Hon. OREN HARRIS, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Chairman, Committee on Interstate and Foreign Commerce, DEAR MR. CHAIRMAN: This letter is in further reference to H.R. 5260-the proposed "Federal Hazardous Substances Labeling Act," on which we have made reports recommending enactment with certain amendments and on which the Commissioner of Food and Drugs testified before your committee's Subcommittee on Health and Safety-and S. 1283, an amended companion bill which has passed the Senate and is also pending before your committee. Our prior reports on H.R. 5260, and the testimony of the Commissioner of Food and Drugs, recommended enactment of the bill with amendments identical with those now contained in S. 1283, plus an additional title II proposing certain amendments to the Federal Food, Drug, and Cosmetic Act. Since then, my attention has been invited to the fact that section 4(g) of S. 1283, as passed by the Senate, would make the manufacture of a misbranded hazardous substance a prohibited act if such manufacture occurs within a "territory"-a term defined by the bill (sec. 1(a)) to include "any territory or possession of the United States, including the District of Columbia and the Commonwealth of Puerto Rico but excluding the Canal Zone"-whereas, on the other hand, the intraterritorial shipment of a misbranded hazardous substance would be covered by the bill only if it occurred "within the District of Columbia or within any territory not organized with a legislative body." (See the definition of "interstate commerce" in sec. 2(b) of the bill.) We, therefore, recommend that section 4(g) of the Senate version be amended so as to be applicable only if the manufacture occurs "within the District of Columbia or within any territory not organized with a legislative body." This change would make that bill internally consistent, and it would do so in a way which respects the status of the Commonwealth of Puerto Rico and which, moreover, avoids Federal regulatory and enforcement responsibility with regard to wholly intraterritorial transactions and commerce in any of the territories (such as Guam and the Virgin Islands) "organized [by Act of Congress] with a legislative body." There is enclosed herewith a memorandum suggesting additional minor technical corrections in the language of that bill. The Bureau of the Budget advises that it perceives no objection to the submission of this report to your committee. Sincerely yours, ARTHUR S. FLEMMING, Secretary. STAFF MEMORANDUM ON S. 1283 1. Changes in the provision which would make the manufacture of a misbranded hazardous substance within a territory a prohibited act : Section 4(g) of the bill reads as follows: "SEC. 4. The following acts and the causing thereof are hereby prohibited: "(g) The manufacture within any territory, of any hazardous substance that is misbranded." The Secretary's letter recommends that the words "within any territory" be changed to read “within the District of Columbia or within any territory not organized with a legislative body." Moreover, in line with the scheme of the bill, the prohibited act should be described as the manufacture of a "misbranded package of a hazardous substance" (as that term is defined in the bill), rather than the manufacture of a "hazardous substance that is misbranded". As thus revised, section 4(g) would read: "(g) The manufacture of a misbranded package of a hazardous substance within the District of Columbia or within any territory not organized with a legislative body." 2. Definition of "label": The word "appearing", as contained in the definition of "label" in section 2(n), should read "appear". 54043-60 3. Subparagraph “(c)" under section 2(f)1. of the bill-which subparagraph relates to radioactive substances should be redesignated as subparagraph "(C)". 4. In section 2(1), defining “extremely flammable" and "flammable", delete the comma after the word "solids". 5. In section 5(a), delete "offense" and insert "offenses". 6. In section 6 (c), delete "Territory" and insert "territory". 7. In the first proviso to section 18, delete "remains" and insert "remain". Mr. ROBERTS. Our first witness this morning will be Dr. Emil G. Klarmann, vice president in charge of technical services of Lehn & Fink, Inc., New York. Dr. Klarmann, if you will come around, you may proceed with your statement. STATEMENT OF EMIL G. KLARMANN, ON BEHALF OF CHEMICAL SPECIALTIES MANUFACTURERS ASSOCIATION; ACCOMPANIED BY GEORGE T. SCRIBA, UNION CARBIDE CORP. Mr. KLARMANN. Mr. Chairman and members of the committee, my name is Emil G. Klarmann. I am vice president in charge of technical services of Lehn & Fink, Inc., New York City. I appear this morning on behalf of the Chemical Specialties Manufacturers Association to support the enactment of H.R. 5260. I have served as president of this association and I am presently chairman of its precautionary labeling committee. I hold the degrees of chemical engineer and doctor of science, and I am a lecturer at the New York University Post-Graduate Medical School. With me is Mr. George T. Schiba, vice chairman of the precautionary labeling committee, who substitutes today for Mr. Robert L. Ackerly of the firm of Cummings, Sellers, Reeves, Connor & Kendall, counsel of the Chemical Specialties Manufacturers Association, who is away from and out of the country. Mr. Scriba is also a member of the law department of Union Carbide Corp. The Chemical Specialties Manufacturers Association was founded as a trade association in 1914. It represents