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Senator COPELAND. I do not want to let the occasion pass, however, to say that the work Professor Cavers has done has been extremely valuable. I have been in contact with him ever since Christmas, most of the time.

Mr. CAVERs. I wish to speak, as Mr. Campbell explained, with respect primarily to paragraph (h) of S. 2800, and more particularly with respect to the last sentence of that paragraph.

The CHAIRMAN. What page?

Mr. CAVERS. Page 37, which provides, in formulating regulations under paragraphs (b) and (c)—I believe Senator Copeland wishes to add (d) to this section

The findings of fact by the Secretary shall be conclusive if in accordance with law.

The first part of that sentence, up to the word “ section ” in line 7, was not in S. 1944. We had assumed that that would be its interpretation and it was inserted to clear a misunderstanding which arose with respect to its application.

Even as so qualified, however, the provision has been the subject of much controversy, and criticism, and suspicion. Consequently I felt justified in seeking to explain the reasons for its insertion, as I understand them, the scope of its operation, and why I believe it is desirable that it should be continued in the bill.

I shall not seek to discuss the provisions giving to the Secretary the power to establish such regulations. Those are enumerated in paragraphs (b) and (c), and undoubtedly Mr. Campbell has adverted to them from time to time. Among them are the powers to establish regulations with respect to tolerances for poisons, standards of food, and the like.

I do wish, however, to stress two points, that such rule-making power is not an exclusive, un-American policy as to law.

Secondly, few subjects present greater justification for its exercise than that with which we are now concerned. To attempt regulation in a single statute of a product so diverse as foods, drugs, and cosmetics, without resorting to the rule-making power, particularly in view of the diversity of problems which are encountered under that, is to deny the administrative body the most effective and in some instances the only effective means of discharging its duty to the public.

It is urged that the power to make rules having the force and effect of law casts the burden of proof of misconduct not on the Government but on the defendant. A rule by an administrative body having the rule-making power operates to define the elements of the defendant's obligation." Proof of the violation of that obligation remains on the Government.

The situation seems to me, in large measure, analogous to that which might arise if after a statute which prohibited reckless driving were supplemented by a statute prohibiting the passing of stop signs at intersections to be placed by an administrative officer at points where it seemed necessary. In the former case under the broader statute the Government would have to prove reckless driving. After the enactment of that statute the Government would prosecute for failure to stop at the intersection.

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Senator HEBERT. Would that be so if the statute did not provide authority for establishing those stop signs?

Mr. C'AVERS. No, in deed. I was considering the second situation where the statute had been enacted which did provide for the posting at street intersections, the administrative officer would post at street intersections, and therefore the violation of that regulation authorized by statute would be

Senator HEBERT. That is nothing more than a violation of law, then.

Mr. CAVERS. The adoption of rules and the grant of power which this bill contemplates give to those rules the force and effect of law. The delegation of power is to define more specifically the character of the offense by establishing a tolerance or in some instances a prohibition for the use of an article.

Senator HEBERT. You have not that element here. Your example doesn't go to the merits of the discussion that we have here. The objection to this provision is that you place in the hands of one man to ascertain the facts and once he has exercised that authority then that is conclusive upon everybody. It is quite a different question there.

Mr. CAVERS. The facts which furnish the basis for the regulation are to be determined, of course, by the Secretary. The facts which determine the violation of the regulation when established are, of course, to be left to the courts for their determination in the usual process.

Senator HEBERT. That is the point about which there was so much discussion, whether the defendant is precluded from going into the facts once they have been established by the Secretary.

Mr. CAVERS. The fact as to the justification of the regulation itself?

Senator HEBERT. No; the facts which will make one guilty of a violation. If the facts are established and are conclusive, then they cannot, the argument is that they cannot be gone into in the trial of a case. They are conclusive. I have not shared that opinion, as you may have observed, if you have listened to the discussion here, but it is argued that once the facts are established as conclusive by the Secretary then that precludes the defendant from inquiring into the facts in the trial of a case involving a violation of the regulation,

Mr. CAVERS. One of the reasons for that confusion, I believe, comes from the fact that we are considering two sets of facts. In the first place we have the set of facts which are established as the basis for the making of a regulation. Subsequently, after an alleged violation of that regulation, we have another inquiry of facts, whether or not the regulation was actually violated by the defendant.

