Chemical Regulation: Comparison of U.S. and Recently Enacted European Union Approaches to Protect against the Risks of Toxic Chemicals
Released: 2007-09-25T00:00:00

Letter

Background

In the last several decades, Congress has passed various legislation to increase federal agencies’ abilities to identify and address 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, and soil and in 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. 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 information on chemicals and regulate those substances that pose an unreasonable risk to human health or the environment. While other environmental and occupational health laws generally control only 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.

In October 2003, the European Commission presented a proposal for a new EU regulatory system for chemicals. REACH was proposed because the Commission believed that the current legislative framework for chemicals in the EU did not produce sufficient information about the effects of chemicals on human health and the environment. In addition, the risk assessment process was slow and resource-intensive and did not allow the regulatory system to work efficiently and effectively. Under REACH, authority exists to establish restrictions for any chemical that poses unacceptable risks and to require authorization for the use of chemicals identified as being of very high concern. These restrictions could include banning uses in certain products, banning uses by consumers, or even completely banning the chemical. Authorization will be granted if a given manufacturer can demonstrate that the risks from a given use of the chemical can be adequately controlled if a threshold can be determined for the chemical. Or, if no threshold can be determined, the manufacturer has to demonstrate that the socioeconomic benefits outweigh the risks associated with continued use and that there are no suitable alternatives or technologies available. In addition, a key aspect of REACH is that it places the burden on manufacturers, importers, and downstream users to ensure that they manufacture, place on the market, or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle. REACH was approved in December 2006 and went into effect in June 2007. To avoid overloading regulators and companies with the work arising from the registration process, full implementation of all the provisions of REACH will be phased in over an 11-year period (or by 2018).

REACH Requires Chemical Companies to Develop More Information than TSCA on the Effects of Chemicals on Human Health and the Environment

TSCA does not require companies to develop information for either new or existing chemicals, whereas REACH generally requires companies to submit and, in some circumstances, requires companies to develop such information for both kinds of chemicals. For new chemicals, TSCA requires companies to submit to EPA any available human health and environmental data, but companies do not have to develop additional information unless EPA requires additional test data through a test rule or other EPA action. For existing chemicals, companies do not have to develop such information unless EPA requires them to do so. In contrast, companies generally are required under REACH to provide and develop where needed the European Chemicals Agency with health and environmental data. The extent of such data depends on the annual production volume of the chemical.

TSCA Does Not Require Chemical Companies to Develop Information on the Hazards of New Chemicals

TSCA does not require chemical companies to test new chemicals for their effect on human health or the environment, but it requires companies to submit such information if it already exists when they submit a premanufacture notice (PMN) notifying EPA of their intent to manufacture a new chemical. This notice provides, among other things, certain information on the chemical’s intended uses and potential exposure. TSCA also requires chemical companies to submit data and other information on the physical/chemical properties, fate, or health and environmental effects of a chemical, which we refer to in this report as "hazard information," that the companies possesses or is reasonably ascertainable by them when they submit a PMN to EPA. In part because TSCA does not require chemical companies to develop hazard information before submitting a PMN, EPA employs several other approaches for assessing hazards, including using models that compare new chemicals with existing chemicals with similar molecular structures for which test data on health and environmental effects are available. In June 2005, we recommended that EPA develop a strategy for improving and validating the models that EPA uses to assess and predict the hazards of chemicals. EPA is currently devising such a strategy, according to agency officials.

EPA receives approximately 1,500 new chemical notices each year, half of which are exemption requests, and has reviewed more than 45,000 from 1979 through 2005. PMNs include information such as specific chemical identity estimated maximum production volume for 12 months of production a description of how the chemical will be processed and used and estimates of how many workers may be exposed to the chemical. Additionally, EPA requires that the following information be submitted with a PMN: all existing health and environmental data in the possession of the submitter, parent company, or affiliates, and a description of any existing data known to or reasonably ascertainable by the submitter. EPA estimates that most PMNs do not include test data of any type, and only about 15 percent include health and safety data—such as acute toxicity or skin and eye irritation data.

In some cases, EPA may determine during the review process that more data are needed for an analysis of a chemical’s potential risks and often will negotiate an agreement with the chemical company to conduct health hazard or environmental effects testing. According to EPA, more than 300 testing agreements have been issued since EPA began reviewing new chemicals in 1979. In some cases, however, the chemical company may voluntarily withdraw the PMN rather than incur the costs of hazard testing requested by EPA, or for other reasons. EPA does not maintain records as to how many PMNs chemical companies have withdrawn because of potential EPA action.

TSCA Does Not Require Chemical Companies to Develop Hazard Information for Existing Chemicals, and EPA Uses Regulatory and Voluntary Programs to Gather Such Information for Certain Chemicals

While TSCA does not require chemical companies to develop information on the harmful effects of existing chemicals on human health or the environment, TSCA provides that EPA, by issuing a test rule, can require such information on a case-by-case basis. Before promulgating such a rule EPA must find, among other things, that current data are insufficient, testing is necessary, and that either (1) the chemical may present an unreasonable risk or (2) the chemical is or will be produced in substantial quantities and that there is or may be substantial human or environmental exposure to the chemical. EPA officials responsible for administering the act said that TSCA’s test rule provision and data-gathering authorities can be burdensome and too time consuming for EPA to administer. Because EPA has limited information on existing chemicals and the difficulty in promulgating test rules, EPA uses voluntary programs to help gather more data to assess risks on certain chemicals.

