the listing and certification of color additives, but also with respect to regulations establishing fees for such listing and certification. Under present law as consistently interpreted by us since its enactment, the issuance or amendment of regulations establishing schedules of fees for the listing and certification of coal tar colors is not subject to hearing or judicial review (sec. 706 of Federal Food, Drug, and Cosmetic Act). This likewise holds true in the case of fees for certification services for insulin or antibiotics, fees for the pesticide regulation service, and fees for seafood inspection (secs. 408 (0), 506, 507, 702A). The establishment of such fees is purely a matter of cost accounting and, since the services must be self-sustaining, the fees are automatically kept at the appropriate level through auditing of expenditures by the General Accounting Office. To provide for hearing and judicial review with respect to the establishment of fees would thus serve no useful purpose and, on the other hand, might cause delay which could seriously impede or make impossible the performance of the services in question. We, therefore, recommend that the provisions of these bills be corrected by changing the phrase "subsections (b), (c), or (e) of this section" (H.R. 7624, p. 13, line 6; S. 2197, p. 13, line 9) to read "subsection (b) or (c) of this section." Sincerely yours, ARTHUR S. FLEMMING, Secretary. The CHAIRMAN. The latest report from the Department of Health, Education, and Welfare in the form of a letter dated August 7, 1959, will be included with the original report. The first witness we have is the Honorable Arthur S. Flemming, Secretary of the Department of Health, Education, and Welfare. Mr. Secretary, we welcome you here this morning on this highly important legislation, and we will be glad to have your testimony. STATEMENT OF HON. ARTHUR S. FLEMMING, SECRETARY OF HEALTH, EDUCATION, AND WELFARE; ACCOMPANIED BY C. BURROUGHS MIDER, M.D., ASSOCIATE DIRECTOR IN CHARGE OF RESEARCH, NATIONAL CANCER INSTITUTE, NATIONAL INSTITUTES OF HEALTH, PUBLIC HEALTH SERVICE; GEORGE P. LARRICK, COMMISSIONER, U.S. FOOD AND DRUG ADMINISTRATION; AND ROBERT A. FORSYTHE, ASSISTANT SECRETARY FOR LEGISLATION, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Secretary FLEMMING. Mr. Chairman and members of the committee, I am very happy to have this opportunity to discuss proposed legislation dealing with the use of colors in foods, drugs, and cosmetics. This proposed legislation rings to the fore, it seems to me, certain basic issues bearing on the health of our people. It is appropriate for these issues to be reexamined periodically at a time when technological advances in diverse fields occur with such rapidity that it is difficult to keep pace with their impact on the health of all of us. Because of the nature of the issues involved, I have called upon the total resources of the Department, and particularly those of the Food and Drug Administration and the U.S. Public Health Service, to work with me in the development of the positions which I will place before you this morning. PROPOSED COLOR ADDITIVES AMENDMENT As you have indicated, Mr. Chairman, there are two similar bills pending before the committee; namely, H.R. 7624, which was introduced at our request, and S. 2197, which had been introduced by Senator Hill on behalf of himself and Senator Goldwater. (II) such additive in or ou any article of food, drug, or cosmetic, and (111) any substance formed in or on such article because of the use of such additive." The net effect of the change would be to require the Secretary to determine whether, with respect to particular color additives and proposed listings, all of the analytical methods described both in the original bill and in the proposed amendment are needed and, to the extent that they are, to refuse a listing unless these methods exist and are made available to him, whereas, under the bill as originaally introduced, the Secretary must refuse a listing unless all of the described methods of analyses are available to him, without regard to whether, with respect to a particular proposed listing of a color additive, such methods are in his judgment actually needed. The proponents of the amendment believe that some of the requirements of the original bill, and in particular the requirement that there be practicable methods for determining the identity and quantity of any substance formed in or on food because of the use of a color additive, could not always be met in the present state of knowledge and that, in those cases in which there is no need for such a method of aralysis for adequate public health protection, the requirement would unnecessarily bar the use of a color additive which would be perfectly safe. The purpose of the requirement of the bill that there be practicable methods of analysis for determining the quantity of the pure dye and all intermediates and other impurities contained in a color additive is to enable the manufacturer of the color, and also this Department where we are asked to certify batches of color, to determine that the color in actual practice meets the requirements for purity and the definitional standards of our regulations, and to facilitate enforcement. The purpose of the other requirements as to available practicable methods of analysis is to make possible effective enforcement of any conditions or limitations that may be put on the listing of a color for use in foods, drugs, or cosmetics. We, of course, regard practicability and facility of enforcement as essential elements ef safety in determining whether a proposed use of a color additive is