212 FOOD, DRUGS, AND COSMETICS or units. Obviously a peck or a dozen apples, five pears, a half peck of potatoes, a head of cabbage, or a few onions, carrots, etc., have to be wrapped so that the consumer can get them home. It would be unthinkable as well as a tremendous burden of expense to the consumer, retailer, wholesaler, or producer to require all of these packages or parcels (by whatever designation they may be called) to be labeled as required by section 6 (b) and (c). ADULTERATION OF FOOD Section 3, paragraph (a): Strike out the following: "(2) It it bears or contains any added poisonous or added deleterious substance prohibited or in excess of the limits of tolerance prescribed, by regulations as hereinafter provided." Substitute therefor the following: "(2) If it bears or contains any added poisonous or other added deleterious ingredient which may render such article injurious to health." Reasons. We are opposed to the arbitrary methods of prohibition and the fixing of tolerances conferred upon the Secretary in section 10, and with no provision for appeal or other legal review of the regulations of the Secretary. Section 3, paragraph (a) (4), line 6: Strike out the words "may have" and substitute therefore the word "has", so that paragraph (4) will read: "(4) If it has been prepared, packed, or held under insanitary conditions whereby it has become contaminated with filth," Reasons.-Proof not opinion must govern. The commodity has or has not become contaminated. There is a wide difference between "may have" and whether it "has" actually become contaminated. MISBRANDING GENERAL Section 6 (a): Strike out entire paragraph and substitute therefor the following: "(a) If its labeling is in any particular false or misle. ding." Reasons. The paragraph as it now stands in the bill covers a vague and nebulous field and involves matters incapable of proper proof. Ambiguity, inferences, and impressions have no place in this or any penal statute. They are in the field of psychology. Two different persons may and do in a multitude of instances arrive at different "inferences" and "impressions" from identical statements and words. The apple industry uses terms and other marks provided by law, such as "Extra Fancy," Fancy," "U.S. No. 1," "Commercial, Utility." These are official designations of grades. It is quite conceivable that to someone they might create a misleading impression. They have meaning to those with understanding of their purpose. As a matter of fact, "fresh fruits and vegetables" could well be and should be excepted from all of the provisions of section 6 for the reason that the industry is already largely standardized under existing Federal and State specifications, regulations, or laws, covering grades, marks, and the standardization of packages, a violation of which carry penalties. Section 6, paragraph (b): Insert after the word "form" in line 1 the words "except fresh fruits and vegetables", so that paragraph (b) will read as follows: "(b) If in package form, except fresh fruits and vegetables, it fails to bear a label containing etc." Reasons.-1. We have heretofore discussed the method of retailing and the practical impossibility of the retailer labeling every parcel after bulk has been broken and the contents distributed in small quantities. 2. Apparently paragraphs (b) and (c) are intended to apply to manufactured commodities (see regulation 16 under section 8 of the present law), but it is not clear in the proposed bill, since the words "packer, seller, or distributor", might apply to fresh fruits and vegetables as packed at point of production or elsewhere, and also as sold and distributed anywhere in their course from producer to consumer. 3. The fresh fruit and vegetable industry is probably standarized to a greater degree than any other industry, comparable in extent and varieties. (a) The Bureau of Agricultural Economics has long since set upgrades and specifications for nearly all fruits and vegetables and under which its official inspection service operates or under mandatory State grades, according to the facts. (b) The apples industry has not only the permissive grades and specifications of the Bureau of Agricultural Economics, which became mandatory when one elects to pack and mark thereunder, but in addition all of the leading apple producing States have mandatory laws governing grades, branding, or labeling. FOOD, DRUGS, AND COSMETICS 213 Those laws provide, among other things, for the name and address of the grower or packer, variety, grade, size, etc. Apple packages in the so-called "barrel States" are in the vast majority of cases not labeled but are stenciled or stamped. In the box States-Pacific coastthey are generally labeled. These grade specifications, laws, and rules have been developed through a series of years. They should be left where they now are with the Bureau of Agricultural Economics and the States rather than be complicated with the Food and Drugs Administration. (c) Standardization of packages.