While TSCA authorizes EPA to require testing of existing chemicals, the act does not authorize the agency to do so unless EPA first determines on the basis of risk or exposure information that the chemicals warrant such testing. TSCA provides EPA the authority to obtain hazard information needed to assess chemicals by issuing rules under Section 4 of TSCA requiring chemical companies to test to determine the health and environmental effects of chemicals and submit the test data to EPA. However, in order for EPA to issue a test rule, the agency must determine that a chemical (1) may present an unreasonable risk of injury to health or the environment or (2) is or will be produced in substantial quantities and (a) there is or may be significant or substantial human exposure to the chemical or (b) it enters or may reasonably be anticipated to enter the environment in substantial quantities. 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. Once EPA has made the required determination, the agency can issue a proposed rule for public comment, consider the comments it receives, and promulgate a final rule ordering chemical testing. OPPT officials responsible for implementing TSCA told us that finalizing rules under Section 4 of TSCA can take from 2 to 10 years and require the expenditure of substantial resources. EPA has used its authority to require testing for about 200 existing chemicals since the agency began reviewing chemicals under TSCA in 1979. EPA does not maintain estimates of the cost of implementing these rules. However, in our September 1994 report on TSCA, we noted that EPA officials told us that issuing a rule under Section 4 can cost up to a $234,000. Given the difficulties and cost of requiring testing, EPA could review substantially more chemicals in less time if it had authority to require chemical companies to conduct testing and provide test data on chemicals once they reach a substantial production volume. In June, 2005, we stated that Congress may wish to consider amending TSCA to provide EPA such authority.

As an alternative to formal rule making, EPA asserts that Section 4 of TSCA provides EPA implied authority to enter into "enforceable consent agreements" with chemical companies that would require them to conduct testing when there is insufficient data available to assess a chemical’s risk. EPA uses enforceable consent agreements to accomplish testing where a consensus exists among EPA, affected manufacturers and/or processors, and interested members of the public concerning the need for and scope of testing. According to EPA, these agreements allow greater flexibility in the design of the testing program and negotiating these agreements is generally less costly and time consuming than promulgating test rules. EPA has entered into consent agreements with chemical companies to develop tests for about 60 chemicals where the agency determined additional data were needed to assess the chemical’s risk.

Under Section 8 of TSCA, EPA promulgates rules directing chemical companies to 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. Section 8(d) authorizes EPA 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.

According to EPA, the agency has issued about 50 Section 8(d) rules covering approximately 1,000 chemicals. As a result of these rules, EPA has received nearly 50,000 studies covering environmental fate, human health effects, and environmental effects. However, TSCA Section 8(d) only applies to existing studies and does not require companies to develop new studies.

The TSCA Inventory Update Rule (IUR), currently requires chemical companies to report every 5 years to EPA the site and manufacturing information for chemicals in the TSCA inventory that they manufacture or import in amounts of 25,000 pounds or greater at a single site. For the most current reporting cycle and for subsequent reporting cycles, chemical companies must report additional information—such as uses, the types of consumer products the chemical will be used in—including those intended for use by children, and the number of workers who could potentially be exposed—for chemicals manufactured or imported in amounts of 300,000 pounds or more at a single site.

In response to the lack of information on existing chemicals and the relative difficulty the agency faces in requiring companies to conduct additional testing under TSCA, EPA has taken efforts to increase the amount of the information it can access on chemicals by implementing a voluntary program called the High Production Volume (HPV) Challenge Program. The HPV Challenge Program focuses on obtaining chemical company sponsors to voluntarily provide data on approximately 2,800 chemicals that chemical companies reported in 1990 were domestically produced or imported at a high volume—over 1 million pounds. Through this program, sponsors develop a basic set of screening level information on the chemicals either by gathering available data, using models to predict the chemicals’ properties, or conducting testing of the chemicals.

The six data endpoints collected under the HPV Challenge Program are acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, mutagenicity, ecotoxicity, and environmental fate. EPA believes that these basic data are needed to make an informed, preliminary judgment about the hazards of HPV chemicals. In June 2005, we recommended that EPA develop a methodology for using information collected through the HPV Challenge Program to prioritize chemicals for further review. EPA’s Director of OPPT told us the agency developed such a methodology as data from chemical companies became available and are currently applying the methodology to assess HPV chemicals. The methodology was developed based on input received from an advisory committee, the National Pollution Prevention and Toxics Advisory Committee (NPPTAC).

Despite these promising voluntary efforts regarding high-production- volume chemicals, several difficulties remain, as we have noted in our prior work. For example, (1) chemical companies have not agreed to test approximately 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. In addition, this program may not provide enough information for EPA to use in making risk-assessment decisions. While the data in the HPV Challenge Program and the new exposure and use reporting under the IUR may help EPA prioritize chemicals of concern, the data may not provide 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. Although the chemical industry may be willing to take action, even before EPA has the evidence required for rule making under TSCA, the industry is nonetheless large and diverse, and it is uncertain that all companies will always take action voluntarily.

To ensure that adequate data are made publicly available to assess the special impact that industrial chemicals may have on children, EPA launched the Voluntary Children’s Chemical Evaluation Program (VCCEP). In December 2000, EPA implemented VCCEP first as a pilot program. EPA’s goal is to learn from this pilot program before a final VCCEP process is determined and before additional chemicals are selected. For the VCCEP pilot, EPA identified 23 commercial chemicals to which children have a high likelihood of exposure and the information needed to assess the risks to children from these chemicals. Recently, EPA requested comments on the implementation of the pilot program from stakeholders and other interested parties but has not yet responded to the comments or evaluated the program for its effectiveness.

EPA is running a pilot of the VCCEP so it can gain insight into how best to design and implement the VCCEP in order to effectively provide the agency and the public with the means to understand the potential health risks to children associated with exposure to these and ultimately other chemicals to which children may be exposed. EPA intends the pilot to be the means of identifying efficiencies that can be applied to any subsequent implementation of the VCCEP. Another purpose for running the pilot is the opportunity it will offer to test the performance of the peer consultation process. For the VCCEP pilot, the purpose of the peer consultation process is to provide a forum for scientists and relevant experts from various stakeholder groups to exchange scientific views on the chemical sponsor's data submissions and in particular on the recommended data needs.

Under the VCCEP pilot, EPA is pursuing a three-tiered approach for gathering information, with tier 3 involving more detailed toxicology and exposure studies than tier 2, and tier 2 involving more detailed toxicology and exposure studies than tier 1. EPA asked companies that produce and/or import 23 specific chemicals to volunteer to sponsor their chemical in the first tier of the VCCEP pilot. EPA selected these 23 chemicals because the agency believed them to be especially relevant to children’s chemical exposures, such as the presence of the chemical in human tissue or blood, in food and water children eat and drink, and in air children breathe. In addition, many of these chemicals were known to be relatively “data rich” in that chemical data were already available. Chemical companies have volunteered to sponsor 20 of the 23 chemicals in the VCCEP. EPA believes that these 20 chemicals provide an adequate basis for evaluating the VCCEP pilot.

