diethlystilbestrol, but with other chemicals and it is my judgment this issue must be resolved before we can have that hearing.

Senator KENNEDY. Well, there is no reason that you cannot abandon it during that period of time under your power as an imminent health hazard; is there?

Dr. SCHMIDT. We banned it and the ban was overturned.

Senator KENNEDY. As an imminent health hazard?

Dr. SCHMIDT. As an imminent health hazard? I do not have before me any evidence that would support any recommendation that it is an imminent health hazard, in the levels being found in liver of beef cattle, at this time.

Senator KENNEDY. You do not have the power to do that? The basis of the residues that are showing up now?

Dr. SCHMIDT. We have no evidence of there being a health hazard. Senator KENNEDY. A carcinogen-you have not got the evidence? You did not think even though we have direct evidence, it is a human carcinogen, you do not feel under the statutory authority that you have now either sufficient evidence or power to ban it while you develop the criteria?

Mr. HUTT. Senator, this was the subject of discussion in 1972 in hearings before your subcommittee. At that time Dr. Rauscher and Dr. Edwards testified that, from a medical standpoint, they could not justify a medical determination to invoke the statutory requirement of a finding of imminent hazard.

Without the finding of an imminent hazard, we must hold a hearing before DES can be taken off the market.

This is probably one of the things in the statute that is most in need of revision.

Today the Food and Drug Administration, whether we are talking about an animal drug or a human drug, must consider, and deny or hold a full evidentiary hearing before it can remove a drug from the market.

Senator KENNEDY. We understand you did not hold the hearing and that was a mistake. And as I understand the difference, we had, as you pointed out, this hearing 21⁄2 years ago, we are back to ground zero. At that time Dr. Edwards would not indicate it was a human carcinogen.

Dr. Rauscher, you say it is?

Dr. RAUSCHER. It is a human carcinogen based on

Senator KENNEDY. What else do you need, Mr. Commissioner?
What else do you need?

I think under the Delaney language, under it, that you have got the complete authority and power to do it. What else do you need?

You have the head of the Cancer Institute saying it is human carcinogen. You have evidence it is showing up in increasing partsDr. SCHMIDT. I think it is only fair for Dr. Rauscher to continue to talk, because there is more to say than what he said.

Dr. RAUSCHER. We believe, Mr. Chairman, that it is a human carcinogen, when administered to the female, carcinogen in the first trimestral of pregnancy.

It is not like many other carcinogens which, under certain circumstances, are not carcinogens.

Senator KENNEDY. Should pregnant women eat meat that has estrogen in it?

Dr. RAUSCHER. Certainly not.

Senator KENNEDY. You have the head of the Cancer Institute saying that.

What do you say? You do not have the power to put a temporary ban on this in order to develop?

Mr. HUTT. We have the legal authority if the Secretary-and this is nondelegatable-declares it is a imminent health hazard. At least up to now, the medical scientific determination has been that the small amounts of residues in the rare circumstances where they occur and with the unlikely event that anyone would eat enough of the particular organ of the animal in which it is found-namely, only the liver or kidney-are not sufficient that this could be declared an immi

nent health hazard.

If that medical and scientific determination were changed, then there would be a sufficient legal basis to take action.

I would suggest, Senator, that it is terribly important that Congress change the law and remove this restriction so that we could eliminate from the marketplace animal and human drugs which we believe unsafe or ineffective for any reason, whether or not there is an imminent hazard, before determining whether a hearing is justified.

Senator KENNEDY. Yes. We have had 3 years that we have been talking about this. We passed it in the Senate and basically because for one reason or another you did not follow your rules over there, in holding an evidentiary hearing, and your administrative ruling got knocked out. That was over a year ago. You have not had a hearing since.

I agree with you that we are going to act and we certainly are. But I do not see any reason why you people cannot. You are both in the same Department of HEW. Mr. Rauscher is the head of the Cancer Institute, Dr. Rauscher says it is completely inadvisable for a pregnant mother to eat any of the meat that has DES. You say you are not quite sure it is imminent hazard. The Secretary of HEW, you both work for him. I do not think we ought to make that decision, determination.

It seems to me it only makes sense to make that determination, to ban it, then to develop the procedures, and then go ahead. If they are going to reapprove it under certain control circumstances, do it that way, rather than just let it continue to be

Dr. SCHMIDT. Senator, I believe a misleading statement has been made, or at least a misleading impression.

To my knowledge diethylstilbestrol residues identified in liver and perhaps kidney, and so on, but not in meat. I would not like the impression to be left that residues of diethylstilbestrol have been identified in meat unless one defines liver as meat.

Senator KENNEDY. Are you sure of that, Dr. Rauscher?

Dr. RAUSCHER. I believe that is correct; yes.

Senator KENNEDY. That there is none in the residue?

Dr. SCHMIDT. That is the whole point of the sensitivity, Senator. This is why I feel so strongly about holding a hearing on the important issue. Because if you said to me, if there is diethylstilbestrol in liver of a cow, do you think if you had a method sensitive enough you might be able to find a molecule floating around in a blood vessel some place, in strident muscle tissue? I would say probably you could.

