particular food was established in the record." These questions present broad inquiries, difficult of proof, and doubtless apt to be more long-drawn-out in investigation than even the ones which the Secretary pursued. Yet it has been shown that the color of itself has poisonous properties. In the light of the overall purpose of the Act, cf. United States v. Dotterweich, 320 U.S. 277, 280, and the specific terms here involved, it seems to us that Congress did not intend that a verdict of "not proven" on the questions mentioned should preclude the Government from preventing the use of substances like the one in question when they were shown to have poisonous effects by themselves.

We are not persuaded by the respondents' argument, adopted by the Court of Appeals, that the words "harmless" and "poisonous" are relative words, referring not to the effect of a substance in vacuo, but to its effect, taken in a particular way and in particular quantities, on an organic system. Of course this is so, but the question before us certainly does not depend on it. This is not a case like the examples put which remind us that pure water would be deleterious if taken at the rate of four gallons an hour or common table salt at several ounces. The color substances appear to have been administered at toxologically significant levels; they played a relatively small part in the diets of the test animals, generally less, and frequently much less, than 1%.12 Obviously if the color substances themselves are made an item of diet in the trifling percentages used on the test animals, their effect is poisonous." Congress may have intended "harmless" in a relative sense, but we think it was in relation to such laboratory tests as the ones the Secretary performed that Congress was speaking when it required that coal-tar colors be "harmless." We do not believe that Congress required the Secretary first to attempt to analyze the uses being made of the colors in the market place, and then feed them experimentally only in the proportions in which they appeared in certain of the food products in which the colors were used. This appears to be the very procedure on which Congress turned its back in the 1938 Act.

The respondents contend that since the Secretary himself maintains various lists of certified colors, one containing colors harmless and suitable for all food, drug and cosmetic uses, another of colors harmless and suitable for general use in drugs and cosmetics, and a third of colors harmless and suitable for external use in drugs and cosmetics, 21 CFR §§ 9.3, 9.4, 9.5, he has recognized that "harmless," as used in the statute, does not bear the "absolute" meaning he is alleged to give it. From this it is said to follow that the Secretary must, in forbidding the use of colors in foods, restrict his prohibition to specific food uses in which the color is shown to be capable of a deleterious effect. We do not draw this inference. Provisions similar to those dealing with the use of coal-tar colors in foods are repeated in the portions of the Act dealing with drugs and with cosmetics. Section 501 (a) (4), 52 Stat. 1049, 21 U.S.C. § 351(a)(4), proscribes the use of uncertified colors in drugs for the purpose of coloring, and refers to § 504, 52 Stat. 1052, 21 U.S.C. § 354, which authorizes the listing and certification of coal-tar colors which are "harmless and suitable for use in drugs." Comparable provisions are found with respect to cosmetics in §§ 601 (e) and 604, 52 Stat. 1054, 1055, 21 U.S.C. §§ 361 (e), 364. It is clear from these provisions that Congress contemplated that a color might be harmless in respect of drugs or cosmetics but not of foods. And the fact that the Secretary has established a further category, distinguishing between colors intended for external and for general use, we do think inconsistent with our interpretation of the Act. These distinctions can be established through tests run on the color substance as such, in the way in which the Secretary has conducted the tests in the matter before us. It is a far cry from saying that the Act permits a generic distinction capable of laboratory proof, between external and internal uses of a color, to say

11 Considerably more of the color was regularly produced before the entry of the Secretary's order than could be accounted for as actually being on the skins of oranges. Neither the Government nor the respondents account for the difference more than speculatively. The Government urges that the difference must have been used in other food products. Respondents emphasize the inevitable waste of quantities of the color during the orange-coloring process. To us this underlines the approach of the provisions in question; where a color is found to be harmless in itself, no further inquiry can be made of it; if it is harmful, none need be.

