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Mr. O'ILARA. I got that philosophy from working for a number of years with the food industry organizations which I think are quite largely responsible, namely, the Imerican Bakers Association, the American Institute of Baking, the American Meat Institute, the Dairy Industry Committee, and the Millers National Federation, who are all quite responsible dealers in foods in this country; are they not, Jr. Dunn!

Mr. Dunn. Very much so. They are fine organizations.

Mr. O'Hara. And I think you will find my bill, H. R. 366, which I introduced at the start of this session of Congress, with one amendment, is similar to the bill that you strongly supported in testimorry in 1956 before this committee.

Mr. Doxx. Not only that; I had a very large part in drafting it originally.

Nr. O'Hara. I didn't remember that, but I am happy to have you tell me that. [Laughter.)

Anyway, it does indicate the desire of the food industry for safe. sound, sensible legislation; does it not !

Mr. Dunx. Exactly.

Jr. ()'Hara. And would you say that H. R. 366, before the conmittce, is pretty good legislation still, Mr. Dunn?

Mr. Duxx. It is a good bill, except that it raises the controrersial issue which is the heart of this whole legislative problem: Whether an adverse administrative opinion against the safety of a food additive should be reviewed, in effect, by a de novo trial through the district court, which is the heart of your bill, or

Mr. O'HARA. But you rather substantially support that in your var: ious statements of objections to the Administration bill; do you not?

Mr. DUNN. Well

Mr. O'HARA. I mean, you go in by injunctive relief, but there woulit be a trial; would there not?

Mr. Dunx. What I say is this: Your bill makes it mandatory for the district court to determine, by a declaratory judgment proceeding, whether an additive is safe or not, before the Administration has condemned it.

Now, my position is quite different at this time. I am trying to say that, first, the Administration bill should be revised to reduce it to the right legislative form, and it needs a very thorough revision in that respect.

And that, secondly, to meet the objection of the legitimate foodmanufacturing industry, which is so widespread, there ought to bi some way in this bill to provide for a de novo court reriew of the issue where the Administration has adversely condemned a food additive: that a compromise provision might well be to vest a discretionary power, not a mandatory power, in the United States district court to undertake that de novo rule for cause shown, so that when the petition for review is presented to the district court, the Government would state any reasons why that procedure is not a good one.

For example, it may state, as Commissoner Larrick has often said. that the scientific determination of the safety of the additive in ques. tion may take at least 2 years, which is the normal period for deter. mining the safety of an additive by a scientific process; and that, therefore, it would not be feasible, the Government would not be in posi

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tion at the time of the proposed court proceeding to present its testimony.

Now, if the court was persuaded that it would be against the public interest for that or any other reason, then the petition for an injunction proceeding would be denied.

But if, on the other hand, the court was persuaded by the argument of the manufacturer, a legitimate manufacturer, that there should be this de novo inspection trial instead of the appeal procedures as provided by this act, then there would be an opportunity to have it.

Mr. O'HARA. My position is always it should be a matter of right, 210t whether the judge wanted to work on the case, and I still think that is a sound approach to as important a problem as this might be, Mr. Dunn, and I hope after you visit the dedication of the Magna Carta that you will agree with me.

Mr. Dcxx. I respect that position, Mr. O'Hara, and I expect to attend that dedication ceremony, and I knoir I will be very much inspired by it.

But we still feel the United States district court ought to be given the cliscretion, representing the people of this country, in balancing the public interest, to reach the decision whether that review ought to be made, or whether the Administration review procedures should be followed

Jr. O'HARA. Mr. Chairman, I thank you very much.

Mr. WILLIAMS. Mr. Dunn, along those lines, in writing any legislation that comes from this subcommittee, I want to be perfectly sure and satisfied that we do not deny any existing civil rights of any of our people. I want to be sure that you have the same thing in mind.

Do you have any question in mind, Mr. Heselton ?
Mr. HESELTOX. No.

Mr. Dcxx. Vr. Chainnan, may I ask a final question of you !
Do

you want us to submit a rerision of this bill in September, or do you not want us to ?