The sensitivity of the method one uses is basic to the regulatory actions that we take and this has to be an issue in the hearing that we hold.

Senator KENNEDY. When are you going to have the technique?

Dr. SCHMIDT. We will hold the hearing as soon as we can after finalization of the order that sets the sensitivity of the matter.

Senator KENNEDY. When is that? Are you talking about a date?
Dr. SCHMIDT. No, we are not.

Senator KENNEDY. Months? Weeks? What?

Dr. SCHMIDT. The issue of setting of the sensitivity of the method is one of the most difficult ones that has ever been put before the Agency. We published a proposal. We are through the comments. We are on probably the sixth or eighth final draft.

Senator KENNEDY. Will you support emergency legislation now until you get that through? Would you support emergency legislation now? Banning

Dr. SCHMIDT. On what basis?

Senator KENNEDY. Banning it in animal feed.

Dr. SCHMIDT. On what basis?

Senator KENNEDY. As a health hazard.

Dr. SCHMIDT. No.

Senator KENNEDY. How about you, Dr. Rauscher?
Mr. HUTT. Senator.

Dr. RAUSCHER. Let me make one other point here. I think it is important to put on the record that most people feel it is unlikely that doses which are now in liver or in meat would induce cancer in people. On the other hand, my position has to be that we do not know.

Senator KENNEDY. That is right.

Dr. RAUSCHER. And that is the thing I have problems with.
Senator KENNEDY. Yes.

Dr. RAUSCHER. But the dosage is exceedingly low when it is present, but we do not know what that low dose is going to be.

It is my job to get that kind of information.

Senator KENNEDY. You can still eat meat without it, can you not? There are other countries that have abandoned it.

We are not banning meat here, are we? So you would support it?
Mr. HUTT. Senator, can I clarify one point?

When the Senate passed the legislation banning DES, it was limited to DES, which in my judgment was an error.

The problem is broader than DES. We have hundreds of drugs today that are on the market that the National Academy of Sciences has found to be ineffective, but that remain on the market because of the statutory prohibition against our taking them off the market until we have ruled on a request for an evidentiary hearing.

Legislation that would remove that barrier would allow us to act on DES without deciding the issue whether it is a health hazard.

When the Commissioner answered your question, he was answering that it should not be banned as a health hazard.

But it should be banned for other reasons; namely, the lack of assurance that it is safe.

We have no evidence it is a health hazard, but the burden should not be on the government to prove it is a hazard. The burden should be on the industry to prove it is not a hazard. Until they have satisfied that, then the drug should be banned even before an evidentiary hearing.

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Dr. SCHMIDT. I thought you were going to ask me another question, at least I

Senator KENNEDY. If we can get support for legislation, you can put it under whatever reasons you would like.

Dr. SCHMIDT. I am asking what basis-I asked what basis you would be banning it, and I would have a problem supporting legislation on the basis of a demonstrated health hazard.

Then I thought you were going to say, well, would there be any other basis?

Senator KENNEDY. Why do you not answer that one?

Dr. SCHMIDT. I would say probably, yes.

Senator KENNEDY. What would that basis be?

Dr. SCHMIDT. Well, there are several.

I am very interested in Lilly's testimony because it is good to hear that it is the responsibility of the industry to prove safety. I firmly believe that that is true.

I also believe that it is proper for Congress, in the name of the people, to make a benefit-risk judgment of a certain kind, and I would support the right and responsibility.

I have said many times that there are certain kinds of benefit-risk decisions that must be made by the people or by the people's representatives; these decisions are appropriate for Congress. And as I have said many times, I welcome working with Congress, resolving some of the problems that affect everybody in this country, that are a kind of basic benefit-risk questions.

Senator KENNEDY. Well, can you support legislation to ban?
Dr. SCHMIDT. Yes.

Senator KENNEDY. You can, Dr. Rauscher, and the only question is the reasons, the basis for it.

We are going to sit down with your people, starting this afternooon and work out the rationale so that we can introduce it at the earliest time possible.

Let me just as a final question, Commissioner, do you ever talk to Dr. Rauscher about this matter at all? The morning-after pill? Dr. SCHMIDT. I am sorry?

Senator KENNEDY. Did you ever talk to Dr. Rauscher, given these various health issues that have been raised in terms of a cancercausing agent, did you ever talk to the head of the Cancer Institute prior to the time you made the decision to approve the drug?

Dr. SCHMIDT. Because NCI has been involved all along in our discussions, in testifying before our advisory committee, in holding a seminar on the safety issue as a result of

Senator KENNEDY. On this particular issue, DES?

Dr. SCHMIDT. Yes, sir.

Senator KENNEDY. As morning after?

Dr. SCHMIDT. I have known NCI's feeling all along, and I did not specifically talk to Dr. Rauscher. But I reviewed the NCI's position, their testimony, and their actions, and so on, as part of our approval

process.

Senator KENNEDY. I want to thank you very much for coming up here. We will make sure the record is complete, Dr. Rauscher. Thank you very much.

Dr. SCHMIDT. Thank you, sir.

Senator KENNEDY. The subcommittee stands in recess.

[Whereupon, at 1:23 p.m., the subcommittee recessed.]

APPENDIX