Mr. DINGELL. Aromatic hydrocarbons are benzine derivatives. You know what I mean?

Mr. HORSEY. I know what you mean.

Mr. DINGELL. You use these?

Mr. HORSEY. No; we do not.

Mr. DINGELL. Do you mean to say that your industry has never used benzine of benzine derivatives?

You said you used benzine derivatives.

Mr. DITTRICH. Coal tar products, we said.

There might be a different definition, in our opinion.

Mr. DINGELL. Essentially it is the same thing.

Benzine and benzine derivatives are essentially coal tar products, are they not?

Mr. DITTRICH. Mr. Horsey's concern makes aromatic chemicals. My company does not.

Mr. DINGELL. But aromatic chemicals you have used, have you not? Mr. HORSEY. I did not follow your question.

Mr. DINGELL. Your industry has used aromatic chemicals?

Mr. DITTRICH. We use aromatic chemicals.

Mr. HORSEY. This is not the strict chemistry definition. When we speak of aromatic chemicals, we speak of chemicals that have an odor,

an aroma.

Mr. DINGELL. I do not mean that definition of "aromatic." I mean derivatives of benzine, of coal tar.

Mr. HORSEY. There are benzine-derivative chemicals made.

Mr. DINGELL. Which are not found, let us say, in nature, but which are generally produced from coal tar distillates?

Mr. HORSEY. They may not have been found in nature, but whether they are present in nature may not have been ascertained.

Mr. DINGELL. How is Food and Drug going to discern the full safety of the substances used by your industry if they do not have authorization to look at books and records?

Mr. DITTRICH. First of all, you were talking before about some of these things, and I believe you think we are talking about internal or ingestion.

Mr. DINGELL. You are using them on the skin?

Mr. DITTRICH. On the skin, and the percentage, as I pointed out here is a larger percentage than normal usage.

For example, the example I gave on cold cream-a half of 1 percent is much larger than the average usage. Only one-tenth of 1 percent is used in an aerosol shave. It is a minute and miniscule portion.

Mr. DINGELL. But it is found from time to time that in foods and in drugs parts on the order of parts per million are harmful, is this not a fact?

Mr. DITTRICH. That is true.

Mr. DINGELL. So 1 percent is on the order of several thousand or perhaps 10,000 times larger than the level that is sometimes found to be harmful, is this not a fact?

Mr. DITTRICH. That is a fact.

As far as our information is concerned from polling our members, though, we have had no complaints.

In other words, when our finished-goods manufacturers-in other words, the witness before represented our customers, so to speak

when they get a complaint, we would hear about it, if it came from our product.

We have never, to any great degree, I know of none in my own company, and in checking the industry we have heard of very few complaints that came from the items that we manufacture, that we sell to, say, the toilet goods manufacturers.

Mr. DINGELL. Thank you very much, Mr. Chairman.
Thank you, Mr. Dittrich.

Mr. ROBERTS. Anything further, gentlemen?

Thank you very much, Mr. Dittrich.

Our next witness is Dr. J. A. McCallam, American Veterinary Medical Association, 1507 M Street NW., Washington, D.C.

STATEMENT OF J. A. McCALLAM, V.M.D., WASHINGTON REPRESENTATIVE, AMERICAN VETERINARY MEDICAL ASSOCIATION

Dr. MCCALLAM. I am J. A. McCallam, local representative. Unfortunately, due to a chain of circumstances, our witness is not present this morning to testify, Dr. Jones from Chicago, nor did the statement arrive in time.

I talked with him this morning on the telephone. It is on the way, and at this time I request permission that it be included in the record of the hearings.

Mr. ROBERTS. Permission granted.

Dr. MCCALLAM. Thank you.

(The statement referred to is as follows:)

Hon. OREN C. HARRIS,

AMERICAN VETERINARY MEDICAL ASSOCIATION,

Chicago, Ill., August 24, 1962.

Chairman, Committee on Interstate and Foreign Commerce,

House of Representatives,
Washington, D.C.

DEAR SIR: The following statement of the American Veterinary Medical Association regarding H.R. 11581, 87th Congress, 2d session, is submitted for the consideration of the Committee on Interstate and Foreign Commerce.

The attention of the American Veterinary Medical Association (AVMA) has been called to the statement of D. L. Bruner, executive secretary, Animal Health Institute, given to your committee on August 21, 1962, concerning H.R. 11581. The AVMA is unalterably opposed to the writing of a separate statute, or category, in the food, drug, and cosmetic (FDC) legislation for animal drug and feed products. Historically, animal drugs and feed additives did not meet their present high standard until controls for these products were included with the present FDC regulations for drugs used on man. Prior to this time the animal health field was commonly an outlet for drugs that were outdated, impure, not entirely safe, and otherwise undesirable. Recent FDA activities, authorized by a single statute applying to both man and animals, have provided the animal health field with effective, safe drugs. The veterinary profession strongly supports this situation.

