Chemical Regulation: Comparison of U.S. and Recently Enacted European Union Approaches to Protect against the Risks of Toxic Chemicals
Published: 2007-08-17T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Chemicals play an important role in everyday life. However, some chemicals are highly toxic and need to be regulated. 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, but some have questioned whether TSCA provides EPA with enough tools to protect against chemical risks. Like the United States, the European Union (EU) has laws governing the production and use of chemicals. The EU has recently revised its chemical control policy through legislation known as Registration, Evaluation and Authorization of Chemicals (REACH) in order to better identify and mitigate risks from chemicals. GAO was asked to review the approaches used under TSCA and REACH for (1) requiring chemical companies to develop information on chemicals' effects, (2) controlling risks from chemicals, and (3) making information on chemicals available to the public. To review these issues, GAO analyzed applicable U.S. and EU laws and regulations and interviewed U.S. and EU officials, industry representatives, and environmental advocacy organizations. GAO is making no recommendations.
section_title: What GAO Found
paragraphs: REACH requires companies to develop information on chemicals' effects on human health and the environment, while TSCA does not require companies to develop such information absent EPA rule-making requiring them to do so. While TSCA does not require companies to develop information on chemicals before they enter commerce (new chemicals), companies are required to provide EPA any information that may already exist on a chemical's impact on human health or the environment. Companies do not have to develop information on the health or environmental impacts of chemicals already in commerce (existing chemicals) unless EPA formally promulgates a rule requiring them to do so. Partly because of the resources and difficulties the agency faces in order to require testing to develop information on existing chemicals, EPA has moved toward using voluntary programs as an alternative means of gathering information from chemical companies in order to assess and control the chemicals under TSCA. While these programs are noteworthy, data collection has been slow in some cases, and it is unclear if the programs will provide EPA enough information to identify and control chemical risks. TSCA places the burden of proof on EPA to demonstrate that a chemical poses a risk to human health or the environment before EPA can regulate its production or use, while REACH generally places a burden on chemical companies to ensure that chemicals do not pose such risks or that measures are identified for handling chemicals safely. In addition, TSCA provides EPA with differing authorities for controlling risks, depending on whether the risks are posed by new or existing chemicals. For new chemicals, EPA can restrict a chemical's production or use if the agency determines that insufficient information exists to permit a reasoned evaluation of the health and environmental effects of the chemical and that, in the absence of such information, the chemical may present an unreasonable risk. For existing chemicals, EPA may regulate a chemical for which it finds a reasonable basis exists to conclude that it presents or will present an unreasonable risk. Further, TSCA requires EPA to choose the regulatory action that is least burdensome in mitigating the unreasonable risk. However, EPA has found it difficult to promulgate rules under this standard. Under REACH, chemical companies must obtain authorization to use chemicals that are listed as chemicals of very high concern. Generally, to obtain such authorization, chemical companies need to demonstrate that they can adequately control risks posed by the chemical or otherwise ensure that the chemical is used safely. TSCA and REACH both have provisions to protect information claimed by chemical companies as confidential or sensitive business information but REACH requires greater public disclosure of certain information, such as basic chemical properties, including melting and boiling points. In addition, REACH places greater restrictions on the kinds of information chemical companies may claim as confidential.

section_title: Letter
paragraphs: Each year thousands of chemicals are used by U.S. industries to produce  Each year thousands of chemicals are used by U.S. industries to produce  items widely used throughout society, including consumer products such  items widely used throughout society, including consumer products such  as cleansers, paints, plastics, and fuels as well as industrial solvents and  as cleansers, paints, plastics, and fuels as well as industrial solvents and  additives.  While chemicals play an important role in people’s everyday  additives.  While chemicals play an important role in people’s everyday  lives, some may adversely affect human health and the environment and  lives, some may adversely affect human health and the environment and  need to be regulated to address health and safety risks.  Because of  need to be regulated to address health and safety risks.  Because of  concerns that current legislation may not be adequate to protect human  concerns that current legislation may not be adequate to protect human  health and the environment, congressional interest in revising chemical  health and the environment, congressional interest in revising chemical  control laws has heightened in recent years.  control laws has heightened in recent years.
In 1976, the Congress passed the Toxic Substances Control Act (TSCA),  In 1976, the Congress passed the Toxic Substances Control Act (TSCA),  which authorizes the Environmental Protection Agency (EPA) to obtain  which authorizes the Environmental Protection Agency (EPA) to obtain  existing data from and require testing by chemical companies concerning  the environmental and health effects of chemical substances.  TSCA  authorizes EPA to promulgate rules to regulate the manufacture,  distribution, or use of chemicals once EPA has determined the chemicals  present an unreasonable risk of injury to health or the environment.  In  promulgating a rule to control activities based on a finding of  unreasonable risk, EPA must consider, among other things, (1) the  chemical’s effects on human health and the environment and the  magnitude of human and environmental exposure to the chemical; (2) the  benefits of the chemical for various uses and the availability of substitutes  for those uses; and (3) 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.
TSCA addresses those chemicals manufactured or imported into the  United States, but it excludes certain substances because they are  regulated under other laws, such as pesticides that are regulated under the  Federal Insecticide, Fungicide, and Rodenticide Act, and pharmaceuticals  that are regulated under the Federal Food, Drug, and Cosmetics Act.   Whereas other environmental and occupational health and safety laws  generally control only disposal, environmental releases, or workplace  exposures, under TSCA, EPA can control the entire life cycle of chemicals  from their production, distribution in commerce, and use, to their  disposal.
TSCA authorizes EPA to assess chemicals before they enter commerce  (new chemicals) and those chemicals already in commerce (existing  chemicals).  EPA maintains a list of chemicals in commerce called 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  45,000 new chemicals, of which approximately 20,000 were added to the  inventory after chemical companies began manufacturing them.
