direction of Dr. Darby, during which the members of the panel will be able to ask questions of each other. Of course, the members of this committee probably will want to ask some questions of the members of the panel. However, if the subject matter gets too deep for us, why, we will sit back and let you make the record. The committee has held extensive hearings on the legislation during the past several weeks. The point of controversy which I have indicated and the question on which the committee seeks particular information from you gentlemen is whether or not it is possible to establish safe tolerances for food or color additives known to induce cancer in man or animal. On page 10 of H.R. 7624-and I hope the clerk has provided each of you with a copy-lines 11 through 22-there appears the following language, which I have said is referred to as the Delaney clause, and I quote: (B) A color additive (1) shall be deemed unsafe, and shall not be 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, or if it is found, after tests which are appropriate for the evaluation of the safety of additives for use in food, 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 additive, it is found to induce cancer in man or animal. Now, the Senate has approved a bill S. 2197, which does not contain this language or any reference to it. However, the Food Additives Amendment of 1958, Public Law 85-929, contains similar language. Much controversy has developed during our hearings over this clause. You can readily appreciate that the question of retaining, modifying, or eliminating this provision is one of vital importance to the health of our people. Views of this panel on this question, therefore, will be of tremendous help to us in determining legislative policy. Now, I would like to introduce Dr. Darby, the chairman of the panel. Doctor, we are pleased to welcome you back. I recall that you were chairman of a previous panel before this committee in 1957. You may proceed as I have outlined. STATEMENTS OF DR. WILLIAM J. DARBY, DEPARTMENT OF BIOCHEMISTRY, VANDERBILT UNIVERSITY SCHOOL OF MEDICINE, NASHVILLE, TENN.; DR. HAROLD F. BLUM, NATIONAL CANCER INSTITUTE, DEPARTMENT OF BIOLOGY, PRINCETON UNIVERSITY, PRINCETON, N.J.; DR. PAUL R. CANNON, UNIVERSITY OF CHICAGO; DR. FLOYD DE EDS, U.S. DEPARTMENT OF AGRICUL TURE, WESTERN UTILIZATION LABORATORY, ALBANY, CALIF.; DR. CHARLES J. KENSLER, DEPARTMENT OF PHARMACOLOGY, SCHOOL OF MEDICINE, BOSTON UNIVERSITY, BOSTON, MASS.; DR. MORTON L. LEVIN, ROSWELL PARK MEMORIAL INSTITUTE, BUFFALO, N.Y.; DR. G. BURROUGHS MIDER, ASSOCIATE DIRECTOR, NATIONAL CANCER INSTITUTE, NATIONAL INSTITUTES OF HEALTH, BETHESDA, MD.; DR. JAMES A. MILLER, MCARDLE LABORATORY, UNIVERSITY OF WISCONSIN, MADISON, WIS.; DR. WALTER E. O'DONNELL, SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH, DIVISION OF PREVENTIVE MEDICINE, NEW YORK, N.Y.; DR. HAROLD L. STEWART, NATIONAL CANCER INSTITUTE, NATIONAL INSTITUTES OF HEALTH, BETHESDA, MD.; DR. ALBERT TANNENBAUM. MEDICAL RESEARCH INSTITUTE, MICHAEL REESE HOSPITAL, CHICAGO, ILL.; AND DR. M. R. ZAVON, KETTERING LABORATORY OF INDUSTRIAL HEALTH, CINCINNATI, OHIO Dr. DARBY. Thank you indeed. Mr. Harris. First, I should like to express my appreciation for the opportunity of again discussing with you and your committee the scientific considerations which are basic to legislative action aimed at improving and providing our Nation with an abundance of the most wholesome and nutritious food obtainable. As you know, I have long been interested in many aspects of nutrition. My background started in your own home State, Arkansas. From the University of Arkansas" I received an M.D. degree, and subsequently from the University of Michigan a Ph. D. in biochemistry. At the present time, as you indicated. I am professor and head of the Department of Biochemistry at Vanderbilt University, and director of the division of nutrition of that medical school. I have since the formation of the Food Protection Committee of the National Academy of Science been on that committee, and at the present. I am chairman of the food protection committee, and I am also a member of the Food Nutrition Board of the Academy. I have for a number of years been a member of the council on foods and nutrition of the American Medical Association. As a result of interest and attention to some of the questions