has been urged as a solution of the spray residue problem. There is adequate evidence to establish the deleterious character of certain fluorine compounds and reason to look with suspicion upon all such compounds. The presence of fluorine spray residues on fruits shipped within the jurisdiction of the Federal Food and Drugs Act will be regarded as a basis for action under that law. Sincerely yours, R. G. TUGWELL, DEPARTMENT OF AGRICULTURE, Notice to Growers and Shippers of Fruits: This Department, in announcing on April 2, 1933, a spray residue tolerance on lead, stated that it, in cooperation with State agencies, was studying the possibilities of developing effective lead-free spraying materials, and that meanwhile lead residues should "be held to the lowest possible point." That announcement fixed as a limit 0.014 grain of lead per pound of fruit. A wide survey in fruit producing areas has indicated that a schedule of spraying adequate to a control of pests will result in an amount of lead residue so great that the most efficient spray-removal methods now known will not reduce the lead in a material proportion of the crop to the 0.014 tolerance. This tolerance is therefore revised to 0.02 grain lead per pound of fruit for the 1933 crop. The tolerance of 0.014-grain per pound will become effective for the 1934 crop unless the intensive and greatly expanded work now being carried out on nonlead arsenicals proves successful and permits a total abandonment of lead for 1934. The scope of knowledge of the toxicity of fluorine is restricted. Available scientific data indicate that it is not more toxic than arsenic. Limited experments in the removal of fluorine spray residue point to the conclusion that it is more easily removed than either arsenic or lead. For the 1933 fruit crop prosecutions will not be instituted on fluorine spray residue if the fluorine is not in excess of 0.01-grain per pound. Very truly yours, HENRY A. WALLACE, Secretary. DEPARTMENT OF AGRICULTURE, Notice to Growers and Shippers of Fruits: In the Department's announcement of June 20, 1933, a lead tolerance of 0.014 was forecast for the 1934 season. In the absence of a commercially feasible lead arsenate substitute it is evident that despite the most effective washing method a material amount of fruit will not meet the tolerance of 0.014 grain lead per pound. Accordingly, a tolerance of 0.019 grain lead per pound of fruit is announced for the 1934 crop. It is hoped that by the end of the 1934 season the various lines of research now under way will enable the industry to meet a tolerance of 0.014 grain per pound the following year and perhaps, to eliminate lead entirely as is now being done in vegetables. There are no indications of any additional knowledge on the toxicity of fluorine which calls for a change in the tolerance of 0.01 grain per pound announced June 20, 1933. Present indications are that fluorine is not as easily removed as was earlier thought to be the case. The tolerance for arsenic will remain at 0.01 grain arsenic trioxide per pound of fruit. Very truly yours, R. G. TUGWELL, Acting Secretary. The CHAIRMAN. We will be glad to have your brief on the suggested amendment. We will now call upon Dr. George W. Hoover. STATEMENT OF DR. GEORGE W. HOOVER Dr. HOOVER. I am a consulting chemist in Washington, D.C. Previously, I was engaged actively in aiding in the enforcement of the Federal Food and Drug Act for some 20 years. The statements that I have to make are not based on theoretical considerations, but are based upon practical experience and with the enforcement of the Food and Drug Act. Senator MCNARY. Are you for or against the measure? Dr. HOOVER. I am heartily in accord with the intent and purpose of this bill. Senator MCNARY. Otherwise you are against it? Dr. HOOVER. No. The CHAIRMAN. Go ahead. Mr. HOOVER. I have an amendment to offer to this bill. Dr. HOOVER. I suggest there be inserted on page 12, section 9, and to be inserted before "False advertisement." Minor violations. (a) If the Secretary finds food, drugs, or cosmetics in violation of the provisions of this act in minor respects only where no question of public health or fraud and deceit are involved, he shall give the responsible party or parties notice and reasonable opportunity for the correction of such infractions before the application of other provisions of this act. (b) The Secretary is hereby authorized to make and promulgate regulations for carrying out the provision applying to minor violations of the law. The CHAIRMAN. You want to make a distinction between minor violations which have nothing to do with public health and more serious ones which may invade the field of public health or perpetrate a fraud upon it? Senator MCNARY. Will you illustrate the situation? Dr. HOOVER. In the enforcement of the present Federal Food and Drug Act there arises annually hundreds of cases in which the violations are regarded by officials and all those concerned as inconsequential, insignificant, technical, but they are violations nevertheless. I refer particularly to a case in which there is a declaration of the net contents of the food required to be stated on the label, the regulations require that it be stated in certain sized type, and in certain forms. If found at points where it may not be exactly on the right space or in the same size type, and frequently there is found a poor use of a word or phrase that is wrong, it is not wholly in compliance with the law. These people that make these statements do so honestly and believe that they are complying with the law. The notice to these people in over 95 percent of the cases will cause an immediate correction of the situation. The fact is that this law is being enforced in the present as an absolutely mandatory law. Dr. Wiley held, and succeeding doctors have held, that there is no discretion actually in the law. Consequently, these cases based upon these minor, insignificant, technical violations follow the same course that the violations representing substantial violations, vicious violations of the grossest sort, must go to trial or go through the heavy, cumbersome procedure, and some way should be found to take care of those cases in an efficient and expeditious manner. This is in the interests of the public and the manufacturers alike. If a simple procedure is made to take care of 30390-34-15 these cases you handle 12 of them in the time you can handle 1 case in the heavy procedure. The