Mr. WILLLAJS. Mr. Dunn, that is a question I do not think anyone can answer at the moment. If we have not completed work, I am quite sure we would welcome any suggestions which you or any other interested parties might have with respect to revision.

As the chairman of the full committee stated a moment ago, it is highly doubtful whether we will be able to finish consideration of this bill by September.

I do have 1 or 2 questions with regard to your testimony and along the lines you has just mentioned

I note that you made numerous suggestions for modifying and revising this legislation, one in particular with respect to the definition of the term "food additive" or "chemical additive."

Howerer, and I believe you refer to it in the annex of your statement, you submitted suggested language for only one of these amendments, and that is with respect to the definition of the term.

I am wondering if you plan to submit suggested amendments along the lines of the other amendments or modifications suggested in your testimony?

Mr. Dúxx. Well, the amendment in the annex to my statement, Mr. Chairman, contains one rerision we suggest, subject only to the question whether the "generally recognized" clause should be modified.

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Mr. O'HARA. I got that philosophy from working for a number of years with the food-industry organizations which 1 think are quite largely responsible, namely, the Imerican Bakers Association, the American Institute of Baking, the American Meat Institute, the Dairy Industry Committee, and the Millers National Federation, who are all quite responsible dealers in foods in this country; are they not, Mr. Dunn

Mr. Dunn. Very much so. They are fine organizations.

Mr. O'Hara. And I think you will find my bill, H. R. 366, which I introduced at the start of this session of Congress, with one amendinent, is similar to the bill that you strongly supported in testimorry in 1956 before this committee.

Mr. Dunx. Not only that; I had a very large part in drafting it originally.

Mr. O'Hara. I didn't remember that, but I am happy to have you tell me that. (Laughter.]

Anyway, it docs indicate the desire of the food industry for safe. sound, sensible

legislation; does it not! Mr. Dunn. Exactly.

Jr. ()'Hara. And would you say that H. R. 366, before the conmittee, is pretty good legislation still, Mr. Dunn?

Mr. Duxx. It is a good bill, except that it raises the controversial issue which is the heart of this whole legislative problem: Whether an adverse administrative opinion against the safety of a food additire should be reviewed, in effect, by a de novo trial through the district court,

which is the heart of your bill, or Mr. O'HARA. But you rather substantially support that in your various statements of objections to the Administration bill; do you not?

Mr. Dunn. Well

Mr. O'Hara. I mean, you go in by injunctive relief, but there woul. be a trial; would there not?

Mr. Dunx. What I say is this: Your bill makes it mandatory for the district court to determine, by a declaratory judgment proceeding, whether an additive is safe or not, before the Administration has condemned it.

Now, my position is quite different at this time. I am trying to say that, first, the Administration bill should be revised to reduce it to the right legislative form, and it needs a very thorough revision in that respect.

Ånd that, secondly, to meet the objection of the legitimate foodmanufacturing industry, which is so widespread, there ought to be some way in this bill to provide for a de novo court reriew of the issue where the Administration has adversely condemned a food additive: that a compromise provision might well be to rest a discretionary power, not a mandatory potrer, in the United States district court in undertake that de novo rule for cause shown, so that when the petition for review is presented to the district court, the Government would state any reasons why that procedure is not a good one.

For example, it may state, as Commissoner Larrick has often said. that the scientific determination of the safety of the additive in ques. tion may take at least 2 years, which is the normal period for determining the safety of an additive by a scientific process; and that, therefore, it would not be feasible, the Government would not be in posi

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tion at the time of the proposed court proceeding to present its testimony

Now, if the court was persuaded that it would be against the public interest for that or any other reason, then the petition for an injunction proceeding would be denied.

But if, on the other hand, the court was persuaded by the argument of the manufacturer, a legitimate manufacturer, that there should be this de novo inspection trial instead of the appeal procedures as provided by this act, then there would be an opportunity to have it.

Mr. O'HARA. My position is always it should be a matter of right, not whether the judge wanted to work on the case, and I still think that is a sound approach to as important a problem as this might be, Ur. Dunn, and I hope after you visit the dedication of the Magna Carta that you will agree with me.

Mr. Drxx. I respect that position, Mr. O'Hara, and I expect to attend that dedication ceremony, and I know I will be very much inspired by it.

