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that the foregoing administrative findings of fact, on which the order is based, must be judicially sustained if they are supported by substantial evidence when considered on the record as a whole.

We deem that provision to be an inherently unfair one, because the administrator of this act can ordinarily use it to secure an affirmation of his final order, regardless of any evidence to the contrary; and, therefore, the judicial review is ordinarily fruitless and useless.

This basic fact is recognized by the American Bar Association, which drafted and sponsored the Administrative Procedure Act, because it is now developing a revision of this act which, instead, directs that the court shall not acc the administrative findings of fact in a situation like the one before us, where they are clearly erroneous on the record as a whole, which would be a more liberal rule of evidence.

But unfortunately that revision of such act has not yet been enacted, and its aforesaid challenged provision now controls a judicial review of a final administrative order under this amendment; and it may be strongly argued, as the FDA does argue, that Congress should not use the particular FDC Act to revise the general Administrative Procedure Act.

Nevertheless, we maintain that the sound and just rule of evidence . in the judicial review under consideration is that the administrative findings of fact must be sustained only where they are supported by the weight of the evidence in the record as a whole, which is precisely what the Federal Commodity Exchange Act now provides.

In view of its precedent and in the interest of procedural justice, we suggest that this committee study the substitution of that rule in the amendment before us, which it has the right legislatively to recommend.

In conclusion, we have not reached the point where we now hare before us the provisions of H. R. 6747 for an administration food: additive amendment of the FDC Act, in their practical conception; and this explanatory analysis of it, which I hope is an educational one, Mr. Chairman, reveals two ultimate facts:

The first fact is that this bill should be comprehensively revised to give it a right legislative form. And if the committee can await my return from Europe in September and it desires this, I will then undertake to submit a revision of the bill in that form for its consideration.

The second fact is that the legislative policy expressed by this bill is an administrative procedure one in accord with the Administrative Procedure Act, which places defined food additives under a permissive regulation control by the FDA, in effect, subject to the optional review described. And that was the controversy between the FDA and the industries here before.

My association previously opposed the policy of this permissive regulation control, because it amounts to a Government license of the food-manufacturing industry in a vital area of its future progress; and unnecessarily so, we then believed.

But we are now disposed to approve the policy of this control if it is expressed in a right legislative form, for several convincing reasons, and subject to an important qualifying comment that I will add: The first reason is that the FDA uncompromisingly insists on such a permissive regulation control, on the ground that it will more effectively protect the public health; and we, as an industry, desire to cooperate constructively with it, in every available way.

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In addition, the FDA firmly believes that scientific questions under the FDC Act, and under this amendment in particular, are better determined administratively. We respect the FDA, and we recognize its fundamental responsibility to protect the public health, through the FDC Act, which it is duty bound to administer appropriately.

The second reason is that the policy of this control is now firmly imbedded in the new drug, pesticide chemical, food standard, food coal-tar color, and general regulation laws of the FDC Act.

Moreover, the Federal Meat Inspection Act may also be cited as a precedent, together with the Federal biologic drug legislation previously noted; and the Federal Trade Commission Act is also an administrative procedure one.

The third reason is that the amendment proposed by H. R. 6747 contains a provision for an expert and impartial scientific review, which is a new provision in an amendment of this sort, of its permissive regulation control, which would measurably check serious abuse of it.

The fourth reason is that the Judicial Conference of the United States supports the policy of such control, as Judge Biggs testified at the 1956 hearings before a subcommittee of this committee. He did so also on the ground that scientific questions under the FDC Act are best administratively decided, as a rule, subject to a review consistent with the Administrative Procedure Act.

Then there is another reason, Jr. Chairman, which I omitted from my written statement, that should be cited here, why my association has decided to support this control, subject to the qualifying comment which I will now make, and that is this: The late and revered Chairman Priest, of this committee, discussed this amendment at great length with me after the hearings last year, and after he had heard all of the testimony pro and con, and he advised me very earnestly that our great food industry should support the FDA in this situation, provided that the amendment is drawn in a proper form.

Now my qualifying comment is this, and this is a rather important consideration, Mr. Chairman, and I hope that all members of the committee will carefully consider what I now say:

This is my qualifying comment, the qualifying comment of the principal, National Association of Food Manufacturers, that I represent: While the above reasons for the permissive regulation control of food additives have the complete force of their statement, this significant fact remains, and it is an extremely important one from an industrial standpoint.

