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Senator COPELAND. You have another day before you. Do you want to go on tomorrow?
The CHAIRMAN. I would really like to continue the hearing, because I have some other things on hand myself.
Dr. HARRISSON. Mr. Chairman, may I interrupt a moment to say that Senator Copeland will be particularly interested in one phase of one section I have in mind, because he will appreciate the fact as much if not more than any other member of the committee.
The CHAIRMAN. Are you Dr. Harrisson?
The CHAIRMAN. You want to speak on crude drugs, as I understand it?
Dr. HARRISSON. Yes.
STATEMENT OF DR. JOS. W. E. HARRISSON, LA WALL & HARRISSON,
CONSULTING CHEMISTS, PHILADELPHIA, PA.
Dr. HARRISSON. Mr. Chairman and Senators, I primarily came down in regard to one section of the bill but, since being here, I am interested in another section which has come to light within the past few moments, and that is section 12, under the permit factories in which inspection is provided for.
I call your attention to the fact that if this section is carried through and permit factories are established covering such substances as crab meat, lobster, and so forth, which is canned and sold in a fresh, refrigerated state, the Government, if it allows the printing on the label of those products such a statement as that they are produced in permit factories is going to work upon the purchaser an irreparable harm. They are going to remove caution from the purchaser in purchasing such products which they know now to be liable to deterioration.
Senator COPELAND. Does it say that they shall put it on?
Senator COPELAND. There is another reason which you have not mentioned, and that is that it places a responsibility upon the Department which it is not quite fair to impose upon it.
Dr. HARRISSON. It puts the Department in the place of the person that produces that particular product.
I appear particularly in regard to section 8, subdivision (c), parts 3 and 4, as related to drugs. If you will turn to section 8, subdivision (c), parts 3 and 4, you find certain cumulative substances mentioned there, among which is arsenic. You find particularly in part 4 any crude plant material or preparation thereof in which any substance named in subdivision (2) or (3) above is present.
That substance must be named upon the label and its presence and amount declared. The committee has in some way entirely over
looked the fact that arsenic is a natural constituent of root drugs, and particularly those of root origin, to some extent. Arsenic is a natural constituent of many other products, such as food products.
I am going to read to you—
Senator COPELAND. Just a moment. Dr. Beal made a strong argument in favor of omitting from the bill, beginning at line 16, after the semicolon, the language from there to the semicolon on line 21. If we were to do that, you would be satisfied then, wouldn't you?
Dr. HARRISSON. I would not, for this reason: It states that any of the cumulative substances, arsenic and so forth—and I particularly have in mind arsenic, for it provides under the drug section no tolerance for the presence of arsenic. It might be there in infinitesimal quantities, and is usually present in infinitesimal quantities in such products produced from crude natural products or the preparation thereof.
Senator COPELAND. Of course, you know you are speaking about a drug that contains this. You are not talking about some natural product. This has to do with misbranded drugs.
Dr. HARRISSON. That is true. We will take, for instance, as an illustration, the extract of dandelion root, which will contain traces of arsenic. There is no tolerance provided for under the drug section, whereas you provide tolerance under both the food and cosmetic sections, or divisions of this section.
Senator COPELAND. Is it natural to the drug?
Dr. HARRISSON. Not particularly to the dandelion alone. In practically any root drug it is taken up during the time of growth, and is present there only in small amounts.
Senator COPELAND. How would you change it, then?
Dr. HARRISSON. It is rather difficult to word. If Dr. Beal removes the other section, that is; but I can word it if those sections remain, very simply; or it might be worded to the effect that arsenic, unless naturally occurring in a crude drug or preparation thereof-or it might be worded by the adoption of a tolerance such as the toleration allowed under section 22.
Senator COPELAND. What do the rest of you drug people say about that? What would you want to say—is there something else beside arsenic?
Dr. HARRISSON. Arsenic is the only substance in which the exception, so far as I know, applies. Senator COPELAND. Would you want to say after “arsenic”,
"on line 16, “except when traces of it appear from the use of a natural substance ", or something like that?
