LAW OFFICES OF HAMEL, PARK & SAUNDERS, Re labeling of hazardous substances, H.R. 5260, S. 1283. Hon. OREN HARRIS, Chairman, Committee on Interstate and Foreign Commerce, DEAR SIR: The Toilet Goods Association, Inc., an organization of manufacturers of perfumes, cosmetics, and other toilet preparations as defined in the Federal Food, Drug, and Cosmetic Act and representing more than 90 percent by volume of that industry, desires to place before your committee its comments on the above-mentioned bills. The proposed legislation exempts products covered by the Federal Food, Drug, and Cosmetic Act, and such exemption is highly desirable in our view. We believe that products covered by the Food, Drug, and Cosmetic Act should be regulated under that act and no other in the interest of uniformity, ease of enforcement, and the understanding and compliance which comes with the familiarity of terms of the regulatory agency. Thus, this association concurs with the view expressed by Dr. George P. Larrick, Commissioner of the Food and Drug Administration, before the Senate Interstate and Foreign Commerce Committee, insofar as cosmetic products are concerned, that the Food, Drug, and Cosmetic Act be amended to cover any hazards with respect to cosmetic products. This may be accomplished by adding a title II to the proposed legislation. The Senate committee suggested that the Food and Drug Administration confer with industry representatives to work out a suitable amendment to protect consumers of cosmetic products. Accordingly, this was done and the Food and Drug Administration and the Toilet Goods Association came to substantial agreement for a suitable protective amendment to the Food, Drug, and Cosmetic Act as is illustrated by drafts as hereinafter set out. We believe that the language of the association is to be preferred; however, the difference between that and the language of the administrative agency is not of great significance. The association limited its remarks then and its recommendations now are strictly with respect to cosmetic products, where the experience of the association may be of value to your committee. The association suggests that the Food, Drug, and Cosmetic Act be amended by adding the following new paragraph to section 602 of such act: ["A cosmetic shall be deemed to be misbranded-] "(e) If because of its nature, composition or packaging it involves a substantial risk of causing substantial injury to health during or as a result of any reasonably foreseeable handling, storage or use by any individual or as a result of reasonably foreseeable ingestion of children unless in either case it bears (in addition to any other prescribed labeling) (1) such cautionary labeling as is necessary for the protection of such persons and (2) where appropriate and necessary, instruction for first aid treatment. Whenever the Secretary finds that any cosmetics or class of cosmetics is subject to the provisions of this paragraph and in his judgment a declaration to that effect will promote the obiectives of this paragraph by avoiding or resolving uncertainty as to its application he may by regulations declare any such cosmetic or class of cosmetics to be, and it shall during the effectiveness of such regulations be deemed to be effective to such provisions. Nothing in the paragraph shall be construed to exempt any article otherwise subject to the requirements of this paragraph from such requirements by reason of the absence of such a regulation." The proposed amendment of the Food and Drug Administration reads as follows: "(e) If because of its nature, composition, or packaging it involves a substantial risk of causing injury to health during or as the result of any reasonably foreseeable handling, storage, or use, by any individual, whether intentional or otherwise, unless in either case it bears (in addition to any other prescribed labeling) (1) such cautionary labeling as is necessary for the protection of such persons and (2) where necessary or appropriate, instruction for first aid treatment. Whenever the Secretary finds that any cosmetic or class of cosmetics is subject to the provisions of this paragraph and in his judgment a declaration to that effect will promote the objectives of this paragraph by avoiding or resolving uncertainty as to its application, he may by regulation declare any such cosmetic or class of cosmetics to be, and it shall during the effectiveness of such regulation be deemed to be, subject to such provisions. Nothing in this paragraph shall be construed to exempt any article otherwise subject to the requirements of this paragraph from such requirements by reason of the absence of such a regulation." Respectfully submitted. FULLER HOLLOWAY, Counsel for the Toilet Goods Association. STATEMENT BY ROY W. PEET ON BEHALF OF ASSOCIATION OF AMERICAN SOAP & GLYCERINE PRODUCERS, INC. Mr. Chairman, members of the committee, my name is Roy W. Peet, and I am filing this statement on behalf of the Association of American Soap & Glycerine Producers, Inc., 295 Madison Avenue, New York City, N.Y. I have been associated with and worked in the soap industry for the past 40 years, having been employed with one of the large soap companies for 29 years and having been manager of the association since 1948. Our association has approximately 150 companies as members. They include members in all sections of the country and represent over 80 percent of the tonnage of soaps and detergents in thie country. We have an interest in H.R. 5260 and believe that a Federal Hazardous Substance Labeling Act is desirable and establishes a model for uniform State legisllation. We have studied the wording of the bill as introduced and believe we can support the bill in general, provided it incorporates the amendments referred to by Dr. Emil Klarmann and which the Senate subcommittee recommended in the companion bill, S. 1283. We