relative to food additives. I have served as a member-in fact, as chairman of the first joint FAO-WHO Expert Committee on Food Additives. I wonder if I might ask whether it would save time if in giving the individual statements we had the members of the panel qualify them selves at that time, or would you prefer the qualification all at one moment! The CHAIRMAN. I think, doctor, it would be proper and much better for the record if you could have them listed all together. Dr. DARBY. All right, sir. We shall do that. The CHAIRMAN. In order to save time, I think each one of you should file such a statement for the record, and it will appear in the record at this point, if that procedure is all right with you. Dr. DARBY. Yes, it is perfectly all right. We shall proceed then as you suggested. Tho CHAIRMAN. I knew you had an interesting background, Dr. Darby, and for that reason you would be highly qualified for this purpose. Dr. DARBY. Thank you: (The statements of background which were furnished are as follows:) CURRICULUM VITAE GEORGE BURROUGHS MIDER Date and place of birth: August 9, 1907, Windsor, N.Y. Education: A.B., Cornell University, 1930; M.D., Cornell Medical College, 1933. Professional training and positions held: Intern, Albany Hospital, Albany, N.Y., 1933–34. Assistant resident surgeon, Albany Hospital, Albany, N.Y., 1934-35. Assistant in surgery, Albany Medical College, 1935–36. Assistant resident in surgery, Strong Memorial Hospital, 1936–37. Assistant in surgery, University of Rochester School of Medicine and Dentistry, 1936-37. Fellow in surgery, University of Rochester School of Medicine and Dentistry, 1987-38. Instructor in surgery, University of Rochester School of Medicine and Dentistry, 1938-39. Research fellow, National Cancer Institute, 1938-41. Instructor in pathology, Cornell Medical College, 1941-42 Assistant professor of pathology, Cornell Medical College, 1942–44. Associate professor of pathology, University of Virginia School of Medicine, 1914-5. Research associate in surgery, University of Rochester School of Medicine and Dentistry, 1945–48. Professor of cancer research, University of Rochester School of Medicine and Dentistry, 1918-52. Associate director in charge of research, National Cancer Institute, 1952-. Board certification: American Board of Pathology, in pathologie anatomy. Memberships: American Association of Pathologists and Bacteriologists. American Society for Experimental Pathology. Harvey Society. James Ewing Society. American Association for Cancer Research; director, 1952-55; chairman, Program Committee. 195: chairman, Finance Committee, 1956-. Editorial Advisory Board of Cancer Research, 1944–56. Scientific Advisory Committee, Detroit Institute of Cancer Research, 1972-60. Gordon Research Conference on Cancer: chairman, 1952, vice chairman, 1251. Panel on Clinical Investigations, Committee on Growth, National Research Corucil, 1951-52. Tumor Registry Committee, American Academy of Pediatrics, 1952-55. Committee on Occupational Cancer, Council on Industrial Health, American Medical Association: chairman, 1954–. American Cancer Society; board of directors, 1944-45; board of directors, Monroe County branch, 1950-52; board of directors, New York State division, 1951-52; Advisory Committee on Institutional Research Grants, 195658; chairman, Survey Committee, 1958-59. Editorial Advisory Board, Cancer, 1957–. American Association for the Advancement of Science. AAAS Sele:tion Committee for AAAS-Anne Frankel Rosenthal Memorial Award for Cancer Research, 1955–59. Committeeman-at-large, Section AAAS, 1957–. Washington Academy of Medicine; Clinico-Pathological Society of Washington. Cancer Control Committee (National Cancer Institute), and Subcommittee on Environmental Cancer, 1958-. Advisory Board of the Biomedical Division, the Samuel Roberts Noble Foundation, Ardmore, Okla., 1958-. Education: Ph. D. CHARLES J. KENSLER Columbia College, A.B. Columbia University, M.A. Cornell University, Research and teaching appointments: Chemical assistant, Rockefeller Institute, New York, 1938–39. U.S. Army, Edgewood Arsenal, toxicologist POA, 1943–46, Professor and chairman, department of pharmacology and experimental therapeutics, Boston University School of Medicine, 1957– Fellowships: U.S. Public Health Service, 1947-4S. National Research Council, 1948-49. Traveling fellow, Oxford