But we still feel the United States district court ought to be given the discretion, representing the people of this country, in balancing the public interest, to reach the decision whether that review ought to be made, or whether the Administration review procedures should be followed.

J1r. O'HARA. Mr. Chairman, I thank you very much.

Mr. WILLIAMS. Mr. Dunn, along those lines, in writing any legislation that comes from this subcommittee, I want to be perfectly sure and satisfied that we do not deny any existing civil rights of any of our people. I want to be sure that you have the same thing in mind.

Do you have any question in mind, Mr. Heselton!
Jr. HESELTOX. No.

Mr. Dcxx. Mr. Chainnan, may I ask a final question of you! Do you want us to submit a rerision of this bill in September, or do you not want us to ?

Mr. WILLIAMS. Mr. Dunn, that is a question I do not think anyone can answer at the moment. If we have not completed work, I am quite sure we would welcome any suggestions which you or any other interested parties might have with respect to revision.

As the chairman of the full committee stated a moment ago, it is highly doubtful whether we will be able to finish consideration of this bill by September.

I do hare 1 or 2 questions with regard to your testimony and along the lines you has just mentioned.

I note that you made numerous suggestions for modifying and rerising this legislation, one in particular with respect to the definition of the term “food additive" or "chemical ad tive."

Howerer, and I believe you refer to it in the annex of your statement, you submitted suggested language for only one of these amendments, and that is with respect to the definition of the term.

I am wondering if you plan to submit suggested amendments along the lines of the other amendments or modifications suggested in your testimony !

Mr. Duxx. Well, the amendment in the annex to my statement, Mr. Chairman, contains one revision we suggest, subject only to the question whether the "generally recognized" clause should be modified.

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for use.

And on that point I am quite firm in my own belief that it should be reasonably modified; and other revisions will be submitted.

You can see, as a layman, I think we can all see, that you should not practically require a manufacturer to do any more than this, from the standpoint of an appropriate scientific investigation by experts: First, to consult the available scientific literature on the point. This is what they do, anyhow.

Secondly, to consult arailable scientific experts who are competent to advise on the question.

Now, if you have a clearance from both of these sources, you should be in a position to go ahead, whereas the amendment as it is now drawn says, in effect, that you cannot use an additive unless it is generally recognized by all scientific experts, who are qualified on this subject, as safe for use under the conditions of its intended use. Does it mean scientists in Europe, for example ?

I am counsel indiridually for many food manufacturers. We cannot go all over the United States picking out every single scientist that there is who might have some knowledge of this subject, and then reach a conclusion that, on the basis of their advice, it is safe

And we certainly cannot consult the scientists in Europe who are qualified, equally qualified.

It is just commonsense that this formula in the definition of "food additives” should be limited to the point that the manufacturer should only be required, first, to consult the available scientific literature in point, which is in erery good scientific library; and, secondly, that he should consult competent scientific experts on this question.

But when you tell him he must consult everybody, why, it is impossible. And that is literally what this definition says. It has been in the law all these years, I realize that.

I am counsel for the pharmaceutical industry as well, and when it was added to the neir drug law in 1938 we did not object to it because that new drug lat went through so fast, because of the tragic accidents with some elixir out in Tennessee was pressing Congress to enact a new drug law at once, and there was practically no consideration by the Congress.

Mr. HESELTON. Mr. Chairman, one question.

I notice on page 17 the word "prolonged" in parentheses as a suggested amendment. Do you intend to include that in the suggested amendment ? Mr. Dunx. No, sir. I suggest that it be excluded, simply because the generic question here, the basic question, is whether any use has

Mr. HESELTOX. You would leare it “through use in or on food” ?
Mr. Dunn. That is right.
Mr. HESELTON. Yes.

Mr. Donn. That is enough, because there are considerations other than time which enter into this question.

Mr. WILLIAMS. Are there any further questions of Mr. Dunn!

Mr. Dunn, the House is in session, and it is going to be necessary for the committee to adjourn.

We would like to thank you very much for your comprehensive and clear testimony which was given to us this morning. I think a lot of us, myself included, have a new appreciation of the problem we are confronted with in this additive field.

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