It is altogether logical that the FDA statute for regulation of human and animal products remain as one, because:

1. Most of the drugs employed in man are in use to a greater or lesser degree in animals. These drugs come off the same production lines and differ only in respect to packaging. Thus, the problems of production, inspection, distribution, and even use are similar, if not the same, in many instances.

2. Many new drugs are now available for injection into, spraying on, or feeding to animals producing food for man. Many of these drugs will leave, for varying lengths of time, tissue residues in animal foods eaten by man.

3. As an agency with consumer protection responsibilities, we are frankly fearful of a backsliding of control over the products going into the animal health field if separate statutes are introduced for human- and animal-line products.

The animal outlet constitutes a massive market for a needed and effective drug; and this need should neither be hindered by excessive regulation, nor so loosely controlled as to constitute a hazard to the livestock industry and the public. We do sympathize, however, with the current problem of drug manufacturers in getting new drugs approved under the "triplicate" control arrangement existing in the FDA. The necessity for many new drugs having to be cleared by three different sections of FDA (veterinary medicine, antibiotics, and food additives) with three different sets of requirements is unrealistic. Previously, all animal products were cleared by the Division of Veterinary Medicine to the reasonable satisfaction of parties concerned.

When the food additives amendment was passed in 1958, the legalistic interpretations were allowed to prevail over the knowledge and judgment of scientists within the FDA-resulting in the current state of confusion and delay in making desirable products available for use in the animal health field. The AVMA believes that the difficulties responsible for the current problems of manufacturers of animal health products and feed additives-and attributed by them to faulty legislation can be corrected by returning all responsibility over animal health products to the Division of Veterinary Medicine to operate under current regulations. In this section there are veterinary scientists with knowledge and judgment to advise the Commissioner of the Food and Drug Administration for concise, prompt decisions.

The AVMA opposes any proposals to decrease the supervisory power of the Food and Drug Administration over the manufacture and use of nonprescription drugs and food additives. In fact, we feel that FDA supervision should be greater over food additives and nonprescription drugs than over prescription drugs, because with the latter there are professional practitioners controlling the dispensing and use of prescription products. Although the FDA cannot be expected to duplicate the supervision of prescription drugs provided by the professional man, we believe that increased control of nonprescription drugs and food additives for man and animals is necessary in the interest of greater consumer protection.

The AVMA firmly supports the general goal of consumer protection espoused by H.R. 11581, specifically, the efforts to "assure the safety, efficacy, and reliability of drugs," and to "authorize standardization of drug names." With respect to other items mentioned in H.R. 11581, the AVMA is willing to accept judgment of the Department of Health, Education, and Welfare in requesting the authorities contained in the bill and to support the provisions of H.R. 11581 not discussed above.

The AVMA presumes that it is not the intent of H.R. 11581 in title II, section 704, to regulate and limit the professional freedom of the practitioner to serve his patient. However, the wording of the above section is such as to cause the AVMA to urge that the following paragraph be included in the revised bill. "The provisions of section 201 and 704 shall not apply to practitioners of any profession who are lawfully entitled under a State or territory law to either prescribe, compound, or dispense any food, drug, device or cosmetic for patients within such State or territory, nor shall anything in this Act be construed as enlarging, reducing, or otherwise altering professional rights and privileges conferred by a State or territory law."

The AVMA, in behalf of the members of the veterinary profession in the United States, respectfully requests the committee's consideration of the views expressed herein and would request that this statement be also made a part of the record of the hearings conducted on H.R. 11581.

Respectfully,

L. MEYER JONES, D.V.M., Ph. D.,
Director of Scientific Activities,
American Veterinary Medical Association.

Dr. MCCALLAM. I should also like to request, Mr. Roberts, that the statement presented to your subcommittee, I believe on August 7, be included as part of the record of this hearing, if appropriate. Mr. ROBERTS. Without objection, it will be so ordered.

88589-62- -36

(The statement referred to is as follows:)

STATEMENT OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION RE H.R. 12420, H.R. 12437 AND H.R. 12715

Mr. Chairman and members of the committee, the veterinary profession, as represented by the American Veterinary Medical Association (AVMA), has a keen interest in all proposed legislation involving the Food, Drug and Cosmetic Act. We are vitally interested in having a constant supply of safe, efficacious and reliable drugs for treating and preventing animal ailments. We are also concerned that the drugs used in food-producing animals not affect the animal product in any way deleterious to man.

Most of the drugs employed in man are in use to a greater or lesser degree in animals. Some of the drugs used in animal feeds for growth stimulatory purposes and for mass medication are the same drugs used in human medicine, veterinary medicine, and as feed additives. Therefore, the American Veterinary Medical Association feels it should comment on these matters, since they do concern the practice of veterinary medicine.

