and Agriculture will be appearing further before your committee and can therefore provide the cominittee with more detailed information on this matter. Our general comments on H.R. 7624 were presented to your committee in our letter of August 10, 1959. Sincerely yours, PHILLIP S. HUGHES, Assistant Director for Legislative Reference. Hon. OREN HARRIS, DEPARTMENT OF AGRICULTURE, Chairman, Committee on Interstate and Foreign Commerce, DEAR CONGRESSMAN HARRIS: This is in reply to your request of June 11, for a report on H.R. 7624, a bill to protect the public health by amending the Federal Food, Drug, and Cosmetic Act so as to authorize the use of suitable color additires in or on foods, drugs, and cosmetics, in accordance with regulations prescribing the conditions (including maximum tolerances) under which such additives may be safely used. This Department would have no objection to enactment of the proposed legislation. The proposed legislation would enable the Secretary of Health, Education, and Welfare to take a realistic position with respect to the use of colors in food products, many of which are agricultural products. The bill would enable the Secretary of Health, Education, and Welfare to establish tolerance limitations and other conditions of safe use for all color additives in or on foods, drugs, and cosmetics, in a manner similar to that set forth in the Food Additives Amendment of 1958. Under existing law the said Secretary may not establish tolerance limitations for coal tar colors. A color additive would be deemed unsafe under the proposed bill if, among other things, it is found after tests which are appropriate for the evaluation of such additives to induce cancer in man or animals. The proposed legislation also contains a provision that its terms should not be construed to exempt any meat or meat food product or any person from any requirement imposed by or pursuant to the Meat Inspection Act or the Poultry Products Inspection Act. This provision is considered to be consistent with and in no way modifying the provisions of sec tion 902(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 392) which exempts meat and meat food products from the terms of that act to the extent of the application thereto of the Meat Inspection Act. Section 18 of the Poultry Products Inspection Act contains an exemption with respect to poultry and poultry products similar to that contained in section 902(b) of the Federal Food, Drug, and Cosmetic Act for meat and meat food products. We believe that all dyes and colorings for use in or on foods, drugs, and cosmetics should be subject to the same principles presently applicable to food additives. The Secretary of Health, Education, and Welfare should be permitted to establish tolerances for these materials. Enactment of the proposed legislation will avoid such special legislation as that enacted recently permitting the addition of coloring to oranges (Public Law 86-2, approved Mar. 17, 1959). The Bureau of the Budget advises that there is no objection to the submission of this report. Sincerely yours, E. L. PETERSON, Acting Secretary. Hon. OREN HARRIS, DEPARTMENT OF AGRICULTURE, Chairman, Committee on Interstate and Foreign Commerce, DEAR CONGRESSMAN. HARRIS: This is to supplement the Department's statement of March 11, before your committee on H.R. 7624 and S. 2197. These bills proposed amendments to the Federal Food, Drug, and Cosmetic Act concerning color additives. The Department, in its testimony, favored amending section 101 of Senate bill 2197 by adding before the period on line 10 of page 3 the following language: "or any soil or plant nutrient or any material subject to registration under the Federal Insecticide, Fungicide, and Rodenticide Act." Dr. Clarkson stated at that time that the language suggested was preliminary and that discussions were being held with representatives of the Department of Health, Education, and Welfare. As a result of these discussions, we are now revising our proposal by recommending that section 101 of S. 2197 be amended by adding a new paragraph 3 ou page 3, as follows: “(3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest." I wish to thank you for the courtesies extended Dr. Clarkson in his appearance before your committee. Sincerely yours, E. L. PETERSON, Assistant Secretary. Hon. OREN HARRIS, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, August 7, 1959. Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D.C. DEAR MR. CHAIRMAN: We understand that representatives of some of the industries that would be affected by H.R. 7624 (to be known as the "color additive amendments of 1959") have suggested an amendment to the bill, relating to the requirements concerning analytical methods for color additives. Under the bill in its present form (p. 9. lines 3-16), the proposed section 706(b)(4) of the Federal Food, Drug, and Cosmetic Act would preclude the Secretary from listing a color additive for any use in or on food, drugs, or cosmetics unless the data before him establish "(A) that such use, under the conditions of use to be specified in the regulations, will be safe; "(B) that practicable methods of analysis exist for determining the quantity of the pure dye and all intermediates and other impurities contained in such color additive: and "(C) that practicable methods exist for determining the identity and quantity (i) of such additive in or on any article of food, drug, or cosmetic, and (ii) of any substance formed in or on such article because of the use of such additive." The proposed amendment suggested by industry representatives would consolidate the matter contained in the above-quoted paragraphs (B) and (C) and, with appropriate editorial revision, transfer it to section 706(b)(5), which be gins on the same page and enumerates some of the most important factors which the Secretary must consider in passing on the safety of a proposed use of a color additive. As so amended, section 706(b)(4) and (5), beginning on page 9, line 3, and ending on page 10, line 10, of the bill, would read as follows: "(4) The Secretary shall not list a color additive under this section for a proposed use unless the data before him establish that such use, under the conditions of use specified in the regulations, will be safe. “(5) (A) In determining, for the purposes of this section, whether a proposed use of a color additive is safe, the Secretary shall consider, among other relevant factors "(i) the probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs, or cosmetics because of the use of the additive: "(ii) the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in such diet; "(iii) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of color additives for the use or uses for which the additive is proposed to be listed, are generally recognized as appropriate for the use of animal experimentation data; and "(iv) the availability of any needed practicable methods of analysis for determining the identity and quantity of (I) the pure dye and all intermediates and other impurities contained in such color additive, and Agriculture will be appearing further before your committee and can therefore provide the cominittee with more detailed information on this matter. Our general comments on H.R. 7624 were presented to your committee in our letter of August 10, 1959. Sincerely yours, PHILLIP S. HUGHES, Assistant Director for Legislative Reference. Hon. OREN HARRIS, DEPARTMENT OF AGRICULTURE, Chairman, Committee on Interstate and Foreign Commerce, DEAR CONGRESSMAN HARRIS: This is in reply to your request of June 11, for a report on H.R. 7624, a bill to protect the public health by amending the Federal Food, Drug, and Cosmetic Act so as to authorize the use of suitable color additires in or on foods, drugs, and cosmetics, in accordance with regulations prescribing the conditions (including maximum tolerances) under which such additives may be safely used. This Department would have no objection to enactment of the proposed legislation. The proposed legislation would enable the Secretary of Health, Education, and Welfare to take a realistic position with respect to the use of colors in food products, many of which are agricultural products. The bill would enable the Secretary of Health, Education, and Welfare to establish tolerance limitations and other conditions of safe use for all color additives in or on foods, drugs, and cosmetics, in a manner similar to that set forth in the Food Additives Amendment of 1958. Under existing law the said Secretary may not establish tolerance limitations for coal tar colors. A color additive would be deemed unsafe under the proposed bill if, among other things, it is found after tests which are appropriate for the evaluation of such additives to induce cancer in man or animals. The proposed legislation also contains a provision that its terms should not be construed to exempt any meat or meat food product or any person from any requirement imposed by or pursuant to the Meat Inspection Act or the Poultry Products Inspection Act. This provision is considered to be consistent with and in no way modifying the provisions of sec tion 902(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 392) which exempts meat and meat food products from the terms of that act to the extent of the application thereto of the Meat Inspection Act. Section 18 of the Poultry Products Inspection Act contains an exemption with respect to poultry and poultry products similar to that contained in section 902(b) of the Federal Food, Drug, and Cosmetic Act for meat and meat food products. We believe that all dyes and colorings for use in or on foods, drugs, and cosmetics should be subject to the same principles presently applicable to food additives. The Secretary of Health, Education, and Welfare should be permitted to establish tolerances for these materials. Enactment of the proposed legislation will avoid such special legislation as that enacted recently permitting the addition of coloring to oranges (Public Law 86-2, approved Mar. 17, 1959). The Bureau of the Budget advises that there is no objection to the submission of this report. Sincerely