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It was found, soon after we undertook to make provision for the elimination of those sections of the act containing jokers, as in the case that I have demonstrated, and to correct the existing deficiencies of the law, that a mere amendment of the present statute presented, from a drafting standpoint, an impossible task. That is the reason the bill appears as one to supplant entirely the present act; but, as I have said, we have sought to preserve all of the worthwhile features of that law, and to make provision for the badly needed additional requirements which the experience of almost 30 years in the enforcement of the act has shown should be provided if the public is to be properly protected.
Senator COPELAND. Is the same language used in this bill as appears in the original act?
Mr. CAMPBELL. The same language is used in many places. In other places, advantage has been taken of interpreting court decisions to make more plain and more definite to the agencies subject to the terms of the law just what the significance of the statements now in the act may be. We will take this up from time to time as we proceed.
The first section of the bill is devoted to definitions. The definition of the term "food” is precisely that of the present act, with the exception in line 9, on page 1, of the words "or entering into the composition of.” Those words are not to be found in the existing definition. The reason for the incorporation of those words was to make certain of jurisdiction in the case of products like cream of tartar and phosphates which are not in and of themselves food but are employed so extensively in the manufacture of food, such as baking powders.
The definition of the term “drug” has been widened. In the present act that tecm is defined as including all medicines and preparations recognized in the United States Pharmacopoeia 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 animal.
There has been raised in that connection a question about the meaning of the words "substance or mixture of substances", whether the present definition of the term “drug” is sufficiently broad to include sutures, surgical dressings and the like. The importance of such products must be apparent immediately. We have found some such products on the market that were not sterile and have taken action, whether justified by the terms of the present law or not.
Senator COPELAND. Would that go so far as to cover the use of a truss or implements of that sort?
Mr. CAMPBELL. Under this particular definition it would. The words "device" in line 6, on page 2, is the word of the new definition which extends the scope of the law to cover not only surgical dressings but trusses or any other mechanical appliance that might be employed for the treatment of disease or intended for the cure or mitigation or prevention of disease.
Senator COPELAND. Would it refer to ultraviolet lights and various instruments of that sort?
Mr. CAMPBELL. It would. The third portion of the definition of the term drugs, 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 animal, is admittedly an inclusive, a wide definition.
The purpose of the drafters of this bill in the formulation of that part of this section, Mr. Chairman, was to make possible the regulation of a great many products that have been found on the market that cannot be alleged to be treatments for diseased conditions.
I have in mind such products as antifat remedies. Obesity may not be a disease. There has been lately a tendency to market products on the claim that they will have slenderizing effects. Some of these products are definitely harmful. One of those which the Federal Trade Commission undertook to control was characterized by the Supreme Court as a dangerous product.
There can be no question about the necessity for the protection of public health by the extension of the provisions of this act to cover those articles.
Again, there are devices that are advertised, as the Secretary of Agriculture in his statement indicated to you, for heightening people; devices that are sold to make people taller; devices that are advertised to correct physiological or anatomical defects that may not in themselves be diseases, such as nose straighteners; most of them are pure frauds; many of them if used will produce physical harm, sometimes of an irreparable nature.
The next definition is that of cosmetics. Of course, this has no counterpart in the existing law. It may be of interest, however, to the committee to know that in the first drafts that were prepared of the existing act the term “cosmetics” was included. In the bill submitted originally by Dr. Wiley the definition of drugs included cosmetics. That was eliminated in the progress of that measure in Congress.
Senator COPELAND. Did the bill as introduced contain cosmetics?
Mr. CAMPBELL. There were several bills introduced, Senator, bills for the regulation of foods and drugs having made their appearance in Congress several years prior to 1906. I am not sure whether this definition of drugs to include cosmetics appeared in the first measure. Certainly it appeared in some of the later measures.
