Document 5eJX5Zn4zLZpeojLYNjO7Vy5

TELEPHONE HUDSON 3-6126 Manufacturing Chemists' Association, Inc. (FOUNDED 1872) 1825 Connecticut Avenue, N. W. Washington, D. C. 20009 September 7, 1967 TO: Members of the Food, Drug, and Cosmetic Chemicals Committee SUBJECT: Report of Carcinogenicity Task Group Gentlemen: I am enclosing a copy of the report prepared by Drs. Treon, Shaffer, and Zapp for your consideration prior to the September 12 meeting. Sincerely yours, MMH:sjg Enclosure Morgan M. Hoover ASI 00002096 August 20, 1967 Proposed Position Paper for FCA - PDCC Subco--alttee on Carcinogenicity Wa believe there is ample guidance in the published literature (1,2,3,4,5) to techniques for the conduct of teste for carcinogenicity. The important questions are the extent to Which these tests should be used in the routine evaluation of the safety of chemical food additives, etc., under what circumstance# such t sta should be carried outr and what strains and species should be used as test aninals. Since the interest of the MCA is prlamrily in chsnica.ls, as components of food and cosmetics, our consents will be confined to these classes. /' Pood chemicals reach the public by the ingeation route, and Pood Additiva Amandnent of 1958 takes cognizance, appropriately. of only those substances Which are found to induce cancer When ,fhg eted ^by man or anirnla. We believe that this ia s* sound/princlpia. Any recoHaended tast for carcinogenicity on or in aninals should tafceiafUTl be one in which the teet substance is applied or administered by the route in which the public ia to be exposed. For substances to be ingested, tests by parenteral injection (4,5) or topical applicati n are of doubtful relevance and should not be required. For substances to be applied to the skin, topical application ia the relevant route of ad ministration, etc. 00002097 P& I 2- - August 29, 19*7 Carcinogenicity is only one aspect of testing for chronic toxicity (1,5). We believe that it should be conscientiously looked for in the course of all tests performed to evaluate the chronic toxicity of a substance. If a chemical food or cosmetic additive produces no hint or suggestion of carcinogenicity in the coarse of all the tests currently required for the evaluation of the safety of such chemical additives, additional specific tests by other techniques or different routes of administration appear to us to be an unnecessary burden unlikely to produce results of practical significance. The position, which we have enunciated here, is essentially t that which has been taken by the PDA, since the Pood, Drug and Cos- metic Act of 1938 was enacted and which we believe has been successful in protecting the public against the introduction of significant car cinogenic haxards ,'t > y into foods and cosmetics. MANUFACTURING CHOHSTS* PDCC COMMITTEE, ASSOCIATION, INC. eg ASI 00002098 i, August 28, 1967 - T- 1. "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", Association of Food and Drug Officials of U.8., 1959. 2. "Problems in the Evaluation of Carcinogenic Hazard from Use of Food Additives", Food Protection Comittee of the Food and Nutrition Board, National Academy of Sciences - Rational Research Council, Publication No. 749, December, 1959. 3. "Evaluation of the Carcinogenic Hazards of Food Additives*, Fifth report of the Joint Food and Agricultural Organization World Health Expert Committee on Food Additives, WHO Technical Report Series No. 220, 1961. 4. "Subcutaneous Sarcoma as an Index of Carcinogenic Potency", P. Grasso and L. Golberg, Food and Cosmetics Toxicology, 4 (No. 3); 297, June, 1966. 5. "Procedures for Investigating Intentional and Unintentional Food Additives", Report of a World Health Organisation Scientific Group, WHO Technical Report Series No. 348, 1967. ASI 00002099