Chemical companies volunteering to sponsor a chemical under the program have agreed to make chemical-specific public commitments to make certain hazard, exposure, and risk assessment data and analyses publicly available. For toxicity data, specific types of studies have been assigned to each of the three tiers. For exposure data, the depth of exposure information increases with each tier. If data needs are identified through the peer consultation process, the sponsor will choose whether to volunteer for any additional data generation or testing and whether to provide additional assessments in subsequent tiers. However, company sponsors are under no obligation to volunteer for tiers 2 and 3, even if EPA determines additional information is needed. After the submission of tier 1 information and its review by the 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, 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 to determine whether 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 15 of the 20 assessments on chemicals to EPA and the peer consultation group. The peer consultation group has issued reports on 13 of the 15 chemical submissions. EPA has issued Data Needs Decisions on 11 of these 13 chemicals for which EPA determined that 5 chemicals needed additional data. One of the sponsors agreed to commit to tier 2 and to provide the additional data to EPA. The sponsor of two other chemicals declined to commit to tier 2 since it had ceased manufacturing the chemicals in 2004. The sponsor of the other 2 chemicals told EPA it will decide whether to commit to the additional testing by the end of July 2007.

In November 2006, EPA requested comments on the implementation of the pilot program from stakeholders and interested parties. As part of its request for comments, EPA included a list of questions that the agency believed would be helpful in its evaluation of the pilot program. The questions ranged from asking about the sufficiency of the hazard, exposure, and risk assessments provided by the chemical sponsors; to the effectiveness and efficiency of the peer review panel; to the timeliness of the VCCEP pilot in providing data. EPA received comments from 11 interested parties, including from industry representatives, environmental organizations, children’s health advocacy groups, and other interested parties. Generally, the industry groups provided positive comments about the pilot while the children’s health advocacy and environmental groups provided negative comments about VCCEP. For example, the American Chemistry Council commented that the pilot is proceeding well, the current tiered approach is sound, and that only minimal improvements are needed. One of the improvements the chemistry council suggested is that EPA should make the data generated under the pilot more accessible to the public, other EPA program offices, and to other federal and state agencies. Conversely, the American Academy of Pediatrics commented that the VCCEP pilot is failing in its goal to provide timely or useful information on chemical exposures and their implications to the public or to health care providers. EPA plans to prepare a comments document summarizing the comments received from the stakeholders and publish it on the VCCEP Web site. In addition, EPA plans to have a final evaluation of the effectiveness of the VCCEP pilot in late 2007.

REACH Requires Chemical Companies to Submit Hazard Information for New and Existing Chemicals That Meet Specified Production and Toxicity Levels

REACH created a single system for the regulation of new and existing chemicals and, once implemented, will generally require chemical companies to register chemicals produced or imported at 1 ton or more per producer or importer per year with a newly created European Chemicals Agency. Information requirements with registration will vary according to the production volume and suspected toxicity of the chemical.

For chemicals produced at 1 ton or more per producer or importer per year, chemical companies subject to registration will be required to submit information for the chemical, such as the chemical’s identity; how it will be produced; how it will be used; guidance on its safe use; exposure information; and study summaries of physical/chemical properties and their effects on human health or the environment. REACH specifies the amount of information to be included in the study summaries based on the chemical’s production volume, i.e., how much of the chemical will be produced or imported each year. The information requirements may be met through a variety of methods, including existing data, scientific modeling, or testing. REACH separates the production volume information requirements into four metric tonnage bands—1 ton or more, 10 tons or more, 100 tons or more, and 1,000 tons or more. Hazard information must be submitted for each tonnage band with each higher band requiring the information for the lower bands in addition to the ones specified for that band. For example, at the one or more tonnage band, REACH requires information on environmental effects that include short- term toxicity on invertebrates, toxicity to algae, and ready biodegradability. At the 10 or more tonnage band, REACH requires such information in addition to a chemical safety assessment, which includes an assessment of the chemical’s human health and environmental hazards; a physiochemical hazard assessment; an environmental hazard assessment; and an assessment of the chemical’s potential to be a persistent, bioaccumulative, and toxic pollutant, which are chemicals that create pollutants that persist in the environment, bioaccumulate in food chains, and are toxic.

Table 1 shows the total number of chemical endpoints—the chemical or biological effect that is assessed by a test method—required for chemicals produced at various production volumes, where applicable, for TSCA, the HPV Challenge Program, and REACH. While industry participation in the EPA’s HPV Challenge Program is voluntary, we have included information on the number of endpoints to be produced for chemicals in the program for comparison purposes. As the table shows, companies will provide a greater number of endpoints on chemicals under REACH than TSCA or the HPV Challenge Program. Additionally, appendix IV provides a listing of specific information requirements or endpoints for three testing categories: physical/chemical, human health, and environmental effects/fates.

TSCA Generally Requires EPA to Demonstrate That Chemicals Will Cause Unreasonable Risk While REACH Requires Chemical Companies to Ensure No Adverse Chemical Effects

Both TSCA and REACH provide regulators with authorities to control chemical risks by restricting the production or use of both new and existing chemicals. Under TSCA, EPA must generally compile data needed to assess the potential risks of chemicals and must also develop substantial evidence in the rule-making record in order to withstand judicial review. However, REACH is based on the principle that chemical companies—manufacturers, importers, and downstream users—should ensure that the chemicals they manufacture, place on the market, or use do not adversely affect human health or the environment.

EPA Has Had Difficulty Proving That Chemicals Pose Unreasonable Risks and Has Regulated Few Existing Chemicals under Section 6 of TSCA

Even when EPA has toxicity and exposure information on existing chemicals, the agency has had difficulty demonstrating that chemicals present or will present an unreasonable risk and that they should have limits placed on their production or use. Since the Congress enacted TSCA in 1976, EPA has issued regulations under Section 6 of the act to 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. In addition, under Section 5(a)(2) of TSCA, for 160 existing chemicals, EPA issued significant new use rules that require chemical companies to submit notices to EPA prior to commencing the manufacture, import, or processing of the substance for a significant 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 under Section 6(a), 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.

