purposes has no bearing whatsoever on the use of this drug in the practice of medicine. Medical use of stilbestrol was first authorized in 1941. The drug can only be sold on a physician's prescription, and therefore is administered only under medical supervision.

"It is generally agreed among physicians that drugs of this type are quite useful in the control of the symptoms of many patients without significant hazard under the usual conditions of clinical practice.”

In other words, this question is raised quite often in connection with some of the issues that confront us-I mean, the basic issue that you raise.

Of course, we all recognize that it is one thing to have a doctor prescribe something for a patient after he becomes thoroughly familiar with the condition of the patient. It is another thing to have the entire population absorb a substance indiscriminately.

Mr. DEROUNIAN. Cancer in one patient is even dangerous. Nowhere in that statement does it there say there is no hazard of cancer by a patient taking it orally. It says, "no significant hazard."

Going back to your own test on color, if color produces one trace of cancer in animals, you are going to ban it, are you not? Secretary FLEMMING. That is correct.

Mr. DEROUNIAN. And rightly so. Why not stilbestrol? Secretary FLEMMING. I would like to ask Dr. Mider, who is here with me, to comment on that question.

Dr. MIDER. I cannot claim the competence that Dr. Hertz has in this field of endocrinology. However, there are many drugs which we use in clinical medicine which are poisonous and we always weigh the benefit to be gained against the risk involved.

There are physicians who have reported cases in which they have associated the cancers that occurred in patients receiving stilbestrol with the administration of stilbestrol. It is sort of a post hoc ergo propter hoc argument. The number of cases is small in relation to the total number of patients that have received stilbestrol.

Mr. DEROUNIAN. I just wanted to bring up the point.

Secretary FLEMMING. I do not know whether you were here or not when I identified Dr. Mider. Dr. Mider is the Associate Director for Intramural Research for the National Cancer Institute. He prepared the basic document that I presented this morning, and also the summary of that document which I presented in my testimony. Mr. DEROUNIAN. I understand that. Thank you.

Mr. AVERY. Mr. Chairman, my question is not addressed to the Secretary, but I want to ask it before he leaves, because of the confusion that will be in the room. And it is this: Whenever we discuss matters of public health, we usually have a room full of people like we have today. We have industry people, we have legislative witnesses; and, of course, the people from the press. That is good.

I am curious to know if the consumer, John Q. Public, is very well represented in a matter of this kind, so I wonder if I can impose upon the committee briefly for everybody to hold up their hands not representing anybody except the consumer group. I notice that there are 5 hands; Mr. Chairman, would you estimate that we had about 100 people here in the room?

Mr. LARRICK. I might say that we represent the consumer. [Laughter.]

Mr. AVERY. Of course, Mr. Larrick, and you would naturally expect us to respond that we think we represent the consumer. I was

curious to know just how much the consumer is represented in person here in the audience.

Secretary FLEMMING. Thank you.

Mr. AVERY. Thank you.

The CHAIRMAN. Mr. Secretary, let me on behalf of the committee thank you for your appearance here today and your willingness to answer all questions and to present very ably your reasons why this legislation should be approved in the interests of the health of the country.

It may well be that during the course of the hearings and the consideration of it, we will have questions that will arise. I am sure that you and Mr. Larrick and Dr. Mider and others of your staff would not mind if we found it necessary to ask you to come back and meet with us further, in order to give us the benefit of your views on this subject. Secretary FLEMMING. I will be very happy to do it at any time that the committee would like to have me do it. I do regard this as very important legislation.

I want to do everything I can to be of help to the committee in its consideration of the legislation.

The CHAIRMAN. Thank you. We try to represent the public and the consumers of the country in connection with this matter. We want to thank you for your helpfulness in making the record.

You have a big job. You have one of the biggest jobs in our Government, and I know that you have a large staff, and you have to have a good, capable staff.

The right thing has to be done, because to meet a problem of this kind, mistakes cannot be made.

Secre ary FLEMMING. That is right.

