63 



in what is obviously a study, EPA finds it difficult to prevent industry from claiming 

 confidentiality and limiting public access. A large portion of the TSCA information 

 EPA receives is claimed as confidential. For example, a 1992 study found that more 

 tha^n 90 percent of premanufacture notices for new chemicals contained some infor- 

 mation claimed as confidential. Although EPA officials believe that much of this in- 

 formation is not proprietary, the process of challenging the claims is resource-inten- 

 sive and EPA has challenged only a small percentage of the claims. As a result, 

 EPA must expend considerable effort to protect large amounts of confidential data. 

 In addition, the data cannot be disseminated to others, such as State officials who 

 have responsibilities for health and environmental protection. EPA would also like 

 to make the information available as part of an overall strategy to use public infor- 

 mation and education as a means to control the use of toxic chemicals. 



The other countries that we visited also allow industry to make confidentiality 

 claims. However, these countries generally specify more tjT)es of data that cannot 

 be claimed as confidential. While health and safety studies are the only type of data 

 on which TSCA restricts confidentiality claims, Canada generally does not allow 

 claims on data such as chemical uses and safe handling procedures. Exposure data 

 are confidential in Germany, but claims are generally not allowed for information 

 such as the chemical's trade name, physical chemical properties, precautionary and 

 emergency measures, and toxicological tests results. Sweden is more restrictive in 

 that it generally limits claims to chemical identity and some business aspects, such 

 as the volume of production. 



CONCLUSIONS 



TSCA is a unique piece of environmental legislation. Whereas other environ- 

 mental laws, such as the Clean Air and Clean Water acts, generally deal with 

 chemicals as pollution by establishing how much can be released to the environ- 

 ment, TSCA potentially provides the means to take up-front or preventive actions 

 through restrictions on chemical production, distribution, and use. 



However, EPA has taken few actions under TSCA to control toxic chemicals be- 

 cause it is extremely difficult for the agency to demonstrate that a chemical pre- 

 sents an unreasonable risk under the standards of evidence required by the act. 

 Furthermore, EPA officials responsible for implementing TSCA do not believe that 

 the act gives them a clear mandate to control more than a few chemicals that can- 

 not be addressed through other health or environmental laws. Moreover, EPA's ex- 

 perience in implementing the act has shown that gaps often exist in the data needed 

 to assess the risks of both new and existing chemicals and that obtaining the needed 

 data places a heavy burden on EPA, given available resources. 



As EPA emphasizes its efforts to protect human health and the environment by 

 preventing pollution, TSCA's emphasis on prevention continues to have potential to 

 provide EPA with a valuable tool to achieve this objective. In addition, EPA would 

 like to make more information on chemical risks publicly available as part of a 

 strategy to involve the public more in its pollution prevention efforts. Industry's con- 

 fidentiality claims, however, limit the amount of data that can be released. Our re- 

 port on TSCA's implementation will provide some specific options for revising TSCA 

 in these areas. 



In continuing our work for the subcommittee, we will be looking at ways to make 

 TSCA a more effective statute. In doing this, we will be considering three broad 

 matters: 



• First, whether setting a clear goal for TSCA and expectations for what EPA 

 is to achieve under the act is desirable. Key to this would be clarifying whether 

 TSCA is to be used as a backstop when other laws are lacking or whether TSCA 

 is to play a more prominent role in controlling toxic chemicals. 



• Second, whether to continue to hold EPA responsible for assessing and 

 proving chemicsd risk, or whether to shift the burden to manufacturers to assess 

 and demonstrate chemical safety. Also of concern is whether to modify the 

 threshold for taking regulatory action under TSCA. Approaches used by other 

 industrial countries could be looked to as models for how to proceed in this re- 

 gard. 