University, England, 1949-50. Professional society membership: American Society for Pharmacology and Experimental Therapeutics, American Association for Cancer Research, Harvey Society, Society for Experimental Biology and Medicine, Biochemical Society (England), fellow AAAS. fellow New York Academy of Sciences, New York State Society for Medical Research (president 1952-53), Sigma Xi. Member of: Editorial board, Journal American Society for Pharmacology and Experimental Therapeutics, 1957-39. Drug Evaluation Panel, Department of Health. Education, and Welfare, Cancer Chemotherapy National Service Center, 1957-. Chairman, Pharmacology Committee, 1959 Subcommittee on Carcinogenesis of the Food Protection Committee of the National Research Conneil, National Academy of Sciences, 1957– Scientific Advisory Committee on Lung Cancer, American Cancer Society, 1957-59. Scientific Advisory Committee on Aetiology of Cancer, American Cancer Society, 1959 Dr. DARBY. In introducing this subject, I think there are certain objectives which we might try to keep in mind. First, there is that objective which I have jus, indicated of the need to provide an abundant, wholesome and nutritions food supply for our Nation. To obtain this objective today and in the future we must assure that proper use is made of the many important and effective means at our disposal for the continued enhancement of agricultural production, of improved food preservation, of improvement in food distribution and improvement in nutritional quality of foodstuffs. It is essential that the complex of agriculture and industry combine for fulfillment of this objective and that they do so within a regulatory framework which assures maximum benefit and maximum health of the consumer, and at the same time permits the introduction of new improvements as these improvements are developed or become possible as a result of scientific progress, whether, indeed, we are thinking of improvements such as new varieties of crops, new methods of culture or new processing procedures. It was this philosophy which led, in fact, to the establishment of the Food Protection Committee of the National Academy (FPC) in 1950, and this Committee, as you know, has given attention to many aspects of the use of food additives and food additive problems. I have here only three of the several publications of the FPC which I might call your attention to. One is the so-called green book, "The Use of Chemical Additives in Food Processing," which report of the Food Protection Committee discusses the reasons for use of additives. It lists a large number of additives which either have been used, are in use, or have been proposed for use or possibly could be used. Not all of these are used. More recently, in 1958, the Food Protection Committee published a report entitled "Food Packaging Materials, Their Composition and Uses," dealing with the matter of food packaging. Then in December 1959, especially pertinent to the point of this panel, there appeared a report from the Food Protection Committee which is Publication No. 49, of the National Academy of SciencesNational Research Council, "Problems in the Evaluation of Carcino genic Hazard From the Use of Food Additives." I have brought a number of copies of this, and I hope that they will be distributed to any members of the committee who would be interested in brousing through this publication. The CHAIRMAN. Do you have copies of this which you can distribute to members! Dr. DARBY. Yes. The CHAIRMAN. What is the other one, Dr. Darby? Dr. DARBY. The other one is "The Use of Chemical Additives in Food Processing." I do not believe we brought copies of this, nor of the food packaging material report, but if you should like copies we will be glad to supply them. The CHAIRMAN. Very well, we will receive them for the files, and then we will look it over and see whether any part of it should be included in the record, but we will have them in the files and by reference. Dr. DARBY. The present panel contains some of the members of the Subcommittee on Carcinogenesis of the Food Protection Committee, responsible for developing this report. However, the present panel has a variety of persons who had not been concerned directly with the development of this report and who were not members of the Food Protection Committee. I think you recognize that the panel |