26 FOOD, DRUGS, AND COSMETICS that, when they are unnecessary, added deleterious substances should be eliminated altogether. We recognize, at the same time, that tolerances must be established for fruit and vegetables, but should be restricted to amounts safe for consumption. The CHAIRMAN. It occurs to me that ense of administration would be materially promoted if you have a small group of poisons now known to the Department as likely to be found in food-Jam referring now to chemical poisons--that if you actually wrote into your bill the tolerances and quantities which would be permitted, you would have the same ease of administration that you have with regard to butter. Mr. CAMPBELL. Quite right, if that could be done. Of course it would be the ideal and proper way, but I doubt whether it can be done. Shall I go ahead with section 4? The CHAIRMAn. You may proceed. Mr. CAMPBELL. On line 3, page 4, under item (3) of this subparagraph, the same language is used to define adulteration that is now employed in the present net. Under item (4), you will find the new language. It is: "if it bas been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth;" Under the present law, the only action that can be taken to require the observance of sanitary precautions in the handling of food is to be found in section 7, paragraph 6, which deems a food product to be adulterated if it is filthy. The CHAIRMAN. Would that cove" rat dirt and the excreta of animals? Mr. CAMPBELL. Yes; it would cover that and as a matter of fact, those instances where food had been prepared under objectionable and thoroughly insanitary conditions, even though you could not find, upon an objective examination of the sample, the evidence or definite proof of that filthy condition. Let me illustrate: On the Eastern Shore of Maryland and Virginis, there is a concentrated industry engaged in the preparation of fresh crab meat. It is a favored article of food along the eastern coast, and also in certain other sections of the country, at certain times of the year. In some places, it has been found that the conditions under which this perishable food product was prepared were such as to lend themselves to contamination of this food. Such contamination has manifested itself by outbreaks of illness in the principal consuming sections of the country. Perhaps the very food that may have been responsible for the illness had been sampled and examined by the Department, but the Jimitations of bacteriological examination are such that affirmative evidence of the filthy condition could not have been obtained in all Cases. The only thing that is required here is that there be adopted a decent system of cleanliness in manufacture. Particularly is this essential in perishable foods of this type. This is a requirement that is imposed by a great many of the States in one form or another. Those States which have adopted_requirements, in some form, comparable or identical with the langunge suggested here, are Maine, Maryland, Mississippi, Nevada, New FOOD, DRUGS, AND COSMETICS 27 Hampshire, New York, Oregon, Pennsylvania, South Dakota, Texas, and Wisconsin. If there is required to be maintained this standard of acceptable sanitation, in the production of food products for consumption in those States, and if there is no protection by means of a provision in the terms of a Federal law, and if there is a State which has no legal requirement for the observance of these sanitary conditions, it is utterly impossible for those States just enumerated to take any legal action for the protection of consumers in such States. I do not imagine there will be any objection voiced to this item by anyone, Souator. It is obviously an essential requirement. Item 5 of that paragraph is the same as found in the present law. Item 6 is a new one. "If its container is composed of any poisonous or deleterious substance which may by contamination render the contents injurious to health." This is not to be found in the present law, but need for it will be definitely recognized when I refer to the use of lead chests, or lead containers, for the packing of ten. It has been found that through the abrasion of the leaves the lead content of the container does become, in the course of time, and through extensive handling, more or less disseminated through the tea, throughout the package. It has been found in the brew made from such tea. There are other packing methods that can be adopted that will avoid this objection. The elimination of lead foil by the use of tin foil or of aluminum foil would do so. There is a definite remedy, and there is no definito hurdship placed upon the manufacturers because of the variety of containers that exist today. The provision certainly is essential for the protection of the health of consumers. In paragraph (b) of section 3, the first, the second, the third, and the fourth items are substantially as they are to be found now in the law. In some instances these requirements have been made in modified form. Paragraph (c). Confectionery. It retains the existing prohibition against the presence of alcohol. It also prohibits resinous glaze, or nonnutritive substances except coloring and