Finally, EPA must also develop substantial evidence in the rule-making 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 rule-making record.” According to EPA officials responsible for administering TSCA, 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.

According to EPA officials in OPPT who are responsible for implementing TSCA, the use of Section 6(a) has presented challenges as the agency must, in effect, perform a cost-benefit analysis, considering the economic and societal costs of placing controls on the chemical. Specifically, these officials say that EPA must take into account the benefits provided by the various uses of the chemical, the availability of substitutes, and the reasonably ascertainable economic consequences of regulating the chemical after considering the effects of such regulation on the national economy, small business, technological innovation, the environment, and public health.

EPA’s 1989 asbestos rule illustrates the evidentiary requirements that TSCA places on EPA to control chemicals under TSCA Section 6(a). The rule prohibited the future manufacture, importation, processing, and distribution of asbestos in almost all products. Some of the manufacturers of these asbestos products filed suit against EPA, arguing that the rule was not promulgated on the basis of substantial evidence regarding unreasonable risk. In October 1991, the U.S. Court of Appeals for the Fifth Circuit agreed with the manufacturers, concluding that EPA had failed to muster substantial evidence to justify its asbestos ban and returning parts of the rule to EPA for reconsideration.

In reaching this conclusion, the court found that EPA did not consider all necessary evidence and failed to show that the control action it chose was the least burdensome reasonable regulation required to adequately protect human health or the environment. As articulated by the court, the proper course of action for EPA, after an initial showing of product danger, would have been to consider the costs and benefits of each regulatory option available under Section 6, starting with the less restrictive options, such as product labeling, and working up through a partial ban to a complete ban. The court further criticized EPA's ban of asbestos in 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.

The court’s decision on the asbestos rule is especially revealing about Section 6 because EPA spent 10 years preparing the rule. In addition, asbestos is generally regarded as one of the substances for which EPA has the most scientific evidence or documentation of substantial adverse health effects. Since the U.S. Court of Appeals for the Fifth Circuit’s ruling in October 1991, EPA has not used TSCA Section 6 to restrict any chemicals. However, EPA has used Section 6 to issue a proposed ban on certain grouts, which was later withdrawn when industry agreed to use personal protection equipment to address worker exposure issues, and issue an Advance Notice of Proposed Rule Making for methyl-t-butyl ether because of widespread drinking water contamination. Although TSCA’s Section 6 has been used infrequently, the Director of OPPT and other EPA officials responsible for implementing TSCA told us that they believe that taking action under this section remains a practicable option for the agency.

TSCA’s Section 5 Provides Limited Authority to Restrict New Chemicals

Section 5(a)(2) requires chemical companies to notify EPA at least 90 days before beginning to manufacture or process 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. According to the Director of OPPT, it is less difficult for the agency to demonstrate that a chemical “may present” an unreasonable risk than it is to show that a chemical “will present” such a risk. Thus, EPA has found it easier to impose controls on new chemicals when warranted.

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 3,800 of the 33,000 new chemicals that chemical companies have submitted for review since 1979. These actions included, among other things, chemical companies voluntarily withdrawing their notices of intent to manufacture new chemicals, and entering into consent orders with EPA to produce a chemical only under specified conditions. In addition, EPA has promulgated significant new use rules requiring chemical companies to notify EPA of their intent to manufacture or process certain chemicals for any uses that EPA has determined to be a "significant new use." For over 1,700 chemicals, companies withdrew their PMNs sometimes after EPA officials indicated that the agency planned to initiate the process for placing controls on the chemicals, such as requiring testing or prohibiting the production or certain uses of the chemical. The Director of OPPT told us that after EPA has screened a new chemical or performed a detailed analysis of it, chemical companies may drop their plans to market the chemical when the chemical’s niche in the marketplace is uncertain and EPA requests that the company develop and submit test data or apply exposure controls. According to EPA officials, companies may be uncertain that they will recoup costs associated with the test data and controls and prefer to withdraw their PMN. In addition, for over 1,300 chemicals, EPA issued orders requiring chemical companies to implement workplace controls or practices during manufacturing pending the development of information on the risks posed by the chemicals and/or to perform toxicity testing if the chemicals’ production volumes reached certain levels.

For over 570 of the 33,000 new chemicals submitted for review, EPA required chemical companies to submit 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 begin. 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 PMN.

REACH Requires Chemical Companies to Request Authorization to Use Certain Hazardous Chemicals and Search for Safer Substitutes

To control chemical risks, REACH provides procedures for both authorizing and restricting the use of chemicals. Authorization procedures under REACH have three major steps. First, the European Chemicals Agency will publish a list of chemicals—known as the candidate list—that potentially need authorization before they can be used. The chemical agency will determine which chemicals to place on the candidate list after it has reviewed the information that chemical companies submit to the agency at the time the chemicals are registered under REACH and after considering the input provided by individual EU member states and the European Commission. In making this determination, the agency is to use criteria set forth in REACH, covering issues such as bioaccumulation, carcinogenicity, and reproductive toxicity. Secondly, the European Commission will determine which chemicals on the candidate list will require authorization and which will be exempted from the authorization requirements. According to the Environment Counselor for the Delegation of the European Commission to the United States, some chemicals may be exempted from authorization requirements because, so far, sufficient controls established by other legislation are already in place. Finally, once a chemical has been deemed to require authorization, a chemical company will have to apply to the European Commission for an authorization for each use of the chemical.

The application for authorization must include an analysis of the technical and economic feasibility of using safer substitutes and, if appropriate, information about any relevant research and development activities by the applicant. If such an analysis shows that suitable alternatives are available for any use of the chemical, then the application must also include a plan for how the company plans to substitute the safer chemical for the chemical of concern in that particular use. The European Commission is generally required to grant an authorization if the applicant meets the burden of demonstrating that the risks from the manufacture, use, or disposal of the chemical can be adequately controlled, except for (1) PBTs; (2) very persistent, very bioaccumulative chemicals (vPvBs); and (3) certain other chemicals including those that are carcinogenic or reproductive toxins. However, even these chemicals may receive authorization if a chemical company can demonstrate that social and economic benefits outweigh the risks. In addition, 6 years after REACH goes into effect (or in 2013), the European Commission will review whether endocrine disrupters should also be excluded from authorization unless chemical companies can demonstrate that the social and economic benefits outweigh their risks.