Dr. HARRISSON. I can reword that in just a second :
Any other cumulative substances--arsenic-except when derived from naturally occurring arsenic in crude drugs.
It will have to be reworded to make it a little bit smoother than that, probably. That is, of course, taking into consideration that section 4 will be dropped.
Senator COPELAND. Except naturally when traces of it appear from the use of what?
Dr. HARRISSON. Natural crude drugs.
Senator COPELAND. You mean natural crude products?
Dr. HARRISSON. No; I would not except it to products unless the other members of the groups which might be here
Senator COPELAND. Crude plant materials; is that what you mean? That is, you would like to have it read something like this: “Any of the cumulative substances, arsenic", and then, in parentheses, cept when traces of it appear from the use of natural food plant material "?
Dr. HARRISSON. That would be perfectly satisfactory, or some similar wording. The committee has gone on record as recognizing tolerances
Senator COPELAND. Dr. Crawford, is the pharmacologist expert here?
Dr. CRAWFORD. No; he is not here, Senator.
Senator COPELAND. What do you say about this suggestion? What would be the objection to it?
Dr. CRAWFORD. Of course, this was intended primarily to apply to drugs which contain arsenic as an ingredient.
Senator COPELAND. Yes; that is what I understood.
Dr. CRAWFORD. I think it could be provided at the end of the paragraph, exempting those drugs containing arsenic as the result of plant drugs not containing arsenic.
Senator COPELAND. The natural elements of the plant substance, or something like that? That is not an unreasonable request. Is that all you had to say?
Dr. HARRISSON. I will conclude my remarks with the following statement: I
appear in opposition to the present wording of parts 3 and 4, subdivision (c), section 8, which refers to the required declaration of certain substances described as cumulative, to wit: arsenic, digitalis, głucosides, mercury, ouabain, and so forth.
Under the present wording of the proposed act, if any arsenic is present in any medicinal product, crude drug, or preparation thereof, its presence, and amount must be declared upon the label.
It is a well-recognized fact that arsenic in minute quantity occurs incidentally in practically all root drugs. This amount is so small that we cannot believe that it is the legislative intent to require the declaration of it. Rather we feel that the particular phrase has reference to the presence of appreciable amounts of arsenic, which can only occur through its addition. That this is true is borne out by the wording of that section covering foods and also cosmetics, which provides for the establishment of tolerances governing added arsenic. Apparently the framers of this measure appreciated the fact that many foods naturally contained appreciable quantities of arsenic, and justly provided that the regulations to be issued governing added arsenic provided that the regulations to be issued governed added arsenic only. That much must have been the intent is borne out by the fact that many sea foods contain 10, 20, or 40 times the amount of arsenic now recognized as the safe arsenic tolerance.
Such foods or any food approaching the present maximum arsenic tolerance would contribute a far larger quantity of arsenic even when consumed in moderate quantity than any medicinal product
prepared from crude drugs and without any requirement of warning to the consumer.
The Department of Agriculture will, under the present wording of the proposed act, have no alternative but to require the labeling of such minute quantities of arsenic.
We therefore respectfully submit that in fairness to those who deal in such medicinal products, that the particular section be reworded so as to cover the actual legislative intent and protect against a manifest injustice.
We submit the following proposed redraft of that section:
or (3) any of the cumulative substances arsenic when present in excess of the arsenic tolerance as promulgated for food products under section 10, digitalis glucosides, mercury, ouabain, strophanthin, or strychnine; or (4) any crude plant material or preparation thereof in which any substance named in and as provided for in subdivision (2) or (3) above is present;
This will correct the unintentional inclusion of incidentally present arsenic which is natural to most root drugs. The words added are italicized. No other change is made.
May we urgently request your careful consideration of our suggestion, in view of the clear wording in the suggested bill which would manifestly work a possible injustice if and when it becomes law.
The CHAIRMAN. We will now adjourn to meet in the caucus room tomorrow morning at 10 o'clock.
(Thereupon an adjournment was taken until tomorrow, Wednesday, Feb. 28, 1934, at 10 a.m.)