"(B) A color additive (i) shall be deemed unsafe, and shall not listed for any use which will or may result in ingestion of all or part of such additive, if the additive is found to induce cancer when ingested by man or animal in an amount and under conditions reasonably related to the intended use, or if it is found, after tests which are appropriate for the evaluation of the safety of the additive for its intended use, to induce cancer in man or animal, and (ii) shall be deemed unsafe, and shall not be listed, for any use which will not result in ingestion of any part of such additive if, after tests which are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additives, it is found to induce cancer in man or animal".

CONCLUSION

The Proprietary Association is appreciative of the committee's consideration. If the foregoing amendments-or the substance of them-are adopted, the members of this association will endorse and support the legislation.

This statement has been duly authorized by the association's officers and appropriate committee.

The CHAIRMAN. Commissioner George B. Larrick has submitted a letter together with a report; I assume, for the record. This will go along with his statement during the early part of these hearings.

When Dr. Carney was testifying he submitted a file of materials by Smith Kline & French Lairatories which apparently consists of various and sundry letters. This will be received for the files of the committee.

Dr. CARNEY. I did not submit that, Mr. Chairman. It is not mine, no, sir.

The CHAIRMAN. Does anybody know the identity of this? There seems to be no identification as to whom it belongs, but there are innumerable letters from doctors here. Dr. Carney, you did submit for the committee's use this display, did you not?

Dr. CARNEY. No. That also is Mr. Worley's.

The CHAIRMAN. I did not understand, Doctor, while you were testifying, if you asked that this memorandum or report on the safety of stilbestrol

Dr. CARNEY. That I submitted for your consideration, yes, sir. The CHAIRMAN. Let it go in the record just after Dr. Carney's statement in view of the fact that we have other reports on it. I believe that is all the requests we have at this time, so the committee will adjourn the hearing subject to the call of the Chair.

(Whereupon, at 4:20 p.in., the committee adjourned subject to the call of the Chair.)

COLOR ADDITIVES

FRIDAY, MARCH 11, 1960

HOUSE OF REPRESENTATIVES,

COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,

Washington, D.C.

The committee met, pursuant to. call, at 10 a.m., in room 1334, New House Office Building, Hon. Oren Harris (chairman of the committee) presiding.

Present: Representatives Oren Harris (presiding), Moulder, Staggers, Friedel, Rhodes, Jarman, O'Brien, Dingell, Rogers of Florida, Hemphill, Brock, Schenck, Younger, Avery, Glenn, Nelsen, Keith, and Curtin.

Also present: W. E. Williamson, chief clerk.

The CHAIRMAN. The committee will come to order.

This morning the committee resumes hearings on H.R. 7624 and S. 2197, referred to as the color additives amendment to the Federal Food, Drug, and Cosmetic Act. We have held rather extensive hearings in the past in which the Secretary of Health, Education, and Welfare and his staff have testified, as well as representatives of various and sundry groups interested in this particular matter, and Members of the Congress.

Today we are pleased to have Dr. M. R. Clarkson, Associate Administrator of the Agricultural Research Service of the U.S. Department of Agriculture, who will present the views of the Department on these proposed color additives bills.

Dr. Clarkson is appearing here by the direction of the Secretary of Agriculture pursuant to an invitation from me as chairman to the Department to comment on these proposals.

Dr. Clarkson, we are glad to welcome you to the committee, and I think before you start, it might be advisable for the record to identify your associates.

Mr. CLARKSON. Thank you, Mr. Chairman.

On my left is Dr. T. C. Byerly, the Deputy Administrator of the Agricultural Research Service for Farm Research: and on my right is Dr. W. L. Popham, who is the Deputy Administrator of the Agricultural Research Service in charge of regulatory programs.

Mr. Chairman, there are several other representatives of the Department here who may be called on to answer specific questions. Would you like to have them introduced at this time, also?

The CHAIRMAN. Yes, I think that information should be supplied for the record, Doctor.