approximately more than 400 companies which are engaged in the manufacture and distribution of chemical specialty products for household use in the aerosol, automotive, wax, soap, insecticide, and disinfectant industries. Most of the members of this association manufacture or distribute products for household use the labeling of which will be regulated by H.R. 5260. More than 30 years ago, Congress recognized the need for warning labels on caustic and corrosive substances for household use by enacting, in 1927, the Caustic Poison Act. This act listed 12 chemical substances by name which in specified concentrations were defined as dangerous, caustic or corrosive substances. Any products containing these substances in the specified concentrations were required to be labeled in accordance with this act. A substantial number of States followed this leadership by later adopting the caustic poison law to regulate the intrastate movement of these products. The inadequacy of the Caustic Poison Act has been recognized for many years. Since 1927 many new products have been developed for use in the household. While a large percentage of those products which are hazardous are labeled voluntarily and for protection against civil liability, nevertheless, most interested groups have recognized the necessity of replacing the Caustic Poison Act by legislation which would include all hazardous household substances presently on the market and to be marketed in the future. This of course requires broad definitions and standards in the law. Our association has, through its precautionary labeling committee, studied this field intensively for the past 10 years. This committee is made up of representatives of member companies and includes toxicologists, attorneys, chemists, and others skilled and trained in the development and distribution of products intended for household use and in the preparation of cautionary labels. The committee prepared and released a proposed model law for use by those States interested in legislation on the subject of precautionary labeling of hazardous substances intended for household use. This model served as the basis for legislation which has been enacted in the States of Connecticut, Colorado, Indiana, Illinois, Kansas, Ohio, Texas, and Vermont and for regulations which have been promulgated by New York City and New York State. A similar bill is currently pending in the Massachusetts Legislature. The States of Michigan and Washington have refrained from enacting a law pending the passage of H.R. 5260, which it is believed, will serve as a model for future State legislation. On August 13, 1959, a hearing was held by the Senate Committee on Interstate and Foreign Commerce on S. 1283, which bill is identical with H.R. 5260. This should be supplemented, by the way, by saying that S. 1283 as reported with Report No. 1158 on March 10, 1960, is a bill which contains certain amendments which I shall refer to subsequently. At the hearing, industry representatives presented a number of amendments, which were the result of conferences with representatives of this association, the Manufacturing Chemists Association, the American Petroleum Institute, the Association of Soap and Glycerin Manufacturers, and representatives of the Department of Health, Education, and Welfare. These meetings permitted a full opportunity for an exchange of views both from the industry standpoint and the regulatory standpoint. Since this legislation is relatively new, problems arose in the discussions which had not been considered previously. The result was the series of amendments which were submitted at the Senate committee hearings. These amendments were supported not only by industry representatives but also by the Commissioner of the Food and Drug Administration of the Department of Health, Education, and Welfare who testified before the Senate committee. Recently the Senate committee reported S. 1283 with these amendments. We recommend these same amendments this morning to this committee as appropriate amendments to H.R. 5260. Not only are the industry groups and the Food and Drug Administration in accord with these amendments but also if H.R. 5260 and S. 1283 are identical, the enactment of this legislation this year will be much more likely. Next year, beginning in January, more than 40 State legislatures will be in session. In addition to Michigan and Washington which have already expressed an intent to enact pertinent legislation next year, other States are known to be studying the subject in prepara tion for the 1961 legislative session. The history of similar legislation at the Federal level, particularly the Food, Drug, and Cosmetic Act, and the Federal Insecticide, Fungicide, and Rodenticide Act, has been that the Federal statute serves as a uniform bill for enactment at the State level. Uniformity of precautionary labeling is most desirable for the consumer who will come to recognize and understand the pattern of precautionary labeling and, of course, uniformity is essential to manufacturers who distribute products in interstate commerce for sale on a nationwide basis. We are in full accord with and support the principle of H.R. 5260, and recommend to the committee the amendments adopted by the Senate Committee on Interstate and Foreign Commerce to S. 1283. For the convenience of the committee, these amendments are set forth in detail in a separate document which has already been submitted to the committee, and may I interject again here that where there are any differences