The CHAIRMAN. That is the way I view it. For that reason, I want You have been very helpful to get as much information as I can. will be very today in this hearing. I am sure that as we go along, you helpful to us and to yourself in your administration of the law. And so with that, thank you again for your time here today. Secretary FLEMMING. I am very, very happy to have had this opportunity, Mr. Chairman.

There is just one more thing. Congressman Younger asked for certain information on the number of applications filed in connection with the packaging. I do have some figures here, but I think probably it would be best if I could submit that later.

The CHAIRMAN. Submit them for the record.

Secretary FLEMMING. I think it would be best if I could file this for the record tomorrow.

The CHAIRMAN. That will be perfectly all right.

Secretary FLEMMING. And in that way prepare a better report.
(The information to be furnished follows:)

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
FOOD AND DRUG ADMINISTRATION,
January 27, 1960.

(A) Formal petitions submitted under the food additives amendment to the Federal Food, Drug, and Cosmetic Act with respect to packaging ingredients: (1) Petitions submitted: 27.

(2) Petitions which related to substances that are not food additives (firms so advised): two.

(3) Petitions not filed because they were incomplete (firms so advised): 10.

(4) Petitions filed or in process of being filed: 15.

The pending petitions (item 4 above) are being handled within the time limits established within the food additives amendment; i.e., 90 days plus an additional 90 days where extension of time is necessary.

Three of the petitions have been pending since October 1959 (two of these were submitted earlier but because of deficiencies had to be supplemented and thus have only been pending since they were completed and filed).

Three petitions have beeu pending since December 1959.

Nine petitions have been pending since January 1960.

The 27 petitions referred to above were submitted by 23 firms.

(B) The Food and Drug Administration has received, since the food addi-' tives amendment was enacted, 1,149 letters from 530 firms inquiring about the status of packaging materials.

Answers have issued on 994 letters indicating:

(1) That the evidence available shows the product not to be a food additive (approximately 25 percent of the firms), or

(2) That the evidence shows that the proposed use of the product will require the filing of a food additives petition (approximately 20 percent of the firms), or

(3) That the evidence before the administration is not sufficient to permit a decision and the inquirer will need to present further data (approximately 55 percent of the firms).

The 155 letters that are pending have been submitted by 128 firms. Three were received in October 1959, 19 in November 1959, 50 in December 1959, and 83 in January 1960.

The CHAIRMAN. Since this subject is so important to the health of the people, is there any question involved with respect to cigarettes, filters, and so forth, that comes into this problem at all, such as the color, and other things?

Secretary FLEMMING. We do not have any authority over cigarettes. We are not asking for any authority in this legislation. The responsibility in that area, of course, rests with the U.S. Public Health Service.

As you know, they have followed the practice, for which I commend them, of assembling the evidence on this issue, both pro and con, and then evaluating that evidence after they have assembled it. Then the Surgeon General issues a statement.

The Surgeon General prepared an article for inclusion in the Journal of the American Medical Association some weeks ago, and that, of course, was called to the attention of the public. I feel that the Public Health Service has rendered a very fine service in consistently keeping in touch with research in that area, with the studies in that area, and then from time to time bringing the results of all of the studies, both pro and con, together and then giving the country the benefit of their own evaluation.

The CHAIRMAN. Mr. Secretary, I want to thank you very much. Secretary FLEMMING. Thank you, sir.

The CHAIRMAN. The committee will stand adjourned until 10 in the morning.

(Whereupon, at 3:55 p.m., the committee adjourned, to reconvene at 10 a.m., Wednesday, January 27, 1960.)

COLOR ADDITIVES

WEDNESDAY, JANUARY 27, 1960

HOUSE OF REPRESENTATIVES,

COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,

Washington, D.C.

The committee met, pursuant to recess, at 10 a.m., in room 1334, New House Office Building, Hon. Oren Harris (chairman of the committee) presiding.

Present: Representatives Harris (presiding), Williams, Roberts, Rhodes, O'Brien, Rogers of Florida, Brock, Glenn, Keith, and Curtin. The CHAIRMAN. The committee will come to order.