Many, perhaps most-and I have tried to talk with all of the leading food manufacturers of this country in our organization-many, per. haps most, legitimate food manufacturers remain very uneasy, indeed, over the policy of this permissive regulation control of food additives, because it does involve a drastic Government license of their industry to which they are instinctively and philosophically opposed, and they have always opposed, as this committee knows, in the record of enactment of pure-food legislation down the many years and when I have testified before it; and our industry has always preferred a food law which is drawn in the traditional form of making the necessary protective requirements on an objectire basis for their due Government enforcement, which is the state of the present food law of the FDC Act.

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Now, these inanufacturers, these fine legitimate manufacturers, have no objection whatever to the FIC Act requiring a pretesting of potentially dangerous additives and a submíttal of the pretesting and other related data to the FDA for its evaluation in enforcing this act.

What they do not like, instinctively, is that further step made by the amendment before us, which places their necessary food additives under a permissive Government control.

Moreover, while these manufacturers trust, fully trust, the present FDA officials and deem them able and fair and dedicated to the public welfare, they must consider from a long-range standpoint whether other and different officials will hereafter replace them and may misuse such control to injuriously suppress essential progress by their industry in this basic food-additive area.

In view of that situation, I have given very careful consideration, Mr. Chairman, and I telephoned to Chairman Harris about it, to the question whether H. R. 6717 before us could be further revised, after it has been fully revised as it should be revised in its own self, whether it should be further revised on a compromise basis whereby the administrative structure of its amenilment is maintained as now, but a provision is added to satisfy this strong feeling of legitimate food manufacturer's.

I believe that such a provision is arailable. It is one that would authorize a manufacturer, for example, adrersely affected by an administrative order under the amendment before us, to petition the appropriate United States district court to enjoin that order for cause shown, after due pro and con argument, pending a trial, a de novo trial, on its inerits.

This provision Tould grant such court the discretion to reject that petition for cause shown, so that it would not be mandatory power, and that situation should protect the Government in the circumstances.

But it would have the value of giving the manufacturer this alternative appeal remedy, where it appears needed or advisable in the circumstances, and he feels that he shonld have the merits of his food chemical additive, his new food chemical additive-which may be immensely important to him, and the production of which may have cost him millions of dollars decided in this way. I remedy which would be used only occasionally, at most; and certainly it would not be used in a case where a scientific advisory committee has sustained the FDA order in question.

But where it is industrially needed or advisable in the circumstances, this remerly would have a great and just procedural value, for the reasons I have stated.

Then I should add that if the court denics such a petition for an injunction, the standard appeal provisions of the amendinent before us vould operate; whercas if it grants this petition, the foregoing dded provision that we have in nind would stipulaté expressly that the relevant pretesting data subìnitted by the petitioner to the FDA shall be taken as adimissions by hiin, for the purpose of this proceeding.

In short, this compromise provision would operate to meld the proposed adininistration amendment of F. R. 6747 and the proposed fcod-industry amendment of II. R. 8.390 and the other bills suggested, introduced by Mr. O'Ilara and Mr. Wolverton, in particular, on a compromise basis.

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Hence, I suggest that the committee duly study the question of such an added provision,

But then I conclude by saying that if the committee rejects this compromise provision, then my National Association of Food Manufacturers approves the administrative amendment proposed by H. R. 6747, provided it is revised in a due legislative form.


We suggest that the definition of a food additive, proposed by the amendment before us, be revised to read as follows, and the significant revision is printed in italic:

(1) The term "chemical additive" peans, except as bereid otherwise provided, ang substance used or intended to be used for any purpose in the manufacture, processing, preparation, packing, or other fabrication of any food, or in the treating, packaging, transporting, or holding of any food

(a) which thus becomes or could reasonably be expected to become a component of such food, either directly or indirectly; or

(0) which thus otherwise affects or could reasonably be expected to affect any characteristic of such food, either directly or indirectly, including any sulistance intended to preserve or alter such food and any radioactive mate

rial intended for use in such food or as a source for its irradiation, if such substance is not generally recognized, among experts qualified by scientific training and experience to eraluate the toxicity of such substance or its viber potentiality for injury to health, as baving been adequately shown through appropriute scientific procedures or througb (prolonged) use in or on food to be safe for use under i he conditions of its intended use.

