result. Clearly, any restrictions on private industry going beyond what is required in the interest of public health would be totally uncalled for, and would not be authorized by the act. In spite of this authority that would be granted to the Secretary, and his responsibilities to the public and industry in exercising that authority, the proposed bills do not provide for any of the safeguards long thought necessary in a democratic form of government. Section 203(d)(2)(A) provides that "regulations under this section shall, from time to time, be issued, amended, or repealed by the Secretary without regard to the requirements of the basic act. ***" The effect of this provision is to eliminate the need for publication, notice, comments, objections, hearings, findings, and judicial review. This association and its canning members believe that section 203 (d) (2) (A) is contrary to all concepts of sound legislation, good government, constitutional requirements, fair procedure, and due process of law. We do not understand why such a provision was thought to be necessary. Surely the public health can be adequately protected without complete disregard for all procedural safeguards. Even if the unlikely situation arises where newly discovered evidence discloses that a long-used additive must be removed from the market in the interest of public safety, the regulatory procedures outlined in the basic act could be used, supplemented, if necessary, by public announcement, seizure, restraining order and injunction. We propose, therefore, that section 203(d) (2) (A) of the bills be changed to accord with proposed section 706(d), which inakes applicable the procedural provisions of section 701 of the basic act, as modified by the standard of judicial review in the food additives amendment. At this point I would like to add to our statement that we agree with the suggestion which we understand will be made by another witness today that proposed section 203 (d) (3) be eliminated. That provision is entirely unnecessary once procedural safeguards are included, and we feel its ambiguity can only confuse and interfere with the proper functioning of the provisional listing procedures. In summary, then, the National Canners Association urges the enactment of a color additive bill similar in scope to the Food Additives Amendment of 1958. We feel this can be effectively achieved by a series of revisions in H.R. 7624 or S. 2197: 1. Redfine "color additive" to mean those substances that are "artificial colorings" as defined in the current FDA regulations under section 403(k), except that the term shall not include substances used primarily for purposes other than coloring, or substances generally recognized as safe for use. All ingredients used in foods that are not covered by this definition would have to meet the tests provided in the food additives amendment. 2. Remove all references to economic determinations by the Secretary, and limit the bill to the question of public health. This would involve: (a) The removal of the term "suitable" throughout the bill; Economic adulteration and misbranding violations would, of course, remain subject to the traditional sanctions of the basic act. 3. Provide procedural safeguards for provisional listing, by changing section 203 (d) (2) (A) to conform to section 706(d). If these few, but necessary, changes are made, we believe that the resulting bill would accomplish all of the acknowledged objectives of the legislation, and would assure the consumer of the safety of color additives used in foods, drugs and cosmetics. Mr. WILLIAMS. Does that complete your statement? Mr. DUNKELBEFGER. Yes, sir. Mr. WILLIAMS. Thank you very much. Mr. YOUNGER. Yes; I do, Mr. Chairman. Where you use the expression "generally recognized as safe," would that be more inclusive than where you say it has been generally used over a period of years? Mr. DUNKELBERGER. No, sir. When we talk in terms of general use over a period of years, that is just a shorthand way of referring to a provision in the act that would cover general recognition of safety. As I understand it, the general recgonition of safety clause in the food additives amendment does not apply to all substances that were used prior to the enactment of the act but only to those substances which scientists and experts qualified to judge could say were generally recognized as safe. We would merely take that same test, the general recognition of safety provision, which is now in the food additives amendment and put it in the color bill. Mr. YOUNGER. In other words, you would not have the test as having been used? Mr. DUNKELBERGER. No, sir. The only test would be whether the substance was generally recognized as safe; and in two ways that could be established; having been shown by scientific procedures to the satisfaction of experts, or through common long use, either one. Mr. YOUNGER. You are proposing that even a new color additive that has never been used in the canning industry at all, could be used without the approval, provided you could furnish satisfactory evidence, scientific evidence, that it is safe? Mr. DUNKELBERGER. I do not believe it would work that way, Mr. Congressman. As I understand the FDA's operation of