FOOD, DRUGS, AND COSMETICS 387 It represents packers of more than 60 percent of the canned foods produced in the United States, not including milk. Its membership is about 650 firms, operating 1,070 plants. The association is in full sympathy with the purpose of the Department of Agriculture to correct such deficiencies as have been found to exist in the present Food and Drugs Act, and the recommendations it presents on behalf of the industry are based upon its desire to assist those responsible for legislation in formulating a measure that will accomplish the purposes desired without imposing unnecessary hardship. It is the opinion of the industry that many, if not most, of the new or revised provisions embodied in S. 1944 are more directly applicable to products other than foods, and for that reason we earnestly petition that you give consideration to the preparation of a separate food bill. Foods differ as widely from drugs and cosmetics both in nature and in character of control necessary over them that separate legislation would eliminate many of the problems involved in formulating and enforcing a law designed to cover all these classes of products. The suggestions and recommendations we have to make relate to the provisions as carried in S. 1944. If a separate food bill should be prepared, these suggestions and recommendations we request be embodied in that bill. As a general amendment, we recommend that wherever the word "health" is used there be substituted the words "public health." The word "health" alone might be interpreted to mean the susceptibility of an individual to injury from a food that may be eaten with impunity by the normal person. Other specific recommendations are as follows: The term "canned food" shall mean all food which is in hermetically sealed containers and is sterilized by heat, except meat and meat food products which are subject to the provisions of the meat inspection act of March 4, 1907 (34 Stat. 1260), as amended, and except canned milk. The addition of this definition is because of revisions that will be word "may have. Delete the words "or may be." The canning industry believes that the determinations provided for in this section should be based upon fact rather than conjecture. Section 7 (a), line 19, page 8. After the word "food" insert the words "other than canned food." After line 24, page 8, add "If it be canned food and falls below the standard of quality or fill of container, promulgated by the Secretary for such canned food, and its package or label does not bear a plain and conspicuous statement prescribed by the Secretary of Agriculture indicating that such canned food falls below such standard." The addition of this paragraph is also requested because of recommendations that will be made in connection with section 11. Section 7 (f), line 6, page 9. Delete the phrase "in order of predominance by weight." This phrase is not necessary to accomplish the purpose of the paragraph which, we are advised, is for the protection of individuals suffering from some form of allergy. Moreover, it 388 FOOD, DRUGS, AND COSMETICS would appear to be confiscatory in view of the fact that it required practically a revelation of manufacturing formulae which are the private property of the producers. Section 11, line 14, page 15. After the word "food" insert "other than canned foods." Insert following section 11 the following as 11 (a): Section 11 (a). The Secretary is hereby authorized to fix, establish, and promulgate from time to time reasonable definitions of identity and a reasonable standard of quality and fill of container for each class of canned food as will in his judgment promote honesty and fair dealing in the interest of the consumer, and he is authorized to alter or modify such standard from time to time as in his judgment, honesty, and fair dealing in the interest of the consumer may require. Whenever the Secretary deems that for the purpose of this act any such standard would be established for any canned food, he shall give notice of a proposed standard and of the time and place of a public hearing to be held thereon not less than 30 days after the date of such notice. After such public hearing the Secretary may fix, establish, and promulgate such a standard for such canned food. The standard so promulgated shall become effective on a date fixed by the Secretary, which date shall not be prior to 90 days after its promulgation. Any such standard may be amended or repealed after notice and hearing as hereinbefore provided, and if amended or repealed the amendment or repeal shall become effective in the manner and at the time hereinbefore provided. The purpose of this proposed amendment is to continue in effect the provisions of the McNary-Mapes amendment to the Food and Drugs Act, which was proposed by the industry itself and enacted with the approval of the Department as a measure directly in the interest of the consumer. When the industry proposed the amendment it recognized the need of a mandatory labeling requirement enforceable under a criminal statute. It desired a mandatory provision because of the need of control over that small minority of manufacturers who, under a system of permissive labeling, might continue practices that are not in the consumer's interest. It desired a provision under a criminal statute so as to give greater strength to the enforcement of the law's requirements. It desired standards based upon tangible characteristics and qualities susceptible of accurate determination or measurement rather than upon personal