between these amendments and S. 1283, Report 1158 as reported on March 10, it is understood that we support the Senate amendments. We have also prepared a clean draft of H.R. 5260 with these amendments so the committee will readily see how these provisions will appear if the amendments are approved. The amendments which the Senate committee has adopted to H.R. 5260 which we have submitted and which we would like now to review, we would now like to submit to the committee, are designed to clarify some provisions of the bill and to facilitate the problem of enforcing its provisions after it is enacted. Mr. ROBERTS. Doctor, pardon me. We have the amendments before us in the form of attached exhibits to your statement. Mr. KLARMANN. Yes, sir. The first suggestion concerns the definition of the term "hazardous substance." The definition of "hazardous substance" in section 2(f) is perhaps the most important definition in the bill since it deseribes those substances or products which will be subject to the requirements of the bill. The definition in H.R. 5260 is consistent with the definition used in existing State laws and regulations and is, we believe, the appropriate definition for this bill. Hazardous substance is defined by first enumerating the classes of hazard to be covered. They include a substance or mixture of substances which is either toxic, corrosive, an irritant, a strong sensitizer, flammable or one which generates pressure through heat, decomposition or other means. These categories include all known classes of hazards in household products excepting radiation which is to be dealt with separately. A product within this definition is subject to the bill if it may cause substantal personal injury or illness during or as a proximate result of any customary or reasonably foreseeable handling or use. Thus, relatively innocuous materials are excluded to prevent overlabeling which could defeat the purposes of the bill. The Department of Health, Education, and Welfare raised the question of whether this definition includes hazards resulting from ingestion of household products by children as well as from accidental or careless use of the product. Unquestionably the definition does include such hazards when reasonably foreseeable. It is well recognized that the primary problem of injury and illness resulting from the handling and use of household products occurs with small children. However, to insure that there will be no question that these classes of hazard are included, we suggest that the definition be amended to state that the customary or reasonably foreseeable handling or use of a product includes reasonably foreseeable ingestion by children. It is our understanding of this bill that it does not intend to extend a manufacturer's liability beyond the common law responsibility of manufacturers and distributors to label their products adequately. The bill, of course, provides a means of enforcing this responsibility. The definition of hazardous substance in this bill is necessarily broad in order to include all products which are truly hazardous substances within the scope of the bill. It uses the words of art of the common law of civil liability and is, we believe, substantially as broad as is common law. The Department of Health, Education, and Welfare has suggested that the Secretary of the Department be delegated specific authority to issue regulations following notice and opportunity for hearing to list substances which the Secretary finds meets the definition of a hazardous substance in this bill. Our industry is in agreement with this recommendation since it will add an area of certainty and clarity to the enforcement program. We also recommend that the exemption for economic poisons as well as for foods, drugs, and cosmetics now contained in section 2(o) (2) be transferred to section 2(f), which contains the definition of hazardous substances, for purposes of clarity. The definition of the term "highly toxic" in section 2(h) (1) is generally accepted as an appropriate method of identifying those substances which should be labeled with the word "POISON" in addition to the other labeling requirements of this bill. This definition is stated in terms of the effect of the product on laboratory animals through ingestion, inhalation, or absorption through the skin in prescribed dosages. The level of dosage is 50 milligrams per kilogram of body weight for ingestion, 200 parts per million or 2 milligrams per liter for inhalation and 200 milligrams per kilogram of body weight for skin absorption. If in any of these tests half or more than half of the animals die within 14 days of the administration of the prescribed dosage, the product is declared to be highly toxic. This definition has long been used by the Department of Agriculture in its enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act and by the Interstate Commerce Commission and has been uniformly adopted by those States which have legislation or regulations governing the labeling of hazardous substances and economic poisons. Section 2(0) (1) (C) would establish, through the use of animal tests identical to those used to determine substances which are "highly toxic," a higher level of toxicity approximately 20 times greater to determine those substances on which the signal word "Danger" should be used. In our discussions with the Department of Health, Education, and Welfare it became apparent that these tests would entail an enormous amount of laboratory testing merely to determine the use |