The remainder of this section is devoted to the definition of such terms as “person”, “Secretary”, “label”, and “labeling”; the last is one to which I wish to direct your attention. I
. At the present time the law has control over those statements that are attached to or that accompany the package in the form of circulars. For purposes of the subsequent requirements of this bill these have been divided into two classes; first, "label" meaning the principal label or labels upon the immediate container of any food, drug, or cosmetic, and upon the outside container or wrapper, if any there be, of the retail package of any food, drug, or cosmetic. Then the term "labeling” is defined so as to include not only the label but all circulars and material and placards for display purposes and the like that may in any form whatever accompany the article of food, drug, or cosmetics. There is the definition of the term "advertisement" and, finally, the term "in package form” including wrapped meats enclosed in paper or other material as prepared by the manufacturers thereof for sale.
There is no attempt made to define the package form of food, drugs, or cosmetics. In the existing law there is a requirement made by the Gould amendment of that act that foods in package form bear a plain declaration of the net weight.
The interpretation of the term "in package form” was such that it did not include wrapped meat; and subsequently Congress passed an act, known as the Kenyon amendment, definitely and legally extending the terms of "in package form” to include meat products. Congress having expressed its purpose to have this included, the only reference in this section to definitions of "package form” is to assert that the requirement of Congress as previously expressed shall be carried in the pending bill.
Senator COPELAND. May I ask one question regarding line 13 where it speaks about graphic matter. That would cover the picture of some nice succulent peas in a can?
Mr. CAMPBELL. Exactly.
Senator COPELAND. Can you reach that obviously misleading practice under the present law; that is, in the definition of the term "labeling"?
Mr. CAMPBELL. We can because the term "misbranded” refers to designs and devices. So the reference to graphic matter in the bill is no addition to the present terms of the act, Senator.
Section 3 defines the adulteration of foods. It is the first of the several substantive provisions to appear. It declares a food to be adulterated if its use may be dangerous to health. That provision
In the present act the statute declares food products which may contain added deleterious or poisonous ingredients to be adulterated, and then only, when they have been added in sufficient amount to render the foods possibly dangerous to health.
The purpose of this language in the bill is to proscribe the interstate shipment of food products that may be dangerous to health, whether the danger to health is normal in the food product or may be due to an added ingredient.
There is a practical necessity for that thing. Under the present law we are unable utterly to proceed against those products which may constitute a prejudice to health because of some natural ingredient which is deleterious. Certain beans, like Burma beans, that is, of the lima bean type, contain a glucoside which will yield prussic or hydrocyanic acid. A number of deaths have been recorded among consumers of such beans. As a matter of fact, we do not permit them to enter this country, but once in this country, and commingled with commerce, we cannot invoke the import sections of the act. There is no power to take them off the market. We encountered on one occasion that precise situation.
On the western coast certain mussels in their biological development at certain seasons of the year have been found to be definitely injurious. Under local regulations a ban has been placed throughout those seasons upon digging, marketing, and sale of these mussels. If they were to escape local officials, if such products were to go into interstate commerce, there would be no power under the terms of the present Federal law by which they could in any way be libeled. Obviously it is to the interest of consumers to protect them from such dangerous products, whether the dangerous ingredient is an added one or normal.
Senator COPELAND. Would that cover the possibility of the germs of botulism being in ripe olives?
Mr. CAMPBELL. Yes; it would cover that. Under this section of the bill, since ripe olives containing the botulinus germ are dangerous to health, they would be covered. We can, and do deal with the botulinus situation under the present terms of the law, however, on the ground that foods containing this organism are in part decomposed.
The next provision is, “If it bears or contains any poisonous or deleterious ingredient prohibited, or in excess of the limit of tolerance prescribed by regulations as hereinafter provided.”
I think perhaps a better understanding of the measure, at least from a subject matter standpoint, can be acquired if we turn now to section 10 of the act to which this language refers and discuss it briefly. You will find that on page 14.
Senator COPELAND. This proposed legislation would cover spray residue for fruit?
Mr. CAMPBELL. Yes. Paragraph (a) of section 10 states that, If the Secretary finds that the presence of an added poison or added deleterious substance in or on food or cosmetics is or may be injurious to health, taking into account other ways in which the consumer or user may partake of or be exposed to the same or other poisonous or deleterious substances, then the Secretary shall by regulations promulgated after notice and hearing prohibit such added substance in or on food or cosmetics, or establish tolerances limiting the amount therein or thereon, to such extent as he may deem necessary to prevent such injury to health.