Our first witness this morning will be our esteemed colleague, the Honorable James J. Delaney, a Representative from the Seventh Congressional District in the State of New York.

We will be glad to have your presentation on this very important subject. I might say that it is well known that you, as one of the able Members of the Congress, had much to do with this legislation. The work which your select committee performed during the 82d Congress was the basis for the Food Additives Amendment of 1958 to the Federal Food, Drug, and Cosmetic Act and likewise forms a basis for the color additive legislation now before us for consideration. So it is a long history that you have had in connection with these problems.

We will be glad to hear from you now.

STATEMENT OF HON. JAMES J. DELANEY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW YORK

Mr. DELANEY. Thank you, Mr. Chairman and members of the committee. It is a pleasure to be here this morning. After the long and comprehensive testimony that we heard all day yesterday from Secretary Flemming, anything that I might add on this proposition would be merely repetitious.

This kind of testimony must be backed up by scientific evidence. Secretary Flemming presented a wealth of such evidence for every statement that he made yesterday.

I am glad that there is no dispute between the Senate bill and the House bill, insofar as pretesting of colors is concerned.

In the early days, after the close of the original investigation of the use of chemicals in foods and cosmetics, pretesting was what we desired most; to shift the burden from the Government to those who would sponsor new and insufficiently tested chemicals. I am happy to say that is now generally accepted.

I want it to be understood that Secretary Flemming supported the House bill in every respect.

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May I say this, Mr. Chairman, in answer to one of the questions relative to the word "cancer" in the cancer clause that was brought up here yesterday: For several years after the committee had concluded its hearings in 1950, 1951, and 1952, there was no cancer clause in the food additive bill. However, evidence of the need for such a clause was brought to my attention from time to time, and after the cancer symposium of the International Union Against Cancer in Rome in 1956, it was again brought to my attention. Thereafter, I believe it was in 1957, after numerous consultations with cancer experts, the carcinogen amendment was first introduced into the bill. So it was not originally planned that way. It was one of those developments that took place because of scientific information that was given me some years after the conclusion of the investigation and the original recommendations of the committee.

I can say that in this matter of color additives there is every reason why we should have a strong bill. Some food additives serve a useful purpose. They have helped to develop and improve our food supply in many ways.

However, color additives provide no nutrient value. They have no value at all, except so-called eye appeal. We should be particularly careful with them, therefore. They add nothing in any other way.

I can see no reason why this bill, with the carcinogen clause, should not be passed immediately.

I had a prepared statement, but it was merely repetitious of what Secrtary Flemming said yesterday, and I do not want to take this committee's time to repeat it. I support the Harris bill as it is written, and I hope that we will pass it very speedily.

The CHAIRMAN. Thank you very much.

Mr. Glenn, do you have any questions!

Mr. GLENN. I wish to compliment you on that amendment, in the original legislation, because I think it was of great service to the public.

I am sure that we are all against cancer like we are against sin.

I am sure that we appreciate your coming in and being here today. Mr. DELANEY. Thank you.

The CHAIRMAN. Mr. Curtin.

Mr. CURTIN. I wish, also, to congratulate you on your long and successful fight in this field.

Mr. DELANEY. It was not done alone. Mr. Harris took the lead, together with Mr. Williams in the last Congress. And many other colleagues, like Mrs. Sullivan, joined with us in it.

am happy to see that we are continuing to have their support, people who are willing to study this important problem.

As you suggested yesterday, we have not scratched the surface on this. It is a job that is not for Congressmen alone. It should be for the scientific groups to apply their full time to it. What we should do is take a composite thinking and attempt to put it into legislation for the protection of the American public.

Mr. CURTIN. I agree with you. I think that we all agree with you on that.

The CHAIRMAN. Thank you very much. We are very glad not only to have had you here with us as a witness, but to have your continuing interest in this important subject, and we should like to have you with us during the balance of the hearings.