by chemical companies under TSCA.
section_title: What GAO Found
paragraphs: EPA's reviews of new chemicals provide limited assurance that health and environmental risks are identified before the chemicals enter commerce. Chemical companies are not required by TSCA, absent a test rule, to test new chemicals before they are submitted for EPA's review, and companies generally do not voluntarily perform such testing. Given limited test data, EPA predicts new chemicals' toxicity by using models that compare the new chemicals with chemicals of similar molecular structures that have previously been tested. However, the use of the models does not ensure that chemicals' risks are fully assessed before they enter commerce because the models are not always accurate in predicting chemical properties and toxicity, especially in connection with general health effects. Nevertheless, given the lack of test data and health and safety information available to the agency, EPA believes the models are generally useful as screening tools for identifying potentially harmful chemicals and, in conjunction with other information, such as the anticipated potential uses and exposures of the new chemicals, provide a reasonable basis for reviewing new chemicals. The agency recognizes, however, that obtaining additional information would improve the predictive capabilities of its models. EPA does not routinely assess the risks of all existing chemicals and EPA 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. Partly because of a lack of information on existing chemicals, EPA, in partnership with industry and environmental groups, initiated the High Production Volume (HPV) Challenge Program in 1998, under which chemical companies began voluntarily providing information on the basic properties of chemicals produced in large amounts. It is unclear whether the program will produce sufficient information for EPA to determine chemicals' risks to human health and the environment. EPA has limited ability to publicly share the information it receives from chemical companies under TSCA. TSCA prohibits the disclosure of confidential business information, and chemical companies claim much of the data submitted as confidential. While EPA has the authority to evaluate the appropriateness of these confidentiality claims, EPA states that it does not have the resources to challenge large numbers of claims. State environmental agencies and others are interested in obtaining confidential business information for use in various activities, such as developing contingency plans to alert emergency response personnel of 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.

section_title: Letter
paragraphs: 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. Many of these chemicals play an important role in  people’s everyday lives. Consumers use products containing or made from  chemicals ranging from cleansers and paints to plastics and fuels. In a wide  variety of other products and industrial processes, companies use  chemicals as solvents and additives. Although chemicals are important in  producing goods and services, some may adversely affect human health  and the environment. For example, asbestos, which refers to several  minerals that typically separate into very tiny fibers, is a known human  carcinogen that can cause lung cancer and other diseases if inhaled.  Materials that contained asbestos were used widely for fireproofing,  thermal and acoustical insulation, and decoration in building construction  and renovation before the adverse effects of it were known.
In 1976, the Congress passed the Toxic Substances Control Act (TSCA) to  provide the Environmental Protection Agency (EPA) with the authority to  obtain more information on chemicals and regulate those chemicals that  pose an unreasonable risk to human health or the environment. TSCA  addresses those chemicals manufactured, imported, processed, distributed  in commerce, used, or disposed of in the United States, but excludes  certain substances including, among other things, pesticides that are  regulated under the Federal Insecticide, Fungicide, and Rodenticide Act  (FIFRA); and food; food additives; drugs; cosmetics or devices that are  regulated under the Federal Food, Drug and Cosmetic Act (FFDCA).
TSCA authorizes EPA to assess chemicals before they enter commerce  (new chemicals) and review those chemicals already in commerce  (existing chemicals). EPA lists chemicals 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, EPA has reviewed more than 40,000  substances as new chemical submissions, of which, approximately 20,000  were added to the inventory after chemical companies began  manufacturing them.
EPA has developed programs to assess, test, and manage identified  potential risks from new and existing chemicals. To assess risks, EPA  evaluates a chemical’s potential exposure levels and adverse effects on  human health and the environment. For new chemicals, TSCA generally  requires a company to notify EPA at least 90 days before manufacturing a  new chemical by submitting a premanufacture notice. These notices are to  provide information on the chemical’s identity, production process,  anticipated production volume, intended uses, potential exposure and  release levels, disposal, byproducts, test data possessed or controlled by  the chemical company, and a description of any other data concerning the  chemical’s environmental or health effects known to or reasonably  ascertainable by the chemical company.
Information on chemical risks that EPA collects under TSCA is not always  available to state and local governments and the public. In order to protect  trade secrets and privileged or confidential commercial or financial  information, TSCA allows chemical companies to designate information  provided to EPA as confidential and, if it meets certain criteria, EPA must  protect this information from disclosure.
In response to your request, we reviewed EPA’s efforts to (1) control the  risks of new chemicals not yet in commerce, (2) assess existing chemicals  used in commerce, and (3) publicly disclose information provided by  chemical companies under TSCA. In addressing these issues we also  obtained information on some of EPA’s voluntary chemical control  programs designed to complement TSCA and on the chemical control  programs of Canada and the European Union (EU). In addition, we  identified some legislative options that we have noted in the past could  strengthen EPA’s ability to assess and regulate chemicals under TSCA. This  information is presented in appendixes I, II, and III, respectively.
To review the extent to which EPA has assessed the risks of new and  existing chemicals and has made information obtained under TSCA public,  we identified and analyzed EPA’s policies and guidelines on how the  chemical review and control programs for new and existing chemicals  work, including the handling of confidential information, and determined  what actions EPA has taken to control chemicals. We also gathered  documentation on EPA’s voluntary programs. These efforts were  augmented by interviews with EPA officials and representatives of the  American Chemistry Council (a national chemical manufacturers  association), Environmental Defense (a national, nonprofit, environmental  advocacy organization), and the Synthetic Organic Chemical  Manufacturer’s Association (a national, specialty chemical manufacturer’s  association). We also obtained and reviewed studies conducted by EPA on  the usefulness of confidential business information to states. To identify  potential options to strengthen EPA’s ability to assess and regulate  chemical risks under TSCA, we (1) interviewed officials at EPA, the  American Chemistry Council, Environmental Defense, EPA’s National  Pollution Prevention and Toxics Advisory Committee, and the Synthetic  Organic Chemical Manufacturer’s Association; (2) reviewed pertinent  literature, including prior GAO reports, case law, and congressional  hearings on TSCA; (3) attended various public meetings and conferences  sponsored by EPA and others; and (4) discussed chemical laws in Canada  and the EU with their representatives. A detailed description of our scope  and methodology is presented in appendix IV. We performed our work  between July 2004 and April 2005 in accordance with generally accepted  government auditing standards.
subsections: section_title: Background
paragraphs: In the last several decades, the Congress has passed legislation to increase  federal agencies’ ability to determine the health and environmental risks  associated with toxic chemicals and to address such risks. Some of these  laws, such as the Clean Air Act, the Clean Water Act; the Federal Food,  Drug and Cosmetic Act; and the Federal Insecticide, Fungicide, and  Rodenticide Act; authorize the control of hazardous chemicals in, among  other things, the air, water, soil, food, drugs, and pesticides. Other laws,  such as the Occupational Safety and Health Act and the Consumer Product  Safety Act, can be used to protect workers and consumers from unsafe  exposures to chemicals in the workplace and the home. These laws were  generally enacted in or before the early 1970s. Nonetheless, the Congress  found that human beings and the environment were being exposed to a  large number of chemicals and that some could pose an unreasonable risk  of injury to health or the environment. In 1976, the Congress passed TSCA  to provide EPA with the authority to obtain more information on chemicals  and regulate those chemicals that pose an unreasonable risk to human  health or the environment.
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  commerce or otherwise regulating them, such as by placing restrictions on  those already in the marketplace. While other environmental and  occupational health laws generally only control the release of chemicals in  the environment, exposures in the workplace, or the disposal of chemicals,  TSCA allows EPA to control the entire life cycle of chemicals from their  production and distribution to their use and disposal. However, the act  does not apply to certain substances such as nuclear material, firearms and  ammunition, pesticides, food, food additives, tobacco, drugs, and  cosmetics.
TSCA’s role in ensuring that chemicals in commerce do not present an  unreasonable risk of injury to health or the environment is established in  six major sections of the act, as shown in table 1.
Under section 4, EPA can promulgate rules to require chemical companies  to test potentially harmful chemicals for their health and environmental  effects. To require testing, EPA must find that a chemical (1) may present  an unreasonable risk of injury to human health or the environment or (2) 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 or may reasonably be anticipated to enter the  environment in substantial quantities. (For the remainder of this report, we  will refer to parts (a) and (b) of this second finding in abbreviated form as a  finding “that there is or may be substantial human or environmental  exposure to the chemical”). EPA must also determine that there are  insufficient data to reasonably determine or predict the effects of the  chemical on health or the environment and that testing is necessary to  develop such data.
Section 5 requires chemical companies to notify EPA at least 90 days before  beginning to manufacture a new chemical or before manufacturing or  processing a chemical for a use that EPA has determined by rule is a  significant new use. EPA has these 90 days to review the chemical  information in the premanufacture notice and identify the chemical’s  potential risks. Under section 5(e), if EPA determines that there is  insufficient information available to permit a reasoned evaluation of the  health and environmental effects of a chemical and that (1), in absence of  such information, the chemical may present an unreasonable risk of injury  to health or the environment or (2) it 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, then EPA can  issue a proposed order or seek a court injunction to prohibit or limit the  manufacture, processing, distribution in commerce, use, or disposal of the  chemical. Under section 5(f), if EPA finds that the chemical will present an  unreasonable risk, EPA must act to protect against the risk. If EPA finds  that there is a reasonable basis to conclude that a new chemical may pose  an unreasonable risk before it can protect against such risk by regulating it  under section 6 of TSCA, EPA can (1) issue a proposed rule, effective  immediately, to require the chemical to be marked with adequate warnings  or instructions, to restrict its use, or to ban or limit the production of the  chemical or (2) seek a court injunction or issue a proposed order to  prohibit the manufacture, processing, or distribution of the chemical.
Section 6 requires EPA to apply regulatory requirements to chemicals for  which EPA finds a reasonable basis exists to conclude that the chemical  presents or will present an unreasonable risk to human health or the  environment. To adequately protect against a chemical’s risk, EPA can  promulgate a rule that bans or restricts the chemical’s production,  processing, distribution in commerce, disposal or use, or requires warning  labels be placed on the chemical. Under TSCA, EPA must choose the least  burdensome requirement that will adequately protect against the risk. In  promulgating a rule, EPA must consider and publish a statement regarding:  the effects of the chemical on health and the environment and the  magnitude of human and environmental exposure; the benefits of the  chemical for various uses and the availability of substitutes for those uses;  and the reasonably ascertainable consequences of the rule, after  consideration of the effect on the national economy, small businesses,  technological innovation, the environment, and public health. If another  law would sufficiently eliminate or reduce the risk of injury to health or the  environment, then EPA may not promulgate a TSCA rule unless it finds that  it is in the public interest to do so, considering all relevant aspects of the  risk, a comparison of the estimated costs of compliance under TSCA and  the other law and the relative efficiency of actions under TSCA and the  other law to protect against risk of injury.