-A standard apple barrel law was passed by Congress, approved August 3, 1912. This was followed by law fixing the standard barrel for fruits and vegetables approved March 4, 1915. These laws specify length of stave, diameter of head, circumference of barrel, and cubic capacity. Following this the Standard Container Act was enacted, approved August 31, 1916. This law prescribes specifications and makes it unlawful to manufacture or sell filled or unfilled, other types. Still later the Standard Container Act of 1928, approved May 21, 1928. This law specifies cubic capacity and makes it unlawful to manufacture or sell other types, filled or unfilled, or to make deceptive packages. These laws apply to barrels, round bottom, and tub bushel and other sized baskets, hampers, climax and splint baskets of all sizes and tills including quart and pint sizes and provide for their marking as to capacity or volume and penalties if not properly marked when used. The Barrel Acts and the Container Act of 1928 are weights and measures laws under the Bureau of Standards and apply to intrastate and interstate commerce. The Container Act of 1928 provides that specifications for any package covered by the law must be submitted to the Department of Agriculture before manufacture. The administration of certification of dimensions essential to comply with the law rests with the Department. In addition there are many State statutes. As to the box, the Pacific Coast States, where the box is primarily used, have standardized it by State law and regulations. Other States like Virginia and New York have done likewise. Standards of fill or the marking of the quantity of contents are also provided in the leading producing States. 4. Conclusion.-In view of the foregoing, it is clear that the proposed bill would set up dual, duplicating, and possibly conflicting control over factors already covered. These various standards have been developed through a series of years by both the Federal and State Governments. It is a specialized field in which constant progress has been made. We believe this whole question of standards including grades, marks, and containers should be left with the agencies through which they have been developed, i.e., the Bureau of Agricultural Economics, the Bureau of Standards, and the States. Nothing is to be gained by covering the same factors in whole or in part in a multiplicity of statutes and administered in whole or in part by different bureaus with the inevitable conflicting and overlapping regulations. MISBRANDING OF FOOD Section 7, (a), (b), (c), (d), and (e): We have already discussed in part the extent to which standardization of grade, marks, and packages has proceeded in the fresh fruit and vegetable field and will discuss it further under section 11. Paragraph (a), (1), and (2) are already primarily covered by present standardization laws. We have no objection, however, to coming under paragraph (a) (1), although it is unnecessary, but do take exceptions to coming under (a) (2) and (d) and (e). Reasons: 1. Standards of fill in the fresh fruit and vegetable field are already sufficiently established by standard package laws, Federal and State. 2. Definitions of identity, standards of quality, and the question of mandatory labeling as provided in (d) and (e) should not be lodged with the Food and Drugs Administration, since they are already covered by the Bureau of Agricultural Economics and State statutes. 3. As to paragraphs (b) and (c), it is inconceivable, for example, that an apple would be offered as a peach or a pear as a potato or a cabbage, or under any other name than what they are, neither can they or will they be offered as an imitation. 4. Paragraph (f): Fresh fruits and vegetables should be definitely exempted by a proviso after the word "color" in line 8 to read: 214 FOOD, DRUGS, AND COSMETICS "Provided that the foregoing shall not apply to fresh fruits and vegetables in their natural state." If no definition of identity is prescribed under section 11, then fresh fruits and vegetables would technically come under section 7 (f). Obviously paragraph (1) could not have been intended to apply to fresh fruits and vegetables in their natural state, but it should be made clear: First: Fresh fruits and vegetables are already identified, not by the Food and Drugs Administration, but by long common usage, such as apples, pears, peaches, prunes, potatoes, cabbages, oranges, etc. Varieties have been and are identified by the American Pomological Society and the United States Bureau of Plant Industry. It should hardly be required that these names be stamped on packages merely because a definition of identity had not been established by regulation by food and drugs. Second: Also it would be clearly impossible and prohibitive to analyze and label each package of apples, pears, peaches, etc., with the name of each ingredient thereof in order of predominance by weight. FALSE ADVERTISEMENT Sec. 9 (a): Strike out the words: "or by ambiguity or inference creates a misleading impression." We have already given our reasons therefor. To make persons responsible under highly penal statutes for alleged impressions drawn from alleged ambiguity and inference opens a wide avenue for great injustice. A person files a complaint and testifies that he had a misleading impression because of ambiguity and inference. Who can disprove it? Who is to decide the question? The Secretary of Agriculture will decide it under sections 15 and 23 (c) and the Secretary's findings under 23 (c) "shall be conclusive." Basing penal statutes on the varying psychological and mental reactions of 120,000,000 persons is, we submit, excceding the limits of proper law making. TOLERANCES, SECTION 10 We have no objection to the fixing of tolerances under proper procedure and safeguards, and subject to review by appeal and to proof in the event of seizures and cases brought that the quantity of alleged poisons found is or may be injurious to health. Section 10, as now written, goes way beyond the above and way beyond present law. Strictly speaking, the Secretary now has no power to fix tolerances although as a matter of practice tolerances are now promulgated. As stated above we do not object to the fixing of tolerances, but to the arbitrary and conclusive methods proposed and the absence of safeguards. What is the Secretary required to do and what is the procedure specified by section 10 and other sections? 