have worked with CSMA and the other industry groups on the wording of this bill and the proposed amendments. We believe these amendments clarify the bill, eliminate some of the vagueness and broad generalities and help to protect people from hazardous substances without needlessly involving nonhazardous substances. Typical of the latter are the ordinary household soaps and detergents which have been used by millions of people of all ages for a great many years with great benefit and without harm. In conclusion, we endorse this bill provided the changes outlined by Dr. Klarmann, and now incorporated in the Senate companion bill, are adopted. We understand that these amendments have been fully endorsed by the other interested industry groups and by the Department of Health, Education, and Welfare. We believe that with these amendments the bill would be a sound piece of legislation protecting the public from truly hazardous substances insofar as they can be protected and without involving nonhazardous substances. May I take this opportunity of thanking the chairman and the members of this subcommittee for presenting us with this opportunity to express our views on this bill. THE ASSOCIATION OF STATE AND TERRITORIAL HEALTH OFFICERS, Indianapolis, Ind., March 18, 1960. Hon. OREN HARRIS, Chairman, House Committee on Interstate and Foreign Commerce, House Office Building, Washington, D.C. DEAR CONGRESSMAN HARRIS: It is my pleasure to forward to you, at the instruction of the Association of State and Territorial Health Officers, the action taken by that organization at its annual conference held on October 14-16, 1959. The association recommended that in the interests of accident prevention and as a matter of public policy, packages or containers of materials should have uniform information clearly stated on the label, identifying: (1) The most toxic ingredients; (2) The paths of absorption by which the ingredients may enter the body; (3) The kind of hazard involved (pictorial representation, if available); (4) The approximate toxicity expressed either as a grade of precautionary wording or as some visual method of quantitation; (5) Any known antidote and first-aid procedures; (6) The precautions to be taken in using the material; (7) The precautions to be taken where special hazard materials (such as medications or household materials) might be easily available to children. Because the resolution pertains to congressional action, and most particularly to your committee, I am forwarding it to you with the hope that it will be helpful in any deliberations on this subject. Please be assured that the association will be available to provide additional information should this be necessary. Sincerely, A. C. OFFUTT, M.D., Secretary-Treasurer. Hon. KENNETH A. ROBERTS, AMERICAN HOSPITAL ASSOCIATION, WASHINGTON SERVICE BUREAU, Chairman, Subcommittee on Health and Safety, Interstate and Foreign Commerce Committee, House Office Building, Washington, D.C. DEAR CONGRESSMAN ROBERTS: Your subcommittee, I understand, has under consideration H.R. 7352, which embodies the provisions of the proposed Uniform Hazardous Substances Act. The American Hospital Association supports the principles underlying this proposal. We believe there is a need for legislation which will control more effectively the labeling of hazardous substances that are not covered by the Federal Food, Drug, and Cosmetic Act. The concern of hospitals in this area is based both on their general interest in the health of the people and in accident prevention, and on the fact that many hospitals operate poison control centers. We think it important not only that there be adequate warning of danger, but also that as complete information as is practicable regarding remedial measures be made available to users, since time is so often a vital factor in cases of poisoning. There is one minor point which is of some concern to hospitals, though with respect to Federal legislation our concern is probably limited to the District of Columbia and other Federal territory. Hospitals frequently compound, on their own premises, disinfectants, or other cleaning materials for use within the hospitals, and it would seem to us inappropriate and needlessly burdensome to require that the containers of such materials bear all of the warnings that should accompany similar materials sold for household use. I doubt that the provisions of H.R. 7352 would be construed to apply to materials produced in a hospital for its own use, but if you agree that application in such cases would be inappropriate, I believe that a statement to this effect in the report of your subcommittee would be helpful. If it is not too late, I should like to request that this letter be incorporated in the record of the hearing before your subcommittee. Sincerely yours, Hon. OREN HARRIS, KENNETH WILLIAMSON, Associate Director.. U.S. ATOMIC ENERGY COMMISSION. Chairman, House Committee on Interstate and Foreign Commerce, DEAR MR. HARRIS: I have been informed by the Bureau of the Budget, that your committee is now considering H.R. 5260 a bill to regulate the interstate distribution and sale of packages of hazardous substances intended or suitable for household use. As you know, a similar bill is before the Senate as S. 1283. I thought you might be interested in a copy of the comments on the bill which we submitted to the Senate Committee on Interstate and Foreign Commerce. Sincerely yours, DWIGHT A. INK, Assistant General Manager.. Hon. WARREN G. MAGNUSON, U.S. ATOMIC ENERGY COMMISSION, Chairman, Committee on Interstate and Foreign Commerce, DEAR SENATOR MAGNUSON: This letter is in reply to your request for the Commission's comments on S. 1283, a bill to regulate the interstate distribution and sale of packages of hazardous substances intended or suitable for household use. By far, the greatest volume of radioactive material which