47 



are produced at levels of over 10,000 pounds per year. EPA employs hazard-based 

 and exposure-based screening techniques to identify priority testing candidates from 

 among this 14,000-chemical subset. 



Over the past several years, the General Accounting Office (GAO), the Congress, 

 and others have noted a number of shortcomings in the testing program, the most 

 significant being a lack of productivity and the absence of a clear agenda for testing. 

 In response to these criticisms, the Agency developed and instituted a series of man- 

 agement reforms that have accelerated the completion of testing actions and im- 

 proved the program's focus on meeting priority testing needs. 



The first of these reforms is an effort to expand testing by not only utilizing TSCA 

 § 4 Test Rules, but also using new tools negotiated Enforceable Consent Agreements 

 (ECAs) and voluntary testing programs. 



Enforceable Consent Agreements are used when chemical manufacturers or 

 groups of manufacturers agree to conduct testing under the potential sanctions of 

 TSCA. OPPT is currently developing ECAs for over 20 chemicals. In July 1992, 

 OPPT announced an "open season" to encourage chemical manufacturers and proc- 

 essors to submit offers to enter into Enforceable Consent Agreements to test chemi- 

 cals for which OPPT had not yet issued final testing actions. OPPT received and 

 evaluated 22 testing offers covering 12 individual chemicals and 4 chemical cat- 

 egories. 



Voluntary testing initiatives are proactive efforts to enter into voluntary testing 

 agreements with industry. A voluntary program of particular importance to EPA is 

 the Organization for Economic Cooperation and Development (OECD) Screening In- 

 formation Data Set (SIDS) program. The OECD/SIDS program is a cooperative 

 international effort to obtain test data for international high production volume 

 (HPV) chemicals. Responsibility for testing individual chemicals is allocated among 

 the OECD countries through a gross national product (GNP)-based formula. The 

 United States is responsible for testing 25 percent of the SIDS chemicals; other 

 OECD countries are responsible for the balance. Prior to the SIDS program, the 

 United States was conducting more than 90 percent of the world's chemical testing. 

 The SIDS program provides an opportunity to "share the burden" of testing among 

 all OECD countries. And we believe that the screening level data that will be gath- 

 ered will be key to our long term strategy of assessing high volume chemicals in 

 commerce. Since the OECD/SIDS program began several years ago, work has been 

 initiated or completed on over 230 chemicals: testing and assessment by OECD have 

 been completed on 25 chemicals; more than 50 chemicals have completed SIDS test- 

 ing and are awaiting OECD review; and testing is underway on almost 70 chemi- 

 cals. Testing on over 85 additional chemicals will be initiated during the next year. 

 The fact that over 95 percent of the OECD/SIDS-HPV chemicals are in U.S. com- 

 merce makes this voluntary international testing progrsun a very important compo- 

 nent of EPA's domestic chemical testing program. 



Enforceable Consent Agreements and voluntary testing initiatives all clearly 

 lower the transaction costs for government and the regulated community alike. 

 These mechanisms may provide opportunities for industry to offer balanced pro- 

 grams combining testing activities with pollution prevention and product steward- 

 ship efforts. These are two examples of the potential benefits of these approaches. 

 We have negotiated a voluntary product stewardship program, via a formal Memo- 

 randum of Understanding (MOLD, with the major manufacturers of the diglydicyl 

 ether of bisphenol A. This MOU, which is an adjunct to testing that will be con- 

 ducted via an Enforceable Consent Agreement, is expected to be signed by all par- 

 ties in the very near fiiture. The stewardship program includes pollution prevention, 

 waste minimization, exposure reduction, and health and safety data communication 

 activities by the manufacturers. A second example concerns cyclohexane where, as 

 part of the consent agreement, manufacturers will work with their customers over 

 the next 5 years to reduce emissions of cyclohexane and will report back to EPA 

 on their efforts. 



Our formal TSCA §4 rulemaking activities, although somewhat cumbersome, are 

 continuing as well. In July 1993, we promulgated a TSCA §4 Multi-Chemical 

 Neurotoxicity End-Point Test Rule covering 10 chemicals. In October 1993, however, 

 we were sued by the Chemical Manufacturers Association; settlement was reached 