The AVMA strongly supports the activities of the Food and Drug Administration, Department of HEW, its supervision of consumer foods, drugs and devices for man and animals. In the past, the FDA has extended its jurisdiction for protecting consumer interests over both man and animals. The AVMA will object strongly to any thinking and any effort to dissociate the supervision of foods, drugs and devices for animals from that of man. Newer knowledge about drug residues harmful to man in tissues of food-producing animals makes entirely clear the necessity for consumer protection through FDA supervision of drug usage in animal medicine. In particular, the AVMA commends the Division of Veterinary Medicine within the Bureau of Medicine, FDA, for many improvements in the area of animal drugs and feed additives within recent years. Furthermore, the AVMA urges that the scientists within the Food and Drug Administration be given full opportunity to use their scientific knowledge and judgment in determining a Government decision on problems arising under the Food, Drug and Cosmetic Act. This position is consistent with the White House Report of May 14, 1960, prepared under the chairmanship of Dr. Kistiakowsky, which stated that the supervision of drugs and feed additives for man and animals would not be improved until the scientists in the Food and Drug Administration were given the opportunity of making the decisions on the basis of their scientific knowledge and judgment.

The provisions of H.R. 12420 and 12715, as we interpret the language, provides the Secretary of HEW with authority to restrict a product if there is "substantial doubt as to its safety." We believe this feature is important and should be incorporated into the legislation as approved by this committee.

All three bills (H.R. 12420, H.R. 12437 and H.R. 12715) approach the problem of "prior sanction" as it affects the animal feed industry from an economic standpoint. The AVMA supports early correction and redress of this unfair and discriminatory situation among manufacturers of animal feeds and feed additives. The AVMA prefers the features of H.R. 12420 (Nelsen bill) and H.R. 12715 (Dominick bill) because of the previously mentioned safety clause. The AVMA opposes any proposals to decrease the supervisory power of the Food and Drug Administration over the manufacture and use of nonprescription drugs and food additives. In fact, the AVMA feels that FDA supervision should be greater over food additives and nonprescription drugs than over prescription drugs, because with the latter there are professional practitioners controlling the dispensing and use of prescription products. Although the FDA cannot be expected to duplicate the supervision of prescription drugs provided by the professional man, we believe that increased control of nonprescription drugs and food additives for man and animals is necessary in the interest of greater consumer protection.

We view the proposed legislation outlined in H.R. 12420 and H.R. 12715 as support for the Food and Drug Administration. We would be opposed to any efforts to decrease FDA supervisory powers over drugs administered to animals, or added to their feed. If any changes are made, these should consist in more careful and extensive scrutiny of the safety, efficacy and reliability of chemicals and drugs distributed by nonscientific, nonprofessional persons for administering or feeding to animals producing food for man. The possibility of tissue residues harmful to man in food products from animals receiving drugs or chemicals is

not to be ignored. The only way such a circumstance can be prevented is to provide the FDA with the authority needed to insure the consumer public and the livestock feeders that drugs for animals are safe, efficacious and reliable.

In behalf of the practitioners of veterinary medicine, we wish to thank the committee for its courtesy and time in hearing this testimony.

Mr. ROBERTS. Mr. Ernest Giddings, National Retired Teachers Association and American Association of Retired Persons, 1346 Connecticut Avenue, Washington, D.C.

STATEMENT OF ERNEST GIDDINGS, DIRECTOR OF LEGISLATION, NATIONAL RETIRED TEACHERS ASSOCIATION AND AMERICAN ASSOCIATION OF RETIRED PERSONS

Mr. GIDDINGS. Mr. Chairman and members of the committee, my name is Ernest Giddings. I am director of legislation for two nonprofit organizations of older persons, the National Retired Teachers Association and the American Association of Retired Persons. I am appearing today on behalf of the 500,000 members of our associations to urge an early favorable report by your committee on H.R. 11581 in order that the bill may be taken to the floor of the House of Representatives for debate and action during the next few weeks before adjournment.

The associations I represent were organized to help older persons help themselves and to encourage them to accept a major share of the responsibility for making their later years meaningful and independent. Membership in the National Retired Teachers Association is open to any retired teacher. Membership dues are $2 a year. Membership in the American Association of Retired Persons is open to any person 55 years of age or over upon payment of the annual membership fee which is also $2. Both organizations are nonprofit and nonpartisan. The combined membership of the two organizations is approximately 500,000.

NRTA and AARP are dedicated to the purpose of serving the needs of their elderly membership. When our campaign for insurance protection was initiated there was no hospitalization or medical program exclusively for retired persons, and most programs designed to serve employed men and women arbitrarily excluded them from participation in the plan the day they reached the age of 65, or the company advanced the premiums with lowered benefits. To break this age barrier the officers of the two organizations worked for 7 years before convincing an insurance company to be daring enough to pioneer with us. The success of this breakthrough is attested by the fact that today more than 350,000 retired men and women are covered by a hospitalization program which was denied them until a few years ago, on no more valid grounds than that of age.

pro

During the years 1958 and 1959 our members by the thousands tested the cost of the drugs. As a final result we established and have conducted for several years a nonprofit drug service for our membership. The major function of our drug service is to fill prescriptions and provide the vitamins ordered by our members. Several registered pharmacists are employed as well as total facilities to meet the regular standards of safety and sanitation.