is in commercial or other use in this country is source, special nuclear or byproduct material subject to the regulations of the Atomic Energy Commission pursuant to the Atomic Energy Act of 1954, as amended. The act established a comprehensive system of regulatory control by the Atomic Energy Commission over such materials in order to protect health and safety and the common defense and security. Except for very small quantities of source material exempted by Commission regulations, the possession, use or transfer of such materials without a license from the Commission is unlawful; and licensees are required to observe such regulations and orders as may be issued by the Commission in order to protect health and safety. In order to carry out its responsibilities under the Atomic Energy Act of 1954 the Commission has issued a number of regulations to protect health and safety, which apply to the possession and use of source, byproduct, and special nuclear material. These regulations include part 20, "Standards for Protection Against Radiation"; part 30, "Licensing of Byproduct Material"; part 40, "Control of Source Material"; part 50, "Licensing of Production and Utilization Facilities"; part 70, "Special Nuclear Material"; and part 71, "Protection Against Accidental Conditions of Criticality in the Shipment of Special Nuclear Material." Copies are enclosed. Other regulations are in course of preparation. The Commission's regulations establish detailed requirements and criteria for the issuance of licenses; and permit the use of licensed materials only for such uses as the Commission has found by regulation or in the applicable license to be consistent with health and safety. Appropriate labeling of articles containing source, byproduct, and special nuclear material is required. Exceptions from labeling requirements are contained in part 20 only for exceedingly small quantities of such materials. Basically, the Commission's regulations require that: 1. Each licensee or his staff must have suitable training or experience to possess and use the material or facility safely for the purpose for which it is requested; 2. His equipment, facilities, and operating procedures must be adequate to protect health and minimize danger to life and property; 3. The location of the proposed use must be suitable for the purpose; 4. He may use the material or facility only for a purpose authorized in his license; 5. He may not transfer the material or facility except to a person authorized to receive it and may not dispose of radioactive material except as authorized. Exemptions from specific licensing requirements are provided only for the very small quantities of byproduct material specified in section 30.72 and very small quantities of source material. Depending on the nature of the licensed activity, periodic inspections of licensees are made to assure their compliance with the Commission's requirements and to determine whether previously unforeseen hazards may arise. The Commission has authorized the introduction of byproduct material into products intended for household use only if authorized in a specific license issued pursuant to section 30.71. Under that section the Commission has authorized the introduction of byproduct material into the four types of devices specified in that section, namely, static elimination devices, spark gap, and electronic tubes, light meters and ion generating tubes. It should be emphasized that section 30.71 is effective only when the specified devices contain not more than the quantity of byproduct material specified in the section and then only if the device has been "manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued to him pursuant to the regulations ***." The quantity of source material permitted without a license, and the quantities of byproduct material permitted under a general license are not large enough to permit their introduction on a significant scale into household products without a specific license from the Commission. In addition, persons possessing byproduct material under a general license may not administer such material to human beings or add it to any food, beverage, cosmetic or drug, or include it in any device intended for use in the treatment of human beings or animals. In view of the Commission's extensive authority under the Atomic Energy Act of 1954 and the comprehensive scope of its regulatory program to protect against hazards to health and safety arising out of the possession, use and transfer of byproduct, source and special nuclear material, the Commission is aware of no purpose which would be served by including those materials within the scope of the bill. Indeed, the bill would apply only with respect to substances which "may cause substantial personal injury or illness during any customary or reasonably anticipated handling or use" (sec. 2(f)); and the Commission would not under such circumstances authorize the introduction of byproduct, source or special nuclear material into household products. In view of the fact that the Commission is presently exercising far more extensive controls with respect to source, byproduct, and special nuclear material to protect health and safety than would be provided in S. 1283 with respect to such materials, we urge that these materials be excluded from the applicability of the bill. For this purpose, we suggest that the following be added at the end of subsection 2(f) of S. 1283: "the term 'hazardous substance' shall not include any source material, special nuclear material or byproduct material as defined in the Atomic Energy Act of 1954, as amended, and regulations issued pursuant thereto by the Atomic Energy Commission." Sincerely yours, A. R. LUEDECKE, General Manager. Mr. ROBERTS. The subcommittee will stand in recess until further call of the Chair. (Whereupon, at 12:10 p.m., the hearing was adjourned.) |