Senator HEBERT. That has been my contention. I thought I was right in that. I am glad to have you explain that as clearly as you may, in order to make the record complete.

Mr. ČAVERS. I think you are clearly right, and I should consider very doubtful the constitutionality of a provision to the contrary. Certainly, if that were the situation, if an administrative officer were to, by an inspection of fruits we will say which contained lead residues, which contained lead residues in excess of the tolerance established by regulations, and his findings to that effect were con

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clusive on the defendant, I should say clearly the defendant would be denied due process of law. That, of course, is not the situation. The administrative officer, after a tolerance has been established, must inspect the apple. If the apple contains a residue in excess of the limit of tolerance he would then have to go into court and prove beyond reasonable doubt that the apple did actually contain lead in excess of that tolerance. The defendant in that inquiry would be surrounded by all the safeguards which govern a criminal prosecution.

Senator HEBERT. Well, now, there is another element that enters into that. He establishes a tolerance. Whether or not that is conclusive upon the defendant and the defendant may not show that it is not justified by experience, in other words, that that tolerance is not sufficiently broad, and that same latitude should be allowed to the defendant, and yet not be injurious to health in his practices. That is the question I would like to have answered.

Mr. CAVERS. That is the question I was ultimately coming to.
Senator HEBERT. Very well.

Mr. CAVERS. I believe there has been, however, the attitude expressed at various times during either this hearing or the preceding one, that the very grant of power to make rules and regulations casts on the defendant a burden of proof, and it was with that in view that I had addressed this original argument.

The grant of rule-making power, for example, as we find it in the Interstate Commerce Act, where the Commission has the power to make rules and regulations having the force and effect of law, I don't think would normally be regarded as having the application of casting the burden of proof on the defendant.

Furthermore, even though we were to say that the findings of fact of the Secretary should not be conclusive, none the less, in accordance with the general principles of administrative law, it is clear that the regulation would be given prima facie or presumptive value, so that the defendant would have the burden of proof of attacking and setting aside that regulation.

So that whether that sentence remains in the bill or not, the same argument might be raised against the very grant of rule-making power, namely, that it passed the burden of proof upon the defendant. That, it seems to me, neglects the operation of the rulemaking power to define and make explicit a general grant as contained in the bill itself.

I think before one can appraise the full operation of the last sentence in section 22 one would have to consider the process which would be followed in setting up a regulation. The section provides that the Secretary shall call into conference 1 of the 2 committees which are anticipated by the provisions (b) and (c) of section 22. Before, however, he deems any regulation should be established there will have been a long period of investigation by the staff of the Food and Drug Administration. In other words, the Secretary will not, or his administrative official will not certainly think, “ Let us have a regulation on this subject”, and invite the committee. That will be a matter for a consinderable period of study, during which I have no doubt the representatives of the industries concerned will have been consulted at considerable length. After that period of study the facts which have been revealed there - will be submitted to the committee, and on this basis the committee will formulate a proposed regulation. So that at a second point we have experts investigating very carefully the need for and desirability of a given regulation.

The regulation having been proposed, notice of a public hearing is given, and again the opportunity afforded for the industries affected and for consumers to present their views as to the desirability of this given regulation.

Then finally, after the hearing, or probably hearings, the Secretary will make his findings on the basis of them and either accept or modify the regulation. In the event that he modifies the regulation, it will require again the approval of the committee. So that a transcript of the hearing will be sent to all members of the committee together with the findings and regulation as modified.

Senator HEBERT. You do not mind my interrupting you?
Mr. CAVERS. Not at all.

Senator HEBERT. Are you speaking of the requirements of the statute when you detail all these proceedings?