Eventually, all chemicals granted authorizations under REACH will be reviewed to ensure that they can be safely manufactured, used, and disposed. The time frame for such reviews will be determined on a case- by-case basis that takes into account information such as the risks posed by the chemical, the availability of safer alternatives, and the social and economic benefits of the use of the chemical. For example, if suitable substitutes become available, the authorization may be amended or withdrawn, even if the chemical company granted the authorization has demonstrated that the chemical can be safely controlled.

In addition to such authorization procedures, REACH provides procedures for placing restrictions on chemicals that pose an unacceptable risk to health or the environment. The restriction may completely ban a chemical or limit its use by consumers or by manufacturers of certain products. REACH’s restrictions procedures enable the EU to regulate communitywide conditions for the manufacture, marketing, or use of certain chemicals where there is an unacceptable risk to health or the environment. Proposals for restrictions will be prepared by either a Member State or by the European Chemicals Agency at the request of the European Commission. The proposal must demonstrate that there is a risk to human health or the environment that needs to be addressed at the communitywide level and to identify the most appropriate set of risk reduction measures. Interested parties will have an opportunity to comment on the restriction proposal. However, the final determination on the restriction proposal will be made by the European Commission. Because no chemicals have undergone REACH’s authorization and restriction procedures, it is not possible to comment on the ability of these procedures to control the risks of chemicals to human health or the environment.

Both TSCA and REACH Have Provisions to Make Certain Information Available to the Public, but REACH Requires Greater Public Disclosure

TSCA and REACH require public disclosure of certain information on chemicals and both laws protect confidential or sensitive business information, although the extent to which information can be claimed as confidential or sensitive varies under the two laws. In this regard, one of the objectives of REACH is to make information on chemicals more widely available to the public. Accordingly, REACH places greater limitations on the kinds of information that companies may claim as confidential or sensitive.

EPA’s Ability to Share Data Collected under TSCA Is Limited

TSCA has provisions to protect information claimed by chemical companies as confidential or sensitive business information, such as information on chemical production volumes and trade secret formulas. Health and safety studies, however, generally cannot be considered confidential business information, and TSCA has provisions for making such studies available to the public. Additionally, EPA can disclose confidential business information when it determines such disclosure is necessary to protect human health or the environment from an unreasonable risk. EPA interprets the term health and safety study broadly and, as such, it may include but is not limited to epidemiological, occupational exposure, toxicological, and ecological studies.

However, TSCA generally allows chemical companies to claim any information provided to EPA, other than health and safety studies, as confidential. TSCA requires EPA to protect the information from unauthorized disclosure. More specifically, TSCA restricts EPA’s ability to share certain information it collects from chemical companies, such as information about the company (including its identity); the chemical’s identity; or the site of operation, including with state officials or with officials of foreign governments. If a request is made for disclosure of the confidential information, EPA regulations require the chemical company to substantiate the claims by providing the agency information on a number of issues, such as whether the identity of the chemical had been kept confidential from competitors and what harmful effects to the company’s competitive position would result from publication of the chemical on the TSCA inventory. State environmental agencies and others are interested in obtaining chemical information, including that claimed as confidential, for use in various activities, such as developing contingency plans to alert emergency response personnel of the presence of highly toxic substances at local manufacturing facilities. Likewise, the general public may find information collected under TSCA useful to engage in dialogues with chemical companies about reducing chemical risks and limiting chemical exposures at nearby facilities that produce or use toxic chemicals.

While EPA believes that some claims of confidential business information may be unwarranted, challenging the claims is resource-intensive. According to a 1992 EPA study, the latest performed by the agency, 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. The study found that many of the confidentiality claims submitted under TSCA were not appropriate, particularly for health and safety data. For example, between September 1990 and May 1991, EPA reviewed 351 health and safety studies that chemical companies submitted with a claim of confidentiality. EPA challenged the confidentiality claimed for 77, or 22 percent of the studies and, in each case, the submitter amended the confidentiality claim when challenged by EPA. Currently, while EPA may suspect that some chemical companies’ confidentiality claims are unwarranted, the agency does not have data on the number of inappropriate claims.

As we reported in June 2005, 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 chemical companies. According to the EPA official responsible for initiating challenges to confidentiality claims, the agency challenges about 14 such claims each year, and the chemical companies withdraw nearly all of the claims challenged.

Chemical companies have expressed interest in working with EPA to identify ways to enable other organizations to use the information given the adoption of appropriate safeguards. In addition, chemical company representatives told us that, in principle, they have no concerns about revising TSCA or EPA regulations to require that confidentiality claims be periodically reasserted and reviewed. However, neither TSCA nor EPA regulations require periodic reviews to determine when information no longer needs to be protected as confidential. In our June 2005 report, we recommended that EPA 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. In July 2006, EPA responded to Congress that the agency planned to initiate a pilot process, using its existing authorities, to review selected older submissions containing CBI claims. According to EPA officials, the agency is examining PMNs and notices of commencements submitted to EPA from fiscal years 1993 thorough March 2007 and plans to compile statistics on the numbers and percentages of submissions and the types of CBI claims made. Based on the agency’s review, and in light of its other regulatory priorities, EPA will consider whether rule making is appropriate to maximize the benefits of a reassertion program, including benefits to the public. However, no completion date has been determined for the pilot.

REACH Has Provisions to Protect Confidential Business Information but Allows Greater Public Access to Chemical Information than TSCA

Similar to TSCA, REACH has provisions to protect information claimed by chemical companies as confidential or sensitive, including trade secret formulas and production volumes. In addition, REACH treats some information as confidential, including the following, even if a company did not claim it as confidential: (1) details of the full composition of the chemical’s preparation; (2) the precise use, function, or application of the chemical or its preparation; (3) the precise tonnage or volume of the chemical manufactured or placed on the market; or (4) relationships between manufacturers/importers and downstream users. In exceptional cases where there are immediate risks to human health and safety or to the environment, REACH authorizes the European Chemicals Agency to publicly disclose this information.

