department to accomplish its purpose; and you might also consider that it might not even be more effective in enabling the department to effect its purposes because it might be more easily enforced.

Mr. WILLCOX. That is a good suggestion, Mr. Reece.

The next part, part F, beginning at the bottom of page 45 and running to the top of page 49, relates to biological products, such as serums and antitoxins. As it appears in the bill it involves only a few verbal changes from existing law (42 U. S. C. 141-148).

This part is taken, in the main, without change from the present law. I say, "in the main." I want to point out two or three changes and to suggest further changes.

The inclusion on page 46, lines 3 to 5, of arsphenamine or its derivatives or other organic compounds analogous thereto is taken from appropriation acts (see p. 16, Public Law 135, 78th Cong., LaborFederal Security Agency Appropriation Act, 1944). This addition never having been written into the basic law.

We wish to recommend some change in this provision, and an insertion elsewhere in the bill, to clarify the line of division in this field between the authority of the Public Health Service and that of the Food and Drug Administration. The change we suggest at this point is to make the paranthetical clause read "(or any other trivalent organic arsenic compound)." This would provide, I am told, a clear boundary of the Public Health Service jurisdiction in this field.

Mr. BULWINKLE. Just one minute. I want a little explanation .there. Mr. WILLCOX. I am afraid I will have to refer that question to the doctors.

Dr. PARRAN. Mr. Chairman, when the arsphenamines were first discovered as remedies for syphilis, the methods of testing them involved the use of animals-rats and other animals. At that time, the Congress did not anticipate that other arsenical compounds would be developed which would be effective. The arsenamines are trivalent. Later a simpler series of compounds within the trivalent series was developed for the treatment of syphilis, and we found ourselves in the position of not being authorized to control the quality of such compounds. Therefore, language was added to the appropriation acts to take care of the newer developments in science. The slight change, or more specifically, division of the other arsenic compounds, as suggested by Mr. Willcox, meets the present state of our scientific knowledge. There are many compound drugs used in the treatment of syphilis-bismuth, mercury, and others—which are subject to control by the Food and Drug Administration along with its other broad authority. However, because of the difference in the method of testing and the historical call upon the National Institute of Health, to deal with this subject, it has been agreed that in this particular field the control shall continue to rest in the Institute of Health.

Mr. WILLCOX. The Federal Food, Drug, and Cosmetic Act of 1938 contains a provision that it should not be considered as repealing or modifying the Biologics Act, but it contains no express exclusion from its terms of products licensed under the Biologics Act. By administrative interpretation such products have been held to be

exempt from the new drug provisions of the Federal Food, Drug, and Cosmetic Act, those provisions establishing a licensing procedure similar to that under the Biologics Act. We recommend the inclusion in this bill of a provision expressly exempting such products from that one provision of the Federal Food, Drug, and Cosmetic Act, but confirming what we believe to be the present legal situation, that such products are subject to all other provisions of that act.

That would leave the products subject to the misbranding and adulteration provisions, and, in particular, to the seizure provision of the Food, Drug, and Cosmetic Act.

Mr. BULWINKLE. That would be in section (b)?

Mr. WILLCOX. It might be inserted in this section somewhere, or it might be placed in the miscellaneous provisions at the end of the bill.

Mr. BULWINKLE. Now, you have got (b) which is apparently a part of the Food, Drug, and Cosmetic Act anyhow, according to my recollection.

Mr. WILLCOX. The main difference, as I understand it, Mr. Chairman, is that the Public Health Service does not have any seizure power under the Biologics Act and if one of these products gets out and is defective, we think it important that the authority of the Food and Drug Administration to pick it up where it finds it should be continued.

Mr. BROWN. That is something like this sulfa drug that they put out some time ago and killed a number of people down in Tennessee. Mr. WILLCOX. That is the sort of situation that might be involved. Mr. BULWINKLE. I want to know what you are talking about in (b). You say:

No person shall falsely label or mark any package or container of any virus— and so forth. That is a violation of the Food, Drug, and Cosmetic Act anyhow, is it not?

Mr. WILLCOX. That is true, sir. The remedy, however, of the Food and Drug Act is not available to the Public Health Service, the effective remedy in such cases to protect the public being the seizure power. It may be there is some duplication in paragraph (b), and it may be that we should consider that.

