followed by everyone, and that competent scientific judgment is being brought COMMITTEE ON CHEMICALS INTRODUCED IN FOODS, FRANKLIN C. BING, Ph. D., Chairman. FRED C. BLANCK, Ph. D. OLAF MICKELSEN, Ph. D. BERNARD L. OSER, Ph. D. BERNARD E. PROCTOR, Ph. D. GLENN G. SLOCUM, Ph. D. STATEMENT OF MRS. J. A. BOORAS, WASHINGTON, D. C. TO HON. J. B. WILLIAMS, CHAIRMAN, HEALTH AND SC'ENCE SUBCOMMITTEE OF HOUSE INTERSTATE AND FOREIGN COMMERCE COMMITTEE Mr. Chairman, and members of the committee, health is one of our nations most precious possessions, as we live in a dynamic and changing world new problems face us daily, one of which is the safety of the food we eat. In years gone by many people raised much of their own food, small truck farms some time surrounded towns, in this way people could get a variety of foods in its original, primitive state from natural, organic soil. I remember as a child mother and I would drive out to the farm on Saturday to buy our fruits and vegetables. Then as the population grew man was forced to confine himself to smaller areas of living, he then had to condition himself to the refinement, processing and storing of his foodstuffs, all of this done on a large scale. In recent months I have read about chemical additives used in foods, as a housewife and because I have a responsibility to my family, I would like to have the assurance that I am buying the best available food for my family's health, as I understand it, these additives are the chemicals which are put in foods to improve color, texture, or flavor, or to lengthen the time that the food will stay fresh. According to the Food and Drug Administration, there are about 150 chemicals used in foods today which have not been adequately tested for safety. The possibility of degenerative effect caused by taking small quantities of the chemicals in our bodies every day for years, because traces of these chemicals are absorbed and retained by foods so treated, so that there should be grave concern with what may happen to our younger generation, I feel sure the members of this committee share this same apprehension. If a chemical does not serve a useful purpose it should not be used. But a safety tolerance should be established where it is necessary to use chemical additives and to spell out clearly the purpose so as to give every possible effective protection. Since the individual is powerless to protect himself against any threat from food to which chemicals have been added and since the use of chemicals in our modern food supply is a very large and complex subject the Federal Government must be empowered to inspect, test, approve, or to deny the use of the socalled additives if it endangers the health in any way. Because of my interest in this matter, I have listened to testimony given before the committee and read the other bills on chemical additives the one bill which meets specific protection against harmful use of chemical additives and is a marked improvement over the other bills is H. R. 7798, it also does not contain a grandfather's clause. The carcinogen prohibition follows recommendations made by the International Union Against Cancer in Rome in August 1956. In view of this chemical additives should be pretested specifically for carcinogenicity, and the only way to do this is through effective legislation. I am deeply concerned with the entire food-additive problem, hearings and investigations have been going on for over 5 years seemingly nothing has occurred in the meantime to carry out and implement meaningful protection against dangerous chemical additives used on foods, as a homemaker I wish to have complete confidence in the safety of the foods which I buy, therefor I earnestly urge prompt passage of H. R. 7798 to safeguard the health of the people, the same safety requirements should be used for foods that now exist for new drugs and meats. FOOD ADDITIVES 531 Hon. JOHN BELL WILLIAMS, SUNKIST GROWERS, Ontario, Calif., May 9, 1958. Chairman, Subcommittee on Health and Science of the House Committee on Interstate and Foreign Commerce, House Office Building, Washington, D. C. GENTLEMEN: The pending food additive legislation studied by your committee is largely concerned with manufactured foods. Applications of pesticide chemicals to raw agricultural commodities are already controlled under the Miller amendment. Most manufactured foods, however, at some stage of their perparation are derived from raw agricultural commodities. In the interest of maximum safety and minimum cost we have devised a "bridge" between the established raw agricultural commodity provisions and the new provisions for manufactured foods such as will comprise future legislation. This, we are The proposal is briefly described in the attached single page. advised, will appear later this month in Food Technology. We are pleased to call it to your attention in advance of its publication. Very truly yours, WILLARD E. BAIER, Manager, Research Department. [To be published in May 1958 Food Technology] A NEEDED ADDITIVE TO FOOD ADDITIVE LEGISLATION (Willard E. Baier and Clarence W. Wilson, Sunkist Growers research department, Ontario, Calif.) Proposed legislation is concerned mostly with new intentional food additives in prepared foods. The very proper goal is to provide for the same kind of pretesting that