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exposure to a chemical. Both EPA and European Union representatives considered 

 this accuracy rate to be too low to characterize chemical risks. 



TSCA currently requires the chemical industry to give EPA a 90-day notice of its 

 intent to manufacture or import a new chemical. This notice is to contain certain 

 information that EPA needs to review the chemical, such as its molecular structure, 

 proposed uses, estimated production amounts, estimated exposure, and the results 

 of any testing that has been conducted. The Congress could revise TSCA to require 

 manufacturers to perform certain minimum tests and submit the results to EPA 

 with their premanufacture notices. To reduce industry's testing costs, the act could 

 require that only certain basic tests be performed initially and that more extensive 

 testing be done when a chemical's production reaches certain levels. Only a small 

 percentage of chemicsds would likely reach these levels and require the additional 

 testing. Such an approach is used by Canada and countries belonging to the Euro- 

 pean Union. 



Industry's costs could be reduced further by requiring testing for only those chem- 

 ical effects or characteristics, such as vapor pressure, for which the 1993 study 

 showed that structure activity relationships analysis did not perform well. In addi- 

 tion, some chemicals may not need to be tested. EPA currently provides a very lim- 

 ited review of certain types of new chemicals that agency officials believe pose little 

 risk because of their chemical structures. 



EPA, at the conclusion of its review of the premanufacture notice, could designate 

 the additional testing to be performed. Once the testing is completed, the manufac- 

 turer would submit the results to EPA. At that time, the manufacturer could also 

 update key information in the premanufacture notice, including any new uses and 

 estimated exposures to the chemical. Cvurently, to require reporting on significant 

 new uses, EPA has to issue rules on a chemical -by-chemical basis, which is costly 

 and burdensome. 



Minimize Burden by Requiring Notices When New Chemicals Are Marketed 



TSCA currently requires manufacturers to submit information to EPA on chemi- 

 cals that they intend to manufacture and market, but that have thus far been pro- 

 duced only under controlled conditions in the manufacturers' research and develop- 

 ment laboratories. In contrast, European Union countries do not require manufac- 

 turers to submit a notification, including their test data, until a chemical has been 

 manufactured and is ready to be marketed. 



In her May 17, 1994, testimony to this Subcommittee, the EPA Assistant Admin- 

 istrator pointed out that, since 1979, about half of the approximately 19,000 

 premanufacture notices that EPA reviewed were for chemicals that never entered 

 the marketplace. She pointed out that reviewing all of these notices — about 2,000 

 annually— is a continuous challenge to the agency. Revising TSCA to have EPA re- 

 view new chemicals only when they are ready to be marketed could increase EPA's 

 efficiency. 



This change could also help minimize industry's testing and reporting costs. In- 

 dustry would have to prepare fewer notices than it currently does, and a require- 

 ment for certain initial tests, if included in TSCA, would apply to fewer chemicals. 



Accelerate the Review of Existing Chemicals 



In addition to requiring the review of new chemicals, TSCA authorizes EPA to re- 

 view the risks of chemicals already in coerce. About 62,000, or 86 percent, of the 

 approximately 72,000 chemicals in the TSCA inventory were in commerce when the 

 new chemical review program began in 1979 and have not been reviewed as new 

 chemicals. EPA has reviewed only about 1,200, or 2 percent, of these substances 

 under its existing chemicals program. While TSCA specifically requires the review 

 of new chemicals within a certain period, the act contains no explicit requirement 

 for reviewing existing chemicals. Consequently, EPA historically has given higher 

 priority to reviewing new chemicals. Furthermore, while industry is responsible for 

 collecting and submitting to EPA the data needed to review new chemicals, EPA 

 must assume the burden of initiating existing chemical reviews and collecting the 

 necessary data. 