Mr. BULWINKLE. It would require an amendment, if it is a duplication of the Pure Food, Drug, and Cosmetic Act.

Dr. PARRAN. Except, Mr. Chairman, subsection (b) relates only to "virus, serum, toxin, antitoxin, or other product aforesaid," while the control over such products is excluded by provision in the Pure Food, Drug, and Cosmetic Act.

Mr. BULWINKLE. Is it? I had forgotten about that.

Dr. THOMPSON. There is a special part of the Food and Drug Act which pertains to biologics, which exempts them.

Mr. BULWINKLE. We had passed some amendment to the Pure Food and Drug Act in the last 2 or 3 years in regard to these toxins, or serums. I had forgotten about it.

Mr. WILLCOX. That was with regard to insulin, Mr. Chairman.

At the present time it seems pairly clear that all of these products are subject to the Food and Drug Act, except for the new drug provision of that act.

Mr. BULWINKLE. And it is suggested by Mr. Randolph that a provision of the Federal Trade Act refers to that. Have you looked at the Federal Trade Act as to labeling?

Mr. WILLCOX. That has to do with the advertising, as distinguished from the labeling, Mr. Chairman.

Mr. BULWINKLE. Advertising and broadcasting of the contents of it. Mr. WILLCOX. Yes, sir.

Mr, BULWINKLE. We do not want to run into or have too many agencies of the Government going around and seizing things.

Mr. WILLCOX. That is right. The Food and Drug Administration, of course, is also a part of the Federal Security Agency, and I believe that the enforcement activities can be effectively correlated to avoid any duplication. The only thing that we are particularly concerned with is to make sure that the broader legal remedies of the Food and Drug Act be preserved with respect to these biological products.

Mr. BULWINKLE. Have you gone over this with the Pure Food, Drug, and Cosmetic people?

Mr. WILLCOX. Yes, sir; these suggestions are made as a result of discussions between them and the Public Health Service.

Mr. BULWINKLE. Go ahead, sir.

Mr. WILLCOX. Subsection (d) of section 351 has been reworded to provide guides for the promulgation of administrative regulations governing the issuance of licenses. That is the language in lines 21, 22, and 23 of page 47—

to insure the continued safety, purity, potency, and efficaciousness of such products. Section 352 is new matter, but I understand accords with present practices.

Subsection (a) would authorize the Public Health Service to prepare biological products for its own use, while subsection (b) would authorize it to prepare them for the use of other Government agencies, and for public or private agencies when the products are not available from licensed establishments.

Mr. BULWINKLE. Is that in existing law now?

Mr. WILLCOX. Not in express terms, sir. I think probably the legal authority for that exists in connection with the laboratory functions of the service.

Dr. THOMPSON. That is right.

Mr. BULWINKLE. Well, do you supply much of these products?

Dr. THOMPSON. There are two main ones, Mr. Chairman, yellow fever vaccine which is supplied to the Army, and typhus fever vaccine. Those are not manufactured at the present time by chemical concerns, but they have to be manufactured for use of the Army. There is also Rocky Mountain spotted fever vaccine.

Mr. WILLCOX. The next part, part G, relates to quarantine and inspection. This is a field in which, it seems to me, codification is most urgently called for. The existing statutes are both long and confused, and there is much overlapping of different provisions.

For that reason, it is rather difficult to point specifically to the provisions of existing law which are picked up in each of the various sections and subsections.

The first sentence of section 361 (a) expresses what we think is the gist of a long and complex provision of the act of February 15, 1893 (42 U. S. C. 92). That statute authorizes regulations to prevent the

spread into the country, or between the States, of contagious or infectious diseases. It conditions the issuance of such regulations on the nonexistence or inadequacy of State and local regulations; yet it contains the inconsistent requirement that Federal regulations must be uniform. It provides that Federal regulations, when issued, shall be enforced by the State and local officers if they are willing to do so, but that if they fail or refuse to do so the President shall execute and enforce the regulations.

The States, as I understand it, have wholly withdrawn from the field of foreign quarantine regulation. So far as this part of the authority is concerned, the conditions upon the exercise of Federal authority which may have been appropriate in 1893 seem no longer to have any function. In the field of interstate quarantine I think it is true to say in general that Federal regulation has been confined to matters pertaining to the interstate movement of people or things over which the States have both constitutional and practical difficulties in achieving effective control. In eliminating the conditions upon the exercise of Federal regulatory power, we believe that we have eliminated nothing of substance.

