Mr. DINGELL. Sufficiently sound so that you can stand on that, but not be examined further! Mr. WILLIAMS. Well, I do not think that you and I would get far, frankly, in an argument on that point, Mr. Dingell, as much as I would enjoy it. [Laughter.] Mr. DINGELL. You talked about strontium 90, and whether or not it should be construed as being subject to the Delaney amendment. You also said that the fact that strontium 90 is in foods is also a basis for us to consider that there is a threshold level for safety. Have you read some of the scientific works on this subject! Mr. WILLIAMS. Now, just a minute. I did not say what you said I said, Mr. Dingell. Mr. DINGELL. Well, I refer you to page 11 of your statement, and what you did say. then ask you Mr. WILLIAMS. All right, I will tell you what I said. I said that the Department, through the releases of Mr. Flemming and, perhaps, the Food and Drug Administration Mr. DINGELL. Were these releases directly construing the Delaney amendment? Mr. WILLIAMS (continuing). Have recognized threshold levels of strontium 90 which is an admitted carcinogen. I merely used that as an example of the inconsistencies to which you are led when you apply a per se construction to the Delaney clause. Mr. DINGELL. Were these constructions of the particular statute, these press releases or these statements that you have referred to! These were not constructions of the Delaney clause or of the Food and Drug Act at all, were they? Mr. WILLIAMS. No, they were merely recognitions of threshold levels. Mr. DINGELL. Well, now I intend to go into that. Further, as a matter of fact, these statements merely were that, as I recall them, and I am sure my recollection is about the same as yours, they were merely statements by the Department that they could not show that there was any harm coming from these substances; is that correct? And they did not come out and say that the milk was safe. They just said they cannot prove the milk was not safe; isn't that correct! Mr. WILLIAMS. No, sir. Mr. DINGELL. Then there was another body Mr. WILLIAMS. Do you care to hear what they said? Mr. DINGELL. Yes, I would like to hear it. Mr. WILLIAMS. This is the release of January 12, 1960: Analyses of single samples of wheat, cabbage, and potatoes from 12 States, and ore cample of soybeans from one of these States showed levels of strontium 30 to be within the limits recommended by the National Committee on Radiation Protection and Measurements as permissible for lifetime exposure. Mr. DINGELL This does not say they cause cancer or did not cause cancer, does it? Mr. WILLIAMS (reading): The Food and Drug Administration noted that the total radioactivity in the dried fruits above referred to was below the levels which would indicate a need to determine strontium 90 levels. It is all in terms of levels, Mr. Dingell. My only point was that they are recognizing there are levels below. which there is no danger. Mr. DINGELL. They did not say though this was a level below which or above which cancer would be created. They made no mention of cancer in those releases, did they? Mr. WILLIAMS. I think it would have been even more embarrassing if they had, than it was. Mr. DINGELL. But they made no mention of it, did they? Mr. WILLIAMS. No, they did not. Mr. DINGELL. And, as a matter of fact, there are a number of other things that you can determine from analysis of strontium 90, that it destroys bone marrow, it inhibits growth, it has a number of other toxic effects, including attacking the red blood cells and many, many other things; am I correct? Mr. WILLIAMS. I do not know. Mr. DINGELL. Well, these are true. Now, you made one statement on page 12 that I wanted to point to. You said: We want to avoid any misunderstanding of our position. We do not advocate the addition to the carcinogenic materials normally in our food supply. That would imply that much-it would imply that you would support the Delaney amendment which says, "We don't allow the addition of any additional carcinogenic materials." Am I correct? Mr. WILLIAMS. Perhaps you did not read the whole sentence. Mr. DINGELL. Well, as much as I just want to see whether our understandings are clear as far as we have gone. Mr. WILLIAMS, Then the answer is I did not intend that because I state at the end a qualification which may increase the incidence of cancer among the population. That is the whole point. Mr. DINGELL. Then you go on: Of the additional substances which may increase the incidence of cancer among the population. We desire simply to establish the proposition uniquivoc ally in the statute