Furthermore, unlike TSCA, REACH places substantial restrictions on the types of data that chemical companies may claim as confidential. Consistent with one of the key objectives of REACH, the legislation makes information on hazardous chemicals widely available to the public by limiting the types of hazard information that chemical companies may claim as confidential, and generally does not allow confidentiality claims related to, among other things, guidance on the chemical’s safe use, and the chemical’s physical chemical properties, such as melting and boiling points, and results of toxicological and ecotoxicological studies, including analytical methods that make it possible to detect a dangerous substance when discharged into the environment and to determine the effects of direct exposure to humans. In addition, other information, such as study summaries and tonnage band information will be available unless the chemical companies justify that disclosing the information will be harmful to its commercial interests.

REACH also requires that safety data sheets for PBTs and vPvBs and other chemicals classified as dangerous be provided to ensure that commercial users—known as downstream users and distributors of a chemical, as well as chemical manufacturers and importers, have the information they need to safely use chemicals. The data sheets, which chemical companies are required to prepare, include information on health, safety, and environmental properties, and risks and risk management measures.

Similar to TSCA, REACH requires public disclosure of health and safety information and has provisions for making information available to the public. REACH also includes a provision for public access to basic chemical information, including brief profiles of hazardous properties, labeling requirements, authorized uses, and risk management measures. The European Union’s rules regarding the public’s access to information combine a variety of ways that the interests of the public’s right to know is balanced with the need to keep certain information confidential. As such, nonconfidential information will be published on the chemical agency’s Web site. However, some types of information are always to be treated as confidential under REACH, such as precise production volume.

REACH also includes a provision under which confidential information can generally be shared with government authorities of other countries or international organizations under an agreement between the parties provided that the following conditions are met: (1) the purpose of the agreement is cooperation on implementation or the management of legislation concerning the chemicals covered by REACH and (2) the foreign government or international organization protects the confidential information as mutually agreed. In our June 2005 report, we suggested that Congress should consider amending TSCA to authorize EPA to share with the states and foreign governments the confidential business information that chemical companies provide to the agency, 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. Furthermore, chemical industry representatives told us that chemical companies would not object to Congress revising TSCA to allow those with a legitimate reason to obtain access to the confidential business information provided that adequate safeguards exist to protect the information from inappropriate disclosures. In addition, EPA officials said that harmonized international chemical assessments would be improved if the agency had the ability to share this information under appropriate procedures to protect confidentiality.

Concluding Observations

Substantial differences exist between TSCA and REACH in their approaches to obtaining the information needed to identify chemical risks; controlling the manufacture, distribution, and use of chemicals; and providing the public with information on harmful chemicals. Assuming that the EU has the ability to review chemical information in a timely manner, specific provisions under REACH provide a means for addressing long-standing difficulties experienced both under TSCA and previous European chemicals legislation in (1) obtaining information on chemicals’ potentially harmful characteristics and their potential exposure to people and the environment and (2) making the chemical industry more accountable for ensuring the safety of their products. Furthermore, REACH is structured to provide a broader range of data about chemicals that could enable people to make more informed decisions about the products they use in their everyday lives.

We have identified, in our previous reports on TSCA, various potential revisions to the act that could strengthen TSCA to obtain additional chemical information from the chemical industry, shift more of the burden to chemical companies for demonstrating the safety of their chemicals, and enhance the public’s understanding of the risks of chemicals to which they may be exposed.

Agency Comments and GAO Response

We provided EPA and the Environment Counselor for the Delegation of the European Commission to the United States a draft of this report for review and comment. Both EPA and the Environment Counselor for the Delegation of the European Commission provided technical comments, which we have incorporated into this report as appropriate. EPA also provided written comments. EPA highlighted the regulatory actions it has taken under TSCA and noted that TSCA is a “fully implemented statute that has withstood the test of time” and that, in contrast, “REACH is not yet in force, and there is no practical experience with any aspect of its implementation.” Furthermore, while EPA agreed that it is possible to compare the approaches used to protect against the risks of toxic chemicals under TSCA and REACH, “it is not yet possible to evaluate or compare the effectiveness of the different chemical management approaches or requirements.” EPA’s written comments are presented in appendix V.

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- 3841 or stephensonj@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Key contributors to this report are listed in appendix VI.

Appendix I: Scope and Methodology

Our objectives were to describe how Toxic Substances Control Act (TSCA) compares with Registration, Evaluation and Authorization of Chemicals (REACH) in its approaches to (1) identifying chemicals harmful to public health and the environment, (2) controlling chemical risks, and (3) disclosing chemical data to the public while protecting confidential business information. In addressing these issues, we also obtained information on Environmental Protection Agency’s (EPA) voluntary chemical control programs that complement TSCA. 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 in the agency’s Office of Pollution Prevention and Toxics (OPPT), the EPA office with primary responsibility for implementing TSCA, the High Production Volume (HPV) Challenge Program, and the Voluntary Children’s Chemical Evaluation Program (VCCEP) pilot. In addition, we interviewed representatives of the American Chemistry Council (a national chemical manufacturers association), Environmental Defense (a national, nonprofit, environmental advocacy organization), and the Synthetic Organic Chemical Manufacturers Association (a national, specialty chemical manufacturer’s association). We also attended meetings of EPA’s National Pollution Prevention and Toxics Advisory Committee (NPPTAC) and attended various conferences sponsored by EPA and others. We selected the industry and environmental experts we interviewed based on discussions with NPPTAC representatives and based on our prior work on TSCA. Finally, we obtained and reviewed EPA documents related to its chemical program.