You will recall that in section 311 of the bill is a provision authorizing the Surgeon General to accept from State and local authorities any assistance in the enforcement of quarantine regulations which they may be able and willing to provide.

The same sentence in section 361 (a) would also supersede a specific authority of the Federal Security Administrator to make regulations, when the President determines it to be necessary, to prevent the interstate spread of cholera, yellow fever, smallpox, or plague (42 U. S. C. 95).

I take that today there would be no particular reason for selecting those four diseases for special legislation. Is that true, Dr. Parran? Dr. PARRAN. That is true.

Mr. WILLCOX. The second sentence of subsection (a) would expressly authorize the Public Health Service to make inspections and take other steps necessary in the enforcement of quarantine. This is now done under regulations pursuant to the general authority referred to and similar provisions of law (see, e. g., 42 U. S. C. 93, 94, 105). I believe that this language might be changed so as more clearly to provide for the disposition of animals and articles which are potential sources of infection.

The remaining subsections of section 361 are designed to clarify, and perhaps to enlarge, the authority with respect to the apprehension and detention of individuals.

I might say that the general authority to invoke quarantine seems to have two rather different meanings-one being an authority to stop people at, let us say, the national boundary line or a State boundary line; and the other, which is commonly exercised under State quarantine laws, the authority to isolate individual persons who are considered dangerous to the community.

Under present regulations detention of persons occurs at ports of entry. There is a question, however, whether at present persons who could be detained for quarantine purposes may be released on condition-for instance, on condition that they report from time to time to health authorities in the cities and States where they are going-with

a power to punish those who violate the condition. Authority to use this means of enforcement has become important because of the rapidity of travel by air, and the possibility that persons who have been exposed to disease may enter the country and show no sign of disease at the time when they actually enter.

Subsection (b) is expressed as a limitation upon apprehension, detention, or conditional release of individuals, permitting such action only for diseases specified in Executive orders of the President upon recommendation of the National Advisory Health Council and the Surgeon General. At present the so-called quarantinable diseases are in a few cases listed in the statutes (see 42 U. S. C. 95, 105), but for the most part are set forth in regulations. In addition to lodging the power to specify diseases in the President, the principal effect of the subsection is to make clear that conditional release is permissible.

Subsection (c) would continue the authority, exercised under present law, to apprehend, detain, and examine individuals entering a State or possession from a foreign country or from Hawaii or a possession. For the reasons stated above, it also authorizes conditional release in such cases.

I may remark at this point that, by reason of the inclusion of Puerto Rico and the Virgin Islands in the definition of "possession" in section 2, this subsection would apply to persons coming into the continental United States from these islands.

Subsection (d) would write into law an authority which we believe probably exists under the present statutes (42 U. S. C. 92, and, as to the venereal diseases, 42 U. S. C. 25), but which is seriously doubtful and which has not been exercised. It would authorize the apprehension and examination of individuals reasonably believed to be infected with a communicable disease and to be moving or about to move from one State to another, or to be probable sources of infection to persons who will be moving from one State to another. If such persons are found to be infected, their detention would be authorized. This subsection would apply only to diseases specified in an executive order under subsection (b).

Dr. Parran mentioned the other day the similar provision of section 363, which would confer like authority in time of war, but would be predicated upon the protection, not of interstate commerce, but of members of the armed forces and war workers.

While we believe that this authority exists under present law, we were advised by the Attorney General against attempting to assert it without a clearer legislative basis than now exists. As I believe Dr. Parran stated, the only diseases with respect to which there has been any thought of using such an authority at present have been the venereal diseases, but these provisions are written in broader terms in order to make it possible to cope with emergency situations which we cannot now foresee.

Mr. BULWINKLE. Let me go over that. That was in (2) of (d)— to be a probable source of infection to individuals who, while infected with such disease in a communicable stage, will be moving from a State to another State. Do you think that covers someone at one of these war plants, who has an infectious disease?

Dr. PARRAN. You are referring to page 50, Mr. Chairman.
Mr. BULWINKLE. Yes, sir.