1. The section applies both to "constituent" and "added" poisons. 2. The Secretary shall by regulations promulgated "after notice and hearing prohibit such added substances 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." It will be observed (a) That the character of the "notice and hearing" are not prescribed, nor those who are entitled to be notified, heard, consulted, or considered. In section 11 relating to "Definitions and standards" 30 days' notice of a public hearing_is specified. Under the Export Control Act, approved June 10, 1933 (Public, No. 39, 73d Cong.), the Secretary is required to "provide opportunity, by public hearing or otherwise, for interested persons to examine and make recommendation with respect to any standard of export proposed to be established or designated, or regulation prescribed * Under the proposed wording the Secretary can notify few toxicologists or physicians or health officers or experts on very short notice, hold a limited brief hearing behind closed doors, and announce tolerances that are iron clad, nonappealable, conclusive, and the soundness or unsoundness of which cannot be raised or questioned in any way. We are not reflecting in the slightest upon the merits of toxicologists, physicians, et al. As everyone knows, however, there are wide differences of opinion on toxicological and medical subjects among the professions themselves and changes in opinion from time to time. The Secretary should be required to give notice to and hear interested parties including the industries to be affected, otherwise entire industries may be sum FOOD, DRUGS, AND COSMETICS 215 marily wrecked without opportunity for readjustment or cause tremendous loss and damage. The fixing of the tolerance for lead on fruit during the past year illustrates the above points. No hearing was held in which the industry participated. The Department in January 1933 had become suddenly very active on lead and as applied to the old crop then in storage, the major portion of which could not be recleaned at that season of the year, due to the lateness of the season, the damage that would be caused the fruit by handling when it was so far along in its life and the heavy expense of unpacking and repacking. The question then arose in the minds of the industry as to what tolerance would be fixed for the new crop, i.e., the 1933 crop. It became rumored that the Secretary (Food and Drug Administration) might place it as low as 0.014 grains of lead per pound of fruit. The apple and pear industries knew from practical experience that such a tolerance could not be met if insects were to be controlled and a crop of fruit raised. These industries knew that no efficient substitutes for arsenate of lead had been discovered either by the Government, States, or any other agency. There industries urged with all emphasis possible that anything as low as 0.014 would be impossible and that the matter of fixing a tolerance be delayed until the results of analyses of the old crop could be further completed. Suddenly out of a clear sky on Sunday April 2 and without a hearing and without a conference with the industry an order was issued by Assistant Secretary of Agriculture R. G. Tugwell, reading in part as follows: Beginning with the 1933 shipping season, fruits shipped within the jurisdiction of the Federal Food and Drugs Act containing lead in excess of 0.014 grains lead (Pb) per pound will be subject to seizure and the shippers to prosecution.' The order among other things stated: "This Department and cooperating State agencies are earnestly studying the possibilities of developing effective lead-free spraying materials." These very same agencies had been studying the very same possibilities ever since 1926 and had found no efficient substitute. It was perfectly well known on Sunday April 2, 1933. that no such substitute existed and, as a practical matter, that none could be discovered and used on the 1933 crop. No efficient substitute has yet been discovered. The order further recited: "The lead problem should be avoided entirely wherever possible by the choice of spray materials which do not contain lead." All of the foregoing resulted in curtailed spray prograins and the use of vary ing substitutes which failed to control insects or which injured the foliage and stunted the fruit. It is impossible to say what all of this cost the growers of the country, but we do know that it ran into very large figures. Following this and on June 20, Secretary Wallace issued an order raising the tolerance to 0.02 grain of lead per pound. The order recited that the question of substitutes was being investigated, but that a wide survey of producing areas indicated that a spray schedule "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 was precisely what the industries involved had