51 



companies have voluntarily withdrawn their notices, often in the face of possible 

 regulatory action, on an additional 5 percent of PMNs. 



TSCA Section 5 gives EPA several possible options for action when the Agency 

 detetTiiines that a new chemical substance may pose an unreasonable risk or have 

 significant production volume and exposure potential. 



In some cases, EPA requires that additional test data be developed to address 

 Agency concerns about the chemical. During the testing period, the Agency may 

 allow controlled use of the substance through the negotiation of a Section 5(e) con- 

 sent order. We have found this to be a successful vehicle and have signed over 600 

 Section 5(e) consent orders with industry since 1979. Some of the orders require spe- 

 cific tests by specific times, while others provide for disposal controls and worker 

 protection. 



In cases where EPA determines that the potential unreasonable risk from expo- 

 sure to a chemical cannot be mitigated by a Section 5(e) consent order, the manufac- 

 turer or importer may choose to suspend further EPA review of the substance and 

 voluntarily undertake additional testing to address Agency concerns. This course 

 has been chosen for over 250 PMNs. Section 5(f) of TSCA allows the Agency, where 

 EPA determines that the new substance will present an unreasonable risk, to pro- 

 hibit its commercial development or use. This prohibition has been applied to 4 

 PMNs. 



The new chemicals program has expedited the review process for chemicals by de- 

 veloping PMN exemption categories implemented under Section 5(h) (4) of TSCA. 

 EPA has determined that low-volume chemicals (produced in amounts less than 

 1,000 kilograms a year) and certain polymers present relatively low risks and 

 should be subjected to a shorter review. For low-volume substances, the submitter 

 agrees to adhere to the conditions and practices under which the chemicals can be 

 manufactured, used, or imported as specified in the exemption notice. 



The new chemicals program is viewed by many in the government and industry 

 as the Agency's premier pollution prevention program. Program staff routinely in- 

 corporate pollution prevention principles and information into the review of new 

 chemicals. The Agency asks companies to voluntarily include pollution prevention 

 information on their PMN applications, and, based on this information, we often are 

 able to work with the PMN submitter to significantly reduce pollution. Whenever 

 possible, the program will identify alternative processes and provide information 

 sources to help the PMN submitter assess the alternatives and develop less risky 

 chemicals. The new chemicals program also offers the PMN submitter the option of 

 developing a pollution prevention plan for reducing unnecessary exposure to or re- 

 lease of the PMN chemical. These plans may be incorporated into the 5(e) consent 

 order or voluntarily incorporated into industry's own program of product steward- 

 ship for the chemical. 



One of the unique features of the new chemicals program in the United States 

 is that it does not require any testing prior to PMN submission. As a result, over 

 half of all PMNs are submitted without any test data. In response to this lack of 

 data, the Agency has developed tools to use Structure Activity Relationships (SAR) 

 to predict and assess the fate and effects of new chemicals. Other systems, most no- 

 tably the Premarketing Notification scheme used in the European Union (EU), re- 

 quire that notifiers develop and submit a "base set" of testing on new chemicals. 

 EPA and the European Union recently concluded a joint study to compare the re- 

 sults obtained in assessing a series of European new chemicals using two methods — 

 the U.S. SAR-based approach and the European Union's testing-based approach — 

 and to estimate the extent to which SAR-based conclusions might change if a base 

 set of test data were available. The study concluded that the SAR approach to 

 screening new chemicals is useful and effective in identifying chemicals that may 

 be toxic and in need of further scrutiny, but it also concluded that the overall proc- 

 ess could be improved through selective incorporation of specific testing require- 

 ments. Full copies of the study have been provided to a number of Hill Committees. 

 As a general matter, this study suggests that the new chemical program would be 

 strengthened by the ability to obtain test data where SAR techniques are less pre- 

 dictive, a step that would make sense in combination with a move from 