Mr. CAVERS. This is a composite picture, Senator, of the requirements of the statute, plus my

Senator HEBERT. Your construction of what would happen?

Mr. CAVERS. Plus my construction of what would happen. In other words, the statute requirements are set out in paragraph (d) of section 22 as requiring that he advise the committee when he deems there is need for a regulation.

Now my contribution to that is prior to that advice he will have made a study of the problem.

Senator HEBERT. Which, however, need not be done under the law

Mr. CAVERS. Which need not be done under the law. Practically, I should say, it would be impossible to proceed without it. If it were not done, then of course that burden would be cast upon the advisory committee, in order to enable it to formulate a regulation.

Senator HEBERT. And it need not be done by the advisory committee?

Mr. CAVERS. No; that is a possibility. Senator HEBERT. And yet the Secretary could arrive at findings of fact which are conclusive!

Mr. CAVERS. We still have more steps to take, however, Senator.

Senator HEBERT. You mean in your interpretation or in the statute?

Mr. CAVERs. In the statute, fortunately.

The next step is upon the receipt of a proposed regulation by a dilatory or negligent committee the Secretary will give notice of a public hearing, and at that hearing evidence will have to be laid before him with respect to the substance of the regulation, with regard to its desirability and validity.

After that hearing or hearings the Secretary is authorized to formulate and promulgate the regulation, but no such regulation will be promulgated without the approval of a majority of the members of the committee. Incidentally, I should have stated, the regulation proposed must be approved by a majority of the committee.

Now the Secretary will have had to have evidence presented to him at that hearing on behalf of the standard or tolerance, whichever may be involved, because otherwise there would be no basis in fact for his finding, no basis in the evidence in the record of the hearing. We provide that the findings of fact by the Secretary shall be conclusive if in accordance with law. "If in accordance with law” is a phrase common in administrative law statutes and has recently been interpreted in a case before the United States Supreme Court from which Senator Copeland quoted a sentence yesterday. Chief Justice Hughes in that case said:

An award not supported by evidence in the record is not in accordance with law.

That was our understanding in the drafting of this sentence.

Senator HEBERT. Would you go so far as to say, inasmuch as law is based upon reason that if a finding were unreasonable then it would not be in accordance with law, if it looks to you to be unreasonable then it would not be in accordance with law?

Mr. CAVERS. The question of what evidence would sustain a finding would, I suppose, have to be considered by the court. When we

I say, “supported by evidence ", that evidence would have to be relevant, that evidence would have to be substantial. A mere scintilla of evidence certainly would not meet that requirement.

Senator HEBERT. If you don't mind, let us take the concrete illustration here, this package before me on the table. There is a tolerance to be allowed here as to how near the top the contents must go, so that the will not be misleading. Now then, after all this investigation, the Secretary makes an order and says that it must go within a half an inch, the contents must reach within half an inch of the top not to be misleading. Well, it is misleading, nevertheless, in a lesser degree than if it were 1 inch, if the contents reached 1 inch from the top, but there is tolerance and after the Secretary has made his finding, that is conclusive. Well, what remedy is there for the manufacturer of that? That is the point that has been brought up all the way through this discussion.

Mr. CAVERs. The regulation, I should say, is not conclusive. The findings of fact which the Secretary will have made to support that regulation are what we regard as conclusive. Now what those findings would be in the case of a package is something that I suppose Mr. Campbell would be in a better position to answer than I. I should say one of the considerations would have to be the commercial problem of how full packages of this sort could properly be consistent with the requirements of manufacturing and selling, the shaking down process, the expansion and shrinkage of the material. Another consideration would be the expectation of purchasers, also the good trade practice with respect to such packages.

After he had made those findings, supported by evidence in the record, he would then promulgate the regulation which you suggest, namely, that such packages must be filled within one half inch of the top. Let us suppose that a manufacturer feels aggrieved at such a regulation. He then avails himself of the provisions of section 23 and files a bill to enjoin the Secretary from enforcing that regulation. The question is then brought before the court. The court will look to the record, will ascertain whether the evi

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