Mr. CLARKSON. We have Dr. II. L. Haller, Assistant to the Administrator; Dr. A. R. Miller, Director of the Meat Inspection Division; Mr. Justus C. Ward, Chief of the Pesticide Regulations Branch,

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Plant Pest Control Division; Mr. Carl R. Bullock, Director of the General Regulatory Division of the Office of General Counsel; and Mr. S. P. Lejko, Assistant to the Administrator.

The CHAIRMAN. Off the record.

(Discussion off the record.)

The CHAIRMAN. You may proceed.

STATEMENT OF M. R. CLARKSON, ASSOCIATE ADMINISTRATOR, AGRICULTURAL RESEARCH SERVICE, DEPARTMENT OF AGRICULTURE; ACCOMPANIED BY T. C. BYERLY, DEPUTY ADHINISTRATOR, FARM RESEARCH; W. L. POPHAM, DEPUTY ADMINISTRATOR, CROPS REGULATORY PROGRAMS; H. L. HALLER, ASSISTANT TO THE ADMINISTRATOR; S. P. LEJKO, ASSISTANT TO THE ADMINISTRATOR; A. R. MILLER, DIRECTOR, MEAT INSPECTION DIVISION; JUSTUS C. WARD, CHIEF, PESTICIDE REGULATIONS BRANCH, PLANT PEST CONTROL DIVISION; AND CARL R. BULLOCK, DIRECTOR, GENERAL REGULATORY DIVISION, OFFICE OF GENERAL COUNSEL

Mr. CLARKSON. Mr. Chairman and members of the committee, thank you for the invitation extended to the Department of Agriculture to discuss legislation pending before your committee to amend the Federal Food, Drug, and Cosmetic Act in regard to color additives, as contained in H.R. 7624 and S. 2197.

The Department's position II.R. 7624, offering no objection to the proposed legislation, was transmitted to the committee on August 11, 1959. The Department was not requested to file a report on S. 2197 while that bill was pending in the Senate.

The Department has made a thorough review of the impact that both of these bills might have on agricultural practices and upon the activities of the Department of Agriculture in the light of the information previously presented to your committee and the discussions that have taken place during recent hearings.

The Department believes that legislation on color additives is necessary and would be in the public interest. We support the broad objectives of II.R. 7624 and S. 2197 to provide safeguards for the health of our people-a matter of first importance.

The purpose of these bills is to provide a scientifically sound basis for listing the colors that may be safely used in foods, feeds, drugs, and cosmetics and to provide for other safeguards in the use of such colors including where necessary appropriate tolerance limitations on the amount of color that may be used.

The bills also would provide for a continuation of the present system of certifying the safety of individual batches of the so-called coal tar colors and would extend this system where necessary to natural colors not now covered by the certification system.

As we understand it, the legislative proposals are generally in accord with requests transmitted to the Congress by the Department of Health, Education, and Welfare which is responsible for administration of the Food, Drug, and Cosmetic Act, except that that Department has recommended the inclusion of a proviso dealing especially with color additives which may be carcinogenic.

S. 2197 contains several amendments which were, as we understand it, inserted by the Committee on Labor and Public Welfare and agreeable to the Department of Health, Education, and Welfare. The Senate bill as amended is acceptable to the Department of Agriculture subject to the following comments.

In view of the very broad scope of the definition of the term "color additive" it should be made clear that the incidental effect on the development of color in foods or feeds resulting from the appropriate use of plant nutrients, either organic or chemical, or the appropriate use of pesticides and other agricultural chemicals is not included within the definition. The appropriate use of pesticide chemicals is, of course, closely regulated under the pesticide chemicals amendment of the Food, Drug, and Cosmetic Act and the Federal Insecticide, Fungicide, and Rodenticide Act, which is administered by the Department of Agriculture. It would be disrupting and confusing to require a further clearance of pesticide chemicals because of an incidental effect upon the development of color in agricultural products. Some plant regulators which are used for the control of undesirabie growth of plants and for preventing premature drop of fruits have some effect on the color development of the crops.

Appropriate soil fertility has a marked effect upon the desirable development of color in certain fruits and vegetables. The normal development of the red surface color and the yellow ground color of apples is related to the nitrogen level of the tree at harvest time. The availability to the tree of potassium, an essential plant nutrient and a common constituent of fertilizers, has a noticeable effect upon the color of the fruit. Experiments have shown that appropriate levels of both nitrogen and potassium contribute to improved fruit color as well as to the general health and growth of the tree.

