A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its ...

FEDERAL FOOD, DRUG, AND COSMETIC ACT

Dr. MILLER. That is right.

Mr. Dres. And that it is absolutely obligatory upon the Food and Drug Administrator to formally act upon every matter!

Dr. MILLER. That is right.

Mr. DIES. The fact that there is an advisory committee, there is nothing that would relieve the Food and Drug administrators of their responsibility!

Dr. MILLER. He must take some action within 30 days after the advisory committee's report.

Mr. DIES. Thank you.

Mr. DEROUNIAN. Dr. Miller, does your bill require a complete review of all chemical additives in existence today?

Dr. MILLER. Oh, no; only those that have some evidence that they may not be proper for use in food. We set up a cutoff date of January 1, 1956. However, any chemical, and there are hundreds of them in use, and most of them are safe, I think there are 3 or 4 that there is some doubt about it requires industry to come in with new data to support the evidence that they can be used.

Mr. DEROUNIAN. What about carbonated drinks? Are there additives in such that will apply to this!

Dr. MILLER. I would not want to get into the softeners in bread and additives in soft drinks. In the Delaney committee hearings we had people who brought teeth and dropped them into certain carbonated drinks, and I will not mention their names, and the teeth became soft. Whether it was something in the carbonated water or something else, I do not know.

As to the celebrated bread hearings that went for 18 months down in hearings and then came a court decision. Time may prove the court wrong. A board of scientific men advising the court would have been a great help. But certainly in the bread decision a group of experts coming before the department could say, "This is what we believe," and then in 30 days you have to make a decision-that would have solved a controversy that still drags out.

Mr. HAYWORTH. Dr. Miller, is it possible for chemical additives to be harmful in certain combinations with other chemicals or in certain foods, but not to be harfmul in other situations?

Dr. MILLER. That is quite possible, Mr. Hayworth, yes.

Our select committee found that combinations of chemicals produced one of the most diflicult problems that the department must deal with, as to what happens when certain chemical reactions take place.

Mr. HAYWORTH. And is it also possible for a chemical additive to be harmful to some individuals and not to other individuals! Dr. MILLER. We all have different reactions to them, yes.

Mr. HAYWORTH. Well, it would seem to me as though the testing procedures would be rather dificult and perhaps extensive, in some instances.

Dr. MILLER. Indeed they are and they should be.

Mr. HAYWORTH. Now, if that is the case, what facilities does the department have for making these tests?

Dr. MILLER. Well, the responsibility is upon industry to make all of the tests and come before the department with all of the data and say, "Gentlemen, here it is," and then it is the responsibility of the department to examine that data through their experts not through

FEDERAL FOOD, DRUG, AND COSMETIC ACT

extensive laboratory techniques of testing in animals, a whole string of animals as industry does, but for the department to take the data bẹfore them and say, "It is safe," or "It is not safe."

Mr. HAYWORTH. I notice you require samples of the additive to be submitted. I assume that those will be fore some kind of testing.

Dr. MILLER. If the department wants to have it tested, they can do it. They do have facilities for testing now. But I do not think it is as extensive as industry has and should not be, because industry has the prime responsibility. It is upon them to furnish evidence that whatever chemical they propose to use is safe.

Mr. HAYWORTH. How do you arrange for that to be distributed, over large or small producers, or do you depend upon anyone producer that wants to take the initiative?

Dr. MILLER. Well, the producers themselves generally have their own techniques and their own laboratories in which they test chemicals. Some of the smaller ones, of course, must go to commercial laboratories to have chemicals tested that they desire to use. But the data, they must collect and submit to the departinent.

Mr. HAYWORTH. Thank you, Mr. Chairman.

The CHAIRMAN. Dr. Miller, we appreciate very much your appearance before the committee and the suggestions that you have given

us.

We will continue to study this question and would appreciate at any time any suggestions that you can give us because we know it will come after careful consideration on your part, both as a Member of Congress and as a physician, who understands some of the technical aspects, perhaps better than a layman may understand them.

If there are no further questions, we thank you very much, sir.
Dr. MILLER. Thank you, Mr. Chairman.

The CHAIRMAN. It was the intention of the chair to proceed with proponents of the legislation and the chair is not certain that Judge John Biggs is a proponent or an opponent, but the chair has been notified that he could not be present any day except today. We will hear next the Honorable John Biggs, Jr., Chief Judge of the Third Circuit Court from Wilmington, Del.

STATEMENT OF HON. JOHN BIGGS, JR., CHIEF JUDGE OF THE THIRD JUDICIAL CIRCUIT OF THE UNITED STATES, APPEARING ON BEHALF OF THE JUDICIAL CONFERENCE OF THE UNITED STATES

The CHAIRMAN. You may.proceed with your testimony.

Judge BIGGS. Thank you, Mr. Chairman and gentlemen, for letting me be here.

My name is already on the record, John Biggs, Jr., Chief Judge of the Third Judicial Circuit of the United States. That is a court which sits at Philadelphia and embraces Delaware, New Jersey, Pennsylvania, and the Virgin Islands.

I appear here, as I say, on behalf of the Judicial Conference of the United States, with whom you gentlemen are doubtless familiar. It consists of the Chief Justice of the United States and the 11 Chief Judges of the respective circuits. It meets at the call of the Chief Justice.