For reviewing REACH, we obtained laws, technical literature, and government documents that describe the European Union’s (EU) chemical control program. We also interviewed EU officials who helped develop and who will be involved in implementing REACH, including the Environment Counselor for the Delegation of the European Commission to the United States and representatives from the European Commission and the European Parliament. Our descriptions of these laws are based on interviews with government officials and written materials they provided. In addition, we interviewed representatives of the American Chamber of Commerce to the EU, American Chemistry Council (a national chemical manufacturers association), Environmental Defense (a national, nonprofit environmental advocacy organization), the European Chemical Industry Council (an EU chemical manufacturers association), the European Environmental Bureau (a federation environmental advocacy organization based in the EU Member States), and the Synthetic Organic Chemical Manufacturers Association (a national, specialty chemical manufacturer’s association). Furthermore, we interviewed staff from the U.S. Mission to the EU. Finally, for the purposes of this report, we compared TSCA to the REACH legislation that was approved in December 2006, as the basis for analysis.

Our review was performed between January 2006 and May 2007 in accordance with generally accepted government auditing standards.

Appendix II: Comparison of Selected Provisions of U.S. Toxic Substances Control Act and the EU’s Registration, Evaluation and Authorization of Chemicals

New chemicals are those not on the TSCA inventory.

Existing chemicals are those listed in the TSCA Inventory.

REACH creates a single system so that there will be virtually no distinction between new and existing chemicals.

Originally 62,000. Of the more than 82,000 chemicals currently in the TSCA inventory, approximately 20,000 were added to the inventory since EPA began reviewing chemicals in 1979.

EU officials estimated the number of chemicals with production or import levels of at least 1 metric ton (2,205 pounds) to be about 30,000. Chemical registration will be phased in over 11 years after enactment of REACH.

Companies are required to notify EPA prior to manufacturing a new chemical. Companies notify EPA of its intent to manufacture a new chemical through submission of a Premanufacture Notice (PMN) or of an application for exemption. After the PMN review period has expired and within 30 days of the chemical’s manufacture, companies submit a Notice of Commencement of Manufacture or Import to EPA. The chemical is then added to the TSCA Inventory, and the chemical is classified as an existing chemical.

TSCA generally does not require chemical companies to notify EPA of changes in use or production volume. However, every 5 years companies are required to update EPA on information such as the processing, use, and production volume of chemicals produced at over 25,000 pounds.

In general, REACH treats new and existing chemicals the same. Chemical companies register chemicals with the European Chemicals Agency once production or import of a chemical reaches 1 metric ton (2,205 pounds).

Companies must also notify EPA if the company obtains information that reasonably supports the conclusion that the chemical presents a substantial risk to human health or the environment.

After registration, companies are required to immediately notify the European Chemicals Agency of significant changes in use or production volumes of the registered chemical.

Based on information compiled through a series of steps, including a chemical review strategy meeting, structure-activity relationship analysis, and exposure-based reviews, EPA makes a decision ranging from “dropping” a chemical for further review to banning a chemical pending further information.

TSCA does not require EPA to systematically prioritize and assess existing chemicals.

The European Chemicals Agency will develop the criteria for prioritizing chemicals for further review based on, among other things, hazard data, exposure data, and production volume.

However, TSCA established an Interagency Testing Committee—an advisory committee created to identify chemicals for which there are suspicions of toxicity or exposure and for which there are few, if any ecological effects, environmental fate, or health-effects testing data— to recommend chemicals to which EPA should give priority consideration in promulgating test rules.

Member states may use these criteria when developing their list of chemicals to be reviewed.

EPA also plans to use the High Production Volume (HPV) Challenge Program and the information under the Inventory Update Rule to help the agency prioritize the chemicals it will review.

New chemicals once they have commenced manufacture are added to the TSCA Inventory. Such former new chemicals can be subject to significant new use rules (SNUR) or restrictions on the manufacture, processing, distribution in commerce, use, or disposal of the chemical under TSCA 5(e) consent orders.

Chemical companies report use information once every 5 years under TSCA’s Inventory Update Rule (IUR), which is primarily used to gather certain information on chemicals produced at the threshold of 25,000 pounds or more.

Chemical companies must immediately inform the European Chemicals Agency in writing of new uses of the chemical about which the company may reasonably be expected to have become aware.

However, in the absence of a SNUR on a particular chemical, there is no requirement for chemical companies to notify EPA of significant new uses of existing chemicals in the intervening years or for chemicals produced at less than 25,000 pounds.

Manufacturers and processors of existing chemicals subject to a SNUR must notify EPA 90 days before manufacture of or processing for significant new use.

Chemical companies are not required to perform risk assessments on the risks of new chemicals. However, if a company has voluntarily performed risk assessments, they must submit these data with the PMN.

Chemical companies are not required to complete assessments on the risks of existing chemicals.

However, TSCA requires chemical companies to notify EPA immediately of new unpublished information on chemicals that reasonably supports a conclusion of substantial risk.

Chemical companies must conduct a risk assessment in addition to European Chemicals Agency review for all chemicals produced at a level of 1 ton or more per year. Additionally, chemical companies must conduct a chemical safety assessment for all chemicals produced at a level of 10 tons or more per year.

TSCA contains no specific language relating to reducing animal testing. However, according to EPA officials, TSCA’s approach of not requiring companies to test new chemicals for health hazards or environmental effects absent EPA action, combined with EPA’s use of Structure Activity Relationship (SAR) analysis reduces the need for animal testing compared with requiring a base set of data without the use of SAR analysis.

No specific language relating to reducing animal testing. However, under the HPV Challenge Program, EPA encourages companies to consider approaches, such as using existing data, sharing data, and using SAR and read across approaches that would reduce the amount of animal testing needed. Further, EPA does not require retesting for chemicals with adequate Screening Information Data Sets data. EPA has expressed its commitment to examining alternate test methods that reduce the number of animals needed for testing, that reduce pain and suffering to test animals or that replaces test animals with validated in vitro (nonanimal) test systems.

REACH states that testing on vertebrate animals for the purposes of regulation shall be undertaken as a last resort. To reduce the amount of animal testing, REACH encourages the sharing and joint submission of information. REACH implementation guidance encourages the use of SAR and read across approaches. Further, registrants may use any study summaries or robust study summaries performed within the 12 previous years by another manufacturer or importer to register after due compensation of the costs to the owner of the data.

In addition, under the Voluntary Children’s Chemical Evaluation Program (VCCEP), EPA encouraged participating companies to reduce or eliminate animal testing.