Section 8 requires EPA to promulgate rules under which chemical  companies must maintain records and submit such information as the EPA  Administrator reasonably requires. This information can include, among  other things, chemical identity, categories of use, production levels,  by-products, existing data on adverse health and environmental effects,  and the number of workers exposed to the chemical. In addition, section 8  provides EPA with the authority to promulgate rules under which chemical  companies are required to submit lists or copies of any health and safety  studies to EPA. Finally, section 8 requires chemical companies to report  any information to EPA that reasonably supports a conclusion that a  chemical presents a substantial risk of injury to health or the environment.
Section 9 establishes TSCA’s relationship to other laws. The section  includes a mechanism for EPA to alert other federal agencies of a possible  need to take action if EPA has a reasonable basis to conclude that an  unreasonable chemical risk may be prevented or sufficiently reduced by  action under a federal law not administered by EPA. Section 9 also requires  EPA to use authorities under other laws that it administers if its  Administrator finds that a risk to health or the environment could be  eliminated or sufficiently reduced under those laws, or unless EPA  determines that it is in the public interest to protect against such risks  under TSCA.
Section 14 details when EPA may disclose chemical information obtained  by the agency under TSCA. Chemical companies can claim certain  information, such as data disclosing chemical processes, as confidential  business information. EPA generally must protect confidential business  information against public disclosure unless necessary to protect against  an unreasonable risk of injury to health or the environment. Other federal  agencies and federal contractors can obtain access to this confidential  business information in order to carry out their responsibilities. EPA may  also disclose certain data from health and safety studies.
section_title: EPA Lacks Sufficient Data to Ensure That Potential Health and Environmental Risks of New Chemicals Are Identified
paragraphs: While TSCA authorizes EPA to promulgate rules requiring chemical  companies to conduct tests on chemicals and submit the resulting data to  EPA, TSCA does not require chemical companies to test new chemicals for  their toxicity and exposures before they are submitted for EPA’s review  and, according to EPA officials, chemical companies typically do not  voluntarily perform such testing. In the absence of chemical test data, EPA  largely relies on scientific models to screen new chemicals. However, use  of the models can present weaknesses in an assessment because models do  not always accurately determine the chemicals’ properties and the full  extent of their adverse effects, especially with regard to their general  health effects. Nevertheless, EPA believes that the models are useful as  basic screening tools where actual test data on health and environmental  effects information is not available from chemical companies. EPA believes  that the models are an effective tool that, in conjunction with other factors,  such as premanufacture notice information on the anticipated production  levels and uses of a chemical, supplies a reasonable basis for either  dropping the chemical from further review or subjecting it to more detailed  review and possible controls. EPA routinely updates database sources for  models with new data received through premanufacture notice  submissions, required testing from consent orders, substantial risk  submissions, and voluntary testing. EPA acknowledges, however, that  future efforts to obtain additional test data could enhance the models’  usefulness by providing a more robust database for their further  development and validation for regulatory purposes.
Furthermore, the information in premanufacture notices that EPA uses to  assess potential exposures to new chemicals, such as production volume  and anticipated uses, are estimates that can change substantially once EPA  completes its review and manufacturing begins. Although TSCA authorizes  EPA to require a manufacturer to submit a new notice under certain  conditions, the agency must first, after consideration of relevant statutory  factors, promulgate a significant new use rule in which it identifies  significant new uses or activities for which a new notice is required.
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: 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) under section 5(e)  of TSCA, 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 (SAR) 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 applies models where actual test data in general, and health and  environmental effects test data in particular, are not available. EPA officials  said that the models make conservative predictions that the agency  believes result in erring on the side of protecting human health and the  environment in screening chemicals. EPA’s own attempts to determine the  strength of these models shows them to be highly accurate in predicting  some chemical characteristics, but less accurate for other characteristics.  For example, in 1993, EPA and the EU jointly conducted a study to  compare EPA's predictions of individual physical and chemical properties  or health or environmental effects with those identified by the EU based on  test data submitted with EU notifications. The joint evaluation showed  that the accuracy of EPA’s predictions varied, depending on the effect or  the property being compared. For example, the study concluded that EPA  methods are likely to identify those substances that are not readily  biodegradable—in other words, slowly degrading chemicals. However, the  study concluded that EPA methods do not appear to work as well in  identifying chemicals that readily degrade as determined by the EU’s “ready  biodegration” base set test. The model performance is explained by  recognizing that EPA’s model does not focus on ready biodegration but  rather on ultimate biodegredation. Since the 1993 study, EPA and others  have conducted studies on selected aspects of some of its models, such as  a 2001 study conducted by PPG Industries on the accuracy of aquatic  toxicity predictions for different types of polymers. This study showed  mixed results in that the models proved to be highly accurate for predicting  the toxicity of the chemicals tested on rainbow trout, but were in error for  about 25 percent of the cases in which the models’ results were compared  with actual test data for determining the chemicals’ effects on the growth  of aquatic algae, an important environmental end point.
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 potential for low toxicity to human health or 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.
EPA officials told us that while they take efforts to improve and validate  their models for regulatory purposes where opportunities arise (e.g.,  models are subjected to peer review when significant modifications are  introduced in their design or structure), they do not have a specific  program to do so. EPA officials stated that they routinely use test data to  improve the models as it becomes available but TSCA does not require  companies to routinely conduct tests and submit such data to the agency.  Unless EPA requires testing under section 4 of TSCA, TSCA only requires  chemical companies to provide notice to EPA of information the  companies obtain that reasonably supports the conclusion that the  chemical presents a substantial risk of injury to health or the environment.  Under section 4 of TSCA, EPA may promulgate a rule requiring companies  to conduct tests and submit test data but may do so only if it first  determines 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. EPA  officials said that chemical companies may have test data that shows that a  chemical has low toxicity. These officials also said that such data would be  useful for helping to improve the accuracy of their models. EPA has  authority under section 8 of TSCA to promulgate rules requiring companies  to submit any existing test data concerning the environmental and health  effects of a chemical or copies of any health and safety studies conducted  or initiated by, or otherwise known by, the chemical company.
EPA officials told us that other efforts are under way to validate these  models for regulatory purposes. Organization for Economic Co-operation  Development (OECD) member countries are undertaking collaborative  efforts to develop and harmonize SAR methods for assessing chemical  hazards. However, EPA is hampered in its ability to provide supporting test  data to aid OECD as part of this effort because confidentiality provisions in  TSCA do not allow EPA to share confidential business information  submitted by chemical companies with foreign governments. EPA officials  said that international efforts to validate SAR models for regulatory  purposes and to move toward harmonized international chemical  assessments would be improved if EPA had the ability to share this  information under appropriate procedures to protect confidentiality.  TSCA’s provisions are in contrast to those of the Canadian Environmental  Protection Act (CEPA), for example, which authorizes the Canadian  Minister of the Environment 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 countries to share information in order to harmonize  chemical assessments among developed countries and improve chemical  risk assessment methods by allowing countries to cooperate in improving  models used to predict chemical toxicity. The chemical industry is  concerned, however, that the confidential information shared be protected  from inappropriate disclosure. These chemical industry representatives  told us that some countries currently do not have stringent enough  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. In this  regard, chemical industry representatives stated that such policies and  procedures should include provisions such as requiring that those who  handle confidential information be briefed on the importance of not  disclosing the information to those without the proper clearance and  keeping such information in locked storage.
EPA officials told us that, in addition to assisting international efforts to  enhance modeling tools and harmonize international chemical  assessments, the ability to share confidential business information with  foreign governments would be beneficial for developing a strategy to  identify the resources needed to develop and validate new models for  regulatory purposes—a measure that is especially important given the  continuing central role of scientific models in EPA’s assessment program  for new chemicals. These officials also suggested that it would be  productive to explore regulatory and voluntary approaches that could be  used to obtain additional information from chemical companies on  chemical properties and characteristics, including “negative” studies—i.e.,  evidence that a chemical is not harmful. According to EPA, such  information is useful for understanding the chemical and thus for  developing and validating models for regulatory purposes. Under TSCA,  companies submitting a premanufacture notice must, at the same time,  submit data such as anticipated production volume, manufacturing  process, and any test data in their possession and a description of any other  reasonably ascertainable data concerning the environmental and health  effects of the chemical. If EPA feels it needs more information on these  chemicals, it could explore promulgating a test rule under section 4 or  issuing a proposed order pending the development of information under  section 5(e). In addition, as noted above, EPA has authority under section 8  of TSCA to promulgate rules requiring companies to submit any existing  test data concerning the environmental and health effects of a chemical or  copies of any health and safety studies conducted or initiated by, or  otherwise known by, the chemical company.
Chemical industry representatives with whom we spoke told us that they  see much merit in working toward a strategy that would give EPA data that  could help the agency improve its models. They believe that it is to  everyone’s benefit to have approaches that produce models that are useful  for identifying both safe and problematic chemicals. This is especially true  for enabling industry to make timely decisions--especially for chemicals  having short life spans and requiring quick production decisions essential  to innovation. These chemical industry representatives also said that a  comprehensive strategy for improving models would be particularly  beneficial to developing countries lacking extensive experience in  manufacturing chemicals because it would enable them to speed their  progress toward developing chemicals that are safe and effective.
section_title: Estimates of Exposures and Other Information Provided in Premanufacture Notices Can Change after Manufacturing Begins
paragraphs: Chemical companies are generally required to submit to EPA, 90 days  before beginning to manufacture a new chemical, a premanufacture notice  containing information including the chemical’s identity, its production  process, categories of uses, estimated production volumes, potential  exposure levels and releases, any test data in the possession or control of  the chemical company, and a description of any other data concerning the  environmental or health effects known to or reasonably ascertainable by  the chemical company. 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 the premanufacture notice do not have to be amended  once manufacturing begins. That is, once EPA completes its review and  production begins, absent any requirement imposed by EPA such as a  significant new use rule, 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 such a rule specifying that a particular use of  a chemical would be a “significant new use.” The manufacturers, importers,  and processors of the chemical for that use would then be required 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 Numerous Control Actions
paragraphs: When EPA’s assessment of new chemicals 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 section 6 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 3,500 of the 32,000 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 certain chemicals for new uses prior to manufacturing or  processing the chemicals for such uses.
For over 1,600 chemicals, companies withdrew their premanufacture  notices, sometimes after EPA officials 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 screened the chemical or performed 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.
According to an EPA official, companies may be uncertain that they will  recoup the costs of testing and prefer instead to withdraw their  premanufacture notice.
For over 1,200 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 EPA 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) it  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. Under section 5 of TSCA, EPA cannot require  that chemical companies develop this information, but TSCA authorizes  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 about 570 of the 32,000 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. For example, in 2003, EPA promulgated a significant new  use rule requiring chemical companies to submit a notice for the  manufacture or processing of substituted benzenesulfonic acid salt for any  use other than as described in the premanufacture notice.