officials will have time to devote themselves to things that they do not have the time to devote now. The CHAIRMAN. I am impressed by your suggestion. You will recall yesterday that I asked Mr. Campbell about putting the word "material" in there because it seemed to me that there might be violations unimportant in the sense of their effect on the public health, and I will be very glad if you will give me also a copy of this proposed amendment, and one for the record. Mr. HOOVER. That represents all I have to say. The CHAIRMAN. We will call upon at the present time Mr. Donald J. Burke. Mr. THOMAS. At this time I would like to introduce into the record the National Durg Trade Conference draft of suggested amendments to drug provisions of the present Food and Drug Act, subject to revision, which is to be connected with the statement of Dr. James H. Beal, representing the National Drug Trade Conference. In the following bill each section is designated by the number as given in the code; also by section number of the original act; matter to be deleted is given in brackets; new matter in italic. In view of the fact that Dr. Beal made certain remarks in the record, I should like to have it included in the record, too, if it can be done. The CHAIRMAN. In view of your request, it may be included in the record. Just give it to the stenographer and he will take care of that. A BILL To amend the Food and Drugs Act, June 30, 1906, as amended, August 23, 1912, March 3, 1913, March 4, 1913, July 24, 1919, January 18, 1927, and July 8, 1930, for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, cosmetics, and liquors, and for regulating traffic therein, and for other purposes 8717. SECTION 1. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That it shall be unlawful for any person to manufacture within any Territory or the District of Columbia any article of food, drug or cosmetic which is adulterated or misbranded, within the meaning of this act; and any person who shall violate any of the provisions of this section shall be guilty of a misdemeanor, and for each offence shall, upon conviction thereof, be fined not to exceed five hundred dollars or shall be sentenced to one year's imprisonment, or both such fine and imprisonment, in the discretion of the court, and for each subsequent offense and conviction thereof shall be fined not less than one thousand dollars or sentenced to one year's imprisonment or both such fine and imprisonment, in the discretion of the court. 8718. SEC. 2. That the introduction into any State or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or from any foreign country, or shipment to any foreign country of any article of food, drug, or cosmetic which is adulterated or misbranded, within the meaning of this act, is hereby prohibited; and any perons who shall ship or deliver for shipment from any State or Territory or the District of Columbia to any other State or Territory or the District of Columbia, or to a foreign country, or who shall receive in any State or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or foreign country, and having so received, shall deliver, in original unbroken packages, for pay or otherwise, or offer to deliver to any other person, any such articles so adulterated or misbranded within the meaning of this act, or any person who shall sell or offer for sale in the District of Columbia or the Territories of the United States any such adulterated or misbranded foods, [or] drugs or cosmetics, or export or offer to export the same to any foreign country, shall be guilty of a misdemeanor and for such offense be fined not exceeding $200 for the first offense, and upon conviction for each subsequent offense not exceeding $300 or be imprisoned not exceeding 1 year, or both, in the discretion of the court: Provided, That no article shall be deemed misbranded or adulterated within the provisions of this act when intended for export to any foreign country and prepared or packed according to the specifications or directions of the foreign purchaser when no substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article is intended to be shipped; but if said article shall be in fact sold or offered for sale for domestic use or consumption, then this proviso shall not exempt said article from the operation of any of the other provisions of this act. 8719. SEC. 3. That [the Secretary of the Treasury] the Secretary of Agriculture, [and the Secretary of Commerce and Labor] shall make uniform rules and regulations for carrying out the provisions of this act, including the collection and examination of specimens of foods, [and] drugs and cosmetics manufactured or offered for sale in the District of Columbia, or in any Territory of the United States, or which shall be offered for sale in unbroken packages in any State other than that in which they shall have been respectively manufactured or produced, or which shall be received from any foreign country, or intended for shipment to any foreign country, or which may be submitted for examination by the chief health, food, or drug officer of any State, Territory, or the District of Columbia, or at any domestic or foreign port through which such product is offered for interstate commerce, or for export or import between the United States and any foreign port or country. 8720. SEC. 4. That the examination of specimens of foods, [and] drugs and cosmetics shall be made in [the Bureau of Chemistry of the Department of Agriculture] such existing bureau or bureaus in the Department of Agriculture as may be directed by the Secretary of Agriculture, or under the direction and supervision of such bureau, for the purpose of determining from such examinations whether such articles are adulterated or misbranded within the meaning of this act; and if it shall appear from any such examination that any of such specimens is adulterated or misbranded within the meaning of this act, the Secretary of Agriculture shall cause notice thereof to be given to the [party from whom such sample was obtained] manufacturer of such article if known or if unknown to the party who caused said article to be introduced into interstate commerce. Any party so notified shall be given an opportunity to be heard, under such rules and regulations as may be prescribed as aforesaid, and if it appears that any of the provisions of this act have been violated by such [party] manufacturer or such person who introduced the article in interstate commerce, then the Secretary of Agriculture shall at once certify the facts to the proper United States district attorney, with a copy of the results of the analysis or the examination of such article duly authenticated by the analyst or officer making such examination, under the oath of such officer. After judgment of the court, notice shall be given by publication in such manner as may be prescribed by the rules and regulations aforesaid. 