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cals and provide adequate information on environmental and health effects to chem- 

 ical users. These assessments are subject to government review. 



REVIEW OF EXISTING CHEMICALS 



EPA has made little progress in reviewing chemicals in commerce. Under its ex- 

 isting chemicals program, EPA has reviewed the risks of about 1,200 substances, 

 some 2 percent of the about 62,000 chemicals that were in commerce when the new 

 chemical review program began in 1979. Not all of these chemicals are the same 

 priority for review. For example, EPA states that about 14,000 of these may be of 

 concern because of their large production volumes and chemical structures. How- 

 ever, EPA officials estimate that the agency can review only 20 to 30 existing chemi- 

 cals per year, given its current level of resources. And, as we previously pointed out, 

 EPA may need to review chemicals again as their production increases or new uses 

 are found for them. 



For existing chemicals, EPA is responsible for compiling available information on 

 the chemicals' effects and exposures. This effort is time-consuming and resource-in- 

 tensive, and complete data are often not available, especially for exposures. EPA 

 must use various models to estimate or project the amounts and types of exposure, 

 and the results are uncertain. Basic exposure-related information, such as the vol- 

 ume of environmental releases, the number of workers exposed to a chemical, and 

 the types of chemical uses, are generally not available, incomplete, or outdated. 



To require industry to test or submit additional exposure-related information on 

 a chemical, EPA must issue a rule. Such an effort can be lengthy and costly. For 

 example, TSCA authorizes EPA to require industry to test an existing chemical if 

 the agency finds that the chemical may present an unreasonable risk or may result 

 in significant human or environmental exposure. According to EPA, issuing a test 

 rule for a chemical can take as long as 24 to 30 months and cost the agency fi-om 

 $68,500 to $234,000. The testing, which does not begin until the rule is issued, can 

 take from a few months to a few years to complete. Since the testing program began 

 in 1977, EPA has issued 30 test rules covering 121 chemicals. In addition, EPA has 

 entered into negotiated test agreements or consent agreements for the testing of 59 

 more chemicals. 



The other countries that we visited place more of the burden on industry for the 

 review of chemical risks. As previously stated, Sweden's Act on Chemical Products 

 places the main responsibility on manufacturers and importers to assess chemical 

 risks. In Canada and Germany, the government is responsible for assessing the 

 risks of existing chemicals. However, it is easier for the govenunent to obtain the 

 chemical information that it needs. Germany is implementing a 1993 European 

 Community directive that requires member countries to carry out a systematic re- 

 view of existing chemicals. For these reviews, chemical manufacturers smd import- 

 ers have to compile and report certain data. The government may require industry 

 to provide additional data (which could involve performing additional testing) during 

 the assessment process. Under the Canadian Environmental Protection Act, the gov- 

 ernment can require industry to provide additional chemical data without having 

 to issue a rule. 



CONFIDENTIAL BUSINESS INFORMATION 



Recognizing the need to protect trade secrets, TSCA allows chemical manufactur- 

 ers, processors, and distributors to claim information submitted to EPA as confiden- 

 tial. Under the act, EPA is responsible for protecting the data that contain trade 

 secrets or financial information from unauthorized disclosure. Federal employees 

 and contractors who need the information to carry out their official duties are au- 

 thorized access to confidential data. 



Making confidentiality claims under TSCA is a simple procedure. Claims do not 

 have to be substantiated, and TSCA does not establish a penalty for filing a false 

 claim. Although TSCA limits the information in health and safety studies that can 

 be protected as confidential to data that disclose manufacturing processes or por- 

 tions of a chemical mixture, the act broadly defines what constitutes a study. Thus, 

 unless data relating to a chemical's effects on public health and safety are contained 