12) The term "safe for uxe," with reference to a chemical additive used in or un a food, mcans it is rcasonably provable that such additive can be thus used under the conditions of its intended use without rendering the food injurious to health.

(3) The term "chemical additive," as used berein, does not include (A) a pesticide chemical in or on a raw agricultural commodity, or a pesticide chemi. cal when intended solely for use in the production, storage, or transportation of any ram agricultural commodity; or (B) ans substance used in accordance with a sanction or approral granted pursuant to this act, prior to the enactment of this paragrapb.

(The additional similar exception with respect to the Federal Meat Inspection Act bas been eliminated, for the reasons previously stated.)

Thank you very much.

Mr. Williams. Mr. Dunn, I think anyone who has heard your stateinent will agree with me you are thoroughly acquainted with the subject you have talked about this morning. Certainly your statement points up the complexity of the problem that is before this committee. We appreciate very much your having prepared such a comprehensive analysis of the various aspects of this problem.

There may be questions by members of the subcommittee and ex officio members of the subcommittee, which you might be able to anster, and I would like to ask Mr. Harris if he has any questions, first.

The CHLAIKMAX. I believe not, Mr. Chairman, except to say that I am very glad to have had the privilege of hearing Mr. Dunn'in his presentation this morning on this very important and highly technical subject.

I recall a previous occasion on which Mr. Dunn last appeared before this committee, and he has always been very helpful. We are glad to welcome you back again.

The presentation you have made does point up the importance of the subject to which this committee must give a great deal of attention and careful consideration.

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I have just this one question, and that is, I understood you to say in your statement that legislation in this field is absolutely necessary.

Mr. Dunn. Yes, sir.
The CHAIRMAN. Is that true!
Mr. Dunn. Yes, sir.
The CHAIRMAN. 'Is that recognized by everyone so far as you know!

Mr. Dunn. There is no dispute on that question in the food-manı. facturing industry that I know of.

The CHAIRMAN. In other words, all sides, so far as you know, recognize the fact that legislation is necessary!

Mr. Doxn. Exactly. And we take the further position, Mr. Harris, that the responsible Administration bill should be used as the basis for enacting and developing this legislation, revising it as the circumstances require, and the committee believes, in a balanced form to equally protect the consuming public and the legitimate regulated industries.

These other bills which have been introduced are very valuable, indeed, from the standpoint of comparison, and taking out from them the good features that they have, which should be added to an amendment of this sort.

I participated in the development of the food-industry bills which Mr. O'Hara introduced and which you, Mr. Harris, subsequently introduced, with Mr. Wolverton, in their original conception. And at that time we had no FDA or Administration bill before the committee, so that we were plowing an original legislative path through these food-industry bills.

But now that the FDA-which, after all, administers our great and essential national pure-food law, and is very competent to do so has now proposed an amendment drawn from the standpoint of its point of view, our position is, that from a responsible standpoint the food industry and I believe also this committee should use that bill as the basis for its development of this amendment, modified as it should be modified from every standpoint.

The CHAIRMAN. Thank you very much.

Mr. WILLIAMS. In that respect, Mr. Dunn, which one of these bills more closely conforms to the views of your organization !

Mr. Dunn. Well, I cannot answer that question “yes” or “no."

I would say this: That H. R. 8390, by Mr. Harris, and the companion bill by Mr. Wolverton, was the bill that the responsible food and chemical manufacturing industries originally developed, with some modifications.

But, a great deal of water, Mr. Chairman, has gone over the dam since we developed those bills, and the principal consideration facing you and facing us at this time is the fact that the Administration it. self has noir proposed its own bill, and therefore we believe that the food-industry bills, if I may call them such, should be now used for the purposes of reforming the Administration bill, so that we will come out with a bill which melds all points of view in an appropriate way.

The CHAIRMAN. Of course, that will be developed during the course of the hearings. The committee can make the determination later on.

Mr. Williams. I note that H. R. 8390, which you say is the industry bill, was introduced on June 26, 1957, which is some just 2 or 3 week's

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