Finally, in 1984, EPA issued proposed rules that were effective upon  publication to impose certain controls on four new chemicals the agency  determined would pose an unreasonable risk to human health or the  environment. The rules—which remain in effect today—prohibit adding  any nitrosating agent, including nitrites, to metal working fluids that  contain these substances. According to EPA, adding nitrites or other  nitrosating agents to the substances causes the formation of a substance  known to cause cancer in laboratory animals. See appendix V for more  information on the rules issued to control these four chemicals.
section_title: EPA Does Not Routinely Assess Existing Chemicals, Has Limited Information on Their Health and Environmental Risks, and Has Issued Few Regulations Controlling Such Chemicals
paragraphs: TSCA authorizes but does not specifically require EPA to review the risks  of existing chemicals. Further, EPA cannot require chemical companies to  test the safety of existing chemicals and provide the resulting test data to  the agency, unless EPA first determines on the basis of risk or production  and exposure information that the chemicals warrant such testing. 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, according to EPA, in part because it is costly and  labor-intensive for EPA to require the development of toxicity and  exposure data, the agency has performed internal reviews of only an  estimated 2 percent of the chemicals that were in the TSCA inventory when  EPA began chemical reviews in 1979. Additionally, EPA has rarely banned,  limited the production, or restricted the use of existing chemicals. Only five  chemical substances or groups of chemical substances have been regulated  under section 6, and the last final action EPA took to control existing  chemicals under section 6 was published in 1990. Since 1998, EPA has  focused its efforts on obtaining information on existing chemicals through  voluntary programs, such as the HPV Challenge Program. This program will  provide basic data on the characteristics of about 2,800 chemicals  produced in excess of 1 million pounds a year. However, while EPA has  received recommendations from the NPPTAC on a process for screening  these chemicals, the agency has not yet implemented guidelines for  reviewing the data so that the chemicals can be prioritized and more  detailed information can be obtained to further assess their risks to human  health and the environment. Canada and the EU have recently taken  action—passing legislation and proposing a new regulation,  respectively—to further regulate or assess existing chemicals. When  implemented, these actions may require U.S. chemical companies to  submit information on some chemicals manufactured or processed in or  exported to Canada and the EU. EPA has authority under section 8 of TSCA  to require that copies of such data for chemicals manufactured or  processed by chemical companies in the United States be made available to  EPA.
subsections: section_title: EPA Has Limited Toxicity and Exposure Data with Which to Review Existing Chemicals
paragraphs: According to EPA officials, EPA’s toxicity and exposure data on existing  chemicals is often incomplete and TSCA’s authority to require testing is  difficult to use in support of the agency’s review process. While TSCA  authorizes the review of existing chemicals, it generally provides no  specific requirement, time frame, or methodology for doing so. Instead,  EPA conducts initial reviews after it receives information from the public  or chemical companies that a chemical may pose a risk. For example, if a  chemical company voluntarily tests a chemical or otherwise obtains  information about a chemical that reasonably supports the conclusion that  the chemical presents a substantial risk to human health or the  environment, TSCA requires that the chemical company immediately notify  EPA about this information. EPA then reviews the information to  determine the need for additional testing or risk management. However,  chemical companies are not required to develop and submit toxicity  information to EPA unless EPA promulgates a testing rule, thus placing the  burden for obtaining or requiring industry development of data on the  agency. 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.  Facing difficulties obtaining such information, as noted above, EPA has  made little progress in reviewing existing chemicals since EPA began  reviewing chemicals under TSCA in 1979.
The limited amount of information available to EPA on existing chemicals’  toxicity was illustrated in a 1998 EPA report of publicly available data on  2,863 high-production-volume chemicals produced and/or imported at over 1 million pounds per year in 1990. For each of these chemicals, EPA  examined the readily available data corresponding to six basic end points  that have been internationally agreed to as necessary for a screening level  assessment of a chemical’s toxicity and environmental fate. EPA estimated  that only about 7 percent of the 2,863 chemicals had information on all six  basic end points, 50 percent had information for one to five of the end  points, and 43 percent had no information for any of the end points.  According to EPA officials, the agency has access to even less information  for chemicals not considered high-production-volume chemicals.
Furthermore, EPA has limited information on how existing chemicals are  used and how they come into contact with people or the environment. To  gather more exposure information, in 2003, EPA amended its TSCA  Inventory Update Rule (IUR), which is primarily used to gather certain  information on chemicals produced at more than a basic threshold volume  in the year reported. Among other things, EPA raised the basic  production volume reporting threshold from 10,000 to 25,000 pounds,  required chemical companies producing or importing chemicals at a site at  or above this threshold to report the number of workers reasonably likely  to be exposed to the chemical at each site, and added a reporting threshold  of 300,000 pounds per site at or above which chemical companies must  report readily obtainable exposure-related use and processing  information.
Nevertheless, TSCA does provide EPA with the authority to obtain  information needed to assess chemicals by issuing rules under section 4 of  TSCA requiring chemical companies to test chemicals and submit the test  data to EPA. However, because promulgating test rules to obtain test data  on chemicals can be time consuming, EPA has negotiated agreements with  chemical companies to conduct testing. In 1979, EPA instituted a process to  negotiate with chemical companies and reach voluntary agreements to test  the safety of certain chemicals. However, in 1984, the United States District  Court for the Southern District of New York found that EPA had failed to  discharge its obligations under TSCA by negotiating such voluntary  agreements instead of initiating rulemaking with respect to chemicals  designated for testing by the Interagency Testing Committee (ITC) under  section 4(e) of TSCA. The court determined that EPA had made de facto  findings that testing of the ITC-designated chemicals was necessary. The  court noted that the very negotiation and acceptance of voluntary testing  agreements demonstrated EPA’s belief that additional data on the particular  chemicals at issue needed to be developed. Upon making such findings, the  court stated that it is EPA’s duty under TSCA to make the mandatory choice  between initiating rulemaking proceedings or publishing its reasons for not  doing so and that EPA had not done this. The court found no support either  in TSCA or “on some vague assertion of agency discretion” for EPA’s use of  the negotiated testing agreements instead of rulemaking proceedings. The  court also found that, in addition to violating the test rule promulgation  process set forth in TSCA, EPA’s failure to use the rulemaking process  bypassed several other important provisions within the statutory  framework of TSCA. The court stated that it was not EPA’s prerogative to  “substitute for this intricate framework a number of haphazard and  informal purported equivalents” and that negotiated testing programs  without rulemaking cannot be sanctioned under TSCA.
In order to address the concerns raised by the court, EPA promulgated a  rule in 1986, revising its procedures and providing for its current use of  enforceable consent agreements, which EPA believes bind the companies  signing them to perform the testing they agree to perform. EPA  regulations state that when EPA believes testing is necessary, it will explore  whether a consent agreement can be negotiated that satisfies those testing  needs. The regulations further require EPA to publish a notice in the  Federal Register when it decides to initiate negotiations. EPA will meet  with manufacturers, processors, and other interested parties (those  responding to EPA’s Federal Register notice) to attempt negotiation of a  consent agreement. All negotiating meetings are open to the public, and  EPA is to prepare meeting minutes and make them—as well as testing  proposals, correspondence, and other relevant material—available to the  public. When EPA prepares a draft consent agreement, it is circulated for  comment to all interested parties, who have 4 weeks to submit comments  or written objections. Where consensus exists on the draft consent  agreement, as determined under the criteria listed in EPA’s regulations,  the draft will be circulated to EPA management and interested parties for  final approval and signature. EPA will then publish another Federal  Register notice summarizing the consent agreement and listing the name of  the chemical to be tested in its regulations.
According to EPA, these agreements allow greater flexibility in the design  of the testing program because test methods can be negotiated. The  relationship between EPA and the chemical industry is typically  nonadversarial, and it usually takes less than a year for testing to begin on  chemicals subject to enforceable consent agreements. According to EPA,  negotiating these agreements is generally less costly and time-consuming  than promulgating test rules because EPA does not have to determine that  (1) a chemical poses or may pose an unreasonable risk or (2) a significant  or substantial potential may exist for human exposure to the chemical.  However, chemical companies must be willing to participate in such  negotiations. EPA has entered into consent agreements with chemical  companies to develop tests for about 60 chemicals. EPA officials told us  that, for an additional 250 chemicals, EPA issued formal decisions not to  test. In a number of these cases, EPA had initiated the process to either  require testing or to negotiate consent agreements but prior to finalizing  the rules or agreements chemical companies or other organizations had  met EPA’s need for the data.
While it appears that EPA’s enforceable consent procedures have been a  good mechanism for acquiring needed test data, as the United States  District Court for the Southern District of New York noted, “t is not an  agency’s prerogative to alter a statutory scheme even if its assertion is as  good or better than the congressional one.” In this regard, it is not clear  whether EPA’s current use of enforceable consent agreements would fare  better than its previous use of voluntary agreements if challenged in court.  EPA’s regulations require enforceable consent agreements to address many  of the provisions of TSCA triggered by test rules that the court found were  lacking in EPA’s earlier voluntary agreements. However, some important  differences remain between the TSCA framework for testing rules and  EPA’s regulations for enforceable consent agreements. First, the  enforceable consent agreement regulations would not account for some of  the TSCA provisions that would be triggered by a test rule. For example,  the regulations do not require the submission of test data along with the  premanufacture notices for new chemicals. The regulations also neither  preempt state or local testing rules, as a TSCA test rule would, nor do they  have the same reporting and recordkeeping requirements. Second, unlike a  testing rule, which would trigger TSCA requirements for all manufacturers  and processors of a particular chemical, the consent agreement would  generally only trigger such requirements for those manufacturers and  processors that sign the agreement. While EPA regulations state that any  person exporting or intending to export a chemical that is the subject of an  enforceable consent agreement must notify EPA, it is unclear how EPA  would enforce this provision if the person had not signed the agreement.  Despite EPA’s attempts to incorporate a number of the test rule-triggered  TSCA provisions into its enforceable consent agreements, its efforts may  still fall short. Like EPA’s earlier use of voluntary agreements, its use of  enforceable consent agreements is not explicitly authorized under TSCA,  and, if a court determined that EPA’s use of enforceable consent  agreements equated to a de facto finding that testing was necessary, a court  could again find that EPA lacked discretion to require testing other than  through promulgation of a test rule.
EPA officials believe that the agency’s revised procedures address the  court’s findings, and that, while TSCA does not specifically authorize the  use of consent agreements to obtain test data, a sound legal basis exists for  invoking TSCA’s enforcement provisions against chemical companies that  violate such agreements. Representatives of the American Chemistry  Council (ACC) also told us that they have always considered the consent  agreements to be enforceable and binding on the chemical companies  signing them. Bolstering these views somewhat is the fact that EPA has  been using the enforceable consent agreement process since establishing it  by rule in 1986—nearly two decades ago. Nevertheless, an EPA legal  memorandum states that although EPA could reasonably take the position  that it is authorized to enter into enforceable consent agreements requiring  testing—ultimately concluding that enforceable consent agreements could  be enforced by EPA and would be upheld by the courts—“the matter is not  free from doubt.” EPA officials have stated that revising TSCA to explicitly  provide authority to enter enforceable consent agreements would be  beneficial for clarifying when EPA has authority to enter into such  agreements. Chemical industry representatives agreed with EPA that  explicit authorization could be useful.