13 A single dose of 100 milligrams of the color substance (0.0035 oz. avoirdupois, or the weight of a standard aspirin tablet) produced a rapid diarrheic effect in test dogs. 13 One respondent assails the validity, even within the framework of the Secretary's interpretation of the statute, of the tests performed on the experimental animals. The Court of Appeals found that the evidence justified the Secretary's finding that the color was poisonous, 246 F. 2d, at 859, and we are in agreement.

that it commands that the colors cannot be inquired of at all except in the specific contexts of their use in food, drug and cosmetic products.

Second. But even if the Secretary's approach of viewing the harmlessness of coal-tar colors in terms of the colors themselves, rather than in their specific applications, is correct, the respondents insist, as the court below indicated, that the Secretary should establish tolerances for the use of colors in food, even though not found to be "harmless." The respondents point to § 406(a) of the Act which allows the Secretary to establish tolerances for poisonous substances added to food where the substance is "required in the production" of the food or "cannot be avoided by good manufacturing practice." They argue that this provision should be used by the Secretary to establish a maximum tolerance for the application of Red 32 to the skins of oranges, either because it applies by its own terms or it is applicable by analogy." The Secretary contends that he is without power to permit the use of harmful coal-tar colors in specific foods through a system of tolerances. We believe he is correct.

The Federal Food, Drug, and Cosmetic Act is a detailed and thorough piece of legislation. Its treatment of many public health and food problems is quite specific, and of course it is the duty of the courts in construing it to be mindful of its approach in terms of draftsmanship. Here again, in our construction of this explicit Act, we must be sensitive to what Congress has written, and recall that "It is for us to ascertain-neither to add nor to subtract, neither to delete nor to distort." 62 Cases of Jam v. United States, 340 U.S. 593, 596. Section 406 (a), which provides for the system of tolerances, constitutes by its terms a definition of the term "unsafe,” which appears in § 402(a)(2), a prohibition on foods which bear or contain "any added poisonous or added deleterious substance.. which is unsafe within the meaning of section 406." This is a prohibition entirely separate and distinct from the prohibitions of § 402(c) on foods containing or bearing uncertified coal-tar colors. The existence of a tolerance is specifically stated in § 406 (a) only to give sanction to what would otherwise amount to adulteration within the terms of § 402(a) (1). Accordingly, it is obvious from the language of the statute that the provisions authorizing the establishment of tolerances apply only to § 402 (a) (1) and (2) and do not apply to $402(c)'s flat prohibition against the use of uncertified colors. Respondents do not direct us to any substantial contrary indication in the legislative history. Nor can the tolerance provisions be applied to coal-tar colors through some form of analogy. The command of the statute is plain: where a coal-tar color is not harmless, it is not to be certified; if it is not certified, it is not to be used at all. In this regard also, an approach in terms of the toxicity of the coloring ingredient, rather than of the food product as a whole was chosen by Congress. It evidently took the view that unless coal-tar colors were harmless, the considerations of the benefits of visual appeal that might be urged in favor of their use should not prevail, in the light of the considerations of the public health. In the case of other sorts of added poisons, though only where they were required in the production of the food concerned or could not under good manufacturing practice be avoided, a different congressional policy was expressed in the 1938 enactment. It is the duty of the Secretary to give effect to this distinction; he has done so with apparent substantial uniformity and has done so here.

Third. After the promulgation of the Secretary's order, Congress afforded temporary relief to those economically interested in the coloring of oranges with Red 32. Legislation was enacted in the summer of 1956 to afford a period of approximately three years (until March 1, 1959) during which use of the color would be allowed solely in application to the skins of oranges.15 The statute

14 The Court of Appeals' judgment had the effect of staying the Secretary's order in toto as it affected orange coloring until he developed a tolerance. The Secretary argues here that even if he is authorized to establish a tolerance for the use of Red 32 on oranges, his order should stand until he has established it. In the view of the case that we take, we do not reach this contention.