FEDERAL FOOD, DRUG, AND COSMETIC ACT

Under section 331 of title 38, the Judicial Code, the Judicial Conference is required by the Congress to make recommendations for legislation respecting the business of the courts. And I appear here today without the specific sanction of the Conference in regard to the bills that I want to discuss, because I was not aware that they were coming up so soon and I only heard of this hearing the latter part of last week. Nonetheless, the Conference has gone on record in respect to certain provisions of similar bills in opposition; and, therefore, I think I am entitled to say that I represent the Conference's views in respect to this.

I am really a proponent of this legislation. I have had experience some time ago in our court where we had what the last witness, Dr. Miller, referred to as the bread case, which actually was the case of Atlas Powder Co. v. Ewing and was decided by our court, 201 Federal 2d, 437, with certiorari denied by the Supreme Court.

But the opposition that I wish to express is only in regard to certain small portions, but I am afraid a rather important portion, Congressman O'Hara, of H. R. 8271 and 8275. Those are the review provisions and appear in 8271 on page 7, line 3, down to line 15, and in 8275, on the same page.

These sections, which are subsection e of the new section entitled "Section 409," provides for a declaratory judgment procedure to pass upon the correctness of the ruling of the Secretary in respect to the propriety of the use of any food additive.

What this provision does is give a trial de novo just as any other declaratory judgment provision, or case, would be, under section 2201 of title 28, and it would render the courts in the position of the administrative agency dealing, I am afraid, with matters with which they really are not competent to deal and giving them a function which goes far beyond the review function or functions which are provided, for example, by the Administrative Procedures Act to which Congressman Dies has referred.

Let me give you a practical view of this. We have the bread case, to which reference was made, the Atlas Powder Co. case. It is my recollection that the record in this case was a very, very large record. I think that it took about 18 months, or 18 to 20 months, to take it before the hearing officer of the Secretary. It deal with a very technical additive, which had been developed by Atlas Powder Co. in its laboratories, which incidentally are in or around Wilmington, and it is a Delaware corporation. The name of that chemical is polyoxethylene monostearate, and it had a chemical formula, gentleman, which was one of the most complex things I have ever seen in my life. There was also a good deal of disagreement as to how and why it worked. It was a preservative. If you put it in bread, it had the tendency to keep the bread fresh. The Secretary had held that it was not a safe additive, and an appeal was taken to the Court of Appeals of the Third Circuit because Atlas was a Delaware corporation, and venue, of course, was laid in our court because Delaware is a part of the third circuit. We finally succeeded in getting an opinion out which sustained the decision of the Secretary.

Now, the courts cannot adequately act as administrative agencies. Their function must be to review the whole record and decide whether or not there is, on the whole record, a substantial basis for the ruling

FEDERAL FOOD, DRUG, AND COSMETIC ACT

of the department and whether or not the ruling of the department is in accordance with law.

I am very much afraid that if this particular provision were enacted by the Congress, which deals with one only of the numerous agencies, the Congress, in effect, would break the line and we would have them in all other or many other situations and this is a process, suggested here, which, I say, with all deference to the proponents of the bill, I know of in no other instance in the entire Federal system.

It would require a very substantial increase in the number of judges, and many of these cases, or most of them I think would probably come into the rather heavily burdened United States District Court for the District of Columbia, because, under the way the bill is drawn, it seems to me the Secretary is of necessity a party.

I would like to say, before I try to answer any questions that might he asked, that there is, of course, an appeal given to the Court of Appeals from any ruling of the Secretary under the present method. The appeal must be and is in terms substantially similar to that given by the Administrative Procedures Act.

There have been recent decisions of the Supreme Court, particularly in the Watterman case, Universal Camera Corporation v. National Labor Relations Board (340 U. S. 474), decided in 1951, and in this companion case of National Labor Relations Board v. The Pittsburgh Steamship Co. (340 U. S. 498), also decided in 1951.. The Supreme Court held what is in substance now embodied in the Administrative Procedures Act, that the Court must decide on the whole record, that is, the Court must take the whole record and, unless the position of the agency is supported by substantial evidence on the entire record, then it cannot be sustained. But the Administrative Procedures Act provides that anyhow. So it would seem that the law is quite clear on that point.

Just in conclusion, on this, the question of the courts doing this sort of thing was put a way back in 1907 by the Honorable Charles Evans Hughes, who was then Governor of New York. He dealt and foresaw the problems which would arise if the courts were burdened with functions which properly belonged to the administrative agencies which were just then beginning to come into existence.

In a famous speech which he delivered on May 3, 1907, at Elmira, N. Y., he made the statement that the dealing of the courts as administrative tribunals with administrative problems would tend to bring the courts into disrepute because they were not well qualified to handle it.

He said, among other things:

You must have administration, and you must have administration by administrative officers. You cannot afford to have it otherwise. Under the proper maintenance of your system of Government and in view of the wide extension of regulating schemes, which the future is destined to see, you cannot afford to have that administration by your courts. With the courts giving a series' of decisions in these administrative matters, hostile to what the public believes and free from that direct accounting to which administrative officers are subjected, you will soon find propaganda advocating a short-term judiciary, and you will turn upon our courts, the final safeguard of our liberties, that hostile and perhaps violent criticism from which they should be shielded and will be shielded if left with the jurisdictions which they were intended to exercise.

I have repeated that from a speech by the Honorable Alben Barkley, that he made on the floor of the Senate on May 6, 1940.

FEDERAL FOOD, DRUG, AND COSMETIC ACT

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