Finally, according to EPA, the lack of information on existing chemicals  and the relative difficulty in requiring testing under TSCA on such a large  scale as would be required for the more than 2,000 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  information on the chemicals, either by gathering available data, using  models to predict the chemicals’ properties, or conducting testing of the  chemicals.
EPA plans to use the data collected under the HPV Challenge Program to  prioritize high-production chemicals for further assessment. However, EPA  has not yet adopted a methodology for prioritizing the chemicals or  determining those that require additional information. At EPA’s request in  2005, a federal advisory group has proposed a methodology for prioritizing  the HPV Challenge Program chemicals. EPA anticipates implementing the  recommendation and beginning screening in early 2006.
While EPA will soon be collecting limited exposure information on  chemicals produced at or above 25,000 pounds per year, the agency does  not regularly collect exposure information on lower volume chemicals.  EPA officials stated, based on the success of the HPV Challenge Program,  there may be promise in a future effort to develop an appropriate level of  information for lower volume chemicals, although given the demands of  current efforts by EPA, industry, and others on HPV chemicals, no steps  have been taken in this regard. Furthermore, EPA has no voluntary or test  rule program in place for obtaining test data on chemicals that are  currently produced in low volumes but which may be produced at high  volumes in the future. While chemical industry organizations have said that  they will voluntarily provide a basic set of test data on certain  high-production-volume chemicals that are not part of the HPV Challenge  Program, it is unclear that their efforts will produce information sufficient  for EPA to make determinations of a chemical’s risk to human health or the  environment or provide the information in a timely manner.
EPA officials told us that, in cases where chemical companies do not  voluntarily provide needed test data and health and safety studies in a  complete and timely manner, requiring testing of existing chemicals of  concern is the only practical way to ensure that needed information is  obtained by the agency. For example, there are currently over 300  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 this number in the future because the specific  chemicals used in commerce are constantly changing, as are their  production volumes. Chemical industry representatives told us that TSCA  (under section 8) 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 under section 4 of TSCA 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 section 8 of TSCA (which can take months or years to develop) to  obtain exposure data or available test date that the chemical industry does  not voluntarily provide to EPA and then (2) issuing additional rules under  section 4 of TSCA requiring companies to perform specific tests necessary  to ensure the safety of the chemicals tested. They also said that EPA’s  authority to issue rules requiring chemical companies to conduct tests on  existing chemicals under section 4 of TSCA has been difficult to use  because of the findings the agency must first make before EPA can require  testing. Section 4 of 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.
For example, if EPA wanted to issue a test rule on the basis of a chemical’s  production volume, it would still need to make the other requisite findings.  In this regard, according to EPA officials, obtaining exposure information  needed for rulemaking is particularly difficult. To fully assess human  exposure to a chemical, EPA needs to know how many workers,  consumers and others are exposed; whether the exposure occurs through  inhalation or other means, such as skin absorption; and the amount and  duration of the exposure. For environmental exposure, EPA needs to know  such things as whether the chemical is being released in the air, water or  land; how much is being released; and the extent of the area affected.  Another important factor in environmental exposure is chemical fate, that  is, how the chemical acts and is ultimately disposed of in the environment.  EPA must rely on its estimates for most of this information because actual  measurements of exposure in the environment, workplace, and home, for  the thousands of chemicals in use are not practicable because of the  monitoring equipment and staff resources that would be required.
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 under section 4 of TSCA 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 only  185 of the approximately 82,000 chemicals in the TSCA inventory. Because  EPA has used section 4 so sparingly, it has not continued to maintain  information on the cost of implementing test rules. However, in our  October 1994 report on TSCA, we noted that EPA officials told us that  issuing a rule under section 4 can cost between about $68,500 and $234,000.
Given the difficulties involved in requiring testing, EPA officials do not  believe that TSCA’s authorities under section 4 provide an effective means  for testing a large number of chemicals. They believe that EPA could  review substantially more chemicals in less time if they had authority to  require chemical companies to conduct testing and provide test data on  chemicals once they reach a substantial production volume, assuming EPA  has also determined that testing is necessary in order to obtain these data.
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. 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 five existing chemicals  or chemical classes. The five chemicals or chemical classes are  polychlorinated biphenyls (PCB), fully halogenated chlorofluoroalkanes,  dioxin, asbestos, and hexavalent chromium. (See app. V for additional  information on these five chemicals). In addition, for 160 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.
In order to regulate an existing chemical under section 6(a) 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. Before regulating a chemical, the EPA Administrator must  consider and publish a statement regarding   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.
Further, the regulation must apply the least burdensome requirement that  will adequately protect against such risk. For example, if EPA finds that it  can adequately manage the unreasonable risk of a chemical through  requiring chemical companies to place warning labels on the chemical,  EPA could not ban or otherwise restrict the use of that chemical.
Additionally, if the EPA Administrator determines that a risk of injury to  health or the environment could be eliminated or sufficiently reduced by  actions under another federal law, then TSCA prohibits EPA from  promulgating a rule under section 6(a) of TSCA, unless EPA finds that it is  in the public interest considering all aspects of the risk, the estimated costs  of compliance, and the relative efficiency of such action to protect against  risk of injury. According to EPA, it has found it difficult to meet all of these  requirements for rulemaking.
Finally, EPA must also develop substantial evidence in the rulemaking  record in order to withstand judicial review. Under TSCA, a court reviewing  a TSCA rule “shall hold  unlawful and set  aside…if the court finds  that the rule is not supported by substantial evidence in the rulemaking  record.” 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 by substantial evidence that EPA is promulgating the least  burdensome requirement.
EPA’s 1989 asbestos rule illustrates the evidentiary requirements that TSCA  places on EPA to control existing chemicals. In 1979, EPA began exploring  rulemaking under TSCA to reduce the risks posed by exposure to asbestos.  Based upon its review of over 100 studies of the health risks of asbestos as  well as public comments on the proposed rule, EPA concluded that  asbestos was a potential carcinogen at all levels of exposure. In 1989, EPA  promulgated a rule under TSCA section 6 prohibiting the future  manufacture, importation, processing, and distribution of asbestos in  almost all products. 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 chemical  companies, concluding that EPA had failed to muster substantial evidence  to justify its asbestos ban and returning parts of the rule to EPA for  reconsideration.
In its ruling, the court concluded that EPA did not present sufficient  evidence to justify the ban on asbestos because it did not consider all  necessary evidence and failed to show that the control action it chose was  the least burdensome regulation required to adequately protect human  health or the environment. EPA had not calculated the risk levels for  intermediate levels of regulation, as 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, after an initial showing of  product danger, would have been to consider each regulatory option,  beginning with the least burdensome, and the costs and benefits of each  option. The court further criticized EPA’s ban of products for which no  substitutes were currently available stating that, in such cases, EPA “bears  a tough burden” to demonstrate, as TSCA requires, that a ban is the least  burdensome alternative. Since the court’s 1989 decision, EPA has only  exercised its authority to ban or limit the production or use of an existing  chemical once (for hexavalent chromium). However, EPA officials said that  they had started the process for promulgating the rule for hexavalent  chromium years prior to the asbestos decision.
As the court noted, TSCA is not a zero-risk statute. EPA generally is  required to choose the least burdensome regulatory action and the  Congress has indicated its intent that EPA carry out TSCA “in a reasonable  and prudent manner  the environmental, economic, and  social impact of any action.” While concerns about the potential  economic and social impacts of EPA’s regulations are legitimate, according  to EPA officials, requiring EPA to satisfy before taking regulatory action  that the regulation uses the least burdensome approach to mitigate  unreasonable risks and that its rulemaking is supported by substantial  evidence has proven difficult for EPA to meet.
section_title: Canada and the EU Are Moving Toward Greater Control of Existing Chemicals
paragraphs: Canada and the EU have recently taken action to prioritize and review  existing chemicals. The Canadian legislation (CEPA), enacted in 1999,  requires the Minister of the Environment and the Minister of Health to  compile, and from time to time amend, a Priority Substances List specifying  those substances that the ministers believe should be given priority for  assessing whether they are toxic or capable of becoming toxic. Within 7  years of the act, the ministers are to categorize existing chemicals for the  purpose of identifying substances that, in their opinion, and on the basis of  available information, (1) may present to individuals in Canada the greatest  potential for exposure or (2) are persistent or bioaccumulative in  accordance with the regulations, and inherently toxic to human beings or  to nonhuman organisms, as determined by laboratory or other studies. The  ministers shall then conduct screening assessments for such chemicals.  The EU is currently considering a proposed regulation that, among other  things, would require chemical companies to register and submit  information on chemicals produced or imported in volumes of 1 metric ton  or more per year, and would require submission of a chemical safety report  documenting an assessment of chemicals manufactured or processed in  quantities of 10 metric tons or more per year.
Under CEPA and the proposed EU regulation, U.S. chemical companies  may be required to provide information on some existing chemicals that  are manufactured or processed in, or exported to, Canada and the EU.  Under current EPA regulations, these U.S. chemical companies generally  would not be required to submit the same information to EPA, although  section 8 of TSCA provides the EPA Administrator authority to promulgate  rules requiring chemical companies to submit such existing information on  chemicals manufactured in or imported into the United States. While EPA  officials told us that they are aware of the agency’s authority to require the  submission of at least some of the types of information that U.S. chemical  companies may be required to submit to Canada and the EU, they have not  decided whether or when to use such authority. For example, these  officials said that while the concept of obtaining copies of the information  that U.S. chemical companies submit to foreign countries has merit, they  might be able to obtain the information through voluntary arrangements  with the foreign governments. Furthermore, EPA officials told us that any  requirement for chemical companies to provide EPA a copy of the  information they submit to Canada and the EU would have to meet the  requirements under the Paperwork Reduction Act of 1995. Under this act,  federal agencies must, among other things, conduct a review of the  proposed information collection and obtain Office of Management and  Budget approval before requesting most types of information from the  public.
EPA officials acknowledged that exchanging information through  voluntary arrangements with foreign governments would have limitations,  such as EPA’s inability to provide other countries with confidential  business information. EPA officials also acknowledged that requiring  copies of the submissions directly from the companies would produce a  substantial amount of information that EPA could use to improve its  models for assessing and predicting chemical risks. They told us that, given  the recency of the Canadian chemical control changes and the pending  nature of the EU regulation, EPA has not assessed all options or decided on  a preferred approach for obtaining the data that U.S. chemical companies  may be required to submit to foreign governments. EPA officials told us  that the agency does not currently have a strategy or milestones for  identifying resource needs and making decisions regarding future agency  efforts to obtain such data.