that the regulatory agency, the Food and Drug Administra tion, shall be empowered to determine whether the addition of a particular substance will have that effect. Are you familiar with the work of the International Union Against Cancer, and more specifically the remarks of Dr. G. Burroughs Mider, M.D., on this subject! Mr. WILLIAMS. I have a vague familiarity with those things. Mr. DINGELL. I wondered if you drew from that some of the same things I drew, where he said that carcinogenie substances can have accumulative effect, both insofar as repeated exposure to the same substances, and so far as exposures to different substances at reasonably contemporaneous times, having accumulative effect? Mr. WILLIAMS. I under stand that is true of many toxic drugs. Mr. Dingell. And he reported out that, as I understand, different persons would react differently to different carcinogenic substances. Did you draw that? Mr. WILLIAMS. Did I what? Mr. DINGELL. Did you draw that inference, too! Mr. WILLIAMS. That persons Mr. DINGELL. Did you draw the same inference that I did that different persons would have different reactions! Mr. WILLIAMS. I would assume different persons would react differently. That is true in many fields. Mr. DINGELL. I wonder if you derive from that the same thing I did, where he says Mr. WILLIAMS. But there is nothing new Mr. DINGELL. Where he says that: If a substance is shown by adequate tests to be carcinogenic for one mammalian species, it is probable that it is carcinogenic for many, but not necessarily for all others, although quantitative differences between species may be marked. Did you get that inference from his work? Mr. WILLIAMS. I have not read that particular part of his work. All I know is Mr. DINGELL. I would recommend it very highly. It might be that you would want to change your statement after you read it. Mr. WILLIAMS. I listened to Mr. Flemming, and I read what Mr. Flemming quoted, but I assure you that our people have read it very carefully. Mr. DINGELL. The last thing he said is this: There are nontumorigenic levels of exposure to carcinogens for given experi mental conditions, but threshold levels may be affected by a number of factors associated with carcinogenic process. The burden of his remarks in this portion was that we cannot always fix levels; in fact, we cannot fix levels at all. Would you take any issue with that, I wonder? Mr. WILLIAMS. The fact that you cannot always fix levels? Mr. DINGELL. That you cannot. Mr. WILLIAM. I would assume you could not always. I do not know for a fact. Mr. DINGELL. Would there be agreement between you and me as to this point all through your testimony here today? Mr. WILLIAMS. No, sir, Mr. Dingell; because all we are advocating is that this whole matter be returned to a scientific basis; that the Department of Health, Education, and Welfare, through the Food and Drug Administration, be permitted to use its scientific facilities to determine in each case, in each specific case, whether a given substance, whether it is a carcinogen or some other toxic substance, is safe for use under the conditions under which it is to be used. We are not trying to-we are perfectly willing to face the problem of convincing the Department in individual cases. That is a matter of evidence and scientific judgment. Mr. DINGELL. What would you say about the substantial volume of scientific opinion, and informed scientific opinion, of capable, competent people, who say that any exposure to any one of these carcinogenic substances creates an irreversible change within the cell, which can never be changed, and which can never be reversed? Mr. WILLIAMS. Well, as a layman, I would doubt it. Mr. WILLIAMS. As a layman. After all, we are Mr. DINGELL. After all, we, in ignorance, could agree or disagree. Mr. WILLIAMS. We are exposed to them all the time we eat these. Mr. DINGELL. I am aware of this. Do you want to take on any more of these substances than you have in your lifetime! Mr. WILLIAMS. No, sir. I think that I explained my position. I wanted the Food and Drug Administration to decide what we should take on or what we should not. Mr. DINGELL. Let me just ask you one or two more questions. As a general premise, would I be correct in this, that if we err in the field of cancer and carcinogens, any error which is made in legislating in this field should be made on the side of safety of the consumers who will have to take this substance more or less unknowingly, unwittingly, and unintentionally; is that a correct statement? Mr. WILLIAMS. If there is an error? Mr. DINGELL. Yes. It