prevails now under the Miller amendment in the case of incidental additives in raw agricultural commodities. There should be a way of avoiding the very expensive reconsideration of subtolerance levels of approved pesticide chemicals in raw agricultural commodities when these commodities are used in processed foods. Nothing is to be gained by compounding the provisions of existing and future legislation. We propose, in defining new additives in legislation pertaining to processed foods, wording such as the following "The term new additive does not include a pesticide chemical in or on a raw agricultural commodity as defined in section 201 (q) of this act; nor such a pesticide chemical present in a processed food as the result, through good manufacturing practice, of being derived from a raw agricultural commodity which complies with section 408 of this act provided that its established tolerance when calculated to the basis of the nonaqueous matter content of the raw agricultural commodity is not exceeded in the processed food when similarly calculated; or a food additive or treatment in use prior to January 1, 1956, which presents no reasonable probability of injury to health; or any substance approved for use in food by or under this act." Difficulties otherwise encountered in translating from raw to processed foods are avoided by referring both of them to the nonaqueous matter basis. The rationale of this concept was given in earlier articles.1 It is the confident belief of the authors that some such wording as above suggested has great potentiality. Improved safety will result. At the same time conserved effort easily equivalent to millions of dollars would accrue as compared with the alternative of reconsideration of each incidental additive in all foods into. which it may be carried by the raw agricultural commodities. We see no reason for not using this simple device in proposed legislation. (Whereupon, at 4:40 p. m., the subcommittee adjourned, subject to the call of the Chair.) 1 Baier, W. E., and Wilson, C. W., Food Technol. 5, 38-40 (1951), also Food, Drug, Cosmetic Law J. 9, 170-177 (1954). 532 FOOD ADDITIVES [H. R. 10404, 85th Cong., 28 sess.] A BILL To amend the Federal Food, Drug, and Cosmetic Act for the protection of the public health, by prohibiting new food additives which have not been adequately pretested to establish their safe use under the conditions of their intended use Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 201 of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end thereof the following new paragraph: "(8) The term 'new food additive' means any substance which, after January 1, 1958, is intended to be newly used for any purpose in the manufacture, packing, processing, preparation, or other fabrication of any food and thus to become a component of such food, but which is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of food, as safe for use under the conditions of its intended use. The term does not include a pesticide chemical in or on a raw agricultural commodity, or any substance permitted in a food, by or under this Act. Each new food additive shall be deemed a food, for the purpose of this Act." SEC. 2. Paragraph (j) of section 301 of the Federal Food, Drug, and Cosmetic Act is amended to read as follows: (1) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding under this Act, any information acquired under authority of section 404, 409, 505, 506, 507, or 704 concerning any method or process which as a trade secret is entitled to protection." SEC. 3. Section 301 of the Federal Food, Drug, and Cosmetic Act is further amended by adding at the end thereof the following new paragraph: "(o) A violation of section 400 (a) or (e)." SEC. 4. Clause (2) of section 402 (a) of the Federal Food, Drug, and Cosmetic Act is amended to read as follows: "(2) (A) if it bears or contains any added poisonous or added deleterious substance, which is unsafe within the meaning of section 406, except a pesticide chemical in or on a raw agricultural commodity or a new food additive; or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section 408 (a); or (C) if it is or if it bears or contains a new food additive which is unsafe for use under the conditions of its intended use ;". SEC. 5. Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end thereof the following new section: "NEW FOOD ADDITIVES "SEC. 409. (a) No person shall introduce or deliver for introduction into interstate commerce any new food additive or any food which bears or contains any new food additive unless (1) protesting data such additive have been fully submitted to the Secretary in accordance with this section, and (2) the Secretary has had an opportunity to evaluate said data, as provided by this section. "(b) The pretesting data on a new food additive submitted to the Secretary shall include, in addition to any explanatory and supporting memorandums "(1) the name of and all available pertinent information about such additive, including its chemical identity and composition; "(2) the conditions of the intended use of such additive; "(3) all directions, recommendations, and suggestions for the use of such additive, including proposed labeling for such additive; "(4) to the extent that it is necessary, to determine whether such additive is safe