Chemical companies must provide EPA a reasonable third year estimate of the total production volume of a new chemical at the time a PMN is submitted.

Chemical companies report production quantities every 5 years for those chemicals on the TSCA inventory and produced at quantities of 25,000 pounds or more through the Inventory Update Rule (IUR).

Chemical companies must include information on the overall manufacture or import of a chemical in metric tons per year in a technical dossier with their registration. Chemical companies must immediately report any significant changes in the annual or total quantities manufactured or imported.

No specific requirement relating to downstream users.

No specific requirement relating to downstream users.

Assemble and keep available all information required to carry out duties under REACH for a period of at least 10 years after the substance has been used. Prepare a chemical safety report for any use outside the conditions described in an exposure scenario or if appropriate use and exposure category described in a safety data sheet or for any use the supplier advises against.

Downstream users may also provide information to assist in the preparation of a registration.

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 a chemical 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 the 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.

TSCA requires EPA to apply regulatory requirements to chemicals for which EPA finds a reasonable basis 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, use or disposal, or requires warning labels be placed on the chemical.

Chemicals may be regulated under provisions known as authorization and restriction.

Authorization is required for the use of substances of very high concern. This includes substances that are (1) carcinogenic, mutagenic, or toxic for reproduction; (2) persistent, bioaccumulative, and toxic or very persistent and very bioaccumulative; or (3) identified as causing serious and irreversible effects to humans or the environment, such as endocrine disrupters.

Section 6(a) authorizes EPA to regulate existing chemicals, including restriction or prohibition. EPA is required to apply the least burdensome requirement and the rule must be supported by substantial evidence in the rule- making record.

Restrictions on substances relating to its manufacture, marketplace, or use, including banning, may be required where there is an unacceptable risk to health or the environment.

EPA maintains compliance officials to monitor compliance with TSCA.

EPA maintains compliance officials to monitor compliance with TSCA.

Reach requires EU Member States to monitor compliance with provisions of REACH.

No specific language relating to substitution or finding safer alternatives.

No specific language relating to substitution or finding safer alternatives.

Authorization applications (for chemicals of very high concern) require an analysis of possible alternatives or substitutes.

TSCA allows companies to make confidentiality claims on nearly all information it provides EPA.

TSCA allows companies to make confidentiality claims on nearly all information it provides to EPA.

REACH allows chemical companies to make confidentiality claims; however, it places restrictions on what kinds of information companies may claim as confidential.

TSCA requires that existing health and safety-related information must be made available to the public.

TSCA requires that existing health and safety-related information must be made available to the public.

EPA uses its HPV Challenge Program to voluntarily gather information from industry and ensure that a minimum set of basic data on approximately 2,800 high- production-volume-chemicals is available to the public.

REACH requires public disclosure of information such as the trade name of the substance, certain physicochemical data, guidance on safe use, and all health and safety-related information.

No specific language relating to children’s health.

No specific language relating to children’s health.

No specific language relating to children’s health. However, under the TSCA Inventory Update Reporting Regulation of December 2005, manufacturers of chemicals in volumes of 300,000 pounds or more must report use in or on products intended for use by children.

Appendix III: Additional Options For Strengthening EPA’s Ability to Assess and Regulate Chemicals under TSCA

As requested, we identified a number of options that could strengthen EPA’s ability under the TSCA to assess chemicals and control those found to be harmful. These options have been previously identified in earlier GAO reports 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.

The Congress may wish to consider revising TSCA to place more of the burden on industry to demonstrate that new chemicals are safe. Some of the burden could be shifted by requiring industry to test new chemicals based on substantial production volume and the necessity for testing, and to notify EPA of significant increases in production, releases, and exposures or of significant changes in manufacturing processes and uses after new chemicals are marketed.

To put existing chemicals on a more equal footing with new chemicals, the Congress could consider revising TSCA to set specific deadlines or targets for the review of existing chemicals. These deadlines or targets would help EPA to establish priorities for reviewing those chemicals that, on the basis of their toxicity, production volumes, and potential exposure, present the highest risk to health and the environment. The Congress could also consider revising TSCA to shift more of the burden for reviewing existing chemicals to industry. If more of the responsibility for assessing existing chemicals was shared by industry, EPA could review more chemicals with current resources. In deciding how much of the burden to shift to industry, the Congress would need to consider the extent to which providing data to show that chemicals are safe should be a cost of doing business for the chemical industry.

To ensure that EPA can implement its initiatives without having to face legal challenges and delays, the Congress may wish to consider revising TSCA to provide explicit authority for EPA to enter into enforceable consent agreements under which chemical companies are required to conduct testing, clarify that health and safety data cannot be claimed as confidential require substantiation of confidentiality claims at the time that the claims are submitted to EPA, limit the length of time for which information may be claimed as confidential without reaffirming the need for confidentiality, establish penalties for the false filing of confidentiality claims, and authorize states and foreign governments to have access to confidential business information when they can demonstrate to EPA that they have a legitimate need for the information and can adequately protect it against unauthorized disclosure.

Appendix IV: Summary of Chemical Hazard Information Requirements under REACH and TSCA by Production Volume

Once a company begins production of a chemical, it is placed on the TSCA Inventory and is classified as an existing chemical.

For the HPV Challenge Program, only one of the three tests of oral route, inhalation, or dermal route are required. For REACH, the oral route test is the only one required at one ton or above and all three (oral, inhalation, and dermal) are required at 10 tons or above.

These tests may be required at production volumes of 1 million pounds (about 454 tons) or more.

Three biotic degradation tests are specified: simulation testing on ultimate degradation in surface water; soil simulation testing (for substances with a high potential for adsorption to soil); and sediment simulation testing (for substances with a high potential for adsorption to sediment). The choice of the appropriate test(s) depends on the results of the chemical safety assessment.

Appendix V: Comments from the Environmental Protection Agency

Appendix VI: GAO Contact and Staff Acknowledgments

Staff Acknowledgments

In addition to the individual named above, David Bennett, John Delicath, Richard Johnson, Valerie Kasindi, Ed Kratzer, and Tyra Thompson made key contributions to this report.