To implement TSCA, EPA has developed programs to assess and require  testing of chemicals, and manage identified potential risks from new and  existing chemicals.  To assess risks, EPA reviews information it obtains  from companies and other sources on a chemical’s potential exposure  levels and its potential adverse effects on human health and the  environment.  If EPA finds that a reasonable basis exists to conclude that a  chemical presents or will present an unreasonable risk to human health or  the environment, EPA can promulgate a rule to ban or restrict the  chemical’s production, processing, distribution in commerce, use, or  disposal, or to require that warning labels be placed on the chemical.
Information about a chemical’s effects on human health or the  environment are useful to the public in making informed decisions about  the products they use and the risks of chemicals that may be produced or  used in nearby facilities.  Information about a chemical’s hazards includes  data on physical properties (such as melting point or flammability) and  health and environmental effects (such as skin irritation, cancer, birth  defects, or toxicity to plants and animals).  However, certain information,  such as the chemical’s identity, that EPA collects under TSCA is not  always available to 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.
Like the United States, the European Union (EU) has laws and regulations  governing the manufacturing and use of chemicals.  However, the EU has  recently revised, but has not yet implemented, its chemical control policy  through legislation known as Registration, Evaluation and Authorization of  Chemicals (REACH).  The purpose of REACH is to ensure a high level of  protection of human health and the environment while enhancing  competitiveness and innovation in the chemical industry.  REACH went  into effect on June 1, 2007, and many of its provisions will be phased in  over an 11-year period.  A newly created European Chemicals Agency that  will administer REACH is currently being organized and staffed.
In this context, you asked that we provide comparative information on  TSCA and REACH.  Specifically, you asked that we compare the  approaches used under TSCA and REACH for (1) requiring chemical  companies to develop information on their chemicals’ effects on human  health and the environment; (2) controlling risks from the production,  distribution, or use of chemicals; and (3) making information on chemicals  available to the public while protecting confidential business information  (CBI).  In addressing these issues, we also obtained information on some  of EPA’s voluntary chemical control programs designed to complement  TSCA.  In addition, we identified some legislative revisions that we have  reported on in previous reports as options for strengthening EPA’s ability  to assess and regulate chemicals under TSCA.  Information on these  revisions is presented in appendix III.
To compare TSCA and REACH in their approaches to identifying  chemicals harmful to public health and the environment, controlling  chemical risks, and disclosing chemical data to the public while protecting  confidential business information, we identified and analyzed the policies  and guidelines of the United States and the EU on these issues.  These  efforts were augmented by interviews with (1) EPA officials responsible  for implementing TSCA including the Director of EPA’s Office of Pollution  Prevention and Toxics (OPPT), the EPA office with primary responsibility  for implementing TSCA, and (2) 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.  We also interviewed representatives of the American Chamber of  Commerce to the European Union, 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 of environmental  advocacy organizations based in the EU), and the Synthetic Organic  Chemical Manufacturers Association (a national, specialty chemical  manufacturers’ association).  We also gathered documentation on EPA’s  voluntary programs.  A detailed description of our scope and methodology  is presented in appendix I.  We performed our work between January 2006  and May 2007 in accordance with generally accepted government auditing  standards.
subsections: section_title: Background
paragraphs: 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).
section_title: REACH Requires Chemical Companies to Develop More Information than TSCA on the Effects of Chemicals on Human Health and the Environment
paragraphs: 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.
subsections: section_title: TSCA Does Not Require Chemical Companies to Develop Information on the Hazards of New Chemicals
paragraphs: 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.
section_title: 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
paragraphs: 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.
section_title: REACH Requires Chemical Companies to Submit Hazard Information for New and Existing Chemicals That Meet Specified Production and Toxicity Levels
paragraphs: 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.
section_title: TSCA Generally Requires EPA to Demonstrate That Chemicals Will Cause Unreasonable Risk While REACH Requires Chemical Companies to Ensure No Adverse Chemical Effects
paragraphs: 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.
subsections: section_title: EPA Has Had Difficulty Proving That Chemicals Pose Unreasonable Risks and Has Regulated Few Existing Chemicals under Section 6 of TSCA
paragraphs: 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.
section_title: TSCA’s Section 5 Provides Limited Authority to Restrict New Chemicals
paragraphs: 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.
section_title: REACH Requires Chemical Companies to Request Authorization to Use Certain Hazardous Chemicals and Search for Safer Substitutes
paragraphs: 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.
section_title: Both TSCA and REACH Have Provisions to Make Certain Information Available to the Public, but REACH Requires Greater Public Disclosure
paragraphs: 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.
subsections: section_title: EPA’s Ability to Share Data Collected under TSCA Is Limited
paragraphs: 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.
section_title: REACH Has Provisions to Protect Confidential Business Information but Allows Greater Public Access to Chemical Information than TSCA
paragraphs: 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.
section_title: Concluding Observations
paragraphs: 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.
section_title: Agency Comments and GAO Response
paragraphs: 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.
section_title: Appendix I: Scope and Methodology
paragraphs: 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.
section_title: Appendix II: Comparison of Selected Provisions of U.S. Toxic Substances Control Act and the EU’s Registration, Evaluation and Authorization of Chemicals
paragraphs: 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.
section_title: Appendix III: 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  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.
section_title: Appendix IV: Summary of Chemical Hazard Information Requirements under REACH and TSCA by Production Volume
paragraphs: 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.
section_title: Appendix V: Comments from the Environmental Protection Agency
section_title: Appendix VI: GAO Contact and Staff Acknowledgments
subsections: section_title: Staff Acknowledgments
paragraphs: 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.