pointed out, so far as they were allowed to do so, prior to and after the order of Sunday, April 2. Possibly if there had been a hearing or a conference with the industries, they might have been able to make the facts clearer. By the time the order of June 20 was issued a material part of the damage had been done. Substitutes which did not control had already been applied in the early stages in many sections or had been purchased. Spray programs are complicated. They cannot be shifted or changed over night. Supplies have to be purchased in advance. Certain sprays cannot be applied in conjunction with or immediately following others. In brief, plans have to be made in advance. The order of June 20, which raised the tolerance to 0.02 grains also stated (underscoring ours): "The tolerance of 0.014 grains 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." Now let us see how the matter of the discovery of substitutes worked out. On December 11, 1933, the Department issued an order which, among other things, fixed the tolerance on lead for the 1934 crop at 0.019 grains per pound, 216 FOOD, DRUGS, AND COSMETICS or 0.001 grains less than the order of June 20 covering the 1933 crop. The order, among other things, says underscoring ours): "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." Copies of the respective orders are attached hereto. The foregoing concretely illustrates the wisdom and necessity of hearings or definite consultation with the industries or parties interested. No matter how good the intent or how high the purpose of administrative officials, and we do not question them in any way but on the contrary pay tribute to their sincerity of purpose, yet no man or men are possessed of infinite wisdom and there are many factors which they cannot know without full consultation. Fruit growing is an increasing battle with pests, as well as the production of practically all food. If man is to eat, these pests must be controlled. We in no sense advocate or ever have advocated injury to public health. We think it will be conceded that no industries have ever given a greater, more complete, more earnest, and loyal effort in cooperation with the Government or have brought about a greater readjustment than the apple, pear, and fruit industries. (b) It will further be observed that the fixing of the tolerance by the Secretary is final and from which there is no appeal. Section 10 says that a hearing shall be held, but the type of hearing is not specified, as we have indicated. Section 23 (c) prescribes that as to all hearings under the act, "the findings of fact by the Secretary shall be conclusive if in accordance with law." All that the Secretary needs to do is to fix a tolerance, which is conclusive, make seizures under the act even on suspicion (sec. 16), present an analysis that the commodity seized is in excess of the tolerance, without even being required to give the other party to the seizure a sample, (sec. 16 (c)), and the case is complete. Under the present law the Government is required to prove its case, i.e., that the quantity of adulteration or alleged poison found is or may be injurious to health. Under the proposed law no such proof is necessary. The Government should be required to prove its case as at present. Assume that under the present law that a tolerance was arbitrarily fixed at 0.014 grain per pound. A Government analysis shows 0.015 or 0.016 grain. All the Government needs to do is to prove the two points above and its case is complete. The defendant is not even given the right to have a part of the Government's sample for his own analysis. That is entirely in the discretion of the court (sec. 16 (c)). Furthermore, it is generally recognized and conceded that analyses carried to the third decimal point in terms of grains per pound, or variations of 0.001, 0.002, etc., are in the range of scientific error, depending on various factors, the skill of the analyst, his methods, character of apparatus, purity of chemicals used, etc. Stated in terms of parts per million 0 01 is equivalent to one part in 700,000 and 0.001 is equivalent to one part in 7,000,000. Analyses cannot be carried to these extreme lengths with any degree of surety. Two different analysts may and actually do arrive at different results on the same sample. Moreover, such minute variations, even if accurate, will not be prejudicial to health in a food like fruit. Therefore, we again submit that the Government should be required to prove its case and to prove by competent evidence that the amount alleged to be found is or may be injurious to health. The defendant should then be allowed to have his "day in court" and prove, if he can, by competent evidence that the Government's case is not well founded. This is an axiomatic principle of all legal procedure and the rights of citizens. (c) It will be further observed that the proposed bill allows no appeal and no review. The Secretary is constituted a dictator. Court procedure to carry out the dictates of the Secretary are a mere formality with the rights of the defendant foreclosed and prejudged before he gets to court. DEFINITIONS AND STANDARDS FOR FOOD Section 11: Insert after the word "food" in line 14 the following: "other than fresh fruits and vegetables". We have already shown the extent to which standardization of grades, packages, definitions of identity and standards of quality exist in the fresh fruit and vege |