should be made on the side of safety of the consumers. Mr. WILLIAMS. Yes. I think, in general, that is true. But I think that whether Mr. DINGELL. But here we ought to make a specific exception! Mr. WILLIAMS. But I should think it should be evaluated by a scientific agency, not by Congress. The way you did it before, when you passed this bill originally, you left it up to the scientific agency, the Food and Drug Administration. And then suddenly this clause was inserted, and now it becomes a great thing for some reason, I do not know why, just since last summer so far as I can figure. Mr. DINGELL. Should not any error which is made in this field be made on the side of safety for the consumer, and I am talking about legislatively as well as scientifically? Mr. WILLIAMS. If there is an error, naturally you would want to make it on the side of safety. But to my mind it would not be an error to give the decision to the qualified agency involved. Mr. DINGELL. Thank you very much. Thank you, Mr. Chairman. The CHAIRMAN. Mr. Keith! Mr. KEITH. No questions. The CHAIRMAN. Mr. Williams, I would like to turn to the last page of your statement for just one moment. As I understand, under present law the burden is on the industry to show that there is nothing present in a particular additive that will produce carcinoma ? Mr. WILLIAMS. I believe it amounts to that; in effect, proving a negative, whichi, of course, is impossible. The CHAIRMAN. Now, under the proposal of the languago here, would the burden be shifted from the industry to the Food and Drug Administration? Mr. WILLIAMS. No, sir. The CHAIRMAN. The burden would still be on the industry then to show that such material were not present? Mr. WILLIAMS. To the satisfaction of the Food and Drug Administration. The CHAIRMAN. To the satisfaction of the Food and Drug Administration. Mr. WILLIAMS. That is correct. Mr. WILLIAMS. I would assume different persons would react differently. That is true in many fields. Mr. DINGELL. I wonder if you derive from that the same thing I did, where he says Mr. WILLIAMS. But there is nothing new Mr. DINGELL. Where he says that: If a substance is shown by adequate tests to be carcinogenic for one mammalian species, it is probable that it is carcinogenic for many, but not neces sarily for all others, although quantitative differences between species may be marked. Did you get that inference from his work? Mr. WILLIAMS. I have not read that particular part of his work. All I know is Mr. DINGELL. I would recommend it very highly. It might be that you would want to change your statement after you read it. Mr. WILLIAMS. I listened to Mr. Flemming, and I read what Mr. Flemming quoted, but I assure you that our people have read it very carefully. Mr. DINGELL. The last thing he said is this: There are nontumorigenic levels of exposure to carcinogens for given experi. mental conditions, but threshold levels may be affected by a number of factors associated with carcinogenic process. The burden of his remarks in this portion was that we cannot always fix levels; in fact, we cannot fix levels at all. Would you take any issue with that, I wonder? Mr. WILLIAMS. The fact that you cannot always fix levels? Mr. DINGELL. That you cannot. Mr. WILLIAM. I would assume you could not always. I do not know for a fact. Mr. DINGELL. Would there be agreement between you and me as to this point all through your testimony here today? Mr. WILLIAMS. No, sir, Mr. Dingell; because all we are advocating is that this whole matter be returned to a scientific basis; that the Department of Health, Education, and Welfare, through the Food and Drug Administration, be permitted to use its scientific facilities to determine in each case, in each specific case, whether a given substance, whether it is a carcinogen or some other toxic substance, is safe for use under the conditions under which it is to be used. We are not trying to-we are perfectly willing to face the problem of convincing the Department in individual cases. That is a matter of evidence and scientific judgment. Mr. DINGELL. What would you say about the substantial volume of scientific opinion, and informed scientific opinion, of capable, competent people, who say that any exposure to any one of these carcinogenic substances creates an irreversible change within the cell, which can never be changed, and which can never be reversed? Mr. WILLIAMS. Well, as a layman, I would doubt it. Mr. DINGELL. You would doubt it, as a layman? Mr. WILLIAMS. As a layman. After all, we are Mr. DINGELL. After all, we, in ignorance, could agree or disagree. |