Chemical industry representatives told us that the industry would have no  objections to EPA using its authority to require that chemical companies  submit to EPA the same information that they provide to Canada, the EU,  or other foreign governments. They indicated that few additional costs  would be incurred by providing this information, but that companies could  face additional burdens depending on the specific requirements governing  the submission of data. For example, it would be easier for the chemical  companies to provide the information periodically, such as annually, rather  than concurrently along with the submissions to foreign governments.
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 some of the  information they provide to EPA under TSCA 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, such as state health and environmental officials and foreign  governments. However, some state officials believe this information  would be useful for informing and managing their environmental risk  programs. While EPA believes that some claims of confidential business  information may be unwarranted, challenging the claims is  resource-intensive. Lacking the resources needed to challenge claims on a  wide basis, EPA identified several possible changes aimed at discouraging  the submission of unwarranted claims of confidential business information  under TSCA, but few were adopted.
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 order of a court, if the company submitter 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. 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 potential risks from  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 dialogues with chemical companies about  reducing chemical risks, preventing accidents, and limiting chemical  exposures.
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. 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, they have no  data on the number of inappropriate claims.
EPA officials also told us that the agency does not have the resources that  would be needed to investigate and, as appropriate, 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.
During the early 1990s, the EPA Office of General Counsel led an agency  wide review of EPA’s confidential business information regulations, but this  review did not lead to substantial changes. Subsequent to this effort, EPA  developed a plan involving various voluntary and regulatory measures to  reduce industry’s use of TSCA confidentiality claims. These measures  included exploring ways to make confidential information available to  states, having senior corporate officials certify that the information  claimed as confidential meets applicable statutory and regulatory  requirements, and requiring companies to reassert their claims at a future  date when confidentiality may no longer be necessary. While most of these  changes were not implemented, EPA officials said they did make some  changes to TSCA confidential business information regulations as a result  of this review such as requiring up-front substantiation requirements for  claiming plant site identity as confidential. EPA serves as an intermediary  between chemical companies and state agencies that wish to have access  to TSCA confidential information and, according to EPA, in recent years,  state agencies have not been very aggressive in requesting such  information. EPA believes, based on informal discussions with state  officials, that obtaining such information may no longer be a high priority  of the states, although the agency has not fully analyzed this issue. In  addition, EPA officials said that chemical companies had expressed  concerns about the costs of changing confidentiality procedures and have  suggested that providing this information to states could increase the risk  that some confidential information could be revealed to competitors.
However, as noted previously, chemical industry representatives told us  that chemical companies would not object to revising TSCA to enable  states to obtain access to the confidential business information that  companies provide to EPA—provided that adequate safeguards exist to  ensure that the information would be used only for legitimate reasons and  would be protected from inappropriate disclosures. EPA would need to  ensure that the states receiving confidential information have policies and  procedures similar to those that EPA uses to protect confidential  information from improper disclosures. For example, when EPA provides  confidential TSCA information to other federal agencies as permitted under  the act, EPA ensures that the agencies have policies and procedures for  protecting the information. In this regard, among other things, the agencies  provide security briefings to those handling the confidential information,  take steps to prevent the information from being stored on electronic  systems open to the Internet, and require that such information is kept  locked away when not in use.
Chemical company representatives also told us that, in principle, they have  no concerns about revising TSCA or EPA regulations to require that  confidentiality claims be reasserted at a future date. They said that  chemical companies make bona fide claims at the time the information is  submitted to EPA, but this information may not need to be kept  confidential after a certain date because confidentiality may no longer be  necessary in order to protect trade secrets. However, EPA has no  mechanism for determining when information no longer needs to be  protected as confidential. Chemical company representatives said that  companies sometimes choose to inform EPA that the information is no  longer confidential, but neither TSCA nor EPA regulations require them to  do so. Chemical industry representatives said that a requirement to  reassert claims of confidentially at some later date would not be disruptive  to the industry if the effective date of the requirement occurred after a  considerable period had passed, such as 5 years or more after the  information was initially claimed as confidential.
section_title: Conclusions
paragraphs: While TSCA allows EPA to require the testing of existing chemicals through  the rulemaking process, EPA has found it difficult and costly to make the  findings necessary to promulgate rules, including findings that a chemical  may pose unreasonable risks or that the chemical will be produced in  substantial quantities, and that there is or may be substantial human or  environmental exposure to the chemical. Consequently, to obtain the test  information needed on existing chemicals, EPA relies extensively on the  chemical industry to perform specific tests of certain chemicals under (1)  consent agreements negotiated with chemical companies and (2) voluntary  industry efforts under the HPV Challenge Program. Although the agency  believes that the negotiated agreements are enforceable and consistent  with EPA's authority under TSCA section 4, the enforceable consent  agreements have never been tested in court, and EPA believes that explicit  reference to the agreements in TSCA would be beneficial.
Chemical companies have begun voluntarily providing some test data that  EPA needs to assess chemical risks through the HPV program. However, in  cases where the industry does not agree to voluntarily perform testing in an  adequate and timely manner, EPA believes that requiring such testing is the  only practical way to ensure that testing is performed. In this regard, while  the chemical industry believes that EPA can use its existing authority under  TSCA to promulgate testing rules and require testing as needed on a  case-by-case basis, EPA notes its relative lack of experience in  promulgating large multichemical test rules and that the testing authorities  may prove difficult to implement on a large number of chemicals. For  example, EPA has pointed out that, despite notable voluntary efforts  regarding high-production-volume chemicals, (1) chemical companies have  not agreed to test 300 chemicals identified by EPA as  high-production-volume chemicals, (2) additional chemicals will become  high-production chemicals in the constantly changing commercial  chemical marketplace, and (3) chemicals without a particularly  high-production volume may also warrant testing based on their toxicity  and the nature of exposure to them. Furthermore, although the chemical  industry may be willing to take action even before EPA has the evidence  required for rulemaking under TSCA, the industry is nonetheless large and  diverse, and it is uncertain that all companies will always take action  voluntarily.
While the protection of confidential business information is obviously a  legitimate concern, TSCA currently prohibits EPA from disclosing much of  this data for useful and important purposes such as providing complete  information to state environmental management agencies and assisting  international efforts to develop and validate, for regulatory purposes, SAR  models or to harmonize chemical assessment approaches by sharing  information with foreign governments—a goal generally shared by  government and industry. Both EPA and the chemical industry believe that  revising TSCA to allow the sharing of such information would be beneficial  and appropriate provided that EPA ensures that recipients have in place  policies and procedures designed to prevent inappropriate disclosures of  the information. In addition, EPA and the chemical industry agree that the  need to protect industry data often diminishes over time, and thus it would  be appropriate to revise TSCA regulations to require companies to  periodically reassert the confidentiality of business information.
Largely because of limitations in the amounts and types of test data  provided with new chemical notifications, over the past decades EPA has  moved toward innovative approaches to assessing new chemicals and to  obtaining test data needed to assess chemicals. Most notably, these  approaches include the development and extensive use of models to assess  new chemicals and voluntary chemical testing approaches to obtain test  data needed to assess some existing chemicals. While of many of EPA’s  models have not been validated for regulatory purposes, EPA believes that  they are useful screening tools that have supported EPA’s actions to control  the production or use of about 3,500 of the more than 32,000 new chemicals  reviewed under TSCA. Nonetheless, EPA recognizes that, given the central  role that these models play in the chemical review process, the agency  needs a multifaceted strategy for improving the models, which includes  obtaining additional information on chemical properties necessary to  further develop and validate the models for regulatory purposes.
Likewise, EPA is encouraged by the early results of the HPV voluntary  chemical testing program for existing chemicals, which has already  produced substantial amounts of basic test data. The agency has moved  toward, but has not yet implemented, a methodology necessary for using  the data to prioritize chemicals for further review and identify the specific  additional data needed to determine whether and what controls should be  placed on their production or use. The impact of EPA’s programs could be  substantially enhanced as a result of additional information that companies  may be required to provide to Canada and the EU. By promulgating a rule  requiring U.S. companies and their subsidiaries to submit to EPA the same  information that they submit to foreign governments, the agency could  acquire substantial additional basic test data and health and safety studies,  at little, if any, additional cost to the chemical companies.
section_title: Matters for Congressional Consideration
paragraphs: To improve EPA’s ability to assess the health and environmental risks of  chemicals, the Congress should consider amending TSCA to  provide explicit authority for EPA to enter into enforceable consent  agreements under which chemical companies are required to conduct  testing;   give EPA, in addition to its current authorities under section 4 of TSCA,  the authority to require chemical substance manufacturers and  processors to develop test data based on substantial production volume  and the necessity for testing; and  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.
section_title: Recommendations for Executive Action
paragraphs: To improve EPA’s management of its chemical review program, we  recommend the EPA Administrator  develop and implement a methodology for using information collected  through the HPV Challenge Program to prioritize chemicals for further  review and to identify and obtain additional information needed to  assess their risks;  promulgate a rule under section 8 of TSCA requiring chemical  companies to submit to EPA copies of any health and safety studies, as  well as other information concerning the environmental and health  effects of chemicals, that they submit to foreign governments on  chemicals that the companies manufacture or process in, or import to,  the United States;  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; and  revise its regulations to require that companies reassert claims of  confidentiality submitted to EPA under TSCA within a certain time  period after the information is initially claimed as confidential.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided EPA a draft of this report for its review and comment. EPA did  not disagree with the report’s findings and recommendations. EPA,  however, offered two substantive comments. Regarding our  recommendation to the Administrator to promulgate a Section 8 rule to  obtain data submitted by chemical manufacturers to foreign governments,  EPA commented that, while such a reporting rule may bring useful  information, other targeted approaches for collecting information which  are directed at EPA’s domestic priorities, rather than foreign government  mandates, may be more prudent. We believe that having access to the  information submitted to foreign governments would provide EPA with an  important source of information that would be useful for assessing the  risks of existing chemicals and improving the models that EPA uses to  assess new chemicals. EPA could tailor this rule more narrowly, however, if  it saw good reason to do so, such as to avoid duplication of information it  already possesses. Regarding the matter for Congressional consideration  that Congress consider amending TSCA to explicitly recognize enforceable  consent agreements, EPA stated that it believes that there is currently  strong legal authority for these agreements. As we noted in our report,  TSCA does not explicitly authorize EPA to enter into these agreements and  a court could find that EPA lacked discretion to require testing other than  through promulgation of a test rule. EPA’s comments are reproduced in  appendix VI.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date.  At that time, we will send copies of this report to the  congressional committees with jurisdiction over EPA and its activities; the  Administrator, EPA; and the Director, Office of Management and Budget.  We also will make copies available to others upon request. In addition, the  report will be available at no charge on the GAO Web site at  http://www.gao.gov.