15 The Act of July 9, 1956, c. 530, 70 Stat. 512, added the following proviso to § 402 (c) of the Act:

"Provided further, That this paragraph shall not apply to oranges meeting minimum maturity standards established by or under the laws of the States in which the oranges were grown and not intended for processing (other than oranges designated by the trade as 'packing house elimination'), the skins of which have been colored at any time prior to March 1, 1959, with the coal-tar color certified prior to the enactment of this proviso as FD&C Red 32, or certified after such enactment as External D&C Red 14 in accordance with section 21, Code of Federal Regulations, part 9: And provided further, That the preceding proviso shall have no further effect if prior to March 1, 1959, another coal-tar color suitable for coloring oranges is listed under section 406."

does not, in our view, affect the situation presented to the courts for judicial review; the Secretary's order remains to be tested under the permanent provisions of the Act, insofar as they will affect respondents after March 1, 1959. The statute accordingly operates as a legislatively ordained stay of the Secretary's order insofar as it affects the present respondents and those similarly situated. See H.R. Rep. No. 1982, p. 3, and S. Rep. No. 2391, p. 3, 84th Cong., 2d Sess. In view of the very temporary nature of this legislative "stay," the automatic resumption of the status quo upon its expiration, and the effect of the order on the respondents, even during the legislative stay, we agree with the parties that the matter before us is not moot. The Secretary's order was the promulgation of a general rule, prospective in operation, and the facts of the respondents' business are such that if the order is upheld, there will be a practical effect on them even during the span of the temporary legislation. Accordingly, the respondents remain persons adversely affected by the Secretary's order, and it is proper for us now to determine the legal situation in regard to them when the temporary legislation expires. Under the permanent provisions of §§ 402 and 406 the Secretary's order was lawful, and the respondents present no grounds on which they can legally object to its application_to them. The judgment of the Court of Appeals, setting the Secretary's order aside in part, must be

Reversed.

Thereafter, Frank R. Schell, joined in by all other respondents, filed a petition for rehearing which was denied January 26, 1959 (358 U.S.948).

The final order affirming the Secretary's order was entered in the United States Court of Appeals for the Fifth Circuit on February 19, 1959.

17. Coal-tar colors, FD&C Orange No. 1, FD&C Orange No. 2, and FD&C Red No. 32. The Certified Color Industry Committee, et al. v. The Secretary of Health, Education, and Welfare, Marion B. Folsom. Petition to the United States Circuit Court of Appeals for the Second Circuit for review of an order deleting the above-mentioned colors from the list of colors which were safe for unlimited use in food, drugs, and cosmetics. Decree entered affirming the order.

On February 7, 1956, The Certified Color Industry Committee, Allied Chemical & Dye Corp., American Cyanamid Co., Bates Chemical Co., Inc., Dyestuffs & Chemicals, Inc., H. Kohnstamm & Co., Inc., Wm. J. Stange Co., Sterwin Chemicals, Inc., and Warner-Jenkinson Manufacturing Co. filed a petition with the United States Court of Appeals for the Second Circuit for review of an order dated November 10, 1955, and published in the Federal Register, November 16, 1955, promulgated by the Secretary deleting the three coal-tar colors, FD&C Orange No. 1, FD&C Orange No. 2, and FD&C Red No. 32 from the list of colors which may be certified as harmless and suitable for use in food, drugs, and cosmetics.

The case was argued on May 14, 1956, and the court handed down the following opinions affirming the order, on August 10, 1956:

236 F. 2d 866

MURPHY, District Judge. These are petitions to review an order of the Secretary of Health, Education and Welfare delisting certain coal-tar colors (FD&C Orange No. 1, Orange No. 2 and Red No. 32) manufactured by petitioners. Prior to this order the dyes in question had been certified since 1939 as "harmless" and placed on the approved list for unrestricted use in foods, drugs and cosmetics. Prompted by hearings before a Select Committee of Congress to Investigate the Use of Chemicals in Food concerning the toxicity and possible carcinogenicity of coal-tar colors, respondent conducted extensive experimental research with laboratory animals which conclusively showed that the colors in question produced

substantial deleterious effects and sometimes death. This information and experimental data was given to petitioners sufficiently in advance of the hearing to permit them to offer contradictory evidence. After the hearing on notice, at which petitioners offered no opposing scientific data, the Secretary found the dyes to be "not harmless and suitable for use in coloring food or for use in coloring drugs or cosmetics intended for other than external application," and ordered that they be deleted from the listing.

