John Dingell

Does FDA believe nontraditional compounders should be subject to appropriate good manufacturing practices the way manufacturers are?

One of the things we have do is to clarify it so that everybody knows who is supposed to and who can do what.

I have long believed that we must provide agencies like FDA with clear authorities and necessary responses to properly help and to carry forward their mission.

Many in the private sector are already doing the right things to protect their systems and should not be diverted from these efforts through new requirements.

Mr. Chairman, I thank you for your courtesy.

The changes to Section 113(h) expand the opportunities for litigation, meaning communities would have to live longer without a cleanup remedy.

Such actions will delay cleanup for years while a federal judge sorts through the technical merits of a selected cleanup remedy.

Could you check and submit that?

It permits a splendid opportunity to obfuscate the process, delay the cleanup, and cost a lot more money in litigation, which is a prodigiously expensive undertaking.

I believe that Ms. Dillen--I have trouble seeing--I believe you were of the same view. Is that correct?

I am unaware that this Subcommittee has conducted any oversight that has identified problems necessitating the amendments before us today.

I do not see the factual record in this matter justifying significant changes to the existing law here.

I feel with regret that the amendments appear to be solutions in search of a problem.

I have some familiarity with the subject matter before us today since I have chaired both the committee and the conference committee.

What does that mean?

Many of these amendments appear unnecessary and are without a factual basis or predicate.

But the answer is very few, if any. Is that right?

And one of the problems I believe with Superfund is that these things are litigated till hell freezes over; isn't that right?

Good. Now, in a situation where the state wants the most gold-plated remedy which might require the excavation and disposal of hundreds of tons of contaminated soil so its future operation and maintenance costs for which the state is…

You would think it would.

Please, Mr. Trimble.

The basic policy behind Superfund is that polluters should pay to clean up their pollution.

I have the distinct feeling you do not have the resources to do the job.

In other words, you do not have enough money to do the cleanup at the same rate or the necessary rate because of that cut.

I hope the majority would hold fair and open hearings so that we can have a proper input and all the information that is needed.