If you have any questions about this report, please contact me at (202)  512-6225 or stephensonj@gao.gov. Contact points for our Offices of  Congressional Relations and Public Affairs may be found on the last page  of this report. Key contributors to this report are listed in appendix VII.
section_title: EPA’s Voluntary Programs
paragraphs: The Environmental Protection Agency (EPA) has initiated voluntary  programs to help gather data to assess chemical risks and to promote the  use of more environmentally safe chemicals. The following information  does not offer an exhaustive account of EPA’s voluntary programs but  rather a discussion of three specific programs that are designed to  complement EPA’s efforts to assess and control chemicals under the Toxic  Substances Control Act (TSCA) and to encourage pollution prevention  under the Pollution Prevention Act (PPA).
subsections: section_title: High Production Volume Challenge Program
paragraphs: In response to several studies that showed that there were relatively few  U.S. High-Production-Volume (HPV) chemicals for which an internationally  agreed upon set of hazard screening data was available to the public, EPA,  in cooperation with industry, environmental groups, and other interested  parties, officially launched the HPV Challenge Program in late 1998. The  program was created to ensure that a baseline set of data on approximately  2,800 high-production-volume-chemicals would be made available to the  public. HPV chemicals are manufactured or imported in amounts equal to  or greater than 1 million pounds per year and were identified for this  program through data reported under TSCA Inventory Update Rule (IUR).  Under the HPV Challenge Program, EPA invited chemical companies to  voluntarily sponsor the approximately 2,800 chemicals. As part of their  commitment to the HPV Challenge Program, sponsors submit data  summaries of existing information along with a test plan that proposes a  strategy to fill data gaps for either individual chemicals or for a category of  chemicals. Sponsors could fill data gaps by (1) using existing scientifically  adequate data, (2) using an estimation technique such as Structured  Activity Analyses (SAR), or (3) proposing new testing. Testing will only be  conducted when there are inadequate existing data or when other  approaches, such as SAR, are not adequate to meet the need. EPA  requested that companies perform a self-assessment on the quality of  information they are providing to EPA.
EPA officials believe that the early results of the HPV Challenge Program  are promising. Nonetheless, several problems remain. While chemical  companies collectively have agreed to sponsor, or provide data for, most of  the chemicals that are produced at a high-production-volume, about 300  chemicals, called, “orphans,” have not been sponsored by any chemical  company. EPA has issued a proposed rule under section 4 of TSCA  requiring chemical companies to conduct tests on and provide data for 37  orphan chemicals in 2000, but has not yet finalized these rules. According  to EPA officials, due in part to the difficulty and cost in developing and  issuing such rules, EPA has not determined how to proceed on obtaining  data on the remaining orphan chemicals. EPA officials do not know if they  can make the findings necessary to issue test rules for the additional  unsponsored chemicals. In addition, since 1990, other chemicals are  produced at or above the high-production-volume threshold. Although EPA  has not developed a plan to address these new HPV chemicals, several  chemical associations have announced a joint initiative to extend industry’s  work to chemicals that meet the HPV threshold as of 2002 and to provide  use and exposure information for chemicals sponsored through EPA’s and  industry’s programs. Finally, while the HPV Challenge Program looks  promising in that, if successful, it will provide EPA and the public with  information not previously available on the properties of chemicals  produced at large volumes in the United States, this program may not  provide enough information for EPA to use in making risk assessment  decisions. While the data in the HPV Challenge Program may help EPA  prioritize chemicals of concern, the data may not present sufficient  evidence for EPA to determine whether a reasonable basis exists to  conclude that the chemical presents an unreasonable risk of injury to  health or the environment and that regulatory action is necessary.
section_title: Voluntary Children’s Chemical Evaluation Program
paragraphs: The Voluntary Children’s Chemical Evaluation Program (VCCEP) is a pilot  program developed by EPA to ensure that there is adequate publicly  available toxicity and exposure information to assess the potential risks to  children posed by 23 specific chemicals. The pilot VCCEP was announced  in a Federal Register notice in December 2000. EPA is running a pilot of  the VCCEP in order to gain insight into how best to design and implement  the program in order to effectively provide the agency and the public with  the means to understand the potential health risk to children associated  with certain chemical exposures. EPA intends the pilot to be the means of  identifying efficiencies that can be implemented in future VCCEPs. EPA  asked companies that produce and/or import 23 specific chemicals to  volunteer to sponsor their chemical in the first phase of a pilot of the  VCCEP. Chemical companies have volunteered to sponsor 20 of the 23  chemicals in the VCCEP.
Chemical companies volunteering to sponsor a chemical under the  program make chemical-specific public commitments to make certain  hazard, exposure, and risk assessment data and analyses publicly available.  EPA is pursuing a three-tiered approach for gathering information, with  Tier 3 conducting more detailed toxicology and exposure studies than Tier  2, and Tier 2 conducting more detailed toxicology and exposure studies  than Tier 1. After the submission of Tier 1 information and its review by a  peer consultation group consisting of scientific experts with extensive and  broad experience in toxicity testing and exposure evaluations, EPA reviews  the sponsor’s assessment and develops a response focusing primarily on  whether any additional information is needed to adequately evaluate the  potential risks to children. If additional information is needed to assess a  chemical’s risk to children, EPA will indicate what information should be  provided in Tier 2. Companies will then be given an opportunity to sponsor  chemicals at Tier 2. EPA plans to repeat this process for determining if Tier  3 information is needed. Information from all three tiers may not always be  necessary to adequately evaluate the risk to children.
According to EPA officials, since the program’s inception, sponsors have  submitted six assessments on chemicals to EPA and the consultation  group. EPA officials believe that they will collect Tier I data for all 20  sponsored chemicals within the next 4 to 5 years. According to EPA  officials, as of December 2004, three assessments are in the peer  consultation stage, and industry has indicated that three or four  assessments will be ready for peer consultation in 2005. Although EPA has  not currently assessed the effectiveness of VCCEP, it plans to have an  interim evaluation in 2005, and a final evaluation in 2007.
section_title: Sustainable Futures
paragraphs: In December 2002, EPA announced the Sustainable Futures Program, a  voluntary program designed to help industry develop new chemicals that  are sustainable economically and environmentally. Industry participants in  the program are offered (1) hands on training on some of EPA’s chemical  risk screening models, (2) regulatory relief in the form of expedited review,  (3) small business assistance, (4) technical assistance, and (5) public  recognition. In Sustainable Futures, EPA has sought to reduce the  likelihood of harmful new chemicals entering into commerce by making its  screening tools available to chemical companies. EPA provides companies  training for and access to the same chemical risk screening models that  EPA uses in screening and evaluating the risks of new chemicals. Use of  these tools may enhance companies’ ability to identify concerns and halt or  redirect work on a potentially risky chemical early in the research and  development phase. This approach can save a company the resources it  might otherwise invest in a chemical that ultimately may encounter  problems during EPA’s review process for new chemicals. By getting early  feedback on the potential hazards of a new chemical, a company can  reduce regulatory uncertainty, lower development and production costs,  and make production decisions that consider a broader array of factors  other than the potential profitability of a new chemical. Additionally, by  using these screening tools, companies may choose not to produce  chemicals that could be regulated by EPA, thus, potentially reducing EPA's  regulatory burden.
section_title: Canadian and EU Chemical Legislation
paragraphs: Canada and the European Union (EU) have inventories of chemicals  already in the marketplace and require chemical companies to notify  regulators about the manufacture or importation of new chemicals.  Officials we spoke with identified several notable aspects of the Canadian  and EU chemical legislation that differ from the Toxic Substances Control  Act (TSCA). First, in the EU, chemical companies must notify regulators  prior to marketing new chemicals, which is after production has already  begun. Second, Canadian law requires chemical companies to conduct  testing of new chemicals based on production or import volume, while EU  legislation requires testing based on marketed volume. Finally, the EU is  considering changes to its basic chemical legislation that would require  chemical companies to submit testing information on existing, as well as  new, chemicals. A chart generally describing some of the provisions of  TSCA and chemical control legislation in the EU and Canada, along with  the proposed EU Registration, Evaluation and Authorization of Chemicals  (REACH) regulation, is provided in table 2.
subsections: section_title: Canadian and EU Processes for Assessing the Health and Environmental Risks of Chemicals
paragraphs: Canadian Environmental Protection Act (CEPA) regulations and EU  legislation require chemical companies to submit certain test data on new  chemicals before they enter commerce. Canada defines new chemicals as  those chemicals that are not on Canada’s Domestic Substances List—a list  of all known substances that were in commercial use in Canada between  January 1, 1984, and December 31, 1986, were manufactured in or imported  into Canada by any person in a quantity of 100 kilograms or more in any  calendar year during that period, or that have subsequently been fully  notified and assessed under CEPA. Under CEPA regulations, chemical  companies must submit certain information and test data to the  government when production or importation volumes reach specified  levels. The information required for new chemicals differs depending on  whether the new chemical is listed on the Non-Domestic Substances List— a list that is based on the TSCA Chemical Substances Inventory. Chemicals  that are on the Non-Domestic Substances List are subject to notification  requirements at higher volume thresholds than are applicable to other new  chemicals and are exempt from certain information submission  requirements. In addition, the requirements to submit test data for low  volume chemicals are less extensive and complex than those for high  volume chemicals. According to Canadian officials, a new chemical is  generally not added to the existing chemical inventory until a certain level  of production or import has been reached, and specified testing for that  level has been performed without conditions being placed on the  chemical’s manufacture or import.
The EU currently maintains a separate inventory for new chemicals, which  are subject to additional testing and review before they are marketed in  volumes starting at 10 kilograms. Existing chemicals are not subject to the  same testing requirements. However, under the proposed EU REACH  chemical regulation, according to officials, this distinction between new  and existing chemicals would largely be eliminated. All chemical  companies would generally be required to register substances they produce  or import in volumes of 1 metric ton or more per year. REACH would  require chemical companies to gather and submit information on the  properties of their substances and where necessary perform tests to  generate health and safety data. For all substances subject to registration  manufactured or imported by the registrant in quantities of 10 metric tons  or more per year, REACH would require submission of a chemical safety  report, documenting a chemical safety assessment including, among other  things, human health and environmental health hazard assessments.  Substances would not be allowed to be manufactured or imported in the  European community unless they met the registration requirements. Thus,  according to EU officials, REACH would reverse the burden of proof that is  now placed on public authorities to manage the risks and uses of particular  existing chemicals.
section_title: Confidentiality Claims
paragraphs: CEPA and EU legislation allow chemical companies to make confidentiality  claims. However, according to officials we spoke with, these countries  place some greater restrictions than TSCA does on the types of data that  may be claimed as confidential.
In Canada, information that companies request be treated as confidential is  not to be disclosed except in certain circumstances. The Minister of the  Environment may disclose certain information upon giving 24 hours notice  to the company, if (a) the disclosure is in the interest of public health,  public safety or the protection of the environment and (b) the public  interest in the disclosure (1) outweighs in importance any material  financial loss or prejudice to the competitive position of the person who  provided the information or on whose behalf it was provided and (2) any  damage to the privacy, reputation or human dignity of any individual that  may result from disclosure. However, CEPA maintains certain protections  for information protected under Canada’s Privacy Act, Access to  Information Act, and Hazardous Materials Information Review Act.