yours, E. L. PETERSOx, Acting Secretary. Hon. OREN HARRIS, DEPARTMENT OF AGRICULTURE, Chairman, Committee on Interstate and Foreign Commerce, DEAR CONGRESSMAN. HARRIS: This is to supplement the Department's statement of March 11, before your committee on H.R. 7624 and S. 2197. These bills proposed amendments to the Federal Food, Drug, and Cosmetic Act concerning color additives. The Department. In its testimony, favored amending section 101 of Senate bill 2197 by adding before the period on line 10 of page 3 the following language: "or any soil or plant nutrient or any material subject to registration under the Federal Insecticide, Fungicide, and Rodenticide Act." Dr. Clarkson stated at that time that the language suggested was preliminary and that discussions were being held with representatives of the Department of Health, Education, and Welfare. As a result of these discussions, we are now revising our proposal by recommending that section 101 of S. 2197 be amended by adding a new paragraph 3 ou page 3, as follows: “(3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest." I wish to thank you for the courtesies extended Dr. Clarkson in his appearance before your committee. Sincerely yours, E. L. PETERSON, Assistant Secretary. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, August 7, 1959. Hon. OREN HARRIS, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D.C. DEAR MR. CHAIRMAN: We understand that representatives of some of the industries that would be affected by H.R. 7624 (to be known as the "color additive amendments of 1959") have suggested an amendment to the bill, relating to the requirements concerning analytical methods for color additives. Under the bill in its present form (p. 9. lines 3-16), the proposed section 706(b) (4) of the Federal Food, Drug, and Cosmetic Act would preclude the Secretary from listing a color additive for any use in or on food, drugs, or cosmetics unless the data before him establish "(A) that such use, under the conditions of use to be specified in the regulations, will be safe; "(B) that practicable methods of analysis exist for determining the quantity of the pure dye and all intermediates and other impurities contained in such color additive; and "(C) that practicable methods exist for determining the identity and quantity (i) of such additive in or on any article of food, drug, or cosmetic, and (ii) of any substance formed in or on such article because of the use of such additive." The proposed amendment suggested by industry representatives would consolidate the matter contained in the above-quoted paragraphs (B) and (C) and, with appropriate editorial revision, transfer it to section 706(b)(5), which begins on the same page and enumerates some of the most important factors which the Secretary must consider in passing on the safety of a proposed use of a color additive. As so amended, section 706(b) (4) and (5), beginning on page 9, line 3, and ending on page 10, line 10, of the bill, would read as follows: "(4) The Secretary shall not list a color additive under this section for a proposed use unless the data before him establish that such use, under the conditions of use specified in the regulations, will be safe. “(5) (A) In determining, for the purposes of this section, whether a proposed use of a color additive is safe, the Secretary shall consider, among other relevant factors— "(i) the probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs, or cosmetics because of the use of the additive: "(ii) the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in such diet; "(iii) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of color additives for the use or uses for which the additive is proposed to be listed, are generally recognized as appropriate for the use of animal experimentation data; and "(iv) the availability of any needed practicable methods of analysis for determining the identity and quantity of (I) the pure dye and all intermediates and other impurities contained in such color additive, (II) suck additive in or on 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 analysis 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 of safety in determining whether a proposed use of a color additive is safe within the meaning of the bill. There are unny 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 Hureau of the Budget advises that it perceives no objection to the submission of this report to your committee. Sincerely yours, ELLIOT L. RICHARDSON, Hon. OREN Harris, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Chairmza, Clammittee on Interstate and Foreign Commerce, #tesse of Representatives, Washington, D.C. DEAR MR CHAPMAN; The purpose of this letter is to recommend a correcthen by the aring provision in tite I of the proposed Color Additive Amendtents of 1900 (HR. 7624 and S. 2197) now pending before your committee. As Prafted by this Department and submitted to Congress, and as contained In the hills, the hearing provision would, through an inadvertent cross-referchce 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 |