10 



But I think that it's a reasonable question to ask — whether it 

 might be more desirable to wait until the premarketing period in- 

 stead of premanufacturing period and then to require more infor- 

 mation. 



Senator Reid. When TSCA was enacted, a good deal of thought 

 was given to whether we should have a premanufacturing or 

 premarketing system for use of new chemicals. We decided on the 

 premanufacturing approach, but as you have already explained, a 

 number of other countries have the premarketing system. 



What are the advantages and disadvantages of the two ap- 

 proaches? 



Dr. Goldman. Well, I think the advantage of the 

 premanufacturing approach is that for the industry, they will get 

 a signal more rapidly from the agency about whether or not it 

 might be worth pursuing the marketing of a product, and you can 

 see that there were some 974 out of those not in commerce that 

 were simply withdrawn. And one might infer that those may have 

 been withdrawn because there were strong signals that they would 

 have had to go through more testing. 



On the other hand, I think that you could also see the disadvan- 

 tage in terms of the resource. We're spending a lot of time on as- 

 sessing new chemicals that will never go in commerce. The 8,043 

 that we would have just let right through the net never went into 

 commerce, and so was it worth our effort of evaluating those 8,043 

 chemicals as opposed to we could have spent more time on the 

 9,776 that went into commerce to make sure that we were really 

 making the right decisions with those. 



Senator Reid. Or the manufacturer also could be required to 

 come forward with information and not place the burden on the 

 EPA, right? 



Dr. Goldman. Right. 



One thing I do believe is that we have more of a handle on 

 chemicals when they're new chemicals than we ever will once 

 they're in commerce because of the inherent problems that once a 

 chemical is a part of a manufacturing process, then the entire cost 

 benefit equation becomes a very, very different equation than be- 

 fore you market a new chemical. 



Senator Reid. We have an ever increasing universe of chemicals 

 with hundreds of new ones annually. 



The question I've always had is are any of these new chemicals — 

 and I'm sure the question must be yes — substitutes for the higher 

 risk existing ones? 



Dr. Goldman. Yes, many of them are, and, in fact, we believe 

 that one of the reasons why it's been, I think, a good thing that 

 we've been able to process so many PMNs is that many of these 

 newer chemicals do have potential for reducing risk by substituting 

 older, higher risk chemicals. 



Senator Reid. In one of my prior lives, I had some dealings with 

 the Federal Food and Drug Administration, and they have a proc- 

 ess for approving new drugs that is entirely different than what we 

 have for improving new chemicals. 



Are you generally familiar with their program? 



Dr. Goldman. Generally speaking, yes. 