EU legislation also allows chemical companies to make confidentiality  claims. However, according to an EU official we spoke with, the EU places  some greater restrictions on the types of data that may be claimed as  confidential than TSCA does. In the EU, a company may indicate that  information is commercially sensitive and that disclosure may be harmful  to the company industrially and commercially and, therefore, that the  company wishes to keep the information secret from all persons other than  the competent authorities and the European Commission. Secrecy,  however, shall not apply to  the trade name of the substance,  certain physicochemical data concerning the substance,   possible ways of rendering the substance harmless,  the interpretation of the toxicological and ecotoxicological tests and the  name of the body responsible for the tests, and  certain recommended methods and precautions and emergency  measures.
The authority receiving the information is to decide on its own  responsibility what information is covered by commercial and industrial  secrecy. The company can go to court and appeal the authority’s decision.
Under REACH, as currently proposed, one of the objectives of the new  system for the management of industrial chemicals would be to make  information on chemicals more widely available. Whenever a request for  access to documents held by the proposed European Chemicals Agency is  made, the agency would be required to inform the registrant of the  chemical or other party concerned of the request. That party would have 30  days to submit a declaration identifying information considered to be  commercially sensitive and disclosure of which might harm the party  commercially that the party wishes to be kept confidential. The agency  would consider the information and decide whether to accept the  declaration. The party could appeal this decision. The following  information would be among the types of information that would not be  treated as confidential:   the trade name(s) of the substance; physicochemical data concerning  the substance and on pathways and environmental fate,  the result of each toxicological and ecotoxicological study,  if essential to classification and labeling, the degree of purity of the  substance and the identity of impurities and/or additives which are  known to be dangerous,  guidance on safe use, and  information contained in the safety data sheet (except for the name of  the company or otherwise accepted as confidential in REACH).
The following information would be treated as confidential, even if the  company did not claim it as confidential:  details of the full composition of a preparation,  the precise use, function, or application of a substance or preparation,  the precise tonnage of the substance or preparation manufactured or  placed on the market, and  links between a manufacturer or importer and his downstream users.
However, in exceptional cases where there are immediate risks to human  health, safety or the environment, REACH would authorize the proposed  European Chemicals Agency to disclose this information.
section_title: Additional Options for Strengthening EPA’s Ability to Assess and Regulate Chemicals under TSCA
paragraphs: As requested, we identified a number of options that could strengthen the  Environmental Protection Agency’s (EPA) ability under the Toxic  Substances Control Act (TSCA) to assess chemicals and control those  found to be harmful. These options are those that we previously identified  in an earlier GAO report on ways to make TSCA more effective.  Representatives of environmental organizations and subject matter experts  subsequently concurred with a number of these options and commented on  them in congressional testimony. These options are not meant to be  comprehensive but illustrate actions that the Congress could take to  strengthen EPA’s ability to regulate chemicals under TSCA.
subsections: section_title: Options to Reduce EPA’s Evidentiary Burden to Take Action under TSCA
paragraphs: The Congress could amend TSCA to reduce the evidentiary burden that  EPA must meet to take regulatory action under the act by (1) amending the  unreasonable risk standard that EPA must meet to regulate existing  chemicals under section 6 of TSCA, (2) amending the standard for judicial  review that currently requires a court to hold a TSCA rule unlawful and set  it aside unless it is supported by substantial evidence in the rulemaking  record, or (3) amending the requirement that EPA must choose the least  burdensome regulatory requirement.
Currently, under TSCA section 6, EPA may only regulate existing chemicals  if it finds 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.” Several options are available to amend this standard. For  example:   The Congress could authorize EPA to regulate existing chemicals when  it identifies “significant,” rather than “unreasonable,” risks of injury to  health or the environment. “Significant risk” is the standard under TSCA  section 4(f) by which EPA is to identify chemicals for priority review.  EPA officials view the term “significant risk” as a very high threshold for  action. However, they believe that demonstrating significant risk would  be less demanding than demonstrating unreasonable risk. While  “significant risk” implies a finding that the risks are substantial or  serious, EPA believes that a finding of “unreasonable” risk requires an  extensive cost-benefit analysis. When reviewing EPA’s asbestos rule, the  United States Court of Appeals for the Fifth Circuit stated that in  evaluating what risks are unreasonable EPA must consider the costs of  any proposed actions; moreover, the court noted that TSCA’s  requirement that EPA impose the least burdensome regulation  reinforces the view that EPA must balance the costs of its regulations  against their benefits.
The Congress could amend TSCA to require that EPA demonstrate that a  chemical “may present” an unreasonable risk, rather than requiring a  demonstration that a chemical “presents or will present” an  unreasonable risk. Such a change would still require EPA to develop  documentation of evidence supporting its assessment, although to a  lesser extent than is currently required under TSCA.
In addition, TSCA currently requires a court to hold unlawful and set aside  a TSCA rule if it finds that the rule is not supported by substantial evidence  in the rulemaking record. As several courts have noted, the substantial  evidence standard is more rigorous than the arbitrary and capricious  standard normally applied to rulemaking under the Administrative  Procedure Act. The Congress could amend the standard for judicial review  to instead reflect a rational basis test to prevent arbitrary and capricious  administrative decisions.
Finally, TSCA currently requires that EPA choose the least burdensome  requirement when regulating existing chemicals. As we noted earlier, in its  ruling that EPA had failed to muster substantial evidence to justify its  asbestos ban, the United States. Court of Appeals for the Fifth Circuit  concluded that EPA did not present sufficient evidence to justify the ban on  asbestos because it did not consider all necessary evidence and failed to  show that the control action it chose was the least burdensome regulation  required to adequately protect human health or the environment. EPA had  not calculated the risk levels for intermediate levels of regulation, as 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, after an initial showing of product danger, would have been to  consider each regulatory option, beginning with the least burdensome, and  the costs and benefits of each option. Congressional testimony has  indicated that, under this court decision, the process “is not merely  onerous; it may well be impossible.” The Congress could amend or repeal  this requirement.
section_title: Options for Requiring Chemical Companies to Provide Additional Information on New Chemicals
paragraphs: TSCA could be revised to require companies to test their chemicals and  submit the results to EPA with their premanufacture notices. Currently,  such a step is only required if EPA makes the necessary findings and  promulgates a testing rule. A major drawback to testing is its cost to  chemical companies, possibly resulting in a reduced willingness to perform  chemical research and innovation. To ameliorate such costs, or to delay  them until the new chemicals are produced in large enough quantity to  offset the cost of testing, requirements for testing could be based on  production volume. For example, in Canada and the EU, testing  requirements for low-volume chemicals are less extensive and complex  than for those for high-volume chemicals.
Another option would be to provide EPA with greater authority to require  testing targeted to those areas in which EPA’s structure activity relationship  (SAR) analysis does not adequately predict toxicity. For example, EPA  could be authorized to require such testing if it finds that it cannot be  confident of the results of its SAR analysis (e.g., when it does not have  sufficient toxicity data on chemicals with molecular structures similar to  those of the new chemicals submitted by chemical companies.) Under such  an option, EPA could establish a minimal set of tests for new chemicals to  be submitted at the time a chemical company submits a premanufacture  notice for the chemical for EPA’s review. Additional and more complex and  costly testing could be required as the new chemical’s potential risks  increase, based on production or environmental release levels.
According to some chemical companies, the cost of initial testing could be  reduced by amending TSCA to require EPA to review new chemicals before  they are marketed, rather than before they are manufactured. In this  regard, according to EPA, about half of the premanufacture notices the  agency receives from chemical companies are for new chemicals that, for  various reasons, never enter the marketplace. Thus, requiring companies to  conduct tests and submit the resulting test data only for chemicals that are  actually marketed would be substantially less expensive than requiring  them to test all new chemicals submitted for EPA’s review.
section_title: Options for Requiring the Systematic Testing of Existing Chemicals
paragraphs: TSCA’s chemical review provisions could be strengthened by requiring the  systematic review of existing chemicals. In requiring that EPA review  premanufacture notices within 90 days, TSCA established a firm  requirement for reviewing new chemicals, but the act contains no similar  requirement for existing chemicals unless EPA determines by rule that they  are being put to a significant new use. 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, such as that included in the HPV  Challenge Program to EPA, for example, as a condition of manufacture or  import above some specified volume.
section_title: Options for Reducing Risks through Chemical Use Reduction
paragraphs: Given the thousands of chemicals in use and the many ways that exposures  and releases to the environment can occur, TSCA’s chemical-by-chemical  approach means that the act is unlikely to address more than the most  serious chemical risks. The process of collecting information on chemical  effects and exposures to support regulatory actions under TSCA is a  resource intensive and time-consuming process. A different approach  would be to set goals for reducing the use of toxic chemicals overall. Under  this approach, legislation could establish national goals for reductions in  the use of toxic chemicals and provide EPA with various tools, such as  pollution taxes and other economic incentives to encourage chemical  companies to engage in risk reduction activities. This approach differs  from a command-and-control approach in which the regulator specifies  how pollution must be reduced or what pollution control technology must  be used. An approach employing economic incentives gives companies  more flexibility in choosing how to reduce pollution and could lead to more  cost-effective solutions to pollution problems. An approach employing  economic incentives can take several forms, including systems under  which firms can buy and sell emission reduction credits and pollution  taxes. A pollution tax is a tax on the emissions of a pollutant or on harmful  products or substances. Such a tax would have to be carefully designed and  implemented to be effective in achieving environmental and economic  benefits.
Because of their inherently greater flexibility, market-based incentives may  be both a less costly and a more effective means of controlling pollution.  More chemicals could also be addressed under TSCA if the Congress were  to amend TSCA to expand the types of circumstances under which EPA  could take action under the act to specifically include situations in which  (1) it identifies pollution prevention opportunities, such as when safer  chemical substitutes can be shown to exist at a reasonable cost, or (2) the  use of a toxic chemical cannot be shown to pose a current problem, but its  continued use could be a long-term problem because it persists in the  environment or accumulates in plant or animal tissue. To better support  EPA’s pollution prevention initiatives, TSCA could also be amended to  expand the range of regulatory control options available to EPA to reduce  chemical risks. Such additional options could include the authority to  require the use of safer chemical substitutes or manufacturing processes  that result in less exposure or fewer environmental releases.
section_title: Scope and Methodology
paragraphs: Our objectives were to review the Environmental Protection Agency’s  (EPA) efforts to (1) control the risks of new chemicals not yet in  commerce, (2) assess existing chemicals used in commerce, and (3)  publicly disclose information provided by chemical companies under the  Toxic Substances Control Act (TSCA). In addressing these issues we also  obtained information on EPA’s voluntary chemical control programs that  complement TSCA, the chemical control programs of Canada and the  European Union (EU), and identified some legislative options that GAO  and others have previously noted could strengthen EPA’s authority to  assess and regulate chemicals under TSCA.