8721. SEC. 5. That it shall be the duty of each district attorney to whom the Secretary of Agriculture shall report any violation of this act, or to whom any health or food or drug officer or agent of any State, Territory, or the District of Columbia shall present satisfactory evidence of any such violation, to cause appropriate proceedings to be commenced and prosecuted in the proper courts of the United States, without delay, for the enforcement of the penalties as in such case herein provided. 8722. [SEC. 6. That the term "drug", as used in this act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals. The term "food", as used herein, shall include all articles used for food, drink, confectionery, or condiment by man or other animals, whether simple, mixed, or compound.] SEC. 6. The term "food" includes all substances and preparations used for, or entering into the composition of food, drink, confectionery, or condiment for man or other animals. The term "drug" includes (1) all substances and preparations recognized in the United States Pharmacopoeia or National Formulary or supplements thereto; and (2) all substances, preparations, and devices intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) all substances and preparations, other than food, and all devices, intended to affect the structure or any function of the body of man or other animals. The term "cosmetic" includes all substances and preparations intended for cleansing, or altering the appearance of, or promoting the attractiveness of, the person. 8723. SEC. 7. That for the purposes of this act an article shall be deemed to be adulterated; In case of drugs: First. If, when a drug is sold under or by a name recognized in the United States Pharmacopoeia or National Formulary or supplements thereto, it differs from the standard of strength, quality, or purity, as determined by the test laid down in the United States Pharmacopoeia or National Formulary or supplements thereto, it differs from the standard of strength, quality, or purity, as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation: Provided, That no drug defined in the United States Pharmacopoeia or national Formulary shall be deemed to be adulterated under this provision if the standard of strength, quality, or purity be plainly stated upon the bottle, box, or other container thereof, although the standard may differ from that determined by the test laid down in the United States Pharmacopoeia or National Formulary: And provided further, That no drug defined in the United States Pharmacopoeia or National Formulary or supplements thereto, shall be deemed to be adulterated under this provision if it complies with the standard of strength, quality and purity as determined by the test laid down in the United States Pharmacopoeia or National Formulary or supplements thereto, notwithstanding that it may have been made by a modification of the official formula or directions made necessary to meet manufacturing requirements. Second. If its strength or purity fall below the professed standard or quality under which it is sold. In the case of confectionery: If it contain terra alba, barytes, talc, chrome yellow, or other mineral substance or poisonous color or flavor, or other ingredient deleterious or detrimental to health, or any vinous, malt, or spirituous liquor or compound or narcotic drug. In the case of food: First. If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength. Second. If any substance has been substituted wholly or in part for the article. Third. If any valuable constituent of the article has been wholly or in part abstracted. Fourth. If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed. Fifth. If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health: Provided, That when in the preparation of food products for shipment they are preserved by any external application applied in such manner that the preservative is necessarily removed mechanically, or by maceration in water, or otherwise, and directions for the removal of said preservative shall be printed on the covering or the package, the provisions of this act shall be construed as applying only when said products are ready for consumption. Sixth. If it consist in whole or in part of a filthy, decomposed, or putrid animal or vegetable substance, or any portion of an animal unfit for food, whether manufactured or not, or if it is the product of a diseased animal, or one that has died otherwise than by slaughter. In the case of cosmetics: If it contains poisonous or deleterious ingredients in such quantities as likely to be imminently dangerous to the user under the conditions of use prescribed in the labeling thereof, or when used under such conditions of use as are customary or usual. 8724. SEC. 8. That the term "misbranded", as used herein, shall apply to all drugs, or cosmetics, or articles of food, or articles which enter into the composition of food, the package, [or] label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular, and to any food, [or] drug or cosmetic [product] which is falsely branded as to the State, Territory, or country in which it is manufactured or produced. The term "package" or "original unbroken package" as used herein means the immediate container of the article which is intended to be delivered for consumption by the public. The term "label" includes all written, printed, and graphic matter in any form whatsoever accompanying any food, drug, or cosmetic. That for the purposes of this Act an article shall also be deemed to be misbranded: In case of drugs: First. If it be an imitation of or offered for sale under the name of another article. Second. If the contents of the package as originally put up shall have been removed, in whole or in part, and other contents shall have been placed in such package, or if the package fail to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis, chloral hydrate, or acetanilid, or barbituric acid, or any derivative or preparation of any such substances contained therein. |