the general recognition of safety clause, they circulate a larger number of experts in the field and ask them if in accordance with their knowledge, this substance can be regarded as generally recognized as safe. I do not think they feel that it could be applied to new additives, and we would agree I believe with that position. A new substance developed after the enactment of the act-just by the fact that none of the experts would have known about it could not be regarded as generally recognized as safe. All new substances after the enactment of the act would, in order to qualify, have to be subject to the pretesting and licensing procedures in the bill. Mr. YOUNGER. Your paper does not make that definition as certain as I would have liked to have seen it. Now, your concern about the power of the Secretary to issue rules and regulations without hearings, and so forth. Is it your feeling that this act, as drawn, removes it from the Administrative Procedure Act! Mr. DUNKELBERGER. Well, that is a question that ultimately will have to be determined, I guess, when someone challenges it in court. The cases interpreting when judicial review has been withdrawn, under the terms of the Administrative Procedure Act, go in a million different directions. In the provisional listing section, the term is regulations shall be issued without regard to the requirements of the basic Act. Now, whether that would be interpreted by a court as saying it is meant that no judicial review would be available, is questionable. We feel that since even the permanent listing in this bill, Food Additives, Pesticide Chemicals, and all of the other regulations issued by the Food and Drug Administration are covered by specific procedures, these same procedures should be applied in this one section, the pro visional listing section. That would then Mr. YOUNGER. That question was asked of Mr. Flemming when he was before the committee. Mr. DUNKELBERGER. Yes, sir. Mr. YOUNGER. And certainly it was his interpretation and the interpretation of the Department that in no way did this bill take the color additives outside of the Administrative Procedure Act. Would you be satisfied with the Administrative Procedure Act in regard to regulation! Mr. DUNKELBERGER. Mr. Congressman, I understood the Secretary to say that if the procedures were not provided in the provisional section, he would not be opposed to them being included in the section. He pointed out that the permanent listing has the same procedures that Food and Drug has operated under since 1938 and perhaps before, and that he would go along with including those procedures in the provisional listing section. I did not understand him to say that he would leave the provisional listing to be covered by the Administrative Procedure Act. We would prefer that any question of ambiguity be resolved in favor of certainty. If it is felt that the APA would apply, we cannot see why there would be any objection to a specific provision providing for procedures for notices and hearing and judicial review, which has been included in all other amendments to the act. Mr. YOUNGER. That is all, Mr. Chairman. Mr. WILLIAMS. Mr. Rogers. Mr. ROGERS of Florida. Mr. Chairman, I thought the statement was a very excellent one and has brought up some points that I think we have not yet considered. I think the point you make about the purpose is probably well made that we should go into it. In carrying on the discussion that you have just had with Congressman Younger, it is my recollection that the Secretary stated that under the provisions, as the bill is now drawn, it would be possible, for instance, for them to delist anything without any hearing at all, although it might be subject to judicial review later on. There would be no requirement for a hearing, and he said he would have no objections to that being applied to this act. So I think probably that could be remedied without too much trouble. That is all I have, Mr. Chairman. Mr. WILLIAMS. Mr. Avery. Mr. AVERY. No questions, Mr. Chairman. Mr. BROCK. No questions, Mr. Chairman. Mr. WILLIAMS. The next witness is the Honorable James A. Haley, Member of Congress from the State of Florida. Mr. Haley, we will be glad to hear you. STATEMENT OF HON. JAMES A. HALEY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF FLORIDA Mr. HALEY. Mr. Chairman and gentlemen of the committee, in view of my previous appearance before this committee and the introduction of special legislation for the purpose of allowing the certification of Citrus Red No. 2, this committee is well informed of my intense interest. It has been clearly established that the coloring of oranges is an economic necessity and the color used has been thoroughly tested with reference to cancer, as well as to whether it is safe otherwise, and its safety has been determined as to all factors. It is now being listed and certified under the special legislation passed. My chief interest is to see that this listing is not disturbed and that the regulations are such that at all times there shall be an adequate, safe color for the use of the citrus industry. The record clearly shows and statements by Dr. Larrick and the Secretary also show that the ethylene method and the use of