safe within the meaning of the bill. There are many circumstances where it would be necessary to have practicable analytical methods for all or most of the above-mentioned purposes. We can, however, visualize some situations in which these analytical methods, or some of them, would not be necessary for any of the purposes which we have mentioned and would thus not be essential in the interest of sound public health protection. We therefore recognize that in requiring such analytical methods to be available in all cases without regard to actual need the original bill goes further than absolutely necessary for public health protection. Under the proposed change, we would consider ourselves bound to require those analytical methods specified in the bill for which, on the basis of our general knowledge or on the basis of the particular situation, we find that there is a need for the above-mentioned purposes, or otherwise in the interest of safeguarding the public health, and we would therefore feel bound to refuse to list a color where such needed methods are not available. At the same time, the proposed amendment would relieve us of the necessity of imposing these requirements where they are not needed. We therefore would not object to the proposed change in the bill. The Bureau of the Budget advises that it perceives no objection to the submission of this report to your committee. Sincerely yours, ELLIOT L. RICHARDSON, Hon. OREX HARRIS, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Chairm sa, Committee on Interstate and Foreign Commerce, DEAR MR. CHAIRMAN: The purpose of this letter is to recommend a correction in the bearing provision in title I of the proposed Color Additive Amendnents of 1959 (ILR. 7624 and S. 2197) now pending before your committee. As drafted by this Department and submitted to Congress, and as contained In these bills, the hearing provision would, through an inadvertent cross-reference to the subsection on fees, provide for hearing and judicial review not only with respect to the issuance, amendment, or repeal of regulations relating to the listing and certification of color additives, but also with respect to regulations establishing fees for such listing and certification. Under present law as consistently interpreted by us since its enactment, the issuance or amendment of regulations establishing schedules of fees for the listing and certification of coal tar colors is not subject to hearing or judicial review (sec. 706 of Federal Food, Drug, and Cosmetic Act). This likewise holds true in the case of fees for certification services for insulin or antibiotics, fees for the pesticide regulation service, and fees for seafood inspection (secs. 408 (o), 506, 507, 702A). The establishment of such fees is purely a matter of cost accounting and, since the services must be self-sustaining, the fees are autoinatically kept at the appropriate level through auditing of expenditures by the General Accounting Office. To provide for hearing and judicial review with respect to the establishment of fees would thus serve no useful purpose and, on the other hand, might cause delay which could seriously impede or make impossible the performance of the services in question. We, therefore, recommend that the provisions of these bills be corrected by changing the phrase "subsections (b), (c), or (e) of this section" (H.R. 7624, p. 13, line 6; S. 2197, p. 13, line 9) to read "subsection (b) or (c) of this section." Sincerely yours, ARTHUR S. FLEMMING, Secretary. The CHAIRMAN. The latest report from the Department of Health, Education, and Welfare in the form of a letter dated August 7, 1959, will be included with the original report. The first witness we have is the Honorable Arthur S. Flemming, Secretary of the Department of Health, Education, and Welfare. Mr. Secretary, we welcome you here this morning on this highly important legislation, and we will be glad to have your testimony. STATEMENT OF HON. ARTHUR S. FLEMMING, SECRETARY OF HEALTH, EDUCATION, AND WELFARE; ACCOMPANIED BY C. BURROUGHS MIDER, M.D., ASSOCIATE DIRECTOR IN CHARGE OF RESEARCH, NATIONAL CANCER INSTITUTE, NATIONAL INSTITUTES OF HEALTH, PUBLIC HEALTH SERVICE; GEORGE P. LARRICK, COMMISSIONER, U.S. FOOD AND DRUG ADMINISTRATION; AND ROBERT A. FORSYTHE, ASSISTANT SECRETARY FOR LEGISLATION, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Secretary FLEMMING. Mr. Chairman and members of the committee, I am very happy to have this opportunity to discuss proposed legislation dealing with the use of colors in foods, drugs, and cosmetics. This proposed legislation rings to the fore, it seems to me, certain basic issues bearing on the health of our people. It is appropriate for these issues to be reexamined periodically at a time when technological advances in diverse fields occur with such rapidity that it is difficult to keep pace with their impact on the health of all of us. Because of the nature of the issues involved, I have called upon the total resources of the Department, and particularly those of the Food and Drug Administration and the U.S. Public Health Service, to work with me in the development of the positions which I will place before you this morning. PROPOSED COLOR ADDITIVES AMENDMENT As you have indicated, Mr. Chairman, there are two similar bills pending before the committee; namely, H.R. 7624, which was introduced at our request, and S. 2197, which had been introduced by Senator Hill on behalf of himself and Senator Goldwater. HR. 70% minden the bgnitive proposals submitted by the De panume to the Cozma u Kay D. 250. Wah your permissio Mr. Cairman, I nova lie to move into the remed a copy ofá ný bantay to the main tree the propel together wirs the enne promiga, be in and nail of the proposal The Caxis. It viewed with the report referred to Hersary Praxxis. Thank yOL BIT. 4. 