Peti

This order was made November 10, 1955, effective February 10, 1956. tioners filed the instant Petition to Review on February 7, 1956, three days before their time would have expired. On January 27, 1956, only twelve days before, they made a motion before the Secretary to reopen the hearings to receive evidence of the maximum extent to which these colors are used in foods (but not of drugs or cosmetics) under normal conditions of use, which were represented to be far less than the levels of administration causing damage to the test animals. This motion was denied on February 20, 1956, on a number of grounds, viz., (1) as to the color Red 32 (a) because no safe levels were found for animals and (b) this color recently caused 196 persons (adults and children) to become acutely ill after eating popcorn with this color added; (2) man appears to be much more susceptible to color dyes than test animals; (3) the proposed proof was inaccurate and incomplete and did not take into account all uses; (4) the statute did not permit tolerances for toxic colors; (5) although the tests proved the colors toxic they did not establish the extent of toxicity to a certainty so as to permit the establishment of safe tolerances, and (6) the Secretary had no authority to establish tolerances with regard to colors.

Petitioners suggest that the basic question for review is whether the statutory language "harmless and suitable for use" (Federal Food, Drug, and Cosmetic Act, § 406(b), 21 U.S.C. 346 (b)) is to be interpreted in an absolute sense or in a relative sense meaning “incapable of producing harm under normal conditions of use." Subsidiary to this, they say, is the question whether the Secretary is authorized to impose limitations or tolerances under which colors may continue to be certified. It is their position that the legislative intent can be found in the prior construction by respondent's predecessors which Congress was aware of since it knew that coal-tar colors were toxic and must have realized that their authorized use would have to have some relation to the quantities used. All of this follows, it is argued, since many substances, e.g., salt and vinegar, are concededly not harmless in an absolute sense. The second string to their bow is the argument that the Secretary should authorize limitations or tolerances for these colors for normal use the same as the Secretary does with regard to poisonous or deleterious substances added to food but which are necessary or unavoidable in good manufacturing practice. (Federal Food, Drug, and Cosmetic Act, § 406 (a), 21 U.S.C. 346 (a).)

We turn to the legislative history of the act in an effort to resolve the question whether "harmless" should be construed in a relative or absolute sense. The 1906 Act provided that food should be deemed adulterated "if it contain[s] any added poisonous or other added deleterious ingredient which may render such article injurious to health." (Food and Drugs Act of 1906, § 7, 34 Stat. 769.) Although no specific provisions were then enacted dealing with coal-tar colors, the Food and Drug Administration early recognized the necessity of special treatment for these dyes. Without express statutory authority it issued regulations to the effect that only harmless colors might be used and proceeded to certify for use only those coal-tar dyes which satisfied its specifications. This practice continued until the act was amended in 1938. Under the amended statutory scheme a food is deemed adulterated. "If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health ***" (Federal Food, Drug, and Cosmetic Act, § 402(a), 21 U.S.C. 342 (a).) Section 402 (c) (21 U.S.C. 342(c)) was added to deal specifically with the problem of coal-tar colors. It provides flatly that a food shall be deemed adulterated if it contains a coal-tar color other than one from a batch certified under § 406 (b) (21 U.S.C. 346(b). This latter section authorizes the Secretary to "promulgate regulations for the listing of coal-tar colors which are harmless and suitable for use in food, and for the certification of batches of such colors * * *" Section 406 (a) (21 U.S.C. 346 (a)) gives the Secretary permission to set up tolerances for added poisonous

or deleterious substances which are required or cannot be avoided by good manufacturing practice. At least to the extent that the amendment authorized the certification of coal-tar colors, it codified the administrative practice of the past 30 years.1