judgments, opinions, or tastes, because of the difficulties and dangers involved in the enforcement of a criminal statute upon the grounds of personal opinion. To appreciate the truth and force of this statement it must be remembered that in connection with canned foods there are certain undefinable elements, and elements of major importance, such as flavor and appearance, which it is impossible to describe with the degree of accuracy necessary in connection with enforcement of a criminal statute. It desired a law that, while not attaining immediately the whole purpose of completely informative labeling, would affect improvement and thorough actual experience enable the industry and the Government to extend the program for better labeling. It desired, above everything else, to secure a law that could be and would be enforceable, rather than a law the enforcement of which would prove unfeasible and thus open the way to abuses more injurious to both the industry and the consumer than existed under former legislation. For these reasons the industry earnestly requests the retention of the McNary-Mapes provisions, in the belief that they represent a feasible, practical method of working out a solution of the labeling question as applied to canned foods, and that provisions going beyond FOOD, DRUGS, AND COSMETICS 389 the McNary-Mapes requirements and seeking to attain an immediate ideal solution of the problem will prove ineffective and unenforceable, and thus simply delay the improved conditions desired by both the industry and the consuming public. Section 12 (a), line 6, page 16. Delete words "the Secretary finds that"; line 12, page 16, delete word "he" and insert the word "are." These revisions are recommended in the belief that action by the Secretary of Agriculture should be based upon established facts rather than upon opinion. Section 13 (a) (2), lines 22 and 23, page 17, Delete the words "methods, processes. It is recommended that these be eliminated because their inclusion would give an opportunity for the acquirement of secret and confidential procedures which are not necessary to accomplish the purposes of the Act, and the dissemination of which would be greatly to the disadvantage of the manufacturer. Section 13 (b) (1), line 10, page 12. Delete the words "methods, processes" for reasons above stated. Section 17 (b). We recommend that the minimum fines provided for in lines 7 and 10, page 24, be eliminated. As written, the bill makes it mandatory to assess a heavy fine for a possibly trivial offense. It is believed that the penalties for trivial offenses should be less severe than are appropriate for offenses of a graver nature. Moreover, there will be difficulty in obtaining a conviction where conviction carries a comparatively heavy fine for an offense that may not be of a grave character. We also recommend the addition to this paragraph of a provision substantially the same as in the present Food and Drugs Act (section 2) relating to foods that are exported, to read as follows: Provided that no food not adulterated according to Section 3 (a) shall be deemed misbranded or adulterated within the provisions of this act when intended for export to any foreign country 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 such food shall be, in fact, sold or offered for sale for domestic use or consumption, then this proviso shall not exempt such article from the operation of any of the other provisions of this Act. Section 18: It is the feeling of the industry that section 18, which makes no distinction between acts that are willfully criminal or due to criminal negligence, and acts that are inadvertent or accidental, may impose undue hardship upon officials and others who are endeavoring in every way to comply with the law. Section 21: We recommend that the words "and for the protection of the consumer against fraud," lines 2 and 3, page 29, be eliminated. The industry believes that the dissemination of precautionary information is justified when questions of public health are involved, but does not believe that beyond this there should be authority by publicity in advance of the findings of fact. Section 22: We ask the elimination of this section, as serving no useful purpose so far as canned foods are concerned. It seems futile and undesirable to set up machinery for certification of unenforceable definitions. To the extent that certification of quality standards for canned foods in connection with wholesale transactions is desirable, which desirability is not here questioned, the provisions of the warehouse act are available. This act provides for Federal examination of submitted samples and grade certification according to standards 390 FOOD, DRUGS, AND COSMETICS established by the Bureau of Agricultural Economics, and also provides for voluntary cannery inspection and certification service. It is understood that to some extent canners have availed themselves of these services and facilities with satisfactory results in intertrade transactions. A certain small portion of the canning industry believe that the Bureau of Agricultural Economics grades are as suitable for enforcement purposes under a criminal statute as under civil statutes, and may appear as active proponents of section 11 and section 22 of this bill as drawn; but the governing board of the National Canners Association rightly holds that experience and evidence cannot be ignored. There can be cited convincing public statements of informed and responsible officials to fully substantiate what we have said respecting the