This is an extremely important, in fact, one of the most important provisions of this bill. It may be impossible to preclude absolutely poisonous ingredients from foods. Some of the deleterious ingredients with which we have to deal are to be found universally. But it is important that they not only be kept to such a low limit in each article of food in which they may be found that that article of food itself may not be dangerous to health, but important, furthermore, that the total intake of poisons by the consumer of foods from all sources be restricted to an amount which will not be dangerous to health.
Perhaps, with the development of the country, the extension of industrial activities, we can anticipate to some degree the more or less universal appearance of some of these poisons. Let me illustrate in a concrete way. One manufacturer of an article of food in which sugar was used in material quantities undertook control of his product by effecting a complete elimination of harmful ingredients. He found arsenic appearing in the article of food. He traced the ingredients of which that food product was prepared to their source in every instance in an attempt to determine the cause for the appearance of arsenic. One of the last ingredients to be investigated was sugar. He found to his surprise that the stock of sugar which he had on hand and from which this product was being prepared did contain arsenic. That is not a normal ingredient in sugar. But in the particular refinery where this stock had been prepared it was found that the sugar when stored in barrels and before those barrels were headed was placed on a floor of a room in which the windows were open, the smoke from a nearby smokestack entered the open windows and contaminated the sugar with arsenic.
I am referring to that merely to illustrate the circumstances under which added poisonous ingredients may make their appearance in food products, not as the result of careless operations in all instances
by manufacturers of such food, but despite precautions that they may take to effect absence of them.
There is a counterpart to this particular measure in that portion of the Food and Drugs Act to which I have referred once or twice already. Section 7, paragraph (5), declares that a food product will be held to be adulterated if it contains any added poisonous ingredient which may render the article injurious to health. It is under that section that one of our greatest activities under the Food and Drugs Act has been carried on. It is under that section that we are attempting to deal now with the spray-residue problem. We are spending on this project approximately one third of the appropriation for the enforcement of this law. There is no method by which many crops can be grown to maturity for marketing without the application of poisons to kill pests. If those poisons remain in sufficient quantity on the product at the time of harvest, of course they will be injurious to the consumer.
You know the extent to which this matter has been agitated; fruit and vegetable growers have followed the instructions issued to them by official agencies for the use of insecticides. It became the obligation of the same agencies then to advise the growers about methods by which this spray residue could be removed. Methods more or less satisfactory have been devised, and in the majority of cases, particularly the fruit products, the amount of residue encountered now is below the tolerance which has been determined as safe for consumption. But, Mr. Chairman, and this is another important argument for this particular paragraph, under the terms of the present law we are able to consider only a single commodity. If that single article of food does not contain poison in excess of the tolerance that has been determined as safe for consumption, it is not in violation of the present law. But suppose that article contains just a little less than the safe tolerance. Multiply that by the number of articles of food also containing traces of added poisons which constitute our daily diet, and you can get some conception of what the general intake of poisonous substances would be.
Now, while there is an economic need for the use of poisonous sprays, there is no justification at all for the appearance of these poisonous ingredients in a great many food products.
We are encountering the very same deleterious ingredients that are to be found on fruits and vegetables which are sprayed with insecticidal poisons in articles of food where the cause is entirely a matter of carelessness; a condition which can be definitely overcome if there is a serious attempt on the part of manufacturers of such foods to do so.
Under the terms of this bill the Secretary will be permitted to establish tolerances. There will be a definite recognition of the fact that at least for the time being and until, perhaps, the ideal spray has been found which will destroy pests and not be injurious to man and not damage foilage, we will have this spray residue question with us; but if there is a recognition of a definite tolerance in that case it does not follow that an equal amount of poison should be tolerated in other articles of food where there is no excuse whatever for it. But, in the face of the present limitations of the law we are permitted to deal with but one article of food at a time and are not permitted to consider various other sources of poison.