Petitioners argue that the 1938 amendment, insofar as these sections are concerned, amounts to nothing more than legislative recognition of existing practice and procedure; that the word "harmless" must be equated to "added poisonous or other added deleterious ingredient which may render such article injurious to health," and that these words must be given the meaning assigned to them in Wood Mfg. Co. v. United States, 286 Fed. 84 (7th Cir. 1923). The Wood case adopted a standard of relativity and held that an infinitesimal quantity of arsenic in a coal-tar color was not a poisonous or deleterious substance, injurious to health, as ordinarily used, and that the Government was required to prove that the substance was in fact injurious as used. Respondent, on the other hand, urges that the use of a different word-"harmless"-instead of the more familiar statutory language is evidence of Congressional intent to provide an absolute standard. We are unable to agree with either of these interpretations. However, we do agree that the word "harmless" as used in § 406(b) must have some relation back to § 402 (a). But the provisions of that section, as amended, are substantially different from those of its predecessor—§ 7 of the 1906 Act. The new provision treats deleterious substances separately depending upon whether they are added to or are an integral part of the food. Thus, if the deleterious substance is inherent in the food there nevertheless is no adulteration if the quantity of the substance used does not ordinarily render it injurious to health. But if the complained of ingredient is an added one, then the food is adulterated if the substance may render it injurious to health. This, so far as added substances are concerned, would seem to indicate legislative discontent with the Wood case, and a return to the principles enunciated by the Supreme Court in United States v. Lexington Mill & Elevator Company, 232 U.S. 399 (1914), wherein it was said:

"It is not required that the article of food containing added poisonous or other added deleterious ingredients must affect the public health, and it is not incumbent upon the Government in order to make out a case to establish that fact. The act has placed upon the Government the burden of establishing *** that the added poisonous or deleterious substances must be such as may render such article injurious to health. The word 'may' is here used in its ordinary and usual signification, there being nothing to show the intention of Congress to affix to it any other meaning. It is, says Webster, 'an auxiliary verb, qualifying the meaning of another verb by expressing ability *** contingency or liability, or possibility or probability.' In thus describing the offense Congress doubtless took into consideration that flour may be used in many ways, in bread, cake, gravy, broth, etc. It may be consumed, when prepared as a food, by the strong and the weak, the young and the old, the well and the sick; and it is intended that if any flour, because of any added poisonous or deleterious ingredient, may possibly injure the health of any of these, it shall come within the ban of the statute. If it cannot by any possibility, when the facts are reasonably considered, injure the health of any consumer, such flour, though having a small addition of poisonous or deleterious ingredients, may not be condemned under this act" (at p. 411).

By restricting the ordinary usage test to nonadded substances, the inference is inescapable that Congress meant to similarly restrict the Wood case and to

1 Parenthetically it may be noted that on July 9, 1956, the President signed into law a bill further amending § 402 by the addition of a provision permitting the use of Red 32 on the skins of oranges not intended for processing, such permission to last only until March 1, 1959 or until another suitable color is listed under $406, whichever is sooner. Pub. L. No. 672, 84th Cong., 2d Sess., Chapt. 530 (July 9, 1956). What is significant, however, is the vast difference between the bill as proposed and the bill as passed. The former provided for the promulgation of regulations respecting the listing of coal-tar colors for use on orange skins "which are safe in the manner in which used and suitable for such use.' The Secretary objected to this but did not oppose the bill in its final form. Hearings Before the Subcommittee on Health and Science of the House Committee on Interstate and Foreign Commerce, 84th Cong., 2d Sess., at 1-3 (1956).