2151, wongtaly introlwod va ideial with HR 764 and our propral wich we submitted, except that the Senate bill cams tie antytent provvalon. As reported out of commitee and passed by the baz, 5, 217 also incorpores minor amendments to the will which are acceptable to us. Th, if the anticancer clause of the House bui were inserted in S. 2197, xe would support it in that form. The purpose of these bills is to provide a scientifically sound basis for Baris q'the colors that may be safely used in foods, drugs, and cosmedies; 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. They would, on the other hand, permit us to exempt any listed color from the certification requirement where certification is not necessary for the protection of the public health. When the present law was enacted in 1998, it was thought that its coal tar color provisions represented the ultimate in consumer protection. It provided for listing by the Food and Drug Administration of coal tar colors found to be "harmless and suitable for use” in foods, drugs, and cosmetics; and for the testing of every batch of the permitted colors in Food and Drug Administration laboratories before any color from the batch could be marketed for such use. But experience with this law and advances in scientific knowledge regarding the testing of compounds for safety have shown that the consumer is not in fact receiving adequate protection. The Law as it stands arbitrarily divides all coal tar colors into two classes: Those that are considered "harmless" and which may be used without any limitation of the amount, and those considered not harmless and which may, therefore, not be used at all. We now know that this arbitrary classification is not realisticand that the amount of the color to be used must be taken into account in determining whether the use will be safe, except for cancerproducing agents, which I shall discuss later. The crux of the matter with respect to the deficiency in consumer protection under the law as it now stands is simply this: While the coal tar colors now permitted were originally listed on the premise that they were "harmless," our own retesting program-using newer scientific knowledge--has shown this premise to be false with respect to most of the colors retested so far. This makes it probable that the premise will also prove to be false on many of the remaining colors. Yet, under the present law, we must continue our tests and assume the burden of proving as to each listed color that it is not harmless before we can take that color off the permitted list. It would take many years for the Food and Drug Administration to complete this testing of the coal tar colors now in use. This burden, it seems to us, properly belongs on those who manufacture the colors, just as you have place a comparable burden under the food additives law on those who manufacture the food additives. On the other side of the coin, however, is the fact that once we have shown a particular color to be not harmless, per se, we are obliged under the present law to remove this color from the permitted list, even though the amount of the color consumed under particular conditions of use would be completely safe. If the law is not changed, it, therefore, appears certain that many colors may have to be ruled out, even though they could be used without harm under proper re strictions. The bill we have submitted provides that: (1) The burden of proof of the safety of colors now in use and proposed for future use would be placed upon the manufacturer. (2) Listing of a color for use would be forbidden if such use would promote consumer deception or would otherwise result in adulteration or misbranding in violation of the Federal Food, Drug, and Cosmetic Act. (3) The Government would be authorized to take into consideration, in determining whether a proposed use is safe, the amount of color which would be used and the manner of use; and it would be. empowered to set safe limits on the amount and conditions of use as necessary to protect the public health. We have no authority to set tolerances under the present law even though we find that the use of a color in specified amounts would not be harmful. If it is harmful to use a color in large amounts, it cannot be used at all. We have recommended, however, that the law contain a provision that would prohibit the use of a color in any quantity if it is found by appropriate tests to cause cancer in either man or animal. At this point, therefore, I should like to discuss our reasons for believing that an anticancer proviso should be included in the color additives legislation. THE BROAD ISSUE In discussing this issue, I propose: First, to describe in rather broad terms the environmental factors involved in considering this subject. Second, to define the role of Government in the kind of situation we are discussing. Third, to discuss the role of certain chemical and physical agents in relation to cancer. Fourth, I am prepared to summarize the specific recent actions of the Department under the policy of the anticancer, or Delaney, clause of the Food Additives Amendment of 1958. Our changing environment Hippocrates, in the fourth century B.C., taught that man's health depended on his living in harmony with his external surroundings. And he used the word "physician" to indicate that every practitioner of medicine must "strive to know what man is in relation to food, drink, occupation, and which effect each of these has on the other." |