for use under the conditions of use, a description of "(A) the methods and controls used for the production of such additive, and "(B) the methods available for determining the identity and quantity of such additive (including any known reduction products) in or on food; "(5) a report of the pretesting investigations made to determine whether such additive is safe for use under the conditions of its intended use; and "(6) any samples of such additive and its component articles, requested by the Secretary. The Secretary shall hold such protesting data in confidence, except: "(A) where such data has been submitted pursuant to section 409 (b) (1), (4) (B), and (5) and its disclosure either (i) has been authorized in writing by the person submitting it, in which event said data shall be published from time to time or otherwise made available by the Secretary to the public, or (ii) is required to protect the public health; or "(B) where the disclosure of said data is required in an enforcement. proceeding under this Act. "(c) The Secretary shall promptly evaluate the pretesting data submitted by any person on a new food additive to determine whether in his opinion such additive is safe for use under the conditions of its intended use. The evaluation shall be completed within a period not exceeding one hundred and twenty days, unless it is extended by mutual agreement of the parties for a period not exceeding sixty days; and during this period such person may consult with the Secretary and submit additional pertinent data and memorandums. "(d) When the evaluation has been completed the Secretary shall within ten days notify by registered mail the person submitting said protesting data on a new food additive, whether, in his opinion so reached, such additive is safe for use under the conditions of its intended use. If the opinion is favorable the Secretary nevertheless may thereafter modify or withdraw it by written notice to such person whenever new facts require this action to protect the public health. "(e) No person who has thus received an opinion or a notice by the Secretary, pursuant to subsection (d), that a new food additive is unsafe for use under the conditions of its intended use shall thereafter introduce or deliver for introduction into interstate commerce such additive or a food bearing or containing it, without prior notice to the Secretary given by registered mail at least thirty days before the proposed shipment and disclosing its identity, quantity, and destination. "(f) Whenever the Secretary then concludes that this action is necessary to protect the public health, he shall cause an appropriate injunction proceeding to be instituted under section 302 to restrain a violation of section 301 (a) with respect to such additive or a food bearing or containing it; and the final hearing in said proceeding shall be given precedence and otherwise expedited. In said proceeding a temporary restraining order may be issued in accordance with the Rules of Civil Procedure before the United States district courts promulgated under the Act of June 25, 1948 (ch. 646, 62 Stat. 961), as amended (28 U. S. C. 2072). For the purpose of determining whether such order shall issue, the relevant pretesting data submitted by the defendant under this section shall be taken as admissions by him. This subsection shall not be construed to preclude the institution of any other enforcement proceeding authorized by this Act, with respect to such additive or a food bearing or containing it. "(g) No person shall be subject to the penalties of section 303 (a) for having received in interstate commerce and used in good faith a new food additive, if he establishes a guaranty, signed by and containing the name and address of the person residing in the United States from whom he received such additive, to the effect that the food hearing or containing such additive as so used is not adulterated or misbranded within the meaning of this Act. "(h) The Secretary shall promulgate regulations to exempt from this section any new food additive and any food bearing or containing such additive intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety of food." SEC. 6. There are hereby authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for the purposes and administration of this Act. SEC. 7. This Act shall take effect upon the date of its enactment. 85TH CONGRESS 2D SESSION H. R. 10404 IN THE HOUSE OF REPRESENTATIVES JANUARY 30, 1958 Mr. WILLIAMS of Mississippi introduced the following bill; which was referred to the Committee on Interstate and Foreign Commerce 1 A BILL To amend the Federal Food, Drug, and Cosmetic Act for the protection of the public health, by prohibiting new food additives which have not been adequately pretested to establish their safe use under the conditions of their intended use. Be it enacted by the Senate and House of Representa 2 tives of the United States of America in Congress assembled, 3 That section 201 of the Federal Food, Drug, and Cosmetic 4 Act is amended by adding at the end thereof the following 5 new paragraph: 6 "(s) The term 'new food additive' means any substance 7 which, after January 1, 1958, is intended to be newly used 8 for any purpose in the manufacture, packing, processing, 9 preparation, or other fabrication of any food and thus to I |