flavoring--this is new. That particular phrase or nonnutritive substance" was intended to take care of the candy-carrying trinkets of the sort that have been in the recent past extremely popular. If you will notice, from the specimen of candy in this jar, the individual pieces of candy have been cut apart in order to let you see the location of the trinkets inside. Those that have not been cut contain these trinkets inside. You can see the different types of trinkets, themselves. There is no question about the risk to children in the consumption of this candy, not only because there is a likelihood of breaking teeth, but because of the possibility of swallowing the candy, and aspirating the trinket, and requiring a surgical operation of a serious character to remove it. Here is an X-ray photograph showing that this is not merely an imaginative danger or a mere speculation as to possible victims of the consumption of this candy, but it shows the location in the trachea, of this metallic trinket. 28 FOOD, DRUGS, AND COSMETICS Note, please, that this same item involves a specific prohibition against resinous glaze. A great deal of candy of certain types is found to be coated with this glaze. In a great many instances it is nothing more or less than shellac. Under the terms of the present law we cannot take action against it. Under the torms of the present law we can take no action against that specimen containing trinkets. Wo brought prosecutions but the court held that that practice was not violative of the prosent law. Stroud Jordan, in his Confectionery Standards, states: Glaze of any kind is not essential if the products are handled properly. Resinous glazes have no place in confectionery. They can only be classed as unnecessary adulterants. There is one provision of that paragraph, Mr. Chairman, that we recognize would work a hardship, as it stands now. This was not apparent to us at the time the bill was drafted. There would be, perhaps, a complete prohibition against chewing gum, the chicle in it being a nonnutritive substance. Wo would suggest that the wording be modified, and that after the phrase "or nonnutritive substance except coloring and flavoring," the following words be added “and masticatory substances used in chowing gum.' The CHAIRMAN. You desire to add these words at the end of the line "and masticatory substances used in chewing gum"? Mr. CAMPBELL. Yes, sir. Paragraph (d) of this act makes it an offense to use a coal-tar color other than one from a batch that has boon certified by the Secretary in accordance with regulations as hereinafter provided. In section 10, to which we referred, on page 14, you will find, in the second paragraph of that section, line 8, page 15, that the Secretary is authorized to make regulations after notice and hearing, for the certification of coal-tar colors which he finds to be harmless for use in food. The CHAIRMAN. That is not in the law now? The CHAIRMAN. It is there by regulation. Mr. CAMPBELL. By regulation wo have actually done that. After the existing law became effective the then Bureau of Chemistry, in recognition of the impurities to be extensively found in a great many coal-tar colors and the poisonous character of some of the colors themselves, issued regulations designed to assure the manufacturers and other purchasers that the colors used by them would be nontoxic and free from doleterious ingredients. These regulations established the practice of oxamining and certifying the purity and safety of coaltar colors as a method for the protection of the public. It is desirable that it be continued. In this language we are asking for legislative confirmation of a practice which has existed since 1907. The CHAIRMAN. Has that been disputed particularly by the tradethose regulations? Mr. CAMPBELL. There were some objections in the early days, of course; but it has not, in recent years, been disputed or protosted by manufacturers of colors themselves. The CHAIRMAN. I suppose that is due to the fact there is wider knowledge of the real menace of the use of these products otherwise? FOOD, DRUGS, AND COSMETICS Mr. CAMPBELL. Yes. The next is section 4, the adulteration of drugs. 29 Paragraph (a) is now. There is no provision in the act at the present time to suppress the marketing of dangerous drug products. The necessity for that is very distinctly and definitely illustrated, Mr. Chairman, in the consequences from the consumption of Rudithor which, as the label states, is a radium-containing water. The product has resulted in death, despite repeated warnings by the Department. There is no provision in the law that will enable us to remove it from the market. It has been claimed that this provision may affect all types of medicine because all medicines which are potent are capable of producing injury, but this particular paragraph, as you will note, is one that condemns such drug products if dangerous to health under the conditions of use prescribed on the labeling thereof. And, in a later section it will be made a requirement that the conditions of use shall be stated on the container of the drug. I wish to rush along with this as rapidly as possible. If there is any question you