Peas grown in soil containing adequate levels of potassium are of better coloration and better cooking quality than are peas grown in soils without adequate levels of this fertilizer. The same is true in regard to the normal coloration of cabbage, kale, brussels sprouts, cauliflower, tomatoes, and radishes.

These usages with only incidental color effects should not be handled in the same manner as the addition of a dye or a pigment to food. The legislative record should be clear on this point. If necessary to accomplish the purpose, it is suggested that some additional language be included, such as the following:

of

Amend section 101 of S. 2197 by adding before the period on line 10 page 3:

or any soil or plant nutrient or any material subject to registration under the Federal Insecticide, Fungicide, and Rodenticide Act.

Mr. Chairman, we have been in discussion with representatives of the Department of Health, Education, and Welfare on this matter, and I am able to say that we are in agreement as to the objectives. We have still some discussions underway as to the precise language, and we would like the opportunity to offer an amendment to this language later, if that should be mutually agreed upon.

The CHAIRMAN. Yes, I think, Doctor, you will find also that some of the other witnesses offered amendments or language along this line that you might want to take a look at, too.

Mr. CLARKSON. Yes, sir.

Plant Pest Control Division; Mr. Carl R. Bullock, Director of the General Regulatory Division of the Office of General Counsel; and Mr. S. P. Lejko, Assistant to the Administrator.

The CHAIRMAN. Off the record.

(Discussion off the record.)

The CHAIRMAN. You may proceed.

STATEMENT OF M. R. CLARKSON, ASSOCIATE ADMINISTRATOR, AGRICULTURAL RESEARCH SERVICE, DEPARTMENT OF AGRICULTURE; ACCOMPANIED BY T. C. BYERLY, DEPUTY ADHINISTRATOR, FARM RESEARCH; W. L. POPHAM, DEPUTY ADMINISTRATOR, CROPS REGULATORY PROGRAMS: H. L. HALLER, ASSISTANT TO THE ADMINISTRATOR; S. P. LEJKO, ASSISTANT TO THE ADMINISTRATOR; A. R. MILLER, DIRECTOR, MEAT INSPECTION DIVISION; JUSTUS C. WARD, CHIEF, PESTICIDE REGULATIONS BRANCH, PLANT PEST CONTROL DIVISION; AND CARL R. BULLOCK, DIRECTOR, GENERAL REGULATORY DIVISION, OFFICE OF GENERAL COUNSEL

Mr. CLARKSON. Mr. Chairman and members of the committee, thank you for the invitation extended to the Department of Agriculture to discuss legislation pending before your committee to amend the Federal Food, Drug, and Cosmetic Act in regard to color additives, as contained in H.R. 7624 and S. 2197.

The Department's position II.R. 7624, offering no objection to the proposed legislation, was transmitted to the committee on August 11, 1959. The Department was not requested to file a report on S. 2197 while that bill was pending in the Senate.

The Department has made a thorough review of the impact that both of these bills might have on agricultural practices and upon the activities of the Department of Agriculture in the light of the information previously presented to your committee and the discussions that have taken place during recent hearings.

The Department believes that legislation on color additives is necessary and would be in the public interest. We support the broad objectives of I.R. 7624 and S. 2197 to provide safeguards for the health of our people-a matter of first importance.

The purpose of these bills is to provide a scientifically sound basis for listing the colors that may be safely used in foods, feeds, drugs, and cosmetics and to provide for other safeguards in the use of such colors including where necessary appropriate tolerance limitations on the amount of color that may be used.

The bills also would provide for a continuation of the present system of certifying the safety of individual batches of the so-called coal tar colors and would extend this system where necessary to natural colors not now covered by the certification system.

As we understand it, the legislative proposals are generally in accord with requests transmitted to the Congress by the Department of Health, Education, and Welfare which is responsible for administration of the Food, Drug, and Cosmetic Act, except that that Department has recommended the inclusion of a proviso dealing especially with color additives which may be carcinogenic.