Citrus Red No. 2 is safe, and that neither Citrus Red No. 2 nor the ethylene method promote deceit, and that the ethylene method is not covered under the definition of "food additives." We also understand that there has been assurance of immediate listing of Citrus Red No. 2 under the provisions of this act. If it is thought an amendment is necessary to assure this, I respectfully urge that the bill be amended to so include. The continued, uninterrupted use of the coloring of oranges is absolutely necessary. During the period when there was no color listed and coloring was not allowed in Canada, shipments of fresh fruit were reduced by more than half. I wish to thank the committee for its previous help in our problem and stand ready to furnish any further information which the committee may desire. Mr. WILLIAMS. The committee has received a communication for insertion in the record at this time, one which I think perhaps would be of particular interest to the committee, and also the public, and I want to take the liberty at this time of asking the clerk if he will read that for the information of the committee. Mr. WILLIAMSON. Mr. Chairman, this letter is from the Health, Education, and Welfare Department, dated February 8, 1960: DEAR MR. CHAIRMAN: It has come to my attention that two questions have been raised concerning the scope of the proposed color additives legislation now being considered by your committee (S. 2197 and H.R. 7624). Since these ques tions were not covered by my testimony on January 26, I am taking this opportunity of letting you have the views of our Department on them. A representative of the packaging industry has expressed to us an apprehension that the Department's proposed legislation might be construed as applying to coloring materials used in food wraps and other food packaging materials even where the color does not migrate from the wrap to the food or, if there is migration, where it is so slight that it would cause no color in food discernible by the unaided eye. It is our view that the color additives amendment would not apply to color materials in food wraps that do not migrate from the wrap to the food. Additionally, it is our view that the bill is intended to regulate substances that color or are capable of coloring food to a degree apparent to the naked eye. Thus, a component of food packaging that migrated into food but did not change its color in the ordinary sense of the term would continue to be regulated, if necessary, under the food additives amendment and would not become subject to the proposed color additives bill. The second question relates to pesticide chemicals as defined in section 201 (q) of the Federal Food, Drug, and Cosmetic Act. We are advised that certain fungicides used in fruit production have the effect not only of protecting the tree against plant diseases but also of affecting or supporting natural plant processes so the plant produces better color and finish in the fruit; and some plant growth regulators, when applied to plants, likewise enhance the development of normal color in produce derived from them. It is our view that pesticide chemicals used in this way are not color additives within the meaning of the proposed legislation and do not impart an artificial color to the raw agricultural commodities. Rather, they promote the development of the natural color of produce as a result of the normal physiological processes of the plant. The legislation which we drafted was not intended to apply to pesticide chemicals which enhance color by affecting or supporting natural plant processes and we would expect to continue to regulate pesticide. chemicals, if the bill is enacted in its present form, under the pesticide chemicals amendment and not the color additives amendment. Sincerely yours, Mr. WILLIAMS. Thank you very much. ARTHUR S. FLEMMING, Secretary. I believe the next witness is Mr. Paul Gerden. STATEMENT OF PAUL GERDEN, GENERAL COUNSEL AND SECRE TARY, ABBOTT LABORATORIES; ACCOMPANIED BY EDWARD J. MATSON, DIRECTOR OF SCIENTIFIC ADMINISTRATION Mr. GERDEN. Mr. Chairman, I am secretary and general counsel of Abbott Laboratories; and I would like to introduce my associate, Edward J. Matson, director of scientific administration for Abbott Laboratories. Mr. WILLIAMS. Would you like to have him sit with you! Mr. GERDEN. I would like to have him sit with me, sir, if you have no objection. Mr. Chairman, Abbott Laboratories appreciates this opportunity to present to you its views on proposed color additive legislation. The extreme importance of this legislation derives not only from the public health protection it seeks to insure but also from its impact on the very wide segment of American industry that is now and will be affected by the regulation of colors for use in foods, drugs, and cosmetics. Abbott Laboratories' particular interest in this legislation is not that of a producer of color additives, but that of a pharmaceutical user, to which the variety, safety, and effectiveness of available colors is a matter of great commercial and medical concern. Abbott Laboratories is a major producer of a wide line of pharmaceutical products, most of which are sold through pharmacists on doctors' prescriptions, : |