care to ask, I shall be glad in that event to discuss that item more fully with you. I wish to give concreto reasons for some of these provisions. Provision (b) deals with official products, that is, those recognized by the United States Pharmacopoeia, or National Formulary. The CHAIRMAN. Is there anything new in regard to that? Mr. CAMPBELL. The phrase "or simulates" in line 5, on page 5, is new. The other language is substantially the same as the present law down to line 9 "and when it fails to meet the definition, formula, and description set forth therein." That is new. The present law requires official drugs to comply only with the standards of strength, quality, and purity as determined by the tests prescribed by the United States Pharmacopoeia and National Formulary. The CHAIRMAN. Let me ask you about line 15. Do you now have that arrangement at present, that power given to the Secretary? Mr. CAMPBELL. No. All of this language from line 13 down to and including "standards" is new language. The purpose of that is to make it possible for the Secretary of Agriculture, in cases of emergency which will arise from time to time, to provide methods for the determination of the standards of quality, strength, and purity of drug products which may supplement those already found in these authorities. Its only purpose is to maintain the integrity of the official standards. The CHAIRMAN. I assume you are to have some support of scientific assistance there that you spoke of, professional assistance to help you in such a case? Mr. CAMPBELL. Yes, there is no question about that. There is no question but what some of the methods from time to time become obsolete. The United States Pharmacopoeia Association meets once in 10 years. The Pharmacopoeia is issued once in every 10 years. Under present circumstances the revision committee has been empowered by that organization to effect ad interim revisions. If that authority were revoked and the Pharmacopoeial method were found insufficient to establish the identity, purity, quality or strength of a 80390-84- -3 30 FOOD, DRUGS, AND COSMETICS drug or drug product, there could be no relief until the Pharmacopocial Association met again. The CHAIRMAN. I assume you would not use that system provided the United States Pharmacopoeia Association permitted the coinmittee to act, ad interim; you would have no occasion to have it? Mr. CAMPBELL. I doubt whether it will ever be found necessary to invoke this authority at any time. As we find new methods that reflect, more accurately, the character of the product, our purpose would be to report them to the revision committee and expect that modification of the official test would be made in the conventional way. In other words, as we find new methods that reflect with greater accuracy the exact characteristics of some product it would be our idea to report them immediately to the revision committee, and we would expect an ad-interim modification to be made promptly and in the conventional way. The CHAIRMAN. The rest of the subsection is the same? In line 22, the word “differ" is used. At the present time a product, sold under a pharmacopoeial name, which declares its own standard of strength, quality, or purity meets the requirements of the law, even though its label does not indicate wherein it differs from the United States Pharmacopoeia. The purpose of the wording used there is to make it possible for a buyer to know how the product differs from the United States Pharmacopoeia standard without having to refer to the official book to ascertain that information. Paragraph C is substantially what is in the art at the present time, with the exception that in line 5, the words, "and its identity or strength differs from", involve a new requiremen . At the present time the law states that if a drug product falls below its own declared standard of strength, it shall be adulterated. Perhaps the most serious danger to purchasers of drugs is to be found in those drug products which are of excessive potency rather than those that are below the declared standard of strength. If such products are relied upon by physicians and exceed the expected standard of strength, and the physician is using them under the impression that they are of the standard of strength set forth, you can see what the result might be in a case of serious illness and delicacy. This language here reads, "if it is not subject to the provisions of paragraph B of this section, and its identity or strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. In the present law it reads, "if its strength or purity fall below the professed standard of quality under which it is sold.' So, it will be observed that the language is the same in substance, with the addition which I stated. Paragraph D is new, but its purpose is merely to preserve or guarantee the integrity of the product. The next is cosmetics. This is, of course, without counterpart in the existing law. I do not know much about conditions to be found in the general run of cosmetics today. The effects of the use of cortain articles have come to our attention in some few instances where we have made investigations of a superficial nature. |