limitations in the matter of grade definitions of canned foods. To the extent of such limitations the folly and futility of idealistic and unenforceable laws must now be, as never before, apparent. Section 23 (a), line 5, page 30. Delete the words "he may deem" and substitute "are"; lines 11 and 12, delete words "they may deem" and substitute the word "are." This recommendation is in line with the previous recommendation as to section 3 where it was stated that determination should be based upon facts rather than upon conjecture. Section 23 (c), lines 2, 3, and 4, page 31. Delete last sentence of paragraph. The elimination of this sentence is requested because of recommendations hereafter to be made. Section 24. We recommend that section 24 be eliminated from the bill. This section gives the consumer no rights which he does not already have under other legislation and the relatively drastic provisions of this bill will doubtless invite an increase in the fraudulent claims for injury which have been increasing at an alarming rate, and, in certain sections, constitute a racket. Add new section to constitute section 27 as follows: Section 27 (a). In any action suit or proceeding involving any regulation made. promulgated, or prescribed under this act, such regulation and any evidence considered by the Secretary and any findings made by the Secretary may be reexamined by any court as to any question of fact as well as law. (b). In any proceeding involving the issue, renewal, suspension, or reinstatement of any permit under this act, or in any other action, suit, or proceeding involving the rights of any person affected by this act or any action taken thereunder, any action by the Secretary, any evidence considered by the Secretary, and any findings made by the Secretary, may be reexamined by any court as to any question of fact as well as law. The addition of this section is recommended as a precautionary safeguard against possible misuse of delegated powers. The CHAIRMAN. Thank you very much. I will call upon Mr. Bruce Kramer at this point. STATEMENT OF BRUCE KRAMER ON BEHALF OF THE DRUG INSTITUTE OF AMERICA Mr. KRAMER. Mr. Chairınan, I do not desire to discuss the measure before the committee but, for the purpose of the record, as the counsel for the Drug Institute of America, an organization comprising a membership of approximately 40,000 units in the industry, I desire to have the record show that the Drug Institute of America endorses the views FOOD, DRUGS, AND COSMETICS 387 It represents packers of more than 60 percent of the canned foods produced in the United States, not including milk. Its membership is about 650 firms, operating 1,070 plants. The association is in full sympathy with the purpose of the Department of Agriculture to correct such deficiencies as have been found to exist in the present Food and Drugs Act, and the recommendations it presents on behalf of the industry are based upon its desire to assist those responsible for legislation in formulating a measure that will accomplish the purposes desired without imposing unnecessary hardship. It is the opinion of the industry that many, if not most, of the new or revised provisions embodied in S. 1944 are more directly applicable to products other than foods, and for that reason we earnestly petition that you give consideration to the preparation of a separate food bill. Foods differ as widely from drugs and cosmetics both in nature and in character of control necessary over them that separate legislation would eliminate many of the problems involved in formulating and enforcing a law designed to cover all these classes of products. The suggestions and recommendations we have to make relate to the provisions as carried in S. 1944. If a separate food bill should be prepared, these suggestions and recommendations we request be embodied in that bill. As a general amendment, we recommend that wherever the word "health" is used there be substituted the words "public health.” The word "health" alone might be interpreted to mean the susceptibility of an individual to injury from a food that may be eaten with impunity by the normal person. Other specific recommendations are as follows: Section 2 (a), line 2, page 2. Add— The term "canned food" shall mean all food which is in hermetically sealed containers and is sterilized by heat, except meat and meat food products which are subject to the provisions of the meat inspection act of March 4, 1907 (34 Stat. 1260), as amended, and except canned milk. The addition of this definition is because of revisions that will be Delete the words "or may be." The canning industry believes that the determinations provided for in this section should be based upon fact rather than conjecture. Section 7 (a), line 19, page 8. After the word "food" insert the words "other than canned food." After line 24, page 8, add "If it be canned food and falls below the standard of quality or fill of container, promulgated by the Secretary for such canned food, and its package or label does not bear a plain and conspicuous statement prescribed by the Secretary of Agriculture indicating that such canned food falls below such standard." The addition of this paragraph is also requested because of recommendations that will be made in connection with section 11. Section 7 (f), line 6, page 9. Delete the phrase "in order of predominance by weight.' This phrase is not necessary to accomplish the purpose of the paragraph which, we are advised, is for the protec tion of individuals suffering from some form of allergy. Moreover, it |