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. 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. 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 existing chemicals, companies do not have to  develop such information unless EPA requires them to do so. 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. In addition, this program may not provide enough information for  EPA to use in making risk-assessment decisions. 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. 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. Further, the regulation must apply the least burdensome requirement that  will adequately protect against such risk. EPA has these 90 days to  review the chemical information in the premanufacture notice and identify  the chemical’s potential risks. In addition to such authorization procedures, REACH provides procedures  for placing restrictions on chemicals that pose an unacceptable risk to  health or the environment. 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. 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. Toxic Substances Control Act and the EU’s Registration, Evaluation and Authorization of Chemicals

New chemicals are those not on the TSCA inventory. 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. 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.
Why GAO Did This Study

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.

What GAO Found

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.