To review the extent to which EPA has assessed the risks of new and  existing chemicals and has made information obtained under TSCA public,  we reviewed the relevant provisions of TSCA, identified and analyzed EPA’s  regulations on how the new and existing chemical review and control  programs work, including the handling of confidential information, and  determined the extent of actions taken by EPA to control chemicals. These  efforts were augmented by interviews with EPA officials and  representatives of the American Chemistry Council (a national chemical  manufacturers association), Environmental Defense (a national, nonprofit,  environmental advocacy organization), and the Synthetic Organic  Chemical Manufacturer’s Association (a national, specialty chemical  manufacturer’s association). We also obtained and reviewed  documentation provide to EPA by the states on the usefulness of  confidential business information to states. We interviewed several EPA  officials to assess the reliability of data related to assessment and control  of new chemicals. We determined the data were sufficiently reliable for the  purposes of this report.
To understand efforts EPA has taken to assess and control the risks of new  and existing chemicals, we identified several voluntary programs designed  to promote environmentally safer chemicals and to gather information to  assess the risks of chemicals, in particular, EPA’s Sustainable Futures  Program, Voluntary Children’s Chemical Evaluation Program (VCCEP), and  the High Production Volume (HPV) Challenge Program. We selected  Sustainable Futures because it is a risk assessment tool used to  complement EPA’s other pollution prevention programs. Sustainable  Futures represents a pollution prevention program that impacts  manufacturer’s chemical decision-making process for chemicals not yet in  commerce; while other pollution prevention programs focus on chemicals  already in commerce. We selected the HPV Challenge Program and VCCEP  because they represent significant data collection efforts to provide  information for EPA’s assessment of existing chemicals. To enhance our  understanding, we interviewed EPA officials and representatives at  American Chemistry Council, Environmental Defense, and the Synthetic  Organic Chemical Manufacturer’s Association; we also attended EPA’s  National Toxic and Pollution Prevention Advisory Committee meetings.  Finally, we obtained and reviewed agency documents related to these  programs.
To understand other chemical control regulation, we collected  documentation and interviewed individuals knowledgeable about (1) the  Toxic Substances Control Act and (2) foreign chemical control laws or  proposed legislation: (a) the Canadian Environmental Protection Act 1999  and (b) the European Union’s Chemical Directives and proposed  Registration, Evaluation and Authorization of Chemicals. The EU and  Canada were chosen because they have recently taken action to revise  their chemical legislation. In 1999, Canada revised its chemical control law  and in 2003, the EU proposed a new regulation. The EU and Canada were  also selected because they have characteristics that are similar to those of  the United States: Canada and the EU member countries are industrialized  nations and have extensive experience with the review and control of  chemical substances. In addition, Canada and the EU produce a  considerable amount of chemicals. Furthermore, EPA officials and  chemical industry representatives recommended these countries for  comparison with TSCA. For each of the countries, we obtained laws,  technical literature, and government documents that describe their  chemical control programs. We also interviewed foreign officials  responsible for implementing the chemical substances control laws in  Canada and for representing the European Commission in the United  States. Our descriptions of these countries’ laws are based on interviews  with government officials and written materials they provided.
To identify potential options to strengthen EPA’s ability to assess and  regulate chemical risks under TSCA, we (1) interviewed officials at EPA,  the American Chemistry Council, Environmental Defense, EPA’s National  Toxic and Pollution Prevention Advisory Committee, and the Synthetic  Organic Chemical Manufacturer’s Association; (2) reviewed pertinent  literature, including prior GAO reports and congressional hearings on  TSCA; (3) attended various public meetings and conferences sponsored by  EPA and others; and (4) reviewed chemical legislation in Canada and and  proposed legislation in the EU. This report does not discuss all possible  options for revising TSCA. Those options that are discussed were selected  because they have been identified as addressing constraints in EPA's  authority under the act. Our selection of these options reflects (1) our  knowledge of EPA’s implementation of TSCA obtained during this and  previous reviews of the agency’s toxics programs, (2) foreign countries’  approaches to reviewing and controlling harmful chemicals, and (3) views  provided by U.S. government officials and representatives of the chemical  industry and environmental groups.
Our review was performed between June 2004 and April 2005 in  accordance with generally accepted government auditing standards.
section_title: Regulations Promulgated under Section 6 of TSCA
paragraphs: The Environmental Protection Agency (EPA) has promulgated rules under  section 6 of the Toxic Substances Control Act (TSCA) to place restrictions  on five existing chemicals or chemical categories and four new chemicals.  The five existing chemicals/chemical categories are polychlorinated  biphenyls (PCB), fully halogenated chlorofluoroalkanes, dioxin, asbestos  and hexavalent chromium. The four new chemicals are all used in metal  working fluids that, when combined with nitrites, could cause the  formation of a cancer causing substance. EPA’s rules for the four new  chemicals were immediately effective, unlike EPA’s rules for existing  chemicals, which required a comment period.
subsections: section_title: Existing Chemicals
subsections: section_title: Polychlorinated Biphenyls
paragraphs: Because the Congress believed that PCBs posed a significant risk to public  health and the environment, section 6(e) of TSCA prohibited the  manufacture, processing, distribution in commerce, or use of PCBs other  than in a totally enclosed manner after January 1, 1978, unless otherwise  authorized by EPA rule. Under TSCA, EPA may, by rule, authorize the  manufacture, processing, distribution in commerce or use of any PCB in a  manner other than a totally enclosed manner if EPA finds that it will not  present an unreasonable risk of injury to health or the environment. EPA  was also required by July 1977 to promulgate rules to (1) prescribe  methods for PCB disposal and (2) require PCBs to be marked with clear  and adequate warnings and instructions with respect to their processing,  distribution in commerce, use, or disposal. EPA has issued various rules to  implement these statutory requirements and provide for some exemptions  to the PCB prohibitions. About 50 percent of PCBs were used in electrical,  heat transfer, and hydraulic equipment. PCBs were also used in numerous  other applications, including plasticizers and fire retardants.  Approximately half of the PCBs manufactured were disposed of or released  into the environment prior to EPA promulgating rules for the disposal  requirements under TSCA. PCBs are toxic and very persistent in the  environment. When released into the environment, they decompose very  slowly and can accumulate in plants, animals, and human tissue.  Laboratory tests show that they cause cancer in rats and mice and that they  have adverse effects on fish and wildlife.
section_title: Fully Halogenated Chlorofluoroalkanes
paragraphs: In 1978, EPA banned nonessential uses of fully halogenated  chlorofluoroalkanes as propellants in aerosol spray containers. EPA took  this action because of concerns that these chemicals were destroying the  upper atmosphere’s ozone layer, which shields the earth from ultraviolet  radiation. Increased exposure to ultraviolet radiation has been linked to  increased skin cancer. Depletion of the ozone layer is also thought to lead  to climate changes and other adverse effects. Chlorofluorocarbons, halons,  and other fully halogenated chlorofluoroalkanes have been relied upon for  applications including air conditioning, refrigeration, fire suppression,  insulation, and solvent cleaning. According to EPA officials, in advance of  its obligations under the Montreal Protocol, the United States began  phasing out production of the most potent ozone depleting chemicals in  1994 and is now gradually phasing out hydrofluorocarbon production as  well. According to EPA officials, other industrialized countries have  followed the U.S. lead, and developing countries with assistance from the  Multilateral Fund are now complying with the protocol phase out  requirements. The regulation of fully halogenated chlorofluoroalkanes was  eliminated in 1995 by an EPA final rule because EPA had banned such  chlorofluorocarbons propellants under the Clean Air Act, making the TSCA  rule obsolete.
section_title: Dioxin
paragraphs: In 1980, EPA promulgated a rule prohibiting Vertac Chemical Company and  others from removing for disposal certain wastes containing 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD) stored at Vertac’s Jacksonville,  Arkansas, facility. The rule also required any persons planning to dispose  of TCCD contaminated wastes to notify EPA 60 days before their intended  disposal. TCDD, one of the most toxic of the about 75 dioxins in existence  and an animal carcinogen, is a contaminant or waste product formed  during the manufacture of certain substances. EPA concluded that it was  likely to result in adverse human health effects. This TSCA action was  superseded by a 1985 Resource Conservation and Recovery Act regulation.
section_title: Asbestos
paragraphs: Asbestos, which refers to several minerals that typically separate into very  tiny fibers, is a known human carcinogen that can cause lung cancer and  other diseases if inhaled. Asbestos containing materials were used widely  for fireproofing, thermal and acoustical insulation, and decoration in  building construction and renovation before the adverse effects of asbestos  were known. Asbestos also has numerous other applications, for example,  in friction products such as brake linings. After initially regulating asbestos  under the Clean Air Act in the early 1970s, EPA issued a final rule under  TSCA to ban the manufacturing, importing, and processing of nearly all  asbestos products in July 1989. The rule was to begin phasing out  asbestos-containing products in August 1990, and complete the phaseout  by 1997. EPA’s rule was challenged in federal court by asbestos product  manufacturers, and in October 1991, the United States Court of Appeals for  the Fifth Circuit vacated most of the rule—the rule continued to apply to  asbestos products no longer in commerce—and remanded it to the agency  for further consideration.
section_title: Hexavalent Chromium
paragraphs: In 1990, EPA banned the use of hexavalent chromium-based water  treatment chemicals in comfort cooling towers (CCT) and the distribution  of them in commerce for use in CCTs on the basis of health risks associated  with human exposure to air emissions. According to EPA, hexavalent  chromium was being released from a large number of unidentified cooling  towers. At the time, hexavalent chromium was a known human carcinogen.  EPA could have issued an emissions standard under the Clean Air Act.  However, the agency believed that regulation under TSCA would be more  efficient and effective because the act could be used to regulate use and  distribution of hexavalent chromium-based water treatment chemicals.
section_title: New Chemicals
paragraphs: EPA issued proposed rules to impose certain controls on four new  chemicals: (1) mixed mono and diamides of an organic acid, (2)  triethanolamine salts of a substituted organic acid, (3) triethanolanime salt  of tricarboxylic acid, and (4) tricarboxylic acid. The agency determined  these chemicals would pose an unreasonable risk to human health or the  environment. According to EPA, adding nitrites or other nitrosating agents  to the substances causes the formation of a substance known to cause  cancer in laboratory animals. EPA promulgated the rules regulating these  chemicals in 1984 to prohibit adding any nitrosating agent, including  nitrites, to metal working fluids that contain these substances. EPA  promulgated the rules under TSCA section 5(f). Under this section of  TSCA, if EPA determines that there is a reasonable basis to conclude that  the manufacturing, processing, distribution in commerce, or disposal of a  new chemical presents or will present an unreasonable risk of injury to  health or the environment before EPA can promulgate a rule under TSCA  section 6, EPA may limit the amount or impose other restrictions via an  immediately effective proposed rule. The restrictions on these chemicals  remain in place today.
section_title: Comments From the Environmental Protection Agency
section_title: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the individual named above, David Bennett, John Delicath,  Richard Frankel, Ed Kratzer, Malissa Livingston, Jean McSween, Marcella  Phelps, and Amy Webbink made key contributions to this report.