81 



ciated with a chemical that has gone through this review, a testament to its appar- 

 ent effectiveness. 



Twenty years of implementation, however, do suggest three areas for improve- 

 ment -with respect to this aspect of the law. First, the new chemical review program 

 of TSCA is in need of a thorough scientific review, and this should be repeated every 

 5 years or so. The new chemical program has never had such a review. This rec- 

 ommendation is not meant to suggest that the Agency is doing a bad job. On the 

 contrary, I think that the staff has done a good job. But the program operates en- 

 tirely behind a cloak of confidentiality. Without some type of technical audit or sci- 

 entific review, good work goes unrecognized, and at the same time no forces of exter- 

 nal accountability operate to assure that the program continues to function well. 

 Over time, it is just too easy to reassign the best staff or to cut the budget from 

 a program that is invisible. This year, premanufacture review is scheduled for sig- 

 nificant budgetary cuts, but no assessment of program performance is available for 

 judging whether these cuts may trim the program or gut it. Periodic outside review 

 would provide that answer and create incentives for Agency management to make 

 sure that cuts are effective, not excessive. 



Second, in contrast to Europe, there are no testing requirements associated with 

 new chemicsd review under TSCA. This results in EPA making scientific guesses 

 every day about the possible effects of chemicals being reviewed. In many cases, the 

 proposed conditions of use or the nature of the proposed chemicals makes it easy 

 to conclude that they are not likely to pose an unreasonable risk. In other cases, 

 this is less clear, and EPA should have more data upon which to base its judgments. 

 At a minimum, EPA should have the benefit of the submitting company's reasoning 

 regarding the potential safety of the proposed use. A straightforward improvement 

 would be for companies to submit their own unreasonable-risk assessment for the 

 intended uses of their chemicals, as part of premanufacture notification. With this 

 mechanism, any need for more test data to support the safe introduction of a pro- 

 posed chemical would be evident to the company through its own assessment. More- 

 over, this is a reasonable expectation for any firm committed to product steward- 

 ship. 



Third, there is one loophole in the premanufacture notice (PMN) review process. 

 When a company submits a PMN to EPA, it provides information on the expected 

 uses for the chemical. EPA carries out its risk and benefit assessments largely 

 based on these stated uses. If the chemical completes the PMN process, it is eligible 

 to go on the existing chemical inventory, in which case it may be produced by any 

 manufacturer for any purpose, including those never contemplated in the PMN re- 

 view. PMN reviews should be based upon a range of uses, as requested by the sub- 

 mitter. If that company, or any other company, later wishes to use the chemical in 

 an application that has more or fundamentally different human or environmental 

 exposure, the chemical should be subject to a new review. The same logic should 

 also apply to fundamentally new uses of existing chemicals. The effect of this pro- 

 posal would be to convert the Section 8(b) Existing Chemical Inventory into an Ex- 

 isting Chemical Use Inventory, with the use categories being the same as those dis- 

 cussed above under norms. 



5. Make Producers and Users Responsible for Testing 



I have already addressed my views about additional testing for new chemicals. I 

 share similar views with respect to existing chemicals. In general, I believe that 

 product stewardship and sound public policy should place responsibility on the 

 shoulder of industry to make sure that the chemicals that it produces and uses are 

 not an unreasonable risk. To the extent that such a conclusion cannot be made with- 

 out additional data, companies would have the choice of limiting uses of their chemi- 

 cals to those where human and environmental exposures are so low as to make ad- 

 ditional tests irrelevant, or to conduct additional tests. 



In some cases, this approach will not prove to be practical (e.g., in the case of a 

 chemical used primarily by tiny companies). In such cases, government sponsored 

 testing would seem warranted. 



The current approach of writing testing rules to require companies to test their 

 chemicals is fatally flawed. In many cases, it requires the Agency to make a more 



